• 4SC AG, of Martinsried, Germany, raised €9 million (US$10.4 million) in a third round of financing. The company said it would use the proceeds to fund advancement of its hyperproliferative and infectious diseases products into clinical trials, and for ongoing corporate development. To date, 4SC has raised more than €30 million. The latest financing primarily was made of existing investors, including 3i Group, Deutsche Venture Capital DVC, Mulligan Biocapital, Beteiligungsgesellschaft fur die Deutsche Wirtschaft and BioM. All 4SC management board members also participated.

• Aastrom Biosciences Inc., of Ann Arbor, Mich., was awarded a Phase I Small Business Innovation Research grant from the National Institute of Biomedical Imaging and Bioengineering, a unit of the National Institutes of Health in Bethesda, Md. The $101,000 grant will support the development of a system to produce a variety of primary human cell types. The system is expected to incorporate components of Aastrom's technologies in cell production processes and devices and is intended to meet cell production needs for early clinical-stage cell therapies at sites where the full production capabilities of the AastromReplicell System are not yet needed.

• Acacia Research Corp., of Newport Beach, Calif., completed a private placement of about 2.4 million units of its Acacia Research-CombiMatrix stock and warrants at $2.20 per unit. Each unit is one share of Acacia Research-CombiMatrix stock and one half warrant. Each full warrant has an exercise price of $2.75 per share. Net proceeds of about $4.9 million have been allocated by Acacia to its CombiMatrix Group. Acacia Research-Acacia Technologies and Acacia Research-CombiMatrix are separate common stocks issued by Acacia Research Corp.

• Aclara BioSciences Inc., of Mountain View, Calif., reported the signing of an antibody supply agreement with Research and Diagnostic Systems Inc., a subsidiary of Techne Corp., of Minneapolis, for the use and resale of R&D Systems' reagents with Aclara's eTag Assay System. Under the nonexclusive agreement, R&D Systems will supply Aclara with certain reagents, including cytokines and related proteins and antibodies that are being incorporated into the eTag Assay System.

• Advanced Life Sciences, of Woodbridge, Ill., licensed a proteomics-based technology from Argonne National Laboratory in Illinois. The license involves the compound ALS-499, which demonstrated activity in the laboratory toward inhibiting amyloid protein aggregation that is characteristic of the development of several diseases, including Alzheimer's and Type II diabetes. ALS will have exclusive worldwide rights to commercialize ALS-499, as well as the platform technology, as a method for preventing amyloid fibril formation.

• Atrix Laboratories Inc., of Fort Collins, Colo., said major construction has been completed on the expansion of its manufacturing facility. It has received the certificate of occupancy and has started the FDA-mandated validation process.

• Biovation Ltd., of Aberdeen, UK, signed a research agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, under which Biovation will apply its DeImmunisation technology to generate biopharmaceuticals. Biovation will receive research fees and could earn license fees, milestone payments and royalties. The technology involves the identification and removal of T-cell epitopes from molecules.

• BioXell SpA, of Milan, Italy, raised €17 million (US$19.9 million) in a second round of financing. Focused on urology and inflammatory diseases, the company said it would use the proceeds to leverage existing technology platforms and move several programs into clinical development over the next three years. To date, BioXell said it has raised more than €39 million. NIB Capital Private Equity, which led the round, will nominate a director to BioXell's board. Existing investors also participated, including MPM Capital, Index Ventures and Life Sciences Partners, while Investimenti Piccole Imprese was a new investor.

• Celgene Corp., of Warren, N.J., bolstered its JNK (c-Jun N-terminal kinase) inhibitor program by licensing three issued European patents and a pending U.S. patent application from Tufts University in Medford, Mass. The patents and application cover methods for treating and preventing insulin resistance and related disorders. Celgene is developing small-molecule therapies to modulate the JNK signaling pathway, including its lead JNK inhibitor, CC-401, which has completed a Phase I study. Financial terms were not disclosed.

