Medicis shares gain on generic delay. PDL BioPharma settles with Novartis. After the bell: Novavax soars on HHS contract Print E-mail
By Staff and Wire Reports   
Monday, 28 February 2011 19:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 28, 2011.

After the bell, shares of Novavax, Inc. (Nasdaq:NVAX) soared more than 38% after it was reported that the company has received a contract from the U.S. Department of Health and Human Services for the development of flu vaccines. The contract is worth $97 million over three years and carries an option to extend the contract for an additional two years for a total potential contract value of $179 million.

"The 2009 H1N1 pandemic demonstrated the need for technologies that can provide vaccines more rapidly," HHS Secretary Kathleen Sebelius said in a statement Monday. "These next-generation flu vaccines hold the potential to be even more effective and to make the first and last doses of vaccine available sooner than existing flu vaccines by weeks and months which can save more lives during a pandemic as well as during seasonal flu outbreaks."

The stock was recently featured here on BioMedReports.

Shares of Novavax were up 26 cents or 11% to $2.60 in Monday trading. In extended trading, shares added 99 cents to $3.59.

Shares of Medicis (NYSE:MRX) surged more than 24% Monday after it was reported late Friday that the company has settled with Teva Pharmaceuticals, delaying marketing of a generic version of its flagship acne product, Solodyn, until 2018. As part of the settlement, Teva will pay royalties to Medicis to produce 65mg and 115mg strength versions of Solodyn.

Shares jumped $6.27 to $32.09.

PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) gained more than 14% today after the company announced that it has resolved all disputes with Novartis. According to the settlement, Novartis has agreed not to oppose PDL's patent in Europe for an eye-care drug using PDLI technology. In turn, PDLI has agreed to share a portion of European sales of the drug, Lucentis. Novartis agreed to withdraw its challenge in the European Patent Office of PDL's Queen patent. PDL will continue to pursue its claims against Genentech Inc. and Roche Ltd.

More than 15 million shares traded hands as the stock gained 69 cents to $5.55.

Nile Therapeutics, Inc. (Nasdaq:NLTX), jumped more than 7% Monday after the company focused on the development of novel therapeutics for heart failure patients, announced that it will collaborate with Medtronic, Inc. (NYSE:MDT) on the clinical development of Nile's proprietary natriuretic peptide, cenderitide (formerly CD-NP), for heart failure and renal disease applications.

"We are very pleased to partner with Medtronic on cenderitide," said Joshua Kazam, Chief Executive Officer of Nile Therapeutics. "This collaboration will be an important step on our path to developing cenderitide as a potential new therapy for patients with cardiovascular and renal disease following hospitalization for acute heart failure."

Shares traded as high as $0.72 before settling the day at $0.60 cents, up 4 cents.

Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZ.to) today announced that it had received a net sales milestone of $2.5 million from Cowen Healthcare Royalty Partners, L.P. This milestone was payable pursuant to the previously announced sale to Cowen Royalty of Aeterna Zentaris' rights to royalties on future net sales of Cetrotide, covered by the Company's license agreement with Merck Serono, and was contingent on 2010 net sales of Cetrotide reaching a specified level.

Anika Therapeutics, Inc. (Nasdaq:ANIK) today announced that Kansas City-based Visco Technologies LLC will serve for the next five years as a U.S. distributor for ANIKAVISC, the Company’s viscoelastic for cataract surgery. Anika recently received U.S. Food and Drug Administration approval for the ANIKAVISC product. For more than 20 years, the Company has manufactured premium ophthalmic viscoelastics for companies including Bausch & Lomb, Staar Surgical and HOYA Surgical Optics.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "We are pleased to have reached this $2.5 million milestone which will be incremental to advance perifosine, AEZS-108 and other innovative oncology compounds from our extensive product pipeline."

Derma Sciences, Inc. (Nasdaq:DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s patent-pending MEDIHONEY® Gel Wound and Burn Dressing. This latest MEDIHONEY line extension is dispensed from a tube and is comprised of Active Manuka (Leptospermum) honey blended with natural-based gelling agents.

FUJIFILM Corporation and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceutical industry and wholly owned by Merck.

"Fujifilm continues to build upon its ongoing commitment to delivering pharmaceutical business," said Shigetaka Komori, president and chief executive officer of FUJIFILM Corporation. "This acquisition provides an important addition to our pharmaceutical business with diverse capabilities and technical expertise in production of protein therapeutics."

Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) today announced that in a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy, ARCALYST (rilonacept) met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period.

Santarus, Inc. (NASDAQ:SNTS) and biotech company Pharming Group NV (NYSE Euronext:PHARM) today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration for the RHUCIN (recombinant human C1 inhibitor) Biologics License Application (BLA) submitted by Pharming. In the letter the FDA indicated that the BLA was not sufficiently complete to enable a critical medical review.

Synta Pharmaceuticals Corp. (NASDAQ:SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that a Phase 2b/3 clinical trial of ganetespib (STA-9090) in combination with docetaxel in non-small cell lung cancer (NSCLC) will be initiated in the second quarter of 2011.

