• AEterna Laboratories Inc., of Quebec City, and its wholly owned subsidiary Zentaris GmbH reported statistically significant positive results from a recently completed Phase II program designed to evaluate cetrorelix in three different indications: endometriosis, pre-surgical treatment of uterine myomas and benign prostatic hyperplasia. The findings, which also demonstrated good tolerability in all indications, will form the basis for further development of cetrorelix in different indications through a collaboration with Solvay Pharmaceuticals BV, of Brussels, Belgium. More detailed data, along with a new depot formulation of the luteinizing hormone-releasing hormone antagonist in endometriosis and in pre-surgical treatment of uterine myomas, will be presented at next month's World Congress of the International Federation of Fertility Societies in Montreal.

• AGY Therapeutics Inc., of South San Francisco, moved its headquarters to 270 E. Grand Ave. in South San Francisco. The new space provides a 25,000-square-foot facility that will accommodate all employees. The building also will support preclinical activities. AGY Therapeutics is focused on discovering and developing central nervous system therapeutics.

• Applied Biosystems Group, of Foster City, Calif., and Stanford University said a team of their researchers published findings in the April 29, 2004, issue of The New England Journal of Medicine describing the identification of six genes associated with survival in diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin's lymphoma. The paper presents an analysis of 36 genes associated with survival in DLBCL, which were selected from among more than 10,000 candidate genes. Expression profiles for the 36 genes were measured in 66 DLBCL tumor samples using real-time PCR and the Applied Biosystems TaqMan Gene Expression Assays on an ABI Prism 7900HT Sequence Detection System.

• ARYx Therapeutics Inc., of Santa Clara, Calif., initiated dosing within its Phase I trial of ATI-7505, a pro-kinetic agent for the treatment of gastroesophageal reflux disorder and gastroparesis. ATI-7505 is an analogue of cisapride and has been designed to have similar efficacy to cisapride but with improvements and changes to the metabolism and cardiac safety profile of the drug. ARYx said it anticipates that those changes will overcome the side effects caused by cisapride.

• Barrier Therapeutics Inc., of Princeton, N.J., raised $75 million after pricing 5 million common shares in its initial public offering at $15 apiece. The company, which sold all the shares, develops dermatology products. Its four most advanced candidates, which are in or entering Phase III trials, are in development for seborrheic dermatitis, Candida-associated diaper dermatitis, fungal infections and congenital ichthyosis. Barrier's shares will trade on the Nasdaq National Market under the symbol "BTRX." The company granted the underwriters a 30-day overallotment option to purchase up to an additional 750,000 shares. Morgan Stanley acted as book-running manager, with co-management from Banc of America Securities LLC and JP Morgan Securities Inc.

• Biogen Idec Inc., of Cambridge, Mass., and Fumapharm AG, of Lucerne, Switzerland, reported results from a Phase II study of BG-12, an oral fumarate, in patients with severe psoriasis. Patients who received BG-12 in the trial showed greater improvement in their psoriasis than patients receiving placebo. The trial, conducted by Fumapharm, involved 144 patients with severe forms of psoriasis. At week 12, median percentage reductions from baseline Psoriasis Area and Severity Index score were 71 percent for patients receiving 720 mg, 52 percent for patients receiving 360 mg, 31 percent for patients receiving 120 mg and 6 percent for patients receiving placebo. The results were presented Thursday at the spring symposium of the European Academy of Dermatology and Venerology in Budapest, Hungary.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said a comparative preclinical study demonstrated its calcium phosphate nanotechnology-based vaccine adjuvant, BioVant, might be more effective than aluminum salt derivatives. The study was conducted in collaboration with the Centers for Disease Control and Prevention. In addition to a BioVant formulation that promotes an antiviral immune response, the company's researchers developed a formulation that produces an antibacterial response. Both formulations were tested in the study to assess the efficacy in eliciting cellular and humoral immune responses to a recombinant circumsporozoite protein from the infectious stage of malaria.

• Caliper Life Sciences Inc., of Hopkinton, Mass., began shipping a protein assay for the LabChip 90 Automated Electrophoresis System, which it called an alternative to the conventional method for sizing and quantification of proteins (SDS-PAGE). Capable of automated sampling from 96-well microtiter plates, the company said the LabChip 90 system benefits laboratories short on personnel.

• CancerVax Corp., of Carlsbad, Calif., reported preclinical results that support the anti-angiogenic effects of H8, a humanized monoclonal antibody to denatured collagen licensed to its wholly owned subsidiary Cell-Matrix Inc. The data indicated that H8 inhibits angiogenesis in animal models of choroidal neovascularization, an ophthalmologic condition caused by excess growth of blood vessels within the eye. The data were presented this week during the annual meeting of the Association for Research in Vision and Ophthalmology held Sunday through Thursday in Ft. Lauderdale, Fla.

