BioWorld Today - Apr. 08, 2008
AspenBio, of Castle Rock, Colo., said it has entered a long-term exclusive license and commercialization agreement with Novartis Animal Health Inc., of Basel, Switzerland, for the development and commercialization of AspenBio's recombinant single-chain bovine products BoviPure LH and BoviPure FSH. Under the deal, AspenBio receives an undisclosed up-front cash payment and ongoing royalties based upon net direct product margins as defined in the agreement. The agreement calls for AspenBio to fund 35 percent of the development and registration costs. AspenBio said it licensed the single-chain technology from Washington University in St. Louis for use in all animal species.
Biopure Corp., of Cambridge, Mass., said it plans to meet with UK regulators in response to a letter issued by the Commission on Human Medicines stating that major pharmacological and clinical issues remain regarding BioPure's application for marketing authorization for Hemopure (bovine hemoglobin glutamer - 250). While the commission stated that it was "reassured" on some fronts since its initial comment letter, it indicated that other issues were not yet resolved or were resolved only in part. The commission has not advised the company to withdraw its application, BioPure said. Hemopure currently is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. The company is developing Hemopure for other indications and is supporting the U.S. Navy's government-funded efforts to develop a potential out-of-hospital trauma indication.
Callisto Pharmaceuticals Inc., of New York, said that its wholly-owned subsidiary Synergy Pharmaceuticals Inc. has filed an investigational new drug application with the FDA for Guanilib (SP-304) for the treatment of chronic constipation and constipation-predominant irritable bowel syndrome. Guanilib, an analog of uroguanylin, a natural hormone produced in the gastrointestinal tract that is a key regulator of intestinal function, works by activating the GC-C receptor on intestinal epithelial cells, promoting fluid and ion transport. Preclinical animal studies have shown Guanilib to be well tolerated and has almost no absorption systemically into the body, exerting its effect locally on GC-C receptors within the gut. Pending clearance by the FDA, Callisto intends to initiate a Phase I clinical trial of Guanilib in the second quarter to evaluate safety, pharmacokinetic and pharmacodynamic properties.
EntreMed Inc., of Rockville, Md., received a deficiency notice from the listings qualifications department of Nasdaq because its common stock failed to close above the minimum closing bid price of $1 per share for 30 consecutive business days. The company will have 180 calendar days to regain compliance.
Galderma Pharma, of Lausanne, Switzerland, completed its $420 million tender offer for fellow dermatology drug company CollaGenex Pharmaceuticals Inc., of Newtown, Pa., with 97 percent of CollaGenex's common stock tendered by shareholders. Galderma's offer for CollaGenex expired at midnight Friday. Under the terms of the deal, each outstanding share of CollaGenex common stock will be converted into the right to receive $16.60 per share in cash. Once Galderma completes its acquisition of the shares, CollaGenex will become a majority owned subsidiary of Galderma Laboratories.
Hawaii Biotech Inc., of Honolulu, said it has received a grant from the Pediatric Dengue Vaccine Initiative, of Seoul, Korea, to support the manufacture of the company's dengue vaccine for eventual clinical testing. Hawaii Biotech emphasized that it has not yet initiated regulatory filing for its dengue vaccine formulation.
Hemispherx Biopharma Inc., of Philadelphia, said that it is accelerating a strategic initiative to explore the therapeutic potential for Ampligen as an adjuvant to vaccines for HIV/AIDS, and for avian influenza. Hemispherx said it has filed a new drug application with the FDA for Ampligen as a monotherapy for chronic fatigue syndrome. For avian flu and HIV, the firm is targeting Ampligen as a vaccine enhancer using a TLR-3 modulator or broad-spectrum immune modulation strategy. The company said the stepped-up initiatives follow recent disappointments by other vaccines targeting HIV, including Whitehouse Station, N.J.-based Merck & Co. Inc.'s vaccine candidate MRKAd5 trivalent, and new reports in Indonesia that avian influenza now poses an increased threat due to recent mutations of the virus.
In 2005, Targeted Genetics and Sirna Therapeutics formed a collaboration to develop therapeutics using an AAV delivered RNAi approach to target the Huntington's disease gene.
