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.
FDA Headlines: AtriCure, Albany, Trubion, Intellipharmaceutics, Cytori, Onyx
Written by Staff and Wire Reports FDA Updates Jun 14, 2010
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nowBuzz up!Below is a list of the companies that made news in the healthcare sector on Tuesday, June 15, 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.”
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.
http://www.themarketfinancial.com/f...trubion-intellipharmaceutics-cytori-onyx/3773
