• Advanced Tissue Sciences Inc., of La Jolla, Calif., entered into an agreement to sell its NouriCel product line and related intellectual property to SkinMedica Inc., of Carlsbad, Calif., subject to the approval of the bankruptcy court. The closing of the transaction is also subject to a satisfactory due diligence review by SkinMedica. Following bankruptcy court approval, SkinMedica will make a $5 million cash payment to ATS and will issue a $2 million, two-year promissory note.

• Allos Therapeutics Inc., of Westminster, Colo., signed a licensing agreement for a Phase II cancer compound, thus further expanding its oncology development pipeline. Allos licensed exclusive worldwide rights to an antifolate (DHFR inhibitor) known as PDX from the Memorial Sloan-Kettering Cancer Center, Southern Research Institute and SRI International. PDX is an injectable small-molecule cytotoxic agent that has a superior potency and toxicity profile to methotrexate and other DHFR inhibitors, the company said.

• Amgen Inc., of Thousand Oaks, Calif., and Transkaryotic Therapies Inc., of Cambridge, Mass., perhaps received a measure of finality in their litigation. Amgen said the U.S. Court of Appeals for the Federal Circuit upheld the District Court's decision that Transkaryotic and Aventis SA, of Frankfurt, Germany, infringe two of Amgen's patents relating to erythropoietin. The Appeals Court remanded the case to the District Court of Massachusetts for further consideration of certain validity issues. Transkaryotic said the court issued a decision affirming in part, reversing in part, and remanding the patent infringement suit. Transkaryotic said the decision was "very encouraging as we believe it represents a major step in the right direction towards making Dynepo available to patients." Transkaryotic's stock (NASDAQ:TKTX) fell $1.80 Tuesday, or 18 percent, to close at $8.20. Amgen's stock (NASDAQ:AMGN) fell 3 cents to close at $50.24. The original decision in the case was handed down in January 2001. (See BioWorld Today, Jan. 23, 2001.)

• Applied Biosystems Group, of Foster City, Calif., and the Immune Tolerance Network at the University of California at San Francisco formed a multiyear agreement to study genes expressed in clinical samples that are believed to be related to immune response modulation in organ transplantation, autoimmune disease, and allergy and asthma. Financial terms were not disclosed. The agreement follows a previous deal in which the organizations developed a set of functionally validated gene expression assays based on genes predicted to be involved in the modulation of the immune response.

• Axeda Systems Inc., of Mansfield, Mass., said Chiron Corp., of Emeryville, Calif., licensed the Axeda DRM System to enable the proactive monitoring, service and support of its Procleix System. The Procleix System is being used to test more than 70 percent of the U.S. blood supply. Chiron will use the Axeda DRM system to remotely monitor Procleix Instrumentation installed at customer facilities, designed to improve service response times and instrument uptimes of those medical instruments.

• Celgene Corp., of Warren, N.J., said it will initiate a Phase II trial of Actimid in metastatic hormone-refractory prostate cancer this quarter. The study will evaluate the safety and preliminary efficacy of Actimid in patients with metastatic hormone-refractory prostate cancer. The company revealed its plans at the JP Morgan H&Q Healthcare Conference this week in San Francisco and said it had advanced several of its clinical programs. Actimid also is being evaluated in an ongoing Phase I/II trial in refractory and relapsed multiple myeloma.

• Cellomics Inc., of Pittsburgh, released three BioApplication software modules - Molecular Translocation, Micronucleus and Cell Cycle - for the ArrayScan High Content Screening Reader and the vHCS:Discovery ToolBox. The company said the new releases increase the level of sophistication of biological analyses that can be conducted.

• Centocor Inc., of Malvern, Pa., said Remicade (infliximab) has been designated for priority review by the FDA for use in maintaining fistula closure in patients with fistulizing Crohn's disease. Remicade is approved to reduce signs and symptoms and induce and maintain clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. It also is indicated as a short-term treatment for reducing the number of draining enterocutaneous fistulas in patients with fistulizing Crohn's disease, the company said.

• CuraGen Corp., of New Haven, Conn., said is it working with Pfizer Inc., of New York, to evaluate compounds under consideration at Pfizer. CuraGen scientists will apply its Predictive Toxicogenomics Screen (PTS) and protein pathway mapping technologies to gain a better understanding of the mechanisms that enable drugs to effectively treat certain diseases. CuraGen's PTS is applicable in early drug development to evaluate very small quantities of compounds prior to optimization.

