|Raptor Pharmaceutical surges after liver drug meets primary endpoints. InterMune jumps higher before PDUFA action date|
|By BioMedReports.com Staff|
|Monday, 03 May 2010 18:46|
Below is a list of the companies that made news in the healthcare sector on Monday, May 03, 2010.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP), soared today after the company announced positive Phase 2a clinical trial results from its pilot study of delayed-release cysteamine bitartrate in 11 adolescent patients with non-alcoholic steatohepatitis ("NASH"), a progressive form of liver disease believed to affect 5% to 11% of the U.S. population. Patients showed a marked decline in enzymes alanine transaminase (ALT) levels during the treatment period with 7 of 11 patients achieving a greater than 50% reduction and 6 of 11 reduced to within normal range. Additionally, aspartate aminotransferase (AST) levels also saw significant improvements with patients averaging 41% reduction by the end of the treatment phase. The reduction in liver enzymes was largely sustained during the 6 month post-treatment monitoring phase. Other important liver function markers showed positive trends. Levels of cytokeratin 18, a potential marker of disease activity in Non-alcoholic Fatty Liver Disease ("NAFLD"), decreased by an average of 45%. Adiponectin levels increased by an average of 35% during the treatment period. Reduced adiponectin levels are thought to be a marker of the pathogenesis and progression of NASH. Shares of Raptor jumped 40% or 98 cents, closing the day at $3.43.
InterMune, Inc. (Nasdaq:ITMN) surged more than 13% as investors anticipated the FDA's decision for its experimental drug pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis, or IPF. A New Drug Application for pirfenidone was granted Priority Review status by the FDA 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. If approved by the FDA, pirfenidone would be the first approved medicine for the approximately 100,000 Americans who suffer from this disease. In March 2010, pirfenidone received Marketing Authorization Application (MAA) in the European Union.Despite voting for approval, the advisory committee also raised a number of questions about safety and efficacy of the drug. Shares of InterMune surged $5.53 to close the day at $48.04.
In other news Monday:
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that positive interim results from the company's U.S. Phase 2b trial designated RESTORE-CLI has been accepted for presentation at this year's Vascular Annual Meeting of the Society for Vascular Surgery.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) fell today after the company announced that it has signed agreements to purchase shares of its Series F convertible preferred stock pursuant to a registered direct offering to institutional investors, representing gross proceeds to ADVENTRX of approximately $19.2 million. ADVENTRX plans to use the net proceeds from the offering to fund activities relating to acquiring and developing additional product candidates, to continue development of its current lead product candidates, and for general corporate purposes.
Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), jumped higher today after the specialty pharmaceutical and medical device company announced that it has entered into an exclusive distribution agreement with B. Braun for its proprietary Quill(TM) SRS product line in the United Kingdom, Ireland, and France. The term of the distribution agreement will be for five years.
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced detailed results from a new biomarker analysis of the FRANCIS study. FRANCIS examined the effects of once-daily varespladib vs. placebo as an adjunct treatment to high-dose atorvastatin and standard of care on inflammatory biomarkers known to be predictive of secondary cardiovascular events in patients with a recent acute coronary syndrome (ACS). This new analysis examines the anti-inflammatory effects of varespladib, an inhibitor of secretory phospholipase A2 (sPLA2), in diabetic patients with a recent ACS.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) edged higher today after the company announced that development of its GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been reinitiated. Manufacturing of new GVAX Prostate is in process, regulatory steps to lift the GVAX Prostate clinical hold prior to trial initiation are being taken, and prostate cancer patients are expected to be treated in a Phase II human clinical trial beginning in the fourth quarter of 2010 at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. Stephen M. Simes, BioSante’s president and chief executive officer stated: "Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that our GVAX Prostate can be a valuable addition to prostate cancer patient care."Unlike the recently approved Provenge for the treatment of prostate cancer, which requires isolation of cells from the patient that are then modified to produce the vaccine which is then re-introduced into the patient, GVAX Prostate is an off-the-shelf, non-patient-specific vaccine. It is comprised of prostate cancer cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety.
BioTime, Inc. (NYSE Amex: BTIM), a biotechnology company that develops and markets products in the field of human stem cells and regenerative medicine, today announced that it has completed its acquisition of the Singapore company ES Cell International Pte Ltd ("ESI"). Established in 2000, ESI has been a worldwide leader in the development of human embryonic stem cell technology, being one of the initial providers of human embryonic stem cell lines to the research community, having filed numerous early stem cell patent applications, and having built important relationships within the worldwide stem cell research community.
