Companies in the News

 

March

Ironwood Pharmaceuticals Initiates Phase IIb Clinical Trial of IW-3718 in Refractory Gastroesophageal Reflux Disease

Business Wire: March 23, 2016 – CAMBRIDGE, MA, U.S.A. – Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced that it initiated a phase IIb clinical trial of IW-3718 in patients with refractory gastroesophageal reflux disease (GERD). Refractory GERD is a chronic condition in which patients continue to suffer from symptoms such as heartburn and regurgitation despite receiving treatment with a proton pump inhibitor (PPI). Data from this trial are expected in 2017.

“There is a significant unmet medical need among the estimated 10 million patients in the United States with refractory GERD,” said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. “For these patients, PPIs are not enough to control their heartburn and regurgitation. They continue to suffer from frequent and bothersome symptoms, and there is a dearth of approved prescription medicines for this condition. For these reasons, the advancement of IW-3718 is a top priority for Ironwood.”

The randomized, double-blind, placebo-controlled, dose-ranging phase IIb clinical trial is designed to evaluate the safety, efficacy, and dose-response relationship of IW-3718. The trial is expected to enroll approximately 260 adult patients who have been diagnosed with GERD and report experiencing heartburn or regurgitation at least four days per week during the previous eight weeks despite ongoing PPI treatment. The study design calls for eligible patients to continue taking their daily PPI therapy and to be randomized to receive additional treatment with placebo or one of three doses of IW-3718, twice-daily for eight weeks. The primary efficacy endpoint is change from baseline in heartburn severity.

Ironwood previously reported positive data from its randomized, double-blind, placebo-controlled phase IIa study of IW-3718 for refractory GERD. Data from that study showed that IW-3718 improved heartburn severity in the intent-to-treat population. IW- 3718 was generally well-tolerated with the most common adverse event being constipation.

An estimated 45 million Americans have gastroesophageal reflux disease (GERD), an estimated 10 million of whom are thought to suffer from the refractory form of the condition, meaning they continue to experience symptoms such as heartburn and regurgitation despite receiving the current standard of care treatment with a proton pump inhibitor (PPI). While PPIs suppress production of stomach acid, research suggests reflux of bile from the intestine into the stomach and esophagus may play a role in the ongoing symptoms of refractory GERD. There are few FDA-approved treatment options for these patients. If left untreated, refractory GERD can lead to serious complications including Barrett’s esophagus and, in rare instances, esophageal cancer.

IW-3718 is a novel, investigational gastric retentive formulation of a bile acid sequestrant, developed by Ironwood using the proprietary Acuform® drug delivery technology licensed from Depomed, Inc. IW-3718 is designed to remain in the stomach and duodenum (upper small intestine) over an extended period of time and to work in combination with a PPI to reduce the detrimental effects of bile and acid on the esophagus.

Cerulean Announces Publication Showing CRLX101 Localizes Selectively in Human Tumors, Sparing Adjacent Healthy Tissue

Business Wire: March 23, 2016 – WALTHAM, MA, U.S.A. – Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced the publication of clinical data for its lead compound, CRLX101, in the journal Proceedings of the National Academy of Sciences (PNAS). The publication highlights results from an investigator-sponsored clinical trial, in which pre- and post- treatment tumor biopsies from patients with gastric cancer treated with CRLX101 show the presence of CRLX101 and its payload, camptothecin, in tumors, and their absence in surrounding normal tissue. Importantly, inhibition of the molecular targets of CRLX101 was demonstrated in post-treatment biopsies. The article was published online. Initial results from the trial were presented at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on November 7, 2015.

“CRLX101 delivers a powerful anti-cancer drug to the tumor, sparing adjacent healthy tissue, results that directly translate observations from the lab to the clinic,” stated Mark Davis, Ph.D., Warren and Katharine Schlinger Professor of Chemical 

Engineering at California Institute of Technology. “Toxicities prevented the clinical development of camptothecin. Creating an NDC that incorporates camptothecin as its payload overcomes this major hurdle.”

“The data Dr. Davis and colleagues at the City of Hope Comprehensive Cancer Center published in PNAS demonstrate the power of NDCs,” said Christopher D.T. Guiffre, president and chief executive officer of Cerulean. “Dynamic tumor targeting is no longer something we have shown only in rodents—it has now been confirmed in humans with CRLX101. Targeting tumors and sparing healthy tissue has long been a major objective of oncology drug development, and CRLX101 achieves that important goal.”

The article describes results from nine patients with advanced gastric cancer enrolled in a pilot study sponsored by the City of Hope Comprehensive Cancer Center. All patients progressed on at least one prior line of systemic therapy. Tumor and adjacent healthy tissue biopsies were obtained through endoscopic-assisted biopsies prior to and 24–48 hours after receiving 15 mg/m2 of CRLX101. In all nine patients, the CRLX101 payload, camptothecin, was detected in patient tumor tissue and neither CRLX101 nor camptothecin was detected in post-treatment healthy tissue samples adjacent to tumors. Immunohistochemistry in patient tumors demonstrated that sufficient camptothecin is released from CRLX101 in the post-treatment tumors to have the intended biological effects of inhibiting  its molecular targets, topoisomerase-1 and hypoxia inducible factor 1a, two proteins that are believed to be involved in the progression of the cancer.

