Baxalta and Momenta Announce Initiation of Pivotal Clinical Trial for M923; Boston Scientific Receives FDA Approval For SYNERGY™ Print E-mail
By David Fowler   
Monday, 05 October 2015 18:58

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 5, 2015. 

 

Baxalta Incorporated (NYSE: BXLT) and Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), announced the initiation of a pivotal clinical trial in patients with chronic plaque psoriasis for M923, a biosimilar version of HUMIRA® (adalimumab). The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. The companies are targeting first regulatory submission in 2017 and a first commercial launch in 2018.

    

"We are committed to expanding treatment access and providing additional options for patients who suffer from chronic plaque psoriasis," said Dagmar Rosa-Bjorkeson, executive vice president and president, Biosimilars, Baxalta. "Chronic plaque psoriasis is a debilitating disease that can have a significant impact on a patient's quality of life and physical wellbeing. We look forward to bringing a high-quality and

cost-effective biosimilar version of adalimumab to patients around the world."

       

Chronic plaque psoriasis is the most common form of psoriasis that affects one to three percent of the general population1. It is characterized by scaly plaques or lesions on the body and

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the scalp, which may itch or sting, and can bleed when injured. Though there are treatments available, there is no cure for psoriasis.

      

"We believe that our extensive analytical and

biocharacterization work has allowed us to create a high-quality biosimilar candidate of HUMIRA," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. "We look forward to progressing M923 toward regulatory approval and commercialization with our collaborative partner Baxalta and to the potential of providing a more affordable biosimilar option for the many patients suffering from chronic autoimmune and inflammatory diseases."

      

This milestone is part of a global collaboration between Baxalta and Momenta to develop and commercialize M923. With this collaboration, Baxalta leverages its leading clinical development, biologic manufacturing expertise, and global commercial capabilities, while Momenta provides its expertise in high-resolution analytics, characterization, clinical and regulatory strategy for complex products, and product and process development.

   

   

   

   

   

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Boston Scientific (NYSE: BSX) has received U.S. FDA approval for the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease.

    

With this FDA approval, Boston Scientific will commence commercialization of the first and only BP-DES in the U.S. Notably, both the drug coating and the polymer – which modulates drug release – are fully absorbed shortly after drug elution is complete at three months.

    

The SYNERGY Stent provides synchronized drug and polymer absorption. It is designed to enable more rapid and complete arterial healing, and to thereby reduce the risk of complications associated with long-term polymer exposure compared to currently-used drug-eluting stents (DES) with permanent polymers.

     

Existing DES devices reduce coronary restenosis, but the polymer remains on the stent after the drug is delivered. Long-term exposure to the polymer may cause inflammation, which delays healing and has been associated with complications, including neoatherosclerosis and stent thrombosis. The SYNERGY Stent is designed for faster and sustained healing by eliminating long term polymer exposure.

    

"Data from the EVOLVE II trial, which included the most complex patient population studied in a U.S. regulatory approval stent trial, demonstrated exceptional performance and safety of the SYNERGY Stent," said Dean Kereiakes, M.D., principal investigator of the EVOLVE II trial and medical director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center, Cincinnati. "The U.S. cardiology community will have access to a bioabsorbable polymer DES which will provide excellent clinical outcomes and should optimize vessel healing."

     

Results previously reported from EVOLVE II, a global, multi-center, randomized, single-blind, non-inferiority pivotal trial demonstrated 0% definite stent thrombosis (ST) after 24 hours. Four-year EVOLVE trial data demonstrated a continued 0% stent thrombosis rate and a very low target lesion revascularization (TLR) rate of 1.1%.

     

Boston Scientific will continue to advance the robust clinical program supporting the SYNERGY Stent with the initiation of the EVOLVE Short Dual Anti-Platelet Therapy (DAPT) Study, expected during the first quarter of 2016. The company has received an Investigational Device Exemption (IDE) for this prospective study designed to assess the safety of three-month use of DAPT in patients at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent.