Boston Scientific Corporation (NYSE:BSX) today announced the start of patient enrollment in the EVIDENCE Clinical Trial, which compares the therapeutic effectiveness and cost effectiveness of spinal cord stimulation (SCS) therapy to spine reoperation in patients with failed back surgery syndrome (FBSS).
Bristol-Myers Squibb Company (NYSE: BMY) announced on Saturday that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation.
While no new clinical studies have been requested, the complete response letter requests the 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of belatacept. The company will work with the FDA to provide the data as soon as they are available. The Biologics License Application submitted for belatacept included 24-month data from the Phase 3 studies.
BSD Medical Corporation (NASDAQ:BSDM) today announced that it entered into a securities purchase agreement with two institutional investors for the sale of 1,644,737 shares of its common stock in a registered direct offering at $1.52 per share.
Corcept Therapeutics Incorporated (NASDAQ:CORT), moved higher today after the pharmaceutical company engaged in the discovery and development of drugs for the treatment of severe metabolic and psychiatric disorders, today updated the status of enrollment in its Phase 3 trial in Cushing's Syndrome and discussed its recent financing.
"Forty-five of fifty patients have been dosed in our Phase 3 study of CORLUX for the treatment of Cushing's Syndrome, and the remaining patients are now being screened to enable completion of enrollment in the coming weeks," said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. "We continue to expect to announce results of this study in the fourth quarter of 2010, and we remain on track to submit our New Drug Application for the use of CORLUX in Cushing's Syndrome by year end."
Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that it has successfully completed enrollment and treatment of the last patient in its Phase I clinical trial of CUDC-101, Curis’ first-in-class HDAC, EGFR and HER2 inhibitor.
CytRx Corporation (NASDAQ:CYTR) today announced interim study results that showed its doxorubicin prodrug INNO-206 demonstrated statistically significant anti-tumor activity in human myeloma tumor cells growing in immune-deficient mice compared to a control group, while exhibiting significantly less toxicity than doxorubicin even though INNO-206 was administered at much higher doses. The study is being conducted by the Institute for Myeloma & Bone Cancer Research under the direction of the Institute’s Medical and Scientific Director, noted multiple myeloma authority James R. Berenson, MD. Multiple myeloma is an incurable malignant tumor of the plasma cells in the bone marrow and is the second most common blood-based cancer.
Genomic Health, Inc. (NASDAQ:GHDX) today announced results from a study which found that results of the Oncotype DX breast cancer test are available sooner in the treatment decision making process when breast surgeons order the test. Oncotype DX measures the expression of 21 genes of an individual tumor to generate a Recurrence Score (RS) result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for patients with estrogen receptor positive, early-stage breast cancer. The time from the initial breast cancer surgery to final Oncotype DX report delivery was, on average, about two weeks shorter when surgeons ordered the test compared to when medical oncologists ordered the test.
Hansen Medical, Inc. (NASDAQ:HNSN) and Siemens Healthcare today announced joint development and cooperation agreements to co-develop integrated products designed to help simplify complex cardiac procedures for the diagnosis and treatment of cardiac arrhythmias, or irregular heartbeats.
The agreements will enable the creation of integrated product solutions by combining Siemens' Artis zee family of angiography systems and the syngo DynaCT Cardiac (angiographic computed tomography) with Hansen Medical's Sensei X Robotic Catheter System. The integrated products will be designed to enable electrophysiologists to perform complex cardiac procedures with greater confidence and improved efficiency.
Omeros Corporation (Nasdaq:OMER) today announced additional data from a Phase 2 trial of OMS103HP, its PharmacoSurgery™ product candidate for arthroscopy, showing that patients treated with OMS103HP during arthroscopic meniscectomy surgery achieved statistically significant clinical benefits. OMS103HP is an investigational drug product that is added to arthroscopic irrigation solution and is designed to improve postoperative joint function and motion and reduce postoperative pain.
Landec Corporation (Nasdaq:LNDC), today announced that it has acquired Lifecore Biomedical, Inc. from Warburg Pincus Private Equity IX, LP. When acquired by Warburg Pincus in March 2008, Lifecore was comprised of two divisions, the Dental Division and the Hyaluronan Division. The Dental Division was merged into a Warburg Pincus portfolio company. The Hyaluronan Division, now Lifecore, based in Chaska, MN, is a leading supplier of premium hyaluronan-based biomaterials for the medical and veterinary markets. Lifecore hyaluronan biopolymers are used in a wide and ever-growing range of therapeutic treatments, including cataract surgery, degenerative joint disease, spinal defect filling, medical device coatings, cosmetic soft tissue enhancement and equine osteoarthritis, as well as in numerous research initiatives.
