|RxNews Recap for Tuesday 03-23-10. Dynavax rises on positive Hep B Vaccine safety data.|
|By BioMedReports.com Staff|
|Tuesday, 23 March 2010 20:40|
Dynavax Technologies Corporation (NASDAQ:DVAX) rose sharply today after the company reported that they will present for the first time a detailed analysis of safety data for HEPLISAV™, an investigational adult hepatitis B vaccine, including two major findings: 1) The safety profile of HEPLISAV was comparable to that of Engerix-B®, one of two currently licensed vaccines for the prevention of hepatitis B infection, and 2) There is no difference in autoimmune adverse events or laboratory markers of autoimmunity between subjects vaccinated with HEPLISAV and Engerix-B.
The results of nine completed clinical studies comparing HEPLISAV to Engerix-B and an analysis of approximately 9,300 blood samples from subjects vaccinated with HEPLISAV or Engerix-B will be presented at the Drug Information Association's (DIA) Third Oligonucleotides-based Therapeutics Conference in Bethesda, MD on March 24, 2010. The safety data was originally prepared for submission to the FDA as part of extensive documentation that formed the basis upon which HEPLISAV's clinical development was allowed to resume in late 2009.
Shares finished the day up 14.17% or 18 cents to close at $1.45.
After the bell Tuesday:
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) announced after the bell today financial results for the fourth quarter and year ended December 31, 2009. Cyclacel also provided an overview of its recent achievements and planned 2010 milestones.
The Company's net loss for the fourth quarter of 2009 was $4.3 million or $0.18 per share, compared to a net loss of $7.9 million or $0.39 per share for the fourth quarter of 2008. For the year ended December 31, 2009, the Company reported a net loss of $19.6 million or $0.88 per share, compared to a net loss of $40.4 million or $1.98 per share for the year ended December 31, 2008. As of December 31, 2009, cash and cash equivalents totaled $11.5 million.
MDRNA, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, announced today that it has acquired intellectual property for bridged nucleic acids from Valeant Pharmaceuticals North America.
Stryker Corporation (NYSE:SYK) today after the bell announced that it has been informed by the U.S. Food and Drug Administration (FDA) that the actions undertaken by the Company to address the issues raised in a 2007 Warning Letter are sufficient.
The Company received the Warning Letter from FDA regarding compliance with certain quality system requirements at its reconstructive implant manufacturing facility in Mahwah, New Jersey in 2007.
Following FDA re-inspection in 2009 and additional corrective actions, the Company has been informed that issues raised have been adequately addressed and no further formal corrective actions are required.
Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT) today announced that the second patent covering the composition and use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate, has been issued by the United States Patent and Trademark Office. Transcept has previously announced the issuance of a Notice of Allowance for claims under the application for this patent, U.S. Patent Application Serial No. 11/833,323, on November 4, 2009. The newly issued patent, U.S. Patent No. 7,682,628, titled "Compositions for Delivering Hypnotic Agents Across the Oral Mucosa and Methods of Use Thereof," will expire no earlier than February 2025.
Earlier in the day:
Abbott (NYSE:ABT) today announced that its wholly-owned subsidiary, Amber Acquisition Inc., has commenced its cash tender offer for all outstanding shares of common stock of Facet Biotech Corporation at a price of $27 per share. The tender offer is being made pursuant to an Offer to Purchase, dated March 23, 2010, and in connection with the Agreement and Plan of Merger, dated March 9, 2010, by and among Abbott, Amber Acquisition Inc., and Facet, which Abbott and Facet announced on March 9, 2010.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that it has earned a $20 million technology transfer payment from Takeda Pharmaceutical Company Limited as part of the strategic alliance the companies formed in May 2008. This payment is related to the achievement of certain pre-defined objectives in the transfer of Alnylam’s platform technology, including documents, materials, and know-how, to Takeda for the development of RNAi therapeutics. Alnylam has previously received $120 million in upfront and technology transfer payments from Takeda. In addition to this current $20 million payment, Alnylam is eligible to receive an additional $10 million in near-term technology transfer payments. Alnylam is also eligible to receive significant milestones and royalties related to the Takeda’s advancement of RNAi therapeutic products, and has retained certain product opt-in rights in the U.S. market.
