|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".|
|By BioMedReports.com Staff|
|Thursday, 18 March 2010 19:51|
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.
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