• Cephalon Inc., of West Chester, Pa., reported data from two Phase II studies at the 156th annual meeting of the American Psychiatric Association in San Francisco, showing that Provigil (modafinil) C-IV improves attention deficit hyperactivity disorder symptoms in children in both school and home settings. The studies also showed that Provigil was well tolerated with different dose regimens. Cephalon said it would initiate Phase III studies in children with ADHD later this year.

• Cryo-Cell International Inc., of Clearwater, Fla., said that Ernst & Young LLP, of New York, resigned as the company's independent auditor. Cryo-Cell said it is awaiting guidance from the SEC with respect to the proper accounting treatment for its revenue-sharing agreements and is working with former auditor, Weinick Sanders Leventhal & Co. LLP, of New York, in connection with the company's anticipated restatement of its prior financial statements, which, as previously reported, has delayed the company's quarterly filing for the quarter ended Feb. 28.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., reported new data on its antibiotic, Cidecin (daptomycin for injection), at the American Society for Microbiology meeting in Washington. Findings from various in vitro and animal studies showed daptomycin's bactericidal activity against vancomycin-resistant Staphylococcus aureus and methicillin-resistant S. aureus. Cubist filed a new drug application for Cidecin late last year. (See BioWorld Today, Dec. 23, 2002.)

• Genaera Corp., of Plymouth Meeting, Pa., reported clinical results at the American Thoracic Society meeting in Seattle, describing the relationship of its mucoregulator target, the human calcium-activated chloride channel (hCLCA1), to mucus overproduction in cystic fibrosis. Findings suggested that hCLCA1 is a new therapeutic target to control mucus overproduction in cystic fibrosis airway disease. Genaera also reported that its second-generation hCLCA1 inhibitor, MSI-2216, can decrease the mucus hypersecretion and airway inflammation in a model of acute respiratory infection, produced by the Gram-negative bacterial cell wall component endotoxin. Its stock (NASDAQ:GENR) gained 20 cents Wednesday, or 17.1 percent, to close at $1.37.

• Genome Therapeutics Corp., of Waltham, Mass., working with scientists at BioMerieux, of Paris, identified genetic markers specific to nearly 700 bacterial species. The results were presented at the 103rd general meeting of the American Society for Microbiology in Washington. Genome Therapeutics retains rights to a portion of revenues from any produced products.

• GlycoFi Inc., of Lebanon, N.H., and Baxter Healthcare Corp., of Deerfield, Ill., formed a collaboration under which Baxter will evaluate the potential of GlycoFi's fungal expression platform for the production of human therapeutic proteins. Financial terms were not disclosed. GlycoFi engineers yeast and other fungal-based protein expression systems to produce glycosylated human therapeutic proteins.

• Guava Technologies Inc., of Hayward, Calif., said it introduced a new suite of single-cell tests designed to help biologists gain a profile of the stages of apoptosis. The tests/assays are designed to run on Guava's cell analysis systems.

• Harvard Bioscience Inc., of Holliston, Mass., said Tuesday that a court's judgment in favor of Affymetrix Inc., of Santa Clara, Calif., regarding the dispute with Harvard Bioscience's Genomics Solutions subsidiary will have no impact on forecasted revenues or earnings. On April 30, Affymetrix was granted summary disposition, requiring payment by Genomics Solutions of about $1.5 million in a breach of contracts suit. Harvard Biosciences said it is evaluating whether to appeal or move for reconsideration of the judgment in Affymetrix's favor. Additionally, Harvard Biosciences said it settled a dispute with Oxford Gene Technology Ltd., of Oxford, UK, and will pay a nominal amount to the company.

