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Other News To Note
(BioWorld Today Via Acquire Media NewsEdge) , of Research Triangle Park, N.C., said it has filed to voluntarily delist its common stock from the NYSE Alternext US LLC. The company had been notified that it failed to meet certain listing requirements, and its board elected not to submit a plan of compliance and voluntarily file for delisting. The shares are expected to be delisted effective Jan. 29. The company's common stock continues to trade under the symbol "AHX" on the Toronto Stock Exchange.
? Anesiva Inc., of South San Francisco, said the FDA approved its supplemental new drug application to expand the indication for Zingo to treat the pain associated with blood draws to include adults. Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system is approved to treat the pain associated with peripheral I.V. insertions and blood draws in children 3 to 18 years of age. In November Anesiva ceased Zingo commercial activities and is seeking to license Zingo. Shares of Anesiva (NASDAQ:ANSV) rose 8 cents to close at 76 cents.
? Array BioPharma Inc., of Boulder, Colo., said it plans to accelerate partnering initiatives and scale back discovery research spending over the next two years to help ensure sustainable growth through the current uncertain capital market conditions. During 2009, Array expects to reduce net cash used in operating activities from a planned $30 million per quarter to about $20 million, before new partner or milestone payments. Array had $101 million in cash, cash equivalents and marketable securities as of Sept. 30, 2008, and received an additional $40 million in cash in December when Deerfield Capital funded the second draw under its credit facility with Array. The company said it believes that it can secure about $80 million through new partnering deals and milestone payments from existing collaborations over the next year.
? Azur Pharma Ltd., of Dublin, Ireland, licensed the exclusive U.S. marketing rights for Niravam (alprazolam orally disintegrating tablets), Parcopa (carbidopa-levodopa orally disintegrating tablets), Kemstro (baclofen orally disintegrating tablets) and Fluxid (famotidine orally disintegrating tablets) from UCB SA, of Brussels, Belgium. Financial terms were not disclosed. Niravam, Parcopa and Kemstro are central nervous system products, as is Azur's FazaClo which it markets in the U.S.
? Biotechnology Value Fund LP, of San Francisco, has requested a special meeting of the board of directors of Avigen Inc., of Alameda, Calif., to replace the board with BVF's slate of stockholder nominees. BVF previously accused company officials of "outrageous," "disrespectful" and "offensive" actions, including implementing excessive "golden parachutes," adopting "poison pill" rules designed to keep the fund from purchasing additional stock in the company, and generally destroying shareholder value in the company.
? Biovail Corp., of Toronto, has agreed to pay a $5.4 million settlement agreement to end a Ontario Securities Commission investigation of the company. The investigation related to specific accounting and financial disclosure practices that occurred between 2001 and March 2004 and resulted in a statement of allegations by the OSC in March 2008. The settlement does not include four individuals who also were named in the allegations.
? EyeGate Pharma Inc., of Waltham, Mass., said the FDA granted orphan drug status to EGP-437 (dexamethasone phosphate), the company's lead drug delivered via the EyeGate II Iontophoretic Delivery System, in corneal graft rejection. That designation offers regulatory assistance and guarantees seven years of marketing exclusivity upon approval.
? Kylin Therapeutics, of West Lafayette, Ind., has received a $1.2 million grant from the Indiana 21st Century Research and Technology Fund to further develop its cancer and disease pipeline from Purdue University. Kylin Therapeutics is in the preclinical stage of commercializing a technology called pRNA. Kylin's pRNAi is a platform technology that leverages the power of RNA and a natural process called RNA interference (RNAi) to directly target and "turn off" disease-causing genes.
? Northwest Biotherapeutics Inc., of Bethesda, Md., said it settled a putative securities class action lawsuit and agreed to pay $1 million, to be funded out of insurance proceeds. The case stemmed from allegations that the company had misrepresented certain facts resulting in the artificial inflation of its stock price between April 17, 2007, and July 18, 2007. Though the company disputed those allegations, Northwest said it offered to settle the lawsuit to avoid protracted litigation. The company also reported that the formal investigation by the SEC into those issues has been closed without any action taken.
? Ovation Pharmaceuticals Inc., of Deerfield, Ill., said the FDA's Peripheral and Central Nervous System Drugs Advisory Committee Thursday unanimously voted to recommend Sabril (vigabatrin) as a monotherapy for infantile spasms, an orphan indication that affects about 8,500 infants in the U.S, striking between 3 months to 6 months of age. The vote followed a unanimous vote Wednesday by the same committee in favor of approval of Sabril as an adjunctive treatment for adults with refractory complex partial seizures who have inadequately responded to several antiepileptic drugs. The committee both days said the drug should be approved only under a restricted distribution program. Sabril, an irreversible inhibitor of gamma-aminobutyric acid transaminase, currently is marketed in more than 50 countries worldwide, including most countries of the European Union, Canada and Mexico. (See BioWorld Today, Jan. 8, 2009.)
? Sirius Genomics, of Vancouver, British Columbia, said it has signed a collaborative agreement with the UK Critical Care Genomics Group to develop Sirius' pharmacogenomic diagnostic for responsiveness to recombinant activated protein C, which is sold as Xigris by Eli Lilly and Co., of Indianapolis. Financial terms of the agreement were not disclosed.
? XDx Inc., of Brisbane, Calif., said it signed a pharmacogenomics agreement with New York-based Bristol-Myers Squibb Co. to identify biomarkers in the field of systemic lupus erythematosus for clinical diagnostic purposes associated with development of BMS' Orencia (abatacept). Under the terms, BMS will make an undisclosed up-front payment to XDx in addition to milestone payments upon the achievement of specific research and development objectives. XDx will receive commercial rights to certain diagnostic applications resulting from the collaboration.
? XenoPort Inc., of Research Triangle Park, N.C., and GlaxoSmithKline plc, of London, said GSK has resubmitted the new drug application to FDA requesting approval of Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary restless legs syndrome. The FDA had requested that data in a single study be reformatted. In addition, GSK reviewed other clinical studies taking that input into account. The withdrawal was not related to the content of the filing, the companies said.
Copyright ? 2009 Thomson BioWorld, All Rights Reserved.
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