• Aastrom Biosciences Inc., of Ann Arbor, Mich., entered an alliance to jointly develop tissue regeneration treatments with the Musculoskeletal Transplant Foundation in Edison, N.J. The partners initially plan to combine Aastrom's Tissue Repair Cells (TRCs) with the foundation's allograft matrices for bone graft applications. They will share in the development and clinical trial expenses, and will adopt a coordinated promotion and marketing strategy for future products. In addition to allograft-based bone graft treatments, they plan to explore joint cartilage regeneration products and combinations of TRCs with the foundation's ceramic matrix technology. Aastrom's stock (NASDAQ:ASTM) gained 12 cents Tuesday, or 10 percent, to close at $1.32.

• Amylin Pharmaceuticals Inc., of San Diego, reported that Ginger Graham was named president and CEO, effective Sept. 1. Graham recently worked with Guidant Corp., where she was group chairman, office of the president. Amylin is focused on the development of therapies for metabolic diseases and has two late-stage, first-in-class diabetes product candidates, Symlin (pramlintide acetate) and exenatide (synthetic exendin-4). Joseph Cook Jr., the current chairman and CEO, will remain chairman.

• AnorMED Inc., of Vancouver, British Columbia, said that Fosrenol (lanthanum carbonate), a phosphate binder for use in end-stage renal disease patients and licensed to Shire Pharmaceuticals Group plc, of Andover, UK, became the first noncalcium phosphate binder to demonstrate sustained efficacy and a good safety profile during three years of treatment, according to data presented at the World Congress of Nephrology in Berlin on Tuesday. In the study comparing lanthanum carbonate to calcium carbonate, data from a subgroup of dialysis patients who had completed at least 36 months of lanthanum carbonate treatment revealed that 71.7 percent of patients had controlled serum phosphorus after one year and 68.9 percent after three years. AnorMED granted Shire an exclusive worldwide license to develop, manufacture, use and sell Fosrenol in 1996. Separately, AnorMED reported a restructuring of the senior management team. Effective July 1, Geoffrey Henson will leave his role as chief operating officer and will work with AnorMED in an advisory capacity.

• BioSeek Inc., of Burlingame, Calif., was awarded a Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The two-year, Phase II grant will support the expansion of BioSeek's BioMAP (biological multiplexed activity profiling) technology for compound validation and prioritization in human primary cell-based inflammatory disease models.

• Biota Holdings Ltd., of Melbourne, Australia, issued 5.6 million shares to a subsidiary of Australia-based Babcock & Brown Pty. Ltd. at A45 cents per share for proceeds of A$2.5 million (US$1.6 million). Also, Andrew Tyndale, of Babcock & Brown, was named a director of Biota. Biota is focused on viral diseases.

• Cell Pathways Inc., of Horsham, Pa., said its stockholders voted to approve its acquisition by OSI Pharmaceuticals Inc., of Melville, N.Y. Cell Pathways added that the all-stock transaction, originally worth about $32 million, would close within the next few days. OSI will exchange .0567 of its shares for every share of Cell Pathways upon closing. (See BioWorld Today, Feb. 11, 2003.)

• Cell Therapeutics Inc., of Seattle, said it is advancing the development of its camptothecin polymer conjugate. The company expects to begin Phase I and Phase II studies of CT-2106 in combination with standard chemotherapy in colorectal cancer and as a single agent in small-cell lung cancer. CT-2106 links 20S-camptothecin to CTI's polyglutamate polymer, creating the second agent in the company's portfolio to use that delivery technology.

• Chiron Corp., of Emeryville, Calif., said that as of 3 p.m. London time Monday, valid acceptances of the offer to acquire all the outstanding shares of PowderJect Pharmaceuticals plc, of Oxford, UK, had been received in respect of, in aggregate, about 66 million PowderJect shares, representing about 71.9 percent of PowderJect. The offer has been extended and will remain open for acceptance until 3 p.m. June 23. Also, at 3 p.m. Monday, Chiron UK had acquired or agreed to acquire, or received valid acceptances under the offer in respect of, in aggregate of nearly 70 million PowderJect shares, or about 75.9 percent of PowderJect. (See BioWorld Today, May 20, 2003.)

