• Aastrom Biosciences Inc., of Ann Arbor, Mich., reported the results of a study in which its tissue repair cells were used to safely generate bone in a girl with hypophosphatasia were published in the April edition of the Journal of Bone and Mineral Research. Aastrom's TRCs are produced from small samples of bone marrow, using the AastromReplicell System, the company's automated platform.

• Aclara BioSciences Inc., of Mountain View, Calif., and Amersham Biosciences, of Piscataway, N.J., entered a joint marketing and service agreement for the purpose of marketing MegaBACE DNA Analysis Systems from Amersham Biosciences in combination with Aclara's eTag Assay System. Under the nonexclusive agreement, Amersham will continue to sell and support MegaBACE, its automated high-throughput DNA analysis system, as a stand-alone system, but also for use with the Aclara eTag assay chemistries and applications.

• Arryx Inc., of Chicago, reported that the National Institute of Standards and Technology in Gaithersburg, Md., and Emory University in Atlanta are each purchasing Arryx's BioRyx 200 system. The system integrates Arryx's laser steering technology with software to give researchers the ability to manipulate microscopic objects in three dimensions.

• AusAm Biotechnologies Inc., of Santa Monica, Calif., reported positive in vivo results showing that detectable levels of its lead HIV antiviral drug candidate, DES6, were observed eight hours after administration in a small group of volunteers. AusAm, which is collaborating with the National Institutes of Health in Bethesda, Md., and other U.S.-based infectious disease centers, is selecting a clinical site to continue testing later this year with a larger study in both healthy and HIV-infected volunteers.

• AVI BioPharma Inc., of Portland, Ore., reported results from two independent preclinical studies demonstrating the feasibility of treating cardiovascular restenosis using its microbubble delivery technology in combination with its Neugene antisense drug, Resten-NG. In each study, the microbubbles were coated with a restenosis-inhibiting drug and injected intravenously. The drug-coated microbubble accumulated at the sites of vascular injury, where the drug was then deposited. Together the studies showed that microbubble delivery was sufficient to prevent restenosis in the relevant animal models. The results were presented at the American College of Cardiology's annual meeting in Chicago.

• BioDelivery Sciences International Inc., of Newark, N.J., said its board authorized repurchase of up to 100,000 common shares. Under the program, BioDelivery may purchase shares as market conditions warrant and from time to time on the open market or otherwise as determined by management.

• Bioenvision Inc., of New York, reported that following the favorable opinion of the European Agency for the Evaluation of Medicinal Products, the European Commission granted an orphan medicinal product designation for the anticancer drug Clofarabine as a treatment for acute myeloblastic leukemia.

• Biogen Inc., of Cambridge, Mass., revised guidance for its first-quarter earnings per share, now expected to be 39 cents to 43 cents. First-quarter operating earnings per share are expected to be between 47 cents and 51 cents. The guidance is an increase from the estimated 31 cents to 38 cents earnings per share given on Jan. 28. Total revenues for the first quarter are expected to be about $320 million. Biogen's stock (NASDAQ:BGEN) rose $3.70 Wednesday, or 12.2 percent, to close at $33.99.

• BioTransplant Inc., of Medford, Mass., reached a settlement agreement with the Catholic University of Louvain preserving BioTransplant's exclusive license to MEDI-507, and at the same time implemented other measures to reduce its operating expenses. In late February, BioTransplant and its wholly owned subsidiary, Eligix Inc., filed for Chapter 11. Since then, it has terminated its lease at one facility and agreed to terminate its other lease. BioTransplant said it continues to explore partnering options for two unlicensed assets. It has partnered MEDI-507 with MedImmune Inc., of Gaithersburg, Md., which is studying the compound in Phase II psoriasis trials. Only two employees remained at BioTransplant after the company disclosed its filing for bankruptcy protection. (See BioWorld Today, March 3, 2003.)