• DOR BioPHarma Inc., of Lake Forest, Ill., said Alexander Haig joined the company as chairman. Haig graduated from the U.S. Military Academy, was commissioned a second lieutenant of the army and served in Japan, Korea, Europe and Vietnam. DOR develops, among other things, its Microvax synthetic mucosally administered biodefense vaccines. Separately, DOR said it executed an exclusive option with the University of Texas Southwestern Medical Center in Dallas to license patent applications pending in the U.S. and elsewhere pertaining to the use of recombinant ricin A chain mutants as vaccines to protect against aerosolized ricin. The option covers the development of intranasal, oral and inhalable vaccines. DOR's stock (AMEX:DOR) rose 47 cents Tuesday, or 81 percent, to close at $1.05.

• Elan Corp. plc, of Dublin, Ireland, named G. Kelly Martin president and CEO. The appointment is effective Feb. 3. Martin was a member of both the executive management and operating committee of Merrill Lynch & Co. and was formerly president of the International Private Client Group. Garo Armen will remain chairman of Elan.

• Essential Therapeutics Inc., of Waltham, Mass., completed a Phase I trial of ETRX 101. However, the company said that based upon its review of the Phase I data and the data from recently completed nonclinical studies, it decided not to continue the development of ETRX 101 because the data failed to show signs of sufficient efficacy. Essential's stock (NASDAQ:ETRX) fell 8 cents Tuesday, or 13.8 percent, to close at 50 cents.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., said it licensed its HAP Technology to Millennium Pharmaceuticals Inc., of Cambridge, Mass., for use in Millennium's drug discovery and development programs. Millennium will pay Genaissance license fees in the multiyear agreement. Genaissance will have certain rights to support Millennium's DNA biomarker and pharmacogenomic efforts. Financial details were not disclosed.

• Genomatica Inc., of San Diego, received a Small Business Innovative Research grant from the Department of Defense, Defense Advanced Research Projects Agency to develop in silico technology for drug toxicity prediction. Genomatica will use its modeling platform, SimPheny, to develop an approach for toxicity prediction.

• Genzyme Corp., of Cambridge, Mass., reported unaudited revenues for the fourth quarter and the year. Revenues for the fourth quarter were $297 million, up 12 percent, from $265 million in 2001. For the year, revenues were about $1.1 billion, up 10 percent from $982 million the previous year. Sales of Cerezyme (imiglucerase for injection), an enzyme replacement therapy for patients with Type 1 Gaucher's disease, increased 9 percent in the fourth quarter to $158 million. For the year, Cerezyme sales increased 9 percent to $619 million. Sales of Fabrazyme (agalsidase beta), an enzyme replacement therapy for patients with Fabry disease, were $26 million for the year, compared to $6 million in 2001.

• ILEX Oncology Inc., of San Antonio, began a Phase II trial to evaluate Campath (alemtuzumab) vs. Rebif (interferon beta-1a) in patients with early active, relapsing-remitting multiple sclerosis. The trial will examine the drugs against each other for efficacy in preventing sustained accumulative disability. ILEX is sponsoring the trial. Rebif was developed by Serono SA, of Geneva, and the drug received U.S. approval in March. (See BioWorld Today, March 11, 2002.)

• Insmed Inc., of Richmond, Va., said recombinant human IGFBP-3 demonstrated significant decrease in cell proliferation in vitro and a significant inhibition of tumor growth in vivo in several models of human cancers. Research results demonstrated that rhIGFBP-3, as a single agent, decreased proliferation of breast cancer cells and showed an additive effect when combined with radiation therapy. In several solid tumor models, including breast, lung and colorectal, it exhibited in vivo efficacy alone in combination with standard chemotherapeutic agents, the company said.

• Inspire Pharmaceuticals Inc., of Durham, N.C., said it would submit a new drug application for diquafosol (INS365 Ophthalmic) for the treatment of dry eye to the FDA mid-year. The content and format of the NDA were agreed to in a pre-NDA meeting held Jan. 6. The company previously indicated it planned to submit the NDA in 2003. (See BioWorld Today, Oct. 31, 2002.)

• ISTA Pharmaceuticals Inc., of Irvine, Calif., said the FDA accepted the filing by Senju Pharmaceutical Co. Ltd., of Osaka, Japan, of a new drug application for a formulation of timolol for the treatment of glaucoma. Under an agreement between ISTA and Senju, ISTA holds the marketing rights to the product in the U.S. ISTA named the product Istalol. Senju filed for the NDA in September. (See BioWorld Today, Sept. 30, 2002.)

• Lexicon Genetics Inc., of The Woodlands, Texas, said it published a retrospective evaluation of the targets of the 100 best-selling drugs of 2001 as modeled by mouse knockout phenotypes. In an article published in the January 2003 issue of Nature Reviews Drug Discovery, Lexicon concluded that in most cases there is a correlation between the knockout and the therapeutic effect of the drug. Lexicon uses gene knockout technology to discover the physiological functions and medical uses of genes.

