Chrono Therapeutics Receives Investment from Rock Health to Advance SmartStopTM Smoking Cessation Technology

HAYWARD, California -- Chrono Therapeutics, a pioneer in digital drug products, today announced an investment by Rock Health, the leading seed fund in digital health, to support the advancement of Chrono's SmartStop™ programmable transdermal drug delivery system and real-time behavioral support program for smoking cessation.

Smoking kills more than 500,000 Americans each year, and is responsible for approximately one in five deaths in the United States. Of the 45 million smokers in the US, 70 percent report that they want to quit, according to the Centers for Disease Control, while 23 million try to quit each year. The average smoker will attempt to quit eight to ten times. Nicotine replacement therapy (NRT) is one method used to help smokers quit, but conventional NRT does not match craving cycles, leading to six-month efficacy of less than 20 percent.

SmartStop is a wearable device that offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time behavioral support. Research shows that smokers have clear, consistent and predictable daily peak nicotine craving patterns. SmartStop is designed to automatically vary nicotine levels throughout the day to match those patterns. The device uses Bluetooth technology to wirelessly communicate with the SmartStop behavioral support mobile app, providing real-time guidance to help smokers cope with cravings as well as a means for promoting compliance to the NRT and overall quit process.

"Chrono Therapeutics is a leading digital health company developing a truly innovative approach to solve one of the world's most significant public health challenges–the global epidemic of smoking," said Malay Gandhi, Managing Director of Rock Health. "Chrono's SmartStop drug delivery system represents the type of next-generation product technology that Rock Health is seeking to identify and advance in order to significantly impact the future of healthcare. By adopting digital technology to deliver and target treatment along with guided coaching, SmartStop is designed to help smokers quit their addictive, life-threatening habit with a reliable, convenient and effective wearable device."

Rock Health will join Chrono's current investor syndicate, which includes Canaan Partners, 5AM Ventures, Fountain Healthcare Partners, Mayo Clinic and GE Ventures, all of whom participated in the Company's $32 million Series A financing announced in June of 2014.

"Chrono Therapeutics is developing a unique delivery method for nicotine replacement therapy with an automated wearable device integrated with real-time coaching support to help smokers effectively quit," said Alan Levy, Ph.D., CEO of Chrono. "Rock Health's mission is directly aligned with our vision of transforming disease and addiction management through digital health technology, and we're thrilled to have them onboard as an investor."

About Rock Health

Rock Health funds and supports startups building the next generation of technologies transforming healthcare. Find out more at www.rockhealth.com.

About Chrono Therapeutics

Chrono Therapeutics is a pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery that offers real-time behavioral support. Chrono's executive leadership combines years of professional experience and personal passions for developing life-saving medical products. For more information, visit www.chronothera.com.

Opsona Therapeutics Ltd. commences Part B of phase II study of Blocking Toll-Like Receptor 2 in Extended Criteria Donor renal transplant recipients at high risk of Early Graft Dysfunction

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune inflammatory diseases and oncology, today announced the continuation of its double-blind renal transplant study by the initiation of Part B of its adaptive phase II clinical trial in Extended Criteria Donors (ECD) renal transplant recipients at high risk of early graft dysfunction with its lead drug candidate OPN-305.

Based on the completion of Part A of this double blind study, OPN-305 was well tolerated and deemed to be safe by the data and safety monitoring board across all dose groups with no evidence of increased risk of infection in these highly immuno-suppressed patients.

The company is proceeding with Part B in a modified patient population evaluating ECD-only recipients. ECD kidneys make up the largest pool of the cadaveric donor population. Currently up to 45% of ECD kidneys are discarded resulting in a significant deficit in supply versus demand. OPN-305 has the opportunity to turn borderline non-transplantable organs into viable kidneys and functioning grafts resulting in fewer ECD discards, driving an overall increase in the number of deceased donor transplants.

Commenting on today’s announcement, Mary Reilly VP Pharmaceutical Development & Operations said: “We are excited about the initiation of Part B and hope that we can demonstrate an effect of TLR2 blockade on reducing early graft dysfunction in this patient population which is a significant unmet medical need.

Opsona remains committed to further development of OPN-305 and believe that OPN-305 has the potential to be first and best-in-class while also providing a novel treatment option for a wide variety of autoimmune, inflammatory and oncology diseases.”

For further information please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: MReilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

• GenenFund (www.gene.com)

• Inventages Venture Capital (www.inventages.com)

• Novartis Venture Fund (www.nvfund.com)

• Omnes Capital (www.omnescapital.com)

• Roche Venture Fund (www.venturefund.roche.com)

• Seroba Kernel Life Sciences (www.seroba-kernel.com)

• Sunstone Capital (www.sunstone.eu)

Opsona Therapeutics Ltd. Patent issued in USA covering an antibody directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, today announced that the US Patent Office has issued US Patent 8,623,353, which covers an antibody directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof.

TLR-2 plays an important role in the induction and progression of a number of non-pathogen associated inflammatory conditions including ischaemia reperfusion injury (delayed graft function in renal transplantation, myocardial infarct), certain cancer, autoimmune diseases, diabetes, Alzheimer's disease and atherosclerosis.

TLR-2 is one of the key structures of the innate immune system and is part of the first line defense against microbial organisms. Upon stimulation it induces and propagates inflammation. TLR-2 is activated through so called external danger signals (microbial cell wall components) as well as through so called internal danger signals resulting from tissue injury.

This patent describes a cross-reactive antibody which specifically blocks mammalian TLR-2 and further provides for a pharmaceutical composition for the treatment of various inflammatory conditions. The recently issued patent is assigned to the Technische Universitat Munchen (TUM) and Amgen Inc., and is exclusively licensed by Opsona Therapeutics.

Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "The issuance of this patent is an important milestone in the development of Opsona's TLR2 intellectual property portfolio and will facilitate market exclusivity for the use of OPN-305 in the ever expanding area of TLR2 mediated diseases."

Using the TUM/Amgen license, Opsona has developed a clinical anti-TLR-2 antibody candidate, termed ‘OPN-305'. OPN-305 is a humanised IgG4 monoclonal antibody (mAb) antagonizing TLR-2 and is under development as a treatment for the prevention of Early Graft Dysfunction following renal transplantation and Myelodysplastic Syndromes (MDS), in addition to other therapeutic indications.

A three-part multi-center, double blinded and placebo controlled Phase II clinical study to evaluate the safety, tolerability and efficacy of OPN-305 in renal transplant patients at high risk of Early Graft Dysfunction as the first clinical target indication for the development of OPN-305 was initiated in April 2013 and is currently ongoing.