• Cephalon Inc., of West Chester, Pa., transferred its U.S. market manufacturing of Actiq (oral transmucosal fentanyl citrate) from a contract manufacturer to Cephalon's recently expanded facility in Salt Lake City. The move follows the Feb. 19 FDA approval of a new compressed powder formulation of Actiq for breakthrough pain in cancer patients who are tolerant to opioid therapy. The formulation, which the Salt Lake City facility has manufactured for the European market since November 2000, replaces the current sugar melt formulation sold in the U.S.

• Cetek Corp., of Marlborough, Mass., closed a $6 million private equity financing to advance natural product compounds using its Natural Products Factory. Investors in the financing included John and Stephen Davis, James Waters and Gainesborough Investments. Cetek's Capillary Electrophoresis Assay is designed to identify and rank the affinity of synthetic and natural product small molecules to therapeutic target proteins in a high-throughput environment.

• DiaDexus Inc., of South San Francisco, said data were presented at the American College of Cardiology meeting in Chicago showing that both lipoprotein-associated phospholipase A2 (Lp-PLA2) and high-sensitivity C-Reactive Protein (hs-CRP) are independently associated with the incidence of coronary heart disease. Researchers used the firm's test to determine the level of Lp-PLA2 in patients' blood. The data also determined that individuals with normal low-density lipoprotein cholesterol, but with high levels of Lp-PLA2 or hs-CRP, might be at risk for such an event.

• DOV Pharmaceuticals Inc., of Hackensack, N.J., reached an agreement with Biovail Corp., of Toronto, and Biovail Laboratories Inc., for the return of Biovail's exclusive license to DOV's December 2000 patent for immediate- and controlled-release diltiazem, and the termination of the 2001 exclusive license agreement with Biovail for development of the DOV compound for the treatment of angina and hypertension. The separation agreement calls for a $1 million current payment to Biovail, and establishes contingent payments to Biovail of $3 million upon issuance of marketing authority for the drug and up to $7.5 million based on sales. Biovail will retain a limited, non-assignable license under the DOV patent to use a formulation in a manner that the company believes cannot be competitive with DOV's diltiazem.

• Epimmune Inc., of San Diego, said it achieved a second milestone in its collaboration with Genencor International Inc., of Palo Alto, Calif. Epimmune identified epitope candidates for inclusion in the human papilloma virus therapeutic vaccine being developed by the companies. Epimmune received an undisclosed milestone payment from Genencor as a result.

• Eternal Technologies Group Inc., of Orlando, Fla., said its board authorized a common stock repurchase program, effective immediately. The purchases will be made in block trades, open market and private transactions at the discretion of management in accordance with SEC regulations.

• Gene Logic Inc., of Gaithersburg, Md., completed its acquisition of TherImmune Research Corp., also of Gaithersburg. Total consideration in the acquisition was about $52 million. Gene Logic paid about $30.9 million in cash and issued nearly 4 million shares of stock, worth about $21.1 million. TherImmune provides discovery, preclinical and early stage clinical trial drug development services. The acquisition was originally announced in February. (See BioWorld Today, Feb. 26, 2003.)

• GTC Biotherapeutics Inc., of Framingham, Mass., said that the University of Texas Medical Branch at Galveston and Shriners Hospital for Children in Galveston, presented results of a preclinical study on the use of GTC's recombinant human antithrombin to treat acute lung injury from smoke inhalation and pneumonia. Highlights of the presentation included data regarding the inhibition of airway obstruction and impaired gas exchange in the lungs of sheep when treated with rhATIII. The results were presented at the 35th annual meeting of the American Burn Association in Miami.

