• aaiPharma Inc., of Wilmington, N.C., signed a commitment letter with Bank of America for a $40 million, 15-month priority revolving credit facility subject to the consent of a majority of the company's existing senior credit facility lenders and senior subordinated debt holders. AaiPharma is focused on pain management.

• Active Biotech AB, of Lund, Sweden, said it terminated arbitration proceedings with PowderJect Pharmaceuticals plc, of Oxford, UK, in relation to a share-purchase agreement in 2001 for the sale of SBL Vaccin AB, wherein PowderJect raised claims valuing $20 million against Active Biotech. The parties reached an amicable settlement. PowderJect agreed to withdraw its $20 million claim and to waive its rights under the disputed warranties of the share-purchase agreement. Active Biotech reduced its claim concerning the milestone payment for Dukoral vaccine achieving European approval, which was part of the previous royalty agreement between SBL Vaccin and Active Biotech, to $4.5 million. Upon that payment, Active Biotech agreed to waive all rights to further royalty and milestone payments. PowderJect was acquired by Emeryville, Calif.-based Chiron Corp. in July.

• Affymetrix Inc., of Santa Clara, Calif., received $4.9 million from the National Institutes of Health National Human Genome Research Institute for a multicenter research collaboration to resequence portions of the genomes of 50 Drosophila melanogaster strains using GeneChip CustomSeq arrays. The research group, led by Charles Langley, a professor of genetics at University of California in Davis, includes scientists from UC Davis, Johns Hopkins University, Children's Hospital Oakland Research Institute, Emory University and Affymetrix. The study will use next-generation CustomSeq resequencing arrays to catalog genetic variations across two large regions of the Drosophila genome and to develop methods to analyze the resulting data.

• Agencourt Bioscience Corp., of Beverly, Mass., said its scientists contributed to the whole-genome sequencing on the brown Norway rat, featured in the April 1, 2004, issue of Nature. The company said the sequencing represents a draft covering more than 90 percent of the genome and provides an analysis of genes and proteins and their relationship to human disease.

• AnorMED Inc., of Vancouver, British Columbia, began its fifth Phase II trial to evaluate AMD3100 as a stem cell transplantation drug candidate for cancer patients. Findings to date in cancer patients have shown that AMD3100 effectively increases the number of stem cells available for transplantation. The study is designed to optimize the schedule for administering AMD3100 in combination with granulocyte colony-stimulating factor prior to collection of stem cells for transplantation. It will be conducted at multiple U.S. sites and enroll up to 30 non-Hodgkin's lymphoma and multiple myeloma patients.

• Antibodies Inc., of Davis, Calif., began shipping quantum dot-based secondary antibody, Streptavidin, Protein A and Protein G conjugates, and launched a quantum dot conjugation service. Using EviTags from Evident Technologies Inc., of Troy, N.Y., the conjugates will be for use in biology, life sciences, drug discovery, disease diagnostics, proteomics and genomics.

• AVI BioPharma Inc., of Portland, Ore., said positive results reported at this week's American Association for Cancer Research (AACR) meeting in Orlando, Fla., demonstrated the success of its Neugene antisense compounds in two new targeting approaches to cancer. Phase I and in vivo data showed that AVI-4126, which targets the c-myc gene, concentrates in the tumor tissues of patients with both breast and prostate cancer after a single dose. Other results demonstrated that when administered in combination with cisplatin, an XIAP-inhibiting Neugene compound induced apoptosis in the chemotherapy-resistant prostate cancer cells.

• Biobase GmbH, of Wolfenbuttel, Germany, released its Transpath-NetPro product, a database of molecular regulation mechanisms in human and mammalian cells. It combines Transpath, which is used to analyze biological networks and gene expression arrays, and for identification of molecules in signal networks, with NetPro, a protein-protein database.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., dosed the first patients in a Phase IIa trial of BCX-1777, a purine nucleoside phosphorylase inhibitor to treat T-cell cancers. The small-molecule drug causes biochemical changes that result in blocking of the T-cell's DNA synthesis machinery. It received orphan drug designation from the FDA to treat T-cell non-Hodgkin's lymphoma. The Phase II trial is a multicenter, global, open-label study looking at long-term dosing of the drug.