• Ligand Pharmaceuticals Inc., of San Diego, and Royalty Pharma Management LLC, of New York, expanded their selective estrogen receptor modulator (SERM) royalty agreement and formed a new royalty-sharing partnership around Ligand's approved cancer drug, Targretin. Royalty Pharma exercised an expanded option in December and agreed to pay Ligand about $6.8 million for 0.1875 percent of future sales of three SERM products now in Phase III development, and for 1 percent of worldwide sales of Targretin capsules through 2016. The agreement does not apply to sales of Targretin capsules outside the U.S. for cutaneous T-cell lymphoma (CTCL) until the product is approved for an indication other than CTCL. Royalty Pharma also received an additional SERM option with a price of $12.5 million that might be exercised in the fourth quarter of 2003. Separately, Ligand said it earned in the fourth quarter a $2 million milestone payment from GlaxoSmithKline plc, of London, for beginning human trials of SB-497115, an oral small-molecule drug that mimics the activity of thrombopoietin. The companies began their collaboration in 1995.

• Locus Discovery Inc., of Blue Bell, Pa., appointed Joseph Reiser president and CEO and added him to its board. Reiser was most recently president and CEO of Cytogen Corp., of Princeton, N.J. Locus focuses on developing small-molecule therapeutics.

• Medarex Inc., of Princeton, N.J., filed an investigational new drug application with the FDA to initiate Phase I/II trials of MDX-070, a fully human antibody to prostate-specific membrane antigen for metastatic prostate cancer. The multicenter dose-escalation Phase I/II study is expected to accrue up to 40 patients with metastatic prostate cancer. Separately, Medarex said it and Ability Biomedical Corp., of Vancouver, British Columbia, are collaborating on development of fully human antibody drugs to treat inflammation and autoimmune diseases. The companies expect to share equally the cost and responsibility of the development and plan to jointly commercialize any antibody products. Financial details were not disclosed.

• Morphotek Inc., of Exton, Pa., signed a research agreement with Abgenix Inc., of Fremont, Calif., for use of its Morphodoma technology for the development of high-titer cell lines for the manufacturing of one of Abgenix's fully human monoclonal antibody product candidates. Abgenix plans to apply Morphotek's technology to help enhance titer yields for the manufacture of preclinical and, later, clinical material. Morphotek will receive an up-front research payment and research milestones upon successful achievement of program goals. In addition, it may receive commercial license and milestone payments upon clinical development of the antibody cell lines, and royalties should Abgenix advance the product to the market.

• Oxford GlycoSciences plc, of Oxford, UK, signed a contract with its existing proteomics partner, Pfizer Inc., of New York, to provide additional proteomics services. OGS has been working with Pfizer under a joint-research agreement entered in 1998, which was extended in December 2001. That collaboration focuses on the discovery of biomarkers and drug development targets in Alzheimer's disease, arteriosclerosis and other disease targets and indications. The area of research and other specific terms of the new agreement were not disclosed.

• Oxigene Inc., of Watertown, Mass., initiated a Phase I/II combination study of its lead vascular-targeting agent, combretastatin A4 prodrug (CA4P), in patients with advanced cancer of the lung, head and neck, and prostate. The trial will be combined with radiotherapy in a dose-escalating study in about 30 patients. CA4P became the first VTA to move to an advanced stage human trial when Oxigene began a Phase II trial in late December for CA4P in patients with a rare and often incurable form of thyroid cancer, the company said.

• P.P. Luxco Holdings II, a wholly owned subsidiary of Picchio Pharma Inc., said it acquired an additional 500,000 shares of Neurochem Inc., of Saint Laurent, Quebec, through a private purchase, representing 2.35 percent of the outstanding common shares of Neurochem, thereby increasing its stake to nearly 4 million shares, or about 18.6 percent of the company. Assuming the exercise of the 2.8 million warrants currently held by P.P. Luxco Holdings II, it would hold about 24.1 percent of the shares of Neurochem on a fully diluted basis.

• Pharmacyclics Inc., of Sunnyvale, Calif., said the FDA completed a special protocol assessment for its Phase III trial of Xcytrin (motexafin gadolinium) Injection for the treatment of lung cancer patients with brain metastases. The Phase III trial, known as the SMART (Study of Neurologic Progression with Motexafin Gadolinium and Radiation Therapy) trial, is now under way and will enroll about 550 patients at more than 100 medical centers in the U.S., Canada, Europe and Australia. The company disclosed the specifics of the trial in December. (See BioWorld Today, Dec. 20, 2002.)

• Pheromone Sciences Corp., of Toronto, completed a private placement of 2.14 million units at an issue price of 25 cents per unit for gross proceeds of C$535,000 (US$342,725). Each unit will be exercisable, at no additional consideration, into one common share of the company and one common share purchase warrant. Each purchase warrant has a term of 12 months and will be exercisable into one common share at an exercise price of C$0.30 per share. Proceeds will be used to support the company's research and development program, ongoing operations and business development.

