• A.P. Pharma Inc., of Redwood City, Calif., said Nasdaq is reviewing the company's eligibility for continued listing due to noncompliance with the minimum $10 million stockholders' equity requirement. The company in April registered to sell up to $28.8 million in an offering of stock, the successful completion of which would be expected to resolve the deficiency, A.P. Pharma said.

• Accentia Biopharmaceuticals Inc., of Tampa, Fla., made a milestone payment of an undisclosed amount to the Mayo Foundation for Medical Education and Research for a fast-track, pivotal Phase III study of SinuNase, a new formulation of low-dose intranasal amphotericin B being developed for chronic sinusitis. The company has an exclusive worldwide license to the use of the antifungal product in that indication.

• Anaptys Biosciences Inc., of La Jolla, Calif., obtained exclusive licenses to complementary SHM technologies from the UK Medical Research Council and the Albert Einstein College of Medicine of Yeshiva University in Bronx, N.Y. SHM (somatic hypermutation) is a natural process for generating antibody diversity to fight disease, and Anaptys' Omnitrope-SHM System uses the components of SHM to enable the rapid variation and functional selection of evolved proteins with enhanced bioactivities. Financial terms were not disclosed.

• Biosite Inc., of San Diego, said its board of directors has determined that the offer from Inverness Medical Innovations Inc., of Waltham, Mass., to buy Biosite for $92.50 per share is superior to the $90 per share offered by Beckman Coulter Inc., of Fullerton, Calif. Inverness's offer is irrevocable and will remain open until 5 p.m., Pacific Daylight Time, on Friday. Beckman Coulter has until 12:01 a.m., Pacific Daylight Time, on Friday to counter, but the company stated it will not increase its offer and will instead take the $54 million termination fee. (See BioWorld Today, April 11, 2007.)

• Cerus Corp., of Concord, Calif., said French regulatory authorities published specifications for the Intercept plasma system in the Official Journal, authorizing French blood centers to prepare and sell plasma treated with the product. It reduces the risk of transfusion-transmitted diseases. While reimbursement pricing also needs to be established, the company said French blood centers can purchase the plasma system in advance of the reimbursement decision.

• Commonwealth Biotechnologies Inc., of Richmond, Va., and Tripos Inc., of St. Louis, entered into a definitive agreement under which CBI would acquire Tripos Discovery Research Ltd. CBI plans to continue to operate TDR from its base in Bude, UK. The deal is structured with an up-front payment of $350,000 followed by payments of up to $1.8 million from TDR receivables and billings. TDR, which provides drug discovery services, had revenues in 2006 of about $6.5 million. The deal is expected to close this month or in early June.

• Cyto Pulse Sciences Inc., of Glen Burnie, Md., and the Cancer Center Karolinska in Stockholm, Sweden, entered a deal with University Hospital Uppsala in Sweden, which will conduct a safety trial of their prostate cancer vaccine. The DNA vaccine, which uses Cyto's Derma Vax delivery system, is designed to stimulate an immune response against prostate cancer cells remaining in the body after removal or irradiation of the prostate gland. Cyto said it plans to file for Swedish regulatory approval to conduct the study.

• Gemin X Biotechnologies Inc., of Montreal, published preclinical data in the journal Blood demonstrating that obatoclax (GX15-070) induced cell death in vitro in mantle cell lymphoma (MCL) cell lines and in primary cells from 11 MCL patients. The drug also sensitized MCL cell lines to Velcade (bortezomib, Millennium Pharmaceuticals Inc.). Obatoclax, a pan-Bcl-2 inhibitor, is being studied in multiple Phase I and Phase II trials in several types of cancer.

• GeneGo Inc., of St. Joseph, Mich., received a $750,000 Phase II Small Business Innovative Research grant from the National Institute of Environmental Health Sciences to develop functional descriptions for gene expression response to drugs and toxins as part of their MetaTox product line. That money will be used to develop functional descriptors and network models for toxicogenomics data analysis.

• GPC Biotech AG, of Martinsried, Germany, and Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the FDA's Oncology Drug Advisory Committee will review the new drug application (NDA) on July 24 for oral platinum drug satraplatin in the second-line treatment of hormone refractory prostate cancer. The NDA is based on an improvement in progression-free survival demonstrated in a Phase III trial conducted under special protocol assessment. An FDA decision is expected by Aug. 15.

