|Medical Nutrition USA acquired by Danone. Cell Therapeutics rises on positive NHL study data. Questcor Pharma drops after FDA extends PDUFA date|
|By BioMedReports.com Staff|
|Friday, 11 June 2010 18:21|
Below is a list of the companies that made news in the healthcare sector on Friday, June 11, 2010.
Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) dropped after the bell Friday as the company announced that they received notice from the U.S. Food & Drug Administration that the PDUFA date for Questcor's supplemental new drug application (sNDA) to approve Acthar for the treatment of infantile spasms (IS) has been extended to September 11, 2010. The FDA extended the PDUFA date in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor. This follows the May 6, 2010 votes by the Advisory Committee to the Division of Peripheral and Central Nervous System Drugs of the FDA which indicated support for approval of this new Acthar indication.
"We look forward to working with the FDA over the next few months in order to finalize these critical elements," said Don M. Bailey, President and CEO of Questcor.
Shares fell 84 cents to $9.35 in extended trading Friday,
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) reported Friday exploratory analyses of the data at study completion from the Company's pivotal PIX301 trial of Pixuvri(TM) (pixantrone dimaleate), the first randomized controlled trial in patients with relapsed or refractory, aggressive non-Hodgkin's lymphoma ("NHL"). These analyses demonstrated that patients who achieved a complete response (CR)/unconfirmed complete response (CRu) to Pixuvri had up to a 63% probability of being alive at 24 months compared to a 20% probability for patients treated with comparator agents. The study showed a 21% improvement in overall survival for all patients who received Pixuvri that was independent of factors known to influence survival like prior rituximab use, international prognostic index (IPI) score, prior stem cell transplant, baseline level of LDH (lactate dehydrogenase), or refractory status based on univariate Cox regression analyses of survival. These data were presented at a Company-sponsored lymphoma expert panel during the 15th Congress of the European Hematology Association.
"The overall strength of evidence, including the significant increases observed in clinically-important parameters like overall response rates (ORR) and progression free survival (PFS), provides important support to the clinical benefit of Pixuvri compared to current single-agent treatment in a setting where there are no approved or consensus therapies for relapsed or refractory aggressive NHL," said Dr. Andreas Engert, University Hospital of Cologne. "The updated end-of-study survival data demonstrates a lasting benefit of achieving a CR/CRu with Pixuvri, with 8 of the 12 patients known alive at end of study having achieved a CR/CRu. It is particularly notable that overall survival was not influenced by important risk factors, and also that 76% of the patients who achieved a CR/CRu with Pixuvri failed to respond to or had a lesser response to their last multi-agent therapy. I look forward to working with the Company as it prepares for submission of its Marketing Authorization Application for Pixuvri to the European Medicines Agency."
Shares of Cell Therapeutics closed up more than 24% in Friday trading.
Medical Nutrition USA, Inc. (MNI) (NASDAQ:MDNU), a developer and distributor of nutrition-medicine products, announced Friday that it has entered into a definitive merger agreement with Danone North America, Inc., under which Danone will acquire all the outstanding shares of MNI for $4.00 per share in cash, in a transaction valued at approximately $62.3 million.
Flemming Morgan, President of Medical Nutrition for Danone, said, "I am delighted that the MNI team will be joining our medical nutrition division, including Nutricia North America. MNI has developed solid access to the very promising long term care channel, while Danone's medical nutrition products in the US are mainly aimed at infants and distributed in pharmacies. Because MNI's competencies and successful product lines are so complementary to ours, the combination of the two businesses will reinforce Danone's leadership in Advanced Medical Nutrition, and allow us to expand our reach and benefit the quality of life of more patients, particularly in the US."
Medical Nutrition USA develops and distributes products for the nutritionally at risk who are under medical supervision. Its products are used primarily in long-term care facilities, hospitals, dialysis clinics and bariatric clinics. The Company's product lines include Pro-Stat®, Fiber-Stat®, UTI-Stat® and Diff-Stat® as well as private label products.
Shares of Medical Nutrition surged 42% higher on the news, rising $1.17 to $3.95.
Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) jumped more than 17% Friday after the company announced that Cook Medical, a license holder of Angiotech's paclitaxel technology, has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the company's unique polymer-free Zilver(R) PTX(R) Drug-Eluting Peripheral Stent. Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), Zilver PTX is a self-expanding, highly durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an anti-proliferative drug, to the target lesion.