"The acquisition of Lifecore significantly advances our stated strategy to acquire a company that expands our capabilities in materials science, specifically in the area of biomaterials," said Gary Steele, Chairman and CEO of Landec. "Hyaluronic acid (HA) is naturally present in the skin, cartilage and fluid of humans and provides lubricating, connective and shock absorbing functions in both joints and soft tissue. Demand for premium, fermented hyaluronan in biomaterial applications is growing. We view Lifecore’s hyaluronan biopolymers as a technology platform that can provide unique HA product innovations, as well as new products from potential synergies with Landec’s existing Intelimer polymers."
Magellan Health Services, Inc. (Nasdaq: MGLN), an industry leader in specialty health care management, presented the results of a five-year study introducing an analytical model that may be used to provide more effective and efficient mental health services to youth. Magellan, working with Polaris Health Directions, defined a process and a new methodology for ensuring that youth get the right mix of behavioral health services to improve their treatment outcomes.
Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced that its generic division, Par Pharmaceutical, has entered into an exclusive licensing agreement with Glenmark Generics Limited and Glenmark Generics Inc., USA to market ezetimibe 10 mg tablets, the generic version of Merck & Co. Inc.'s Zetia, in the U.S. Zetia is a cholesterol modifying agent with annual U.S. sales of approximately $1.4 billion, according to IMS Health data. Glenmark believes it is the first to file an ANDA containing a paragraph IV certification for the product, which would potentially provide 180 days of marketing exclusivity. In April 2009, Glenmark was granted tentative approval for its product by the U.S. Food and Drug Administration.
Penwest Pharmaceuticals Co. (Nasdaq:PPCO) today announced its financial results for the first quarter ended March 31, 2010. Compared with the first quarter of 2009, first quarter 2010 revenues increased sharply to $8.8 million, and operating expenses decreased by 20%.
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that the Company's Board of Directors has appointed Eric I. Richman to the position of Interim Chief Executive Officer replacing David Wright, who has submitted his resignation.
PROLOR Biotech, Inc. (NYSE Amex: PBTH), surged more than 5% today after the company reported new preclinical data on the company's pipeline of drug candidates designed to reduce the dosing frequency of therapeutic proteins and peptides.The preclinical data shows that the AUC (overall drug exposure) of PROLOR's CTP-modified IFN-Beta administered subcutaneously was more than 200 times greater than an equivalent dose of commercial IFN-Beta, expanding on the results in the January study, which showed that CTP-modified IFN-Beta administered intravenously had 55 times greater overall drug exposure compared to commercial IFN-Beta. In both studies, CTP-modified IFN-Beta also demonstrated strong biological potency as measured by several well-validated biomarkers. The results further validate the potential of IFN-Beta-CTP to significantly reduce the current dose level and dosing frequency of interferon beta for the treatment of MS, potentially also reducing the associated side effects.
QIAGEN N.V. (Nasdaq:QGEN) (Frankfurt:QIA) today announced the results of operations for its quarter ended March 31, 2010. Net sales were at the high end of, and adjusted earnings per share for the first quarter 2010 exceeded the guidance provided by the Company on February 9, 2010.
Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) today announced that it will host a conference call and webcast to discuss the results of the FDA Panel meeting on Monday, May 10, 2010 at 4:30 p.m. Eastern / 1:30 p.m. Pacific. On May 6 the Peripheral and Central Nervous System Drugs Advisory Committee will meet to discuss Questcor's Supplemental New Drug Application for H.P. Acthar Gel.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) surged after the bell after the company announced the presentation of data from its Phase 3 pivotal clinical trials evaluating the efficacy and tolerability of XIFAXAN 550 mg – its minimally-absorbed, gut-selective, broad-spectrum antibiotic – in 1,260 patients with non-constipation irritable bowel syndrome (IBS) during the Distinguished Abstract Plenary Presentation at the annual meeting of Digestive Disease Week (DDW) being held this week in New Orleans. These data demonstrated that a 14-day course of XIFAXAN 550 mg, taken 3 times daily, achieved adequate relief of IBS symptoms in a significantly greater proportion of patients during the first 4 weeks following 2 weeks of treatment, as well as over 3 months, compared with placebo. The safety profiles were similar between XIFAXAN 550 mg and placebo. Shares jumped $1.93 to $42.99 in the after hours session.