• BioGentech Corp., of Irvine, Calif., finalized two outsourcing contracts for the Phase III work on its seasonal allergy product Prehistin. Patheon Pharmaceuticals Inc., of Toronto, will manufacture and provide the study drug, including placebo, for the trials. Quest Diagnostics Clinical Trials, of Van Nuys, Calif., will function as the central laboratory for all blood and urine analyses. Prehistin could become the first over-the-counter allergy drug that helps to prevent the symptoms of seasonal allergies.

• Boston Life Sciences Inc., of Boston, said it reached a binding agreement with the FDA on a protocol design for a new Phase III trial of Altropane, a radioimaging agent under development for the differentiation of Parkinsonian tremors from tremors due to other, non-Parkinsonian causes. The study will enroll at least 500 subjects, half with Parkinsonian tremor and half with non-Parkinsonian tremor, in up to 25 U.S. centers. The company said that if successful, the single, pivotal trial would provide the basis for the submission of a new drug application. Boston Life Sciences first discussed its trial plans last summer. (See BioWorld Today, June 18, 2003.)

• Cell Therapeutics Inc., of Seattle, signed an agreement through which the Gynecologic Oncology Group (GOG) will sponsor and conduct a Phase III trial of Xyotax in ovarian cancer patients. The nonprofit organization will submit an investigational new drug application and use the FDA's special protocol assessment process for the review of a proposed pivotal trial, which will investigate the product's safety and efficacy in about 1,500 patients, compared to no maintenance therapy, to prolong progression-free and overall survival in women who have achieved complete remission following standard front-line chemotherapy. Cell Therapeutics is evaluating the product in Phase III studies for non-small-cell lung cancer as well.

• Ciphergen Biosystems Inc., of Fremont, Calif., said data reported at the AACR meeting showed different diseases generate unique host responses that can be distinguished by the quantitative detection of disease-specific protein fragments, potentially opening up a new approach to multibiomarker diagnostics. The company is developing the concept as the Host Response Protein Amplification Cascade (HR-PAC).

• CSL Ltd., of Melbourne, Australia, completed its acquisition of Aventis Behring from Aventis SA, of Strasbourg, France. CSL will combine Aventis Behring with ZLB Bioplasma to create a new business, ZLB Behring, to be headquartered in King of Prussia, Pa. The company will combine ZLB Bioplasma's IVIG production capabilities with Aventis Behring's coagulation products, hemophilia expertise and specialty products. In order to finalize the financials of the combined entity for the first time, the company's full-year result report was changed from Aug. 18 to Aug. 26.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., completed the second planned safety review of patients enrolled in a Phase III trial of Cubicin to treat infective endocarditis and bacteremia caused by Staphylococcus aureus. An independent data monitoring committee recommended continuation of the trial, which is being conducted in the U.S. and certain Western European countries. Cubist expects trial data to be available in the first half of 2005.

• Cytomedix Inc., of Little Rock, Ark., completed a $4.5 million private placement. The company will use the funds for its clinical trials and operations. Cytomedix is conducting a randomized, double-blind study of the AutoLoGel System against the standard of care for the treatment of chronic wounds. It will begin this month, enrolling about 74 patients at 12 sites throughout the U.S.

• DOV Pharmaceutical Inc., of Hackensack, N.J., said a meeting with a division of the FDA resulted in an agreement for a Phase III program for bicifadine. The company will seek approval in an acute pain indication following three pivotal trials, and a chronic back pain indication following two placebo-controlled studies. The company also must obtain long-term safety observations from at least 100 patients treated for one year and 300 patients treated for six months. DOV expects to begin two pivotal Phase III studies in the third quarter - one a five-day acute, post-surgical bunionectomy trial and the second a three-month chronic back pain study.