An open label Phase I/II study to assess the safety and efficacy of cycles of intravenously infused doses of OPN-305 in second-line lower (low and intermediate-1) risk MDS, a form of blood cancer, as the second clinical target indication for OPN-305 was initiated in January 2015.

For further information please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: MReilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

Opsona Therapeutics Ltd. initiates Phase I/II study in a First-in Class Monoclonal Antibody that blocks Toll-Like Receptor 2

Opsona Therapeutics Ltd. initiates a prospective open label Phase I/II study in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) with OPN-305, a First-in Class Monoclonal Antibody that blocks Toll-Like Receptor 2

Dublin – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, announces that it has initiated a phase I/II clinical trial in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) patients with its lead drug candidate, OPN-305.

The lead principal investigator Professor Guillermo Garcia-Manero, who was closely involved in the preliminary work on the potential benefit of TLR2 antagonism in MDS, will conduct the trial at MD Anderson Cancer Center, Houston, USA, one of the premier cancer centres in the world.

Myelodysplastic syndromes (MDS) are a complex group of bone marrow failure disorders characterized by ineffective hematopoiesis, and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and which have fewer adverse effects.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against the Toll-Like Receptor 2 (TLR2), a target within the innate immune system. Evaluation of OPN-305 in MDS will be the first of a range of oncology indications that the company plans to explore and this will be the first multiple dosing trial with OPN-305 in patients.

OPN-305 is also under development in a large multi-center phase II clinical trial as a treatment in the prevention of delayed graft function (DGF) following renal transplantation. OPN-305 has orphan status in the EU and USA for solid organ transplantation.

Opsona believes that OPN-305 has the potential to provide novel treatment options for a wide variety of autoimmune, inflammatory and oncology diseases.

Professor Guillermo Garcia Manero commented: “Data from our laboratory has indicated that TLR2 is commonly overexpressed in MDS and that alterations in innate immune signalling are a potential therapeutic target in MDS. We are very excited about using OPN-305 in patients with MDS.”

Commenting on today’s announcement, Mary Reilly, VP Pharmaceutical Development and Operations of Opsona Therapeutics said: “We are privileged to be working with world class leaders from MD Anderson, one of the premier cancer center‘s in the world. We are continuing to develop and explore the potential of OPN-305 in bringing a much needed novel therapy option to MDS patients”

For further information please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com

For media enquiries, please contact:

Jim Devlin or Aoife Kelly at FTI Consulting, t. 01 6633600; e. jim.devlin@fticonsulting.com or aoife.kelly@fticonsulting.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

• GenenFund (www.gene.com)

• Inventages Venture Capital (www.inventages.com)

• Novartis Venture Fund (www.venturefund.novartis.com)

• Omnes Capital (www.omnescapital.com)

• Roche Venture Fund (www.venturefund.roche.com)

• Seroba Kernel Life Sciences (www.seroba-kernel.com)

• Sunstone Capital (www.sunstone.eu)

Mainstay Medical Applies to Start US Clinical Trial of ReActiv8®

Dublin – Ireland – Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) has submitted an application to the United States Food and Drug Administration (FDA) to begin a clinical trial of ReActiv8® under an Investigational Device Exemption (IDE). ReActiv8 is an innovative implantable neurostimulation device designed to treat people with disabling Chronic Low Back Pain (CLBP) for whom conventional therapy has not been successful and for whom surgery is not indicated. The goal of ReActiv8 is to reduce pain and disability by addressing the root cause of CLBP in many people by helping to restore control to the muscles that dynamically stabilise the lumbar spine.

The clinical trial protocol submitted to the FDA as part of the IDE submission is for an international, multi-centre, prospective randomized controlled trial designed to show safety and efficacy of ReActiv8. The IDE submission includes details of the extensive preclinical and clinical testing conducted on ReActiv8. Upon successful completion of the trial and if the results support it, the Company plans to submit an application for a Pre-Market Approval (PMA) which is the final step to allow start of commercialization in the United States.

"The submission of the IDE application to start a US clinical trial of ReActiv8 marks a significant milestone in our journey to bring ReActiv8 to the US market," said Peter Crosby, the CEO of Mainstay Medical. "As with all IDE applications, we anticipate that there may be one or more rounds of review by the FDA as we work together to develop a clinical trial that meets the needs of the Company, the FDA, and the millions of people who could potentially benefit from ReActiv8."

Currently, ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world. The ReActiv8-A Trial is ongoing in Europe and Australia to gather data to support an application for a CE Mark which, if granted, would allow start of commercialization in Europe.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the lower back, and a dynamically unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People disabled by CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

Further information can be found at www.mainstay-medical.com

Fountain Healthcare Partners Launches Second Fund

Initial Fund Close of €85 million

Dublin, Ireland and New York, USA – Fountain Healthcare Partners (“Fountain”) today announces the initial closing of its second fund, Fountain Healthcare Partners Fund II, L.P. with €85 million of committed capital.

The fund is a dedicated life science venture capital (“VC”) fund and brings Fountain’s total capital under management to €158 million. Within the life science sector, Fund II will primarily focus on specialty pharmaceuticals, biotechnology, medical devices and diagnostics.

Fountain will invest over 75% of its capital in Europe with the balance in the US market. Having exceeded its initial close target, Fountain is now seeking additional investors to close Fund II with a hard cap of €125 million.

Over 90% of the initial €85 million capital raised was sourced from major domestic and international institutional investors, predominantly fund of funds, sovereign funds, pension funds, and a strategic corporate investor.

Fund II is expected to make 10 to 15 investments and has already completed two deals:

• Chrono Therapeutics, developing a novel, digital transdermal drug delivery platform coupled with real-time behavioral support with initial focus on a next generation smoking cessation therapy; and,

• Innocoll, a Phase III clinical stage specialty pharma company developing products for the treatment of post-operative pain, diabetic foot infections and surgical adhesions.

Dr Manus Rogan, co-Founder and Managing Partner at Fountain, commented:

“Fountain’s investment strategy focuses on building a balanced portfolio of companies with complementary risk and return profiles within the life science sector. This strategy has resulted in both strong absolute and relative returns from our first fund. The performance of our first fund is reflected in both the level and quality of new and existing investor participation in Fund II. With €85 million raised we are also pleased to have exceeded our initial close target of €75 million against a widely accepted challenging fundraising backdrop in the venture capital sector.”

Aidan King, co-Founder and Managing Partner at Fountain, added:

“The life science sector has been one of the best performing sectors in the past two years with returns surpassing the major global indices and a record number of IPOs and public offerings. Strong demand for life science investments is a reflection of investor’s belief in the underlying growth dynamics of the sector and the investment return opportunities presented by innovative life science companies.”

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science venture capital fund with offices in Dublin, and New York. Founded in 2008, Fountain is Ireland’s largest dedicated life science venture capital fund with more than €155 million under management.

Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain typically leads or co-leads its investments and has sourced private and public deals from start-ups, corporate spin-outs and turnaround situations. The four principals at Fountain, Manus Rogan, Aidan King, Ena Prosser and Justin Lynch brings to investees over 70 years of collective experience in the pharmaceutical industry, corporate venture capital and VC across multiple investment and market cycles.

For more information please visit: www.fh-partners.com

Contact Information:

Manus Rogan | Managing Partner
Manus.Rogan@fh-partners.com
T: +353 1 5225111

Jonathan Neilan | FTI Consulting
jonathan.neilan@fticonsulting.com
T: +353 1 6633686, M: +353 (0) 86 231 4135

Jennifer Peters | FTI Consulting
jennifer.peters@fticonsulting.com
T: +353 1 6633684, M: +353 (0) 87 178 7021

Innocoll AG Appoints Tony Zook as Chief Executive Officer as Company Progresses Toward Becoming a Fully-Integrated Commercial Company

Michael Myers Appointed as Head of Portfolio Operations to Continue Guiding Late-Stage Clinical Programs

ATHLONE, Ireland - Innocoll AG (Nasdaq:INNL) today announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca, has been appointed chief executive officer effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations. The executive changes were made to better position the company as its pipeline advances to late-stage clinical development and Innocoll prepares to become a fully-integrated specialty pharmaceutical company.

"Having the right people in executive positions has been an important topic during board meetings, especially due to the rapid progress at the company," said Jonathan Symonds, chairman of the Board of Directors. "Michael and his team are to be commended for successfully advancing our pipeline. As we looked forward, the Board and the current management team planned to appoint an experienced senior pharmaceutical executive as CEO to manage the company's evolution to a commercial-stage company. I worked with Tony during his time at AstraZeneca and he is a highly experienced and accomplished pharmaceutical executive with proven ability to manage both commercial and development organizations and successfully develop and launch innovative new medicines. As we were rapidly approaching the point where we will have multiple late stage opportunities in our pipeline, we believed we needed to move quickly with this exciting appointment."

Michael Myers, Head of Portfolio Operations, and former chief executive officer said, "The opportunity to have Tony join Innocoll adds significant depth and experience to our executive team as we advance toward our goal of becoming a fully integrated pharmaceutical company. I look forward to working with Tony, on behalf of the entire company and its shareholders, to reach our business objectives."

Mr. Zook has extensive pharmaceutical executive management, commercialization and marketing experience. He held several executive positions at AstraZeneca including executive vice president of Global Commercial Operations from 2010 to 2013, president and chief executive officer of the North American division from 2007 to 2010 and president of Medimmune from 2008 to 2010. Prior to joining Innocoll, Mr. Zook was chief executive officer and member of the Board of Directors of Vivus, Inc. in 2013. He has served or continues to serve on several boards including the boards of AltheRx, Inhibikase, Rib-X Pharmaceuticals, the National Pharmaceutical Council, PhRMA, the Pennsylvania Division of the American Cancer Society and his alma mater, Frostburg State University. Mr. Zook earned a B.S. degree fromFrostburg State University and an A.A. degree in chemical engineering from Pennsylvania State University.

"I am excited to be joining the Innocoll team at this time in the company's development," said Mr. Zook. "Our late-clinical stage pipeline, which includes XaraColl, Cogenzia and CollaGUARD, is particularly promising as each candidate addresses patient needs in large global markets that are underserved today. I look forward to working with the Innocoll team to move our clinical candidates forward with the goal of bringing these important products to patients and their physicians in the near future."

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals.

CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Sagentia selected as lead development partner for Chrono Therapeutics’ wearable ‘smart’ smoking cessation device

Sagentia, a global science, product and technology development company, announced today that it is working with Chrono Therapeutics on the development of SmartStop™, the world’s first programmable and wearable nicotine delivery device to help people quit smoking.

Chrono Therapeutics is a California-based pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery (TDD) that offers real-time behavioral support. This past summer, Chrono secured $34M in Series A financing to complete product development and clinical studies for its flagship product SmartStop™, a new and revolutionary wearable device, which offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time digital behavioral support that promotes compliance.

To date, many products on the market which aim to help people stop smoking exhibit low rates of success. For example, standard nicotine patches deliver a steady stream of nicotine throughout the day, while nicotine gum delivers spikes of nicotine, but often the doses are too low or compliance is poor resulting in relatively low efficacy in helping smokers to quit.

SmartStop™ offers a novel solution. It is designed to be worn 24 hours a day and to automatically coincide the dose of nicotine that it delivers with the cigarette craving patterns that have been identified in smokers. The device then uses Bluetooth technology to wirelessly communicate with the SmartStop™ digital support program, providing real-time guidance to help smokers cope with cravings and quit for good.

Sagentia was selected as the lead development partner to help Chrono Therapeutics bring the technology to market. Sagentia’s involvement began with concept generation and early feasibility testing to ensure that the product is small enough to wear comfortably and can be manufactured at the right price point. The Sagentia team is now continuing through the full design, miniaturization and development of the electromechanical microfluidic system, including the durable control unit and the nicotine pump delivery system. Key requirements are that the device be low cost and have a small and light design that is attractive to consumers.

Alan Levy, Ph.D., CEO of Chrono Therapeutics, comments: “Smoking costs people their health and eventually their lives, but current technologies like nicotine gums and patches are not effective in enabling smokers to quit permanently because they do not address the cyclical nature of nicotine cravings and offer little to no behavioral support. We believe we have a very compelling technology that will solve many of the problems that make smoking cessation so difficult and working with Sagentia as a product development partner is allowing us to get this to market faster.”

Dr. Gregory Berman, Head of Drug Delivery at Sagentia, adds: “The SmartStop™ technology has the potential to revolutionize the smoking cessation market and make a big difference to peoples’ lives. The compliance aspect of this device is particularly exciting, providing patients with feedback, support and encouragement on their progress.”

About Sagentia

Sagentia is a global science, product and technology development company. Our scientists and engineers redefine what’s possible and help R&D groups achieve commercial return from their most complex technology projects. We have over 27 years’ experience and have successfully completed over 10,000 projects for start-up and global market leader clients alike, across the medical, industrial, oil & gas and consumer sectors.

Our services span the full product development lifecycle, from new concept generation and technology validation, through prototyping and full product development, to transfer to manufacture and sustainability. Sagentia employs over 150 scientists, engineers and market experts and is part of the Sagentia Group, with headquarters in Cambridge, UK and offices in London, Guildford, Boston, Houston and Dubai.

