• Altana AG, of Bad Homburg, Germany, said Altana Pharma AG officially opened the Altana Research Institute in Waltham, Mass. The institute will focus on genomics and proteomics, but also will have an information technology and bioinformatics component. About 50 scientists are working on projects at the institute now.
• Biogen Inc., of Cambridge, Mass., said it licensed worldwide patent rights relating to fusion proteins, described as immunoadhesons, from Genentech Inc., of South San Francisco. The nonexclusive licenses will apply to Amevive (alefacept), already approved in the U.S. for moderate to severe chronic plaque psoriasis, and other potential products in Biogen's product pipeline. Biogen, which will pay an undisclosed royalty to Genentech beginning immediately, said it already has incorporated the costs into financial guidance for this year.
• Biokeys Pharmaceuticals Inc., of San Diego, changed its name to Adventrx Pharmaceuticals Inc. In connection with the name change, the company was issued a new stock symbol. Its common stock now will trade under the symbol "AVRX" on the Over-the-Counter Bulletin Board.
• Cell Therapeutics Inc., of Seattle, said it was informed by Nippon Shinyaku Co. Ltd., of Kyoto, Japan, that Nippon submitted a new drug application with a request for priority review for Trisenox in Japan. Nippon Shinyaku entered a marketing and distribution agreement for Trisenox with CTI Technologies Inc., a wholly owned subsidiary of CTI in December 2002. Nippon Shinyaku is seeking approval of Trisenox for the treatment of patients with relapsed or refractory acute promyelocytic leukemia. Trisenox was approved for marketing by the FDA in 2002. (See BioWorld Today, Sept. 27, 2000.)
• ConjuChem Inc., of Montreal, said it would raise up to C$12 million (US$8.9 million) after entering an agreement to privately place 6.25 million common shares at C$1.60 apiece on a bought-deal basis with a syndicate of underwriters led by Yorkton Securities Inc., of Toronto. ConjuChem also said it plans to offer an option, exercisable up until 24 hours prior to closing, to purchase up to an additional 2 million shares at the same price. If exercised, the offering's gross proceeds would total C$12 million. ConjuChem said it would use proceeds from the offering, which it expects to close on or about June 27, to fund clinical trials and for general corporate purposes. At the forefront of its clinical efforts is DAC:GLP-1, which has entered a Phase I/II program for Type II diabetes. The company's Drug Affinity Complex (DAC) technology is designed to create new drugs with enhanced therapeutic properties compared to the original formulation. Late last summer, it dropped one program, DAC:TI for clotting, while evaluating the future of another, DAC:Opioid for moderate to severe pain. (See BioWorld Today, Aug. 12, 2003.)
• Deltagen Inc., of Redwood City, Calif., said two board members, Philippe Chambon and Noel Perry, resigned. Chambon is general partner at The Sprout Group, of New York, and Perry is managing director at Baccharis Capital Inc., of Menlo Park, Calif. Deltagen has established small-molecule and secreted-protein drug target discovery efforts in selected areas of immunology and metabolic diseases.
• Durect Corp., of Cupertino, Calif., agreed to privately place $50 million in convertible notes due 2008. The notes will be convertible into stock at $3.15 per share - a 25 percent premium to the closing price of $2.52 on June 12 - and will bear interest at 6.25 percent. The company granted the initial purchaser an option to purchase up to another $10 million in notes. It plans to use the proceeds to fund research, development, manufacturing and commercialization of existing and future products, and for general corporate purposes. (See BioWorld Today, June 13, 2003.)
• Elan Corp. plc, of Dublin, Ireland, and King Pharmaceuticals Inc., of Bristol, Tenn., completed the sale of Elan's primary care franchise - principally its rights to Sonata (zaleplon) and Skelaxin (metaxalone) and rights to enhanced formulations of the products - to King. Elan netted about $314.5 million from the transaction, which was initially announced on May 20. Elan's primary care sales team, consisting of approximately 350 personnel, will be transferred to King. All claims under the pending lawsuit between Elan and King, which had been suspended pending the closing of the transaction, will be dismissed by the parties with prejudice. Elan's shareholders approved an ordinary resolution for the sale of the primary care franchise at a special shareholder meeting Thursday. Total consideration paid by King was $750 million, which included an inventory transfer valued at about $40 million. (See BioWorld Today, Jan. 31, 2003.)
• GeneMedix plc, of Suffolk, UK, and Penang Development Corp., of Penang, Malaysia, (PDC) signed a letter of intent under which GMX and PDC will work together to set up a company in Penang for the development, manufacture and commercialization of human insulin. GeneMedix would outlicense its existing insulin knowledge to a newly formed Malaysian company and help build manufacturing facilities. The total anticipated investment of $34 million is expected to be funded by a mixture of development loans, grants and an issue of equity in the newly formed company to local investors. PDC will make land available and assist in gaining access to the development loans. GeneMedix will receive an up-front payment and potential milestone payments and royalties in return for its outlicensing. It is intended that GeneMedix will be a majority shareholder in the company. The development of the full-scale industrial process will be completed by GeneMedix at its own expense and transferred into the facility, which would be scheduled for completion in mid-2005.
• Gilead Sciences Inc., of Foster City, Calif., reported 96-week data from an ongoing trial demonstrating that resistance to Viread (tenofovir disoproxil fumarate) among treatment-naive patients occurs infrequently. The findings are consistent with data from Gilead's studies in treatment-experienced patients. The data were presented at the 12th International HIV Drug Resistance Workshop in Los Cabos, Mexico. The data are from Study 903, an ongoing three-year trial being conducted in the U.S., Europe and South America. The study was designed to compare the efficacy and safety of a treatment regimen of Viread, lamivudine (3TC) and efavirenz to a regimen of stavudine (d4T), lamivudine and efavirenz in 600 antiretroviral-naive HIV-1-infected patients. Viread is a nucleotide analogue reverse transcriptase inhibitor approved for the treatment of HIV in the U.S. and Europe.
