|CytRx's tamibarotene eradicates cancer in advanced acute promyelocytic leukemia after failure of other therapies. After the bell: FDA approves Impax Lab's generic pain drug|
|By BioMedReports.com Staff|
|Thursday, 22 July 2010 18:56|
Below is a list of the companies that made news in the healthcare sector on Thursday, July 22, 2010.
Impax Laboratories, Inc. (NASDAQ:IPXL) rose after the bell today after announcing that the U.S. Food and Drug Administration has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of OPANA ER (oxymorphone hydrochloride) Extended Release 30mg tablet. In June 2010, the Company was granted final approval for the 5mg, 10mg, 20mg, and 40mg tablets.
As previously announced, in June 2010, the Company reached agreement with Endo Pharmaceuticals and Penwest Pharmaceuticals to grant the Company a license to sell a generic of OPANA ER on Jan. 1, 2013 or earlier under certain circumstances.
The Company was the first to file a paragraph IV certification on these strengths and will be entitled to 180 days of market exclusivity upon product launch. Global Pharmaceuticals, Impax’s generic division will commercialize the product on Jan. 1, 2013 or earlier under certain circumstances.
Endo Pharmaceuticals and Penwest Pharmaceuticals manufacture and market OPANA ER for the treatment of moderate to severe pain. According to Wolters Kluwer Health, U.S. sales of OPANA ER tablets were approximately $254 million for the 12 months ended May 31, 2010.
Align Technology, Inc. (Nasdaq:ALGN) jumped after the bell as the company reported 2nd quarter results that beat estimates. Shares of Align were up more than 12% in extended trading.
Inhibitex, Inc. (Nasdaq: INHX) today after the bell announced that the independent data safety monitoring board (DSMB) responsible for reviewing safety data from the Company’s ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with complete 30-day follow-up safety data on the third quartile (75%) of the patients that the Company plans to enroll in the trial. Based upon its review, the DSMB recommended that the trial continue to completion without modification. The Company anticipates that top-line efficacy data from the completed trial will be available in the fourth quarter of 2010.
In news from earlier in the day:
CytRx Corporation (NASDAQ: CYTR), today announced that a 44-year-old female patient with advanced acute promyelocytic leukemia (APL) achieved molecular complete remission with no evidence of disease in the blood cells and/or bone marrow following treatment with CytRx’s oncology drug candidate tamibarotene. The patient was treated in CytRx’s Phase 2 STAR-1 registration trial, which is evaluating the efficacy and safety of orally available tamibarotene as a third-line treatment for APL. The patient report, "Molecular remission in advanced acute promyelocytic leukaemia after treatment with the oral synthetic retinoid Tamibarotene," (Francesco Lo-Coco, et. al.), was published in the July online issue of the peer-reviewed British Journal of Haematology with publication in the print edition expected later this year.
"This event represents a very significant milestone for CytRx and our drug candidate tamibarotene. Tamibarotene has saved a life and nothing can compare with that," said CytRx President and CEO Steven A. Kriegsman. "These important results indicate that tamibarotene warrants further evaluation as a third-line treatment and in combination as a first-line treatment for APL. We are also considering developing tamibarotene for other cancers as well.
"Previously published reports indicate that tamibarotene is 10-times more potent and may be better tolerated than all trans retinoic acid (ATRA). We believe that the combination of tamibarotene and arsenic trioxide (ATO) could produce a complete response rate similar to the ATRA and ATO combination with fewer toxicities such as APL differentiation syndrome. We currently are conducting a dose escalation trial combining tamibarotene with ATO as an important step in our ultimate goal of evaluating tamibarotene as a first-line treatment for APL," he added.
Shares of CytRx initially shot up nearly 20% on the news before pulling back and settling at 84 cents, up 11.35% on the day.
Shares of Cleveland BioLabs, Inc. (NASDAQ:CBLI) shot up more than 13% today after the company, as reported earlier today on BioMedReports, announced that CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS), has been granted Fast Track status by the U.S. Food and Drug Administration.
Cleveland BioLabs reached an intra-day high of $3.78 before settling at $3.62, a gain of 43 cents on the day.
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced the nomination of a lead clinical candidate in its fourth proprietary program against hepatitis C virus (HCV) infection. The candidate, ACH-2928, is an NS5A inhibitor that in preclinical studies has demonstrated excellent potency against HCV RNA replication, as well as good pharmacokinetic and safety profiles.
Human Genome Sciences, Inc. (Nasdaq:HGSI) today announced financial results for the quarter ended June 30, 2010, and provided highlights of recent key developments.
