|Dendreon breaks through, opens the door for immunotherapy. SeraCare surges on strong results. Pozen moves higher on earnings, pending FDA decision. Medtronic acquires AST Medical|
|By BioMedReports.com Staff|
|Thursday, 29 April 2010 21:20|
Below is a list of the companies that made news in the healthcare sector on Thursday, April 29, 2010.
Dendreon Corporation (Nasdaq:DNDN) today announced that the U.S. Food and Drug Administration has approved PROVENGE, its pioneering, cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class known as autologous cellular immunotherapies.
"The big news here is that this is the first immunotherapy to win approval, and I suspect within five to ten years immunotherapies will be a big part of cancer therapy in general," said Dr. Phil Kantoff, an oncologist at the Dana-Farber Cancer Institute who helped run the studies of Provenge.
The cost of treatment will be $93,000 for the three dose therapy. Previous estimates had the drug costing around $50,000. With the higher price some analysts are predicting the drugs potential to between $1.2 to $2.5 Billion per year in sales.
Shares of Dendreon, after being halted much of the day, quickly jumped to $54 per share and settled the day at $50.18, up $10.56, more than 26%. In the after hours session, shares continued to climb, moving up another $1.61 to $51.79.
SeraCare Life Sciences, Inc. (NASDAQ: SRLS), surged more than 18% today after the global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, reported operational and financial results for its second quarter of fiscal year 2010, ended March 31, 2010.
SeraCare reported revenue of $12.9 million for the quarter ended March 31, 2010 compared to $10.9 million for the same quarter of the prior year, reflecting 18% growth. Gross margins increased to 43% for the quarter compared to 34% for the same quarter of the prior year. The Company earned net income of $2.1 million and earnings per share on a basic and diluted basis of $0.11 for the quarter ended March 31, 2010 compared to a net loss of $0.6 million and a loss per share on a basic and diluted basis of $0.03 during the same period in fiscal 2009.
"SeraCare’s second quarter of fiscal 2010 reflects substantially increased revenues, margins and profitability," said Susan Vogt, President and Chief Executive Officer. "These strong financial results also mark SeraCare’s fourth consecutive profitable quarter—a significant milestone for our Company."
Shares jumped 18.57% or 78 cents to $4.98. The stock continued higher in the after hours session, trading up another 9 cents.
POZEN Inc. (NASDAQ: POZN), surged ahead today after the company announced results for the first quarter ended March 31, 2010 that were better than analysts expectations.
POZEN reported a net loss of $(3.0) million, or $(0.10) per share on a diluted basis, for the first quarter of 2010, compared to a net loss of $(3.5) million, or $(0.12) per share on a diluted basis, for the first quarter of 2009. Wall Street had expected a loss of 18 cents per shares.
Shares were also up in anticipation of an FDA decision which is due Friday April 30th. Pozen and partner AstraZeneca submitted the NDA last year. for the arthritis drug Vimovo If the FDA approves the drug, Pozen is in line to receive a $20 million milestone payment from AstraZeneca and would qualify for $25 million more in the next several months.
Shares of Pozen closed todays session at $12.08, up $1.13 or 10.32%. The stock jumped another 3% in the after hours session.
Medtronic, Inc. (NYSE:MDT), and ATS Medical, Inc. (NASDAQ:ATSI), today announced that the companies have signed a definitive agreement under which Medtronic will acquire ATS Medical by paying $4.00 per share in cash for each share of ATS Medical stock. The total value of the transaction is expected to be approximately $370 million, which includes the purchase of ATS Medical stock and assumption of net debt. "The acquisition of ATS Medical will further strengthen our CardioVascular business," said Scott Ward, senior vice president of Medtronic, Inc., and president of the CardioVascular business. "ATS is an innovative and successful company that is well respected by cardiac surgeons throughout the world." ATS Medical surged 54% or $1.40 on the news.
After the bell:
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) after the bell announced financial results for the first quarter of 2010. GAAP net income was $1.2 million ($0.01 per diluted share) for the first quarter of 2010, compared to GAAP net loss of $13.2 million ($0.13 per diluted share) for the first quarter of 2009. In a separate release the company announced positive results for the Phase I/II trial for BMN 110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. The company expects to initiate a pivotal Phase III trial in the fourth quarter of 2010.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the first quarter 2010 and presented a quarterly update on the Company's development progress. "During the first quarter, we made substantial progress in advancing our Northera registration program in neurogenic orthostatic hypotension and are on track to have pivotal Phase III data from Study 301 in the third quarter," commented Dr. Simon Pedder, President and CEO of Chelsea. "As we prepare to complete enrollment in Study 301 in June, we also look forward to beginning patient enrollment this quarter in both our Northera Study 306 and CH-4051 Phase II trial in rheumatoid arthritis. Combined with ongoing studies in fibromyalgia and adult attention deficit hyperactivity disorder, Chelsea is well-positioned to benefit from multiple, value-creating clinical milestones over the next several quarters."
