|Intellipharmaceutics rises after ANDA filing. Cytori moves higher on loan facility. After the bell AtriCure soars on 510k clearence|
|By BioMedReports.com Staff|
|Monday, 14 June 2010 18:46|
Below is a list of the companies that made news in the healthcare sector on Monday, June 14, 2010.
AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems, today announced that it received clearance from the FDA for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system. The AtriClip system is designed to safely and effectively exclude the left atrial appendage. Initial launch in the United States is anticipated to begin later this month with full commercial release planned during the third quarter of 2010.
"Clearance of the AtriClip system in the United States represents a major product and clinical milestone for AtriCure," said David J. Drachman, President and Chief Executive Officer. "We believe that the AtriClip system provides a safe and efficient method to exclude the left atrial appendage. This key innovation represents a large and exciting new growth platform and demonstrates our steadfast commitment to developing market leading technologies to meet the needs of patients and physicians."
Shares of AtriCure shot up after the bell, jumping nearly 18% or 92 cents to $6.15.
Albany Molecular Inc. (AMRI) (NASDAQ: AMRI) today announced that its motion for a preliminary injunction to prevent Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (Dr. Reddy’s) from the commercial distribution of generic versions of Allegra-D® 24 Hour (fexofenadine HCl 180 mg and pseudoephedrine HCl 240 mg) Extended-Release Tablets in the Unites States has been granted.
On June 14, 2010, US District Court Chief Judge Garrett E. Brown, Jr., District of New Jersey, issued the preliminary injunction based on a March 22, 2010 motion filed by AMRI and sanofi-aventis U.S. LLC, in response to the March 17, 2010 approval of Dr. Reddy’s generic version of Allegra-D® 24 Hour by the FDA.
"We are encouraged by the judge’s ruling," said AMRI Chief Executive Officer Thomas E. D’Ambra, Ph.D. "The positive outcome of this hearing bolsters our belief in the strength of AMRI’s intellectual property rights related to Allegra. AMRI remains committed to vigorously protecting and enforcing its intellectual property. We look forward to the outcome of this trial."
Trubion Pharmaceuticals, Inc. (Nasdaq:TRBN) today announced Pfizer's decision to discontinue development of TRU-015 (PF-05212374), an investigational drug in Phase 2 evaluation for the treatment of rheumatoid arthritis (RA) developed under the companies' CD20 collaboration. However, Pfizer has confirmed that it will continue to develop SBI-087 (PF-05230895), Trubion's next-generation, humanized, subcutaneous CD20 RA product candidate also in Phase 2 clinical evaluation.
Pfizer's decision is based on preliminary results from the Phase 2b (2203) randomized, parallel, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of two dosing regimens (a single dose of 800mg TRU-015 compared with an induction dose of 800mg TRU-015 followed by an additional dose of 800mg TRU-015 at week 12) in combination with methotrexate in patients with active rheumatoid arthritis.
"Given the higher than usual placebo response, TRU-015 did not meet the internal hurdle for continued development," said Scott C. Stromatt, M.D., senior vice president and chief medical officer at Trubion. "It is evident that the drug has significant biological and clinical activity with no significant safety concerns, but market dynamics dictate that we pursue a differentiated and best-in-class product to bring into Phase 3 development. At this time our next-generation CD20 SMIP product candidate, SBI-087, meets that criteria, and its Phase 2 development will continue."
"Although we are not moving forward with this compound, we are encouraged by our analysis to date of SBI-087," said Evan Loh, senior vice president of BioTherapeutics Research and Development at Pfizer. "The goal of our collaboration with Trubion continues to be the development of best-in-class CD20 therapies, and we look forward to the results of the ongoing SBI-087 Phase 2 study."
