• aaiPharma Inc., of Wilmington, N.C., said the FDA approved the new drug application for Allegra-D 24-Hour tablets (fenofenadine HCI 180 mg/pseudophedrine HCI 240 mg). The once-daily formulation was developed by aaiPharma in concert with Osmotica Pharmaceutical, also of Wilmington. Approved for treating seasonal allergy symptoms with nasal congestion in adults and children age 12 and older, aaiPharma said Allegra-D 24 Hour is the only once-daily prescription antihistamine with a decongestant. The company will receive a one-time payment and sales-based royalties. The drug is marketed by the Sanofi-Aventis Group, of Paris, which submitted the NDA in December.

• AEterna Zentaris Inc., of Quebec City, entered a license and collaboration agreement with Tulane University in New Orleans for the development of growth hormone-releasing hormone (GH-RH) antagonists. AEterna Zentaris obtained worldwide, exclusive rights to develop and commercialize the GH-RH antagonists for all potential indications, including cancer and endocrine disorders, in exchange for research funding, an up-front fee and milestone payments, in addition to potential royalties.

• Affymetrix Inc., of Santa Clara, Calif., said researchers will present more than 20 studies using its GeneChip DNA analysis technology at the American Society of Human Genetics' annual meeting in Toronto this week to identify genetic links to more than a dozen conditions including prostate cancer, Alzheimer's disease and neural tube defects. Companies including ParAllele BioScience Inc. and Perlegen Science Inc. also will present data from genotyping and whole-genome association studies using Affymetrix's microarray technology.

• Avanir Pharmaceuticals Inc., of San Diego, said results of its first Phase III trial of Neurodex were published in the Oct. 26, 2004, issue of Neurology and showed that it effectively palliates pseudobulbar affect in amyotrophic lateral sclerosis patients and is more effective than either of its components. Further, treatment improved quality of life and relationships for the patients. The company intends to begin submission of a new drug application to the FDA this year.

• BioVision AG, of Hannover, Germany, received an undisclosed milestone payment for its efforts in identifying and validating new bioactive molecules as part of a collaboration with Novo Nordisk A/S, of Bagsvaerd, Denmark. Terms of the agreement called for BioVision to analyze samples provided by Novo Nordisk using its Peptidomics technologies.

• Chromatin Inc., of Chicago, raised $7.3 million in a Series B round of financing. The company said the funding would enable it to ramp up staff and facilities and accelerate growth in core programs for its mini-chromosome technology. The technology is designed to deliver multi-gene clusters to ensure stable and consistent gene expression in plants. New investors included the National Corn Growers Association, Illinois Ventures and Unilever Technology Ventures. Returning investors included Burrill & Co., Venture Investors and Foragen.

• Columbia Laboratories Inc., of Livingston, N.J., received European approvals for Striant (testosterone buccal system) mucoadhesive 30 mg for testosterone-replacement therapy in men with primary or secondary hypogonadism under the mutual recognition procedure. The UK acted as the reference member state for the procedure.

• Compugen Ltd., of Tel Aviv, Israel, and Tel Aviv University reported the development of a new method for identifying alternative splicing without the need for either expressed sequence tag data or microarray experimentation. Hundreds of predicted proteins discovered to date using the new predictive method are undergoing initial assessment for possible addition to Compugen's pipeline, as well as for licensing. The work was published in Genome Research.

• Corcept Therapeutics Inc., of Menlo Park, Calif., said it has resolved a previously disclosed issue relating to inventorship under a patent exclusively licensed by the company from Stanford University in Palo Alto, Calif. The patent in question covers the use of GR-II antagonists to treat psychotic features of psychotic major depression. Under the resolution, Corcept retains its exclusive rights under the patent, and no additional payments under the license will be required.

• Corixa Corp., of Seattle, said European authorities issued a positive opinion for Fendrix, a hepatitis B vaccine being developed by GlaxoSmithKline plc, of London. Fendrix contains Corixa's MPL adjuvant and is designed to help prevent infection from hepatitis B in specific high-risk groups, such as pre-hemodialysis and hemodialysis patients.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said an independent Data Safety Monitoring Board recommended a Phase III trial continue as planned to examine Cubicin's (daptomycin for injection) safety and efficacy in treating infective endocarditis and bacteremia caused by Staphylococcus aureus, following a fourth planned safety review. The latest review stems from data from more than 135 treated patients. Cubist said it continues to expect to report results in the middle of next year.

