|RxNews Recap for Friday 01-15-10. GenVac (GNVC) announces 184th Event|
|By Mary Davila|
|Friday, 15 January 2010 20:15|
GenVec, Inc. (Nasdaq: GNVC) announced today that 184 events (deaths) have occurred in its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade™ (PACT) in patients with locally advanced pancreatic cancer.
The event represents two-thirds of the total events expected in the trial and triggers the next interim analysis of overall survival in the trial. GenVec expects to share data from this interim analysis in 10-12 weeks.
"This is another significant milestone for the PACT trial. The data released at the last interim look were encouraging and we are looking forward to the top-line results of the upcoming data analysis," stated Dr. Mark Thornton, GenVec's Senior Vice President of Product Development.
The first interim analysis of overall survival in the PACT trial was released GenVec in November 2008. The data demonstrated an approximate 25% lower risk of death in the TNFerade plus standard of care arm relative to standard of care alone. The next and final analysis will be conducted after 276 deaths have occurred (total expected events) in the PACT trial.
In other news Friday:
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced today that it has achieved its protocol-specified objective of enrolling 100 late-stage patients (Stage IIB to IVA) in its pivotal study for forodesine in the treatment of cutaneous T-cell lymphoma (CTCL). The Top-line data will be reported in late 2010. Additionally, BioCryst's exploratory Phase 2 study for forodesine in subjects with chronic lymphocytic leukemia (CLL) is continuing to progress and has enrolled over half of its targeted number of patients.
Celgene Corporation (NASDAQ:CELG) announced today the closing of its acquisition of Gloucester Pharmaceuticals following the early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the merger agreement Celgene Corporation acquired Gloucester Pharmaceuticals for $340 million in cash plus up to an additional $300 million payable upon achievement of certain future regulatory milestones.
The transaction brings to Celgene ISTODAX® (romidepsin), an approved therapy for the treatment of cutaneous T-cell lymphoma (CTCL), providing a strategic fit and expanding the company’s presence in critical blood cancers.
“There is a need for better treatment options for CTCL patients and this acquisition enables Celgene to maximize the clinical and commercial potential of ISTODAX through our existing infrastructure, to the benefit of patients,” said Sol J. Barer, PhD, Chairman and Chief Executive Officer of Celgene Corporation. “ISTODAX now joins REVLIMID®, VIDAZA® and THALOMID® in a robust portfolio of products for the treatment of blood cancers.”
CEL-SCI Corporation (NYSE:CVM), a late-stage oncology company and a developer of vaccines and therapeutics for the treatment of infectious diseases, announced today the appointment of Todd S. Burkhart as Vice President of Manufacturing/Facilities and Commercial Operations for its manufacturing facility.
Impax filed its Abbreviated New Drug Application (“ANDA”) containing a paragraph IV certification for a generic version of WELCHOL® with the U.S. Food & Drug Administration (“FDA”). Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owners of its paragraph IV certification.
On January 14, 2010, Daiichi Sankyo, Inc. and Genzyme Corporation filed suit for patent infringement against Impax in the United States District Court for the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Based on the filing date of the ANDA, the Company believes that it is the first to file an ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity.
Kensey Nash Corporation (Nasdaq: KNSY) released today preliminary results for its second quarter ended December 31, 2009. The Company also updated its guidance for the full fiscal year ending June 30, 2010.
The Company expects to report second quarter fiscal 2010 total revenues of approximately $19.1 million, including net sales of $12.5 million and royalties of $6.6 million, as compared to second quarter fiscal 2009 total revenues of $20.8 million, including net sales of $14.0 million and royalties of $6.8 million.
Kensey Nash previously provided total revenues guidance of $19.3 to $20.1 million, including net sales of $12.5 to $13.0 million and royalties of $6.8 to $7.1 million. The shortfall in royalties is due to lower than expected Angio-Seal™ royalties on sales of vascular closure devices sold by St. Jude Medical. Although Angio-Seal™ royalties increased modestly on a sequential basis, they declined from the prior year. This decline from the prior year was primarily due to fewer shipping days in December 2009 as compared to December 2008. Orthopaedic royalties were in line with the Company's expectations.
Meridian Co., Ltd. (OTCBB:MRDAF) is very pleased to announce the return of Ms. Anna Brazier as Director of Corporate Finances after her one year leave due to medical issues.
Sequenom, Inc. (Nasdaq: SQNM), announced today the entry of a settlement agreement which will resolve the consolidated securities class action lawsuits, In re Sequenom, Inc. Securities Litigation, Master File No: 3:09-cv-00921-LAB-WMC. The defendants have agreed to pay $14 million, which will be funded by insurance proceeds. Additionally the company has agreed to issue to the plaintiffs' class a number of shares of Sequenom common stock. These shares shall constitute 9.95% of the total shares then outstanding, subject to certain limitations. The company has also agreed to adopt or continue its implementation of changes and additions to certain corporate governance policies, protocols and practices. The terms of the settlement are subject to approval by the United States District Court. The settlement agreement contains no admission of liability, but the company is settling the lawsuit to avoid potentially lengthy, costly, distracting and time-consuming litigation.
St. Jude Medical, Inc. (NYSE:STJ) today announced it will sponsor the SCD-HeFT 10-Year Follow-up Study, along with the National Heart, Lung, and Blood Institute (NHLBI) – part of the National Institutes of Health.
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