• Allergan Inc., of Irvine, Calif., said it would pay about $230 million in cash after entering a definitive merger agreement to acquire Oculex Pharmaceuticals Inc., of Sunnyvale, Calif., subject to certain conditions, including Federal Trade Commission and Oculex shareholder approval. Privately held Oculex, which is developing therapeutics for sight-threatening diseases of the eye, has a prior relationship with Allergan. The companies entered a license and research collaboration in May 2001 to develop compounds for ophthalmic use, based on Oculex's biodegradable drug delivery technology. Allergan said the delivery technology offers a superior method to target drugs to the back of the eye for disorders such as age-related macular degeneration, diabetic retinopathy and macular edema. In January 2002, Allergan and EntreMed Inc., of Rockville, Md., entered an agreement to assess Oculex's delivery technology.

• Amarillo Biosciences Inc., of Amarillo, Texas, filed an investigational new drug application for a pivotal Phase III trial of low-dose interferon alpha lozenges administered orally to HIV-positive subjects with oral warts. Two previous studies have demonstrated the ability of interferon alpha lozenges to significantly reduce oral wart load in HIV-positive patients, the company said, adding that it received the FDA's orphan drug designation for natural human lymphoblastoid interferon-alpha for papillomavirus warts in the oral cavity of HIV-positive patients.

• Berlex Laboratories Inc., of Montville, N.J., an affiliate of Schering AG, said Phase II data showed that patients receiving Leukine (sargrasmostim) to treat moderately to severely active Crohn's disease had significantly greater clinical response and remission rates than those receiving placebo. The data were presented at the 68th Annual Scientific Meeting of the American College of Gastroenterology.

• Biosynexus Inc., of Gaithersburg, Md., completed a Phase I/II trial of its topical anti-staphylococcal cream, BSYX-L210, for the eradication of S. aureus nasal carriage. The study met its endpoints for safety and microbiological activity. BSYX-L210 is a topical, intranasal cream formulated for use in eradicating S. aureus from the noses of individuals at high risk for infection or transmission.

• CalbaTech Inc., of Irvine, Calif., acquired intellectual property relating to the efficient and effective delivery of stem cells to diseased or dead areas of the heart. The technology, through the use of an application to an endoscope, allows stems cells to be delivered to areas of the heart that have either died or are diseased. Financial terms were not disclosed.

• Cambridge Antibody Technology plc, of Cambridge, UK, received the first payment of royalties on sales of Humira from Abbott Laboratories, of Abbott Park, Ill. The payment represents Abbott's calculation of the royalties due to CAT on sales in the six-month period ended June 30, though CAT disputes the level of the royalties, related to the applicability of certain royalty offset provisions in the April 1995 license agreement between CAT and Knoll Aktiengesellschaft, which was subsequently acquired by Abbott. Abbott has sought to offset royalties payable to other licensors against the payment to CAT and has paid royalties at the minimum level described in the license agreement, though CAT believes Abbott's interpretation of the agreement is incorrect, it said. The companies have begun a formal resolution procedure.

• Chemical Diversity Labs Inc., of San Diego, reported a virtual screening collaboration with Biogen Inc., of Cambridge, Mass., to help identify drug candidates. Biogen will have access to more than 2 million feasible compounds from Chemical Diversity's collection for virtual screening and hit identification. No financial terms were disclosed.

• Chiron Corp., of Emeryville, Calif., said it and the Children's Hospital and Regional Medical Center of Seattle settled a patent infringement suit against Roxane Laboratories, a subsidiary of Boehringer Ingelheim GmbH, of Boehringer, Germany, regarding Roxane's plans to market a generic equivalent of TOBI tobramycin solution for inhalation. The suit was brought to enforce U.S. Patent No. 5,508,269, which is co-owned by Chiron and the hospital. Roxane, which had previously withdrawn its application for approval of a generic equivalent of TOBI, agreed it would not seek approval to market the product until the expiration of the patent in 2014. Chiron and the hospital agreed to dismiss their infringement relief claims against Roxane, which dropped its challenge to the patent. No party received monetary compensation as part of the settlement, Chiron said.

• Cira Discovery Sciences Inc., of Philadelphia, opened its doors in the city's new life science business incubator, the Science Center Port, to partner its technology to researchers in search of patterns and relationships in their data. Cira uses its algorithms and software to search patient data in partnership with pharmaceutical and biotechnology companies as part of drug discovery.

• Commonwealth Biotechnologies Inc., of Richmond, Va., said it has received $1.5 million worth of contracts so far this month The work is related to biodefense applications of detection assays based on its mass spectrometry and DNA sequence analysis platforms.

• Crucell NV, of Leiden, the Netherlands, and Gene Medicine Japan Inc., of Kobe, Japan, entered a license agreement for Crucell's PER.C6 production technology. Gene Medicine will use the technology to provide manufacturing services for companies, universities and other institutions researching adenovirus-based recombinant vaccines and gene medicine products in Japan and the rest of Asia. Crucell will receive up-front and annual payments, as well as double-digit royalties on contract manufacturing sales.