• Intradigm Corp., of Rockville, Md., and Sequitur Inc., of Natick, Mass., entered an agreement to collaborate on the application of RNAi in animal models of disease and in development of RNAi therapeutics. Sequitur will provide and license its Stealth RNAi technology, which it called a modified form of RNAi that is distinct from siRNA, to Intradigm for a number of therapeutic targets. Intradigm will provide and license its TSGV (targeted synthetic gene vector) in vivo nucleic acid delivery technology to Sequitur for a number of therapeutic targets. The privately held companies did not disclose the deal's financial terms.
• Medicure Inc., of Winnipeg, Manitoba, entered an agency agreement with a syndicate led by Research Capital Corp., of Toronto, and including First Associates Investments Inc., of Toronto, and Paradigm Capital Inc. for the issuance and sale of 8.2 million common shares at 85 cents per share representing gross proceeds of about C$7 million (US$5.3 million). The agents also were granted an overallotment option to increase the size of the offering up to a total of about 9 million shares, on the same terms and conditions. Total gross proceeds including the exercise of the overallotment option would be about C$7.7 million.
• Onyx Pharmaceuticals Inc., of Richmond, Calif., filed a registration statement with the SEC to sell from time to time up to $75 million in common stock. It said in its prospectus it intends to use net proceeds for research and development and general corporate purposes. It also might use a portion to acquire or invest in businesses, products and technologies that are complementary to its focus. The company last week cut staff to focus on its lead product, the cancer compound BAY 43-9006, which is in Phase II studies. (See BioWorld Today, June 13, 2003.)
• OSI Pharmaceuticals Inc., of Melville, N.Y., entered an agreement with Celgene Corp., of Warren, N.J., under which OSI will recover full rights to market and promote Gelclair in the North American oncology setting. Gelclair is a bioadherent oral gel that provides relief for the treatment of pain associated with oral mucositis, a side effect in cancer patients undergoing radiation treatment or chemotherapy. Previously, Gelclair was marketed to oncologists under a co-promotion agreement between Celgene and Cell Pathways Inc., of Horsham, Pa. Gelclair was added to OSI's oncology portfolio as part of OSI's acquisition of Cell Pathways. Financial terms of the agreement were not disclosed.
• OxiGene Inc., of Watertown, Mass., completed its previously reported $15 million private placement of common stock. On Tuesday, the company signed a definitive agreement to sell 1.5 million shares at $10 per share to three institutional investors, resulting in gross proceeds to OxiGene of $15 million and proceeds of $14 million after deducting commissions and expenses. OxiGene intends to use the proceeds to fund its operations and ongoing clinical and preclinical development programs. The three institutional investors also received warrants to purchase 375,000 shares of OxiGene common stock, which would be exercisable at $15 per share. (See BioWorld Today, June 11, 2003.)
• Procyon Biopharma Inc., of Montreal, reported on the antiviral activity of P-1946 at the International HIV Drug Resistance Workshop in Los Cabos, Mexico. Researchers from Procyon's new virology division, created through the recent acquisition of Pharmacor Inc., also of Montreal, said the compounds' antiviral activity was determined for wild type and mutant viral strains, using MT-4 as the cell line. They selected compounds with the highest antiviral activity on the wild type HIV-1 NL4.3 virus shown to be active against two typical strains carrying mutations 48/90 and 10/46/63/82/84. The cytotoxicity of P-1946, an L-lysine amino acid derivative representative of a new family of protease inhibitors, is in the same range as currently marketed protease inhibitors. Procyon said its PL-100 protease inhibitor is derived from the PL-1946 compound, which demonstrates a unique resistance profile on drug- and multidrug resistant strains of HIV.
• Q-RNA Inc., of New York, reported the final closing of a Series B financing of $2.6 million to support research and development of RNA ligands and the development of an improved capability for testing mad cow disease. One half was received Dec. 13 and the other half on June 2, after filing by Q-RNA of a specified patent application in the United States. Durand Venture Associates, Wheatley Partners and Double D Venture Fund were investors.
• SuperGen Inc., of Dublin, Calif., said the University of Texas M.D. Anderson Cancer Center in Houston began a Phase II study of its investigational anticancer agent Dacogen (decitabine) for injection, in combination with Gleevec (imatinib mesylate, from Novartis AG) capsules, in patients with chronic myelogenous leukemia. The primary objectives of the 80-patient study, performed under SuperGen's Cooperative Research and Development Agreement with the National Cancer Institute in Bethesda, Md., are to determine the response rate, duration of response and survival. The study also will examine the safety of the drug combination as well as the effects of the combination on gene methylation.
• The Immune Response Corp., of Carlsbad, Calif., initiated a treatment interruption study in Spain, REMIT-2102, to determine whether patients who have demonstrated sustained control of HIV-1 while receiving Remune plus antiretroviral therapy can maintain control of viral load with Remune alone, in the absence of antiretrovirals. A secondary objective of the study is to determine if patients' sustained control of HIV-1 requires ongoing immunization with Remune every 12 weeks. The study will involve about 50 patients who participated in the Phase II trial of Remune (STIR-2102) and then received treatment with Remune during the open-label follow-up of the study.