STENTYS Announces the CE Marking of the Self-Apposing Stent for Left Main Coronary Artery Disease

Business Wire: March 21, 2016 – PRINCETON, NJ, U.S.A. and PARIS, France – STENTYS (FR0010949404 — STNT) (Paris:

STNT), a medical technology company commercializing the world’s first and only Self-Apposing® coronary stent, today announced that Xposition S, the Sirolimus-Eluting Self-Apposing Stent, received CE marking for the treatment of unprotected left main coronary artery disease on the basis of the results from a study published last year in the peer-reviewed journal Catheterization and Cardiovascular Interventions.

When treating patients with left main coronary artery disease, the large diameter of the left main artery and the significant vessel tapering at that location represents serious challenges for conventional balloon-expandable DES that often result in important stent structural deformations. The STENTYS Self-Apposing Stent can adapt to vessels with varying diameters and ensure optimal fit to the vessel wall along the entire stented length. Xposition S new delivery catheter also enables very accurate stent positioning, a key feature when the lesion is close to the aorta.

The single center, retrospective, two-arm, controlled study, conducted by Carlo Briguori, M.D., Ph.D. (Clinica Mediterranea, Italy), included 75 consecutive patients with tapered distal unprotected left main coronary artery lesions treated with STENTYS DES. The authors concluded that the STENTYS stent offers a valid treatment alternative for this indication.

Gonzague Issenmann, cofounder and chief executive officer of STENTYS, commented: “This CE marking confirms the adequacy of our technology in this complex setting and now allows us to quickly start the multicentric study that will evaluate the efficacy of Xposition S in 200 patients in this indication.”

STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex artery disease. STENTYS’ Self-Apposing® drug-eluting stents are designed to adapt to vessels with ambiguous or fluctuating diameters in order to prevent the malapposition problems associated with conventional stents. The APPOSITION clinical trials in the treatment of acute myocardial infarction showed a very low one-year mortality rate and a faster arterial healing compared to conventional stents. The company’s product portfolio also includes MiStent SES®, a coronary DES whose new drug delivery mechanism is designed to match vessel response, and is marketed through STENTYS’ commercial network in Europe, the Middle East, Asia, and Latin America.

Juniper Pharmaceuticals Affirms Development Pathway for Oxybutynin Intravaginal Ring for Overactive Bladder      in Women

PRNewswire: March 21, 2016 – BOSTON, MA, U.S.A. – Juniper Pharmaceuticals, Inc. (NASDAQ: JNP) (“Juniper” or the “company”), a women’s health therapeutics company, today confirmed that it met with representatives of the Food and Drug Administration (FDA) in a Pre-IND meeting concerning JNP-0101, its oxybutynin intravaginal ring (IVR) for the treatment of overactive bladder (OAB) in women.

“It was a very collaborative meeting,” commented Dr. Bridget Martell, chief medical officer. “The regulatory path for JNP-0101 is clear, and we are on track to complete our IND-enabling preclinical work for this promising product candidate and file our IND application later this year. We plan to begin a phase 2a bioavailability and dose finding clinical study once the IND is active.”

Overactive bladder is characterized by involuntary contraction of the detrusor muscles before the bladder is full. This chronic urological condition affects an estimated 20 million women in the United States, with approximately nine million receiving pharmacologic therapy. The domestic market for OAB therapeutics was $1.3 billion in 2014.

Oxybutynin addresses OAB by decreasing muscle spasms of the bladder and the frequent urge to urinate caused by these spasms. While the most common prescription drug is generic oral oxybutynin, approximately half of women treated discontinue its use within the first year due to undesirable side effects. Juniper believes that delivering oxybutynin intravaginally using its IVR technology could provide an effective treatment for the condition while improving systemic side effects.

It is expected that JNP-0101 will utilize the shared vascular and lymphatic networks of the vagina and bladder to achieve localized absorption of oxybutynin by relevant tissues in higher concentrations, while bypassing hepatic first pass metabolism. Metabolism in the liver can result in increased active metabolites, which are purported to contribute the majority of experienced side effects.

The sustained-delivery oxybutynin IVR is also expected to improve compliance, as well as increase convenience for many patients and improve disease management and overall health outcomes.

Juniper plans to utilize the 505(b)(2) regulatory pathway in the United States. Requisite clinical trials under this pathway would include a phase 2a bioavailability and dose finding study followed by a pivotal phase 3 clinical trial.

Juniper Pharmaceuticals, Inc., is focused on developing therapeutics that address unmet medical needs in women’s health. The company is advancing a pipeline of proprietary product candidates that leverage novel intravaginal drug delivery technologies. Juniper’s commercial product, CRINONE® 8% (progesterone gel), is marketed by Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide and by Allergan, Inc., in the United States. Please visit www.juniperpharma.com for more information.

Gecko Biomedical Raises €22.5 Million Led by Sofinnova Partners

Business Wire: March 17, 2016 – PARIS, France – Gecko Biomedical (“Gecko”), a medical device company developing innovative polymers to support tissue healing, has closed a €22.5 million financing round. This series A2 round was led by Sofinnova Partners, which becomes the largest investor in Gecko, with support from Bpifrance and existing series A investors Omnes Capital, CM-CIC Innovation, and CapDecisif Management, who invested in the company in December 2013. In conjunction with the financing, Antoine Papiernik at Sofinnova Partners and Chahra Louafi at Bpifrance have joined Gecko’s board of directors.

