• AaiPharma Inc., of Wilmington, N.C., completed its acquisition of four pain products - Roxicodone, Oramorph SR, Roxanol and Duraclon - from Elan Corp. plc, of Dublin, Ireland. The company, which purchased the products for $100 million, plans to launch them in mid-January. (See BioWorld Today, Oct. 23, 2003.)

• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix group received a $1.25 million payment from Toppan Printing Corp., of Tokyo, after achieving a milestone in their multiyear agreement to co-develop semiconductor microarrays for life science research, biological and chemical warfare agent detection, as well as diagnostics. CombiMatrix received a $1 million up-front payment in May when the alliance was formed. Upon commercialization, Toppan will manufacture microarrays for CombiMatrix or its partners and will share revenues and royalties.

• Acorda Therapeutics Inc., of Hawthorne, N.Y., set the price range for its initial public offering at $12 to $14 and its number of shares at 4.8 million. The company, which is developing therapies for central nervous system disorders, filed for its IPO two months ago, seeking $75 million. (See BioWorld Today, Oct. 1, 2003.)

• Adenosine Therapeutics LLC, of Charlottesville, Va., was awarded a Phase I Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The $100,000 grant will fund the synthesis of new compounds designed to have a longer duration of action than existing adenosine-A2A agonists, and to evaluate their potency, selectivity, duration of action and oral availability.

• Agilent Technologies Inc., of Palo Alto, Calif., released a high-resolution method for detecting genetically modified content in food products. The company said researchers can use the method to screen samples before running more expensive, lengthier analyses required to quantify genetically modified content.

• Anika Therapeutics Inc., of Woburn, Mass., received an approvable letter from the FDA for its premarket approval application for Orthovisc, a purified, high molecular-weight form of hyaluronic acid for treating patients suffering from osteoarthritis of the knee. The letter states that an approval order will be issued subject to a successful FDA inspection of Anika's manufacturing facility, the company said.

• Atrix Laboratories Inc., of Fort Collins, Colo., said its European licensee, MediGene AG, of Martinsried, Germany, received German regulatory authorization for its one-month prostate cancer product, Eligard 7.5 mg (leuprolide acetate for injectable suspension, known in Germany as Leuprolide). Atrix licensed European marketing rights to MediGene in 2001. Atrix will receive royalty payments based on sales, and will manufacture Eligard at its Fort Collins facility. MediGene is in negotiations with a European marketing partner.

• Avanir Pharmaceuticals Inc., of San Diego, reported positive data on its panel of human antibodies against the key toxin of anthrax at this week's IBC Antibody Engineering meeting in San Diego. Two of its most potent anthrax antibodies, AVP 21D9 and AVP 22G12, completely inhibit toxin complex assembly by attaching to distinct domains of the toxin, the company noted. A third antibody, AVP 1C6, inhibits the anthrax toxins through a mechanism that involves the blockage of host-cell receptor recognition, a more commonly used approach.

• Axcan Pharma Inc., of Mont Saint-Hilaire, Quebec, submitted a supplemental new drug application to Canadian regulatory authorities for Salofalk 750 mg for ulcerative colitis. If approved, the dosage would complement the 250- and 500-mg tablets Axcan already markets the drug in Canada for Crohn's disease and ulcerative colitis.

• Bavarian Nordic A/S, of Copenhagen, Denmark, entered a deal to pay about $40 million to acquire a Dutch drug production facility from Orion Pharma, the pharmaceutical division of Orion Corp., of Espoo, Finland. Bavarian Nordic, which will use the facility as a production site for up to 120 million vaccine doses per year, said it would cover the purchase price with its existing liquidity combined with income and bank financing.

• Cel-Sci Corp., of Vienna, Va., raised about $2.55 million in gross proceeds after completing a private placement of about 3 million common shares at 85 cents apiece to accredited and institutional investors. They also will receive three-year warrants to purchase about 900,000 additional shares at $1.32 apiece. Reedland Capital Partners, an Institutional Division of Financial West Group, advised Cel-Sci in connection with part of the offering.

• Chemical Diversity Labs Inc., of San Diego, and Sienabiotech SpA, of Siena, Italy, entered a collaboration for evaluation and screening of a focused library. Sienabiotech will use its methods and technology to screen the aspartyl protease-focused library provided by CDL, a provider of discovery chemistry services. To create the library, CDL applied its methods of focused library design and also performed diversity optimization. Financial terms were not disclosed.