• Ciphergen Biosystems Inc., of Montreal, said it launched a new line of SEND ProteinChip Arrays that improve the applicability of SELDI-TOF-MS. The new biochip product family enables SELDI-TOF-MS-based metabolomics and enhances MS-based protein ID, it said.

• Corixa Corp., of Seattle, said it raised about $115 million after closing a pair of private placements, one about $85 million of convertible subordinated notes due 2008, and the second $30 million of newly issued common shares. The 4.25 percent convertible subordinated notes, which were offered to unspecified institutional buyers, will be convertible at the holders' option into Corixa common stock at $9.175, subject to adjustment in certain circumstances. At the initial conversion price, a 25 percent premium to the $7.34 closing price of Corixa's common stock on Monday, each $1,000 in principal amount of notes will be convertible into about 109 common shares. The notes will be subordinate to existing and future senior indebtedness of Corixa, which also granted the initial purchasers a 13-day option to buy up to an additional $15 million in principal amount of the notes. At the same time, Corixa issued to the Sprout Group about 3.7 million new common shares at $8.044 apiece. For an additional $.125 per underlying share, the investors also will purchase 669,435 five-year warrants for common stock with the same exercise price. Corixa said it would use the net proceeds for research and development and general corporate purposes, including working capital. Pacific Growth Equities LLC acted as the financing's placement agent. (See BioWorld Today, June 10, 2003.)

• Durect Corp., of Cupertino, Calif., began clinical testing of its postoperative pain-relief depot product, a sustained-release injectable using the Saber delivery system and a local anesthetic. It is designed to be administered locally around a surgical site after surgery. The product is intended to provide local analgesia for up to three days.

• Encelle Inc., of Raleigh, N.C., closed on more than $2 million in the second and final tranche of its Series D preferred stock offering. The round was led by North Carolina Enterprise Fund, also of Raleigh, and Intersouth Partners, of Durham, N.C. The company said funds would be used for the development of new applications of its tissue-regeneration biopolymer, E-Matrix, and to support a collaborative development effort with Smith & Nephew in testing E-Matrix in healing diabetic foot ulcers.

• EXegenics Inc., of Dallas, adopted a stockholder rights plan designed to protect the interests of eXegenics' stockholders by, among other things, encouraging potential acquirers of eXegenics to negotiate with the board so as to enhance the board's ability to achieve the best possible value for all eXegenics stockholders. eXegenics' stock (NASDAQ:EXEG) gained 25 cents Tuesday, or 41.7 percent, to close at 85 cents.

• Galileo Genomique Inc., of Montreal, is collaborating with First Genetic Trust, of Chicago, to provide pharmacogenomics research capabilities to the pharmaceutical and biotechnology industries. The collaboration will create a research resource of large-scale clinical networks from Quebec and the U.S. The collaboration is designed to provide targeted pharmacogenomics services across a range of therapeutic areas, including inflammation and immunological diseases, cardiovascular and metabolic diseases, and central nervous system/psychiatric disorders. Galileo will provide data from its phenotyped patients from the Quebec founder population, as well as other global founder populations.

• Generex Biotechnology Corp., of Toronto, said it raised $1 million through a private placement of 666,667 unregistered common shares to an existing accredited institutional investor. The unnamed investor, which also received three-year warrants to purchase common shares at $1.80 apiece, has the right to require Generex to register the shares and the shares issuable upon exercise of the warrants.

• Genetronics Biomedical Corp., of San Diego, entered into two new Cooperative Research and Development Agreements with the Naval Medical Center San Diego to further assess the feasibility of using in vivo electroporation enhanced DNA delivery of various functional growth factor genes for the purpose of improving the healing process for incisional wounds and laser-injured skin. Experimental studies will be conducted in a large animal model.

• GenoMed Inc., of St. Louis, said it began clinical trials against common RNA viruses including monkeypox, West Nile virus and HIV. GenoMed said the latest trials complement its efforts to combat severe acute respiratory syndrome, or SARS, using an approach to safely modulate the host's immune response.

• Genzyme General, a division of Genzyme Corp., of Cambridge, Mass., said the European Committee for Proprietary Medicinal Products issued a positive opinion on expanding the indication for Cerezyme (imiglucerase) to include Type III Gaucher's disease, the chronic neuronopathic form of the disease. Final approval of the label expansion by the European Commission is expected in three to four months. The European Commission generally follows the advice of the CPMP, but is not required to do so, Genzyme said. Cerezyme is a human enzyme replacement therapy approved in more than 55 countries.

