Biodel surges on analyst comments. BioCryst slumps on flu study delay. After the bell: Cumberland soars on FDA approval Print E-mail
By BioMedReports.com Staff   
Thursday, 13 January 2011 19:30
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 13, 2011.

After the bell, shares of Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) soared more than 20% after the company announced that it has received FDA approval for a new formulation of Acetadote Injection, the company's product used to treat acetaminophen poisoning. The proprietary new formulation, which does not contain Ethylene diamine tetracetic acid or any other stabilization and chelating agents and is free of preservatives, will replace the currently marketed product. The company said it will immediately commence the U.S. launch activities for this next generation Acetadote product and will no longer manufacture the previously approved formulation.

Acetadote, which has been available in the United States since Cumberland's 2004 introduction of the product, is currently used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States, and Acetadote has become a standard of care for treating this potentially life-threatening condition.

"We are committed to further developing our products, whether to expand into new patient populations or to improve upon an existing formulation, and worked with the FDA to develop this new formulation of Acetadote," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We look forward to introducing this next generation product to the hospital community and the growing number of patients who will benefit from it."

In extended trading, shares of Cumberland jumped 21.69% or $1.23 to $6.90.

After the bell Dendreon Corporation (Nasdaq:DNDN) announced that it intends to offer $500 million in convertible senior notes due January 15, 2016. Dendreon intends to use the net proceeds of the offering of the Notes to fund the continued investment in and expansion of its manufacturing facilities, including the construction of a new immunotherapy manufacturing facility in Europe and the expenses associated with increasing capacity at its existing Morris Plains, New Jersey, Atlanta, Georgia and Orange County, California facilities. The company will also use the funds to conyinue its sales and marketing efforts for PROVENGE including its pursuit of non-US approval.

After hours, shares of Syneron Medical Ltd. (NASDAQ:ELOS) moved higher after the company reported that it has received 510(k) clearance from the FDA to market a new Tanda Light Emitting Diode (LED) system for skin rejuvenation. The product is approved for the treatment of wrinkles, rhytides and fine lines in the periorbital (around the eye) region. Syneron expects to begin commercialization of the new Tanda skin rejuvenation product in the second half of 2011 in both the professional and consumer markets.

Earlier Wednesday:

Shares of Biodel Inc. (Nasdaq:BIOD) surged on heavy volume today after an analysts notes sent the stock up nearly 28%. Wedbush Securities Liana Moussatos expressed optimism for the company's insulin product in a note to investors today. The drug, known as Linjeta is a fast acting insulin for patients with Type 1 and Type 2 diabetes. Commented Moussatos; "We believe value-oriented investors may be interested in Biodel’s approximately $60 million market capitalization contrasted to the blockbuster revenue potential".

On volume of more than 10 million shares, the stock gained 54 cents closing the day at $2.50.

Shares of BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) fell today after the company announced top-line results from one of its two Phase 3 studies of intravenous peramivir for the treatment of patients hospitalized with influenza, and provided an update regarding its peramivir program. The company said it wants extend and increase the size its study for peramivir. BioCryst also wants to change the main goal of the trial so it can compare patients treated with peramivir to those who have not been treated with neuraminidase inhibitors, a group of drugs that includes, among other drugs, peramivir and Tamiflu. Peramivir is intended for patients who are hospitalized and too ill to take an oral flu drug. The drug is currently sold in Japan and Korea, while still seeking approval in the U.S.

"Physicians would like to have additional treatments approved for seriously-ill patients with influenza who need hospital care, including an intravenous anti-viral drug," said the study's Principal Investigator, Dr. Michael G. Ison, Assistant Professor, Divisions of Infectious Diseases and Organ Transplantation at Northwestern University Feinberg School of Medicine. "This study is the largest, prospective study of an i.v. influenza anti-viral in the hospital setting completed to date, and significantly expands our knowledge on the anti-viral activity, safety and tolerability of i.v. peramivir in patients hospitalized with influenza."