• DOR Biopharma Inc., of Miami, said the American Stock Exchange granted the company 18 months to regain compliance with the continued listing standards. The company has incurred losses in three of its last four years and must maintain a minimum equity balance of $4 million. DOR will be subject to a periodic review by the exchange staff. DOR specializes in oral and nasal delivery of drugs and vaccines.

• Epoch Biosciences Inc., of Bothell, Wash., said it reached agreement with Millennium Pharmaceuticals Inc., of Cambridge, Mass., to supply Epoch's MGB Eclipse Probe Systems for multiplexed gene expression analysis. Epoch Biosciences will develop, functionally test and supply multiplexed MGB Eclipse assays to gene targets specified by Millennium. Financial terms were not disclosed.

• Evotec OAI AG, of Hamburg, Germany, and Biofrontera Pharmaceuticals Holding AG, of Leverkusen, Germany, entered a co-marketing and distribution agreement to offer natural compounds for drug discovery services. Biofrontera uses a collection of microorganisms and several million natural compounds derived from them, which Evotec will incorporate into its high-throughput screening services augmenting its screening library of small molecules. Biofrontera agreed not to enter similar agreements with other screening service providers, but remains free to collaborate with customers and partners in drug discovery and development. Financial terms were not disclosed.

• Genaera Corp., of Plymouth Meeting, Pa., said Executive Vice President and Chief Financial Officer David Warren was scheduled to open the Nasdaq market today. The timing coincides with World Blindness Awareness Month, it said. The company, which is listed on the exchange under the symbol "GENR," is developing a product called squalamine to treat age-related macular degeneration, a common cause of blindness among older adults.

• GeneThera Inc., of Wheat Ridge, Colo., reported that development of a vaccine for chronic wasting disease (CWD) is under way. The vaccine works in conjunction with GeneThera's live blood test for CWD. GeneThera will be able to detect the efficacy of its vaccine within a short period of time using their genetic testing method. The vaccine is the first therapeutic vaccine developed using its Purivax technology.

• Guilford Pharmaceuticals Inc., of Baltimore, completed enrollment in a Phase II trial of GPI 1485 for Parkinson's disease. The study, which began last November, enrolled 212 patients at 21 U.S. centers to evaluate the neuroimmunophilin ligand's effectiveness, compared to placebo, in slowing the rate of decline of dopamine transporters, a biomarker of the loss of dopamine neurotransmitters which causes Parkinson's disease progression. Clinical endpoints include changes in the daily amount of anti-Parkinsonian medications administered, clinical symptoms using the Unified Parkinson's Disease Rating Scale, cognitive function, sleep, mood and quality of life.

• Imgenex Corp., of San Diego, said it offers a panel of antibodies against severe acute respiratory syndrome spike and nucleocapsid proteins. The two proteins are detected in culture supernatents of cells infected with SARS-CoV. Currently, those antibodies are available for research only, it said.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., presented data at the American Urology Association's New York sectional meeting that showed an early patient response to treatment with trospium for overactive bladder is an accurate predictor of long-term therapeutic success. Trospium is an anticholinergic compound. The drug is under review by the FDA. (See BioWorld Today, April 29, 2003.)

• InSite Vision Inc., of Alameda, Calif., said the American Stock Exchange accepted the company's plan to regain compliance with the exchange's continued listing standards. The company has until Dec. 19, 2004, to regain compliance. InSite is an ophthalmic products company focused on glaucoma, ocular infections and retinal diseases.

• Kos Pharmaceuticals Inc., of Miami, began trading options on the Pacific Exchange. The company, which already trades on Nasdaq under the ticker symbol "KOSP," will trade on the February expiration cycle with exercise limits set at 22,500 contracts. Kos is a specialty pharmaceutical company focusing on aerosol formulations, inhalation devices and gastric retention technology, among other things.

• Laureate Pharma LP, of Princeton, N.J., and FeRx Inc., of San Diego, entered a manufacturing and services agreement for FeRx's MTC-DOX product. Laureate Pharma will provide formulation and filling services to support FeRx's clinical development programs. Terms of the agreement were not disclosed.