• ICN Pharmaceuticals Inc., of Costa Mesa, Calif., began its cash tender offer of $5.60 per share for all outstanding shares of its subsidiary, Ribapharm Inc., that ICN does not already own. ICN currently owns about 80.1 percent of Ribapharm's outstanding shares. The offer is being made by ICN through its wholly owned subsidiary, Rx Acquisition Corp.

• Introgen Therapeutics Inc., of Austin, Texas, said its MDA-7-based cancer drug, INGN 241, demonstrated anti-angiogenic properties in a preclinical study presented during the annual meeting of the American Society of Gene Therapy in Washington. The compound is in a Phase II study in solid tumors. INGN 241 supplies MDA-7 protein, which induces apoptosis in many types of cancer, the company said. Introgen's stock (NASDAQ:INGN) fell $1.46 Tuesday, or 16.4 percent, to close at $7.46.

• Meridian Bioscience Inc., of Cincinnati, signed its second biopharmaceutical manufacturing agreement for its life science production facility located at its subsidiary, Viral Antigens Inc., of Memphis, Tenn. Hawaii Biotech Inc., of Honolulu, selected Viral Antigens to manufacture and supply bulk polyvalent recombinant subunit vaccine for dengue virus 1-4. The bulk vaccine for human studies will be produced in Viral's facility designed for the production of recombinant proteins and antibodies for use in therapeutic agents and vaccines. Financial terms were not disclosed.

• NeuroSearch A/S, of Ballerup, Denmark, said that Abbott Laboratories, of Abbott Park, Ill., initiated Phase I studies with the compound ABT-202 for the treatment of pain. NeuroSearch will receive an undisclosed milestone payment from Abbott. NeuroSearch and Abbott entered an agreement based on compounds modulating a specific family of ion channels in 2000, and an extension was signed in August 2002. The original deal was designed to net $17 million for NeuroSearch for each successfully developed compound. (See BioWorld Today, Jan. 7, 2000.)

• Nymox Pharmaceutical Corp., of Maywood, N.J., reported progress in its collaboration on oncology product development with researchers at Brown University in Providence, R.I. Nymox said the sponsored research and development agreement "has moved ahead significantly." Nymox is involved in compound development for oncological indications, including currently incurable solid tumors.

• Oncolytics Biotech Inc., of Calgary, Alberta, said it entered an agreement to raise C$6 million (US$4.4 million) through the private sale of 2 million units priced at C$3 apiece. Each unit, consisting of one common share and a half-share purchase warrant, entitles the holder to acquire one common share for C$4 for 18 months after closing. The shares will be subject to a four-month hold provision. Oncolytics, which said it would use the proceeds for general corporate purposes, said the placement would close June 19.

• Orexo AB, of Uppsala, Sweden, changed its name from Diabact AB. The company has Rapinyl in a Phase II acute pain trial. The product is based on Orexo's patented fast-dissolving tablets.

• Orphan Medical Inc., of Minneapolis, laid off 25 percent of its work force but gained $29.5 million in cash after selling worldwide rights to Busulfex (busulfan) Injection and its current inventory to ESP Pharma Inc., of Edison, N.J. Orphan said the majority of the layoffs primarily were related to support positions for the drug, which is used as a conditioning regimen prior to hematopoietic progenitor cell transplantation. The company plans to use the proceeds to fund further development and marketing of Xyrem (sodium oxybate) oral solution, a product already FDA-approved for cataplexy and being studied as a treatment for narcolepsy and other sleep disorders. As a result of the sale, Orphan lowered its full-year revenue forecast to a range between $15 million and $18 million, compared to previous estimates between $20 million and $23 million. ESP said the purchase would be added to its revenue base and be accretive to earnings due to Busulfex's high gross margin and opportunities for marketing synergies with its flagship product, Cardene IV.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., raised gross proceeds of about $2 million with eight institutional investors in exchange for the issuance of common stock and warrants. The proceeds from the financing will help fund operations including the continued development of its Vascular Targeting Agent clinical candidate. The company believes it has cash on hand to fund operations through at least October 2004, excluding any revenues to be generated through subsidiaries. It issued about 2.4 million shares at a price equal to an approximate 10 percent discount to the trailing five-day average closing price ending May 29. It also issued 150,000 four-year warrants equal to 7.5 percent of the total number of shares of common stock issued to certain investors with an exercise price equal to the per-share purchase price. About 412,000 common shares sold under the financing did not receive any warrant coverage. It also announced the recent conversion of about $1.5 million in existing convertible debt under an August financing in exchange for common stock at the predetermined conversion price.

