RxNews Recap for Friday 03-26-10. ARCA biopharma doubles on heart treatment patent. Vivus reports FDA panel review date for obesity drug Print E-mail
By BioMedReports.com Staff   
Friday, 26 March 2010 17:28

 

Below is a list of the companies that made news in the healthcare sector on Friday, March 26, 2010.

ARCA biopharma, Inc. (Nasdaq: ABIO), saw its shares more than double today after the biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods of treating heart failure patients with bucindolol based on genetic testing. The patent (USP# 7,678,824) entitled "Methods for Treatment with Bucindolol Based on Genetic Targeting," provides protection in the United States for this novel approach to treating patients with heart failure, one of the largest health care problems in the United States and the rest of the world. ARCA had previously announced the notice of allowance of this patent. Industry sources estimate that approximately 5.7 million Americans have heart failure and nearly 670,000 new patients are diagnosed annually. In addition, heart failure is the underlying reason for approximately 12 to 15 million annual visits to physicians, 6.5 million annual hospital days and over $37 billion in direct and indirect healthcare costs in the United States.

"We are obviously pleased with the USPTO’s issuance of this patent which we believe will extend our pharmacogenetic intellectual property protection around bucindolol and, if approved for marketing, provide Gencaro market exclusivity into 2025," said Michael R. Bristow, President and Chief Executive Officer of ARCA. "Chronic heart failure continues to be a major health care problem, and among the challenges to improving care is the uncertainty of patient responses to drug treatment. We believe that a new heart failure therapy that includes a simple test to identify a substantial subpopulation of patients more likely to benefit has the potential to help alleviate some of the problems encountered with the current standard of practice."

Shares moved up a whopping 210% or $5.57 closing the trading session at $8.22. The stock closed up another 22 cents in the after hours market.

VIVUS, Inc. (Nasdaq:VVUS) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration is tentatively scheduled to review the Company's New Drug Application (NDA) for Qnexa® for the treatment of obesity on July 15, 2010. VIVUS submitted its NDA on December 28, 2009 seeking approval to market Qnexa in the United States; on March 1, 2010, the FDA accepted the NDA filing for review. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010 said Leland Wilson, chief executive officer of VIVUS.

A competitor to VIVUS, Arena Pharmaceuticals (Nasdaq:ARNA) has also filed for FDA review of its experimental weight loss drug, Lorcaserin, with a deadline for the regulators decision being October 22, 2010.

A third drug developer, Orexigen Therapeutics (Nasdaq:OREX), said it intends file an NDA before the end of April for approval of its investigational weight loss drug, Contrave.

Other news from Friday:

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it will meet the U.S. Food and Drug Administration (FDA) in Washington D.C. during the last week of April 2010 to review the Company's New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion) and the FDA's refusal-to-file letter.

Alere Health, LLC, a leader in personal health support solutions (a division of Inverness Medical Innovations NYSE: IMA), today announced a partnership between the Alere® Women's & Children's Health Division (WCH) and UK-based Monica Healthcare Ltd, developers of a groundbreaking wireless, wearable fetal-maternal monitor. Alere WCH is the largest U.S. provider of specialized health management services -- supporting over 225,000 pregnancies in 2009. Monica's AN24™ wireless fetal-maternal monitoring solution opens up a whole new world of passive surveillance, flexible management, and patient comfort during pregnancy.

BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced its acquisition of substantially all of the assets of privately held TranSenda International, LLC ("TranSenda"). Headquartered in Bellevue, WA, TranSenda is a provider of clinical trial management software (CTMS) solutions and is a Microsoft Gold Certified Partner.

BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced after the market close that the Company's Board of Directors has scheduled its Annual Meeting of Stockholders to be held on Thursday, June 17, 2010 at 11:00 a.m. Eastern Daylight Time in New York City. Stockholders of record as of the close of business on April 19, 2010 will be entitled to vote at the Meeting. One of the matters to be voted upon by the Stockholders at the Meeting is a proposal by the Company's Board of Directors for a two-for-one forward stock split in the form of a dividend. As a result of the forward stock split, Stockholders will receive one additional share of the Company's common stock for each share of the Company's common stock held by such Stockholder as of a yet to be determined forward stock split record date.