• Hemispherx Biopharma Inc., of Philadelphia, said the Institute for Antiviral Research, sponsored by the National Institutes of Health in Bethesda, Md., reported a study that screened test compounds for potential use against severe acute respiratory syndrome. The study showed that the company's product, Ampligen, had activity against human coronavirus. Separately, the company said it accelerated several production steps in manufacturing Alferon N, a glycosylated multispecies alpha interferon product sold in the U.S. to treat refractory condylomata acuminata.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said Paladin Labs Inc., of Montreal, licensed the exclusive rights to register, sell, market and distribute Visicol for use in Canada. Paladin paid an undisclosed up-front license fee and will pay royalties to InKine on future sales of Visicol. Paladin will be responsible for all costs to sell, market and distribute the product in Canada. Visicol is a tablet purgative preparation indicated for bowel cleansing prior to colonoscopy.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said Phase II results reported at the Digestive Disease Week meeting in Orlando, Fla., showed that pouchitis patients experience symptom improvements after receiving alicaforsen (ISIS 2302), an antisense inhibitor of the inflammatory target intercellular adhesion molecule-1 (ICAM-1). The 12-patient trial resulted in improvements in endoscopic scores, suggesting a long-term benefit of ICAM-1 inhibition in treating the inflammatory bowel disease.

• Isotechnika Inc., of Edmonton, Alberta, said it is developing an immunosuppressive compound called TAFA93. The therapeutic is a small-molecule mTOR inhibitor, a class of drugs used in the prevention of organ rejection in transplantation and as a coated stent therapy in the treatment of coronary heart disease. The company said that TAFA93 has the potential to be administered as a complementary therapy with its product, ISA247, in the prevention of organ rejection after transplantation.

• Large Scale Biology Corp., of Vacaville, Calif., said it would evaluate field production for its plant-produced human alpha-Galactosidase A as a potential treatment for Fabry's disease, beginning this quarter. In January, the FDA granted the company orphan drug designation for the product, which it plans to develop in a commercial partnership.

• Lorus Therapeutics Inc., of Toronto, reported its intention to move its antisense anticancer drug, GTI-2501, into a Phase II trial for the treatment of advanced metastatic prostate cancer in the fall of 2003. GTI is designed to reduce the expression of the R1 component of ribonucleotide reductase to prevent tumor cell growth.

• NicOx SA, of Sophia Antipolis, France, reported positive clinical endoscopic results with NCX 4016, in development for the treatment of cardiovascular diseases, demonstrating gastro protection even when co-administered with celecoxib. The study involved 32 volunteers and endoscopic results showed celecoxib almost doubled the gastrointestinal injury caused by aspirin, while gastric protection was maintained with NCX 4016. The results were presented at the Digestive Disease Week meeting in Orlando, Fla.

• Novartis Oncology, a division of Novartis AG, of Basel, Switzerland, said the FDA approved Gleevec (imatinib mesylate) for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. The product was first approved in the U.S. in May 2001 for chronic myeloid leukemia in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy. The approval in pediatric patients marks the fourth indication for the drug.

• Option Care Inc., of Buffalo Grove, Ill., said they have been selected as a preferred specialty pharmacy provider of Xolair, a product under review by the FDA for severe allergic asthma in adults and adolescents. The product received a positive unanimous vote from an FDA panel last week. It was developed by Genentech Inc., of South San Francisco; Novartis Pharma AG, of Basel, Switzerland; and Tanox Inc., of Houston.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said researchers from the Keck School of Medicine of the University of Southern California isolated a protein fragment derived from the cancer immunotherapy drug interleukin-2 that functions to enhance the uptake of chemotherapeutic agents by tumor cells by up to 400 percent. The technology is part of a class of compounds called vasopermeation enhancement agents being developed by Peregrine. The research was described in the May 21, 2003, issue of the Journal of the National Cancer Institute.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said that Axcan Pharma Inc., of Mont St. Hilaire, Quebec, revised its hostile tender offer for Salix common stock to $10.50 per share. Salix stock closed at $11.84 on May 20. Axcan also extended the offer period from May 23 to June 27. The offer remains subject to the various terms and conditions imposed by Axcan.