Cytokinetics, Incorporated (NASDAQ:CYTK) after the market closed reported revenues from research and development collaborations of $0.6 million for the first quarter of 2010. The net loss for the first quarter was $12.2 million, or $0.20 per basic and diluted share. This compared to a net loss of $10.7 million, or $0.21 per basic and diluted share, for the same period in 2009. As of March 31, 2010, cash, cash equivalents and investments, excluding restricted cash and the put option on the company's auction rate securities, totaled $103.1 million."Cytokinetics has made significant strides in the last quarter in the development of CK-2017357, the lead drug candidate from our skeletal muscle activator program. In recent months, the speed with which we opened a hypothesis-generating Phase IIa Evidence of Effect clinical trial in amyotrophic lateral sclerosis, or ALS, reflects the strong enthusiasm our clinical investigators maintain for this innovative compound as a potential treatment for patients suffering from this severely debilitating and uniformly fatal disease," stated Robert I. Blum, President and Chief Executive Officer.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced financial results for the three-month period ended March 31, 2010 – the third quarter of the Company’s 2010 fiscal year (3QFY10).
"Favorable clinical data are demonstrating the value of our TAP technology," commented Daniel Junius, President and CEO. "Roche plans to apply in 2010 for marketing approval of T-DM1 for the treatment of advanced HER2+ breast cancer. Additionally, they plan to initiate a Phase III trial assessing T-DM1 as a first-line treatment for HER2+ metastatic breast cancer and also to report preliminary Phase II data on this use during the second half of 2010. During that time period, sanofi-aventis expects to begin Phase II testing with their first TAP compound, SAR3419, and we plan to initiate a randomized trial assessing our lorvotuzumab mertansine compound for the treatment of small-cell lung cancer."
InterMune, Inc. (Nasdaq:ITMN) after the bell announced results from operations for the first quarter ended March 31, 2010. Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "First quarter and recent events have been highlighted by the very important developments related to the regulatory progress of pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis, or IPF. Our New Drug Application (NDA) for pirfenidone was granted Priority Review status on January 4, with a PDUFA action date of May 4, 2010. On March 9, an FDA advisory committee recommended 9-3 in favor of the approval of pirfenidone to reduce decline in lung function. If approved by the FDA, pirfenidone would be the first approved medicine for the approximately 100,000 Americans who suffer from this terrible disease. Regarding Europe, our Marketing Authorization Application (MAA) for pirfenidone in the European Union was validated on March 24, 2010."
In other news Thursday:
BioTime, Inc. (NYSE Amex:BTIM), a biotechnology company that develops and markets products in the field of stem cells and regenerative medicine, today announced that it has agreed to acquire the Singapore-based company ES Cell International Pte Ltd (ESI). The acquisition is expected to close next week, at which time BioTime will provide full details of the acquisition and outline its business plans with respect to the acquired assets.Established in 2000, ESI has been at the forefront of advances in human embryonic stem cell technology, being one of the earliest distributors of hES cell lines to the research community. BioTime stated that it will "acquire all of ESI's approximately $35 million of debt and accrued interest. ESI has no significant liabilities other than the debt obligations that BioTime will own after the acquisition."
Boston Scientific Corporation (NYSE:BSX) today announced the launch of the Pelvic Floor Institute -- a unique training forum and online resource designed to enhance physician knowledge and awareness of pelvic floor reconstruction procedures and techniques.
BSD Medical Corporation (NASDAQ:BSDM) moved higher today after the company announced that Lancet Oncology, the premiere worldwide journal for original oncology research, has published the results of a Phase III clinical study of hyperthermia, using the BSD-2000 Hyperthermia System, combined with chemotherapy for the treatment of high-risk soft-tissue sarcoma cancer (STS) patients, "Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study".
Celgene Corporation (NASDAQ:CELG) jumped higher today after reporting record first quarter results. "Our exceptional first quarter operating results represent the collective efforts of our Celgene team worldwide as we not only continue our global expansion, but also continue our efforts to discover and deliver new therapies," said Chairman and Chief Executive Officer Sol J. Barer, Ph.D. "To this end we highlighted the next generations of Celgene therapies at our recent R&D day and we are aggressively investing in this pipeline to ensure sustainable growth."
