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Other News To Note
(BioWorld Today Via Acquire Media NewsEdge) , of Dallas, said that it had retained Piper Jaffray to augment ongoing business development efforts with the goal of establishing additional strategic development and commercialization partnerships for Access' extensive product pipeline and multiple technology platforms. The Piper Jaffray health care investment banking team will focus on partnering opportunities for ProLindac, Angiolix and the Cobalamin programs.
? Anesiva Inc., of South San Francisco, Calif., said that the company will restructure operations to focus on commercial and late-stage product development to accelerate its transition to a specialty pharmaceutical pain management company. The company is reducing its work force by approximately 20 percent by eliminating its preclinical development function and other noncore positions. Anesiva said that the restructuring and other cost reductions will result in annual operating cost savings of approximately $20 million per year as compared to current levels. The company also said that sales estimates for its Zingo analgesic are expected to be in the range of $2 million to $3 million. In addition, it announced the full enrollment of its Phase III trials of Adlea for knee replacement and bunionectomy surgeries.
? Arno Therapeutics Inc., of Fairfield, N.J., said it has named Roger G. Berlin CEO and board member. Berlin worked previously with Wyeth as president of global research and development, and also was the executive director of clinical research at Merck Research Laboratories.
? Azaya Therapeutics Inc., of San Antonio, signed a licensing deal to further develop a technology that uses liposomes to deliver radiation through direct injection into head and neck tumors and is designed to shrink tumors, delay recurrence and to avoid collateral tissue damage from radiation therapy. The company is getting the technology from the University of Texas Health Science Center at San Antonio. Azaya plans to start a Phase I trial in early 2010.
? Genelabs Technologies Inc., of Redwood City, Calif., appointed Frederick W. Driscoll president and CEO and named him to the company's board. He most recently served as Genelabs' chief financial officer.
? ImClone Systems Inc., of New York, submitted a supplemental biologics license application to broaden the use of Erbitux (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The application, submitted Aug. 29, was prepared in conjunction with ImClone's North American partner, New York-based Bristol-Myers Squibb Co. If the FDA grants a priority review as requested, the agency's decision could come within six months. The sBLA was based on data from the 442-patient EXTREME (Erbitux in first-line Treatment of REcurrent or MEtastatic head and neck cancer) study, in which the drug met its primary endpoint of significantly increasing the median overall survival in combination with platinum-based chemotherapy (10.1 months) compared to chemotherapy alone (7.4 months). Erbitux was approved in March 2006 for use in combination with radiation therapy in locally or regionally advanced SCCHN and as a single agent in patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. ImClone's European partner, Darmstadt, Germany-based Merck KGaA filed a similar supplemental application with European regulators in June to broaden the use of Erbitux to include first-line treatment of patients with recurrent and/or metastatic SCCHN.
? Insmed Inc., of Richmond, Va., said that a Nasdaq hearing panel has decided to grant the request of Insmed to remain listed on the Nasdaq, subject to the condition that on or before Dec. 15, Insmed must have a closing bid price of $1 or more for a minimum of 10 consecutive business days. Should the company be unable to meet the requirements of the panel's decision, its securities would be subject to delisting.
? Neurotech Pharmaceuticals Inc., of Lincoln, R.I., said that the FDA has granted fast-track status to NT-501 for the treatment of visual loss in two indications - retinitis pigmentosa and the dry form of age-related macular degeneration. NT-501 is an intraocular, cell-containing polymer implant designed to provide continuous, long-term release of the therapeutic protein Ciliary Neurotrophic Factor directly into the back of the eye through Neurotech's core technology platform, Encapsulated Cell Technology.
? Opexa Therapeutics Inc., of The Woodlands, Tex., said it has established a multiple sclerosis research partnership with the Myelin Repair Foundation Inc. As part of the collaboration, Opexa and the Saratoga, Calif.-based foundation will work to identify therapeutically relevant biomarkers in MS that may provide important insight to support the continued development of Tovaxin, Opexa's T-cell vaccine currently in Phase IIb testing in MS patients. Under the terms of its collaboration with Opexa, the foundation will receive and analyze patient samples and clinical data from Opexa's Phase IIb study with Tovaxin to identify biomarkers related to safety and efficacy of the therapy in MS patients. As part of the analysis, the foundation will leverage its network of leading MS researchers, as well as its proprietary biochemical and biological assays.
? Somaxon Pharmaceuticals Inc., of San Diego, released data Tuesday from a study of doxepin, which is the active ingredient in Silenor, its insomnia treatment. The data showed that doxepin had antagonistic activity at the H1 histamine receptor - thought to be important in the sleep-wake cycle. Silenor is a low-dose tablet of doxepin hydrochloride in 1-mg, 3-mg and 6-mg strengths and was shown in the study to improve sleep onset and sleep maintenance and helped prevent early awakening, with few side effects, the company said. The data were presented at the European College of Neuropsychopharmacology meeting in Barcelona, Spain.
? United Therapeutics Corp., of Silver Spring, Md., and its wholly owned subsidiary, Lung Rx Inc., said the FDA accepted for review the new drug application for inhaled treprostinil in pulmonary arterial hypertension. The NDA will be subject to a standard review period of 10 months, with a PDUFA date of April 30, 2009.
? ViroPharma Inc., of Exton, Pa., and Lev Pharmaceuticals Inc., of New York City, said they have completed the waiting period required under the Hart-Scott-Rodino Anititrust Improvements Act and will proceed with ViroPharma's proposed acquisition of Lev. The deal is expected to close by the end of this year, pending the approval of Lev stockholders. (See BioWorld Today, July 16, 2008.)
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