Kinetic Concepts, of San Antonio, Texas, said it would acquire LifeCell, of Branchburg, N.J., for $1.7 billion cash, or about $51 per share. The offer represents an 18 percent premium over the closing price of LifeCell's stock on April 4. The boards of both companies have unanimously approved the transaction. LifeCell's flagship product AlloDerm, which is used to repair damaged tissue in hernias and breast reconstruction, had $167 million in revenue last year. The company won U.S. approval last June for its next-generation regenerative product, Strattice. KCI focuses on the operating room and the acute care setting both with its current product offerings and with the development of new products from its negative pressure technology platform. LifeCell will operate as a new global biosurgery division within KCI.
Memory Pharmaceuticals Corp., of Montvale, N.J., said it received notice from Nasdaq that the company is no longer in compliance with the minimum $10 million stockholders' equity requirement for continued listing. Nasdaq requested that Memory provide, on or before April 17, a plan to achieve and sustain compliance.
Microbia Inc., of Cambridge, Mass., has changed its name to Ironwood Pharmaceuticals. It said the new name is the same as the ironwood tree, is a long-lived tree that thrives in the harshest desert environment, with some surviving as long as 1,500 years, providing a shaded microclimate with lower temperatures, higher water availability, and more organic matter for birds, reptiles, insects, animals, and plants.
Pacific Biometrics Inc., of Seattle, said it has signed a series of long-term contracts worth a combined $3 million with an unnamed major multinational sponsor to test for improvements in immunological markers in patients with rheumatoid arthritis. The contracts relate to a series of clinical trials, part of a global Phase II and Phase III program, investigating a potential follow-on biological approach for the treatment of rheumatoid arthritis. Assuming the scope of the studies remains unchanged, the contracts will contribute to revenues over more than five years, starting in fiscal 2008. Pacific Biometrics will provide the sponsor with arthritis biomarker testing on samples collected to support the sponsor's clinical development program, eventually expected to result in a new drug application filing with the FDA and equivalent filings with regulatory agencies in other jurisdictions. The initial phase of testing for this program commenced in the first quarter of 2008 and testing is anticipated to continue through the third quarter of 2015, although several of the studies will be completed by 2012.
Pluristem Therapeutics Inc., of New York, said results from Fraunhofer Institute's additional pre-clinical study using the company's PLacental eXpanded (PLX) cells in treating ischemic stroke showed statistical significance utilizing functional as well as anatomical endpoints. PLX cells are mesenchymal stromal cells obtained from the placenta and expanded using Pluristem's proprietary 3D PluriX technology. The functional endpoints of improvement in beam walking and neurological severity score and the anatomical endpoint of reduction in infarct size reached statistical significance versus controls.
Pro-Pharmaceuticals Inc., of Newton, Mass., has signed a letter of intent with YIACO Medical Co. of Kuwait, for the commercialization of Davanat for the treatment of colorectal and biliary cancer. YIACO Medical represents 80 healthcare companies in the Middle East and North Africa. The FDA has granted a compassionate-use investigational new drug application for Davanat in combination with chemotherapy and a biologic to treat a patient with breast cancer. The drug currently is being tested in two Phase II clinical trials for first-line treatment of patients with colorectal and biliary cancers.
Sangamo BioSciences Inc., of Richmond, Calif., has entered into a license agreement with Open Monoclonal Technologies, of Palo Alto, Calif., providing a non-exclusive, worldwide license to OMT for the commercial use of transgenic animals generated using Sangamo's zinc finger DNA-binding protein technology. OMT will pay Sangamo an upfront license fee, payments upon the achievement of certain clinical development milestones, a share of payments received by OMT from sublicensees, and royalties on sales of any products developed using Sangamo's ZFP technology. For any given OMT Product, OMT has the right to buy out its future royalty payment obligations by paying a lump sum fee to Sangamo. Financial details were not disclosed.
SemBioSys Genetics Inc., of Calgary, Alberta, said it has received a C$850,000 milestone payment from Avac Ltd., also of Calgary. The payments are related to separate agreements that SemBioSys has entered into with AVAC to advance the development of its safflower-produced insulin and the commercial activities of SemBioSys unit Botaneco Specialty Ingredients Inc. SemBioSys received a C$350,000 milestone payment for completing technical objectives in the development of its insulin program. It also received a $500,000 payment as part of the non-dilutive funding from AVAC of up to C$2.4 million for advancing the development of Botaneco.