In news from earlier in the day:
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) today announced that is has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic of Protonix(R) (delayed release pantoprazole sodium). Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome. Sales of pantoprazole sodium delayed-release tablets in the United States were approximately $1.8 billion in 2009. Pantoprazole delayed-release tablets is the fourth ANDA product candidate that Intellipharmaceutics has disclosed from its 15 product pipeline, which includes both ANDA product candidates and the development of new drugs through the S.505(b)(2) New Drug Application (NDA) regulatory pathway.
"I am extremely pleased with the progress we continue to make with the advancement of our product pipeline," commented Dr. Isa Odidi, CEO of Intellipharmaceutics. "Protonix is the second ANDA we have filed with the FDA this year and, together with Focalin XR and Effexor XR, it represents another potential source of future revenue from our Company's ANDA pipeline."
Shares of Intellipharmaceutics soared more than 33% or 73 cents, closing the day at $2.94.
Cytori Therapeutics (NASDAQ: CYTX) rose higher today after the company reported that it has entered into a $20 million secured loan facility from GE Capital, Healthcare Financial Services, Oxford Finance Corporation, and Silicon Valley Bank. The loan funded June 14, 2010.
The funds will be used to support Cytori’s commercialization and clinical development activities in Europe, Asia and the United States. The loan, along with the $30 million raised from the recently completed Seaside 88, LP financing, strengthens Cytori’s cash position. The Company anticipates that these amounts will fund the Company’s operations into 2012.
The loan term is three years at 9.9% with principal repayments beginning in ten months. As part of the new loan, Cytori will use $4.4 million of the proceeds to refinance the loan previously entered into with GE Capital, Healthcare Financial Services and Silicon Valley Bank in October 2008. In addition, Cytori will issue warrants to the lenders to purchase 101,266 shares of Cytori’s common stock exercisable at $3.95 per share.
Shares of Cytori jumped more than 12% or 51 cents to close the day at $4.55.
Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) along with Bayer HealthCare Pharmaceuticals today announced that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting. NExUS evaluated Nexavar versus placebo in combination with two chemotherapeutic agents, gemcitabine and cisplatin. A positive secondary endpoint of progression-free survival (PFS) was observed in the trial. The safety and tolerability of the treatment triplet was as expected and did not show any new or unexpected toxicities. Data from this study are expected to be presented at an upcoming scientific meeting.
Nexavar is currently marketed worldwide for the treatment of hepatocellular carcinoma (HCC), or liver cancer, and advanced renal cell carcinoma (RCC), or kidney cancer.
Enrollment in NExUS commenced in February 2007. In 2008, based on the results seen in a previous Nexavar first-line NSCLC Phase 3 trial, the NExUS study protocol was amended to stop enrolling and treating squamous cell carcinoma patients. Of the squamous cell patients who were enrolled in the NExUS trial before the amendment, a higher mortality was observed. This finding was consistent with what was seen in the previous trial.
Bayer and Onyx will further review the findings of this analysis to determine what, if any, impact these data might have on other ongoing clinical trials evaluating the safety and efficacy of Nexavar.
"Bayer and Onyx are disappointed with these results, in particular, for patients who are suffering from this deadly disease," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare. "We are confident in our clinical trial program exploring Nexavar's potential in a variety of tumor types, including lung cancer. Based on encouraging data from a recently presented prospective biomarker trial and Phase 2 signal-generating lung cancer studies, we believe it's critical to continue our evaluation of Nexavar in combination with targeted agents and as a monotherapy in later lines of treatment in lung cancer patients."
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that the Italian Medicines Agency, the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone. CTI is in the process of preparing a Marketing Authorization Application ("MAA") in the European Union for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL").
"We are pleased that the AIFA has approved the NerPharMa facility to manufacture pixantrone as we continue to receive positive feedback on the clinical trial results from leading clinicians in Europe and make progress in the submission of the MAA in Europe," said Craig W. Philips, President of CTI.
Genzyme Corporation (Nasdaq: GENZ) announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease. "We are extremely pleased that our alemtuzumab development program has been assigned Fast Track status, and look forward to working closely with the FDA to expedite the program’s review process," said Henri Termeer, Genzyme’s chairman and chief executive officer. "Alemtuzumab is a potentially transformative therapy for the treatment of multiple sclerosis, and an important part of our future."