Trius Therapeutics, Inc. (Nasdaq:TSRX) today announced results from its Phase 1 clinical trial to evaluate the ability of torezolid to penetrate into the lung for potential use to treat lung infections. In this study a 200 mg dose of torezolid phosphate was administered orally once-daily for three days to healthy adult volunteers. The trial achieved its primary goal of establishing the steady-state plasma pharmacokinetics and distribution of active drug into epithelial lining fluid (ELF). The same 200 mg once-daily dose of torezolid phosphate is currently being tested in a Phase 3 clinical trial for acute bacterial skin and skin structure infections (ABSSSI). 

Also Monday:

BIOLASE Technology, Inc, (NASDAQ: BLTI) , the World's leading dental laser manufacturer and distributor, today announced that it completed a very successful showing at the 146th Chicago Dental Society Midwinter Meeting, one of the largest dental shows in the country.

Cellceutix Corporation (PINKSHEETS: CTIX) announced today that data from research on Kevetrin™, the Company's flagship compound against cancers, has demonstrated the potential for a major breakthrough in cancer research by exhibiting an activation of p53.p53, often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome" due its crucial role in controlling cell mutations, is a tumor suppressor protein that is encoded by the TP53 gene in humans and has been widely regarded as possibly holding a key to the future of cancer therapies.

China Cord Blood Corporation (NYSE:CO), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced unaudited financial results for the third quarter and first nine months of fiscal year 2011 ended December 31, 2010.

Cytori Therapeutics (NASDAQ: CYTX) will present and provide a webcast of their corporate presentation at the CitiBank 2011 Global Healthcare Conference on Wednesday, March 2, 2011 at 3:30 PM ET.

First China Pharmaceutical Group, Inc. (OTCBB: FCPG)
, a rapidly growing pharmaceutical distribution company headquartered in Yunnan, China, is pleased to announce that the Company recently brought together all key managers and employees for a day long series of meetings aimed at reviewing recent events and to put forward and discuss plans for the last quarter of fiscal 2010 (ending March 31, 2011) and fiscal 2011 (ending March 31, 2012).

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the fourth quarter and year ended December 31, 2010.

Kendle (Nasdaq:KNDL), a leading, global full-service clinical research organization (CRO), today announced Martha R. Feller, PhD, has rejoined the Company as Vice President and Global Head, Study Start-up, effective immediately.

Medizone International, Inc. (OTCBB: MZEI) (OTCQB: MZEI) is pleased to announce the appointment of eminent Canadian medical research scientist, Michael E. Shannon M.A.,M.Sc.,M.D., as President of the Company.

Micro Identification Technologies, Inc. (OTCBB:MMTC) (MIT) previously announced on January 4, 2011 that it had received the first production MIT 1000 System from OSI Optoelectronics (OSIO), a subsidiary of OSI Systems.

Neuro-Biotech Corp. (PINKSHEET: MRES) (OTCQB: MRES) is pleased to provide its shareholders updates about the due diligence process and the conditions of the unsolicited offer.

NeoStem, Inc. (NYSE:NBS), an international biopharmaceutical company with operations in the U.S. and China, announced today that Dr. Robin Smith, the Company's Chairman and CEO, will present on Tuesday, March 1, 2011 at the Wall Street Analyst Forum 22nd Annual Analyst Conference.

Oramed Pharmaceuticals Inc. (OTCBB: ORMP), a developer of oral drug delivery systems, announced today that its subsidiary Oramed Ltd. entered into a Share Purchase Agreement with D.N.A Biomedical Solutions Ltd. (formerly Laser Detect Systems Ltd.), an Israeli company listed on the Tel Aviv Stock Exchange, for the sale of most of its holdings in Entera Bio Ltd., for $1.15 million, and a commitment by D.N.A to invest $250,000 in Oramed.

Omni Bio Pharmaceutical, Inc. (OTC Bulletin Board:OMBP), an emerging biopharmaceutical company formed to acquire, license, and develop existing therapies for indications with substantial commercialization potential, has committed to expand its Phase I/II human clinical trial in recently diagnosed Type 1 diabetes patients from 15 patients to 50.

PAREXEL International Corporation (Nasdaq:PRXL) announced today that it will be presenting at the Raymond James Investors Conference in Orlando, FL.

PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) today announced that its board of directors has adopted a regular dividend policy for 2011 and beyond and declared that the four quarterly dividends to be paid to its stockholders in 2011 will be $0.15 per share of common stock.

Sangamo BioSciences, Inc. (Nasdaq:SGMO) announced today the presentation of positive preliminary clinical data from its Phase 1 trial (SB-728-902).

ShengdaTech, Inc. (NASDAQ:SDTH), a leading manufacturer of nano-precipitated calcium carbonate in China, today announced that Mr. Xiangzhi Chen, the Company's chairman and CEO, Ms. Anhui Guo, COO and acting CFO and Mr. A. Carl Mudd, lead independent director, will attend the Rodman & Renshaw Annual China Investment Conference to be held from March 6-8, 2011 in Shanghai.

Shire plc, (LSE: SHP, Nasdaq:SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the use of once-daily INTUNIV® (guanfacine) Extended-Release Tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents ages 6 to 17 as part of a total treatment program.

VIVUS, Inc. (Nasdaq:VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its highlights and financial results for the fourth quarter and year ended December 31, 2010.

 

 




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