Albany Molecular Research, Inc. (AMRI) (NASDAQ:AMRI) today announced that it along with sanofi-aventis U.S. LLC, has filed a motion for a preliminary injunction in the United States District Court for the District of New Jersey seeking to enjoin Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (Dr. Reddy’s) from the commercial distribution of generic versions of Allegra-D® 24 Hour (fexofenadine HCl 180 mg and pseudoephedrine HCl 240 mg) Extended-Release Tablets in the U.S. This action is in response to the March 17, 2010 approval of Dr. Reddy’s generic version of Allegra-D® 24 Hour by the FDA.
AspenBio Pharma, Inc. (NASDAQ:APPY) reported today that it has completed patient enrollment for its AppyScore™ pivotal clinical trial designed to evaluate 800 patients suspected of having acute appendicitis. The study has now advanced to the data analysis phase. The company estimates approximately six to eight weeks will be required to independently review and validate final clinical and assay data and statistical analysis. Upon completion of this analysis the data will then be included in the FDA 510(k) package. The company continues to plan on completing the FDA 510(k) submission in the second quarter of 2010.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) shot up today after the company announced positive GVAX AML Vaccine results and BioSante’s receipt of Orphan Drug designation from the FDA’s Office of Orphan Products Development for GVAX AML Vaccine in the treatment of acute myeloid leukemia (AML). This Orphan Drug designation is the second GVAX cancer vaccine from BioSante to secure FDA orphan drug designation. Shares rose 13 cents or 7.47% to close the day at $1.87.
Clinical Data, Inc. (NASDAQ: CLDA), today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. "This is a major milestone in the development of vilazodone and, if approved, its dual mechanism of action and safety profile will offer a new alternative for patients suffering from depression," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data.
Competitive Technologies, Inc. (NYSE Amex:CTT) announced that a premier physician oncology practice based in Virginia has begun using CTT's Calmare(R) Therapy pain therapy medical device to treat patients suffering from pain related to cancer, under the direction of several medical oncologists. This group with more than 30 years of experience caring for cancer patients is affiliated with a national cancer treatment and research network.
Generex Biotechnology Corporation (Nasdaq:GNBT) has demanded a retraction of and apologies for the inaccuracies in an online article published to TheStreet.com on March 19. In an entry titled "Biotech Stock Mailbag: Generex," TheStreet.com columnist Adam Feuerstein makes erroneous claims about Generex and its flagship product Generex Oral-lyn(TM), an oral insulin spray currently in Phase III clinical trials for the treatment of Type I and Type II diabetes. Generex also wishes to correct the public record by making clear the facts as outlined in the letter to TheStreet.com's counsel:
GTx, Inc. (Nasdaq: GTXI) and Ipsen (Euronext: FR0010259150; IPN) today announced the expansion of their partnership for the development and commercialization of toremifene 80 mg for the reduction of fractures in men with advanced prostate cancer on androgen deprivation therapy (ADT) and toremifene 20 mg for the prevention of prostate cancer in high risk patients with High Grade Prostatic Intraepithelial Neoplasia lesions (HGPIN).
InterMune, Inc. (Nasdaq:ITMN) today announced that the company's Marketing Authorization Application (MAA), submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, was validated by the European Medicines Agency (EMA). Validation of the MAA by the EMA indicates that the application is complete and that the review process will begin on March 24. The proposed trade name for pirfenidone in both the United States and Europe is Esbriet®.
Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that its Board of Directors has approved an aggregate total of up to $60.9 million to repurchase the Company's outstanding common shares in the open market or in privately negotiated transactions. This authorization includes the $10.9 million balance remaining from the $65 million repurchase program announced in 2007 plus an additional $50 million. To date, Nabi has repurchased 13.9 million shares of common stock for a total of $54.1 million under the 2007 program.
NexMed, Inc. (Nasdaq: NEXM), a company with a revenue generating discovery pre-clinical CRO and a pipeline of products based on the NexACT® technology, today announced that its wholly-owned subsidiary, Bio-Quant has signed a distribution agreement with Cosmo Bio Co., Ltd, under which Cosmo Bio will market Bio-Quant’s discovery and pre-clinical contract research services throughout Japan.