• Human Genome Sciences Inc., of Rockville, Md., said results from a Phase II trial of repifermin (keratinocyte growth factor-2, KGF-2) showed it was well tolerated and had efficacy in treating cancer therapy-induced mucositis. Repifermin is a human protein designed to stimulate the repair of injured skin and mucosal tissues. The study was conducted at multiple centers in 42 patients who underwent chemotherapeutic conditioning regimens for autologous hematopoietic stem cell transplantation. Repifermin had no differences from placebo in adverse events or laboratory abnormalities. Repifermin reduced the incidence of grade two to grade four mucositis, compared to control patients (p< 0.0069). All 14 control patients developed mucositis. In patients receiving 25 mcg/kg of repifermin, the incidence of mucositis was reduced by 29 percent, compared with control. In patients receiving 50 mcg/kg of repifermin, the incidence of mucositis was reduced by 50 percent compared with control. Human Genome's stock (NASDAQ:HGSI) rose $1.18 Wednesday, or 13.9 percent, to close at $9.69.

• IBM, of Somers, N.Y., said it formed an alliance with IDBS, of Guilford, UK, bringing together the companies' technologies to create an informatics platform for drug discovery that integrates both chemical and biological data. The platform is designed to increase research and development efficiency and improve collaboration among researchers. IBM's computing and storage systems and infrastructure software for managing data, data integration and collaboration will be coupled with IDBS' software for the capture, organization, integration and analysis of biological and chemical drug discovery data.

• ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said the World Health Organization in Geneva, the Centers for Disease Control and Prevention in Atlanta, Health Canada and the FDA contacted the company regarding the availability of ribavirin I.V. to treat severe acute respiratory syndrome (SARS). ICN said it has not conducted any clinical research to support the use of ribavirin I.V. in the treatment of SARS, but is cooperating with the agencies.

• ILEX Oncology Inc., of San Antonio, said that the chairman of neurology at Addenbrooke's hospital in Cambridge, UK, presented clinical data from several pilot studies of Campath (alemtuzumab) in multiple sclerosis. Chairman, Alastair Compston, reported that results from one pilot study showed a five-day course of Campath suppressed disease activity for a prolonged period in 36 patients with secondary, progressive MS. In a study involving 17 patients with early, active relapsing-remitting MS without progression or severe disability, the group had a near complete reduction in annualized relapse rate, and in no patient did disability increase.

• King Pharmaceuticals Inc., of Bristol, Tenn., said it would not proceed with its planned acquisition of the primary care business unit of Elan Corp. plc, of Dublin, Ireland. King said various breaches and misrepresentations by Elan have resulted in its decision to pass on the purchase, which would have included Sonata (zaleplon) and Skelaxin (metaxolone). Elan has brought suit against King to force the latter to close the transaction, with a trial date of May 15 scheduled in the Supreme Court of the State of New York. (See BioWorld Today, Jan. 31, 2003.)

• Ligand Pharmaceuticals Inc., of San Diego, decided not to acquire the outstanding stock of X-Ceptor Therapeutics. Ligand, a minority owner since it and a group of private investors formed X-Ceptor, will continue to own about 17 percent of X-Ceptor's stock. Ligand retained an option to purchase all of, but not less than, the outstanding stock by June 30, 2003. (See BioWorld Today, July 2, 1999.)

• Neuro Bioscience Inc., of New York, signed an agreement to acquire a minimum of 75 percent of the outstanding shares of CLL Pharma S.A., of Nice, France. CLL Pharma has five drug delivery systems that address the reformulation marketplace. Neuro Bioscience is focused on central nervous system drugs. Financial terms were not disclosed.

• Neuroregeneron Co., a division of Schwartz Pharma AG, of Monheim, Germany, reported at this week's American Spinal Injury Association meeting in Miami that reversal of amyotrophic lateral sclerosis (Lou Gehrig's disease) might be possible using thrombopoietin and thyroid hormone to cause regeneration of endogenous stem cells of the central nervous system. Evidence from a study of one patient suggests spinal cord injury can be reversed through regeneration by stem cells. The FDA approved the trial after it was demonstrated that platelet growth factors could be increased through use of thrombopoietin, Neuroregeneron said.