• Celmed BioSciences, a subsidiary of Theratechnologies Inc., of Montreal, said interim results of an ongoing open-label study showed that Theralux was able to completely eradicate cancer cells from autologous stem cell grafts in 88 percent of non-Hodgkin's lymphoma patients. The ex vivo photodynamic therapy is a noninvasive process used outside the body to treat disorders affecting the blood and bone marrow. Another analysis with all available patients showed that 77 percent received grafts without detectable levels of cancer cells after the Theralux therapy. The remaining patients received grafts in which greater than 85 percent of cancer cells were eliminated.

• Ceregene Inc., of San Diego, said it will advance its gene therapy for Alzheimer's disease following Phase I data that showed early indications of a potential reduction in the advancement of the disease in patients with a mild to moderate form. Radiologic studies found that brain metabolic activity increased in the treated patients in comparison to non-treated Alzheimer's disease patients. Ceregene has exclusive worldwide rights to the technology.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said it would discontinue its investment in oral formulations of a broad-spectrum antibiotic called ceftriaxone, known collectively as OCTX, as results from human research studies were too variable to confirm therapeutic application of the formulations and did not meet an established threshold of bioavailability. The company originally licensed the technology from International Health Management Associates Inc. and the University of Utah in late 2000, and a little more than a year later demonstrated clinically relevant blood levels of ceftriaxone delivered intraduodenally in human volunteers. Since achieving those results, Cubist scientists have worked to optimize oral-dosage formulations, achieving improved bioavailability in animal and humans, but insufficient levels to justify further internal development and investment. The company decided to spend its resources on the launch of Cubicin (daptomycin for injection) and pursuing potential in-licensing candidates to strengthen its near-term pipeline. The company's stock (NASDAQ:CBST) rose 24 cents Thursday to close at $10.44.

• Emergent Technologies Inc., of Austin, Texas, licensed drug and chemical discovery technology from the University of Texas in Austin. The technology uses a chemical-based platform that adjusts a cell's ability to resist foreign compounds it encounters in its environment. Emergent formed Entercel Ltd. to commercialize the technology of Brian Windsor, formerly scientific director with Texagen Inc., and Stan Roux and Alan Lloyd at the university.

• Galen Holdings plc, of Craigavon, Northern Ireland, sold its UK-based pharmaceutical product sales and marketing business for $72 million in cash to a company under the control of Allen McClay, the founder and former chairman of Galen. The pharmaceutical business achieved sales of $32.9 million for the year ended Sept. 30. It sells products such as Kapake, an analgesic; Regurine for incontinence; and Loestrin, an oral contraceptive. Galen also has an agreement to sell its sterile fluids solutions business for $4.5 million plus working capital to Gambro BCT, of Lakewood, Colo. That business achieved sales of $12 million in 2003.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., signed an amendment to its license agreement with the University of Utah and Yale University, gaining certain rights to a patent estate related to five cardiac ion channel genes associated with Long QT, Brugada and related syndromes. Genaissance entered the license agreement in May 2003 as part of its acquisition of DNA Sciences Inc. The amendment simplifies the royalty structure for the genetic test for cardiac ion channel mutations, which Genaissance expects to launch in May, and other genetic tests and products. It also extends Genaissance's license rights to the patent estate, including the company's right to grant sublicenses.

• Isolagen Inc., of Houston, said it plans to publicly offer 7 million common shares pursuant to its registration statement filed with the SEC. The underwriters also were granted an overallotment option to purchase up to an additional 1.05 million shares (200,000 from the company and 850,000 from selling stockholders). CIBC World Markets Corp. is acting as sole bookrunner and co-lead manager with Legg Mason Wood Walker Inc. Acting as co-manager is Adams, Harkness & Hill Inc.

• Jerini AG, of Berlin, extended a three-year-old collaboration into a strategic alliance with Baxter Healthcare Corp., of Deerfield, Ill., to develop peptidomimetic drugs against an undisclosed target. Baxter also has an exclusive option to jointly identify peptidomimetic drugs against further targets. Starting in 2001, the partners used Jerini's Peptides-to-Drugs technology platform to identify several peptidomimetic lead compounds, and under the extended collaboration, Jerini will further optimize the peptide-derived agonistic molecules. Together, they are aiming to identify a clinical development candidate within the next 24 months. For its work, Jerini will receive an up-front payment, personnel funding, milestones payments for discovery, preclinical and clinical stages, as well as royalties.

• MediGene AG, of Martinsried, Germany, began a 60-patient Phase II trial of Polyphenon E ointment in Germany and Switzerland to treat actinic keratosis. Results are expected in 2005. MediGene had been developing the ointment to treat genital warts, with positive results from a Phase III trial announced last month.