• Draxis Health Inc., of Mississauga, Ontario, raised gross proceeds of C$20 million (US$15.3 million) after entering an agreement with a syndicate of underwriters that will purchase, on a bought-deal basis, about 3 million units at C$6.55 apiece. The company also granted the underwriters an overallotment option to purchase up to an additional 458,016 units, exercisable at the issue price any time up to 30 days following the offering's closing. Each unit will consist of one common share and a purchase warrant for half a share. Each whole warrant will entitle the holder to acquire one common share at C$8.50 at any time prior to two years from the date the offering closes. Draxis said it would use the proceeds to acquire a 32.7 percent interest in its manufacturing subsidiary, Draxis Pharma Inc., held by Societe generale de financement du Quebec. The transaction is expected to close on or about April 19. Draxis is a specialty pharmaceutical company that develops therapeutic and diagnostic radiopharmaceuticals, and provides pharmaceutical contract manufacturing services.

• Elite Pharmaceuticals Inc., of Northvale, N.J., said a settlement of litigation between it and its former president and CEO was ruled enforceable by the Superior Court of New Jersey. The settlement provides for the payment of $400,000 to Atul Mehta, as well as certain benefits for a two-year period, a short-term option to the company or its designee to acquire his stock at $2 per share to which a $100,000 nonrefundable deposit is to be made toward the exercise price, and extension of the expiration dates of certain options he holds. He relinquished rights to Elite's intellectual properties and agreed to certain nondisclosure and noncompetition covenants. The specialty pharmaceutical company primarily is developing oral, controlled-release products.

• Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., said it has yet to resolve the FDA's request for additional clinical trials for oxymorphone extended-release tablets after discussions with the agency. The issue arose last fall as a result of questions raised in approvable letters regarding new drug applications for the company's oxymorphone ER and immediate-release tablets. The FDA indicated more time was required to review Endo's additional analyses of certain data from the oxymorphone ER clinical trials and committed to respond as soon as possible, which Endo believes will be during this quarter. The extended-release formulation was developed in partnership with Penwest Pharmaceutical Co., of Danbury, Conn. Endo said it would conduct a short-term, repeat-dose study with oxymorphone IR to resolve safety and efficacy questions in patients receiving repeated doses.

• Endovasc Inc., of Montgomery, Texas, completed enrollment in its Phase II trial for Liprostin. The study evaluated patients with peripheral vascular disease who do not require angioplasty. Endovasc began prescreening candidates in December. About 80 are receiving treatment at six clinical sites in Mexico and Europe. The company had planned to enroll up to 120 patients, but closed enrollment based on the positive initial response from investigators regarding patient improvement.

• Flamel Technologies, of Lyon, France, received a $5 million milestone payment from Bristol-Myers Squibb Co., of New York, as part of their August licensing agreement for Flamel's formulation of long-acting human insulin. The companies did not disclose what triggered the payment. Flamel is engaged in the development of its Medusa technology designed to deliver therapeutic proteins, and its Micropump technology for the oral administration of small-molecule drugs.

• Guilford Pharmaceuticals Inc., of Baltimore, said data reported at the AACR meeting indicate that administration of GPI 15427, its orally biovailable, soluble and brain-penetrable lead inhibitor of Poly (ADP-ribose) polymerase (PARP), enhances the antitumor efficacy of both chemotherapy and radiation therapy. Significant efficacy with GPI 15427 was observed as a chemosensitizer with temezolomide in a brain metastatic melanoma model and as a radiosensitizer in a model of head and neck cancer.

• HP, of Palo Alto, Calif., and The Center for the Advancement of Genomics, a policy and research center affiliated with the J. Craig Venter Science Foundation in Rockville, Md., entered a research and development collaboration to further the goals of advancing medical and environmental genomic discovery in the life sciences. Among the areas the partners plan to investigate is the use of genomics for predictive medicine.