Gecko was co-founded by Christophe Bancel and Bernard Gilly (both from the iBionext Network), Prof. Jeff Karp (Harvard Medical School, Brigham and Women’s Hospital – Boston, MA, U.S.A.), and Prof. Bob Langer (Massachusetts Institute of Technology – Cambridge, MA, U.S.A.) in late 2013 to advance a state-of-the-art polymer platform. One of its lead inventors, Dr. Maria Pereira, was named a Forbes 2015 “30 under 30.” Pereira is Gecko’s head of research.

The funds raised will be used to further advance the development of Gecko’s first platform, GB-02, for cardiovascular reconstruction and beyond. In addition, the funds will be used to leverage its fully industrialized platform in novel areas including guided tissue repair and localized drug delivery.

Gecko’s platform has demonstrated its ability to be fully industrialized, with a unique level of biocompatibility and a great potential in terms of versatility.

This platform is based on proprietary polymers with unique chemical and physical properties, including high viscosity, hydrophobicity, and fast “on demand” curing for precise local delivery and in situ adhesion. Upon curing, an elastic biodegradable film is formed. The structure of the polymer is tunable, allowing customization for various applications and tissues.

Christophe Bancel, Gecko’s CEO, commented: “Our investors’ support will enable us to complete our international clinical plans in cardiovascular surgery, which, if positive, will allow us to seek our first regulatory approval within one year. In addition, the funds will be used to expand our GB-02 platform to additional applications in tissue reconstruction. We will also drive the development of our next-generation polymer GB-04, for sutureless closure.”

Antoine Papiernik, managing partner at Sofinnova Partners, added: “We are thrilled to be involved with Gecko Biomedical, a company which combines all the key features we are looking for when investing in a company: a very strong management team and a world- class platform technology with a multitude of possible paradigm-shifting applications.”

Gecko Biomedical is a privately owned medical device company based in Paris, France, that is dedicated to the rapid development and commercialization of a unique biopolymers platform. Gecko’s first product (GB-02) is an innovative polymer for tissue healing, targeting cardiovascular reconstruction as an initial indication. The structure of GB-02 is tunable, allowing customization for various applications and tissues. Gecko’s biopolymers platform is fully industrialized and highly versatile, with potential novel applications in other fields of tissue reconstruction, such as guided tissue repair and localized drug delivery.

Gecko’s platform is based on proprietary biopolymers with unique chemical and physical properties, including high viscosity, hydrophobicity, and fast “on demand” curing for precise local delivery and in situ adhesion. The company’s technologies are derived from world-class research and intellectual property from the laboratories of Robert Langer (MIT) and Jeff Karp (Brigham and Women’s Hospital), who cofounded the company in 2013, alongside Christophe Bancel and Bernard Gilly from the iBionext Network. For more information, please visit www.geckobiomedical.com.

Adama Licenses Starpharma’s Priostar® Dendrimer Technology for the Development and Commercialization of a Novel 2,4-D Product for the U.S. Market

PRNewswire: March 17, 2016 – MELBOURNE, Australia, and TEL-AVIV, Israel – Starpharma (ASX: SPL; OTCQX: SPHRY ) and Adama today announced the licensing by Adama of Starpharma’s Priostar® dendrimer technology for the development and

commercialization of an enhanced, proprietary 2,4-D herbicide for the U.S. market. 2,4-D is one of the top three herbicides sold world- wide, with global sales in 2014 estimated by Phillips McDougall to be around US$680 million. The U.S. market in 2014 was worth approximately US$115 million, and it has been projected by the U.S. Department of Agriculture to grow by more than 70% by 2020.

Adama has already commenced development of a novel and unique 2,4-D product containing the Priostar® dendrimer technology, which is expected to provide better flexibility and weed control benefits to the grower, as well as improved safety. This will allow for on-target application, thus benefiting the environment by reducing the amounts of product required.

Under the license, Starpharma will receive royalties on sales of the proprietary Adama Priostar®-improved 2,4-D products. In addition to the United States, the agreement also includes a mechanism to expand the license into additional territories.

Sami Shabtai, head of innovative development at Adama, commented, “As a farmer-centric company, Adama constantly strives to bring new and innovative solutions to farmers that will simplify their lives. The innovative nature and superior performance of the Priostar® formulations fit well with our strategy to deliver simple and efficient solutions to farmers to help them grow. This is yet another step in the evolution and differentiation of our offering, as we continue to introduce unique mixtures and formulations to the market.”

Dr. Jackie Fairley, CEO of Starpharma, said, “We enjoy a positive relationship with Adama, and their extensive trials of Priostar®- improved 2,4-D formulations have led to this license agreement. With Adama’s strong, proven record of innovative product development, we are very pleased to have them as commercial partners for Priostar®-improved 2,4-D products. In addition, we continue to explore other Priostar® product opportunities with Adama.”

Starpharma’s Priostar® dendrimer technology offers formulation and efficacy benefits in crop protection applications including:

• Improved efficacy;
• Increased adhesion, to reduce losses due to rain run-off, and the need for multiple applications
• Reduction in solvent requirements; and
• More concentrated formulations to reduce transport costs;

Adama is one of the world’s leading crop protection companies. We strive to Create Simplicity in Agriculture—offering farmers effective and efficient products and services that simplify their lives and help them grow. With one of the most comprehensive and diversified portfolios of differentiated, high-quality products, Adama’s 4,900 people reach farmers in over 100 countries across the globe, providing them with solutions to control weeds, insects and disease and improve their yields. For more information, visit us at www.adama.com and follow us on Twitter at @AdamaAgri.

