• Aptuit Inc., of Greenwich, Conn., agreed to acquire the assets and operations of EaglePicher Pharmaceutical Services, of Lenexa, Kan., as part of Aptuit's plan to build capabilities in active pharmaceutical ingredient development and drug substance manufacturing. The acquisition is expected to close within 90 days. Financial terms were not disclosed.

• BioDelivery Sciences International Inc., of Morrisville, N.C., said California regulators approved its two Phase III protocols for BEMA Fentanyl, allowing the company to continue recruitment at existing investigational sites and initiate new sites for studies in that state. There was a temporary cessation of recruitment there pending a review, as required under California law, of the informed consent document being used throughout the U.S. in that program. The product is being targeted for the treatment of breakthrough cancer pain.

• Callisto Pharmaceuticals Inc., of New York, said the FDA granted orphan drug designation to Atiprimod for treating carcinoid tumors. Atiprimod, a small-molecule antiangiogenic drug, is being developed to treat advanced carcinoid tumors as well as relapsed multiple myeloma patients. Callisto plans to begin a Phase II trial in advanced carcinoid cancer patients in the coming months.

• Cell Therapeutics Inc., of Seattle, completed its previously reported sale of about 23.1 million common shares at $1.73 apiece for $40 million. The company also granted investors a 90-day option to purchase an additional 5.8 million shares at the same price. Rodman & Renshaw LLC, of New York, served as the deal's lead placement agent and sole book runner, with Punk, Ziegel and Co., also of New York, as co-placement agent. (See BioWorld Today, Sept. 20, 2006.)

• Cephalon Inc., of Frazer, Pa., won FDA approval of Fentora (fentanyl) for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. The drug is the first and only buccal tablet approved for that indication, and Cephalon expects to launch the drug in the first week of next month.

• DeCode Genetics Inc., of Reykjavik, Iceland, filed legal proceedings against five former employees for misappropriation of trade secrets and intellectual property, and related breach of non-competition and non-solicitation provisions of employment agreements. At least four are now employed by the Center for Applied Genomics, a business unit of the Children's Hospital of Philadelphia, DeCode said.

• Genta Inc., of Berkeley Heights, N.J., closed its previously reported offering of about 20 million common shares for gross proceeds of about $16 million. Rodman & Renshaw LLC, of New York, served as the deal's placement agent. (See BioWorld Today, Sept. 21, 2006.)

• Juvaris BioTherapeutics Inc., of Pleasanton, Calif., was awarded one-year Phase I Small Business Innovation Research grant from the National Cancer Institute of the National Institutes of Health in Bethesda, Md., in collaboration with David Claxton at Penn State College of Medicine at Penn State University's medical school. The grant is for developing a therapeutic vaccine approach for acute myelogenous leukemia. Juvaris' vaccine technology will be tested in rodent tumor models to evaluate the impact on leukemia using an antigen-specific immunotherapeutic AML vaccine called JuvaVax.

• PharmAthene Inc., of Annapolis, Md., was awarded a multiyear contract valued at up to $213 million from the Department of Defense (DoD) U.S. Army Space and Missile Command, for advanced development of the company's broad spectrum chemical nerve agent prophylaxis, Protexia. The compound is a form of recombinant human butyrylcholinesterase, a potent organophosphorus scavenger protein produced in the milk of transgenic goats, which is being developed for use as a prophylactic against acute organophosphorus nerve agent toxicity.

• Protalix Biotherapeutics Ltd., of Carmiel, Israel, and Teva Pharmaceutical Industries Ltd., of Jerusalem, signed a collaboration and licensing agreement to develop two proteins using Protalix's plant cell culture platform. The undisclosed proteins, aimed at large-sized markets, are not part of Protalix's current product development pipeline. Teva will be granted an exclusive license to commercialize the developed products in return for royalty and milestone payments to be made upon the achievement of certain goals. Protalix will retain certain exclusive manufacturing rights.

• Quark Biotech Inc., of Fremont, Calif., out-licensed its human gene RTP-801 and molecules that modify its expression or function to Pfizer Inc., of New York, at the same time it received from Alnylam Pharmaceuticals Inc., of Cambridge, Mass., a new license to technology around RNAi therapeutics targeting those genes. RTP-801 is involved in the development of pathologic blood vessels that accelerate the progression of age-related macular degeneration. Quark has filed an investigational new drug application for RTP-801-targeted RNAi products to treat ocular diseases such as macular degeneration. Quark also in-licensed RNAi therapeutic technology targeting p53 for renal failure from Alnylam, and also has filed an IND for that. The Alnylam deal includes up-front, annual and milestone payments, as well as royalties, and Quark agreed to withdraw opposition to certain Alnylam patents in Europe. Financial terms of the exclusive worldwide agreement with Pfizer were not disclosed. Quark had originally in-licensed RTP-801 from Atugen AG, a subsidiary of SR Pharma plc. Atugen could receive milestone payments of up to $95 million, as well as royalties, as a result of the deal between Quark and Pfizer.

• Renhuang Pharmaceuticals Inc., of Harbin, China, a provider of natural bio-pharmaceutical products in China, today announced the listing of its shares on the Nasdaq Over-the-Counter Bulletin Board under the symbol "RHGP." The company recently incorporated in the U.S. through a reverse merger.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., filed a patent lawsuit to prevent Barr Laboratories Inc., a wholly owned subsidiary of Barr Pharmaceuticals Inc., of Woodcliff Lake, N.J., from marketing a generic version of Savient's Oxandrin (oxandrolone). The oral anabolic agent is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infection or severe trauma, and also for patients who, without definite pathophysiologic reason, fail to gain or maintain normal weight. Oxandrin can also be used to offset the protein catabolism associated with prolonged corticosteroid use.

• Scolr Pharma Inc., of Bellevue, Wash., achieved a development milestone resulting in a payment from Wyeth Consumer Healthcare, a division of Wyeth, of Madison, N.J. Scolr expects to report the payment as research and development revenues for the quarter ending Sept. 30. In addition, Wyeth agreed to reimburse Scolr for certain research and development costs already incurred and pay ongoing expenses associated with development of the first product. Scolr granted Wyeth Consumer Healthcare worldwide rights to use its CDT drug delivery platform for potential use in an OTC formulation.

• Third Point LLC, of New York, intends to conduct a consent solicitation in order to remove Thomas McLain as the chairman, president and CEO of Nabi Biopharmaceuticals, of Boca Raton, Fla. Third Point, which owns 9.5 percent of Nabi's shares, may also seek to remove one or more other directors and solicit consents in favor of a shareholder proposal requesting that the board fill any vacancies with one or more individuals named by Third Point.

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