"BENLYSTA continued to make excellent progress toward commercialization in the second quarter of 2010," said H. Thomas Watkins, President and Chief Executive Officer. "We and GlaxoSmithKline have submitted regulatory applications seeking approval to market BENLYSTA in the United States, Europe and Canada, and we expect to submit applications in other countries in the coming months. We have the potential, if FDA grants priority review, to receive approval of BENLYSTA in the United States before the end of 2010. The results of our BLISS-76 Phase 3 trial were presented in June at the 2010 EULAR meeting in Rome, and additional results from our BLISS-52 and BLISS-76 studies were presented at EULAR and at the International Congress on SLE in Vancouver. These results provided additional support for our belief that BENLYSTA could become the first new approved drug for lupus in more than 50 years."
Invacare Corporation (NYSE: IVC) surged $3.48 or 17.40% to $23.48 today after the company announced strong financial results for the second quarter and the six months ended June 30, 2010 and an upgraded outlook for fiscal 2010.
NPS Pharmaceuticals, Inc. (Nasdaq: NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of patient randomization in its Phase 3 registration study of GATTEX (teduglutide). The double-blind, placebo-controlled safety and efficacy study, which is known as STEPS, is being conducted in patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) and is now fully randomized with 86 patients.
"The timely completion of randomization in this Phase 3 study marks a significant milestone in our development program for GATTEX in short bowel syndrome," said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals.
Bristol-Myers Squibb Company (NYSE: BMY) today presented results from a national survey which found that emotional barriers, such as stigma, fear, denial and shame, and structural barriers, such as lack of knowledge, transportation, and insurance coverage, can prevent people living with HIV/AIDS (PLWHA) from seeking care and treatment.
Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) has started shipping tamsulosin hydrochloride capsules.
Dr. Reddy’s Laboratories Ltd. (NYSE:RDY) today announced its unaudited financial results for the quarter ended June 30, 2010 under International Financial Reporting Standards (IFRS).
Forest Laboratories, Inc. (NYSE: FRX) Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KGaA, and Merz Pharmaceuticals GmbH announced today that they have entered into settlement agreements with all remaining defendants in patent infringement litigation related to Forest's NAMENDA® (memantine hydrochloride) immediate release tablets.
Huifeng Bio-Pharmaceutical Technology, Inc. (OTC Bulletin Board: HFGB), specializing in developing and producing botanical extracts and other raw materials for pharmaceuticals and food additives, today announced the receipt of its European order for approximately 80 metric tons of Diosmin from Galenicum Health S.L., a Spanish pharmaceutical company.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced results for the quarter ended June 30, 2010.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today plans to report second quarter 2010 financial results on Thursday, August 5, 2010.
Lotus Pharmaceuticals, Inc. (OTC Bulletin Board: LTUS) a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China, announced today that it has entered into a termination agreement with Yorkville Global Master SPV Ltd. whereby the parties agreed to mutually terminate the Standby Equity Distribution Agreement, dated March 3, 2010, between the company and Yorkville with no further obligations.
MDRNA, Inc.(NASDAQ: MRNA), a leading RNAi-based drug discovery and development company, announced that, at the Company's Annual Meeting of Shareholders held yesterday, MDRNA shareholders approved the issuance of shares of MDRNA common stock in connection with the proposed acquisition of Cequent Pharmaceuticals, Inc.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that the Company will report its second quarter 2010 financial results after the Nasdaq market closes on Wednesday, July 28, 2010.
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) and Pain, announced today that its drug discovery subsidiary, ReceptoPharm, will be presenting at the International AIDS Conference in Vienna, Austria.
Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), today announced that the financial results for its fiscal first quarter 2011 ended June 30, 2010, will be relea ed after the U.S. market closes on August 5, 2010.
Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced today that it will present at the Canaccord Genuity 30th Annual Growth Conference in Boston.
Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced that Patrick J. Zenner has been elected to the company's board of directors.
Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today it will present at the 2010 American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo to be held at the Anaheim Convention Center July 25-29.
Sensient Technologies Corporation (NYSE:SXT) plans to expand its pharmaceutical coating capabilities at its Color Group headquarters site in St. Louis, Missouri, in order to serve growing demand for its products.
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 announced that detailed results from two Phase 3 clinical trials of the company's product Silenor® (doxepin) have been accepted for publication in peer-reviewed scientific journals.
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today reported sales and net earnings for the second quarter ended July 3, 2010.
VirtualScopics, Inc. (Nasdaq: VSCP), a leading provider of quantitative imaging for clinical trials, announced today that it has been added to the Russell Microcap Index.
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.