      

"The introduction of the first bioabsorbable polymer stent in the U.S. is a tremendous milestone in the evolution of stent technology," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "The SYNERGY Stent is a next generation therapy designed to improve patient outcomes and ultimately reduce health care costs associated with the treatment of coronary artery disease."

    

      

      

Also Monday:

   

    

   

Air Methods Corporation (NASDAQ:AIRM), the global leader in air medical transportation, announced today that it has acquired San Antonio AirLIFE, owned by Baptist Health System of San Antonio/Tenet Corporation, and Bexar County Hospital District doing business as University Health System.          "We value our long-term relationship with San Antonio AirLIFE," said Aaron Todd, Air Methods' chief executive officer. "This new venture reinforces Air Methods' commitment to delivering high quality service and emergency air medical response to the residents of Texas. In addition, we are honored to welcome members of the San Antonio AirLIFE team to the Air Methods family, and look forward to this new chapter."           The five San Antonio AirLIFE bases are located in San Antonio, New Braunfels, Kerrville, Uvalde, and Pleasanton, Texas. Each base is staffed with approximately 15 highly-trained air medical professionals, including flight nurses, flight paramedics, mechanics and pilots, in service 24 hours a day, seven days a week. Air Methods acquired substantially all of San Antonio AirLIFE's assets, including the program name, branding, medical equipment and the Flight Communication Center (FLTCOMM). In addition, Air Methods will acquire two aircraft owned by University Health System. The program will continue to operate under the San Antonio AirLIFE program name.

    

     

Applied Genetic Technologies Corporation (Nasdaq:AGTC), a clinical-stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced the appointment of three new employees. Among these hires, Jonathan M. Sparks, Ph.D. will join AGTC as Vice President of Legal Affairs. The Company also announced the appointments of Ellery Mangas as Senior Director, Regulatory Affairs and Eric Olson as Senior Director, Corporate Development.           "We are pleased to welcome Jonathan, Ellery and Eric who bring rich and diverse experience to AGTC during a critical growth period," said Sue Washer, President and Chief Executive Officer of AGTC. "Since the beginning of 2014, we've made significant investments to our team with a total of 30 new hires, including five senior management positions. These additions further strengthen our talented team and will help support AGTC's development following our recent advance into clinical trials for our lead gene therapy candidate for XLRS."

    

    

Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies based on the Arcelis® technology platform, announced the company will host a special briefing conference call focused on the current clinical research landscape in metastatic renal cell carcinoma (mRCC). The briefing will feature Dr. Charles Drake, co-director of the division of immunology, professor of medical oncology, immunology, and urology at the Johns Hopkins Sidney Kimmel Cancer Center. The conference call is scheduled for Wednesday, October 7, 2015 at 4:30pm ET.          During the briefing, Dr. Drake will review data presented during the 40th Congress of the European Society for Medical Oncology (ESMO) held September 25-29, 2015 in Vienna, Austria, and will discuss the implications for clinical research in mRCC moving forward.           In addition to the presentation by Dr. Drake, Dr. Charles Nicolette, Argos' chief scientific officer and vice president of research and development, will also provide an update on the company's lead product candidate, AGS-003, and the pivotal ADAPT phase 3 clinical trial for the treatment of mRCC.

    

    

Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company with a focus on developing innovative therapies for patients with debilitating diseases, today announced that its collaborating investigators at Baylor College of Medicine will present at the American Society of Nephrology (ASN) Kidney Week 2015. In a pre-clinical study of mice with Chronic Kidney Disease (CKD), muscle fibrosis was prevented by administration of the anti-myostatin peptibody, PINTA 745. The meeting will take place from November 3-8, 2015 in San Diego, California.          Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company with a focus on developing innovative therapies for patients with debilitating diseases, today announced the publication of preclinical data that provide insight into the pharmacology of its clinical stage anti-myostatin peptibody, PINTA 745.          In the International Journal of Obesity, investigators from Baylor College of Medicine utilized a high fat diet (HFD)-fed mouse model of obesity and type II diabetes to evaluate the effects of myostatin inhibition using PINTA 745.

