NeoStem Chair, Sends Letter to Holders: Company On Track for Preserve Phase 2 Enrollment; Medical-Device Makers See EU Rules Slowing U.S. Approvals Print E-mail
By Staff and Wire Reports   
Wednesday, 25 September 2013 18:56
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 25, 2013.

NeoStem (Nasdaq: NBS), a leader in the emerging cellular therapy market, continues to position itself for success through scientific discovery, a diversified product development pipeline that addresses cardiovascular and autoimmune diseases as well as regenerative medicine, an expanding contract development and manufacturing business that serves as its revenue generating arm, and a professional and experienced management team.

We are proud to be at the forefront of a paradigm shift in medicine toward cell therapy – a shift away from treating disease with drugs and toward treating disease with our own cells; a shift away from treating symptoms and toward cures for illnesses that cause the most suffering; a shift away from chemical drug development and toward looking inside ourselves to understand and then amplify our bodies' natural repair mechanism. We firmly believe that the future of medicine emanates from within each of us and NeoStem is dedicated to unlocking the potential of cellular therapy for humankind.

NeoStem prides itself on not being "just another biotech company." In the ever-changing global economy, ingenuity is rewarded. We are building the Company based on the foundation and sector expertise provided by our contract development and manufacturing subsidiary, Progenitor Cell Therapy ("PCT"). As a leader in the cell therapy industry in-process development innovation and cost effective scale-up, PCT supports NeoStem's internal development of its therapeutic programs. Our investments in our therapeutic pipeline, which we have approached with scientific discipline and business and market analysis, include significant opportunities which are protected by an expanding intellectual property portfolio, positioning the Company for dynamic partner collaborations.

As more cellular therapies enter clinical trials and therapies start to become commercially available, scores of scientists, doctors and patients are awakening to a simple reality – cell therapies hold the potential to vanquish a plethora of diseases and dangerous medical conditions. NeoStem is dedicated to its leadership role in cellular therapy and we look forward to an amazing future built on the accomplishments of today.

We have been extremely busy and productive at NeoStem as we continue to implement our Company's strategic growth and development plans, all the while never losing sight of our responsibility to the health and wellness of the public. Our pipeline of proprietary cell therapy products continues to develop and, most notably, we are on track to complete enrollment of our PreSERVE Phase 2 clinical trial this year, investigating the Company's most advanced product candidate, AMR-001, in preserving heart function after a severe heart attack, with data read out 6-8 months after the last patient is infused. PCT continues to strengthen its presence in the contract development and manufacturing arena. And lastly, our Company has undergone a positive corporate change by moving our stock listing to NASDAQ intended to make us more competitive in the marketplace and enhance exposure to institutional shareholders, while at the same time providing investors with the best prices, the fastest execution and lowest cost per trade.

Finally, our search for the brightest talent to make our Company the "best in class" has brought us experienced industry executives that we believe will assist in maximizing shareholder value. We have recently added four new key members to our management team – each a seasoned executive in the field – raising the Company's profile in the industry, increasing our core knowledge and skill base, and increasing our competitiveness amongst our peers. The team members include Dr. Douglas Losordo, Chief Medical Officer; Robert Dickey IV, Chief Financial Officer; Stephen W. Potter, Executive Vice President; and Robert Shaw, Vice President of Commercial Sales, PCT.



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U.S. medical-device manufacturers are looking anxiously across the Atlantic as the European Union prepares to tighten the process to approve new products, a step companies say will crimp their lifeline to funding and patients.

The EU’s overhaul is meant to close loopholes that allowed breast implants made with industrial-grade silicone to be implanted in thousands of women. Yet device makers say the new rules will delay approvals without increasing safety. The European Parliament’s Committee for Environment, Public Health and Food Safety today backed a tighter approval process for high-risk devices by experts designated by the European Medicines Agency, a spokesman said. The proposal will be the basis for negotiating with member states on final rules.

Smaller U.S. companies depend on the EU’s easier process to test their products and accumulate patient data that they may use to get approval in the U.S., the world’s most-profitable health-care market. Companies can get their devices approved in Europe years earlier than in the U.S., according to the European device-industry group Eucomed.

