|Cadence announces PDUFA date. Victory Pharma buying Middlebrook's assets. BioVest files Plan of Reorganization|
|By BioMedReports.com Staff|
|Friday, 14 May 2010 19:43|
Below is a list of the companies that made news in the healthcare sector on Friday, May 14, 2010.
Cadence Pharmaceuticals, Inc. (Nasdaq:CADX) after the bell announced that the U.S. Food and Drug Administration has classified the OFIRMEV injection New Drug Application resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010. "If approved, OFIRMEV will be the only intravenous (IV) non-opioid, non-NSAID pain medication available in the U.S., and we are committed to making this important therapeutic option available to patients as soon as possible," said Ted Schroeder, President and CEO of Cadence. "We will continue to work closely with the FDA through this final stage of the review process and maintain our commercial readiness activities for potential approval at any time up to the PDUFA action date." On February 10, 2010, Cadence received a Complete Response letter from the FDA which indicated that the OFIRMEV NDA could not be approved due to deficiencies observed during the FDA's facility inspection of Cadence's third party manufacturer. The Complete Response letter did not cite any safety or efficacy issues or require that any additional studies be conducted prior to approval.
MiddleBrook Pharmaceuticals, Inc. (Pink Sheets: MBRKQ) after the bell announced that the company has entered into an asset purchase agreement with privately held Victory Pharma, Inc. for the sale of substantially all of its assets, and assumption of trade sales and certain other liabilities, of the Company for approximately $17.1 million. The Acquisition is subject to customary closing conditions, a competitive auction process supervised by the United States Bankruptcy Court for the District of Delaware in which MiddleBrook will seek competing bids to obtain the best offer possible for its assets, and approval of the Bankruptcy Court.
"During the Bankruptcy Court supervised process, we remain committed to continuing to promote MOXATAG utilizing our third party partner's electronic promotion program and maintaining MOXATAG and KEFLEX product availability to our trade sales customers," said David Becker, MiddleBrook Executive Vice President and Chief Financial Officer, and Acting President and Chief Executive Officer.
In new from earlier in the day Friday:
Biovest International, Inc. (Pink Sheets: BVTI) today announced that the Company filed its proposed Plan of Reorganization with the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division. With this filing, Biovest is positioned to emerge from Chapter 11 protection this summer as a fully restructured company. Upon Court-ordered confirmation, the Plan of Reorganization is expected to support the planned commercialization of BiovaxID®, Biovest’s personalized cancer vaccine intended to treat certain B-cell lymphomas with an initial indication of follicular non-Hodgkin’s lymphoma (fNHL). The Company is preparing to seek U.S. and international regulatory approvals for BiovaxID based on the positive outcomes from two Phase II trials and its Phase III fNHL trial which demonstrated statistically significant results in extending disease-free survival in vaccinated patients, as reported at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session.
The Plan was prepared in close consultation with the Official Committee of the Unsecured Creditors and has support from the Company’s largest senior secured creditor, as demonstrated by a previously filed motion to compromise which was granted Court approval today.
"Biovest voluntarily filed for reorganization in November 2008 in order to avoid potential disruption of its biotech development plans from what was then a crisis situation in the world-wide capital markets. From the outset, we committed to a strategy that would preserve the interest of all stakeholders - our creditors, employees and shareholders," stated Biovest’s President, Mr. Samuel S. Duffey. "With such a strong level of support from our creditors, the confidence and loyalty of our customers and the unrelenting focus of our talented employees, we are now poised to emerge from Chapter 11 with the enormous opportunity to advance key regulatory, manufacturing and partnering strategies for BiovaxID. Our goal is clear: to help cancer patients by securing marketing approvals for the first personalized lymphoma vaccine that can significantly prolong a cancer-free condition."
Referring to Biovest’s parent company, Accentia Biopharmaceuticals, Inc. (Other OTC: ABPIQ), Mr. Duffey added, "We expect Accentia and Biovest to both emerge from Chapter 11 simultaneously. In this regard, we are diligently working to file Accentia’s separate Plan of Reorganization in the very near future."
Amgen Inc. (Nasdaq:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denosumab, a subcutaneous RANK Ligand inhibitor. The BLA submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus Zometa® (zoledronic acid).
Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and Merck (NYSE: MRK), announced that in a new Phase III study to treat atrial fibrillation, BRINAVESSTM (vernakalant) intravenous, an investigational compound being developed in the European Union, was superior to amiodarone injection, in converting patients' heart rate from atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of administration. The results of the study were presented today during a late-breaking clinical trials session at Heart Rhythm 2010, the annual meeting of the Heart Rhythm Society.
Discovery Laboratories, Inc. (Nasdaq:DSCO), announces the publication of results from its previously-conducted Phase 2a feasibility study of Aerosurf, the Company's aerosolized KL4 surfactant, for the prevention of respiratory distress syndrome (RDS) in premature infants, in the May 2010 issue of the Journal of Aerosol Medicine and Pulmonary Drug Delivery.
GlaxoSmithKline (NYSE:GSK) announced that the Food and Drug Administration has determined that U.S. healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the FDA's recommendation from March 22, 2010 and reflects the agency's assessment that the presence of porcine circovirus type 1 (PCV-1) in the vaccine poses no safety risk.
The FDA stated that the benefits of rotavirus vaccination are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. The FDA further concluded that these benefits outweigh the risk, which is theoretical.
