|RxNews Recap for Monday 03-01-10. Ariad granted Orphan Drug status. Biodel up on NDA acceptance. Enzo soars on patent ruling.|
|By BioMedReports.com Staff|
|Monday, 01 March 2010 18:48|
Below is a list of the companies that made news in the healthcare sector on Monday, March 01, 2010.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) soared today after announcing that its investigational pan-BCR-ABL inhibitor, AP24534, has been granted orphan drug designation by both the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the U.S., the orphan designation of AP24534 is for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and in the E.U., its orphan designation is for CML and acute lymphoblastic leukemia.
"While impressive medical gains have been made over the past decade in treating various forms of leukemia, it is clear that the disease can be severe and life-threatening when it progresses," said Frank Haluska, M.D., Ph.D., vice president, clinical affairs of ARIAD. "Orphan drug designation for AP24534 highlights the lack of therapeutic options available for patients with CML or Ph+ ALL, who are resistant or refractory to currently available therapies. We expect to advance AP24534 into a pivotal registration trial later this year and pursue subsequent regulatory submissions for marketing authorization in these hematological cancers."
Shares of Ariad jumped up 23 cents or 9.03% to close at $2.77.
Biodel Inc. (Nasdaq: BIOD) jumped more than 9% today after the company announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application (NDA) seeking approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It has been tested in more than 875 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel submitted its marketing application to the FDA on December 30, 2009 and expects the Prescription Drug User Fee Act (PDUFA) action date for this NDA to be October 30, 2010.
Shares closed at $4.35, up 36 cents on the day. Volume was 4 times the daily average.
Enzo Biochem, Inc., (NYSE:ENZ) as reported here earlier on BioMedReports today announced that the Board of Patent Appeals and Interferences of the United States Patent and Trademark Office has entered judgment in favor of Enzo and against Bayer HealthCare LLC in a patent interference proceeding relating to Enzo Life Science’s application for nucleic acid signal amplification and Bayer’s U.S. Patent No. 5,124,246.
Shares of Enzo rocketed more than 16% to close the day at $6.06, up 84 cents. Volume was nearly 10 times the daily average.
After the bell:
Icagen, Inc. (Nasdaq:ICGN ) after the market closed today the company reported results of its Phase Ib pain study of ICA-105665, the Company's novel orally available small molecule KCNQ potassium channel agonist, which the company is developing for the treatment of epilepsy and pain. This randomized, double-blind, placebo-controlled, cross-over study was designed to assess the ability of ICA-105665 to decrease the sensation of pain in response to the intradermal injection of capsaicin and to a simulated sunburn. Twenty-four healthy volunteers were enrolled in the study, which was conducted at a single clinical research site in the United Kingdom.
At the dose tested, which was 200mg bid, ICA-105665 did not reduce the pain elicited in the capsaicin or sunburn models. The compound was well tolerated with no serious adverse events and with similar numbers of adverse events across treatment groups. Pharmacokinetic parameters were consistent with expectations.
Shares were down more than 25% in the after hour session.
MedCath Corporation (Nasdaq:MDTH) shares jumped more than 10% after hours after the company announced that its Board of Directors has formed a Strategic Options Committee composed solely of independent directors to consider the sale either of MedCath or the sale of its individual hospitals and other assets. Navigant Capital Advisors has been retained as its financial advisor to assist the Committee in this process. Due to this engagement, Dr. Edward R. Casas, a senior managing director of Navigant Capital Advisors, resigned voluntarily from MedCath's Board and will not stand for reelection to MedCath's Board at its upcoming annual stockholders' meeting on March 3, 2010.
In other news Monday:
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee will review CTI's New Drug Application for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL") on March 22, 2010. The meeting was to take place on February 10, 2010, but the FDA postponed the meeting because of severe weather conditions in the Washington, D.C. area. Following the vote at the rescheduled ODAC meeting, the FDA is expected to make a final decision on approval of CTI's NDA for pixantrone by April 23, 2010.
"Our team is well-prepared to deliver an evidenced-based presentation to the ODAC panel, which we expect will provide a persuasive argument to the clinicians on the panel for the approval of pixantrone," said James A. Bianco, M.D., CEO of CTI. "The ODAC meeting is an important milestone in the review process, and we look forward to discussing the efficacy and safety data for pixantrone with the members of the panel and the FDA review team." Dr. Owen O'Connor, Chief of Hematology Oncology at NYU Cancer Institute, and Dr. John Leonard, Chief of Lymphoma Myeloma at Weill Corner Cancer Center will be presenting on behalf of CTI.
The Board of Directors of Cyanotech Corporation (Nasdaq Capital Market:CYAN), has named David I. Rosenthal as Interim President and Chief Executive Officer, effective February 27, 2010, while a search is underway for a new CEO. He replaces Andrew H. Jacobson, who was removed from his responsibilities of President and Chief Executive Officer by the Board.
Mr. Rosenthal, age 55, has served on the Board of Directors of Cyanotech since November 2000 and is a member of the Audit Committee. Shares dropped more than 12% on the news.
Ferro Corporation (NYSE: FOE) (the “Company”) today announced net sales of $1,658 million for the year ended December 31, 2009, a decline of 26 percent from net sales of $2,245 million in 2008.
GTC Biotherapeutics, Inc. (NASDAQ: GTCB) announced that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of the LFB-GTC joint venture. TG20 has enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), a key feature useful in the treatment of cancer and auto-immune diseases, and it has been shown to have 10-fold enhanced ADCC when compared side by side with rituximab in assays performed with B-cell chronic lymphocytic leukemia, or B-CLL, patient cancer cell isolates.
"This result is an important demonstration of the ability of GTC’s transgenic technology platform to produce monoclonal antibodies with significantly enhanced ADCC", said Geoffrey Cox, Ph.D., Chairman, President and CEO of GTC Biotherapeutics. "Furthermore, this is a critical milestone in our development of TG20, an antibody that has the potential of providing more efficacious and cost-effective treatments for cancers such as non-Hodgkin’s lymphoma as well as auto-immune diseases such as rheumatoid arthritis".
ImmunoGen, Inc. (Nasdaq: IMGN) announced today that management will participate in two upcoming investor conferences with live webcasts.
OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI), announced today that two peer-reviewed articles have been published that further elucidate the biological function of clusterin, its role in promoting tumor resistance to cancer treatment, and the role of an inhibitor of clusterin such as custirsen (OGX-011) that is designed to knock down treatment resistance in the cells and enhance the effectiveness of cancer therapies. Researchers have defined another novel mechanism by which the knockdown of clusterin in cancer cells with OGX-011 may enhance treatment induced apoptosis.
PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that the Company's annual meeting of shareholders will be held on Wednesday, May 26, 2010, in Louisville, Kentucky.
VIVUS, Inc. (Nasdaq:VVUS) popped up today after the company announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa®, for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010. In previously announced pivotal phase 3 trials, patients treated with all three doses of Qnexa achieved significant weight loss compared to placebo, and significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular, inflammatory and metabolic risk factors.
"The FDA's acceptance of the Qnexa NDA marks an important milestone in the development of Qnexa as a treatment for patients who are obese or overweight with co-morbidities," stated Leland F. Wilson, chief executive officer for VIVUS. "We believe that Qnexa, if approved, will play an important role in treating the millions of patients living with obesity and related diseases, and who are in need of safe and effective options." Shares closed up 48 cents to $8.88.
Walgreens (NYSE: WAG)(NASDAQ: WAG) today announced a strategic restructuring of its health care divisions to enable the company to offer integrated “Pharmacy, Health and Wellness Solutions” to employers, managed care organizations, pharmacy benefit managers and government clients.
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