SCOLR Pharma, Inc. (NYSE AMEX: DDD) today announced that the United States Patent and Trademark Office (USPTO) issued a notice of allowance for SCOLR's U.S. Patent Application No. 11/906,303 for a method of forming a tablet. Upon issuance, this patent will provide SCOLR with patent protection for the blending and tableting process currently utilized in their novel extended release ibuprofen formulation and analogous processes for other active pharmaceutical ingredients susceptible to tackiness.
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced an amendment to its 2005 collaboration agreement with AstraZeneca expanding the TC-5619 development program. In addition to the current development of TC-5619 in cognitive dysfunction in schizophrenia (CDS), the amended terms provide for parallel development in attention deficit/hyperactivity disorder (ADHD) and potentially Alzheimer’s disease. AstraZeneca will make an $11.0 million payment to Targacept and maintain its future option to license TC-5619.
Vascular Solutions, Inc. (Nasdaq: VASC) today announced that it has acquired the assets related to the SMARTNEEDLE and pdACCESS Doppler guided needle access business from Escalon Vascular Access, Inc., a division of Escalon Medical Corporation (Nasdaq: ESMC). The SMARTNEEDLE and pdACCESS products consist of a hand-held monitor and one-time use needles designed to provide auditory ultrasound guided access to arteries and veins during catheterization procedures. The original SMARTNEEDLE product was introduced in 1992, with current annualized sales of the combined products of approximately $3.8 million.
Effective immediately, sales of the SMARTNEEDLE and pdACCESS products will transition to Vascular Solutions’ existing direct U.S. sales force. Manufacturing of the products will be transitioned to Vascular Solutions’ existing facility in Minnesota over the next four months. The acquisition price of $5.75 million consists of $5.0 million paid in cash at closing and $750,000 payable in cash upon successful completion of the transfer of the manufacturing processes.
Escalon jumped more than 11% or 18 cents to close at $1.17 while Vascular solutions was up 5.45% or 54 cents to $10.44.
Vivakor, Inc. (OTCBB:VIVK) announced today that it has received a reseller offer agreement from VWR LLC, a multi-billion dollar global laboratory supply and distribution company, for Vivakor's VivaThermic Vials. Vivakor's VivaThermic vials improve cryopreservation of sensitive cell types such as human stem cells.
VIVUS, Inc. (Nasdaq:VVUS) today announced the appointment of Michael P. Miller to the position of senior vice president and chief commercial officer. This newly created position, reporting directly to Leland Wilson, chief executive officer, will be responsible for building and leading the commercial efforts for Qnexa, if approved, for commercial use.
XenoPort, Inc. (Nasdaq:XNPT) announced today that new data from clinical trials of its product candidate arbaclofen placarbil will be presented at the Digestive Disease Week meeting in New Orleans.
Advaxis, Inc. (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, will host an investigator's meeting in Mumbai, India with twenty (20) of the country's leading oncologists.
AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the hiring of Michael McFadden as Vice President of U.S. Sales and Managed Markets.
BioScrip, Inc. (Nasdaq: BIOS) today announced that the Company will present at the Bank of America Merrill Lynch 2010 Health Care Conference to be held May 11 - 13, 2010 at The Grand Hyatt Hotel in New York City.
Clinical Data, Inc. (NASDAQ: CLDA), and Santen Pharmaceutical Co., Ltd. (Osaka Stock Exchange: 4536), today announced that Santen has exercised its option to license Clinical Data's highly selective adenosine A2A agonist compound, ATL313, for the development of topical treatments for certain ophthalmic diseases, including glaucoma.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will provide an update of their business at the Deutsche Bank 35th Annual Health Care Conference on Wednesday, May 5th, at 9:20 a.m. ET. The conference will be held at the InterContinental Hotel, Boston, MA.
Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported expectations of its FDA consultant's report by the middle of this month. The anticipation is based on the commitment by Lifeline's FDA consulting firm.
MedLink (OTCBB: MLKNA), a leading healthcare IT provider of Electronic Health Record (EHR), practice management, and clinical integration software to the medical community announced today a partnership with iMedicor (OTCBB: VMCI).
Medtronic, Inc. (NYSE: MDT), today announced completion of patient enrollment in the first of two studies in the company's CURE-AF (Concomitant Utilization of Radio frequency Energy for Atrial Fibrillation) clinical trial.
Sequenom, Inc. (Nasdaq: SQNM), will report first quarter 2010 financial results after market close on Thursday May, 6, 2010.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it will sponsor a conference call to discuss its financial results for the first quarter ended March 31, 2010.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced today that it has given notice of its intention to redeem all of the outstanding 6 1/8% Senior Subordinated Notes due 2015 (the "6 1/8% Notes").
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