|Acura Announces Update on AVERSION Products; ARIAD Announces Phase 3 Trial of Ponatinib|
|By Staff and Wire Reports|
|Friday, 27 July 2012 18:28|
Acura Pharmaceuticals (NASDAQ: ACUR) announced Pfizer (NYSE: PFE) provided notice it is exercising its right to terminate the license to three development stage products using Acura's AVERSION Technology and return such products to Acura. The termination will become effective in 12 months under the terms of our License Agreement with a subsidiary of Pfizer. A fourth product utilizing Acura's AVERSION Technology, OXECTA (oxycodone hydrochloride) Tablets CII, is being commercialized by Pfizer and Pfizer will retain all rights and obligations to OXECTA under the License Agreement.
The products being returned are oxycodone hydrochloride with acetaminophen, hydrocodone bitartrate with acetaminophen and another undisclosed opioid. The hydrocodone product is the most advanced in development, with a clinical study completed in February 2012, which demonstrated bioequivalence to its reference listed drug. This product also was the subject of a pre-IND meeting held with the U.S. Food and Drug Administration in May 2012 in which the FDA agreed to a development program for this product generally consistent with that used for OXECTA.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced the initiation of the randomized Phase 3 trial of ponatinib, its investigational pan-BCR-ABL inhibitor, in adult patients with newly diagnosed chronic myeloid leukemia. The Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia trial is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients. The efficacy of ponatinib will be assessed in comparison to imatinib based on evaluation of the primary endpoint of major molecular response (MMR) rate at 12 months. ARIAD expects to complete patient enrollment in the trial by the end of 2013.
“The start of the EPIC trial represents an important milestone in the development of ponatinib in CML and builds on the strong clinical data that we have obtained to date in patients with more advanced disease. We have designed the EPIC trial with comprehensive and well-aligned input from key opinion leaders and regulatory authorities in the United States, Europe and Japan and anticipate strong interest from investigators and their patients,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.
Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, will release its financial results for the three and 6 months ended June 30, 2012 after the close of regular market trading on Thursday, August 9, 2012.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that it will release its financial and operating results for the second quarter ended June 30, 2012 after market close on Wednesday, August 8, 2012.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with proprietary medical products for the growing $4B respiratory markets, announced today that the company has finalized its sales program with one of the largest medical suppliers in North America.
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, announced plans to release its financial results for the second quarter of 2012 on August 8, 2012 after the close of the financial markets.
Micro Imaging Technology, Inc. (OTCBB: MMTC) (OTCQB: MMTC) announced that an important segment of the food safety community got its first look at its Rapid Microbial Identification System when it introduced the MIT 1000 at the Annual Meeting of the International Association for Food Protection (IAFP) in Providence, Rhode Island held July 22 through July 25, 2012.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR") today announced that it is filing two additional divisional patent applications that are intended to allow for further protection of the Company's specific antibodies that have particular utility in fighting cancers based on the recent award of the first patent for the Company's anti-CD20 monoclonal antibody in Mexico.
ViroPharma Incorporated (Nasdaq: VPHM) today announced the publication of data demonstrating that routine prophylactic use of Cinryze® (C1 esterase inhibitor [human]) provided effectiveness and maintained a generally favorable safety profile in the majority of treated subjects with hereditary angioedema (HAE).