Starpharma Holdings Limited, an Australian ASX 300 company, is a world leader in the development of novel products based on dendrimers, a type of synthetic nanoscale polymer that is highly regular in size and structure, for pharmaceutical, life science, and other applications. Starpharma has three core development programs: VivaGel® portfolio, DEP™ drug delivery, and agrochemicals with a number of products being developed internally and externally via commercial partnerships. Partners include AstraZeneca, Ansell, and Okamoto, as well as other named and undisclosed partnerships with leading global companies in pharmaceuticals and agrochemicals. For more information, please visit www.starpharma.com.

Chrono Therapeutics’ Smoking Cessation Technology Demonstrates Significant Reduction in Nicotine Cravings

PRNewswire: March 4, 2016 – CHICAGO, IL, U.S.A. – Chrono Therapeutics, a pioneer in digital drug therapy, today announced that clinical data for the company’s smoking cessation technology showed a statistically significant reduction in nicotine cravings in a trial of adult male smokers. The data were presented today at the Society for Research on Nicotine and Tobacco’s 22nd Annual Meeting.

Chrono’s wearable transdermal drug delivery device times nicotine delivery to when smokers have their strongest cravings. For example, 75% of all smokers reach for their first cigarette within 30 minutes of waking up. The Chrono solution is designed to deliver the first dose of nicotine replacement therapy (NRT) shortly before a smoker wakes up and then creates a pattern of “peaks and troughs” of nicotine delivery throughout the rest of the day to assure the smoker has more nicotine support when cravings are predicted to be strongest.

“In the United States, 70% of smokers want to quit, but quitting is extremely difficult. In fact, most people try 8–10 times, and this includes quit attempts with standard cessation medications like nicotine patch and gum and prescription drugs like varenicline,” said Alan Levy, Ph.D., chairman and CEO of Chrono Therapeutics. “Gums and patches are designed to help manage cravings, but they are only 5–9% effective. Our goal is to solve this crisis of public health with an innovative, integrated smoking cessation solution, and the data we presented demonstrates that we are on the right path.”

The clinical trial was a randomized, double blinded study of 24 adult males who smoked 11 or more cigarettes per day, indicating a high level of nicotine dependence. The subjects were divided into two groups. Test group subjects had nicotine administered over a 30- hour time period via Chrono’s prototype device that delivered nicotine according to Chrono’s “peaks and troughs” profile. Control subjects had a placebo solution, with no nicotine, administered at the same intervals via the same prototype device. Across both groups, subjects showed no serious adverse events or study withdrawals due to an adverse event. Skin irritation assessment showed no signs of irritation or erythema.

Cravings were assessed via three different methods: the Questionnaire for Smoking Urges (QSU), the Mood and Physical Symptoms Scale (MPSS), and a single craving question, each of which is a validated tool to assess cravings. When compared to subjects treated with placebo, test subjects had a statistically significant and clinically meaningful reduction in cravings for all assessment methods (p = 0.035; p = 0.034; and p = 0.016, respectively).

“Achieving statistical significance in a 24-subject trial is very striking and happens infrequently in biopharma; so these results are very encouraging,” noted Wende Hutton, general partner at Canaan Partners and a member of Chrono’s board of directors. “Quitting smoking is one of the simplest ways to improve global public health, but as the dismal efficacy of current therapies demonstrates, it is also one of the hardest. I’m very excited to be working with a company that has the potential to solve such a serious problem.”

Effective care of the most hard-to-treat conditions requires approaches beyond simply taking medicine. Chrono’s team is developing the first wearable transdermal drug delivery device that optimizes drug dosing, is embedded with sensor technology to track usage, and is connected via Bluetooth to an evidence-based smartphone application that delivers real-time personalized behavioral support to keep users on track to achieve their goals. Chrono’s first application is in smoking cessation, enabling smokers to overcome the world’s deadliest addiction. For more information, visit www.chronothera.com.

Gensco Laboratories Launches the First Transdermal Medication for Acute Gout Flares

PRNewswire: March 2, 2016 – MIAMI, FL, U.S.A. – Gensco Laboratories announces ColciGel™, a new transdermal medication indicated for the treatment of acute gout flares in adults.

Gout, an extremely painful form of inflammatory arthritis, affects more than 4% of Americans and about 10% of men over the age of

60. It is more common in women after menopause. The disease occurs due to an excess of the bodily waste, uric acid. The acid is deposited as needle-like crystals in the joints or in soft tissue. These crystals cause redness, swelling, stiffness, and intense pain in the joints, which in turn can create gout flares.

“Unfortunately, gout attacks often occur without warning. This sudden attack is referred to as a ‘flare’ and will normally subside within 3–10 days, but during that timeframe, the pain is excruciating if untreated,” said Gary Myerson, M.D., founding fellow of the American College of Rheumatology. “The secret to the treatment of the acute gout attack is to be prepared and treat the flare early.”

A new transdermal gel has been developed and is now available by prescription only to treat the symptoms of gout attacks. “ColciGel™ is a transdermal medication that provides rapid relief of pain at the first sign of acute gout flares without gastrointestinal problems. The medication should be applied directly on the site of the pain,” said Robert L. Wilbur, Pharm.D. C.Ph. “ColciGel™ offers gout sufferers, and physicians that treat these patients, an important new option to stay ahead of the horrible pain before it strikes.”

