• Avanir Pharmaceuticals Inc., of San Diego, was awarded a $2 million grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under its Cooperative Research Partnerships for Biodefense program. The grant provides funds to establish a cGMP manufacturing process and to test efficacy of a fully human monoclonal antibody treatment against inhalation anthrax in nonhuman primates. If successful, the preclinical studies can be used to support the filing of an investigational new drug application for Avanir's anti-anthrax drug candidate, AVP-21D9.

• Barr Pharmaceuticals Inc., of Woodcliff Lake, N.J., increased its offer to purchase all of the shares of Pliva dd, of Zagreb, Croatia, to about $2.3 billion in cash. Under the terms, Pliva shareholders would receive cash and dividends equal to $26.15 per each global depositary receipt.

• Cellectis SA, of Romainville, France, and Bayer BioScience NV, of Ghent, Belgium, signed an agreement under which Bayer CropScience will have access to Cellectis' custom-made "Meganuclease" technology for use in plant research and to develop products for use in agriculture. Financial terms and conditions were not disclosed. Meganucleases are described as a proprietary genome engineering technology developed by Cellectis that allows for highly precise "editing" to genetic sequences.

• Cephalon Inc., of Frazer, Pa., received an approvable letter from the FDA for the Fentora (fentanyl buccal tablet) new drug application filed last summer. The product has been developed to treat breakthrough pain in opioid-tolerant cancer patients. Notably, the agency indicated that no additional safety or efficacy data are required, and that the labeling essentially has been finalized. The company plans to submit a response to the FDA by the end of this month and expects it to be reviewed within 60 days of that resubmission. Cephalon's shares (NASDAQ:CEPH) rose $5.84 Friday to close at $60.10.

• Cytyc Corp., of Marlborough, Mass., entered into a five-year credit agreement with JPMorgan Chase Bank, Banc of America Securities and a syndicate of four other lenders comprised of Citizens Bank of Massachusetts, HSBC Bank USA, SunTrust Bank and Wells Fargo Bank. The agreement provides for a $150 million senior unsecured revolving credit facility to be used for general corporate purposes. Cytyc develops products for cervical cancer screening, breast cancer risk assessment and treatments for excessive menstrual bleeding and breast cancer.

• Generex Biotechnology Corp., of Toronto, entered into contractual arrangements with Cardinal Health Inc. for the manufacture of clinical trial batches of Generex Oral-lyn, an oral insulin spray product. Cardinal Health will formulate and fill clinical trial batches at its facility in Research Triangle Park, N.C. Terms were not disclosed.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said underwriters exercised an overallotment option to purchase an additional 1.05 million shares of its common stock in connection with its common stock offering that priced on June 28. Including the overallotment shares, the offering will total 8.05 million shares at a public offering price of $4.65 per share, resulting in expected net proceeds to the company of about $34.8 million. UBS Investment Bank acted as the sole book-running manager, and CIBC World Markets, JMP Securities and Leerink Swann & Co. acted as co-managers for the offering.

• Innovive Pharmaceuticals Inc., of New York, completed a Series A convertible preferred stock private placement, grossing $13.5 million. Net proceeds will be used for research and development, licensing fees and expenses, and for working capital and general corporate purposes. Paramount BioCapital Inc. served as the lead placement agent with Punk, Ziegel & Co. serving as co-placement agent. The company has three compounds in development: INNO-105, which is in a Phase I solid tumor study; INNO-406, which is slated to enter a Phase I trial in the third quarter for imatinib-resistant or intolerant Philadelphia-positive leukemias or relapsed/refractory Ph+ acute lymphocytic leukemia; and INNO-305, which will enter a Phase I study for acute myelogenous leukemia in the third quarter.

• Ligand Pharmaceuticals Inc., of San Diego, reached an agreement to settle litigation filed against the company on behalf of shareholders in the U.S. District Court for the Southern District of California. In exchange for a release of all claims, the company will pay $12.15 million in cash, money it will partially fund through its insurance carrier. A related investigation by the SEC is ongoing and is not affected by the settlement.

• MediGene AG, of Martinsried, Germany, said the FDA has extended the deadline for the completion of its review of Polyphenon E ointment to treat external genital warts to Oct. 31. The PDUFA date originally was July 28. The extension is a result of the FDA classifying certain documents submitted by the company as a major amendment. The documents were previously requested by the FDA.

• Medivir AV, of Stockholm, Sweden, said Tibotec Pharmaceuticals Ltd., a Cork, Ireland, unit of Johnson & Johnson, agreed to expand their HCV research collaboration, funding it through at least July 2007. The lead drug is in a Phase I trial. Medivir also licensed to Tibotec its preclinical HIV protease inhibitor project and its MIV-210 polymerase inhibitor compound for HIV and hepatitis B virus to Tibotec. In the former deal valued at €64 million (US$81.8 million), Medivir will receive €2 million upon signing of the agreement and is entitled to royalties from worldwide sales everywhere but the Nordic market, where it has retained rights. In the latter deal for the antiviral MIV-210, Medivir can earn to up to $30 million, of which $500,000 will come as a license fee upon signing. It also will receive royalties from worldwide sales except for the Nordic market.

• Pharmaxis Ltd., of Sydney, Australia, said an undisclosed U.S. pharmaceutical company placed an order to purchase Aridol test kits for a series of asthma trials evaluating a new asthma therapeutic. The Phase II trials will be conducted in North America and are expected to commence later this year. Aridol is the only asthma test registered in Australia. Pharmaxis has submitted an application for approval in Europe and is in the final stages of a Phase III trial necessary for filing a marketing application in the U.S.

• SkyePharma plc, of London, completed negotiations with Mundipharma International Holdings Ltd., of Cambridge, UK, the result of which is that SkyePharma will reacquire the rights for the marketing and distribution of DepoBupivacaine in Europe and other international markets excluding the U.S., Canada and Japan. SkyePharma will also obtain rights to the clinical data from the Phase II trials of DepoBupivacaine. That is expected to simplify the ongoing divestment process of SkyePharma's injectables unit. The deal related to DepoBupivacaine was disclosed last April.

No Comments