• 4SC AG, of Martinsried, Germany, received funding as part of the BioChancePLUS support program from the Federal Ministry of Education and Research for development of new drug candidates. The two-and-a-half year, €2.9 million (US$3.7 million) project will aim to develop new chemotherapeutic drug candidates to treat autoimmune diseases, particularly multiple sclerosis.
• aaiPharma Inc., of Wilmington, N.C., filed for Chapter 11 bankruptcy to enable the company to continue normal business operations during a restructuring. The company is receiving $210 million in a post-petition financing, and it has agreed to sell its pharmaceuticals division as part of the reorganization. The financing will be used to replace aaiPharma's existing $180 million senior credit facility and supplement its cash flow. The pharmaceuticals division will be sold for $170 million and contingent royalties.
• Abingworth Management Ltd., of London, opened a new office in Waltham, Mass., which will be run by Michael Bigham. The office will enable Abingworth to focus on East Coast deals in the U.S. The life sciences venture capital group also appointed Roy Lobb as adviser to evaluate new opportunities and assist portfolio companies on the East Coast.
• Acacia Research Corp., of Newport Beach, Calif., said its subsidiary CombiMatrix Corp. has formed a wholly owned subsidiary called CombiMatrix Molecular Diagnostics Inc. (CMD), to take advantage of the company's approach to microarray-based diagnostics. Matthew Watson will serve as CEO and David Baunoch will be president and chief operating officer of CMD.
• Acambis plc, of Cambridge, UK, acquired a Rockville, Md.-based fill/finish facility from BioReliance Corp., a subsidiary of Invitrogen Corp., of Carlsbad, Calif. Acambis intends to develop a commercial-scale fill/finish capability for many of its pipeline vaccines, including ACAM2000 and MVA3000 smallpox vaccines, and its vaccines for West Nile virus and other infections. Acambis will pay $3 million up-front and $4.5 million in 12 equal installments between 2006 and 2017 for the facility, and it will assume a 12-year lease. In other news, Cambridge Biostability Ltd., of Cambridge, UK, signed an exclusive, worldwide agreement with Acambis subsidiary Acambis Research Ltd. to license technology in the field of vaccines against enterotoxigenic E. coli. Acambis will transfer to CBL the development program, materials and intellectual property, but it will retain an option to negotiate an exclusive license to market and sell the vaccine in North America.
• Advancis Pharmaceutical Corp., of Germantown, Md., closed its private placement of common stock and warrants to purchase common stock, raising gross proceeds of $27.25 million. The shares were priced at $3.98, the company's closing stock price on April 25. Investors also received warrants to purchase about 2.4 million shares of common stock, exercisable within five years at $4.78 per share. Advancis plans to use proceeds to complete Phase III trials of Amoxicillin Pulsys. (See BioWorld Today, April 27, 2005.)
• Altachem Pharma Ltd., of Edmonton, Alberta, closed the second and last tranche of its non-brokered private placement with the sale of an additional 4.2 million units for gross proceeds of about $1.1 million. Proceeds will be used to further operations and fund core programs. Total gross proceeds from both tranches are about $1.5 million.
• AmpliMed Corp., of Tucson, Ariz., said research from the Arizona Cancer Center found that the company's lead drug, Amplimexon, might synergize with gemcitabine against human pancreatic cancer cells in vitro and in vivo. The findings might help guide clinical development of the drug, which recently entered a Phase I/II study in combination with gemcitabine to treat patients with previously untreated pancreatic adenocarcinoma. The data were presented at the American Association for Cancer Research annual meeting in April.
• Array BioPharma Inc., of Boulder, Colo., received a $1 million research milestone payment from Amgen Inc., of Thousand Oaks, Calif. The payment resulted from a drug discovery agreement initiated between Amgen and Array in January 2002. To date, Array has received about $1.4 million in total milestone payments. As part of the agreement, Array collaborated with Amgen on the discovery of lead compounds for an Amgen therapeutic target.