• NicOx SA, of Sophia-Antipolis, France, signed a licensing and co-development agreement with Grupo Ferrer Internacional SA, of Barcelona, Spain, for the research, development and marketing of new steroid derivatives for treating dermatological diseases in selected markets. The collaboration's lead compound is NCX 1022, for which NicOx reported Phase IIa data showing that the ointment produced a statistically significant improvement in clinical efficacy symptoms of seborrheic dermatitis, including erythema, scaling and pruritis in 40 patients. NicOx would receive undisclosed development milestones and commercial success fees, plus royalties. NicOx will be responsible for the initial synthesis of the new compounds, while Ferrer will be responsible for and fund all development activities through to registration. Ferrer will have marketing rights for the European Union, EFTA, Latin America, French-speaking Africa and Egypt. NicOx retains all rights for the U.S. and Asia, and will retain a co-marketing right in the European Union and EFTA. A joint development committee will coordinate and oversee all research and development activities.

• Point Therapeutics Inc., of Boston, said data on PT-100 indicated adjuvant properties to antigenic peptides in preclinical models of peptide vaccination. PT-100 appears to induce CD4+ and CD8+ T-cell responses and potentially provide immunity. More specifically, the findings showed that co-administration of PT-100 with a cytotoxic T-lymphocyte (CTL) peptide antigen and a T-cell-helper peptide, administered either orally or intranasally, induced T-cell responses that were dose dependent on PT-100. Immune responses did not require that PT-100 and the CTL peptide be delivered to physically proximal sites, nor were they induced by PT-100 or the CTL peptide alone.

• Repligen Corp., of Waltham, Mass., said initial Phase I data reported at the American Academy of Neurology meeting in San Francisco support the safety and mechanism of action of CTLA4-Ig for multiple sclerosis. Findings showed that a single dose of CTLA4-Ig at either 2mg/kg or 10mg/kg in patients with relapsing-remitting multiple sclerosis appeared to be safe, and the results provide early evidence of a biologic effect of administration of the drug.

• Santarus Inc., of San Diego, said the FDA accepted for filing the company's new drug application for Rapinex powder for oral suspension 40 mg to treat gastric ulcers and to prevent upper gastrointestinal bleeding in critically ill patients. The product is an immediate-release formulation of the proton pump inhibitor omeprazole. Santarus expects the FDA to complete its review of the Rapinex 40-mg NDA by the end of this year. The company also submitted the NDA for a 20-mg version to treat heartburn and other gastroesophageal reflux disease symptoms, and of erosive esophagitis and duodenal ulcer, in August. That review is expected to be complete in June. The NDA for the 40-mg version was filed in February.

• Tercica Inc., of South San Francisco, gained a nonexclusive license to patent rights from Fujisawa Pharmaceutical Co. Ltd., of Osaka, Japan, pertaining to the use of recombinant human Insulin-Like Growth Factor-I (rhIGF-I) for treating certain forms of extreme insulin resistance, including Type A insulin-resistant diabetes. Tercica obtained Fujisawa's rights in extreme insulin resistance to develop and commercialize rhIGF-1 on a nonexclusive basis worldwide, except in Japan. Financial terms were not disclosed.

• The Immune Response Corp., of Carlsbad, Calif., said its T-cell receptor peptide vaccine, NeuroVax, produced a peptide-specific immune response in 94 percent of the patients treated in a Phase I/II trial in multiple sclerosis. Results of the trial, which was discontinued early when an interim analysis revealed the high rate of response, were presented Wednesday at the 54th annual meeting of the American Academy of Neurology in San Francisco. The study involved 37 patients who were randomized to receive either the three TCR peptides with saline, the NeuroVax combination, or adjuvant alone. Using an intent-to-treat analysis, the proportion of patients who were TCR vaccine responders was significantly greater (p<0.001) in the NeuroVax group, compared with one out of 15 for the TCR/saline group and zero out of six for the adjuvant group.

• Topigen Pharmaceuticals Inc., of Montreal, appointed Paul Wotton president, CEO and a member of the board. Wotton was most recently head of global business development for SkyePharma plc, of London. Topigen has discovered a platform technology using DNA/RNA chemistry for the treatment of respiratory diseases.

• Transkaryotic Therapies Inc., of Cambridge, Mass., agreed to sell $90 million worth of 1.25 percent senior convertible notes due 2011. The company, which plans to use the proceeds to fund research and product development activities, as well as other general corporate purposes such as its expected buyout of minority holders of its majority-owned European subsidiary, granted the underwriters an overallotment option for an additional $10 million. The notes are convertible into common shares at an initial conversion price of about $18.49 apiece, a premium of about 22.5 percent over Thursday's closing price. JP Morgan Securities Inc. is the sole book-running manager, SG Cowen & Co. LLC is the joint lead manager, and Pacific Growth Equities LLC and RBC Capital Markets Corp. are co-managers. (See BioWorld Today, April 29, 2004.)