Copay assistance and cash pay programs are available to all patients through participating specialty pharmacies. “As a pharmaceutical manufacturer, we have a responsibility to provide access to safe and effective medications. We recognize the need to assist with the financial burden as our duty,” said Carlos Alfaras, CEO of Gensco Laboratories. “Our corporate focus is to utilize our resources on innovative research and the development of unique delivery systems, and it aligns with our specialty partner’s efforts to improve access and the quality of life for patients who suffer from debilitating diseases. The Gensco specialty pharmacy distribution partnerships foster the growing need to focus on disease states which our new transdermal ColciGel™ serves.”

ColciGel™ is offered through specialty pharmacies including but not limited to Apogee Bio-Pharm, Aureus Health Services, BriovaRx, Cardinal Health Specialty, Cigna Health, MagellanRx Pharmacy, ProCare Rx Pharmacy, Senderra Rx Pharmacy, SMP Pharmacy Solutions, and Walgreens Specialty Pharmacy.

Even though nine out of 10 gout sufferers say gout has affected their daily lives, one in five isn’t doing anything at all to treat the disease—and only 10% of gout sufferers are getting needed treatment. If you are suffering from gout, learn more by speaking with your doctor or visiting www.gouteducation.org. For more information on ColciGel™, visit www.colcigel.com.

Gensco Laboratories is a specialty pharmaceutical company focusing on research, development, and marketing of transdermal prescription products. As an innovator of pharmaceutical products and the development of patented drug delivery systems, Gensco is dedicated to the continual pursuit of novel and effective therapies that improve health.

Johnson & Johnson Innovation Unveils JLABS @ TMC to Help Catalyze Early Stage Research Through to Commercialization for Healthcare Solutions in Houston

PRNewswire: March 2, 2016 – HOUSTON, TX, U.S.A. – Johnson & Johnson Innovation LLC today opened JLABS @ TMC, a new 34,000-square foot life sciences incubator providing entrepreneurs shared lab space, private offices, and modular laboratory suites, as well as state of the art equipment and value-added operational, education, and business services. The new JLABS facility can accommodate up to 50 startups, and will open with 21 companies that represent a range of disciplines and geographies. This first “class” of resident startups includes the four winners of the JLABS Quick Fire Challenge, which awards promising early stage innovation companies with residency at the facility.

JLABS @ TMC builds on the successful JLABS model and is the fifth JLABS facility to open in the United States. The Houston site is the first to open with a medical device prototype lab, including a 3D printer, which will provide entrepreneurs access to highly specialized tools, as well as skills building programs to design and develop smart health technologies.

JLABS @ TMC is housed within the TMC Innovation Institute, adjacent to TMC’s life sciences accelerator TMCx, enhancing its think tank–like environment and encouraging sharing of ideas, collaboration among JLABS, TMC and TMCx residents, and facilitation of relationships with investors and venture capitalists.

“We’re thrilled to expand our JLABS initiative into Houston,” said Paul Stoffels, M.D., chief scientific officer and worldwide chairman, pharmaceuticals, Johnson & Johnson. “The city’s rich research, academic, and investment communities provide a robust ecosystem of early stage innovation and present a unique opportunity to collaborate with Texas startups to deliver much-needed therapeutics, medical devices, and consumer health solutions to patients and consumers more quickly.”

“We have been eagerly awaiting this day when JLABS @ TMC opens its doors and immediately enhances our already robust ecosystem of talented entrepreneurs who are solving the greatest unmet healthcare needs of our generation,” said Robert C. Robbins, M.D., president and CEO of the Texas Medical Center. “TMC has spent decades making healthcare history, and now these business accelerators housed at TMC will take innovation to new heights.”

JLABS @ TMC joins a network of facilities that are based throughout North America in life science clusters, including San Diego (flagship), San Francisco, South San Francisco, Boston and, opening this spring, the first international location in Toronto, Canada. These facilities are currently home to more than 100 early stage companies advancing bio/pharmaceutical, medical device, consumer, and digital health programs. The JLABS facilities will have a total capacity for 225 resident companies once all six are open and operational.

“Houston is already a very active life sciences hub, and we’ve recently seen a drive to further embrace the industry, establish clear leadership in biotech innovation, and close the gap between research and commercialization,” said Melinda Richter, head of JLABS. “JLABS is ideally suited to catalyze this result, not only through supporting the development of new healthcare solutions for patients but also by providing startups with access to the broader JLABS network and its family of incubators.”

Texas Medical Center hosts an increasing number of life sciences and biotech companies via commercialization initiatives, such as its Innovation Institute, steadily growing the opportunities for academic and industry partnerships in Houston.

Johnson & Johnson Innovation has entered into a collaboration with PerkinElmer, Inc., to outfit the new JLABS @ TMC facility with world-class lab instruments and software as well as to provide training, OneSource® Laboratory Services, and on-site technical support for the resident companies.

All JLABS locations are accepting applications from biotech, pharmaceutical, medical device, consumer, and digital health companies. To apply, visit www.jnjinnovation.com/jlabs.