   

    

athenahealth, Inc. (NASDAQ:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced that it will hold a conference call for investors on Friday, October 23, 2015, at 8:00 a.m. ET. During the conference call, management will review highlights from the company's third quarter 2015 results, which will be announced via press release after the close of market trading on Thursday, October 22, 2015.          As a reminder, in conjunction with quarterly earnings press releases, the company publishes management's prepared remarks via a Current Report on Form 8-K and the Investors section of the company's website at www.athenahealth.com.          To participate in the company's live conference call and webcast, please dial 877.853.5645 (408.940.3868 for international calls) using conference code number 50137013, or visit the Investors section of the company's website at www.athenahealth.com. A replay will be available for one week following the conference call at 855.859.2056 (404.537.3406 for international calls) using conference code number 50137013. A webcast replay will also be archived on the company's website.

    

    

CAS Medical Systems, Inc. (NASDAQ:CASM), a leader in medical devices for non-invasive patient monitoring, announces it has named Kimberly K. Strusky as Executive Vice President of U.S. Sales. Ms. Strusky brings to CASMED more than 25 years of sales experience in the medical device industry.          "We are pleased to welcome Kim to CASMED to lead our efforts in accelerating the commercial success of FORE-SIGHT cerebral oximeters and sensors in the U.S.," said Thomas M. Patton, President and Chief Executive Officer of CASMED. "Kim is an experienced sales professional and has built and managed sales organizations and clinical sales teams that captured market leadership positions. Most relevant, Kim propelled depth-of-anesthesia monitor and disposables sales at Aspect Medical from $10 million to $70 million annually before the company was acquired by Covidien. Her extensive experience in conceptual and clinical selling, sales management, strategic planning and sales training makes Kim an important addition to the CASMED team as we continue to build on the strong U.S. performance of our FORE-SIGHT business, which has reported 21 consecutive quarters of double-digit sensor sales growth."

     

     

ICU Medical, Inc., (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced signing of a definitive agreement to acquire Excelsior Medical Corporation, a manufacturer of healthcare devices used to disinfect and protect access into a patient's bloodstream. Excelsior has developed and commercialized the innovative SwabCap® and SwabFlush® products and is a leader in pre-filled saline and heparin flush syringes. Excelsior is owned by RoundTable Healthcare Partners, an operating-oriented private equity firm focused exclusively on the healthcare industry.           ICU Medical's purchase price for Excelsior is $59.5 million. ICU also signed a definitive agreement to sell the operating assets of SwabFlush and the pre-filled saline and heparin flush syringes to Medline Industries, Inc. for $27 million. The transaction with Medline will close immediately following the acquisition by ICU Medical of Excelsior. Both transactions are expected to close within a week. ICU Medical will serve Medline on an OEM basis as a supplier and innovation partner for Medline's SwabFlush business with a long-term exclusive supply contract.

    

    

Inovalon (NASDAQ:INOV), a leading technology company providing advanced cloud-based data analytics and data-driven intervention platforms to the healthcare industry, will host a distinguished roster of healthcare, pharmaceutical and life sciences industry experts this week during its 2015 Client Congress. Taking place at The Ritz Carlton in Washington, D.C., from October 4-6, Client Congress will feature numerous notable speakers, including Peter Orszag, Ph.D., the former director of the Office of Management and Budget under President Obama; Niall Brennan, chief data officer of the Centers for Medicare & Medicaid Services (CMS); Elliott Fisher, M.D., director of the Dartmouth Institute for Health Policy and Clinical Practice; Daniel Mendelson, president of Avalere Health (now part of Inovalon); James Carville and Mary Matalin, famed political strategists; and dozens of additional industry leaders. The conference will be moderated by Susan Dentzer, senior policy adviser for the Robert Wood Johnson Foundation and former chief editor of the Journal of Health Affairs.          "As the size and complexity of healthcare continues to expand, the sophistication of technologies and best practices needed to achieve meaningful and differentiated results is also increasing," said Robert Wychulis, president of Inovalon. "The active exchange of ideas from such esteemed industry experts at Client Congress will undoubtedly elevate the dialogue and drive advancements that bring significant improvements and a quantifiable impact to the healthcare industry as a whole."