China Medical Technologies, Inc. (Nasdaq:CMED), a leading China-based advanced in-vitro diagnostic company, today announced that it received approval for its AUTOMAGLIA 90 fully-automated ECLIA analyzer ("AUTOMAGLIA 90 Analyzer") as well as Down Syndrome screening kit from the State Food and Drug Administration of China (the "SFDA"). AUTOMAGLIA 90 Analyzer is a fully-automated analyzer for immunoassay analysis in various types of diseases and disorders. Major clinical diagnostic applications include thyroid disorders, fertility and infertility disorders, diabetes, infectious diseases and tumor markers.
Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS) exercised the second and third milestone-based options on the Company's existing contract under the Broad Agency Announcement titled, "Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation," for selected tasks in the advanced development of Protectan CBLB502. The value of the contract, originally awarded in September 2008, is $15.6 million over a three-year period, including an increase in the first milestone-based option which was exercised in September 2009.
DivX, Inc. (Nasdaq:DIVX), a digital media company, today announced that members of the DivX management team will address investors at the J.P. Morgan 2010 Global Technology, Media and Telecom Conference on Tuesday, May 18, 2010.
Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has received a new patent in the United States.
Human Genome Sciences, Inc. (Nasdaq: HGSI) moved higher today as the company announced financial results for the quarter ended March 31, 2010, and provided highlights of recent key developments.
"In the first months of 2010, we have continued to make excellent progress toward the commercialization of BENLYSTA," said H. Thomas Watkins, President and Chief Executive Officer. "BENLYSTA met the primary efficacy endpoint in both of its pivotal Phase 3 trials, with results that support our belief that this first-in-class treatment could become the first new approved drug for lupus in more than 50 years. For ZALBIN dosed once a month, we reported positive interim results from a Phase 2b trial that appear to support further evaluation of ZALBIN dosed monthly in a Phase 3 program. The European regulatory application for JOULFERON dosed every two weeks has been withdrawn by Novartis. Meanwhile, the U.S. regulatory application for this ZALBIN dosing regimen continues under review. We expect that the next few months will provide greater clarity regarding the optimal path forward for ZALBIN’s development."
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the pricing of an underwritten offering of 6,460,672 shares of its common stock at a price of $4.35 per share. After the underwriting discount and estimated offering expenses payable by the company, the company expects to receive net proceeds of approximately $26.2 million.
Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that it has initiated a challenge of a patent listed by Shionogi Pharma, Inc. in connection with its Fenoglide (fenofibrate) tablets, 40 and 120 mg.
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) and Gruppo Angelini today announced they have entered into an agreement to establish a joint venture in the United States for the commercialization of OLEPTRO(TM), a novel once-daily formulation of the antidepressant trazodone approved by the U.S. Food and Drug Administration on February 3, 2010.
Novavax, Inc. (Nasdaq:NVAX) reported today that its trivalent seasonal influenza virus-like-particle (VLP)-based vaccine candidate was safe and immunogenic against the 2009-2010 seasonal influenza virus strains in older adults 60 years or higher in age.
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its international partner for Tarceva (erlotinib), Roche, received approval from the European Commission for Tarceva as a monotherapy maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose disease remains largely unchanged (stable disease) after platinum-based initial chemotherapy."We are pleased that the European health authorities recognize Tarceva as a valuable option for lung cancer patients and their physicians when used in the first-line maintenance setting," said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals.
Palomar Medical Technologies, Inc. (Nasdaq:PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, today announced financial results for the first quarter ended March 31, 2010. Revenues for the quarter ended March 31, 2010 were $16.0 million, which represents a 9 percent increase over the $14.6 million reported in the first quarter of 2009. Product and service revenues increased to $13.1 million, a 14 percent increase over the $11.5 million in the first quarter of 2009. Chief Executive Officer Joseph P. Caruso commented, "We are very pleased with the increase in total revenues and product and service revenue this quarter as compared to the prior year. Our extensive product portfolio and platform approach has been well received and perfectly positioned for this economic climate."
Perrigo Company (Nasdaq: PRGO; TASE) jumped higher today after the company announced record results for its third quarter and nine months ended March 27, 2010, and reported higher guidance for full year EPS.