• ChondroGene Ltd., of Toronto, entered a collaboration to make its technology and tools available to researchers belonging to the Canadian Arthritis Network, which links researchers, clinicians, academic institutions, The Arthritis Society, pharmaceutical and biotechnology companies, and government. ChondroGene will gain access to the network's research activities across Canada. The agreement's aim is to develop diagnostic tools for osteoarthritis, as well as therapeutics to treat it.

• Columbia Laboratories Inc., of Livingston, N.J., said its board approved a request allowing Perry Corp. to acquire beneficial ownership, as defined by its shareholder rights plan, of up to 19.9 percent of Columbia's outstanding common stock. Under the plan, Perry would have been limited to up to a 15 percent beneficial ownership. Approval was contingent upon Columbia and Perry entering an 18-month standstill agreement related to additional increases in Perry's investment and change of control transactions. Columbia's stock (AMEX:COB) gained 78 cents Tuesday, or 14.3 percent, to close at $6.23.

• Cytogen Corp., of Princeton, N.J., and Advanced Magnetics Inc., of Cambridge, Mass., said data reported at this week's Radiological Society of North America meeting in Chicago showed that magnetic resonance imaging with Combidex (ferumoxtran-10), an investigational iron oxide nanoparticle, aids in the non-invasive diagnosis of metastatic lymph nodes. The findings stemmed from several studies that included patients with a variety of cancers, including breast, prostate, renal, testicular, bladder, brain and cervical.

• Debiopharm SA, of Lausanne, Switzerland, is looking for a new North American commercialization partner for Trelstar (triptorelin pamoate) after agreeing to reacquire the prostate cancer drug's sales and marketing rights from Pfizer Inc., of New York. Debiopharm previously licensed the rights to the FDA-approved luteinizing hormone-releasing hormone agonist to Pharmacia Corp., of Peapack, N.J., which Pfizer acquired. More specifically, Debiopharm is seeking to partner Trelstar's one- and three-month formulations.

• EPIX Medical Inc., of Cambridge, Mass., said Phase II data published in this month's issue of Radiology showed its contrast agent MS-325 enhanced magnetic resonance angiography (MRA) in the aortoiliac arteries. At doses of 0.03 mmol/kg and higher, MS-325-enhanced MRA provided about a 20 percent increase in accuracy over non-enhanced MRA. In all dose groups in the 238-patient, multicenter North American study, MS-325 exhibited a good safety profile. EPIX is developing the product with Schering AG, of Berlin.

• Genedata AG, of Basel, Switzerland, said it extended an agreement with the University of Minnesota in Minneapolis. The university's Supercomputing Institute for Digital Simulation and Advanced Computation extended its license for Expressionist, Genedata's computational system for large-scale gene-expression analysis. It is designed to enable researchers to better use data from high-density microarrays and others sources to explore gene-expression alterations in a variety of research areas.

• Genetronics Biomedical Corp., of San Diego, extended an agreement with Chiron Corp., of Emeryville, Calif., to conduct additional experiments using its electroporation technology to test an HIV/DNA vaccine. The electroporation devices are being tested in combination with Chiron's PLG DNA particle technology for use in DNA vaccination applications. In addition to studies covered by the agreement, the parties are collaborating on the electroporation-assisted delivery of a second DNA vaccine for an unnamed target indication. Financial terms were not disclosed.

• GenoMed Inc., of St. Louis, said findings published in last week's Nature showed its approach of blocking angiotensin II may play a role in treating severe acute respiratory syndrome. Researchers found the SARS virus binds to an enzyme called ACE 2, and inactivates angiotensin II. GenoMed's treatment to block angiotensin II originally was designed to decrease activation of macrophages, which accumulate in the lungs and cause death. GenoMed said it appears its approach will specifically correct the result of the SARS virus' initial binding to ACE 2, which is to raise angiotensin II levels.

• Hybridon Inc., of Cambridge, Mass., identified an immunostimulatory motif in oligonucleotides that displayed potent activity in in vitro studies in immune cells obtained from a number of species, including pig, chicken, sheep, goat, horse, monkey, mouse and rat. The findings were published in a research paper in a recent issue of the Proceedings of the National Academy of Sciences. Hybridon's stock (OTC BB:HYBN) gained 15 cents Tuesday, or 10.7 percent, to close at $1.55.

