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Other News To Note
(BioWorld Today Via Acquire Media NewsEdge) , of Laguna Niguel, Calif., said it initiated the first of two expected pivotal animal studies of AEOL 10150 as a countermeasure to nuclear and radiological exposure. The trial will test the compound as a treatment for damage to the lungs due to radiation exposure and to determine the most effective dose, duration of delivery and the window of opportunity for treatment after exposure. Results from that study are expected to lead to the final design of a pivotal trial, expected to begin in early 2009. AEOL 10150 is a small molecule designed to catalytically consume reactive oxygen and nitrogen species.
? ChemDiv Inc. and Avineuro Pharmaceuticals Inc., both of San Diego, extended the term of their research and development collaboration, including formulation, safety and early clinical development studies in areas of neurodegenerative and psychiatric disorders. The new agreement provides for research funding of clinical candidate compounds to proof of concept, and Avineuro is responsible for further clinical development and commercialization of drug candidates AVN101, AVN211 and additional compounds that might be nominated for development under the ongoing agreement. In September, ChemDiv entered an out-licensing and collaboration agreement with Avineuro to develop multiple compounds for Alzheimer's disease and schizophrenia.
? CombinatoRx Inc., of Cambridge, Mass., said it was implementing a further restructuring to focus on its core strength of identifying product candidates. The latest restructuring will include a reduction of the company's work force by about 30 employees, bringing the total work force reduction to about 65 percent. Those moves are expected to allow CombinatoRx to operate without additional equity financing for at least four more years. Ongoing operating cash burn will be reduced to between $5 million and $10 million on an annual basis. About 55 employees will remain and will focus on research and partnering activities. The firm also reported that it plans to consolidate its Cambridge facility. Shares of CombinatoRx (NASDAQ:CRXX) fell 5 cents, or 9.8 percent, to close Friday at 46 cents.
? Dicerna Pharmaceuticals Inc., of Watertown, Mass., said data showed its Dicer-substrate 27mers demonstrated substantially greater potency compared to synthetic 21mers in silencing four of the five target genes tested and equivalency against the fifth. They also demonstrated a longer duration of action vs. 21mers in four of the five genes and, again, equivalency against the fifth. Those data were published in the current issue of the Journal of Biomolecular Techniques.
? Dyax Corp., of Cambridge, Mass., said the FDA accepted for filing its biologics license application for DX-88 (ecallantide) in acute attacks of hereditary angioedema and has designated the application for priority review, giving it a PDUFA date of March 23, 2009. DX-88 previously was granted both orphan drug and fast-track status by the FDA. Dyax filed the BLA in September. (See BioWorld Today, Sept. 25, 2008.)
? Eli Lilly and Co., of Indianapolis, said it successfully completed its tender offer for all outstanding shares of New York-based ImClone Systems Inc. for $70 per share in cash. As of the expiration date of the tender offer, about 85.4 million shares were tendered, representing about 95.5 percent of outstanding shares. Lilly, which offered to buy ImClone last month in a deal valued at $6.5 billion, expects to complete the acquisition through a short-form merger today. (See BioWorld Today, Oct. 7, 2008.)
? Keryx Biopharmaceuticals Inc., of New York, said it received notice from Nasdaq that it no longer is in compliance with the listing requirement calling for a minimum of $2.5 million in stockholders' equity, or $35 million market value or $500,000 in net income for the most recent fiscal year or two of the last three fiscal years. The company must provide Nasdaq with a plan for regain compliance on or before Dec. 2.
? Recordati SpA, of Milan, Italy, said it submitted a marketing application for silodosin in benign prostatic hyperplasia to the European Medicines Agency. Silodosin is an alpha-1 adrenergic receptor. The company anticipates approval in the first half of 2010, with a product launch by the end of that year or the beginning of 2011. The drug is approved in the U.S. and is expected to be launched by Corona, Calif.-based Watson Pharmaceuticals Inc. in early 2009.
? Vical Inc., of San Diego, said it is reducing its staff by 29 employees, about 20 percent of its total work force, and is accelerating the closure of a research facility as part of a strategic restructuring process. Following the restructuring, the company will have about 120 employees and expects to reduce net losses and cash burn by about $4 million annually. That cost savings is expected to preserve capital and help the company focus efforts on its most advanced development programs, which include Allovectin-7, an immunotherapeutic in pivotal Phase III testing in advanced metastatic melanoma, and a DNA vaccine for cytomegalovirus (CMV), which is in a Phase II trial in stem cell transplant recipients. Vical said it is exploring partnering opportunities for the congenital disease application of its CMV vaccine and for its pandemic influenza DNA vaccines.
? ZymoGenetics Inc., of Seattle, said its board promoted Douglas E. Williams to CEO, effective Jan. 2, 2009. Current CEO Bruce L.A. Carter will retire, though he will continue to serve as chairman in a nonexecutive capacity.
Copyright ? 2008 Thomson BioWorld, All Rights Reserved.
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