|RxNews Recap for Wednesday 03-17-10. Abraxis BioScience surges after lung cancer trial meets endpoints.|
|By BioMedReports.com Staff|
|Wednesday, 17 March 2010 19:12|
Abraxis BioScience, Inc. (NASDAQ:ABII) soared today after the company announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review. Abraxane is currently approved for treatment of breast cancer. "NSCLC is the most common form of lung cancer and is very difficult to treat. We are extremely pleased with the data from this Phase 3 combination study that demonstrated superiority of ABRAXANE over Taxol as we seek to bring new treatment options to these patients," said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience. "We anticipate filing an sNDA to the FDA during 2011 for what will be the second indication for ABRAXANE in the U.S." Shares of Abraxis shot up more than 30%, closing up $12.15 to $52.00.
In news after the market closed:
EnteroMedics Inc. (NASDAQ:ETRM), after the bell shares moved higher as the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that it has extended its 2005 collaboration agreement with the Mayo Clinic for an additional two years. The collaboration will continue to focus on the research and development of vagal-blocking technology for the treatment of obesity and other gastrointestinal disorders. EnteroMedics will retain exclusive rights to obesity-related devices developed through this collaboration. Mayo Clinic has licensed technology to EnteroMedics and holds equity in the Company.
MediciNova, Inc.(Nasdaq:MNOV) and (Osaka Securities Exchange Code Number: 4875), today after the bell reported positive preliminary results from a Phase Ib clinical trial to evaluate the safety and efficacy of MN-221 in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD). There were no clinically significant safety concerns noted. Preliminary results demonstrated clinically significant improvements in percent change in forced expiratory volume in one second (FEV(1)).
SurModics, Inc. (Nasdaq: SRDX), after the market closed announced today that it has entered into an agreement with ForSight Labs, LLC to license certain non-core ophthalmology technology. The technology licensed in this agreement does not include the Company’s I-vation™ drug delivery technology. While the license agreement contains an up-front license fee, milestone payments and royalties, specific terms of the agreement were not disclosed.
Theravance, Inc. (NASDAQ:THRX), a biopharmaceutical company with a pipeline of internally discovered product candidates, after the bell announced that it intends to offer, subject to market and other conditions, 7,500,000 shares of its common stock in an underwritten registered public offering. Theravance intends to grant the underwriters a 30-day over-allotment option to purchase on the same terms and conditions up to an additional 1,125,000 shares of common stock.
In other news Wednesday:
Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) and King Pharmaceuticals, Inc. (NYSE:KG) today announced that the U.S. Food and Drug Administration has publically announced the scheduling of an April 22, 2010 Advisory Committee meeting to discuss the New Drug Application ("NDA") for Acurox(R) (oxycodone HCl and niacin) Tablets and the results of studies evaluating the addition of niacin for the purpose of reducing the misuse of oxycodone. The scheduled meeting will be a joint meeting of the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees. Acurox(R) is an investigational new drug product and is not approved for marketing or commercial distribution.
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults. Bristol-Myers Squibb and AstraZeneca submitted the NDA with the U.S. FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.
Clarient, Inc. (Nasdaq:CLRT), shares rose today after the provider of technology and services resource for pathologists, oncologists and the pharmaceutical industry announced that data from a new study shows that Clarient's Ovotax™ assay may effectively predict which ovarian cancer patients will respond favorably to taxane therapy and could, therefore, be spared the potential side effects of this rigorous and sometimes toxic chemotherapy agent. The study was presented yesterday at the national meeting on Women's Cancer of the Society of Gynecologic Oncologists by Janelle Fauci, M.D. of the Department of Obstetrics and Gynecology at the University of Alabama, Birmingham (UAB).
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported findings from Study 305, a study evaluating the effect of Northera(TM) (Droxidopa), an investigational agent being studied for the treatment of neurogenic orthostatic hypotension (NOH), on patients' 24-hour blood pressure (BP) profile.
China Sky One Medical, Inc. (Nasdaq:CSKI), saw its shares plummet today after the company announced financial results for the fourth quarter and fiscal year ended December 31, 2009. The company reported that its fourth-quarter profit fell due to stock-based compensation costs and other expenses. "The Company's record revenues in 2009 were primarily driven by positive contribution from the strategic acquisitions that we completed in 2008, heightened consumer brand awareness and expansion of our sales network. Our full year net income was slightly below our expectations due to increased operating costs from several acquisitions in 2008 and our new corporate headquarters and other non-cash expense items as previously discussed," said Mr. Yan-Qing Liu, Chairman and CEO of China Sky One Medical, Inc. "Looking ahead, the Company plans to make significant investment in the development of high margin branded drugs to support long-term sustainable growth. With a growing distribution network and a growing pipeline of SFDA License for drug batch lots, China Sky One is well positioned to be a leading pharmaceutical company in China." Shares dropped more than 15% on the news.
Enzo Biochem, Inc. (NYSE:ENZ), a vertically integrated biotechnology company engaged in the research, development, manufacture, licensing and marketing of innovative health care products, platforms and services based on molecular and cellular technologies, announced today a supply and distribution agreement between Enzo Life Sciences and privately-owned Cancer Genetics Inc., a leading producer of nucleic acid products used in genomic research. This agreement covers Enzo’s proprietary fluorescent dye labels for increasing signal intensity in labeling nucleic acids.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the results of its randomized Phase 2 trial of mapatumumab (HGS-ETR1) in combination with the chemotherapy agents paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC).