“The bar is set artificially high in the U.S.,” said Kevin Sidow, chief executive officer of Moximed, a Hayward, California-based company with a knee-implant system approved in Europe. “If the rest of the world begins to raise the bar of approval to the U.S. level, it will surely damage investment in innovation and patient progress will plateau.” He expects a U.S. regulatory decision on the product, called KineSpring, in 2016, which would be seven years after getting EU clearance.


Also Wednesday:


Actavis, Inc. (NYSE: ACT)
, announced today that it intends to release third quarter 2013 financial results on Tuesday, October 29, 2013, prior to the open of the U.S. financial markets.

Anthera Pharmaceuticals (NASDAQ: ANTH)
, a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, announced today that emerging data from its Phase 2b PEARL-SC study and subsequent Open-Label Extension study will be presented by Dr. Richard Furie at the 2013 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP).

Healthpoint Biotherapeutics today announced it will assume the Smith & Nephew (LSE: SN, NYSE: SNN) corporate identity as part of its ongoing integration into the global medical technology business. Smith & Nephew acquired Healthpoint Biotherapeutics in December 2012.

HPIL Holding (OTCQB: HPIL)
is pleased to announce that its wholly owned subsidiary HPIL ENERGYETCH Inc., on September 23, 2013, entered into a Cooperation Agreement (the "Agreement") with OFFICINE MECCANICHE PEJRANI SRL ("O.M.P."), a private company focused on investing in the ecology and energy sectors.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, announces Will Lewis, Insmed's President and Chief Executive Officer, will deliver a corporate overview at the upcoming Leerink Swann Rare Disease Roundtable taking place October 2, 2013 at the Parker Meridian, New York.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced it has reached a settlement agreement with Medtronic MiniMed, Inc. et al. to settle the pending patent infringement lawsuit brought by Medtronic MiniMed against Insulet.

La Jolla Pharmaceutical Company (OTCBB: LJPC)
, a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced that it has entered into definitive agreements related to a private placement of approximately 96 million shares of common stock at a price of $0.07 per share and 3,250 shares of Series F Preferred Stock priced at $1,000 per share.

Ohr Pharmaceutical (NASDAQ: OHRP)
, a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced that Dr. Irach Taraporewala, CEO, will present a corporate overview and business update at the Aegis Capital Corporation 2013 Healthcare Conference, being held at the Encore at Wynn Las Vegas on September 25-28, 2013.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
, a developer of oral drug delivery systems, announced today that it has been invited to participate in an exclusive Israeli Biotech Corporate Day, hosted by Barclays on September 30, 2013 in Zurich, Switzerland.  

Palatin Technologies, Inc. (NYSE MKT: PTN)
will announce its fourth quarter, fiscal year 2013 operating results on Monday, September 30, 2013 after the close of the U.S. financial markets.

Plandaí Biotechnology, Inc. (OTCQB: PLPL)
, a producer of highly bioavailable plant extracts for industries including health, wellness, nutraceutical, and pharmaceutical, today announced that it has executed a letter of intent with a major producer of nutraceutical cold and flu remedies under which all of 2014 estimated production capacity of Phytofare™ Limonoid Glycoside Complex, estimated at 15 tons, will be purchased.

PTC Therapeutics, Inc. (NASDAQ: PTCT)
announced that four posters will be presented at the 18th International World Muscle Society Congress (WMS) in Asilomar, California, on October 1-5.

Regado Biosciences, Inc. (Nasdaq: RGDO)
, a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced it will present at the Aegis Capital Vegas Healthcare Conference, to be held September 25 – 28, 2013, at the Encore at Wynn Las Vegas.

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH)
, is very pleased to announce the appointment of Tessie Mary Che, Ph.D. to the Company's Board of Directors.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)
today announced that enrollment in the company's pivotal, Phase 3 VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory acute myeloid leukemia (AML) is now complete.

Trovagene, Inc. (NASDAQ: TROV)
, a developer of cell-free molecular diagnostics, announced the issuance of U.S. Patent 8,501,924, "Nucleophosmin protein (NPM) mutants, corresponding gene sequences and uses thereof."



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