• SangStat Medical Corp., of Fremont, Calif., reported data showing that RDP58 reduces inflammation by targeting TRAFYK (TRA-fic), an intracellular protein complex believed to be associated with regulating multiple signal transduction pathways. TRAFYK is the name given to the TRAF6/MyD88/ RAK protein complex implicated in several inflammatory diseases, including ulcerative colitis and Crohn's disease. The data were presented during Digestive Disease Week at a research forum sponsored by the American Gastroenterological Association. RDP58 is the first in a new class of anti-inflammatory compounds being developed by SangStat.

• Schering-Plough Corp., of Kenilworth, N.J., received European Union approval of Remicade (infliximab) both for ankylosing spondylitis and for maintenance dosing to sustain clinical response and remission in Crohn's disease patients who have responded to infliximab. Approval of the antitumor necrosis factor agent provides unified labeling for all 15 member states, as well as Iceland and Norway. Centocor Inc., of Malvern, Pa., maintains exclusive U.S. marketing rights.

• United Therapeutics Corp., of Research Triangle Park, N.C., gave a presentation at the annual meeting of the American Thoracic Society in Seattle that concluded that United Therapeutics' product, Remodulin, demonstrated safety and efficacy for pulmonary arterial hypertension associated with cirrhosis. Thirty-seven patients with cirrhosis-related pulmonary arterial hypertension were treated for up to 19 months. The patients realized statistically significant reductions in pulmonary vascular resistance (p<0.005) and NYHA functional class (p<0.03) from baseline, and experienced other clinically significant improvements in their hemodynamic measurements and exercise capacity, United Therapeutics said.

The University of Texas Health Science Center, of San Antonio, researchers said topiramate, a derivative of monosaccharide D-fructose, is effective in promoting abstinence among alcohol-dependent individuals. The news was reported in the May 17, 2003, issue of The Lancet.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said it completed enrollment in a Phase II trial of VX-148, a second-generation IMPDH inhibitor for moderate to severe psoriasis. Vertex said it expects to provide top-line results in the second half of this year. The company also began a pilot Phase IIa study of VX-702, an orally administered p38 mitogen-activated protein kinase inhibitor targeting acute coronary syndromes, and a Phase I study of VX-765, an orally active anti-cytokine therapy targeting inflammatory diseases.

• Vion Pharmaceuticals Inc., of New Haven, Conn., began a Phase II trial of Triapine in combination with gemcitabine in patients with metastatic or advanced non-small-cell lung cancer. Vion, which said it would report Phase I data on the combination therapy at the American Society of Clinical Oncology meeting scheduled to begin next week in Chicago, also plans to begin a Phase II combination study in pancreatic cancer in the near future. Its shares (NASDAQ:VION) gained 31 cents Wednesday, or 35.6 percent, to close at $1.18.

• Wyeth, of Madison, N.J., and Takeda Chemical Industries Ltd., of Osaka, Japan, announced a new partnership plan that provides for changing the name of their co-venture, Wyeth Lederle Japan Ltd., to Wyeth K.K. It also includes Wyeth incrementally purchasing over the next several years the 40 percent stake held by Takeda in WLJ, and both companies will co-promote Enbrel (etanercept) for rheumatoid arthritis. The product is pending approval in Japan. Enbrel is an Amgen Inc., of Thousand Oaks, Calif., product.

• Xoma Ltd., of Berkeley, Calif., reported the amendment of certain terms of a financing agreement between itself and Millennium Pharmaceuticals Inc., of Cambridge, Mass. The original agreement was signed in November 2001 and relates to an ongoing collaboration with the Millennium biotherapeutic agents - MLN01 and CAB-2 - for certain vascular inflammation indications. Millennium committed to purchase, at XOMA's option, up to $50 million worth of common shares over a three-year period through a combination of convertible debt and equity at prevailing market prices. Now, an extension of the maturity date of the $5 million outstanding convertible loan from May to February 2004 has been added. Also, XOMA's decision on whether to sell the remaining $37.5 million worth of common shares from three option dates over the next 12 months was rescheduled to six option dates over the next 21 months. (See BioWorld Today, Nov. 27, 2001.)

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