RxNews Recap for Thursday 01-21-10. After hours Abbott (ABT) ordered to halt diet drug Print E-mail
By Mary Davila   
Thursday, 21 January 2010 18:53


Below is a list of the companies that made news in the healthcare sector on Thursday, January 21, 2010.

Abbott Laboratories (NYSE:ABT) late Thursday reported that is has stopped European sales of a weight- loss pill in the face of a recommendation by regulators that heart-related risks made the prescription drug too dangerous.

The European Medicines Agency (EMEA) ordered a suspension to sales of drugs containing sibutramine, which are sold under the names Reductil, Reduxade and Zelium in Europe and Meridia in the United States.

"The risks of these medicines are greater than their benefits," EMEA said in its recommendation to the European Commission, adding that weight loss with the drugs is "modest" and may not last after treatment is stopped.

Abbott has agreed to cooperate with the recommendation even though "we respectfully disagree" and "believe there are many patients who benefit" from the drug, company spokesman Kurt Ebenhoch said.

The drug will still be available outside of Europe, Ebenoch added. In the United States, the Food and Drug Administration said it concluded the drug increased the chances of a heart attack or stroke for people with cardiovascular disease and that Abbott agreed to a add stronger warning on its label which states the drug should not be used in patients with a history of cardiovascular disease.

The FDA said its review showed the higher heart risks extended only to patients with a history of cardiovascular disease. The agency advised patients to discuss with their doctors if continued use was appropriate. The FDA plans on holding an advisory meeting with outside experts to study the matter in order to help the agency decide if further regulation will be necessary.

In 2009 Meridia's global sales were around $300 million.

 In other news from earlier in the day:

AlphaRx Inc. (OTCBB: ALRX)announced today that its licensee, Gaia BioPharma Limited, has signed an agreement with a contract manufacturing organization (CMO) to manufacture GAI-122 for use in the planned Phase I and II clinical trials of that product candidate. GAI-122 is being developed as I.V. administered formulation of an intracellular neuro-protectant that employs AlphaRx's proprietary nano-emulsion formulation technology.

Amgen (Nasdaq: AMGN) today announced that detailed results from two pivotal Phase 3 studies evaluating Vectibix® (panitumumab) in combination with chemotherapy for the first and second-line treatment of metastatic colorectal cancer (mCRC) (the PRIME '203' and '181' trials, respectively) will be presented at the 2010 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in Orlando, Florida from Jan. 22-24, 2010.

Auxilium Pharmaceuticals (AUXL) announced today along with Pfizer (NYSE:PFE)that the two have recieved notification from the European Medicines Agency that the Marketing Authorization Application for XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren's contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully. As a result, the scientific/technical review procedure commenced January 21st, 2010. Based on the completion of the validation phase and today's confirmation from the European Medicines Agency of the start of the regulatory review procedure, Auxilium will receive a $15 million milestone payment from Pfizer. Auxilium is partnered with BioSpecifics Technologies Corp. (Nasdaq: BSTC) on the deal (see below).

BioSpecifics Technologies Corp. (Nasdaq: BSTC),a biopharmaceutical company developing first in class collagenase-based products, today announced that its partner Auxilium Pharmaceuticals, Inc. announced that Pfizer Inc. received notification from the European Medicines Agency that the Marketing and Authorization Application (MAA) for XIAFLEX™ for the treatment of Dupuytren's disease (a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers) has completed the validation phase successfully and that the scientific/technical review procedure commenced today.

Bond Laboratories, Inc. (OTCBB:BNLB),a marketer of healthy food and beverage products that support an active and healthy lifestyle, today announced strong operating results for NDS Nutrition Products, Inc. its wholly owned subsidiary. NDS which manufactures and distributes a full line of proprietary health products and nutritional supplements for weight loss, sports nutrition, and general health to high-volume retail outlets as well as specialty health and nutrition store chains throughout the United States, was aquired in October of 2008.

Caleco Pharma Corp. (OTCBB:CAEH)(www.calecopharmacorp.com) is pleased to announce that it has retained Rearden Health Partners, a healthcare media and communications firm that specializes in healthcare product development.