• PPD Inc., of Wilmington, N.C., reported the consolidation of its informatics services under the new name of CSS Informatics Inc., representing the integration of PPD Informatics and Complete Software Solutions Inc., or CSS. CSS was a privately held technical consulting firm acquired by PPD in 2002.

• Primagen Holding BV, of Amsterdam, the Netherlands, said it identified a new virus, belonging to the family of enteroviruses, in collaboration with the Department of Human Retrovirology of the Academic Medical Center, University of Amsterdam. The virus is the subject of a European patent application titled "New enterovirus, vaccines, medicaments and diagnostic kits."

• Protein Polymer Technologies Inc., of San Diego, reported the final closing of $250,000 in a private placement of Series I convertible preferred stock and warrants, yielding total gross proceeds of $3.25 million. The net proceeds will be used to fund the company's research and clinical programs, and for general corporate purposes. Investors included Johnson and Johnson Development Corp., Taurus Advisory Group and other unnamed institutional and accredited investors.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said researchers from Columbia University and Regeneron Research Laboratories reported that Regeneron's VEGF Trap caused shrinkage of established, growing tumors and their metastases in a mouse model of anaplastic Wilms tumor, a highly aggressive kidney tumor that occurs most commonly in children. The results of the study appear in the June 10, 2003, issue of the Proceedings of the National Academy of Sciences.

• Stressgen Biotechnologies Corp., of Victoria, British Columbia, said a Phase II trial of HspE7 showed a statistically significant 78.6 percent difference related to the primary endpoint, a reduction in the number of surgeries for pediatric recurrent respiratory papillomatosis (p=0.015), supporting further studies in a Phase III program. The disease, which causes warts in the upper airways and lungs, results from the same human papillomavirus types that cause genital warts. Stressgen, which will continue longer-term follow-up out to 60 weeks, said it would release more detailed results at a scientific conference later this year. In the meantime, the company said it would meet with the FDA in the second half of this year to discuss a Phase III program, which could begin in the second half of next year when sufficient quantities of commercial-grade material would be released by development partner F. Hoffman-La Roche Ltd., of Basel, Switzerland. The drug already is being studied in a Phase III trial in anal dysplasia. Stressgen's stock (TSE:SSB) fell C59 cents Tuesday, or 22 percent, to close at C2.09. (See BioWorld Today, Nov. 7, 2000, and June 25, 2002.)

• VaxGen Inc., of Brisbane, Calif., was awarded a Small Business Innovation Research grant worth up to $2 million from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md. The Phase II grant, which will fund work to identify antigens for potential use in future HIV vaccine candidates, is in addition to the $210,000 VaxGen received late last year through Phase I.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said it would lay off 111 of its 848 employees as part of a restructuring plan to focus operations in advancing later-stage products through clinical development and commercialization. Vertex, which is reducing its work force among those involved in certain early discovery programs at its Cambridge and San Diego sites, said the operational flexibility is required as its pipeline matures. The pipeline at Vertex, which reported $680 million in cash, cash equivalents and marketable securities as of March 31, includes the HIV protease inhibitor 908, awaiting U.S. and European regulatory approval; four products in Phase II development; three in Phase I; and six in preclinical development, from which the company expects to select two candidates.

• YM BioSciences Inc., of Mississauga, Ontario, reported results from a Phase I/II open-label, dose-finding study for TheraCIM h-R3 in head and neck cancer. The trial was designed to study TheraCIM h-R3 when used in combination with radiation therapy for the treatment of unresectable head and neck cancer. Data collected to date demonstrated a complete tumor response in nine of 12 patients who received 200 mg of TheraCIM h-R3 and eight of 12 patients who received 100 mg given once weekly for six weeks with standard radiation therapy.