The results showed no difference in disease response or progression-free survival for the combination that included mapatumumab vs. the control group, and showed that mapatumumab was well tolerated in this study. HGS expects to present the results in full at an appropriate scientific meeting later in 2010.
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced that two abstracts related to its Toll-like Receptor 9 (TLR9) agonist, IMO-2125, were accepted for presentation at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 14-18, 2010. IMO-2125 is being evaluated for potential applications in chronic hepatitis C virus (HCV) infection. The accepted abstracts include an oral presentation of interim results from a Phase 1 clinical trial which evaluated IMO-2125 in null-responder HCV patients and a poster presentation of gene expression profiles in human peripheral blood mononuclear cells (PBMCs) stimulated with IMO-2125.
King Pharmaceuticals, Inc. (NYSE:KG) today announced that its subsidiaries, Alpharma Inc. and Alpharma Pharmaceuticals LLC ("Alpharma"), have finalized a civil settlement with the United States Department of Justice and the Office of the United States Attorney for the District of Maryland resolving a previously disclosed investigation into Alpharma's sales and marketing activities. As part of the overall resolution of the investigation, Alpharma also agreed to enter into separate civil settlement agreements with states that decide to participate in the settlement.
Medtronic, Inc. (NYSE: MDT) today announced it has completed Pre-Market Approval (PMA) submission in consideration for U.S. Food and Drug Administration (FDA) approval for the Medtronic Arctic Front® Cardiac CryoAblation Catheter System, which is designed for patients with paroxysmal atrial fibrillation (PAF), an irregular quivering of the upper chambers of the heart that starts and stops on its own. Atrial fibrillation (AF) is the most common heart arrhythmia in the United States, with an estimated three million patients suffering from this condition.
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) dropped today after the company reported that it is revising downward its previous sales and earnings guidance for the fiscal year ending September 30, 2010. This action is being taken as a result of weaker than expected operating results for the second quarter ending March 31, 2010, based on preliminary results to date. Separately, Meridian announced that it will file a 510(k) for FDA marketing clearance next week in connection with its illumigene™ C. difficile product.
MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) jumped today after it announced that it has entered into an agreement with DoctorDirectory.com Inc., the Company’s promotion partner for MOXATAG (amoxicillin extended-release) Tablets, 775 mg, to expand its previously announced IncreaseRx® promotion program. The expanded IncreaseRx® promotion program for MOXATAG will incorporate physicians previously detailed by the Company’s field sales force. IncreaseRx® performs as a virtual contract sales organization, providing health care professionals with access to electronic sampling, electronic learning and online educational tools. The expanded IncreaseRx® promotion program for MOXATAG will utilize web-based educational and promotional tactics to reach prescribers with targeted MOXATAG sales and marketing messages.
Nabi Biopharmaceuticals (Nasdaq:NABI) announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX(R) (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. The FDA has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol.
NexMed, Inc. (Nasdaq: NEXM) moved higher today after the company announced that pre-clinical results from the research and development group at its Bio-Quant subsidiary have successfully demonstrated the ability of the NexACT technology to deliver insulin and other large molecule drugs such as Taxol subcutaneously, in a depot-like fashion (or slow release) over a 24 hour period from a single injection. The specialty CRO and a developer of products based on the NexACT® technology also announced today that it raised $1.4 million in gross proceeds from refinancing the mortgage on its manufacturing facility in New Jersey.
PAREXEL International Corporation (Nasdaq:PRXL), today announced that it has completed a large and complex pharmacogenetics-based early phase study. The study was conducted in a healthy volunteer population of poor metabolizers of Cytochrome P450 2D6 (CYP2D6), an important enzyme involved in the metabolism of drugs. The study monitored the QTc interval following administration of a neurological treatment, which has been shown to have a higher drug exposure in poor metabolizers of CYP2D6.
Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX) announced today that it has initiated a phase I clinical trial of PRX-105, the Company's plant cell expressed pegylated recombinant human acetylcholinesterase product candidate in development for biodefense indications. The trial is designed to study the safety of PRX-105 by administering a bolus intravenous injection of PRX-105 in healthy volunteers. The U.S. Food and Drug Administration (FDA) and the Israeli Ministry of Health have each accepted the Company's exploratory Investigational New Drug application to commence the phase I clinical trial of PRX-105. Pre-clinical studies have previously indicated that PRX-105 successfully protects animals exposed to organophosphate nerve gas agent analogs, in both the prophylactic and post-exposure settings. In addition, the safety of PRX-105 has been demonstrated in a well-controlled study in rodents performed under good laboratory practices.
Schiff Nutrition International, Inc., (NYSE:WNI), saw its shares rise today after the company announced results for the fiscal 2010 third quarter and nine months ended February 28, 2010. The company also announced plans to return $0.50 per share to shareholders through a special cash dividend payable on April 14, 2010 to shareholders of record at the close of business on March 31, 2010.
StemCells, Inc. (Nasdaq:STEM) announced today that the United Kingdom (UK) Intellectual Property Office has granted patent number GB2451523 with broad claims covering true (germline competent) rat stem cells and genetically engineered rats derived from these cells. The patented technology is expected to have significant utility to academic and pharmaceutical industry researchers by enabling them to create novel rat models for the study of human diseases. Both mice and rats are used by scientists to model various human diseases. However, rat models are more frequently used by pharmaceutical companies because the physiological characteristics of rats make them better suited for assessing drug efficacy and toxicity.
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.