• Immtech International Inc., of Vernon Hills, Ill., acquired a newly constructed facility located in the Futian Free-Trade Zone, a tax-free region in Shenzhen, China, which the company plans to use to produce commercial quantities of its pharmaceutical compounds. Immtech said the location allows it to import equipment and materials and export products on a tax-free basis, while also qualifying for property and other tax advantages. Its stock (AMEX:IMM) lost $1.99 Tuesday, or 11.4 percent, to close at $15.50.

• Inex Pharmaceuticals Corp., of Vancouver, British Columbia, submitted to the FDA the chemistry, manufacturing and controls section as part of its rolling submission to its new drug application for Onco TCS, its lead product for relapsed aggressive non-Hodgkin's lymphoma. It is the second of three major sections of the submission, a process initiated about two months ago. The company said it would complete the filing during the first quarter of next year with the submission of the clinical section. (See BioWorld Today, Oct. 1, 2003.)

• Inologic Inc., of Seattle, received an undisclosed payment from the Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, after achieving the first milestone in developing INO-4995. The milestone included Inologic's completion of acute toxicology studies and receipt of orphan drug designation from the FDA. The compound, which is being developed to improve the function of cystic fibrosis lung cells, is funded in part by a $1.5 million award from the foundation.

• Insmed Inc., of Richmond, Va., said data published in an electronic edition of Endocrinology showed that its SomatoKine (rhIGF-I/rhIGFBP-3) protects the onset of Type I diabetes in non-obese diabetic mice. Independent researchers found that both free IGF-I and rhIGF-I/rhIGFBP-3 complex were effective in reducing the severity of insulitis, beta cell destruction and delayed the onset of Type I diabetes, though Insmed's product was a significantly more effective treatment in its prevention.

• Jerini AG, of Berlin, said its selective B2 Bradykinin receptor antagonist, Icatibant, is the first in its class to demonstrate positive results in a Phase IIa study in patients with refractory ascites in liver cirrhosis. The company's chief scientific officer said the results show that Bradykinin is a major culprit for the vascular and renal complications seen in decompensated liver cirrhosis. In the randomized, crossover, placebo-controlled trial, patients with decompensation (Child Pugh score 5-8) were challenged with a water/sodium load, and the capacity of the patients to deal with the increased sodium load was assessed. Icatibant improved all parameters in a statistically significant and clinically relevant manner.

• La Jolla Pharmaceutical Co., of San Diego, said it discovered orally active small molecules for the treatment of autoimmune diseases and acute and chronic inflammatory disorders. Its scientists generated highly selective inhibitors of SSAO (semicarbazide-sensitive amine oxidase), an enzyme implicated in inflammatory responses in many tissues and organs. Studies in animal models of multiple sclerosis, rheumatoid arthritis and acute inflammation have shown that treatment with the inhibitors maintained function and reduced disease activity compared to placebo treatment.

• Linden Bioscience, a division of Linden Technologies Inc., of Woburn, Mass., introduced a new protein identification service designed to provide research organizations with access to informatics systems, scientific techniques and project-dedicated scientists. Strategic Proteomic Services features analysis coupled with protein identification through integrated informatics systems and processes. At the heart of the service are the ABI 4700 Proteomics Analyzer and QSTAR Lx mass spectrometer systems, the company said.

• Locus Pharmaceuticals Inc., of Blue Bell, Pa., entered a collaboration with IBM Corp., of Armonk, N.Y., to use the latter's Deep Computing Capacity on Demand center to deploy supercomputing power for research and drug design. Locus, a company focused on computational-based small-molecule drug design and development, said the effort is targeted at one of its HIV/AIDS development programs. Financial terms were not disclosed.

• Peninsula Pharmaceuticals Inc., of Alameda, Calif., said in vitro data showed that doripenem (S-4661) is highly active against two common lung pathogens infecting cystic fibrosis patients. The broad-spectrum carbapenem antibiotic demonstrated between a twofold and 64-fold increase in activity relative to other antibiotics tested against Pseudomonas aeruginosa isolates obtained from both cystic fibrosis and non-cystic fibrosis patients. Unlike other antibiotics with poor or limited anti-Burkholderia cepacia activity, the privately held company said doripenem displayed respectable in vitro potency against the pathogen.

• Pharmacopeia Inc., of Princeton, N.J., received an undisclosed milestone payment from Daiichi Pharmaceutical Co. Ltd., of Osaka, Japan, which began human trials of a product containing a small molecule identified and optimized by Pharmacopeia and Daiichi scientists. Pharmacopeia will be entitled to additional milestone payments if and as the program progresses, as well as royalties on commercial sales of any resultant products. At the time the deal began more than seven years ago, it was valued at $22 million for Pharmacopeia through an equity investment, licensing fees and research funds. (See BioWorld Today, April 2, 1996.)