• Benitec Ltd., of St. Lucia, Australia, identified a clinical candidate for its RNA interference-based therapeutic against the hepatitis C virus. Benitec also reported the beginning of efficacy and safety studies of its clinical candidate in small animal models, including marmosets. The company said it is on track to begin Phase I trials to treat HCV in the second half of 2006.
• Compugen Ltd., of Tel Aviv, Israel, appointed Alex Kotzer president and CEO effective Sept. 1, after his relocation to Israel. Kotzer most recently served as vice president at Serono. He will replace the current president and CEO, Mor Amitai, who announced in October that he intended to resign before the end of 2005. Compugen is a drug and diagnostic discovery company.
• Cytogen Corp., of Princeton, N.J., and Dowpharma contract manufacturing services, of Midland, Mich., a business unit of The Dow Chemical Co., are collaborating to create a targeted oncology product designed to treat prostate and other cancers. Dowpharma's MeO-DOTA bifunctional chelant technology will be used to radiolabel Cytogen's prostate-specific membrane antigen antibody with a therapeutic radionuclide.
• Dynavax Technologies Corp., of Berkeley, Calif., presented data from preclinical studies showing that its immunostimulatory sequence (ISS)-based influenza vaccine induces an immune response potentially capable of eradicating cells infected by divergent influenza viruses. It also has the potential to augment the protective antibody response generated by the standard flu vaccine. The vaccine links ISS to nucleoprotein and then adds the NP-ISS to conventional vaccine to augment its activity. The data were presented at the 8th Annual Conference on Vaccine Research in Baltimore.
• GBS Venture Partners, of Melbourne, Australia, closed its GBS BioVentures III Fund, with $145 million, well over its $120 million target size. The venture capital firm is looking for new life science investments and could invest more than $10 million in each company. The fund will provide investments at the seed, start-up or early expansion stage of companies focused on human therapeutics, diagnostics, medical devices and health information technology.
• Genta Inc., of Berkeley Heights, N.J., and Aventis, part of Paris-based Sanofi-Aventis Group, signed a termination agreement for the development and commercialization collaboration for Genasense (oblimersen sodium injection). In November, Aventis provided Genta with a notice of termination of the Genasense agreements after the compound did not meet key secondary endpoints and had safety issues in a Phase III trial. The parties have no future financial obligations to each other, and the line of credit established by Aventis to Genta will be retired. Aventis also will return its current inventory of Genasense, and Genta will assume responsibility for the European clinical trial of Genasense in combination with docetaxel in patients with hormone-refractory prostate cancer. (See BioWorld Today, Nov. 10, 2004.)
• Marshall Edwards Inc., of Stamford, Conn., released preliminary results from a Phase IIa trial in patients with ovarian cancer that is resistant to first-line chemotherapies of cisplatin or paclitaxel. The trial evaluated phenoxodiol, which was administered in conjunction with cisplatin or paclitaxel in an attempt to reverse the acquired resistance of tumors to the two drugs. Eighty percent of patients on combination therapy had either a complete response, partial response or stabilized disease, providing an overall disease control rate of 77 percent. The phenoxodiol and cisplatin or paclitaxel combination was well tolerated with no unexpected toxicities.
• MedMira Inc., of Halifax, Nova Scotia, received approval from the FDA to provide new features for its Reveal G2 Rapid HIV-1 Antibody Test. The test is designed to provide external control material with an extended shelf-life and additional flexibility, the company said.
• Millenia Hope Inc., of Montreal, executed an agreement with an unaffiliated investor, in connection with the sale of shares of restricted common stock of Millenia Hope and the receipt of funding in the amount of $600,000.
• The National Institute of Allergy and Infectious Diseases awarded 10 grants and two contracts totaling about $27 million to fund development of new therapeutics and vaccines against agents of bioterrorism, including anthrax, botulinum toxin, Ebola virus, pneumonic plague, smallpox and tularemia. Among those receiving grants are NovoBiotic Pharmaceuticals LLC, of Cambridge, Mass.; Nanotherapeutics Inc., of Alachua, Fla.; MaxThera Inc., of Reading, Mass.; and Veritas Inc., of Rockville, Md., among others. XOMA LLC, of Berkeley, Calif., and DVC Dynport LLC, of Frederick, Md., received contracts to develop and produce antibodies that protect against botulinum toxin Type A, and to produce a vaccine candidate against botulinum toxin Type E, respectively.