Shares of BioCryst dropped 34 cents or 6.7% to $4.82.

Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today FDA 510(k) clearance for the Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System. The RV+ test expands Nanosphere's existing test capabilities for the detection of respiratory viruses. In a single test, the RV+ provides Influenza A, Influenza B, RSV A, and RSV B detection, and further subtypes Influenza A as H1, H3, or 2009 H1N1.

Simcere Pharmaceutical Group (NYSE:SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded and proprietary pharmaceuticals in China, today announced the resignation of chief financial officer Mr. Frank Zhao for personal reasons, effective January 15, 2011. Simcere's Board of Directors has appointed Mr. Yushan Wan, Simcere's corporate controller, as acting chief financial officer as of the effective date.

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) today announced that Jan Smilek, Chief Financial Officer and Vice President, Finance, has resigned, effective immediately, to pursue other opportunities. Sucampo will initiate search for a new CFO.

ALDA Pharmaceuticals Corp. (TSX VENTURE:APH) (OTCQB:APCSF) is pleased to announce that it has closed the private placement announced December 8th, 2010.

Angiotech Pharmaceuticals, Inc. (OTCQB: ANPI, TSX: ANP) today announced that trading of shares of the Company's common stock will be transferred from the Nasdaq Stock Market to the OTCQB™ Marketplace effective January 13, 2011.

Caliper Life Sciences, Inc. (Nasdaq:CALP) today announced preliminary revenue for the fourth quarter of 2010 of approximately $36.0 million, which implies fiscal 2010 revenue of approximately $123.5 million, or 10% organic annual growth.

Celsion Corporation (Nasdaq:CLSN), an oncology drug development company dedicated to the development and commercialization of innovative oncology drugs, today announced that it has entered into a definitive securities purchase agreement with a select group of institutional investors, including certain officers and directors of the Company, to sell 5,000 shares of 8% redeemable convertible preferred stock with a stated value of $1,000 and warrants to purchase up to 2,083,333 shares of common stock in a registered direct offering.

Codexis, Inc. (Nasdaq: CDXS) today announced the company will host a conference call and webcast on Thursday, February 3, 2011 at 4:30 p.m. Eastern Time to discuss its fourth quarter financial results for the period ended December 31, 2010.

Cord Blood America, Inc. (OTC Bulletin Board:CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, announced today that Biocordcell Argentina S.A. (BioCells, Inc.) has launched a program to store dental pulp stem cells, the first stem cell storage bank in Argentina to offer this service.

GeneLink, Inc. (OTC Bulletin Board:GNLK), a leading consumer genomics biotech company, has announced that Robert B. Trussell, former CEO and founder of Tempur-Pedic, Inc., has recently formed a company to distribute genetically customized products developed by GeneLink.

Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that the U.S. Food and Drug Administration (FDA) recently cleared use of its Bravo pH Monitoring System in patients four years of age and older.

Herborium Group, Inc., (PINKSHEETS: HBRM)a Botanical Therapeutics™ company, today announced the development of a co-marketing campaign with its largest distributor, Mankind Direct, LTD., to increase sales and market share of AcnEase®, Herborium's proprietary, botanically based acne and rosacea treatment, in the United Kingdom (U.K.).

Kensey Nash Corporation (Nasdaq:KNSY) today announced that it will release its earnings results for its second quarter ended December 31, 2010 at 7:30 A.M. Eastern Time on Tuesday, February 1, 2011.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market a new Tända™ Light Emitting Diode (LED) system for skin rejuvenation.

TRIMEDYNE, INC. (OTCBB: TMED) today announced it reached an amicable settlement of its contract dispute with Lumenis Ltd. of Yokneam, Israel, under which Lumenis has paid Trimedyne $2 million, and Trimedyne and Lumenis have entered into mutual releases.

XenaCare Holdings (OTCQB: XCHO) advises shareholders that its common stock is now quoted on the OTCQB under the stock symbol: XCHO.

 




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