|FDA approves Spectrum's ready-to-use FUSILEV. Biogen soars and Teva tumbles on MS drug trial data. Nektar drug granted orphan status|
|By Mary Davila|
|Thursday, 21 April 2011 19:12|
Spectrum Pharmaceuticals (NasdaqGS:SPPI) today announced that the FDA has approved the Company’s Supplemental New Drug Application for FUSILEV (levoleucovorin) Injection. Unlike the currently available lyophilized product, this approval is for a “Ready-to-Use” (RTU) formulation of FUSILEV for Injection.
“We are pleased that the FDA has approved the RTU formulation of FUSILEV,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “As the name implies, the RTU formulation provides an additional option for physician and medical staff use. The RTU formulation requires no reconstitution, and is of a higher strength than the currently available lyophilized formulation.”
FUSILEV for Injection is currently FDA approved and marketed by Spectrum for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination, and of inadvertent overdosage of folic acid antagonists. FUSILEV is currently under review by the FDA for use in advanced metastatic colorectal cancer. The Prescription Drug User Fee Act (PDUFA) action date for the supplement is April 29, 2011.
Shares of Spectrum were briefly halted at $9.06 and shot up to as high $9.75 when they re-opened. Shares settled the day at $9.32, up 23 cents.
Shares of Biogen Idec Inc. (NASDAQ:BIIB) soared today after the company reported positive data from its late stage trial of BG-12, the company's experimental multiple sclerosis drug. The company said that the drug reduced the proportion of relapsing patients by 49% at two years compared to those patients receiving a placebo. The company also said the drug cut the rate of disability progression by 38% compared to placebo at two years. Shares of Biogen raced to a new 52 week high of $106.99 before settling the day at $99.70, up $13.13 or 15%.
Meanwhile, shares of Teva Pharmaceutical Industries ltd. (Nasdaq:TEVA) fell on the Biogen news as investors feared that BG-12 could evetually pose a threat to Teva's MS drug, Copaxone. In 2010 Teva reported $3.32 billion in sales for Copaxone. Shares of Teva fell $4.16 or 8.46% to $45.01.
Nektar Therapeutics (Nasdaq:NKTR) today announced that the company's oncology drug candidate, NKTR-102, has been granted orphan drug status for the treatment of women with ovarian cancer by the U.S. Food and Drug Administration (FDA).
"This designation is an important step in the overall development program for NKTR-102 and underscores our commitment to treating women with ovarian cancer," said Dr. Lorianne Masuoka, Senior Vice President and Chief Medical Officer of Nektar Therapeutics.
Shares of Nektar gained 29 cents to $9.82.
Oragenics, Inc. (OTCBB:ORNI.ob) announced today the issuance of patent number 7931892 from the United States Patent and Trademark office for ProBiora3, a proprietary blend of naturally occurring oral bacteria shown to produce a wide range of oral care benefits. ProBiora3 contains three strains of beneficial oral bacteria that help maintain a healthy microbial balance in the mouth. It is 100% natural and is made in the USA in an FDA-registered and GMP-certified facility. Shares jumped $1.05 to $3.80.
Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), today announced the death of John G. Curd, M.D., president and chief medical officer. Dr. Curd died suddenly and unexpectedly of apparent natural causes on April 20.
"We are very much in shock and grief by this sudden loss of our colleague and friend, and our immediate thoughts go out to John's family," said Barry Selick, Threshold's chief executive officer. "We will provide a more thorough press release in the coming days that does justice to John's tremendous contributions to Threshold and the biotech community. We will at that time also provide an update on how the company will manage through this loss."
Threshold does not expect that Dr. Curd's passing will have an impact on its ongoing or planned clinical trials.
Amgen (NASDAQ:AMGN) today outlined the Company's strategy, capital allocation plans and provided financial guidance for 2015 during a meeting with investors in New York.
BioNeutral Group, Inc. (OTC Bulletin Board:BONU), a specialty life science technology-based company, today announced several milestone achievements throughout the first two quarters of its fiscal year ending October 31, 2011.
Cephalon, Inc. (NASDAQ:CEPH) today announced that it has filed a definitive Consent Revocation Statement with the Securities and Exchange Commission (SEC) urging shareholders to reject Valeant Pharmaceuticals International Inc.'s proposals to remove Cephalon's entire Board of Directors and replace them with nominees hand-picked by Valeant.
China Botanic Pharmaceutical Inc. (NYSE AMEX:CBP) ("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM") in China, today announced that the Company has successfully completed a feasibility study to analyze the benefits of using straw pellets, a renewable bio-fuel, for its production operations.
Cord Blood America, Inc. (OTC Bulletin Board:CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, is pleased to announce that its shareholders have approved an amendment to the Company's Articles of Incorporation effecting a reverse stock split.
Kendle (Nasdaq:KNDL) announced today it will release its first quarter 2011 financial results after the market closes on Wednesday, May 4, 2011.
Life Technologies Corporation (NASDAQ:LIFE) today opens registration to the Life Grand Challenges, a first-of-its-kind crowd-sourcing competition that calls for innovative ideas and techniques from the science community to double the company's current performance baseline for scalability, speed and accuracy on the Ion Personal Genome Machine (PGM™).
Masimo (NASDAQ:MASI) announced today that a new study published in this month's issue of the peer-reviewed journal, Annals of Emergency Medicine, demonstrates that noninvasive Masimo carboxyhemoglobin (SpCO®) measurements provide an "effective means for screening at-risk populations for CO poisoning" with "acceptable bias and precision" compared to invasive blood gas analysis.
NeoGenomics, Inc. (NASD OTC BB: NGNM), a leading provider of cancer-focused genetic testing services today reported its results for the first quarter 2011.
QIAGEN N.V. (Nasdaq:QGEN) today announced the Webcast of its first quarter 2011 financial results call.
Tibet Pharmaceuticals, Inc. (NASDAQ:TBET), an emerging specialty pharmaceutical company engaged in the development, manufacturing and marketing of traditional Tibetan medicine in China, today released an online corporate overview video.
United Therapeutics Corporation (NASDAQ:UTHR) announced today that it will release its first quarter 2011 financial results before market open on Thursday, April 28, 2011.