For further information visit us at: www.sagentia.com or email info@sagentia.com

About Chrono Therapeutics

Chrono Therapeutics (CHRONO) is a pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery (TDD) that offers real-time behavioral support. Chrono’s executive leadership combines years of professional experience and personal passions for developing life-saving medical products. Steeped with years of experience in product development, science, R&D an understanding of the consumer smoking cessation market, FDA approval experience and bringing life-saving products to market, the team represents a wide-array of knowledge that combined can help address the serious epidemic of smoking.

Background information

Smoking is highly addictive and remains one of the world’s great killers. The World Health Organization estimates that the global death toll is 6 million per year and this is expected to rise to 7 million by 2020. For every death caused by smoking, approximately 20 smokers are suffering from a smoking related disease.

Mainstay Medical Achieves Quality System Certification

Certification is an important step towards the commercialisation of ReActiv8

Dublin, Ireland – Mainstay Medical International plc (“Mainstay” or the “Company”) announces that its Quality Management System has been evaluated and found to be in compliance with the international quality standards ISO 13485:2003 and EN ISO 13485:2012. These international standards provide an accepted international framework for meeting medical device quality standards and compliance certification is an important step towards CE Mark and the commercialisation of ReActiv8. This certification granted by the Company’s Notified Body, BSI Group-Medical Devices, covers the operational activities for developing and bringing to market implantable stimulation systems in the area of pain management.

Mainstay is focused on the development and commercialisation of ReActiv8, an innovative implantable neurostimulation device designed to treat people with Chronic Low Back Pain (CLBP) by helping to restore control to the muscles that stabilise the lumbar spine.

Mr. Peter Crosby, Mainstay’s Chief Executive Officer, noted “We are delighted that all the hard work of the Mainstay team was recognized with the ISO 13485 certification after passing the audits of our Quality Management System at all our facilities in Ireland, Australia and USA without any major observations. This is a testament to the quality and experience of the individuals in the team that made this happen, and an important step towards the commercialization of ReActiv8.”

The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures. In the “full quality assurance” conformity route the Company has chosen, the EU Active Implantable Medical Device Directive requires an evaluation of the Company’s Quality Management System as a prerequisite to obtaining CE Mark. By achieving ISO 13485 certification, Mainstay has met this requirement.

Clinical trials with ReActiv8 are ongoing in Europe and Australia, and several sites continue to enrol subjects. The purpose of the clinical trial is to investigate ReActiv8 as a treatment for adults with CLBP who have few other treatment options.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.  The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spinal surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

Further information can be found at www.mainstay-medical.com

Innocoll AG Announces Third Quarter 2014 Financial and Operating Results

ATHLONE, Ireland -- Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced financial and operating results for the three months and nine months ending September 30, 2014.

"This is our first quarterly report as a public company," said Michael Myers, Ph.D., Chairperson of the Management Board and Chief Executive Officer of Innocoll. "The successful completion of our IPO in July has provided us with funds that have enabled us to advance our clinical development programs for our key pipeline products, XaraColl® for the treatment of post-operative pain, Cogenzia® for the adjuvant treatment of diabetic foot infections, and CollaGUARD®, our collagen membrane barrier for the prevention of post-surgical adhesions. We have significant momentum now and look forward to keeping you updated on the progress of our clinical development programs over the coming quarters."

Summary of Year-to-Date 2014 Highlights

Financial Highlights

• Innocoll received net proceeds of approximately $52.7 million, net of underwriting discounts and commissions and offering expenses, from the issuance and sale of approximately 6.7 million American Depository Shares (ADSs) in its initial public offering, including shares issued upon the partial exercise of the underwriters' over-allotment option.
• On July 25, 2014, Innocoll's ADSs began trading on the NASDAQ Global Market under the symbol "INNL".
• Year to date product sales revenue of €3.7 million was up by 38% compared to the corresponding period last year.
• As of September 30, 2014 cash and cash equivalents were €47.3 million ($60.0 million).

Clinical Highlight

• In July, we initiated a pivotal study comparing the pharmacokinetics and safety of XaraColl our implantable bioresorbable collagen sponge at doses of 200mg and 300mg to a standard bupivacaine solution. Once the data from this study becomes available, which is currently anticipated to be in the first quarter of 2015, we plan to initiate our Phase 3 efficacy program in post-operative pain in the United States.
• On October 27th, we submitted a document to the FDA for Cogenzia for our planned clinical trials in patients with moderate to severe diabetic foot ulcer infections requesting approval for certain improvements to the Phase 3 clinical protocols and for reconfirmation of all of the key understandings that were agreed upon with the FDA in the Special Protocol Assessment (SPA). The agency has informed Innocoll that written feedback to this document will be sent within 30 days of its submission, following which the Phase 3 program for Cogenzia is expected to be initiated.
• We developed a clinical protocol and obtained approval to run a CollaGUARD pilot study in patients undergoing intrauterine adhesiolysis via operative hysteroscopy. This study, which will be conducted in the Netherlands and will commence recruiting patients this month, is being run to generate data that will be used to finalize our pivotal clinical protocol to obtain PMA approval in the U.S. The data will also be used to support commercialization of CollaGUARD in countries where the product is already approved. Innocoll will plan on holding a Pre-IDE meeting with FDA once the pilot study results are available.

Regulatory and Commercial Highlights

• During the quarter, Cogenzia received marketing approval in Canada, Russia, Argentina and Mexico. Cogenzia is now approved in six countries and has also been filed for approval in India and Australia.
• CollaGUARD was approved in Argentina bringing the total number of country approvals to 46 countries in Europe, Asia and emerging markets. The first shipment of product was made to our partner Takeda in preparation for their planned launch of CollaGUARD in Russia. Takeda also filed for approval for CollaGUARD in Ukraine, Belarus, and Kazakhstan this year.
• The RegenePro dental product line was launched in the U.S. by Biomet 3i LLC during the quarter.

Organizational Highlights

• Earlier this year, Innocoll strengthened its supervisory board with the appointment of Jonathan Symonds CBE as Chairman, former CFO of Novartis and AstraZeneca, David Brennan, former CEO of AstraZeneca, Shumeet Banerji, former senior executive at Booz Allen Hamilton and member of the board of directors of Hewlett-Packard, and the pending appointment, subject to shareholder approval, of Joseph Wiley, of Sofinnova Ventures.

Three Month 2014 Financial Results

Net Profit/(Loss) Available to Ordinary Shareholders: Innocoll reported a net profit attributable to ordinary shareholders of €2.0 million, or €1.57 per share ($0.15 per ADS), for the three months ended September 30, 2014, compared to a profit of €13.0 million, or €336.13 per share, for the three months ended September 30, 2013.

Non-GAAP diluted profit excluding stock-based compensation and certain non-cash finance or other income was €0.3 million or €0.20 per share ($0.02 per ADS), for the three months ended September 30, 2014, compared to a loss of €0.8 million, or €1.04 per share, for the three months ended September 30, 2013.