   

    

MannKind Corporation (Nasdaq:MNKD), focused on discovering, developing and commercializing therapeutic products for diabetes, announced today that it will present at the Aegis Capital Corp. 2015 Growth Conference on Thursday, October 8, 2015 at 9:30 am Pacific Time at the Encore at the Wynn Hotel in Las Vegas, Nevada.          Interested parties can access a link to the live webcast of the presentations from the News & Events section of the Company's website at http://www.mannkindcorp.com.

    

    

In a highly competitive and growing field of security services companies supporting the U.S. legal cannabis industry, Medical Marijuana, Inc.’s (OTC Pink:MJNA) subsidiary, Wellness Managed Services’ MPS International (MPSI), rose above the rest.  MPSI is proud to announce that it has been selected as the event security services provider to the National Cannabis Summit held at the Sheraton Downtown Denver October 12th – 13th at 1550 Court Pl, Denver, CO 80202.          According to the National Cannabis Summit website, the event combines three networking groups into one and provides businesses a distinct advantage by uniting business owners from around the country.  The event is being held at the epicenter of the legalized cannabis movement: Denver, Colorado.          In addition to the stringent requirements of event venues, cannabis security is a rapidly growing industry for growers and retailers; all must comply with state and local government mandates.  MPSI is no stranger to providing security services at historic events that include Seattle Hempfest and Denver’s “420” events.           "It is an honor for MPS International, Inc. to win the National Cannabis Summit’s event security services contract," said MPS International Account/Security Manager Sam Grothe. "The field of competitors is loaded, so we consider ourselves very fortunate to provide event security services at such a prestigious event. We have the utmost respect for our competition and we are extremely happy to be in such good company."

       

      

Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that there will be seven poster presentations featured at American Society for Human Genetics (ASHG) meeting being held Oct. 6 to 10, 2015 in Baltimore, Md.          "At Myriad, we are passionately committed to providing the most accurate hereditary cancer tests through extensively validated laboratory and variant interpretation processes. We have spent almost two decades of research to provide the most sophisticated and comprehensive variant classification program," said Rick Wenstrup, M.D., chief medical officer, Myriad Genetics. "We look forward to presenting these seven new studies at ASHG as we continue to advance the state-of-the-art in variant classification with innovative new approaches."

    

    

Oasmia Pharmaceutical AB, a developer of a new generation of drugs within human and veterinary oncology, announced today that it has shipped Paclical, the Company's lead cancer product, to Pharmasyntez, its distribution partner in Russia which is expected to commence sales efforts promptly. Paclical, a novel water-soluble formulation of paclitaxel, was approved in April 2015 by the Russian agency.           Pharmasyntez, the Company's Russia-based distribution partner, is expected to market the product in Russia, Ukraine and Georgia as well as the Commonwealth of Independent States ("CIS") countries. The market for cytostatics in Russia amounts to 2.05 billion USD with an annual growth rate of 36% according to DSM, the Russian equivalent of IMS Health.             "We are pleased to launch Paclical in this important region, effectively providing patients with a treatment that improves their safety profile, enables higher doses, shortens infusion time, and eliminates the need for pre-medication," said Julian Aleksov, Executive Chairman of Oasmia. 

   

    

Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the FDA has cleared the company's Investigational New Drug application (IND) for tinnitus product candidate OTO-311, a sustained-exposure formulation of the N-Methyl-D-Aspartate (NMDA) receptor antagonist, gacyclidine. The IND clearance enables Otonomy to initiate a Phase 1 dose escalation clinical safety trial of OTO-311 in normal healthy volunteers. OTO-311 will be given as a single unilateral intratympanic injection and subjects will be observed for four weeks following dosing.          Tinnitus is the medical term for hearing noise when there is no outside source of the sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. Tinnitus sufferers may have trouble hearing, concentrating, working and sleeping.           "Despite the debilitating nature of tinnitus that impacts millions of Americans, including a high proportion of military veterans, there is no cure and there are no FDA-approved drug treatments," said David A. Weber, Ph.D., president and chief executive officer of Otonomy. "Initiating this Phase 1 trial for OTO-311 before the end of 2015 meets our commitment to investors and also serves as an important first step towards our goal of bringing a single-dose intratympanic treatment to tinnitus sufferers."