• ImClone Systems Inc., of New York, said preclinical data reported at the AACR meeting highlighted its progress in the development of several pipeline programs. Among the findings, the company said treatment of mice with its fully human monoclonal antibody called IMC-18F1 was shown to significantly suppress growth of human breast tumors in several xenograft models. Other data showed that the combination of another antibody called IMC-A12 with irinotecan resulted in tumor inhibition of 85 percent to 90 percent, and a higher frequency of tumor regression than therapy with either agent alone. Also, preclinical findings with an investigational fully human bispecific antibody that targets epidermal growth factor receptor and insulin-like growth factor-I receptor demonstrated that the BsAb was capable of binding to and blocking both targets simultaneously, and inhibited tumor-cell proliferation.

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., received approval for a $375,000 Phase II Small Business Innovation Research grant from the National Cancer Institute. It will use the grant, a continuation of a Phase I grant from last year, to study the antitumor and radiation-protective effects of Incara's catalytic antioxidants. The NCI also contingently approved another $375,000 grant for next year. Incara plans to select a specific catalytic antioxidant compound to enter into more extensive experiments. Compounds from the company's program have protected normal cells in animal models of radiation therapy, and have inhibited the growth of tumors in animal models of cancer.

• Ingenium Pharmaceuticals AG, of Munich, Germany, entered an agreement to provide genetic rat models to Merck & Co. Inc., of Whitehouse Station, N.J. The models, which will have alterations in a gene specified by Merck, will be developed using Ingenium's Ingenotyping technology. No financial terms or further details were disclosed.

• IntegraGen SA, of Paris, said its scientists identified a gene associated with autism. Though it has never been implicated in autism before, the gene is known to be involved in synaptic signal transmission processes. More specifically, it codes for a synaptic protein that is involved in modulating neuronal signals.

• IR BioSciences Holdings Inc., of Scottsdale, Ariz., established a research entity in Singapore named IMM BioSciences Asia Ltd. IR BioSciences will license the use of Homspera through its new entity for studies on the compound's efficacy in treating side effects of cancer, cigarette smoking, influenza, severe acute respiratory syndrome, avian flu, HIV and other disorders.

• Kosan Biosciences Inc., of Hayward, Calif., received a two-year, $750,000 Phase II Small Business Innovative Research grant from the National Cancer Institute in Bethesda, Md., to develop an efficient means of producing analogues of the polyketide discodermolide, a potential cancer agent. The company is evaluating discodermolide analogues in preclinical studies, with the goal of beginning clinical development in 2005.

• Labopharm Inc., of Laval, Quebec, entered a licensing and distribution agreement to allow Hexal AG, of Holzkirchen, Germany, to market and sell a once-daily formulation of tramadol in that country. Labopharm said it has secured marketing partnerships for 19 countries for the painkilling drug. Specific terms of the revenue-sharing agreement were not disclosed.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., formed a collaboration with the National Cancer Institute to study the link between the enzyme angiotensin-converting enzyme 2 and the virus that causes severe acute respiratory syndrome. Millennium discovered the enzyme ACE2 and its potential relevance to human disease through its genomic research in 1997. The NCI will conduct cell-based studies to identify the structure of the complex, possibly allowing for the design of inhibitors that block the binding interaction of the complex.

• Orphan Medical Inc., of Minneapolis, and Celltech Pharmaceuticals, a division of Celltech Group plc, of Slough, UK, received notice that the European Medicines Evaluation Agency accepted the marketing authorization application for Xyrem for review. Xyrem (sodium oxybate) oral solution is a treatment for the symptoms of narcolepsy. The drug has orphan drug designation in Europe. Celltech plans to market the product to neurologists and sleep specialists across Europe following an expected approval in 2005. Celltech licensed the European rights from Orphan Medical in October.