Weighted average shares outstanding increased from 0.04 million during the three months ended September 30, 2013 to 1.25 million during the three months ended September 30, 2014, respectively, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuances in 2014.

Revenues: Revenues were €1.1 million for the three months ended September 30, 2014 as compared to €0.6 million for the three months ended September 30, 2013 an increase of 82%. This increase was primarily due to an increase in sales by Jazz Pharmaceuticals of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, the first shipment of our adhesion barrier CollaGUARD to our partner Takeda in connection with the product's launch in Russia, and Biomet 3i's launch of RegenePro, our product to treat dental wounds in the US.

General and Administrative (G&A) Expenses: G&A expenses were €2.6 million for the three months ended September 30, 2014 as compared to €1.0 million for the three months ended September 30, 2013. G&A expenses in the three months ended September 30, 2014 included €1.2 million in non-cash charges for stock-based compensation compared to €0.0 of such charges in the three months ended September 30, 2013.

Excluding such charges for stock-based compensation, G&A expenses for the three months ended September 30, 2014 were €1.4 million as compared to €1.0 million for the three months ended September 30, 2013. We expect increases in G&A going forward as we build out our infrastructure to support our clinical programs and commercialization.

Research and Development (R&D) Expenses: R&D expenses were €0.9 million for the three months ended September 30, 2014 as compared to €0.2 million for the three months ended September 30, 2013. The increase was primarily due to the commencement of our pharmacokinetics and safety study of XaraColl. Going forward, we expect R&D expenses to increase significantly as we advance our clinical trial programs.

Operating Losses: Operating losses in the three months ended September 30, 2014 and 2013 were €3.6 million and €1.5 million, respectively. Excluding stock-based compensation, adjusted operating losses in the three months ended September 30, 2014 were €2.4 million. The difference between the €2.4 million adjusted operating losses and the €0.3 million non-GAAP diluted profit set out above was primarily due to foreign exchange gains of €2.7 million during the three months ended September 30, 2014.

Finance and Other Income: Finance and other income was €5.6 million for the three months ended September 30, 2014 as compared to €14.5 million for the three months ended September 30, 2013. Finance and other income or expense items were non-cash items arising out of the re-domicile of our parent company to Germany during the third quarter of 2013, and changes in the value of liabilities associated with options issued to pre-IPO investors outstanding during the third quarter of 2014, as well as foreign exchange gains in each quarter.

Although Innocoll options issued to investors are settled in stock and are included in our authorized capital, under IFRS accounting rules, they will continue to be valued on a quarterly basis, which is likely to result in significant non-cash finance expense or income going forward.

Proceeds from Investment, Cash Position: In the second and third quarters of 2014 the company received total net proceeds from the issuance of shares of €52.1 million ($69.9 million), consisting of €12.4 million ($17.2 million) net proceeds of pre-IPO equity issuance and €39.7 million ($52.7 million) net proceeds from the IPO.

As of September 30, 2014, cash, cash equivalents, and short-term investments totalled €47.3 million ($60.0 million), which is expected to be sufficient to fund our clinical programs and operational expenses through the first half of 2016.

Nine Month 2014 Financial Results

Net Profit/(Loss) Available to Ordinary Shareholders: For the nine months ended September 30, 2014 net loss attributable to ordinary shareholders was €16.4 million or €33.36 per share ($3.19 per ADS), compared to a profit of €6.7 million, or €142.70 per share, for the nine months ended September 30, 2013.

Non-GAAP diluted loss excluding stock-based compensation and certain non-cash finance and other income was €7.2 million or €14.70 per share ($1.41 per ADS), for the nine months ended September 30, 2014, compared to a loss of €4.4 million, or €6.00 per share, for the nine months ended September 30, 2013.

Weighted average shares outstanding increased from 0.05 million during the nine months ended September 30, 2013, to 0.49 million during the nine months ended September 30, 2014, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuance in 2014.

Revenues: Revenues for the nine months ended September 30, 2014 were 38% higher at €3.7 million, compared to €2.7 million for nine months ended September 30, 2013. This increase was primarily due to an increase in sales of CollatampG, CollaGUARD and RegenePro as described above.

General and Administrative (G&A) Expenses: G&A expenses were €7.4 million for the nine months ended September 30, 2014 as compared to €2.9 million for the nine months ended September 30, 2013. G&A expenses in the nine months ended September 30, 2014 included €2.8 million in non-cash charges for stock-based compensation, compared to €0.0 of such charges in the corresponding period in 2013.

Excluding such charges for stock-based compensation, G&A expenses were €4.6 million for the nine months ended September 30, 2014 as compared to €2.9 million for the nine months ended September 30, 2013. The increase in G&A was primarily due to accounting, legal and consulting professional fees, insurance costs and investor relations costs related to becoming a public company.

Research and Development (R&D) Expenses: R&D expenses were €2.0 million for the nine months ended September 2014 as compared to €1.2 million for the nine months ended September 30, 2013. The increase was primarily due to the commencement of our pharmacokinetics and safety study of XaraColl.

Operating Losses: Operating losses in the nine months ended September 30, 2014 and 2013 were €9.7 million and €4.4 million respectively. Excluding stock-based compensation, operating losses in the nine months ended September 30, 2014 were €6.9 million.

Finance and Other Income/(Expense): Finance and other income was an expense of €6.6 million for the nine months ended September 30, 2014 as compared to income of €11.2 million for the nine months ended September 30, 2013. Finance and other income or expense items in each period were non-cash items arising out of the re-domicile of our parent company to Germany during the third quarter of 2013, and changes in the value of liabilities associated with options issued to pre-IPO investors outstanding during the second and third quarter of 2014, as well as foreign exchange gains in each period.

For further financial information for the period ending September 30, 2014, please refer to the financial statements appearing at the end of this release. As the financial statements are in euros, all amounts shown in U.S. dollars are for the convenience of the reader only, exchanged at a rate of €1.2687 per euro, the exchange rate as of September 30, 2014.

Conference Call

Innocoll management will host a conference call today at 10 a.m. EST to discuss third quarter 2014 financial results and provide a business update.

To participate in the conference call, please dial 877-407-4018 (domestic) or 201-689-8471 (international) and ask for the "Innocoll third quarter financial results conference call." A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.innocollinc.com

An archived webcast recording and telephone replay will be available on the Innocoll website beginning approximately two hours after the call. To access the telephone replay, please dial 877-870-5176 for domestic callers or 858-384-5517 for international callers and enter the conference code: 13594801. The telephone replay will be available until midnight EST on November 16.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® in Phase 3 development for the treatment of post-operative pain; Cogenzia® in Phase 3 for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD (Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals. All of the Company's products are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany.

