• Adprotech Ltd., of Cambridge, UK, said its most advanced therapeutic, APT070, entered Phase IIa trials to evaluate its ability to prevent graft dysfunction in kidney transplantation. APT70 is designed to reduce injury by binding to kidney tissue and protecting it from attack by a component of the recipient's immune response known as the complement system following re-initiation of blood flow after grafting. APT070, derived from a human protein, differs from other transplant drugs because it is perfused through the donor kidney prior to transplantation, which is designed to provide protection before grafting.

• Advanced Viral Research Corp., of Yonkers, N.Y., said it would pursue all available options, including appealing and/or seeking reconsideration of an order recently entered by the U.S. District Court for the Southern District of New York regarding litigation related to a September 2002 financing agreement. The company said that the court's opinion does not affect its ability to proceed with its Florida lawsuit, which alleges a market manipulation scheme related to the $3 million financing. In December, the company reported it had filed suit in the Circuit Court of the 11th Judicial Circuit of Florida charging that certain investors "misrepresented their intentions in investing in the company" and "engaged in a series of manipulative activities to depress the price of Advanced Viral stock."

• Alkermes Inc., of Cambridge, Mass., said its partner, Janssen-Cilag SA, of Madrid, Spain, received approval from the Spanish Ministry of Health to market Risperdal Consta, a long-acting injectable form of risperidone that was developed using Alkermes' Medisorb drug-delivery technology. The product will be launched following negotiation of a reimbursement pricing. Risperdal is for the management of schizophrenia. It is now approved in 16 countries.

• Altachem Pharma Ltd., of Edmonton, Alberta, contracted an investment banking firm, Madison Keats, of Charlotte, N.C., to assist in evaluating potential business and financing strategies in the U.S. Altachem said the relationship is designed to increase its exposure in an effort to maximize corporate value.

• AVI BioPharma Inc., of Portland, Ore., reported the final results from its Neugene antisense drug (AVI-4126) study in adult patients with autosomal dominant polycystic kidney disease. Results confirm its safety profile in adult patients with PKD. The Phase Ib trial involved 17 patients, and urinary clearance of circulating AVI-4126 was about 10 percent to 11 percent per day, which is similar to the approximate 15 percent seen in normal subjects in previous studies.

• Bavarian Nordic A/S, of Copenhagen, Denmark, said it is enrolling 165 healthy volunteers in a Phase II study to evaluate the safety and immunogenicity of its MVA-BN smallpox vaccine. The day before, the company said it was awarded by the U.S. Department of Health and Human Services a three-year contract to further develop the compound.

• BioDelivery Sciences International Inc., of Newark, N.J., formed a new subsidiary, Bioral Nutrient Delivery LLC, to exploit its nano-encochleation delivery technology for non-pharmaceutical use in the processed food and beverage industries. BioDelivery plans to grant the subsidiary an exclusive worldwide sublicense to its Bioral technology, which is based on soy-derived phospholipids and calcium.

• CeMines Inc., of Evergreen, Colo., reported at the Investment in Innovation conference in Irvine, Calif., that its blood test correctly identified the presence of gastrointestinal cancer in each of 26 tested patients. The privately held firm said its Molecular FingerPrinting tests have correctly identified the presence of cancer in each of the 206 patients known to have four different tumor types - lung, breast, gastrointestinal or prostate - representing 100 percent sensitivity. CeMines said the tests also ruled out cancer in each of the 72 control patients.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said Michael Bonney will succeed Scott Rocklage as Cubist's CEO at the company's annual meeting on June 10. Rocklage will remain the company's chairman. He has served as CEO of Cubist since June 1994 and as the company's chairman since March 2000. Bonney has served as the company's president and chief operating officer since January 2002.

• Dharmacon Inc., of Lafayette, Colo., and Upstate Group Inc., of Charlottesville, Va., released a line of kits that combine Dharmacon's small interfering RNA oligonucleotide reagents with Upstate's antibodies. The reagent kits are the first products resulting from a collaboration between the parties to co-develop and co-market research products.

• Emisphere Technologies Inc., of Tarrytown, N.Y., reported favorable results of a multicenter European Phase IIa study in which Novartis Pharma AG, of Basel, Switzerland, evaluated the performance in 277 post-menopausal women of an oral tablet formulation of the salmon calcitonin peptide, currently available only as nasal spray or an injectable therapy. The study demonstrated activity on bone markers when the peptide was delivered in combination with the Emisphere delivery agent. Specifically, data demonstrated a calcitonin dose response, as measured by changes in bone markers after the first, second and third months, as well as a statistically significant effect on bone markers from baseline levels for two of the five doses administered (p=0.002 and p=0.016). Also, in comparison to placebo, there was a significant reduction in bone markers observed for one of the doses (p=0.012).

• Exelixis Inc., of South San Francisco, said the research phase of its cancer antibody research agreement with Protein Design Labs Inc., of Fremont, Calif., will be completed on schedule in June, based on the delivery by Exelixis of a number of antibody targets for cancer drug discovery. PDL will continue to develop antibodies against selected validated targets delivered to it by Exelixis. Exelixis retains the right to co-fund development of antibodies against targets selected by PDL and will also regain full rights to certain cancer targets that are not selected for further development by PDL. The companies' research collaboration was established in 2001 and included a two-year funded research phase, which will conclude in June. PDL was to make a $30 million investment in Exelixis. (See BioWorld Today, May 24, 2001.)