• PharmaMar SA, of Madrid, Spain, said data reported at the AACR meeting show a molecular fingerprint demonstrative of a Yondelis-induced inhibition of transcription. Other findings showed Aplidin to be significantly more potent than Idarubicin on acute myeloid leukemia cells lines and on fresh leukemic blasts explanted from 30 such patients. Additional data indicated that tumor cells with higher HER2/neu and/or HER3 expression are particularly sensitive to Kahalalide F, also demonstrating that the product induces down-regulation of the erbB pathway. All three products are in clinical trials.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said it was informed by the Centers for Medicare and Medicaid in Baltimore, Md., that Plenaxis (abarelix for injectable suspension) has qualified for transitional pass-through payment under the Medicare hospital outpatient prospective payment system.

• ProMetic Life Sciences Inc., of Montreal, said its wholly owned subsidiary, ProMetic BioSciences Inc., started enrollment in a clinical trial of PBI-1402, an orally active compound aimed at reducing side effects associated with chemotherapy and radiotherapy. Results of the Phase I study, which follows on data generated last year, are expected later this year.

• Protiveris Inc., of Rockville, Md., received a $116,000 award from the Maryland Industrial Partnerships program to support the optimization of the microfluidic sample delivery system in the VeriScan 3000, the company's biosensor system for biological and chemical detection.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., said its PV-10 drug would be evaluated in a cancer study at the School of Veterinary Medicine and the Comprehensive Cancer Center of the University of Wisconsin in Madison as a result of a research award from the Prostate Cancer Foundation. The study is designed to investigate the ability of PV-10 to selectively localize in tumors, be imaged using Computerized Axial Tomography and to act as a radio-sensitizing agent for treatment of cancers with systems for radiation therapy developed by Varian Medical Systems Inc., of Palo Alto, Calif.

• Raven Biotechnologies inc., of South San Francisco, reported data at the AACR meeting demonstrating potent activity of its new monoclonal antibody, KID3, against colon, gastric and pancreatic tumors. More specifically, KID3 binds to a cell-surface drug target found only in primates and humans. As a result, the company selected its chimeric form of the KID3 antibody - RAV12 - for advanced preclinical development and plans to begin clinical studies early next year, leading with gastrointestinal cancers, such as colorectal, gastric, pancreatic and certain types of liver cancer.

• Samaritan Pharmaceuticals Inc., of Las Vegas, made further product development milestones with its HIV products. The company said independent testing protocols provided efficacy data suggesting that its SP-01A compound has promise as an HIV entry inhibitor.

• Seattle Genetics Inc., of Bothell, Wash., appointed Clay Siegall its interim chairman. Siegall serves as the company's president and CEO and has been a member of the board since he co-founded the company in 1997. He replaces H. Perry Fell, co-founder of Seattle Genetics, who will not seek re-election as a director when his term expires in May. Prior to serving as president and CEO since November 2002, Siegall served as president and chief scientific officer. Seattle Genetics is developing monoclonal antibody-based therapeutics to treat cancer and other human diseases.

• Swiss Medica Inc., of Toronto, raised gross proceeds of $2.5 million after completing a financing with a group of institutional and high-net-worth investors. Proceeds will be used to fund Swiss Medica's launch into the U.S. pain-relief market and to fund strategic acquisitions. Full details of the financing will be incorporated in the company's 8-K filing with the SEC. Swiss Medica commercializes bioscience products that relieve chronic ailments.

• ThromboGenics Ltd., of Dublin, Ireland, was granted orphan drug designation by the FDA for use of its microplasmin compound in pediatric eye surgery to treat retinal disorders that cause visual impairment and blindness in children. Microplasmin has the potential to simplify a surgical procedure called vitrectomy, as use of the drug has shown effectiveness in inducing posterior vitreous detachment, a critical part of the procedure.

• Vela Pharmaceuticals Inc., of Ewing, N.J., licensed a late-stage antidepressant from Otsuka Pharmaceutical Co. Ltd., of Tokyo. Privately held VelaPharm, which will develop the molecule as VPI-013, will have exclusive U.S. and major European marketing rights, while Otuska will retain such rights in Japan and several other countries. VelaPharm said it would begin a Phase II trial in June to test VPI-013 in patients with major depressive disorder. Financial terms were not disclosed.