For more information, please visit www.innocollinc.com.

CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Mainstay Medical - Interim Management Statement

Continued progress towards commercialisation of ReActiv8®

Dublin – Ireland, 6 November 2014 – Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) is issuing this Interim Management Statement covering the period from 1 July 2014 to today’s date.

Mainstay is an Irish medical device company with operations in Ireland, Australia and the United States. The Company is focused on the development and commercialisation of ReActiv8, an innovative implantable neurostimulation device designed to treat people with Chronic Low Back Pain (CLBP) by helping to restore control to the muscles that stabilise the lumbar spine.

Business Update

We continue to make progress in the ReActiv8-A clinical trial, with subjects being recruited the UK, Belgium, and Australia, (see http://clinicaltrials.gov/show/NCT01985230). The ReActiv8-A clinical trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. The Company currently expects that data from 40 subjects could be sufficient to apply for a CE Mark. We are pleased to report that over 25 subjects have been implanted as part of the ReActiv8-A clinical trial to date.

In July 2014, the Company submitted an information package about ReActiv8 and the proposed US clinical trial to the US Food and Drug Administration (‘FDA’) under an Investigational Device Exemption (‘IDE’). We met with the FDA in September 2014 and obtained feedback and guidance. We currently anticipate making a submission to start the proposed US clinical trial under an IDE to the FDA in the first quarter of 2015.

Financial Update

There have been no significant changes in the financial position of the group since publication of the Half Year Results for the period ended 30 June 2014. Expenditure relating to clinical trial activities, ongoing research and development and general and administrative expenses is in line with expectations. The Company had $21.4 million cash on hand as at 30 September 2014.

Outlook

Mainstay looks forward to continuing progress with the ReActiv8-A clinical trial as it works towards obtaining CE Mark and commencing the commercialisation of ReActiv8.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from CLBP.

People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spinal surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

Further information can be found at www.mainstay-medical.com

Media queries to:

Jonathan Neilan, FTI Consulting, Dublin Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

Jeanne Bariller, FTI Consulting, Paris
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

ESM Advisers:

Fergal Meegan / Barry Murphy, Davy
Tel: +353 1 6796363
Email: fergal.meegan@davy.ie / barry.murphy2@davy.ie

Acorda Therapeutics Completes Acquisition of Civitas Therapeutics

ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced it has completed its acquisition of Civitas Therapeutics and obtained global rights to CVT-301, a Phase 3 treatment candidate for OFF episodes of Parkinson’s disease. The acquisition also included rights to the proprietary ARCUS® pulmonary delivery technology, and a manufacturing facility with commercial-scale capabilities based in Chelsea, MA. Under the terms of the acquisition agreement, Acorda paid $525 million in cash to acquire Civitas.

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that improve the lives of people with neurological disorders.

Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS), as demonstrated by an increase in walking speed. The Company has one of the leading pipelines in the industry of novel neurological therapies. Acorda is currently developing seven clinical-stage therapies and one preclinical stage therapy. This pipeline addresses a range of disorders including chronic post-stroke walking deficits, Parkinson’s disease, epilepsy, neuropathic pain, stroke, peripheral nerve damage, spinal cord injury, and heart failure.

For more information, please visit the Company’s website at: www.acorda.com.

Genable Technologies Ltd Moving GT038 Into Full Development

Dublin - The Genable team recently attended a Pre-IND meeting with the Food and Drug Administration (FDA) in Washington USA, to discuss the development of GT038 for the treatment of Rhodopsin linked autosomal dominant retinitis pigmentosa (Rho-AdRP). It was a very informative meeting during which the FDA provided feedback and advice on the preclinical and clinical development plans for GT038.

Dr Jason Loveridge Genable CEO commented “ Following a very informative and useful meeting with the US medicines regulatory authority, the FDA, we are delighted to confirm that GT038 has now moved from research to development. The FDA’s input taken together with advice from our Medical Advisory Board and most importantly Genable’s close links with patient groups increases the probability that we can progress GT038 into the clinic and subsequently provide benefit for RP patients.

Background Information

Genable Technologies Ltd. is a privately held Irish bio-pharmaceutical company developing new gene medicines to treat autosomal dominant genetic diseases based on the pioneering work of Professor Jane Farrar, Dr Paul Kenna & Professor Peter Humphries at the Smurfit Institute for Genetics in Trinity College Dublin, Ireland. Genable has received significant financial backing to date from venture capital companies including, Fountain Healthcare Partners, Delta Partners and the patient-led research charities, Fighting Blindness Ireland and Foundation Fighting Blindness Clinical Research Institute.

Genable's approach is innovative and unique, utilising well-established, clinically safe & effective AAV vectors to obtain expression of RNA interference (RNAi) molecules, which suppress the expression of both copies of the disease gene, normal and faulty and a replacement gene which is genetically modified and is refractory to suppression but still encodes a normal wild-type protein. The combination of suppression and replacement overcomes the significant hurdle in dominant disease of mutation variability by eliminating the need to target specific mutations and is applicable to a wide range of disorders

Genable's lead product, GT038, is designed for the treatment of patients with rhodopsin linked autosomal dominant retinitis pigmentosa (Rho-adRP), a debilitating, progressive form of inherited blindness resulting from a diverse array of mutations in the RHO gene. Genable's technology is protected by a broad suite of granted patents and patent applications in the USA, EU and worldwide.

This sub-type of adRP affects approximately 1 in 30,000 people and represents an already identified and potentially treatable population of around 30,000 patients in the US and Europe. Genable will employ the same approach to develop other gene medicines for a number of other sub-types of adRP. The company has received Orphan Drug Designation for GT038 in both the EU and US.

Agreements were executed in 2014 with Spark Therapeutics for the supply of GLP & GMP grade GT038 for the completion of preclinical development as well as the clinical trial programme.

For further information please contact jloveridge@genable.net

Neuravi Introduces Collaborative Clot Research Initiative at ESMINT Conference in September

Advancing Stroke Therapy through The Science of Clot

Galway, Ireland — Neuravi, a developer of innovative stroke therapy, announced today that it will introduce the Neuravi Thromboembolic Initiative (NTI) during a series of workshops on “The Science of Clot” at the upcoming European Society of Minimally Invasive Neurological Therapy (ESMINT) conference in Nice. The NTI brings together Neuravi engineers with clinicians and researchers from leading international institutions in an effort to deepen the understanding of the mechanical properties of clot and occlusion dynamics, with the goal of improving the physician’s ability to restore flow in acute ischemic stroke.

