|RxNews Recap for Thursday 01-28-10. Achillion (ACHN) up on HCV candidate|
|By Mary Davila|
|Thursday, 28 January 2010 20:34|
Below is a list of the companies that made news in the healthcare sector on Thursday, January 28, 2010.
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) saw its shares trade higher today as the company announced the nomination of a lead clinical candidate in its third proprietary program against hepatitis C infection. The candidate, ACH-2684, demonstrated excellent potency in the low pico-molar range, as well as good pharmacokinetic and safety profiles in pre-clinical studies. Milind S. Deshpande, Ph.D., Executive Vice President and Chief Scientific Officer of Achillion reported: "The potency and virology profile of ACH-2684 demonstrates that it very effectively suppresses a broad range of natural variants of the hepatitis C virus, and may be effective in prevention and treatment of emerging resistant variants. This compound also retains potent activity against all genotypes. The very high potency of ACH-2684 was achieved by optimizing its interactions against NS3 protease. We have demonstrated in vitro that ACH-2684 can be used in combination with other HCV inhibitors, and that it is synergistic with NS5B nucleoside polymerase inhibitors, We have leveraged our expertise in HCV drug discovery and structure-based design to create a set of compounds, including ACH-2684, that are part of a discrete intellectual property estate and to which we currently retain all commercial rights." Desphande went on to say: "We are quite pleased to announce a clinical candidate from our third proprietary HCV program, further demonstrating our robust drug discovery expertise in this important therapeutic area. The compound, with its potency--resistance profile and preliminary safety characteristics, has the potential to be highly complementary to both our Gilead-partnered NS4A antagonist compounds as well as our ACH-1625 protease inhibitor, which recently achieved strong proof-of-concept results. We expect to move to IND-enabling pre-clinical testing of ACH-2684, and initiate a Phase 1/1b study in 2011." Shares were up 6% on the day and continued to trade higher by another 4% in the after hours session.
In other news Thursday:
AspenBio Pharma, Inc. (Nasdaq:APPY), announced today that it has entered into a strategic relationship with LRE Medical GmbH (LRE) to complete commercial development and manufacture of the reader instrument to be used with the AppyScore cassette system.
LRE, a wholly owned subsidiary of Esterline Corporation (NYSE:ESL) is a leader in the development and manufacture of medical devices with a special focus in instruments for point-of-care and near patient testing. LRE is ISO 13485 certified, experienced in manufacturing for IVD and MDD devices requiring the CE mark in the EU, and is registered with the FDA as a contract manufacturer for medical device products.
"We are fortunate to be working with LRE who brings over 40 years of experience in medical device manufacturing and has built a successful track record in developing instruments currently in use in emergency and critical care settings," said Daryl J. Faulkner, Chief Executive Officer of AspenBio Pharma. "LRE provides AspenBio with a proven instrument platform to commercialize our novel assay and strengthens an important part of our supply chain."
EnteroMedics Inc. (Nasdaq: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced today that, following a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company’s EMPOWER™ study results and the regulatory process, the Company intends to submit an Investigational Device Exemption (IDE) application for a clinical trial to support a possible Premarket Approval (PMA) application for the next-generation Maestro® RC System in the treatment of morbid obesity.
“We had a constructive dialogue with the FDA about the regulatory steps necessary to move beyond the EMPOWER trial,” stated Mark B. Knudson, Ph.D., President and Chief Executive Officer of EnteroMedics. “The Agency and the Company discussed regulatory direction for the Maestro System and the product approval process in support of our efforts to bring VBLOC therapy to market. As an outcome of this meeting, we will begin the next step in that regulatory process by preparing an IDE application for submission in the first quarter of 2010.” Dr. Knudson added: “The Company remains fully committed to supporting the patients from the EMPOWER trial of the Maestro RF System.” Shares of EnteroMedics traded higher on the news, closing up more than 11% on the day and settling at 66 cents
Genzyme Corporation (NASDAQ: GENZ) announced today that it has adopted new annual and long-term incentive plans for senior executives that will be utilized beginning in 2010.
Repligen Corporation (Nasdaq: RGEN) today reported an extension to its longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies, a highly successful class of biopharmaceutical. Repligen is the world's leading supplier of recombinant Protein A and has manufactured recombinant Protein A for GE Healthcare for more than 10 years. This agreement provides for Repligen to continue to be a strategic supplier to GE Healthcare through 2014. GE Healthcare sells chromatography products which incorporate Repligen's recombinant Protein A to the biopharmaceutical industry for the manufacture of monoclonal antibodies.
"We are very pleased to continue our long standing relationship with GE Healthcare," said Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "This agreement ensures continuity in the supply of high quality recombinant Protein A supported by our business continuity plans and quality systems that are required by the biopharmaceutical industry."
Rite Aid Corporation (NYSE: RAD) today announced sales results for January.
ZOLL Medical Corporation (Nasdaq: ZOLL), a manufacturer of resuscitation devices and software solutions, today announced that revenues for the first quarter of fiscal 2010 increased 18% to $105,212,000, compared to revenues in the first quarter of last year of $89,462,000. Revenue results included a positive foreign exchange impact of approximately $2.3 million compared to the first quarter of fiscal 2009. The results include approximately $4.6 million of revenue derived from our new Temperature Management business, whose assets were acquired from Alsius Corporation in May 2009. Net income was $2,310,000 for the quarter, compared to $2,894,000 in the prior year. Diluted earnings per share were $0.11, compared to $0.14 in the prior year. Backlog at the end of the first quarter was approximately $17.0 million, as compared to $8.3 million at the end of Q1 2009.
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.