Advanced Cell Technology, Inc. (OTCBB: ACTC) announced that human embryonic stem cell (hESC) line MA135 was unanimously approved for federal funding at the 100th Meeting of the Advisory Committee to the Director (ACD) National Institutes of Health (NIH). In addition to MA135, seven additional stem cell lines derived at ACT are currently under review by the NIH. Five of these lines were produced without embryo destruction using ACT’s proprietary single-blastomere "embryo-safe" technology. The federal funding could accelerate the company’s clinical activities.
ImmunoCellular Therapeutics (OTCBB: IMUC) announced that the U.S. Food and Drug Administration has granted orphan drug designation for ICT-107, the company’s dendritic cell-based cancer vaccine candidate which targets glioblastoma multiforme (GBM).
"We are pleased that FDA has recognized the potential that ICT-107 has to treat GBM and has granted us orphan drug status", said ImmunoCellular Therapeutics’ president and CEO said Manish Singh, Ph.D. "The designation should facilitate a shorter time period to approval and reflects the FDA’s views on the importance of developing a treatment which will improve survival outcomes for those afflicted with this terrible disease."
The 12-month disease-free survival from the time of surgery was 75% with ICT-107, compared with a historical control survival rate of 26.9%, and the 18-month disease-free survival with ICT-107 was 49.2%, compared with 18.4% historically. Safety data for ICT-107 also compared favorably to current treatments.
Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) launched a new interactive website for its USFDA-approved Onko-Sure™ in vitro diagnostic (IVD) cancer test. The site, which can be found at www.onko-sure.com, offers detailed information on RPC's proprietary, USFDA-approved Onko-Sure IVD cancer test, CLIA laboratory testing resources and general information on cancer screening, testing and treatment.
Abbott (NYSE:ABT) today declared a quarterly common dividend of 44 cents per share.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it will oppose a motion filed by the Teva defendants to amend their answer to add a new defense in the patent litigation between Cubist and Teva pending in the US District Court for the District of Delaware.
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that APP Pharmaceuticals will immediately begin marketing Oxaliplatin Injection (liquid) in the U.S.
Genta Incorporated (OTCBB: GETA.OB) announced that the Company will host a conference call and live audio webcast of its 2010 Annual Meeting of Shareholders.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a Paragraph IV Certification Notice Letter advising that Lupin Limited submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration requesting permission to manufacture and market a generic version of Ranexa® (ranolazine extended-release tablets).
Human Genome Sciences, Inc. (NASDAQ:HGSI) announced today that its presentation at the Goldman Sachs 31st Annual Global Healthcare Conference will be webcast and may be accessed at www.hgsi.com.
Javelin Pharmaceuticals, Inc. (NYSE-Amex: JAV) today announced that Hospira, Inc. funded a $2 million loan to Javelin on June 10, 2010 under the existing loan agreement between Javelin and Hospira.
KV Pharmaceutical Company (NYSE: KVa/KVb), a specialty pharmaceutical company, conducted its Annual Meeting of Shareholders on June 10, 2010 for the fiscal year ended March 31, 2009.
Laural Resources, Inc. (OTCBB:LRAL) is pleased to announce that effective June 4th it has entered into a Letter of Intent (the "LOI") with Abtech Industries, Inc., a Delaware corporation ("Abtech"), whereby the Company proposes to acquire all of the issued and outstanding capital stock of Abtech.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Traditional Chinese Medicine company Sundise will implement Medidata Rave® as its electronic data capture (EDC) and clinical data management (CDM) solution.
MMR Information Systems, Inc. (OTCBB:MMRF) announced today that a petition has been granted by the U.S. Patent and Trademark Office to reinstate its U.S. Patent titled "METHOD AND COMPOSITION FOR ALTERING A B CELL MEDIATED PATHOLOGY".
NeoPharm, Inc. (Other OTC: NEOL.PK), a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced its first quarter 2010 financial results.
PPD, Inc. (Nasdaq: PPDI) today announced it has been rated one of Europe's top contract research organizations (CROs) in the 2010 CenterWatch European Site Survey.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will webcast its presentations at the Goldman Sachs 31st Annual Global Healthcare Conference on Wednesday, June 16, 2010 at 2:40 p.m. PDT (5:40 p.m. EDT), at the NASDAQ OMX 24th Investor Program on Wednesday, June 23, 2010 at 7:30 a.m. GMT (2:30 a.m. EDT), and at the 2010 Wells Fargo Securities Healthcare Conference on Thursday, June 24, 2010 at 2:30 p.m. EDT.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.