RxNews Recap for Thursday 03-18-10. Somaxon flys on FDA approval. A.P. Pharma jumps ahead of FDA decision, then halted with "pending news". Print E-mail
By BioMedReports.com Staff   
Thursday, 18 March 2010 19:51

Below is a list of the companies that made news in the healthcare sector on Thursday, March 18, 2010.

A.P. Pharma, Inc. (NASDAQ: APPA) soared 32% ahead of FDA's decision regarding its lead product, APF530, for the prevention of both acute and delayed onset of chemotherapy–induced nausea and vomiting (CINV). The FDA had set a Prescription Drug User Fee Act (PDUFA) date of March 18, 2010. Investors drove shares up into the close and the stock continued to climb after the bell. 15 minutes into the after hours session,however, the stock was halted for pending news. As of this writing there has been no news to report regarding the FDA decision.

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) as reported earlier today here on BioMedReports, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance. Shares of Somaxon shot up more than 133% or $5.27 to close the day at $9.21. The stock continued to trade higher in the after hours market, moving up another 12 cents.

In other news Thursday:

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that it has received a Phase 1 Small Business Innovation Research Grant (SBIR) from the National Institute of Allergy and Infectious Disease (NIAID) branch of the National Institutes of Health (NIH) for the further study and characterization of a back-up series of compounds related to its novel antibacterial, ACH-702.

China Sky One Medical, Inc. (Nasdaq:CSKI ), rose after the fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China today announced that Antroquinonol (Hocena) capsule, a new anti-cancer drug co-developed by Taiwan Golden Biotechnology Corporation was recognized as Breakthrough Drug by the Chinese Ministry of Science and Technology.

Celsion Corporation (Nasdaq:CLSN) saw its shares rise today after the company announced that an abstract about the Phase I/II trial of ThermoDox® in Recurrent Chest Wall Cancer (RCW) has been accepted for presentation at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting. The abstract presents the background, rationale, and design of the DIGNITY study which is ongoing and evaluating ThermoDox in combination with hyperthermia in women with recurrent breast cancer on their chest wall. Shares shot up over 8% on the news.

Haemonetics Corporation (NYSE:HAE) today announced that it is extending its previously announced cash tender offer, through its wholly-owned subsidiary Atlas Acquisition Corp., for all outstanding shares of common and preferred stock of Global Med Technologies, Inc., until 12:00 midnight, EST, on Wednesday, March 24, 2010. Also, after the bell the company announced that it has entered into a reagent development and supply agreement with Quotient Biodiagnostics Group and its wholly owned subsidiary Alba Bioscience Limited. This arrangement provides Haemonetics with exclusive access to Alba's comprehensive catalogue of approved reagents for use in connection with the commercialization of its Arryx laser based blood typing platform. Brian Concannon, Haemonetics' President and CEO, said, "Blood typing represents a future $1 billion market opportunity for Haemonetics through the ongoing development of our Arryx technology.

NeoStem, Inc. (NYSE:NBS) announced the exercise of a warrant by a principal shareholder, RimAsia Capital Partners, LP has exercised its NeoStem warrant to purchase 1,000,000 shares, issued to RimAsia in a September 2008 private placement at a price of $1.75 per share for gross proceeds to the Company of $1,750,000. RimAsia is currently subject to a lock-up agreement. The transaction was approved by the Company's board of directors and the Company's independent audit committee on March 11, 2010. On this date the Company's common stock closed at $1.42. Eric Wei is a member of the Company's board of directors and a managing partner of RimAsia.

The Company intends to put the proceeds from the exercise of the warrant towards the funding of the Company's various initiatives, including assisting in the funding of the relocation of the manufacturing facility of Suzhou Erye Pharmaceutical Co. Ltd., the Company's 51% owned subsidiary.

"We would like to thank RimAsia for its continued support of NeoStem and confidence in our strategic growth outlook," said Robin Smith, M.D., NeoStem's CEO and Chairman of the board of directors. "These additional funds, together with some of the proceeds from our recent equity offering, will help to advance the significant expansion of Erye's production capacity to meet rising demand in the Chinese pharmaceutical market.

PROLOR Biotech, Inc., (OTC Bulletin Board:PBTH.ob), a company developing next generation biobetter therapeutic proteins, today announced that it has raised $24.4 million in a private placement of 10,382,975 shares of its common stock, par value $0.00001 per share, to accredited investors at a price of $2.35 per share, which represents an approximate 17% discount to the average closing price of the common stock for the 30-day period prior to closing. The shares have not been registered and no registration rights have been granted to investors for these shares. In addition, the shares are subject to a one-year lockup agreement.

Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), today announced that the U.S. Patent & Trademark Office (USPTO) has granted and will reissue the composition of matter patent for picoplatin as RE41209, replacing USPN 5,665,771 ('771 patent), on April 6, 2010. The reissue was applied for May 8, 2009, and, on March 17, 2010, the USPTO released the "Issue Notification" for the reissue application. The reissue patent includes additional claims specific to the picoplatin compound, its use in the treatment of any cancer, as well as to its pharmaceutical composition and oral dosage form.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has entered into a definitive agreement to acquire ratiopharm, Germany’s second largest generics producer and the sixth largest generic drug company worldwide, for an enterprise value of €3.625 billion. The transaction is subject to certain conditions including relevant regulatory approvals. On a pro forma basis, the combined company would have had 2009 revenues of $16.2 billion. Teva expects to complete the transaction by year-end 2010..