       

      

PetLife Pharmaceuticals, Inc. (Ticker:PTLF), a developer of new generation of high potency veterinary cancer medications and nutraceuticals for pets, today announced that it is finalizing an agreement with a new management team consisting of professionals in the pet pharmaceutical business. The team will bring three new, exclusive and state-of-the-art pet pharmaceutical products to be distributed under Petlife Pharmaceuticals. As part of this transition, PetLife is also in the final stages of finalizing substantial financing for the Company to ensure it has the necessary growth capital to execute on its business plan forward, including its existing Escozine For Pets product line.           "We are very excited to be able to announce a number of very positive developments at PetLife today," said Dr. Arthur Mikaelian, Chief Executive Officer of PetLife Pharmaceuticals. "These latest developments, including the expected appointment of an experienced management team from the pet pharmaceutical business and substantial financing should provide us with both the needed growth capital and key personnel to execute on our business strategy. With the proposed financing, the Company should have both the necessary personnel and a strong, cash-rich balance sheet to be able to begin the sales and distribution of three new product lines. This is a significant event for PetLife considering this will represent our first large revenue stream, which we expect will grow rapidly as we penetrate the market and build brand recognition. We believe with these latest developments, the turnaround at PetLife is well underway and we are now on the right path towards rapid revenue growth, profitability and, most importantly, the generation of shareholder value," concluded Dr. Mikaelian.

     

    

Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today pre-clinical data for PRX-106 in Non-alcoholic Steatohepatits (NASH), a liver disease characterized by an accumulation of fat, along with inflammation and degeneration of hepatocytes. PRX-106 is the Company's orally administered, plant cell-expressed recombinant anti-TNF fusion protein that successfully concluded Phase I clinical trial.          In preclinical studies, PRX-106 alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A (ConA) inflammatory mouse model. Furthermore, the drug was shown to alleviate liver damage and reducing liver necrosis and reduction of liver enzymes, ALT and AST, thus leading to an improvement in liver biopsies.           In a high fat diet model (NASH) PRX 106 demonstrated a reduction of liver enzymes, ALT and AST, reduction of serum triglycerides, along with a trend for reduction of liver fat.

   

   

Sientra, Inc. (NASDAQ:SIEN), a medical aesthetics company, today issued the following statement regarding a recent announcement by the Brazilian regulatory agency ANVISA and the Department of the Secretary of State of the State of Rio de Janeiro (SES-RJ) related to products made by Silimed, one of Sientra's contract manufacturers:          On October 2nd, Sientra learned that Brazilian regulatory agencies announced that, as they continue to review the technical compliance related to Good Manufacturing Practices (GMP) of Silimed's manufacturing facility, they have temporarily suspended the manufacturing of all medical devices made by Silimed, including products manufactured for Sientra. ANVISA has also suspended, as a precautionary measure, the use in Brazil of all implantable products manufactured by Silimed.          In its announcement, ANVISA noted that no risks to patient health have been identified in connection with implanting Silimed products, and, accordingly, there is no need to adopt any procedure or action for those patients who have received them. Furthermore, ANVISA also indicated that, based on their contact to date with foreign regulatory authorities, there have been no reports of adverse events related to the use of Silimed products.           Sientra continues to be in active discussions with the United States Food and Drug Administration (FDA) regarding this matter. Importantly, as these discussions continue, the Company continues to offer and make available its products to surgeons and patients in the United States. Sientra believes it currently has ample inventory to address current and near-term future demand.           We remain committed to patient safety and will keep our doctors and other stakeholders apprised of any new developments.




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