• Pharmacyclics Inc., of Sunnyvale, Calif., was granted fast-track designation by the FDA for its investigational drug Xcytrin (motexafin gadolinium) injection for brain metastases in patients suffering from non-small-cell lung cancer (NSCLC). The company said the agency made its designation based on results of previous clinical trials with Xcytrin in combination with whole-brain radiation therapy, which suggested clinical benefit for lung cancer patients with brain metastases and its potential treatment for the condition. A pivotal trial of Xcytrin began about a year ago in patients with NSCLC and brain metastases. Pharmacyclics stock (NASDAQ:PCYC) increased $1.62 Tuesday, or 24.7 percent, to close at $8.17. (See BioWorld Today, Dec. 20, 2002.)

• SciTegic Inc., of San Diego, and Molecular Networks GmbH, of Erlangen, Germany, said they integrated the Corina 3D molecular structure software into Pipeline Pilot, SciTegic's data pipelining software platform. The integration component will allow Corina and Pipeline Pilot customers to generate 3D structures from within their data processing protocols.

• Serono Inc., of Rockland, Mass., received FDA approval of Zorbtive (somatropin [rDNA origin] for injection) for short bowel syndrome, despite an earlier panel decision to recommend otherwise. A randomized Phase III study showed that the recombinant human growth hormone administered with specialized nutritional support significantly reduced patient dependence on total parenteral nutrition. Serono SA, of Geneva, already markets the product as Serostim in the U.S., Japan, Canada and other small countries for AIDS wasting. It has received orphan drug designation for short bowel syndrome, a rare and sometimes fatal condition, though this summer the FDA's Gastrointestinal Drugs Advisory Committee questioned the pivotal trial data. (See BioWorld Today, June 27, 2003.)

• SkyePharma plc, of London, entered an agreement with Novartis Pharma AG, of Basel, Switzerland, to jointly develop a product for asthma and chronic obstructive pulmonary disease. The product will combine Novartis' long-acting bronchodilator QAB149 with two SkyePharma technologies - its SkyeHaler dry-powder inhaler device and the SkyeProtect powder formulation that protects the drug from atmospheric moisture to ensure product stability and dose-to-dose reproducibility. Upon signing the agreement, Novartis will make an initial payment to SkyePharma, which also will receive future milestone payments should the co-development project progress, as well as royalties on eventual sales.

• Telik Inc., of Palo Alto, Calif., said the FDA granted fast-track designation for Telcyta for third-line therapy for locally advanced or metastatic non-small-cell lung cancer. The FDA previously granted fast-track designation for Telcyta for third-line therapy in patients with platinum-refractory or -resistant ovarian cancer. Telcyta is the company's most advanced drug development candidate.

• Third Wave Technologies Inc., of Madison, Wis., said it delivered 200,000 single nucleotide polymorphism (SNP) assays to Riken (the Institute of Physical and Chemical Research), of Tokyo, for use in various large-scale genotyping projects. Since the beginning of 2003, the company has been supplying its Invader SNP assays to Riken. The institue's personalized medicine director, also director of the Genome Center at the University of Tokyo, is leading the Japanese portion of the HapMap Project - a 25 percent share of the worldwide initiative to create a map of common patterns of SNPs.

• Transgenomic Inc., of Omaha, Neb., entered into several specific agreements with Novartis Pharmaceuticals Corp., of East Hanover, N.J., to provide mutation discovery services for translational research programs in oncology. The work's fundamental goal is to support biomarker discovery efforts in the context of clinical trials by identifying genetic mutations that correlate with patients' responses to cancer therapeutics. Transgenomic's stock (NASDAQ:TBIO) gained 50 cents Tuesday, or 28.6 percent, to close at $2.25.

• VaxGen Inc., of Brisbane, Calif., finalized the commercial terms of its smallpox vaccine collaboration with the Chemo-Sero-Therapeutic Research Institute (Kaketsuken), a government-backed business in Kumamoto, Japan. VaxGen will purchase vaccine in bulk from Kaketsuken and complete all secondary manufacture, including filling and packaging, necessary to sell the finished product in the U.S. Each party is responsible for their development expenses prior to sales of the vaccine. VaxGen will not make any milestone or up-front payments. The agreement covers sales to markets in the U.S., but it contains provisions to expand the scope to other international markets. Additional terms were not disclosed.