• Ligand Pharmaceuticals Inc., of San Diego, reported data at the American Society of Anesthesiologists meeting in San Francisco showing that its once-daily pain product, Avinza (morphine sulfate extended-release capsules), provided stable analgesia for one year in patients with chronic back pain, without increases in dose or the use of rescue medicines. The open-label extension study evaluated the compound in 128 patients with chronic, moderate to severe back pain who had completed one of four previous Avinza clinical studies. Separately, Ligand said its approved cancer drug, Ontak (denileukin diftitox), would continue to be manufactured by Cambrex Corp., of East Rutherford, N.J., under a new five-year contract that covers the existing commercial product as well as a second-generation formulation in advanced development. Cambrex's Hopkinton, Mass.-based subsidiary, Cambrex Bio Science Hopkinton Inc., will manufacture the products. Financial terms were not disclosed.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., began a multicenter Phase II trial of MLN1202 in about 30 rheumatoid arthritis patients. The study, which will be conducted in Europe and Australia, is designed to assess the compound's safety, tolerability, pharmacokinetic, pharmacodynamic properties and biological activity via synovial biopsy. The humanized monoclonal antibody is designed to block the MCP-1/CCR2 chemokine pathway, which Millennium said is believed to play a role in a number of inflammatory conditions, including rheumatoid arthritis.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., reported preclinical data at the North American Association for the Study of Obesity meeting in Ft. Lauderdale, Fla., showing that its nasal spray formulation of PYY 3-36 has a favorable safety profile. Preclinical studies also demonstrated that nasal dosages of PYY at 50 times the expected clinical dose and intravenous doses up to 1,000 times the expected clinical dose showed no toxicities. After nasal administration, PYY is detected in the plasma as soon as five minutes, and reaches peak effect within about 15 to 30 minutes, simulating to the brain the normal release kinetics of having eaten a meal. The product remains in a Phase I program for obesity.

• Novasite Pharmaceuticals Inc., of San Diego, a subsidiary of Applied Molecular Evolution Inc., of San Diego, received two Phase I Small Business Innovative Research grants from the National Institutes of Health in Bethesda, Md., totaling $500,000. The awards support the discovery of highly selective drug leads against the G protein-coupled receptor subfamily of serotonin Type II receptors, which include targets for schizophrenia, depression, obesity and drug abuse.

• Oncolytics Biotech Inc., of Calgary, Alberta, closed its bought-deal financing and issued 1.2 million units, each unit consisting of one common share and one-half of one common share purchase warrant, for gross proceeds of $6 million. Each whole common share purchase warrant entitles the holder to acquire one common share of Oncolytics for $6.25 per share. Canaccord Capital Corp., of Vancouver, British Columbia, acted as underwriter. The company will use the proceeds to fund its clinical trials of Reolysin, a form of the human reovirus in development for cancer, and for general corporate purposes. It now has 27.1 million common shares issued and outstanding.

• Oxxon Pharmaccines Ltd., of Oxford, UK, reported it moved to new premises at the Oxford Science Park. The facilities include more than 7,600 square feet to expand the company's laboratory and commercial space. The facilities contain 60 percent laboratory space, with 40 percent for offices and general facilities. Oxxon is focusing on the development of immunotherapeutics for chronic infectious disease and cancer.

• Phenomix Corp., of San Diego, accessed $13.5 million from a Series A financing commitment reported a year and a half ago. The company, which is using whole animal technology to develop new treatments for disease, said it would use the funding to advance its discovery programs into preclinical development. The original $32 million Series A commitment was a staged investment, to be financed through an initial $12 million followed by two subsequent $10 million tranches. The second tranche was increased by $3.5 million, bringing the total financing to $35.5 million. Phenomix said it would reserve the remaining $10 million to anchor a future Series B round. The additional funding commitment was co-led by Alta Partners and Sofinnova Ventures, and included Bay City Capital, CMEA Ventures, GBS Venture Partners, Versant Ventures and others. The original Series A was announced in March 2002. (See BioWorld Today, March 13, 2002.)

• Silicon Graphics Inc., of Mountain View, Calif., and Beijing Normal University in China introduced the BNU and SGI Bioinformatics Center. The center is powered by SGI Altix 3000 supercluster running the Linux operating system. It uses products from the SGI InfiniteStorage family of storage solutions that allow customers to improve their data management capabilities and capacity. The center is part of the National Base of Life Science and Technology Education initiated by the China Education Ministry in order to broaden the number of students and researchers in the field.

• Targeted Genetics Corp., of Seattle, expanded its contract manufacturing agreement with GenVec Inc., of Gaithersburg, Md. Targeted Genetics will manufacture clinical grade material to support late-stage clinical trials for GenVec's cancer treatment TNFerade. Financial terms were not disclosed.

• TopoTarget Prolifix A/S, of Copenhagen, Denmark, initiated a Phase I study of PXD101, its histone deacetylase inhibitor, in patients with advanced cancers. The trial will evaluate intravenous administration of PXD101 in 24 to 36 patients. In addition to standard clinical evaluations of safety and efficacy, clinicians will monitor pharmacokinetics and pharmacodynamic responses.

• Tularik Inc., of South San Francisco, achieved the first milestones in its collaboration with Amgen Inc., Thousand Oaks, Calif., to discover, develop and commercialize therapeutics aimed at oncology targets. Amgen selected for optimization two compounds identified by Tularik, each directed against a different target and resulting in the payment of two milestones. The two companies entered into the five-year $125 million collaboration in May. (See BioWorld Today, May 22, 2003.)

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