China Pharma Holdings, Inc.(AMEX:CPHI),  today announced that the Company has completed clinical trials for Candesartan, an anti-hypertension drug, and submitted the generic drug production application to the SFDA. China Pharma develops, manufactures, and markets specialty pharmaceutical products in China. Shares opened higher this morning but traded lower as the day progressed, eventually closing down over 7%.

China Sky One Medical, Inc. (Nasdaq: CSKI), a leading fully integrated pharmaceutical company developing and producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that Heilongjiang Tianlong Pharmaceutical Company ("Tianlong"), the Company's wholly owned subsidiary, will change its R&D focus from external use medicines to antibiotics and cardiac drugs.

Covidien plc (NYSE: COV) today announced that its Board of Directors has declared a quarterly cash dividend of $0.18 per ordinary share. The dividend is payable on February 23, 2010, to shareholders of record on February 1, 2010.
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC)  a biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders announced today that it has entered into definitive agreements to raise $5.9 million in gross proceeds, before deducting placement agent fees and other estimated offering expenses, and up to an additional $2.0 million, in a registered direct offering to certain existing institutional investors of the Company.

CytRx Corporation (NASDAQ:CYTR), a bio-pharmaceutical company specializing in oncology, today announced its plans for 2010 which included advancing the clinical development of its high-value drug development pipeline as well as boosting shareholder value.
Said Steven A. Kriegsman, CytRx President and CEO: “After successfully completing all of our 2009 goals, we intend to aggressively move ahead this year with multiple oncology development programs with a focus on rapid commercialization. Our oncology compounds are based on known mechanisms of action, which we believe reduces the development risk, while being clearly differentiated from currently approved treatments"
Kreigsman went on to say: “Among our 2010 plans, we intend to broaden our tamibarotene program by evaluating it in a combination therapy as a first-line treatment for acute promyelocytic leukemia (APL). Preparations are also underway to begin three Phase 2 clinical trials with INNO-206 in advanced pancreatic cancer, advanced gastric (stomach) cancer and advanced soft tissue sarcomas. Also, last week we announced plans to begin testing bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL). INNO-206 and bafetinib have demonstrated results in treating multiple cancers in animal studies. Our development strategy is to test these compounds in advanced-stage cancers, which could allow for rapid indications of efficacy, with the potential for data as early as the fourth quarter of this year. We believe these drug candidates could represent blockbuster opportunities for CytRx with potential revenue exceeding $2 billion,” he added.

"Our many clinical and development accomplishments last year laid the groundwork for pursuing these ambitious milestones in 2010. We also expanded our executive management team by adding proven oncology industry veterans in key positions, including Dr. Dan Levitt as Chief Medical Officer to oversee all drug development operations. We strengthened our business development expertise to support our plans to partner select programs and more recently added to our in-house manufacturing experience and clinical and regulatory skills necessary to support manufacturing and product commercialization. Additionally, we improved our cash position, raising more than $18 million in net proceeds in a July 2009 registered direct equity offering. Our 36% holdings in RXi Pharmaceuticals has increased to a market value of approximately $30.0 million as of January 18, 2010 as a result of the recent RXi stock price improvement, further bolstering our potential cash resources.”

Shares of CytRx are up nearly 20% year to date.

Depomed, Inc. (NASDAQ:DEPO)announced today that it has received a second $500,000 milestone payment under its worldwide license agreement with Covidien focusing on the exclusive development of four acetaminophen/opioid analgesic combination products utilizing Depomed’s Acuform® gastric retentive drug delivery technology.

Immunomedics, Inc. (Nasdaq:IMMU),Shares continued to trade higher today after seeing gains of more than 10% yesterday. The bio-pharmaceutical company focusing on developing monoclonal antibodies to treat cancer and other serious diseases, reported on Thursday that initial studies show that a new blood test using the Company’s proprietary antibody, clivatuzumab (PAM4), might identify patients with early-stage pancreatic cancer. The blood assay for PAM4-protein was evaluated in 68 patients who had pancreatic cancer surgery and in 19 healthy controls.  It was found that the test was 62% sensitive for detecting stage-1 pancreatic cancer (disease confined to pancreas), 86% for stage 2 disease, and 91% for stage 3/4 (local and distant spread) cancers.