The ESMINT conference gathers leaders in minimally invasive neurological therapy from across Europe. “One of the goals of ESMINT is to advance the practice of neuro-intervention through the support of research, education and training,” observed Prof. Laurent Pierot, President ESMINT Congress. “Currently, there is a growing interest in identifying different clots and in understanding how different clot characteristics may impact treatment in acute ischemic stroke. The NTI workshops will help in these efforts.”

The NTI workshops will feature a presentation by Dr. Anastasios Mpotsaris, Uniklinik Köln, as well as interactive hands-on sessions with engineers exploring clot characterization, the dynamics of occlusion formation and clot-device interactions and any potential implications for revascularization. Physicians may sign up to attend the sessions being held September 4-6 by registering via email at clot@neuravi.com.

“The NTI represents Neuravi’s commitment to advance the treatment of stroke by investing and collaborating in research to unravel the science of stroke occlusion,” stated Eamon Brady, CEO of Neuravi. “We are excited to have this opportunity to both share and learn with the neurointerventional community during these interactive workshops.”

Civitas Therapeutics Files Registration Statement for Proposed Initial Public Offering

Chelsea, Mass., - Civitas Therapeutics, Inc., a biopharmaceutical company focused on developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering of its common stock. The number of shares to be offered and the price range for the proposed offering have not been determined.

J.P. Morgan Securities LLC and BofA Merrill Lynch will act as joint book-running managers for the offering. Cowen and Company, LLC and Oppenheimer & Co. Inc. will act as co-managers.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling (866) 803-9204; and from BofA Merrill Lynch, 222 Broadway, New York, NY 10038, Attention: Prospectus Department, or by emailing dg.prospectus_requests@baml.com.

About Civitas Therapeutics

Civitas is a biopharmaceutical company focused on developing and commercializing transformative therapeutics using its proprietary ARCUS™ technology, with an initial focus on treating debilitating OFF episodes in patients with Parkinson’s disease.

Contact:

Stephanie Gillis
Civitas Therapeutics, Inc.
617-660-4121
sgillis@civitastherapeutics.com

Civitas Therapeutics Secures $55 Million in Series C Financing

Proceeds to support Phase 3 clinical trial for CVT-301 Parkinson’s disease program and pipeline expansion

CHELSEA, Mass.– Civitas Therapeutics, Inc., a privately-held biopharmaceutical company developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, today announced the successful completion of a $55 million Series C financing. The financing round included new investors Adage Capital Management, LP, OrbiMed Advisors, Partner Fund Management, LP, Rock Springs Capital, and Sofinnova Ventures, with participation from all existing investors, including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital, RA Capital, and Wellington Management Company, LLP.

“The proceeds from this financing will be used towards the upcoming Phase 3 clinical trials for our lead candidate, CVT-301, an inhaled formulation of levodopa (L-dopa) being developed for rapid and reliable relief from debilitating motor fluctuations, known as OFF episodes, associated with Parkinson’s disease (PD), as well as for additional, early stage pipeline development programs,” said Mark Iwicki, President and Chief Executive Officer of Civitas Therapeutics. Civitas intends to initiate the pivotal Phase 3 clinical trial in early 2015, and expects data to be reported in 2016.

About CVT-301

CVT-301 is being developed as a self-administered, adjunctive, as needed, inhaled L-dopa therapy for OFF episodes, providing rapid delivery of L-dopa to the brain to be used in conjunction with a PD patient’s individually optimized oral L-dopa regimen. CVT-301 leverages Civitas’ proprietary ARCUS™ technology which enables the delivery of a precise dose to the lung to potentially enable rapid and predictable L-dopa absorption through a reusable, pocket-size, breath-actuated inhaler.

CVT-301 clinical studies conducted to date have been funded in part by grants from The Michael J. Fox Foundation for Parkinson’s Research.

About Parkinson’s Disease and OFF Episodes

Over one million people in the US and between seven and ten million people worldwide suffer from PD. PD is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, and is characterized by symptoms including tremors at rest, rigidity and impaired movement. The standard of care for the treatment of PD symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream leading to the unreliable control of symptoms resulting in the emergence of OFF episodes. These OFF episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients today.

About ARCUS™ Technology

Our proprietary ARCUS technology, the basis of CVT-301, allows for the consistent and precise delivery of large quantities of drug per inhalation in a simple, patient-friendly, breath-actuated inhaler. The technology delivers a consistent dose to the lung every time across a wide range of patient inhalation flow rates. The technology has been used to successfully deliver more than one million doses to patients in clinical trials. We have a robust patent portfolio relating to CVT-301 and our ARCUS technology which covers, among other things, important aspects of the formulated drug product, the inhaler, the method of delivery of drug and the manufacturing processes for CVT-301.

About Civitas Therapeutics

Civitas is a biopharmaceutical company focused on developing and commercializing transformative therapeutics using its proprietary ARCUS™ technology, with an initial focus on treating OFF episodes in patients with Parkinson’s disease. Civitas is financed by leading investors including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital, RA Capital, Wellington Management Company, LLP, Adage Capital Management, LP, OrbiMed Advisors, Partner Fund Management, LP, Rock Springs Capital, and Sofinnova Ventures.

For additional information contact:

Stephanie Gillis
Civitas Therapeutics
617-660-4121
sgillis@civitastherapeutics.com

Innocoll AG Announces Closing of Initial Public Offering

ATHLONE, Ireland, - Innocoll AG (Nasdaq:INNL) (the "Company"), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced the closing of its public offering of 6,500,000 American Depositary Shares ("ADSs"), each representing 1/13.25 ordinary shares, at a public offering price of $9.00 per ADS. As part of the public offering, Sofinnova Venture Partners VIII, L.P., or Sofinnova, purchased an aggregate of 1,666,667 ADSs at the public offering price. Sofinnova will have a right to nominate one member to the Company's supervisory board. All of the ADSs were offered by the Company. The Company's ADSs are listed on The NASDAQ Global Market under the symbol "INNL." In addition, the Company has granted the underwriters an option until August 23, 2014 to purchase up to an additional 975,000 ADSs at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any.

The Company received total net proceeds from the public offering of approximately $51.5 million after deducting underwriting discounts and commissions and offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for the following purposes: (i) developing XaraColl, Cogenzia and CollaGUARD, (ii) expanding its manufacturing infrastructure, and (iii) general corporate purposes.

Piper Jaffray & Co. and Stifel acted as joint book-running managers for the public offering. JMP Securities acted as lead manager for the public offering. The offering of these securities was made only by means of a prospectus, copies of which can be obtained from: Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at prospectus@pjc.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, or by telephone at (415) 364-2720 or by email at syndicateops@stifel.com.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on July 24, 2014. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the offered securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals. All of the Company's products are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Denise Carter
Executive Vice President Business Development
and Corporate Affairs
T: (215) 765-0149

Lisa Wilson
In-Site Communications, Inc.
Investor Relations
T: (212) 452-2793

Mainstay Medical Announces Pre-IDE Submission for ReActiv8® to FDA

Mainstay Medical continues progress towards the commercialisation of ReActiv8.