Oncothyreon Inc. (Nasdaq:ONTY) plunged today after the company announced that Merck Serono, a division of Merck KGaA of Darmstadt, Germany, and its U.S. affiliate, EMD Serono, Inc., have temporarily suspended the worldwide clinical development program for Stimuvax(R) (BLP25 liposomal vaccine). The suspension is the result of a suspected unexpected serious adverse reaction in a patient with multiple myeloma participating in an exploratory clinical trial. This decision was taken in alignment with the U.S. Food and Drug Administration's (FDA) clinical hold placed on the Investigational New Drug (IND) application for Stimuvax. Shares fell $1.29 or 26.99% to close at $3.49.
Pfizer Inc. (NYSE:PFE) today announced it has signed a 10-year Provisional Supply Agreement to supply Prevenar 13* (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]), the company’s 13-valent pneumococcal conjugate vaccine, for infants and young children in the world’s poorest countries under the terms of the Advance Market Commitment (AMC) pilot project against pneumococcal disease. The AMC is a novel public-private approach to public health funding designed to create a sustainable marketplace, ensure a stable supply of pneumococcal vaccines and stimulate the development and expansion of manufacturing capacity of vaccines specifically for the world’s poorest countries.
Palatin Technologies, Inc. (NYSE Amex: PTN) announced today that it received $2.5 million from AstraZeneca AB pursuant to the September 2009 amendment of the exclusive research collaboration and license agreement to discover, develop and commercialize compounds that target melanocortin receptors for treatment of obesity and related indications. Payment of the $2.5 million was contingent on the successful completion by Palatin of certain tasks this quarter relating to the program. Palatin received an initial $2.5 million upon signing the September 2009 amendment.
Separately, Palatin announced receipt of a letter from NYSE Amex determining that Palatin successfully resolved the continued listing deficiencies referenced in a December 2008 letter from NYSE Amex.
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (DAX:PJT) today announced that it has been granted a European Patent on its core 3D cell expansion technology. The granting of the European patent follows the issuance of several corresponding US patents as well as corresponding patents in ten additional jurisdictions. A divisional application of the now granted European application has been timely filed. In addition to these granted patents, Pluristem's portfolio consists of 39 pending patent applications on the methods for production and expansion of stromal, progenitor and hematopoietic cells and the use of the obtained cells for the treatment of numerous severe degenerative, ischemic and autoimmune disorders in human subjects and for veterinary regenerative uses..
Pain Therapeutics, Inc. (Nasdaq:PTIE) roase today after the company announced encouraging clinical data with PTI-188, an early-stage drug for metastatic melanoma. Metastatic melanoma is a lethal form of skin cancer in which patients typically have a median survival time of 9 months.
Although efficacy was not a primary endpoint, PTI and its clinical investigators were encouraged by the number of melanoma tumors that had either stabilized or decreased in size after a single dose of PTI-188. In a first Phase I study with PTI-188, most patients (nearly 70%) showed stable disease in target lesions at the conclusion of the six-week study. In a second Phase I study, approximately 40% of patients showed stable disease at week fourteen. Preliminary analysis, combining both clinical studies, indicates a median overall survival time of 13 months (n=19).
Symyx Technologies, Inc. (Nasdaq:SMMX) today announced a partnership with Simulations Plus, Inc. (Nasdaq:SLP) to improve the predictive modeling of metabolites. Under the terms of the agreement, Simulations Plus will use information from the highly regarded Symyx Metabolite database to develop a new system for in silico predictive modeling of metabolic properties, enabling R&D organizations to improve compound design, drive down experiment costs, and reduce late product failures.
TomoTherapy Incorporated (NASDAQ:TOMO), rose today after the maker of advanced radiation therapy solutions for cancer care, today cited the first published results on the concurrent use of hypofractionated TomoTherapy(SM) radiation treatments and chemotherapy for unresectable locally-advanced non-small cell lung cancer (NSCLC)."It is very rewarding to once again see TomoTherapy technology playing a key role in advancing the management of this disease for which survival rates have traditionally been so dismal," said TomoTherapy CEO Fred Robertson. "We appreciate that radiation therapy often must go hand-in-hand with drugs. In this case, the TomoTherapy platform plays its part by safely enabling innovative and aggressive combination treatments.".
Affymetrix, Inc. (NASDAQ:AFFX) and The Jackson Laboratory today announced the full commercial launch of the Affymetrix® Mouse Diversity Genotyping Array.
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.