“Although the number of samples studied is still modest, the test appears to have the ability to detect early disease in a higher percent of patients than any other single test currently available,” Dr. Gold stated. He cautioned, however, that “we will need to expand these initial studies in a prospective trial where we test hundreds of samples from patients with diverse diseases and where there is a high suspicion of possible pancreas disease, including early stages of cancer, and such studies are planned.”

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX)today announced that updated results from its Phase 2 clinical trial of KRX-0401 (perifosine) in combination with capecitabine has been selected for poster presentation at the upcoming ASCO 2010 Gastrointestinal Cancers Symposium, to be held in Orlando, Florida from January 22-24, 2010.

MDRNA, Inc. (NASDAQ:MRNA),saw its shares trade higher today. A leading RNAi-based drug discovery and development company, announced that the European Patent Office intends to grant a patent for application EP06826368 covering formulations for the intranasal delivery of rapid acting insulin, and its use for the treatment of diabetes.

"While our focus remains the development of RNAi-based therapeutics, we believe that the intranasal assets from our predecessor company, Nastech Pharmaceuticals, have considerable value," said J. Michael French, President and CEO of MDRNA. "Specifically, we believe that our insulin intellectual property assets, with the positive results from the Phase II clinical trial completed in 2008, have out-licensing potential."

Oxygen Biotherapeutics, Inc. (Nasdaq: OXBT) chairman and CEO Chris Stern will preside over the NASDAQ Opening Bell on Friday, January 22, 2010.

PerkinElmer, Inc., (NYSE:PKI) a global company focused on improving the health and safety of people and the environment, today announced that on Thursday, February 4, 2010, after market close, the Company will release fourth quarter 2009 and full year 2009 results.

Pfizer Inc. (NYSE: PFE) and Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL)today announced that Pfizer received notification from the European Medicines Agency that the Marketing Authorization Application (MAA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren’s contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully.

Rite Aid Corporation (NYSE: RAD)announced today that John T. Standley, currently Rite Aid President and Chief Operating Officer, will become President and Chief Executive Officer effective June 24, 2010 at the company’s annual stockholder meeting. Mary Sammons, currently Rite Aid Chairman and CEO, will continue as Chairman.

Simulations Plus, Inc. (NASDAQ:SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, announces the launch of a new product that will assist pharmaceutical scientists in estimating the effects of physiological fluids on the solubility of drug-like molecules.

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

Stem Cell Assurance, Inc. (PK: SCLZ) and MDwerks, Inc. (OTC Bulletin Board: MDWK)announced today a financing and marketing partnership today wherein MDwerks, through it's Xeni Finance subsidiary, has provided the first tranche of financing to Stem Cell for the purchase of various medical devices from Cytori Therapeutics, Inc.

SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced that it has opened its new world-class facility for manufacturing and development in Birmingham, Alabama.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA)announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abrreviated New Drug Application (ANDA) to market its generic version of Novartis’ breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg.

Vascular Solutions, Inc. (NASDAQ:VASC) reported today that it has received $3.5 million from Marine Polymer Technologies as payment of the monetary judgment in its product disparagement litigation. This payment followed a two-week trial held in April 2008 with the jury finding that five statements made by Marine Polymer Technologies representatives regarding Vascular Solutions' D-Stat® hemostat products were false, followed by the decision of the First Circuit Court of Appeals in December 2009 affirming liability and modifying the amount of damages.

"We are pleased to have this matter concluded and to have finally received payment for the damages incurred," Howard Root, CEO of Vascular Solutions, an innovative medical device company that focuses on developing customized clinical solutions for coronary and peripheral vascular procedures, said "The $3.5 million we received was larger than our earlier $3.2 million estimate due to a higher statutory interest rate applied to the damages as a result of the First Circuit decision. We appreciate the excellent legal representation we received from our attorneys at Dorsey & Whitney LLP on the trial, appeal and ultimate recovery of this matter."
Watson Pharmaceuticals (NYSE:WPI)today released expectations for 2010. The projected total revenues of approximately $3.5 bln (vs $3.44 bln ) and EPS of $3.05-3.30 (vs $3.14) are above concensus. Watson management predicted continued growth in its Generics, Brand and Distribution businesses,

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