• Nasdaq Stock Market Inc., of New York City, said its semi-annual reshuffling of the Nasdaq Biotechnology Index (NASDAQ:NBI) will go into effect next Monday. Additions include Akorn Inc. (NASDAQ:AKRX), of Buffalo Grove, Ill.; Alexza Pharmaceuticals Inc. (NASDAQ:ALXA), of Palo Alto, Calif.; BioMimetic Therapeutics Inc. (NASDAQ:BMTI), of Franklin, Tenn.; CombinatoRx Inc. (NASDAQ:CRXX), of Cambridge, Mass.; DRAXIS Health Inc. (NASDAQ:DRAX), of Mississauga, Ontario; Dynavax Technologies Corp. (NASDAQ:DVAX), of Berkeley, Calif.; Medivation Inc. (NASDAQ:MDVN), of San Francisco; Sangamo BioSciences Inc. (NASDAQ:SGMO), of Richmond, Calif.; Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), of Rockville, Md.; and Warner Chilcott Ltd. (NASDAQ:WCRX), of Rockaway, N.J. As previously announced, GenVec Inc. (NASDAQ:GNVC), of Gaithersburg, Md.; Maxygen Inc. (NASDAQ:MAXY), of Redwood City, Calif.; and Osiris Therapeutics Inc. (NASDAQ:OSIR), of Baltimore, also will be added. Deletions include Curis Inc. (NASDAQ:CRIS), of Cambridge, Mass.; Gene Logic Inc. (NASDAQ:GLGC), of Gaithersburg, Md.; Inhibitex Inc. (NASDAQ:INHX), of Atlanta; and Threshold Pharmaceuticals Inc. (NASDAQ:THLD), of Redwood City, Calif.

• Omrix Biopharmaceuticals Inc., of New York, said the FDA approved its supplemental biologics license application to market its liquid fibrin sealant, Evicel, in vascular surgery. The company said the vascular surgery market is about twice the size of the market previously addressed with Evicel's indication in liver surgery. Approval of Evicel for general hemostasis in surgery is expected in the first quarter of 2008, Omrix said. Omrix's marketing partner for the product is Ethicon Inc., a division of New Brunswick, N.J.-based Johnson and Johnson.

• Proteros Biostructures GmbH, of Martinsried, Germany, and Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., entered an 18-month deal in the field of protein crystallography. Proteros is entitled to research funding and success payments for the generation and analyses of protein-ligand structures of hits and evolved chemical entities from BI programs. Proteros will use its Free Mounting System and Picodropper technologies in the effort. Terms were not disclosed.

• Reata Pharmaceuticals Inc., of Irving, Texas, said data on RTA 402 were published in the May 2007 issue of Cancer Research. Data showed RTA 402, a Phase II development candidate for cancer, was highly effective in an animal model of breast cancer, and that the drug inhibits signaling activity of STAT3, a cancer target. The article was authored by Reata collaborators from the University of Texas MD Anderson Cancer Center.

• Scynexis Inc., of Research Triangle Park, N.C., expanded the scope of its research collaboration with Merial Ltd., of Duluth, Ga., as a result of the success of their two-year-old initial agreement. Terms of the new multiyear agreement call for the partners to significantly increase the capacity of their biological screening, bioanalytical, ADMET and medicinal chemistry efforts directed toward Merial's animal health projects. Financial terms were not disclosed.

• Sepracor Inc., of Marlborough, Mass., said Adrian Adams, president and chief operating officer, has been elected president and CEO. He assumed the CEO role from Timothy Barberich, who was elected executive chairman of the board. Adams joined Sepracor in March. He was president and CEO of Kos Pharmaceuticals Inc. until its acquisition in December by Abbott Laboratories.

• SIGA Technologies Inc., of New York, reported successful results of a proof-of-concept guinea pig trial of its lead Lassa fever virus drug, ST-193, which showed a significant reduction in mortality at the two doses tested compared to control. Strain 13 guinea pigs were challenged with a lethal dose of Lassa virus and treated with ST-193 once daily for 14 days. At the low dose, 25 mg/kg, 71 percent of the animals survived, whereas all the control animals and those treated with ribavirin succumbed to the disease within 20 days of the challenge. SIGA expects that the guinea pig model is one of the two animal models that will be required to fulfill the FDA's animal efficacy rule. Development of the Lassa antiviral is supported by $6 million grant awarded by the National Institutes of Health in September 2006.

• Solstice Neurosciences Inc., of Malvern, Pa., entered an agreement with Eisai Co Ltd., of Tokyo, for European commercialization of NeuroBloc (botulinum toxin type B) injectable solution, a purified formulation of the neurotoxin produced by the bacterium Clostridium botulinum for treatment of cervical dystonia. Solstice's product, known as Myobloc in the U.S., was approved in the European Union in 2001. Solstice is entitled to receive up to €41 million (US$55.7 million) in up-front and potential developmental milestone payments in the deal. Solstice and Eisai plan to jointly develop the product for additional indications in the territory. Eisai already had rights in Japan.

• TriLink BioTechnologies, of San Diego, said it was awarded a Phase I Small Business Innovation Research grant of about $100,000. TriLink will use the funds to investigate a new approach for Hot Start activation in PCR. The approach, which uses chemically modified triphosphates to inhibit DNA polymerase activity until a thermal activation step, has shown promise in the reduction of off-target amplification products in PCR.

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