• A.P. Pharma Inc., of Redwood City, Calif., completed a public offering of 24.39 million shares of common stock at $1.65 per share. The totals included 3.18 million shares sold pursuant to the underwriters' overallotment option. The offering grossed about $40.3 million. Merriman Curhan Ford & Co. was the sole book-running manager for the offering. Dawson James Securities Inc. was co-manager. (See BioWorld Today, June 15, 2007.)

• Abraxis BioScience Inc., of Los Angeles, entered an agreement with the University of Southern California that provides Abraxis exclusive worldwide rights to a portfolio of diagnostic protein biomarkers. The technology is expected to have applicability in measuring therapy response, therapy toxicity and disease recurrence in colorectal cancers. A goal of the USC research is to combine prognostic markers with specific therapeutic agents, which would enable clinicians to tailor therapy to the molecular profile of the patient. Terms of the deal were not disclosed.

• ArQule Inc., of Woburn, Mass., completed its offering of 7 million common shares at $7.75 per share, for gross proceeds of about $54.25 million. Underwriters have an option to purchase up to 1.05 million additional shares to cover overallotments. UBS Investment Bank and CIBC World Markets acted as joint book-running managers for the offering. Leerink Swann & Co., Fortis Securities LLC and Rodman & Renshaw LLC were co-managers. (See BioWorld Today, June 15, 2007.)

• Avid Radiopharmaceuticals Inc., of Philadelphia, said Bayer Schering Pharma AG, of Berlin, exercised its right to license Avid's 18F-AV1/ZK compound, a molecular imaging agent that targets amyloid plaques in the brain. When used with positron emission tomography imaging, AV1/ZK may enable earlier and more accurate diagnosis of Alzheimer's disease. Schering in December 2005 got an exclusive option for the development of AV1/ZK and related compounds referred to as 18F-stilbenes for PET imaging of AD. Terms of the deal were not disclosed.

• Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., and Onyx Pharmaceuticals Inc., of Emeryville, Calif., said a marketing authorization application has been submitted by Bayer to the European Medicines Agency in London for the approval to market Nexavar (sorafenib) tablets within the European Union for the treatment of hepatocellular carcinoma (HCC), a cancer of the liver. Nexavar currently is approved in more than 50 countries for treatment of advanced kidney cancer. The companies plan to file a supplemental new drug application this summer with the FDA for Nexavar in the treatment of liver cancer.

• Celgene International Sarl, of Boundry, Switzerland, a wholly owned subsidiary of Celgene Corp., said Revlimid (lenalidomide) has been granted full marketing authorization by the European Commission for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. The drug has orphan drug status in the U.S., EU and Australia for treatment of multiple myeloma.

• CuraGen Corp., of Branford, Conn., said it is closing its pilot manufacturing plant effective July 27. As a result, it will reduce its work force by about 40 employees, primarily preclinical and manufacturing researchers. The action is being taken following previously announced reductions in early stage and preclinical drug discovery and decreased emphasis on internal manufacturing capabilities. The move is expected to result in a charge of $8 million, most of it this quarter, including noncash charges of about $6 million related to asset write-offs.

• Dow AgroSciences LLC, of Indianapolis, and Sangamo BioSciences Inc., of Richmond, Calif., said they hit research milestones as part of their joint agreement. The milestones represent the successful application of Sangamo's zinc finger DNA-binding protein technology to the generation of specific traits in two major crop species, maize and canola. The three-year agreement began in 2005.

• EPIX Pharmaceuticals, Inc., of Lexington, Mass., said the FDA has determined that additional trials may not be needed for approval of Vasovist (gadofosveset trisodium injection). The FDA previously had indicated that one or two additional pivotal clinical trials would be required. Instead, the FDA now stated that a blinded re-read of the images obtained from the previously completed Phase III clinical trials of Vasovist could support approval if the results are positive. The FDA response is to a formal appeal EPIX filed Feb. 28 to the Center for Drug Evaluation and Research, seeking approval of the blood-pool imaging agent. In its response, the FDA strongly recommended that EPIX work closely with the FDA to develop the appropriate protocol for the re-read in a special protocol assessment-like fashion, including how the reading will be done, how the data from the re-reading will be analyzed and a plan for statistical analysis, prior to conducting a re-read of the images. After the re-reads are completed and an amended submission is provided by EPIX, the FDA will have up to 180 days to review the submission. Shares of Epix (NASDAQ:EPIX) gained 10 cents Tuesday, to close at $5.94.

• Genta Inc., of Berkeley Heights, N.J., said it intends to request review of a decision by the FDA not to overturn a non-approvable decision for the new drug application for Genasense (oblimersen sodium) Injection in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta expects to formally submit its request within the next four weeks and anticipates a decision from CDER in the third quarter of 2007. In September 2006 the FDA's Oncologic Drugs Advisory Committee recommended against approval of the compound for CLL, saying Genasense's benefit was not substantial enough. The company is claiming that the drug met both its primary and a key secondary endpoint in the only randomized controlled trial ever conducted in patients with relapsed CLL.