• Phytomedics Inc., of Dayton, N.J., signed an agreement with SK Chemicals Life Science R&D Center, a unit of South Korea's SK Group, to start the joint testing of new prescription botanical drugs for the global pharmaceutical markets.

• PPD Inc., of Wilmington, N.C., said that Bayer AG, of Leverkusen, Germany, granted to MRL International, a division of PPD Development, worldwide rights to undertake additional Phase I and II clinical studies on implitapide, a drug having been tested in the area of artherosclerosis. Implitapide is an inhibitor of microsomal triglyceride transfer protein, an enzyme involved in the assembly and release of cholesterol and triglyceride from the liver and intestinal tract. MRLI will have access to Bayer's existing information from preclinical studies and previously conducted trials, as well as regulatory filings to conduct trials in the U.S., Europe and South Africa. Financial terms were not disclosed. Separately, BioDelivery Sciences International Inc., of Newark, N.J., signed a license agreement with PPD, granting PPD the right to apply BDSI's bioral nanodelivery technology to two therapeutic products. BioDelivery will receive an up-front license fee, milestone payments based on certain regulatory filings and approvals, and royalties on worldwide sales.

• Protein Polymer Technologies Inc., of San Diego, received its first milestone payment from Genencor International Inc., of Palo Alto, Calif., under a worldwide exclusive license agreement established at the end of 2000. The license grants Genencor the right to use PPTI's protein polymer design and production technology for industrial and personal care product applications, while PPTI continues to retain all rights related to medical products. The milestone payment became due upon Genencor's incorporation of the licensed technology into a development program with a partner.

• Puresyn Inc., of Malvern, Pa., said a scientific team from Puresyn and the University of Pennsylvania's Institute for Human Gene Therapy published a new method to improve the purification of adenoviral vectors. The process is now available from Puresyn as AdenoServe.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA granted fast-track designation to a component of the development program of Axokine for obesity. The designation covers treatment of severely obese people who are unresponsive to, intolerant of or unsuitable candidates for certain FDA-approved medicines for long-term treatment. Regeneron plans to study the use of Axokine in that patient population, it said. Axokine is a genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor.

• Rigel Pharmaceuticals Inc., of South San Francisco, Calif., received the first milestone payment from Daiichi Pharmaceuticals Co. Ltd., of Tokyo, in conjunction with the companies' partnership to develop a new type of oncology drug. The companies are collaborating on research related to protein degradation, an emerging strategy for treating cancer. The deal, which began last August, is one of the first industry collaborations focused on drug development in that field, Rigel said.

• Synsorb Biotech Inc., of Calgary, Alberta, said it entered an agreement with an investor group that will transform Synsorb into an oil and gas enterprise. If approved by shareholders, Synsorb will issue about $3.5 million in secured debentures, along with 5.5 million common share purchase warrants with 5.5 million associated voting preferred shares attached. If all conversion rights are exercised, the group would own about 45 percent of Synsorb common shares. David Tuer, the leader of the investment group, is a petroleum engineer and has been named CEO and chairman of Synsorb. In December 2001, Synsorb stopped development of Synsorb-Cd for recurrent Clostridium difficile-associated diarrhea because of high Phase III dropout rates and inadequate enrollment. The company's stock lost 52 percent of its value on that news and Synsorb began looking to sell its manufacturing facility and intellectual property surrounding Synsorb-Cd. Synsorb's stock (OTCBB:SYBBF) rose $1.07 Tuesday, or 281.6 percent, to close at $1.45. (See BioWorld Today, Jan. 16, 2002.)

• Targeted Genetics Corp., of Seattle, said the listing of its common stock has been transferred from the Nasdaq National Market to the Nasdaq SmallCap Market as of today. It will continue to trade under the symbol "TGEN." Targeted Genetics develops gene therapy products for treating acquired and inherited diseases.

• Texas Biotechnology Corp., of Houston, implemented a restructuring plan to reduce annual expenses by about $6 million, compared to 2002, and focus its resources on its most advanced compounds - sitaxsentan and bimosiamose - and its most promising drug discovery programs. It reduced its work force by about 29 percent, or 36 employees, primarily in the areas of basic exploratory biology, early stage target identification and support functions. Texas Biotechnology will focus on, among other things, Phase III development and commercialization of sitaxsentan for pulmonary arterial hypertension and Phase II development of bimosiamose for asthma and psoriasis.

• Triangle Pharmaceuticals Inc., of Durham, N.C., said the marketing authorization application for Coviracil (emtricitabine) for the treatment of HIV infection was submitted to the European Agency for the Evaluation of Medicinal Products and accepted for review. Triangle previously submitted a new drug application to the FDA and it was accepted for review Nov. 1. Emtricitabine is a once-a-day nucleoside reverse transcriptase inhibitor. (See BioWorld Today, Sept. 6, 2002.)