Nuvo Research® Inc. Completes Reorganization into Two Publicly Traded Companies

PRNewswire: March 1, 2016 – MISSISSAUGA, ON, Canada – Nuvo Pharmaceuticals Inc. (TSX: NRI) (Nuvo Pharma or the company), formerly known as Nuvo Research Inc. and Crescita Therapeutics Inc. (TSX: CTX) (Crescita), today announced the completion of the reorganization of Nuvo Research Inc. into two separate publicly traded companies (the reorganization). As a result of the reorganization, the shareholders of what was formerly Nuvo Research Inc. now own 100% of Nuvo Pharma, a revenue and EBITDA generating commercial healthcare company, and 100% of Crescita, a drug development company. The reorganization was approved by the shareholders of Nuvo Research Inc. at a special shareholders meeting on February 18, 2016, and by the Ontario Superior Court of Justice on February 24, 2016.

“This transaction gives both businesses greater flexibility to focus on, and pursue, their respective growth strategies,” said John London, president and CEO of Nuvo Pharma. “Nuvo Pharma is a profitable business with significant revenue and EBITDA growth potential.” “We are very excited about the launch of Crescita,” added Dan Chicoine, Chairman and CEO of Crescita. “We have exciting technologies, a proven management team that has obtained FDA approval for four topical pharmaceutical products, and a strong balance sheet to support our growth.”

Under the reorganization, existing Nuvo Research Inc. share certificates now represent common shares of Nuvo Pharma and the right to receive a share certificate representing an equal number of Crescita common shares. The distribution record date (the record date) for certificates representing Crescita common shares is Thursday March 3, 2016. However, the TSX has implemented due bill trading for the Nuvo Pharma common shares (TSX: NRI) until the close of trading on Friday March 4, 2016. Accordingly, shareholders who purchase Nuvo Pharma common shares through the facilities of the TSX prior to the close of trading on Friday March 4, 2016, will automatically receive one Crescita common share for each Nuvo Pharma common share purchased. Crescita common shares (TSX: CTX) are expected to commence trading on the TSX on Monday March 7, 2016. Nuvo Pharma and Crescita shareholders are encouraged to contact their brokers for additional information.

As part of the reorganization, Nuvo has changed its name from “Nuvo Research Inc.” to “Nuvo Pharmaceuticals Inc.” Effective with the reorganization, Nuvo Pharma (TSX: NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo Pharma has three commercial products that are available in a number of countries: Pennsaid 2%, Pennsaid, and the heated lidocaine/tetracaine patch. Pennsaid 2% is sold in the United States by Horizon Pharma plc (NASDAQ: HZNP) and is available for partnering in certain other territories around the world. Nuvo Pharma manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA licensed GMP facility in Varennes, Québec. For additional information, please visit www.nuvopharmaceuticals.com.

Effective with the reorganization, Crescita (TSX: CTX) is a well-capitalized biotech company that owns a pipeline of topical and transdermal product candidates for treating medical conditions in a number of therapeutic areas, including pain and dermatology. Crescita owns multiple proprietary drug delivery platforms that support the development of patented formulations that can facilitate the delivery of active drugs into or through the skin. Crescita has one commercial product, Pliaglis, that is licensed globally (except for Canada, the United States, and Mexico, where Crescita owns the rights). Crescita’s board and management team have demonstrated success in building Nuvo Research Inc., including developing multiple drugs that are now approved and commercialized and negotiating multiple transactions that have generated more than $100 million in non-dilutive funding. For additional information, please visit www.crescitatherapeutics.com.

 

February

Propeller Partners with Global Drug Delivery Systems Provider Aptar Pharma for Development of a Next-Generation, Integrated, Connected Metered Dose Inhaler

PRNewswire: February 25, 2016 – MADISON, WI, U.S.A. – Propeller Health, the leading digital health solution for respiratory medicine, today announced a partnership with Aptar Pharma (Aptar), a global drug delivery systems provider, including technology for metered dose inhalers systems (MDIs) for treatment of asthma and chronic obstructive pulmonary disease (COPD). Under the terms  of the agreement, Propeller and Aptar will jointly develop the world’s first integrated cMDI, with an integrated sensor and a novel electronic dose counter. The device is currently available for licensing and is expected to enter clinical studies later this year.

Pressurized MDIs are the most common type of inhaler device on the market today, with over 600 million units manufactured globally. They deliver aerosolized medications such as bronchodilators, corticosteroids, and combinations that are used daily by patients with chronic respiratory diseases such as asthma or COPD. The Propeller-Aptar partnership will create the first connected inhaler, the most significant improvement in MDIs since the industry added mechanical dose counters over ten years ago.

The new inhaler will combine Aptar MDI components and sensor technology with Propeller electronics directly into the inhaler housing, allowing for accurate and reliable monitoring of when each patient uses their inhaled medication. Information about the use of medications delivered by the cMDI will be put to work as part of the Propeller digital system for patients and providers. Leveraging existing apps, emails, text messages, and other feedback, patients are able to learn more about their disease, how to better manage it, and how to stay on track with their prescribed dosing instructions. In addition, physicians can identify individuals who need more help controlling symptoms, and care managers can efficiently focus on higher risk patients who need more personalized attention.

Propeller’s platform is 510(k) cleared and compatible with a majority of MDIs on the market today including controller medications such as GSK’s Flovent®, Merck’s Dulera®, Teva’s QVAR®, and others, as well as reliever medications such as GSK’s Ventolin® HFA, Merck’s Proventil® HFA, Teva’s ProAir® HFA, and generic albuterol. It is also cleared and compatible with medications utilizing Boehringer Ingelheims’s RESPIMAT® soft mist inhaler (SMI) and GSK’s Diskus® dry powder inhaler (DPI).