Hana Biosciences Inc., (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the first quarter ended March 31, 2010, and provided a corporate update.
"During the first quarter of 2010, we continued our focus on the clinical and manufacturing development for Marqibo(R) in relapsed/refractory adult acute lymphoblastic leukemia," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We continue to move forward with our submission plans following input received from the Food and Drug Administration during our April pre-New Drug Application meeting. We are confident that the complete rALLy data from the entire 65 patient population, which will be reported in an oral presentation at the 2010 Meeting of the American Society of Clinical Oncology, will provide additional evidence of Marqibo's efficacy."
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration has granted tentative approval of the Company’s Abbreviated New Drug Application for generic version of Opana ER (oxymorphone hydrochloride) 5, 7.5, 10, 15, 20, 30 and 40 mg tablets. Endo Pharmaceuticals Inc. markets Opana ER for the treatment of moderate to severe pain.
According to Wolters Kluwer Health, U.S. sales of Opana ER tablets were approximately $241 million for the 12 months ended March 31, 2010.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today its financial results for the first quarter of 2010. Nymox reported a net loss of $1,269,550, or $0.04 per share for the quarter ending March 31, 2010, compared to $1,004,259, or $0.03 per share for same period in 2009. Net losses include stock compensation charges of $195,220 in 2010 and $309,650 in 2009. The increase in net losses is attributable to higher clinical trial expenditures compared to 2009. Product sales increased by 157% to $246,861 for the first quarter of 2010, compared to $96,226 for the same period in 2009..
Radient Pharmaceuticals Corporation (AMEX:RPC) announced today its executive management will be in India May 20, 2010 through May 25, 2010 with the goal of accelerating the commercialization of RPC's Onko-Sure in vitro diagnostic (IVD) cancer test in India through distribution partnerships with Gaur Diagno (New Delhi).
More specifically, RPC's executive management team will be solidifying expanded partnership agreements for the sales and marketing of Onko-Sure test kits with Gaur Diagno; and the development of clinical trials for RPC's Combination Immunogene Therapy (CIT) technology with Jaiva Technologies.
According to Mr. Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals, "Measurable progress for Onko-Sure cancer testing is of the utmost importance for Radient Pharmaceuticals and its employees, customers, partners and shareholders. We have scheduled meetings with a highly anticipated program launch with key government officials in India in support of the commercialization of our US FDA approved Onko-Sure IVD cancer test. Through discussions, we anticipate receiving Indian government support in various regions to implement Onko-Sure as a general cancer screening tool in India -- one of the first major initiatives for Onko-Sure as a cancer testing/screening tool. India is top tier market for RPC's Onko-Sure IVD cancer test."
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today the publication of the first human data from a case study of patients evaluated with its ophthalmic product candidate RGN-259. The data have been published in the May 2010 issue of Archives of Ophthalmology, an American Medical Association peer-reviewed journal. In the study, four patients with chronic neurotrophic keratitis, a degenerative corneal disease induced by a nerve impairment, were treated with RGN-259 under a compassionate use IND.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cinacalcet HCl Tablets 30, 60 & 90 mg.
Upon final approval, Teva's Cinacalcet HCl Tablets will be the AB-rated generic equivalent of Amgen’s Sensipar, indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
The brand product had annual sales of approximately $458 million in the United States, based on IMS sales data.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of Delaware. A trial date has not been set.
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today reported on its recent developments and financial results for the first quarter, and its cash balance as of March 31, 2010.
China Sky One Medical, Inc. (Nasdaq: CSKI), a leading fully integrated pharmaceutical company in the People's Republic of China, today announced that Mr. Yan-Qing Liu, the Company's Chairman and Chief Executive Officer, received the award for "Leadership Excellence in Innovation" from the organizing committee of China Enterprise Innovation Forum.
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been named Biotechnology Firm of the Year at the Tech Council of Maryland (TCM) Annual Tech Awards.
Geron Corporation (Nasdaq:GERN) today announced that Thomas B. Okarma, Ph.D., M.D., president and chief executive officer, will present an update of the company's product development programs at 9:25 a.m. BST / 4:25 a.m. EDT on Monday, May 17, 2010, at the Rodman & Renshaw 6th Annual Global Healthcare Conference in London.
Omnicare, Inc. (NYSE: OCR), announced today that is has extended the Early Tender Deadline of the tender offer and consent solicitation for its outstanding 6.75% Senior Subordinated Notes due 2013 to 5:00 p.m., New York City time, on May 18, 2010, unless further extended.
Oragenics, Inc. (OTCBB: ORNI), a biopharmaceutical company, announced today that it will be presenting at the Rodman & Renshaw 6th Annual Global Investment Conference on Tuesday, May 18th, in London.
Power3 Medical Products, Inc. (OTCBB: PWRM) announced today that it has filed two provisional patent applications with the United States Patent and Trademark Office (USPTO) one on Alzheimer's disease specific differential diagnosis in the clinical setting and the other on important differences in pathophysiology and therapeutic options for the genetically distinct groups of Alzheimer's disease patients.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial-stage biotechnology company with a focus in oncology and hematology, announced today that an overview of the Company's business strategy will be given at the 6th Annual Rodman & Renshaw Global Healthcare Conference, taking place May 16-18, 2010 in London, England.
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.