• Gilead Sciences Inc., of Foster City, Calif., said it has completed the $1 billion stock repurchase program that was authorized by its board in March 2006. Under the buyback program, Gilead acquired about 8.4 million common shares at an average price of $65.13 per share, for $544.9 million, and acquired about 5.6 million shares at an average price of $81.02 per share, for $455.1 million. Gilead now has about 468.1 million shares outstanding.

• Novalar Pharmaceuticals Inc., of San Diego, said the FDA has accepted for filing its new drug application for marketing approval of NV-101, a local dental anesthetic reversal agent. In two Phase III studies and a Phase II pediatric study, NV-101 was well tolerated and met its primary and secondary endpoints. In the Phase III studies the compound induced a 54.8 percent and a 62.3 percent decrease in time to normal sensation for those with anesthesia administered in the mandible and maxilla respectively. In the Phase II pediatric study the time to normal sensation was reduced by 55.6 percent.

• Nuvo Research Inc., of Mississauga, Ontario, said the FDA clarified requirements for additional information relating to Pennsaid, a topical nonsteroidal anti-inflammatory drug for osteoarthritis that already is approved in Canada and certain European countries. Management intends to start all requested long-term dermal animal studies and believes that the longest study can be completed post-approval, provided no safety concerns have arisen from any of the studies prior to resubmitting the application for Pennsaid's clearance. Nuvo anticipates that it will be in a position to complete all necessary studies and file a complete resubmission of its application for Pennsaid approval with the FDA in the first half of 2009 and be eligible to receive final marketing approval in the second half of 2009. The company's stock (TSE:NRI) fell C9 cents (US8 cents) on the news, or 28 percent, to close at C23 cents.

• Onconome Inc., of Seattle, announced the publication of a research study conducted at The Johns Hopkins School of Medicine under the direction of Robert Getzenberg, professor of urology and director of research at the James Buchanan Brady Urological Institute. The study relates to two newly discovered blood proteins, CCSA-3 and CCSA-4 (colon cancer specific antigens 3 and 4) that could provide an additional tool to help clinicians determine the necessity and frequency of colonoscopy. According to the Hopkins study, which is published in the June 15 issue of Cancer Research, measuring CCSA-3 and CCSA-4 protein levels in blood serum demonstrated a high level of accuracy in correctly identifying colon cancer patients vs. noncancer patients and patients with cancers other than colon.

• Profectus BioSciences Inc., of Baltimore, said it was awarded a $300,000 Phase I Small Business Innovative Research grant from the Division of AIDS, National Institutes of Health. The focus of the grant is to develop enhanced adjuvants based on Profectus' technology, in collaboration with the Institute of Human Virology at the University of Maryland. The technology uses the enzymatically active A1 subunit of cholera toxin, which is expressed from a DNA, RNA or viral vector.

• Resverlogix Corp., of Calgary, Alberta, has signed a collaborative research agreement with Larry Sparks of the Sun Health Research Institute to study Resverlogix's ApoA-I therapy for the treatment of Alzheimer's Disease. Sparks discovered the neuropathologic link between cholesterol and Alzheimer's disease. Terms were not disclosed.

• Robcor Properties Inc., of Ewing, N.J., and its wholly-owned subsidiary, Redpoint Bio Corp., of Cranbury, N.J., have completed their merger with Redpoint Bio continuing on as the surviving corporation. The authorized number of shares of common stock was set at 150,000,000 shares, $0.0001 par value per share, and the authorized number of shares of preferred stock was decreased to 10 million at $0.0001 par value per share.

• Senopsys LLC, of Saugus, Mass., entered a collaboration with Patheon Inc., of Toronto, to accelerate the development of palatable drug products. Senopsys will have access to prototype drug formulations manufactured by Patheon, and Patheon will be able to offer its clients taste assessment and optimization services. Terms were not disclosed.

• Stem Cell Sciences plc, of Edinburgh, UK, licensed rights to a technology that it said was expected to accelerate the application of human embryonic stem cells in both research and cell-based therapies. The technology uses Rho-associated kinase, or ROCK, inhibitors to block the onset of stem cell death when the clusters of growing cells are dissociated for transfer and scale-up. SCS has exclusive, worldwide rights to the discovery, except in Japan, where it holds nonexclusive rights. Financial terms were not disclosed. The license was granted by the RIKEN Centre for Developmental Biology in Kobe, Japan.

• ThermoGenesis Corp., of Rancho Cordova, Calif., and the Stem Cell Program at the University of California, Davis have reached a collaborative research agreement to develop stem cell therapies based upon ThermoGenesis' AutoXpress, BioArchive and CryoSeal Fibrin Sealant blood processing systems. University researchers will be investigating the cell populations and fibrin gel carriers isolated from bone marrow and cord blood using the blood processing systems. The focus will be on stem cell treatments for peripheral artery disease, myocardial infarction and dermal wounds. Under the terms of the agreement, ThermoGenesis will supply SCP with an AXP Platform, one BioArchive and one CryoSeal FS System for use in their translational cell therapy research, which will focus on sourcing the stem cells from the patient's own bone marrow or umbilical cord blood. ThermoGenesis will have first option to negotiate a license to the resulting intellectual property.

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