“Patients and physicians deserve better designed inhalers that are easier to use and help them successfully treat their chronic respiratory disease,” said David Van Sickle, CEO of Propeller. “We are excited to work with Aptar to bring important digital innovation to respiratory drug delivery. We expect our connected inhaler to become the cornerstone for a platform of digital programs that will support and encourage better management of and quality of life with chronic respiratory disease. Together I believe we have the scale and expertise to impact millions of patients with asthma and COPD around the world.”

“We are pleased to partner with Propeller to develop the next generation of connected inhalers,” said Salim Haffar, president of Aptar Pharma. “We believe the combination of Aptar’s expertise and technology in inhaler design and development with Propeller’s proven system for asthma and COPD patient management creates a compelling offer to meet the needs of stakeholders in this market place.”

Aptar Pharma is part of the AptarGroup, Inc., family of companies, along with Aptar Beauty + Home and Aptar Food + Beverage. The company creates innovative drug delivery systems that meet the evolving needs of biotechnology, healthcare, and pharmaceutical companies around the world. Aptar Pharma provides customers with a wide range of delivery technologies and analytical services backed by decades of proven expertise. AptarGroup is headquartered in Crystal Lake, Illinois, United States, with manufacturing facilities in North America, Europe, Asia, and South America. For more information, visit www.aptar.com/pharma.

Founded in 2010, Propeller is the leading digital health platform in respiratory medicine. The company has received FDA 510(k) class II clearance to measure and improve medication adherence, predict exacerbations, and help reduce the frequency of symptoms and exacerbations in asthma and COPD. Propeller’s platform has been clinically validated in two randomized controlled trials and more than 10 clinical studies involving over 1,400 patients. It has been used by patients with asthma or COPD in over 35 commercial programs across the United States at major healthcare systems, payers, employers, and other commercial partners. Propeller is backed by Safeguard Scientifics (NYSE: SFE), Social Capital, California HealthCare Foundation, Kapor Capital and other investors, and has been recognized by the TEDMED Innovation Showcase, White House Champion of Change, Bluetooth Breakthrough Product awards, and others. Visit http://propellerhealth.com/contact/ for more information.

Rani Therapeutics Completes Latest Round of Funding, Brings Total Investment to $70M

PRNewswire: February 24, 2016 – SAN JOSE, CA, U.S.A. – Rani Therapeutics announced today that it has closed its latest round of funding, bringing the company’s total investment to more than $70 million. New investors include AstraZeneca, Virtus Inspire Ventures, and Ping An Ventures. Existing investors in Rani Therapeutics include Novartis, Google Ventures, Buttonwood, GF Ventures, KPC Pharmaceuticals, InCube Ventures, and VentureHealth, among others. The funding will support expansion of the team, new facilities, and manufacturing scale up.

Rani, founded in 2012 and spun out of InCube Labs, is developing a novel technology platform to convert injectable drugs such as TNF-alpha inhibitors, interleukin antibodies, basal insulin, and GLP-1 into oral pills. In the last year, the company has entered into strategic collaborations with Novartis and Astra Zeneca/MedImmune to test its platform with selected drugs.

“We developed Rani Therapeutics with a clear vision—give patients suffering from chronic illnesses a convenient, easy and painless alternative to subcutaneous injections,” said Mir Imran, chairman and CEO of Rani Therapeutics. “Our team has created a breakthrough drug delivery platform supported by a solid patent portfolio and that is what is attracting potential partners and investors. We are pleased with our progress and are now laser focused on demonstrating value for a variety of therapies.”

“Delivering biologics orally would have a tremendous impact on patients, especially for those suffering from chronic diseases that require them to regularly take medications,” said Jiang Zhang, managing director, Ping An Ventures. “Rani is developing a revolutionary platform, and we are very excited to support the company in this exciting next phase.”

As part of its next stage of growth, Rani recently hired Robert Gaffney as vice president of operations to lead the company’s expansion. Gaffney joined from Spinal Modulation, an InCube Labs company acquired by St. Jude Medical in 2015, where he served as chief operating officer.

Rani Therapeutics has developed a novel approach for the oral delivery of peptides, proteins, and therapeutic antibodies which to date can only be delivered through injections. The approach and technology for Rani Therapeutics was developed at InCube Labs, a multi- disciplinary life sciences R&D lab focused on developing breakthrough medical innovations. InCube is led by Mir Imran, a prolific medical inventor, entrepreneur, and investor, who has founded more than 20 life sciences companies and holds more than 400 patents. Many of Imran’s innovations have resulted in new standards of care, including the first FDA-approved automatic implantable cardioverter defibrillator. For more information, please visit www.ranitherapeutics.com and www.incubelabs.com.

Novaliq Begins Phase 2 Clinical Trial of CyclASol® for the Treatment of Moderate to Severe Dry Eye Disease

Business Wire: February, 16, 2016 – HEIDELBERG, Germany – Novaliq GmbH, a pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced that it has begun enrolling patients in a phase 2 clinical trial that will evaluate the safety, efficacy and tolerability of CyclASol® for the treatment of moderate to severe dry eye disease (DED). CyclASol is a clear, preservative free ophthalmic solution of cyclosporine in SFA (semifluorinated alkanes).