Alemtuzumab for the treatment of MS is currently being evaluated in two pivotal multi-center, multi-national trials, known as CARE-MS SM (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis). The company’s CARE-MS I Phase 3 trial is a randomized study comparing alemtuzumab to the approved therapy Rebif (high-dose interferon beta-1a) in early, relapsing-remitting multiple sclerosis (RRMS) patients who have received no prior therapy. The second Phase 3 trial, CARE-MS II, is comparing alemtuzumab to Rebif in RRMS patients who had active disease while on other MS therapies.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company’s Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely.
NewCardio, Inc., (OTC BB: NWCI) a cardiac diagnostic technology provider, announced today that five of its most recent medical and technical submissions have been accepted for publication in prominent peer-reviewed medical journals. These publications will present important clinical data supporting the accuracy and effectiveness of its CardioBip™ and Cardio3KG™ products.
Micromet, Inc. (Nasdaq:MITI) today announced the presentation of updated results from a Phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL). Results of the analysis demonstrate that a prolonged hematologic relapse free survival was observed in patients treated with blinatumomab. As of April 2010, six of nine evaluable, MRD responding, non-transplanted patients were in hematologic remission, ranging up to 23 months. Historical experience suggests that the majority of patients with MRD following front-line chemotherapy who do not receive a transplant will relapse within one year. Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body's T cells to kill cancer cells.
In a seperate release the company today announced the presentation of updated results from a Phase 1 trial of the Company's lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin's lymphoma (NHL). A high objective response rate was maintained among patients treated with blinatumomab using an adapted schedule, comparable to that previously reported in patients receiving constant dosing. Blinatumomab is the first in a new class of agents called BiTE® antibodies, designed to harness the body's T cells to kill cancer cells.
MultiCell Technologies, Inc. (OTC Bulletin Board:MCET.ob) has retained Clinical Development & Support Services, Ltd. (CDSS) of Cheshire, England to manage its planned Phase IIb clinical trial in the United Kingdom for MCT-125, the Company's lead drug candidate for treatment of primary multiple sclerosis-related fatigue (PMSF).
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced new research evaluating the substantial disease burden of paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare blood disorder, in patients worldwide.
BioTime, Inc. (NYSE Amex:BTIM) announced today that it has been included on a preliminary list of additions to the Russell 3000 Index and Russell Global® Index.
Celgene International SÃ rl (NASDAQ: CELG) announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival (PFS), the primary endpoint of the study.
Clinical Data, Inc. (NASDAQ: CLDA) today announced operational and financial results for the fourth fiscal quarter and fiscal year ended March 31, 2010, noting the Company’s continued achievement of major clinical and business milestones.
Covance Inc. (NYSE:CVD) today announced that it will present at Goldman Sachs Annual Global Healthcare Conference on Tuesday, June 15, 2010 at 11:35 a.m. ET (8:35 a.m. PT).
Genzyme Corporation (Nasdaq: GENZ) announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C.
Metropolitan Health Networks, Inc. (NYSE AMEX:MDF), ("Metcare"), a leading provider of healthcare services in Florida, today announced that Irene Clavijo, PharmD, has joined its customer care team as its Clinical Pharmacist.
Dr. Reddy's Laboratories (NYSE: RDY) announced today that the U.S. District Court of New Jersey has granted sanofi-aventis and Albany Molecular Research's motion for a Preliminary Injunction.
Rite Aid Corporation (NYSE:RAD) said today that it will release financial results for its First Quarter, which ended May 29, 2010, on Wednesday, June 23, 2010.
Taro Pharmaceutical Industries Ltd. ("Taro" Pink Sheets: TAROF) today provided preliminary, unaudited and unreviewed information on its financial performance for the first quarter of 2010.
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