• ExonHit Therapeutics SA, of Paris, and Allergan Inc., of Irvine, Calif., entered an alliance to develop drugs in the fields of neurodegenerative diseases, pain and ophthalmology. The second collaboration between the companies, the agreement is designed to identify new molecular targets based on ExonHit's gene profiling Datas technology and to jointly develop compounds and commercial products based on these targets. ExonHit will receive ongoing research and development and milestone payments, as well as co-development and co-commercialization options in therapeutic areas outside of Allergan's strategic areas. ExonHit also will receive royalties or, in cases of co-development and co-commercialization, profit sharing on all commercialized drugs.

• Gilead Sciences Inc., of Foster City, Calif., reported the publication of results from two studies evaluating the safety and efficacy of Hepsera (adefovir dipivoxil 10 mg.), Gilead's once-daily oral antiviral for the treatment of chronic hepatitis B, in the Feb. 27, 2003, edition of the New England Journal of Medicine. In both studies, Hepsera significantly reduced liver damage and improved liver function compared to placebo, and provided effective and well-tolerated long-term therapy. The product was approved in the U.S. in September. (See BioWorld Today, Sept. 24, 2002.)

• Lexicon Genetics Inc., of The Woodlands, Texas, said it identified and physiologically validated a target for the development of drugs to treat osteoporosis. Lexicon discovered that inhibiting the enzyme, designated LG881, in female mice resulted in an increase in overall bone mineral density. Most significant was an increase in trabecular bone, the inner meshwork of bone that contributes to bone strength.

• Martek Biosciences Corp., of Columbia, Md., closed a one-year, $10 million secured working capital line of credit facility with Allfirst Bank in Baltimore. Martek said it plans to use the proceeds for general corporate purposes, including financing the expansion of its manufacturing capacity to meet increased demand for its specialty nutritional oils.

• Medicure Inc., of Winnipeg, Manitoba, said that as of March 1, all of the issued and outstanding Class A common shares - totaling 1,280,000 shares - shall be converted into common shares on the basis of one common share for each Class A common share in accordance with the company's articles of continuance. Medicure is a cardiovascular biotechnology company.

• NeoRx Corp., of Seattle, submitted data to the FDA from its Phase II dosimetry study of skeletal targeted radiotherapy (STR) in patients with multiple myeloma. NeoRx also submitted to the FDA a revised proposal for further clinical development of STR. NeoRx is developing STR for use with high-dose chemotherapy and stem cell transplantation to treat multiple myeloma.

• NPS Pharmaceuticals Inc., of Salt Lake City, said clinical investigators provided preliminary data from the first year of the PaTH (parathyroid hormone and alendronate) study of its Preos compound to treat osteoporosis. But they requested that the company not release any numeric results from the study of 238 post-menopausal women with low bone mineral density and an additional fracture risk factor, in advance of presentations or publications planned for later this year. NPS also reiterated an announcement by its licensee, Amgen Inc., of Thousand Oaks, Calif., that it intends to file a new drug application for cinacalcet HCl during the second half of this year. Both drugs are among NPS's four late-stage investigational compounds being joined with Enzon Pharmaceuticals Inc. as part of a proposed $1.6 billion merger. (See BioWorld Today, Feb. 21, 2003.)

• Panacea Pharmaceuticals Inc., of Gaithersburg, Md., said it opened its new facility after it emerged from the Maryland Technology Development Center, a business incubator located in Rockville. The technology incubator project was developed, financed and constructed as a joint partnership between Montgomery County and the state of Maryland.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said it resubmitted to the FDA its new drug application for Plenaxis (abarelix for injectable suspension), designed to treat hormonally responsive advanced prostate cancer. It is seeking approval for a defined subpopulation of advanced prostate cancer patients for whom the use of existing hormonal therapies might not be appropriate. In June 2001, the FDA said the NDA was not adequate for approval and Praecis set about conducting further action. (See BioWorld Today, June 13, 2001.)

• Serologicals Corp., of Atlanta, said the U.S. District Court for the Northern District of Georgia, Atlanta Division, has ordered the dismissal with prejudice of the class action lawsuit alleging securities fraud against the company. A judge granted Serologicals' motion to dismiss the lawsuit on the basis that the plaintiffs failed to plead facts sufficient to show a violation of U.S. securities laws.

• Serono SA, of Geneva, said it submitted a marketing authorization application to the European Agency for the Evaluation of Medicinal Products for Raptiva (efalizumab) for the treatment of adults with moderate to severe psoriasis. The agency said the submission is valid and the review is under way. Genentech Inc., of South San Francisco, and XOMA Ltd., of Berkeley, Calif., submitted a biologics license application for Raptiva in the U.S. in December. (See BioWorld Today, Dec. 27, 2002.)

• ToolGen Inc., of Daejeon, South Korea, said a research article describing its GeneGrip technology, which permits researchers to modulate the in vivo expression of endogenous genes of interest using an artificial genetic switch, was published in the March 2003 issue of Nature Biotechnology. ToolGen is developing therapeutic reagents and conducting research on how to apply the GeneGrip technology to functional genomics, cellular engineering and microbe engineering.

• Xerion Pharmaceuticals AG, of Martinsried, Germany, acquired exclusive rights to cancer targets resulting from a collaboration with the laboratory of Daniel Jay, professor of physiology at Tufts University in Medford, Mass. Xerion plans to generate therapeutic antibodies against the targets. The agreement is a result of an ongoing collaboration between Xerion and Tufts.