This phase 2 study is a randomized, double-masked, placebo-controlled, multi-center trial, designed to evaluate the safety, efficacy, and tolerability of topical CyclASol for the treatment of moderate to severe DED. Patients will be randomized to one of four treatment groups that include two CyclASol groups, a placebo (vehicle control) group and an open label cyclosporine A 0.05% ophthalmic emulsion group. Study subjects will self-administer one drop twice daily, returning for examination periodically and at the end of the trial at four months. The study is being conducted in approximately four sites in the United States, and total planned enrollment is 200 patients.

“CyclASol is differentiated from other cyclosporine containing treatments for dry eye due to its innovative vehicle,” said George Ousler, vice president of Dry Eye at Ora, Inc. “In a murine model of DED, CyclASol was shown to be at least equally effective but with a significantly faster therapeutic response compared to commercially available cyclosporine and dexamethasone products.

Furthermore, the clinical phase 1 data has demonstrated excellent tolerability.”

“The initiation of this phase 2 trial is an important step in advancing our clinical development plan,” said Bernhard Günther, managing director and CEO of Novaliq GmbH. “In 2015, we made our footprint in the OTC dry eye market with the successful European  launch of NovaTears®. Given the lack of treatment options currently available for patients with more severe DED, there is a need for novel, non-blurring, non-irritating, and preservative- and water-free formulations.”

Novaliq GmbH, founded in 2007, is a Heidelberg based specialty pharmaceutical and drug delivery company with the mission to transform poorly soluble drugs into effective ocular therapeutics for both front and back of the eye. Novaliq’s proprietary EyeSol® technology enhances the topical bioavailability, stability, and safety of traditionally insoluble or unstable drugs improving the delivery, efficacy, and convenience of treatments for ocular surface diseases including dry eye through preservative-free and multi-dose formulations. Novaliq’s most advanced product is NovaTears with CE-marking based on Novaliq’s proprietary EyeSol Technology. NovaTears is marketed under the brand name EvoTears™ in Europe. More on www.novaliq.com.

Braeburn Pharmaceuticals and Knight Therapeutics Announce Canadian Sublicense Agreement for Probuphine®

PRNewswire: February 1, 2016 – PRINCETON, NJ, U.S.A. and MONTREAL, Canada – Braeburn Pharmaceuticals, Inc.  (“Braeburn”) and Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, announced today that they have entered into an agreement whereby Knight received the exclusive rights to commercialize Probuphine® in Canada. Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, promoting patient compliance and retention as well as helping to prevent accidental pediatric exposure. Under the terms of this sublicense agreement, Knight will also handle all ongoing regulatory and commercial activities for Probuphine in Canada.

“According to the Canadian Drug Policy Coalition, overdose deaths from opioids have risen sharply in Canada and now account for approximately half of all drug related deaths in the country,” said Behshad Sheldon, president and CEO of Braeburn. “Partnering with Knight Therapeutics is another step in our vision to making a lasting impact on how this chronic disease is treated in North America.”

“We are pleased that we can be instrumental in bringing Probuphine® to Canada,” said Jonathan Ross Goodman, president and chief executive officer of Knight. “Once approved by Health Canada, Probuphine® will be the first product to offer treatment for opioid addiction for six months following a single treatment. This innovative product has the potential to address an important unmet need for opioid dependent patients.”

Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, and to promote patient compliance and retention. Buprenorphine, which is the active ingredient in multiple approved drug products for the treatment of opioid dependence, is currently available in sublingual and buccal formulations that require self- administration by patients on a daily basis.

Probuphine was developed using ProNeura™, the continuous drug delivery system developed by Titan Pharmaceuticals, Inc. (“Titan”) that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in an outpatient office procedure, and removed in a similar manner at the end of the treatment period. Titan licensed the rights to commercialize Probuphine in the United States and Canada in 2012.

The efficacy and safety of Probuphine has previously been studied in several clinical studies. The most recent study enrolled 177 subjects who were randomized to receive either the Probuphine implants or sublingual tablets, for a treatment period of six months. Subjects in one group received four Probuphine implants plus daily placebo sublingual tablets. A second group received four placebo implants plus daily sublingual buprenorphine/naloxone tablets (≤8 mg/day).

The study met its primary objective of showing non-inferiority based on comparison of the proportion of treatment responders in each treatment arm. A responder was defined as having at least four out of six months free of illicit opiates based on urine testing and subject self-report. Additional analyses consistently demonstrated that Probuphine was non-inferior to sublingual buprenorphine/ naloxone arm.

Braeburn, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision medicine in neuroscience. In September 2015, the U.S. Food and Drug Administration (FDA) accepted for review Braeburn’s New Drug Application for its lead candidate, Probuphine®, a six-month buprenorphine implant for treatment of opioid addiction. On January 12, 2016, the FDA Psychopharmacologic Drugs Advisory Committee recommended approval by a vote of 12 to 5. The agency has set February 27, 2016, as the target date for action.

Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these  conditions, which are often complicated by stigma and present significant public health challenges. Braeburn’s investigational product pipeline consists of long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia. Candidates include Probuphine®, a six-month buprenorphine implant for treatment of opioid 

addiction; CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine for treatment of opioid addiction and pain; a risperidone six-month implant for treatment of schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. More information on Braeburn can be found at www.braeburnpharmaceuticals.com