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TMCNet:  Other News To Note

[December 19, 2012]

Other News To Note

(BioWorld Today Via Acquire Media NewsEdge) • Advanced Cell Technology Inc., of Marlborough, Mass., chose not to do a reverse stock split because of market conditions. Shareholders had previously given the company the discretion to complete the reverse split before the end of the year.

• AIMM Therapeutics NV, of Amsterdam, the Netherlands, entered a strategic partnership with Cosmo Pharmaceuticals SpA, of Milan, Italy, to develop oral diagnostic and therapeutic antibodies for gastrointestinal diseases including colon carcinoma. Under the agreement, Cosmo will formulate human monoclonal antibodies generated by AIMM in an extended-release form exploiting its MMX technology. No financial details were disclosed.

• Amarin Corp. plc, of Dublin, Ireland, submitted a supplemental new drug application (sNDA) to the FDA seeking approval for Chemport Inc. as an additional active pharmaceutical ingredient supplier for Vascepa (icosapent ethyl). The sNDA submission contributes to the planned expansion of the Vascepa manufacturing supply chain, after Amarin decided to launch the drug alone and closed a $100 million debt financing earlier this month. (See BioWorld Today, Dec. 10, 2012.) • GlycoVaxyn AG, of Zurich-Schlieren, Switzerland, inked a collaboration with GlaxoSmithKline Biologicals, a unit of GlaxoSmithKline plc, of London, to develop bacterial vaccines using GlycoVaxyn's bio-conjugation technology. GlycoVaxyn's technology is designed to enable or improve the development of antibacterial conjugate vaccines through in vivo synthesis of protein-polysaccharide complexes in E. coli, via recombinant DNA technology. The agreement includes an undisclosed set of pathogen targets in the field of bacterial vaccines, with GSK holding an option to obtain an exclusive license on the targets during the three-year collaboration and to extend both the term and scope of the collaboration. GlycoVaxyn received an up-front payment and equity investment from GSK and is eligible for milestone payments and royalties on licensed vaccine candidates. Additional terms were not disclosed.

• Law firm Bronstein, Gewirtz & Grossman LLC is investigating whether Hemispherx Biopharma Inc., of Philadelphia, and its executives violated federal securities laws after the company's shares fell more than 27 cents, or nearly 43 percent, on Tuesday following unfavorable briefing documents posted by the FDA's Center for Drug Evaluation and Research in advance of Thursday's Arthritis Advisory Committee meeting to discuss chronic fatigue syndrome candidate Ampligen. In the report, agency staff raised multiple concerns with the efficacy and safety of the drug and said the company was warned earlier this year that existing research data may not support approval of Ampligen, which previously received a complete response letter. On Wednesday, shares of Hemispherx (NYSE:HEB) gained 1 cent, closing at 38 cents. (See BioWorld Today, Dec. 3, 2009.) • H3 Biomedicine Inc., of Cambridge, Mass., partnered with Sage Bionetworks, of Seattle, to develop software platforms for cancer genomics research. Sage will use its predictive modeling technology with H3's data to find associations between genomic alterations and pharmacologic drug responses. The two companies will also freely share the data and tools from the project with other organizations involved in cancer research.

• ImmunoGen Inc., of Waltham, Mass., said Amgen Inc., of Thousand Oaks, Calif., licensed the exclusive right to use its maytansinoid targeted antibody payload technology to develop cancer therapeutics for a third, undisclosed target. Amgen licensed rights to two other cancer targets in 2009 and has two compounds in clinical testing under those licenses. The licenses were taken under a 2000 agreement with Abgenix Inc., which Amgen acquired in 2006. For each license, ImmunoGen received $1 million up front and is entitled to milestone payments potentially totaling $34 million, plus royalties on product sales. Amgen is responsible for the development, manufacturing and marketing of any products resulting from the license. (See BioWorld Today, Sept. 7, 2000, and Dec. 15, 2005.) • Intercell AG, of Vienna, Austria, said the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a marketing authorization application by for Ixiaro, a vaccine against Japanese encephalitis. The application is for a pediatric label extension, based on Phase III studies showing the vaccine to be highly immunogenic in children between 2 months and 18 years, with a favorable safety profile. The European Commission will make a decision in February or March of 2013.

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