Biovail Corporation (NYSE, TSX: BVF) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has acquired certain AMPAKINE® compounds, including associated intellectual property, from Cortex Pharmaceuticals, Inc. (see Cortex story below) for use in the field of respiratory depression, a brain-mediated breathing disorder. The acquired compounds include the Phase 2 compound CX717, the preclinical compounds CX1763 and CX1942, and the injectable dosage form of CX1739. As part of the acquisition transaction, BLS has also entered into a field limited license agreement with The Regents of the University of California.

Cortex Pharmaceuticals, Inc. (OTCBB: CORX.OB) announced that it has entered into an agreement with Biovail Laboratories International SRL in which Biovail acquired certain AMPAKINE compounds and the rights to the patent filing for respiratory depression and vaso-occlusive crises associated with sickle cell disease. The transaction with Biovail includes a purchase price of $10,000,000 and additional payments of up to $15,000,000 based upon defined clinical development milestones. Shares of Cortex soared on the news, jumping 27% to close at 21 cents. Volume was almost ten times the daily average.

The Medicines Company (NASDAQ:MDCO) today announced that it filed a complaint against the U.S. Patent and Trademark Office (PTO), the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services seeking to set aside the PTO's denial last week of the Company's Hatch-Waxman application to extend the principal U.S. patent covering Angiomax.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and biopharmaceutical company Eli Lilly and Company (NYSE: LLY - News), announced today that they have expanded their clinical trial materials supply chain relationship. As part of a new five-year agreement, the Fisher Clinical Services business of Thermo Fisher will take over responsibility for Lilly’s in-house clinical trial materials manufacturing, packaging and labeling operations on-site at the Lilly Technology Center – North in Indianapolis. This transition is expected to be completed in the summer of 2010.

Also Friday:

Elan Corporation, plc (NYSE: ELN) today announced the publication and filing of its Annual Report for the fiscal year ended December 31, 2009.

Emerging World Pharma Inc. (PINKSHEETS:EWPI) has been granted an investment option to increase their percentage of profits by up to 25%. Emerging World Pharma had provided an initial investment to African Global Pharma, a division of Global Pharma Corp. operating in West Africa.

ForeverGreen Worldwide Corp. (OTCBB: FVRG) announces the completion of its in-house fully functional information systems.

Geron Corporation (Nasdaq: GERN) today announced the appointment of Thomas Hofstaetter, Ph.D. to its board of directors and as a member of the board’s compensation committee.

Helix BioMedix, Inc. (OTCBB: HXBM), a developer of bioactive peptides, today announced financial results for the year ended December 31, 2009.

Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) announced today that management will present a corporate overview at the upcoming Canaccord Adams' Hepatitis C Conference on Thursday, April 1, 2010 at 10:45 a.m. ET at The Peninsula Hotel, New York.

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) announced today that for the period of March 12, 2010 to September 11, 2010, its Zero Coupon Convertible Subordinated Notes due 2021 (Zero Coupon Notes) will, subject to the terms of the Zero Coupon Notes, accrue contingent cash interest at a rate of no less than 0.125% of the average market price of a Zero Coupon Note for the five trading days ended March 9, 2010, in addition to the continued accrual of the original issue discount. In a seperate news release the company reported today that it is the first national laboratory to offer customers a 21-marker genetic analysis in combination with a double-blind process for parentage/relationship testing on every sample.

Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, today announce its financial results for the year ended December 31, 2009.

PPJ Enterprise (PPJ) (PINKSHEETS: PPE), a leader in proprietary automated health care reimbursement cycle (all specialties), on line health information digital systems and practice information management digital system software for health careand general businesses worldwide, has announced that its subsidiary, Professional Billing Service (PBS), has signed several medical billing and collection agreements with physicians and surgery centers including 2 former billing clients in the Southern California area.

Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, will announce consolidated financial results for the twelve months ended December 31, 2009 and the fourth quarter of 2009 on Wednesday, March 31 after close of market.

SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, announced today the opening of its 2010 inaugural sales conference in India.

ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that Douglas E. Williams, Ph.D., Chief Executive Officer of ZymoGenetics, will present at the Canaccord Adams Hepatitis Conference in New York City on Thursday, April 1, 2010 at 10:15 a.m. Eastern Time.

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.




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