Commenting on today's transaction, Shlomo Yanai, Teva’s President and Chief Executive Officer, said: "This is an important acquisition for Teva. This transaction is perfectly aligned with our long-term strategy in which Europe is an important pillar and growth driver. ratiopharm will provide us with the ideal platform to strengthen our leadership position in key European markets, most notably in Germany, as well as rapidly growing generic markets such as Spain, Italy and France."

The acquisition will position Teva as the leading generic pharmaceutical company in Europe, increasing its European business from sales of $3.3 billion in 2009 to joint pro forma sales of $5.2 billion.

Also Thursday:

Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has published new research findings on ActA as a potential, anti-cancer component and a new complement to the Company’s evolving proprietary Listeria technology platform.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the completion of its initial public offering of 9,000,000 shares of its common stock.

Cardima, Inc. (OTCBB: CADM) today announced that it has applied for the listing of its common stock on the NASDAQ® Stock Market.

Cascade Technologies Corp. (OTCBB: CSDT) announced that it closed the acquisition of privately-owned, Los Angeles-based medical device developer Spectral Molecular Imaging, Inc. ("SMI") for stock.

Cardiac Network, Inc. (PINKSHEETS: CNWI), a developer of advanced mobile medical monitoring systems, confirmed today that it has entered into an agreement and commenced work with product design firm SL! International to provide Cardiac Network, Inc. with proposed designs for its wearable 24/7 WiFi ECG monitors currently under development.

China Jo-Jo Drugstores, Inc. (OTCBB:CJJD) which operates a retail pharmacy chain in the People’s Republic of China (The “PRC”), today announced the appointment of Mr. Marc Thomas Serrio, Mr. Bowen Zhao, Dr. Yuehai Ke, Dr. Shuizhen Wu and Mr. Xiaomeng Yu to the Company’s board of directors as independent directors, effective March 15, 2010.

CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that it will report financial results for the fourth quarter and year end 2009 before market opens on Thursday, March 25, 2010 followed by a conference call at 8:30 a.m. ET in which senior management will provide an update on the company, discuss fourth quarter and year end 2009 financial results and discuss expectations for the future.

Peter Derycz, Chairman and CEO of Derycz Scientific, Inc., (OTC Bulletin Board: DYSC), a company that is pioneering a fresh way of facilitating the flow of information from content publishers to enterprise customers and their constituents, has contributed articles to the journals Pharmaceutical Manufacturing and Genetic Engineering & Biotechnology News.

Emisphere Technologies, Inc. (OTCBB:EMIS) and Alchemia Ltd. (ASX:ACL) today announced that they are joining efforts to develop an oral formulation of the anti-coagulant drug fondaparinux with Emisphere’s Eligen® Technology.

Hercules Technology Growth Capital, Inc. (NASDAQ:HTGC), the leading specialty finance company providing venture debt and equity to venture capital and private equity-backed technology and life science companies at all stages of development, today announced that it has committed over $52.0 million in structured debt financing to new and existing portfolio companies.

ImmunoGen, Inc. (Nasdaq: IMGN) is scheduled to present at the 2010 Barclays Capital Global Healthcare Conference at 3:45 pm ET on March 24, 2010.

MedeFile International, Inc. (OTC Bulletin Board: MDFI), a leader in portable electronic medical records management, announced today the addition of internationally-renowned biotechnology veteran Dr. Gurinder Shahi, M.D., Ph.D., to its Advisory Board.

NeoPharm, Inc. (Other OTC: NEOL.PK), a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced its fourth quarter and full year 2009 financial results.

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that primary and secondary endpoints were not met in Novelos’ pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) with its lead product, NOV-002, in combination with first-line chemotherapy.

PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Gregory S. Weistar, Chief Executive Officer, will make a presentation regarding the Company at the Barclays Capital 2010 Global Healthcare Conference in Miami, Florida, on Tuesday, March 23, 2010, at 8:30 a.m. Eastern Time.

PolyMedix, Inc. (OTCBB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 1B clinical study to evaluate the safety and efficacy of PMX-60056 in reversing the anticoagulant activity of low molecule weight heparin (LMWH).

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) will webcast its presentation at the Barclays Capital Global 2010 Healthcare Conference on Tuesday, March 23, 2010.

Rodman & Renshaw (NASDAQ: RODM) and BioSante (NASDAQ: BPAX) today announced that Rodman will host Stephen M. Simes, CEO of BioSante Pharmaceuticals, for a fireside chat in Rodman's media center, on March 24, 2010.

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX),  today announced financial results for the fourth quarter and full year ended December 31, 2009.

Urigen Pharmaceuticals, Inc. (OTC BB: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain announced an interview of William J. Garner, CEO.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company that is seeking to develop and commercialize a diverse, risk sensitive portfolio of in-licensed cancer drugs addressing unmet medical needs, announced today its financial results for the fourth quarter and full year 2009, and the filing of its Annual Report on Form 10-K with the Securities and Exchange Commission.

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.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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