Dublin, Ireland – Mainstay Medical International plc (Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces that it has submitted a Pre-Investigational Device Exemption (‘IDE’) information package to the US Food and Drug Administration (‘FDA’ or the ‘Agency’) for ReActiv8, its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain.

Under the Pre-IDE Submission Program of the FDA, Mainstay can request feedback from the Agency on its planned ReActiv8 IDE submission. The FDA states that “Receiving and incorporating FDA feedback on various elements of a future IDE submission, such as the proposed study design or statistical analysis plan, can facilitate the IDE review process and reduce the number of review cycles needed to reach full IDE approval.” 1

Mr. Peter Crosby, Mainstay’s Chief Executive Officer, noted “The pre-IDE submission to the FDA is a significant step on the path to regulatory approval and commercialization of ReActiv8. We will consider the FDA’s feedback in our planned IDE submission. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from Chronic Low Back Pain.”

Clinical trials with ReActiv8 are ongoing in Europe and Australia, and several sites have been actively enrolling subjects since March 2014. The purpose of the trial is to investigate ReActiv8 as a treatment for adults with debilitating Chronic Low Back Pain who have few other treatment options.

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About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating Chronic Low Back Pain (CLBP). Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from CLBP.

People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spinal surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

1 Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff. Guidance for Industry and Food and Drug Administration Staff. Document issued on: February 18, 2014.

Further information can be found at www.mainstay-medical.com

Media queries to:

Jonathan Neilan, FTI Consulting Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

Paul McSharry, FTI Consulting
Tel: +353 1 663 3609 / +353 87 240 6642
Email: paul.mcsharry@fticonsutling.com

Jeanne Bariller, FTI Consulting
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

ESM Advisers:

Fergal Meegan / Barry Murphy, Davy
Tel: +353 1 6796363
Email: fergal.meegan@davy.ie / barry.murphy2@davy.ie

Mainstay Medical Announces Expansion of Clinical Trial of ReActiv8® for People with Chronic Low Back Pain to Belgium

Dublin, Ireland, – Mainstay Medical International plc (Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces that it has received authorization from the Belgian Federal Agency for Medicines and Health Products to expand the clinical trial of ReActiv8 (ReActiv8-A), its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain, to include clinical trial sites in Belgium. Enrolment of subjects is commencing in these additional sites. The added sites also participated in the European Feasibility Study, results of which were presented in mid-2013.

Mr. Peter Crosby, Mainstay’s Chief Executive Officer, noted “We continue to make progress, in line with our plan, on the path to regulatory approval and commercialization of ReActiv8. We are pleased to now add Belgium to our clinical trial which follows the commencement of our trial in Australia in March. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from Chronic Low Back Pain.”

The ReActiv8-A clinical trial started in Australia, and several sites have been actively enrolling subjects since March 2014. The purpose of the trial is to investigate ReActiv8 as a treatment for adults with debilitating Chronic Low Back Pain who have few other treatment options.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating Chronic Low Back Pain (CLBP). Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from CLBP.

People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spinal surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

Further information can be found at www.mainstay-medical.com

Media queries to:

Jonathan Neilan, FTI Consulting Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

Paul McSharry, FTI Consulting
Tel: +353 1 663 3609 / +353 87 240 6642
Email: paul.mcsharry@fticonsutling.com

Jeanne Bariller, FTI Consulting
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

ESM Advisers:

Fergal Meegan / Barry Murphy, Davy
Tel: +353 1 6796363
Email: fergal.meegan@davy.ie / barry.murphy2@davy.ie

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should” or “will”, or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Chrono Therapeutics, Inventor of Wearable “Smart” Smoking Cessation Technology, Secures $32 Million in Series A Financing

Syndicate includes Canaan Partners, 5AM Ventures, Fountain Healthcare Partners, Mayo Clinic and GE Ventures

HAYWARD, Calif – Chrono Therapeutics , a pioneer in digital drug products, announced today the close of a $32 million Series A financing round, led by Canaan Partners and5AM Ventures . Additional participants in the financing were Fountain Healthcare Partners , Mayo Clinic andGE Ventures . The funds will be used to complete product development and clinical studies for the company’s SmartStop™ programmable transdermal drug delivery system and real-time behavioral support program for smoking cessation. As part of the financing, Wende Hutton, general partner with Canaan Partners, Jim Young of 5AM Ventures and Aidan King of Fountain will join Chrono’s board of directors.

“Smoking costs people their health and eventually their lives, but current technologies like nicotine gums and patches are not effective in enabling smokers to quit permanently because they do not address the cyclical nature of nicotine cravings and offer little to no behavioral support,” said Alan Levy, Ph.D., CEO of Chrono. “We believe we have a very compelling technology that will solve many of the problems that make smoking cessation so difficult.”

Smoking kills more than 400,000 Americans each year, and is responsible for approximately one in five deaths in the US. Of the 45 million smokers in the US, 70 percent report that they want to quit, according to the Centers for Disease Control , and 23 million try to quit each year. The average smoker will attempt to quit eight to ten times. Nicotine replacement therapy (NRT) is one method used to help smokers quit, but conventional NRT does not match craving cycles, leading to six-month efficacy of less than 20 percent.

SmartStop is a wearable device that offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time behavioral support. Research shows that smokers have clear, consistent and predictable daily peak nicotine craving patterns; SmartStop is designed to automatically vary nicotine levels throughout the day to match those patterns. The device uses Bluetooth technology to wirelessly communicate with the SmartStop digital support program, providing real-time guidance to help smokers cope with cravings as well as a means for promoting compliance to the NRT and overall quit process.

“We have developed a unique approach to the very difficult problem of helping smokers quit their life-threatening habits,” noted Chrono founder Guy DiPierro. “We believe that the blend of a well understood active drug compound in nicotine with a programmable, wearable delivery system that takes into account a person’s habits as well as physiological patterns that each contribute to cravings has the potential to help more smokers quit once and for all.”

Leslie Bottorff, Managing Director of Healthcare at GE Ventures added, “Chrono Therapeutics is paving the way for personal monitoring in healthcare through the creation of the SmartStop integrated digital solution. Their technology is only just beginning, and GE Ventures looks forward to working together to transform disease management.”

“Over the past 20 years, I have had the privilege of backing Alan Levy as CEO in the founding of three life sciences companies,” stated Wende Hutton. “Alan brings an exceptional track record of success in drug/device combination therapies to Chrono.”