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Other News To Note
(BioWorld Today Via Acquire Media NewsEdge) , of Cambridge, Mass., has designated a new development candidate, ACE-536, which selectively increases red blood cells and hemoglobin, as a potential treatment for anemia. ACE-536 utilizes a mechanism fundamentally different from existing therapies to increase hemoglobin levels.
? AVI BioPharma Inc., of Portland, Ore., reported preclinical results demonstrating the effectiveness of a systemically delivered PPMO-base splice switching oligomer or SSO (a morpholino oligomer conjugated to an arginine-rich peptide) in vivo in a mouse model of an inherited blood disorder. Those results, published in the Proceedings of the National Academy of Sciences, showed that the PPMO-based SSOs might be effective in vivo not only in muscle cells for treating Duchenne's muscular dystrophy but also for another genetic disease and in target cells more challenging than muscle fibers.
? Beactica AB, of Uppsala, Sweden, entered a new research collaboration agreement with GE Healthcare, of Chalfont St. Giles, UK, and Uppsala University to develop the next generation of Biacore surface plasmon resonance instruments and applications for fragment-based drug discovery. The project also aims to identify high-quality leads against a clinically important, undisclosed protein target from Beactica's discovery pipeline. Financial terms were not disclosed.
? Celldex Therapeutics Inc., of Needham, Mass., said it has entered into an agreement to sell its poultry vaccines business to Lohmann Animal Health International, of Lampasas, Texas, which has performed all manufacturing, marketing and distribution activities for Celldex's Megan Vac 1 and MeganEgg poultry vaccines since 2002, with royalties paid to the Massachusetts firm. Financial terms of the transaction were not disclosed.
? Celprogen Inc., of San Pedro, Calif., has introduced a nonviral method to reprogram adult somatic cells (primary skin fibroblast, keratinocytes, cardiac, liver and neuronal cells) to their embryonic-like pluripotent cells (iPCs). The process known as de-differentiation was achieved with nonviral induction utilizing Celprogen's De-differentiation media and matrix system for reprogramming adult somatic cells to iPCs in tissue culture.
? Dyax Corp., of Cambridge, Mass., said the FDA's Pulmonary-Allergy Drugs Advisory Committee is set to discuss the company's biologics license application for DX-88 (ecallantide) in treating acute attacks of hereditary angioedema Feb. 4. Dyax submitted its BLA in September based on data from two Phase III studies, and the application was designated for priority review. The PDUFA date is March 23. (See BioWorld Today, Sept. 25, 2008.)
? Elan Corp. plc, of Dublin, Ireland, said its board has engaged Citigroup Global Markets Inc. to conduct, in connection with executive management and other external advisors, a review of the company's strategic alternatives. The range of alternatives that will be assessed could include minority investment or strategic alliance, a merger or sale.
? Exact Sciences Corp., of Marlborough, Mass., said its board unanimously rejected an acquisition proposal by San Diego-based Sequenom Inc. to buy Exact Sciences for $1.50 per share, or about $41 million. The company said it is pursuing a strategic alternative that the board believes can provide greater value that the Sequenom proposal. Shares of Exact Sciences (NASDAQ:EXAS) gained 7 cents, to close Tuesday at $1.57.
? International Stem Cell Corp., of Oceanside, Calif., said it has created layered human tissue from its unique parthenogenetic stem cells and transplanted the tissue into animals in preclinical trials to establish a potential new treatment for human retinal diseases, such as macular degeneration or retinitis pigmentosa. The company noted that because its human parthenogenetic stem cells are created from unfertilized human eggs, they do not require the destruction of human embryos.
? Invitrogen, of Carlsbad, Calif., a division of Life Technologies Corp., said its DynaChip HLA Antibody Analysis System received approval from Health Canada for the detection and identification of antibodies to human leukocyte antigen markers, for use in determining the compatibility of organ donors. The system received FDA clearance last year.