Perrigo's Chairman and CEO Joseph C. Papa commented, "We are excited to announce another outstanding quarter. Consumers continue to realize the value of store brands; however, that is just one of numerous drivers that contributed to our strong performance. All of our segments executed above expectations. This quarter, both our adjusted consolidated gross and operating margins reached all-time highs of 34.6% and 18.2%, respectively. In addition to this strong day-to-day performance, our teams have been hard at work focusing on the future. During the quarter we announced two acquisitions, won a summary judgment in a patent litigation and launched two new products. Those achievements are just a few examples of the exciting opportunities we are working on in adjacent categories, product pipeline extensions and geographical expansions here at Perrigo." Shares were up $4.43 or 7.5% to $63.47.
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) was up more than 9% after the company reported a norrower than expected first quarter loss. The Company reported a net loss of $30.5 million, or $0.38 per share (basic and diluted), for the first quarter of 2010 compared with a net loss of $15.4 million, or $0.19 per share (basic and diluted), for the first quarter of 2009.
Simcere Pharmaceutical Group (NYSE:SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that Jiangsu Yanshen Biological Technology Stock Co., Ltd. ("Jiangsu Yanshen") has received disciplinary notice from China's State Food and Drug Administration ("SFDA") regarding its production of substandard quality human use rabies vaccine.
The SFDA has identified deception and avoidance of regulatory inspection at Jiangsu Yanshen during the second half of 2008 in the production of certain batches of human use rabies vaccine resulting in sales of those batches with potency below the national standard. As a result, the SFDA has revoked Jiangsu Yanshen's license for the manufacturing and marketing of human use rabies vaccine (vero cell) and freeze-dried human use rabies vaccine (vero cell).
In addition, the local investigative authority has informed Jiangsu Yanshen that they will file criminal prosecution against Jiangsu Yanshen and relevant members of its original management team in relation to the production and sale of the aforementioned products.
United Therapeutics Corporation (Nasdaq:UTHR) edged higher today after the company announced its results of operations for the quarter ended March 31, 2010.
Total revenues for the first quarter of 2010 were $128.9 million, up from $79.7 million for the first quarter of 2009. Net income for the first quarter of 2010 was $18.9 million or $0.35 per basic share, compared to $13.2 million, or $0.25 per basic share, for the first quarter of 2009. Gross margin from sales was $113.7 million for the first quarter of 2010, compared to $70.4 million for the first quarter of 2009. Earnings before non-cash charges, a non-GAAP financial measure defined as net income before income taxes, non-cash interest, non-cash license fee expenses, depreciation, amortization, impairment charges and share-based compensation (stock option and share tracking award expense), was $68.1 million for the first quarter of 2010, compared to $38.5 million for the first quarter of 2009.
"We begin this year impressively, with continued strong growth in revenues and operating results, which are primarily due to increased use of Remodulin and Tyvaso," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "As we look ahead, I am encouraged about our prospects to achieve a ninth straight year of greater than 30% revenue growth."
Utah Medical Products, Inc. (Nasdaq:UTMD) announces that its Board of Directors approved a quarterly cash dividend of twenty-three and one-half cents ($.235) per share of common stock payable on July 2, 2010 to shareholders of record at the close of business on June 15, 2010. This is a two percent (2%) increase over the dividend declared in the same quarter of the prior year. Utah Medical Products, Inc., with particular interest in health care for women and their babies, develops, manufactures, assembles and markets a broad range of disposable and reusable specialty medical devices.
Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, today announced that it will report financial results for the first quarter ending March 31, 2010 on Wednesday, May 5, 2010, after the U.S. financial markets close.
Antigenics Inc. (NASDAQ:AGEN) reported today its results for the quarter ended March 31, 2010.
Depomed, Inc. (NASDAQ:DEPO) announced today that its president and chief executive officer, Carl A. Pelzel will be presenting at the Deutsche Bank 35th Annual Health Care Conference in Boston on May 3, 2010 at 4:50 pm EST.
Geron Corporation (Nasdaq:GERN) today reported financial results for the three months ended March 31, 2010.
Living Cell Technologies Limited (OTCQX:LVCLY) announced today the quarterly cash flow report for the quarter ended 31 March 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 today reported that its innovative asthma drug Laevo-Bambuterol has received approval from China's State Food & Drug Administration's to commence clinical trials (No.2010L01309 and 2010L01399).
Medco Health Solutions, Inc. (NYSE:MHS), is scheduled to address the Deutsche Bank 35th Annual Health Care Conference in Boston on Tuesday, May 4, 2010.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma.
Unigene Laboratories, Inc. (OTCBB: UGNE) will release financial results for the quarter ended March 31, 2010, after the market closes on Monday, May 10, 2010.
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