FDA approval sends K-V pharma shares up 140%. Elite Pharma gains on FDA nod Print E-mail
By BioMedReports.com Staff   
Friday, 04 February 2011 19:56
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 4, 2011.

Shares of K-V Pharmaceutical Company (NYSE:KVa) rocketed today after the specialty pharmaceutical company, announced that the FDA has granted approval for Makena, formally known as Gestiva, the first and only FDA-approved treatment that reduces the risk of premature birth in pregnant woman. K-V developed the drug in partnership with Hologic, Inc. (Nasdaq:HOLX). Under terms of the agreement between the two companies, Hologic will transfer to K-V all of its Makena assets in return for $12.5 million payment from K-V. Hologic has previously receved $79.5 million in cash plus expenses from K-V for the development of the drug. K-V is responsible for an additional $107 million in payments within 30 months.

"The communities of healthcare providers and advocacy organizations who are on the front lines of this issue now have access to the benefits of an FDA-approved product," said Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation. "The approval of Makena is not only a milestone for the Company; more importantly, it represents a significant step forward for the thousands of women whose families have been impacted by preterm birth."

Shares of K-V shot up more than 140% or $2.15 to 3.68. The stock continued to climb another 15 cents in extended trading.

Shares of Elite Pharmaceuticals, Inc. (OTCBB:ELTP) moved higher after the company announced that the FDA has approved phentermine HCl 37.5 mg tablets, the generic equivalent of the Adipex-P(R) 37.5 mg tablets. The product had annual sales of approximately $40 million in 2010 and there are currently six other approved generic manufacturers plus the innovator. Adipex-P is an appetite suppressant that affects the central nervous system and is used togther with diet and exercise to treat obesity in people with risk factors such as high blood pressure, high cholesterol, or diabetes. Elite acquired the product from Epic Pharma in September 2010.

11 million shares traded hands as shares of Elite gained 13% or a penny to $0.05.

AstraZeneca (NYSE:AZN) announced today that the FDA has acknowledged receipt of the company’s reply to the Complete Response Letter for the ticagrelor New Drug Application. Accordingly, the agency has accepted AstraZeneca’s resubmission of the ticagrelor NDA, categorized it as a Class 2 resubmission to the CRL, and set a new PDUFA date of July 20, 2011.

Access Plans, Inc. (OTCBB: APNC) , a leading membership benefits marketing company, today announced that the Company will host an investor conference call to discuss its operating results for the first quarter of FY2011 at 11:30 a.m. Eastern Time (EST) on Thursday, February 10, 2011.

Aethlon Medical, Inc., (OTC Bulletin Board:AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.

ALDA Pharmaceuticals Corp. (TSX VENTURE:APH) (OTCQB:APCSF) announces the signing of a non-bindingterm sheet to purchase substantially all of the assets and undertakings of Seavan Health & Beauty Partnership which is operating a manufacturing facility in Vancouver, British Columbia with approvals to sell pharmaceutical, nutritional and personal care productsin Canada and the USA.

Amgen (Nasdaq:AMGN) and Pfizer Inc. (NYSE:PFE) today announced results from a new trial that demonstrated Enbrel® (etanercept) significantly improved scalp involvement in adult patients with moderate to severe plaque psoriasis, compared with placebo.

AVAX Technologies, Inc. (Pink Sheets:AVXT) today announced that it filed a Form 10 with the Securities and Exchange Commission.

Bohai Pharmaceuticals Group, Inc. (OTC Bulletin Board:BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, today announced the appointment of a new independent director, Anthony Chan to its Board of Directors.

Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced the publication of a research article titled "Blood Volume Measurements in Patients with Heart Failure and a Preserved Ejection Fraction: Implications for Diagnosing Anemia" in the journal Congestive Heart Failure (2011; 17(1):14-18).

NeoGenomics, Inc. (OTC Bulletin Board: NGNM) announced today that it plans to release its fourth quarter and full year 2010 financial results on Thursday, February 10, 2011.

Palatin Technologies, Inc. (NYSE Amex:PTN) reported that its exchange listing compliance plan has been accepted by the NYSE Amex. Palatin has been granted an extension until May 26, 2011 to regain compliance with stockholders' equity requirements under Section 1003(a)(iii) of the NYSE Amex Company Guide and until February 28, 2011 to regain compliance with financial condition continued listing requirements under Section 1003(a)(iv).Pharmacyclics, Inc. (Nasdaq:PCYC) today reported recent developments and financial results for its fiscal second quarter that ended December 31, 2010.

Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic tests, will release fourth quarter and full year 2010 financial results after market close on Thursday, February 24, 2011.

Roche (SIX: RO, ROG; Pink Sheets:RHHBY) announced today that the cobas® TaqScreen DPX Test for use on the cobas s 201 system is now available in the US.

SeraCare Life Sciences, Inc. (Nasdaq:SRLS) will release its fiscal first quarter 2011 financial results before U.S. financial markets open on Friday, February 11, 2011.




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