? Jubilant Organosys Ltd., of Noida, India, said its Bangalore-based subsidiary, Jubilant Biosys Ltd., entered a drug discovery partnership with BioLeap LLC, of New Hope, Pa., to integrate BioLeap's computational fragment-based drug design platform with Jubilant's expertise in chemistry, biology and crystallography to create a preclinical drug development platform. Financial terms of the deal were not disclosed.
? MacuClear Inc., of Plano, Texas, said it entered a deal with specialty pharma firm Mystic Pharmaceuticals Inc., of Cedar Park, Texas, to use Mystic's VersiDoser unit dose drug delivery platform in upcoming Phase I/II trials of MC 1101 in age-related macular degeneration (AMD). Financial terms were not disclosed. MC 1101 is a topically delivered solution for treating and preventing the dry form of AMD.
? Micromet Inc., of Bethesda, Md., said an article published in Nature Cell Biology revealed a novel signaling function of the epithelial cell adhesion molecule, or EpCAM (CD326), which is expressed with high frequency on many types of solid tumors. Micromet is developing two antibody drug candidates that target EpCAM: MT110, a T-cell engaging BiTE antibody, and adecatumumab (MT201), a human monoclonal antibody. The firm announced a new deal earlier this week potentially worth more than $390 million with Bayer Schering AG, of Leverkusen, German, for one of its preclinical BiTE antibodies against an undisclosed oncology target. (See BioWorld Today, Jan. 13, 2009.)
? NuVasive Inc., of San Diego, said it agreed to make an undisclosed investment in Progentix Orthobiology NV, of Bilthoven, the Netherlands, to expand its reach in the area of biologics. NuVasive is a medical device firm developing surgical treatments for the spine. Progentix is an orthobiologics company working on a synthetic bone substitute designed to accelerate bone healing.
? ProFibrix BV, of Leiden, the Netherlands, has concluded a commercial license agreement with Crucell NV, also of Leiden, for PER.C6, a human protein production platform. The PER.C6 platform allows ProFibrix to manufacture recombinant human fibrinogen at levels that support the development and commercial rollout of new products. Initially recombinant fibrinogen will be developed for systemic applications in hemostasis and later on for the development of tissue-repair products.
? QLT Inc., of Vancouver, British Columbia, said the U.S. Court of Appeals for the First Circuit affirmed the judgment of the U.S. District Court for the District of Massachusetts in a lawsuit brought against QLT by Massachusetts Eye and Ear Infirmary in connection with U.S. patent No. 5,798,349 and certain of MEEI's research results related to QLT's Visudyne. The Court of Appeals upheld the liability and damages aspects of the 2007 judgment in which QLT was found liable for unfair trade practices and ordered to pay MEEI damages equal to 3.01 percent on past, present and future worldwide net sales of Visudyne plus interest and certain legal fees. Unless the decision is altered on further review, QLT estimates that the amount of damages and interest that it will be required to pay MEEI is approximately $113.2 million.
? Santarus Inc., of San Diego, said partner Schering-Plough HealthCare Products, of Memphis, Tenn., received a complete response letter from the FDA for a new drug application for its Zegerid-branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg in the U.S. over-the-counter (OCT) heartburn market. The NDA for OTC Zegerid was submitted in March under the terms of an October 2006 license deal for OTC proton pump inhibitor products using Santarus' technology. (See BioWorld Today, Oct. 23, 2006.)
? SIGA Technologies Inc., of New York, said it received favorable written guidance from the European Medicines Authority regarding its proposal to evaluate its lead orthopox antiviral drug, ST-246, based on the agency's procedures for marketing approval under exceptional circumstances. SIGA anticipates that the guidance will allow the firm to pursue both U.S. and European approvals in parallel processes using efficacy data derived from animal models and human safety studies.
? Vitro Biopharma Inc., of Golden, Colo., said research indicated that its technology and stem cell lines have applications that may lead to treatments for cancer, and said it hopes to have products available for research use in the near future. The firm said the outcome will allow additional opportunities for short-term revenue generation and provides for a fundamental expansion of its business prospects and multiple opportunities for product and revenue growth.
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