• Nikem Research Srl, of Milan, Italy, and Hybrigenics SA, of Paris, expanded and extended a research service agreement. Nikem will continue using its medicinal chemistry platform and expertise to optimize inhibitors of ubiquitin-specific proteases as new therapeutic agents against cancer. The family of proteases has been the focus of target identification and validation studies by Hybrigenics in the field of oncology.
• Nymox Pharmaceutical Corp., of Maywood, N.J., said that statins, a class of cholesterol-lowering drugs, provide the company with a new approach to treating and preventing Alzheimer's disease. Nymox holds U.S. and global patent rights for the use of statins to prevent and treat the disease. New discoveries have linked statins to important biochemical pathways other than cholesterol-lowering that may impact on the Alzheimer's disease process.
• OrthoLogic Corp., of Tempe, Ariz., has completed enrollment in a pivotal Phase III trial of Chrysalin in patients with wrist fractures. A total of 502 patients with unstable or displaced distal radius fractures have been enrolled in 27 U.S. centers. The trial will measure how quickly the fractures heal when patients are injected with Chrysalin. The product is a 23-amino-acid synthetic peptide representing a receptor-binding domain of the human thrombin molecule.
• Oxis International Inc., of Portland, Ore., said it plans to launch its antioxidant Ergothioneine by the end of this year. The first product will be available as an over-the-counter supplement to help combat age-related diseases such as Alzheimer's and cancer. The company's stock (OTC BB:OXIS) rose 22.9 percent Tuesday, or 8 cents, to close at 43 cents.
• Prometheus Laboratories Inc., of San Diego, said the FDA approved the supplemental new drug application for the additional use of Entocort EC (budesonide) capsules for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum or the ascending colon for up to three months. That accounts for about 70 percent of Crohn's disease patients. The additional approval is based on the results of four double-blind, placebo-controlled, 12-month trials in which 380 patients were treated with either Entocort EC or placebo. The product originally was approved as a topical glucocorticosteroid that worked primarily in the intestines.
• Regeneration Technologies Inc., of Alachua, Fla., said its net revenue was $15 million for the first quarter of 2005, a drop from the $23.6 million reported in the first quarter of last year. The company, a processor of orthopedic, cardiovascular and other allograft implants, watched its shares (NASDAQ:RTIX) sink 30.9 percent Tuesday, or $2.78, to close at $6.22. The company's president and CEO, Brian Hutchison, said the first-quarter results were impacted by order delays.
• Repligen Corp., of Waltham, Mass., settled a dispute with its former licensor of SecreFlo, a diagnostic for chronic pancreatitis and gastrinoma. Repligen will receive a payment of $750,000 and will continue to market SecreFlo for the next several years under a favorable royalty structure. Repligen terminated its 1999 SecreFlo licensing agreement in February 2004, alleging that its licensor had failed to meet certain obligations. The company is relieved of its disputed obligation to pay $1.2 million in royalties for sales from February 2004 to March 2005.
• Sanguine Corp., of Pasadena, Calif., selected Beckloff Associates Inc., a division of Cardinal Health Inc., of Dublin, Ohio, as its contract research organization to conduct FDA testing of its oxygen carrier PHER-02. The tests should begin following a meeting with the FDA later this year. The analysis of the tests will help the company select a single indication and subsequent testing protocol, it said.
• U.S. BioDefense Inc., of City of Industry, Calif., entered a definitive agreement with the University of Texas M.D. Anderson Cancer Center to gain a priority option to review and license patent-pending technology for the use of non-marrow stem cells for cardiac regeneration. The stem cells for myocardial regeneration may be superior to other stem cell sources by circumventing the pain and anesthesia complications associated with bone marrow aspiration procedures.