• Norwood Abbey Ltd., of Melbourne, Australia, said its share purchase plan concluded, raising a total of A$1 million (US$600,000). Intersuisse Corp. Ltd., the underwriter, exercised its right to reduce its underwriting commitment from A$2 million to A$1 million. The funds bring Norwood's total raised to A$6 million for its current quarter. Separately, it said it appointed Richard Williams CEO of Norwood Immunology. The company focuses on laser-assisted delivery, microneedle arrays, needleless-injection systems and pressure wave technology for the transfer of drugs and genetic material.

• Peregrine Pharmaceuticals Inc. of Tustin, Calif., said its wholly owned subsidiary, Avid Biosciences Inc., signed an agreement with an undisclosed biotechnology company for the cGMP manufacture of up to four monoclonal antibodies that are to be used in upcoming clinical studies.

• Protein Pathways Inc., of Woodland Hills, Calif., entered a research collaboration with Merck & Co., of Whitehouse Station, N.J. Merck will apply Protein Pathways' ProNexus technology to its drug discovery efforts. The company said its technology automatically predicts, integrates and analyzes protein interactions from multiple data sources facilitating the rapid identification of therapeutically relevant genes in specific disease pathways. Financial terms were not disclosed.

• Sagres Discovery Inc., of Davis, Calif. acquired MemRx Corp., of San Diego. The merger combines Sagres' Oncogenome and MemRx's knowledge in crystalizing and determining the structures of membrane-bound protein targets. Financial terms were not disclosed. In January, Sagres formed an agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to identify oncology drug targets. (See BioWorld Today, Jan. 10, 2003.)

• Salmedix Inc., of San Diego, began a multicenter Phase II trial of SDX-102 (L-alanosine) in patients with non-small-cell lung cancer, mesothelioma, pancreatic cancer, osteosarcoma and soft tissue sarcoma. Previous clinical trials sponsored by the National Cancer Institute, a unit of the National Institutes of Health in Bethesda, Md., and the University of California at San Diego, established the safety and tolerability of SDX-102. Salmedix said it developed a laboratory test that can be conducted on tumor biopsy specimens to identify patients expected to be selectively sensitive to SDX-102. Salmedix will present three abstracts describing the test, which is being used to identify patients for the trial, at this week's American Association of Cancer Research meeting in Toronto.

• Schering AG, of Berlin, said PTK787/ZK 222584, being developed with Novartis AG, of Basel, Switzerland, entered Phase III trials in metastatic colorectal cancer. The trial will evaluate the product in combination with first- and second-line chemotherapy. The product is an oral angiogenesis inhibitor that is designed to inhibit vascular endothelial growth factor receptor tyrosine kinases.

• Sepracor Inc., of Marlborough, Mass., said the FDA accepted its new drug application for Estorra (eszopiclone) 2 mg and 3 mg tablets for transient and chronic insomnia. The drug was studied at 3 mg for adults and at 2 mg for the elderly population. Sepracor submitted its application Jan. 31.

• Sheffield Pharmaceuticals Inc., of Rochester, N.Y., drew down the second of three $150,000 installments of secured debt financing effected Feb. 25 with an undisclosed lender. The note bears a 9 percent annual interest rate and matures on the closing of a licensing transaction for the Unit Dose NanoCrystal Budesonide drug product being developed through Respiratory Steroid Development Ltd., Sheffield's joint venture with Elan Corp. plc, of Dublin, Ireland. Sheffield said it would use the funds for general operating purposes.

• SurroMed Inc., of Mountain View, Calif., entered a biomarker discovery agreement with Wyeth, of Madison, N.J. Wyeth will supply clinical samples for analysis in SurroMed's BioMarker Discovery Laboratory. SurroMed will analyze the samples using its SurroScan microvolume laser-scanning cytometry system. Financial terms were not disclosed.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said the FDA requested minor revisions to the Phase I study protocol in the investigational new drug application that SYBD submitted for Oxycyte in February. The company completed revisions to the protocol and submitted an amendment to the IND on March 27. Oxycyte is SYBD's perfluorocarbon-based blood substitute and therapeutic oxygen carrier. SYBD also reported the company is in negotiations with private investors for new funding to finance the Phase I study and a Phase II testing program. The company plans to move manufacturing of Oxycyte to a contract pharmaceutical manufacturing firm in southern California, near SYBD's headquarters.

• Texas Biotechnology Corp., of Houston, and GlaxoSmithKline plc, of London, reported at the American College of Cardiology meeting in Chicago, that the direct thrombin inhibitor Argatroban in combination with glycoprotein IIb/IIIa inhibitors (platelet blockers) provided adequate anticoagulation with an acceptable risk of bleeding during percutaneous coronary interventions such as coronary angioplasty and stent placement. Data from a multicenter study showed that 100 percent of combination therapy patients achieved angiographic success and adequate anticoagulation, while only 2 percent had an incident of major bleeding. Argatroban was approved in July 2000 for blood clots in patients with heparin-induced thrombocytopenia.

• The Center for Cardiovascular Disease Prevention at Baylor College of Medicine and Christie Ballantyne, director of the Methodist DeBakey Heart Center in Houston presented new research on Lp-PLA2, a pro-inflammatory risk factor for coronary heart disease at the American College of Cardiology's annual meeting in Chicago.

• Titan Pharmaceuticals Inc., of South San Francisco, said that two years after receiving treatment with Spheramine, patients with advanced Parkinson's disease demonstrated sustained improvements in motor function. New results from Titan's pilot clinical study, which followed six patients for more than 24 months, showed that Spheramine produced on average 41 percent improvement in motor function. Spheramine is a cell therapy in development that uses normal human cells attached to microcarriers and is designed to enhance brain levels of dopamine.

• Unigen Pharmaceuticals Inc., of Broomfield, Colo., entered a collaboration with 21st Century Therapeutics Inc., of Michigan, for the discovery, development and commercialization of anticancer drugs targeted against solid tumors, including colon, lung, breast and prostate cancer. Unigen will supply 21st Century with botanical extracts, fractions and pure compounds for conducting a cellular assay in which drug leads are discovered and targeted to selectively inhibit tumor cell growth. Unigen will apply its technology platform, PhytoLogix, to de-replicate the hit fractions and isolate solid tumor selective natural products for clonogenic, formulation and pharmacological studies at 21st Century.

• University MS Centre, University of Torino in Turin, Italy, presented findings at the American Academy of Neurology's annual meeting, revealing differences in disease activity after increasing the dose and frequency of beta interferon therapy in relapsing-remitting multiple sclerosis patients following treatment with a lower-dose, lower-frequency regimen. The results showed that such reduction is associated with increased disease activity. In the study, 13 patients who had received interferon beta-1b 250 mcg (Betaferon/Betaseron for SC Injection, Chiron Corp., of Emeryville, Calif., with partners Berlex Laboratories Inc. and Schering AG) for three years, and were consistently free of clinical and MRI disease activity, changed to once-weekly interferon beta-1a (Avonex, Biogen Inc., of Cambridge, Mass.) 30 mcg for one year. During that time, disease activity resumed in most patients. All patients then changed back to a high-dose, high-frequency beta interferon regimen - seven received interferon beta-1b 250 mcg every other day, four received interferon beta-1a (Rebif, Serono SA, of Geneva) 44 mcg three times weekly, and two received interferon beta-1a (Rebif) 22 mcg three times weekly. Results showed that during the year on the high-dose, high-frequency regimens, patients had lower relapse rates compared to the preceding year on the lower, once-weekly dose. The proportion of patients who experienced exacerbations was lower, also.

• Vernalis Group plc, of Reading, UK, reported Phase IIIb data at the American Academy of Neurology meeting in Honolulu from a study of frovatriptan for the prevention of menstrually associated migraine. Findings indicated that frovatriptan was effective in preventing menstrually associated migraines when administered for six days during the perimenstrual period. Frovatriptan, a 5-HT 1B/D agonist, is FDA approved for the acute treatment of migraine attacks with or without aura in adults.