• CV Therapeutics Inc., of Palo Alto, Calif., said investigators enrolled angina patients into its Ranexa study ahead of schedule. The trial might provide adequate data for approval, CV said. Should the current rate continue, the company would expect patient enrollment to be completed by the end of the first quarter of next year with data available late in the next quarter or early in the third quarter. Since it began in August, the ERICA study has enrolled 372 of about 500 patients expected to be included. On Wednesday, CV's stock (NASDAQ:CVTX) gained $2.24, or 18 percent, to close at $14.75.

• Discovery Laboratories Inc., of Doylestown, Pa., said that the European Medicines Evaluation Agency determined that the marketing authorization application for Surfaxin for the treatment and prevention of respiratory distress syndrome in premature infants was validated, which means that the company's application is complete and that the review process has begun. In the U.S., Discovery Labs filed a new drug application with the FDA for clearance to market Surfaxin for the prevention of RDS. The FDA accepted the NDA filing and established a target date of Feb. 13 for completion of the NDA's review.

• EPIX Pharmaceuticals Inc., of Cambridge, Mass., said the FDA has questions related to non-contrast MRA comparator scans used in Phase III trials of MS-325, on which the product's new drug application are based, and the statistical treatment of uninterpretable scans. EPIX previously reported that MS-325 virtually eliminated uninterpretable MRA images in the studies, while non-contrast MRA produced a significantly higher rate of uninterpretable images. The MS-325 Phase III trial protocol required investigators to use standard clinical practice for acquiring non-contrast MR angiograms, but the FDA expressed concern that a uniform non-contrast imaging method was not used at all sites. The agency requested analyses to help it understand whether the specific choice of non-contrast imaging technique affects the results of the Phase III trials, and also requested several analyses showing alternative statistical treatment of uninterpretable scans in the calculation of sensitivity and specificity including analyses in which uninterpretable scans are excluded. EPIX said it has provided detailed responses to those questions.

• Exelixis Inc., of South San Francisco, Calif., filed a universal shelf registration statement on Form S-3 with the SEC covering the issuance and sale, from time to time, of common stock, preferred stock, debt securities and warrants, either individually or in units, with a total value of up to $200 million. The securities, which could be offered in one or more offerings in any combination, will in each case be offered pursuant to a separate prospectus supplement issued at the time of the particular offering that will describe the specific types, amounts, prices and terms of the offered securities. Exelixis anticipates using net proceeds for research and development and general corporate purposes.

• FibroGen Inc., of South San Francisco, said its lead anti-fibrotic agent, FG-3019, given as a single two-hour infusion was safe and well tolerated in a 21-patient Phase I study in idiopathic pulmonary fibrosis. No dose-limiting toxicities were seen. The fully human monoclonal antibody is designed to delay or stop the progression of fibrotic disease by blocking connective tissue growth factor. The company said results presented at the annual meeting of the American College of Chest Physicians in Seattle suggest FG-3019 could prevent disease progression and improve lung function by controlling the fibrotic effects of the pathological growth factor. The company plans to begin a Phase II study in the same indication in 2005.

• Hana Biosciences Inc., of South San Francisco, gained a license to exclusive U.S. and Canadian rights from NovaDel Pharma Inc., of Flemington, N.J., to a lingual spray formulation of the anti-emetic compound ondansetron hydrochloride (Zofran, GlaxoSmithKline plc). Ondansetron is available in branded tablets, orally dissolving tablets and intravenous formulations, but the lingual spray formulation of the 5HT3 antagonist might provide a more convenient and rapid delivery. Under the agreement, Hana purchased an undisclosed number of NovaDel common shares and NovaDel received equity in Hana. Hana will pay all development costs related to the product, and NovaDel will receive milestone development payments and royalties.

• Igeneon AG, of Vienna, Austria, completed its exploratory, double-blind, placebo-controlled Phase II trial of IGN101 in patients with several forms of carcinoma, such as cancers of the colon, rectum or upper gastrointestinal tract. The trial was designed to examine survival effects in the different indications. The primary endpoint of the 239-patient trial was overall survival. Analysis is ongoing, with final survival data scheduled to be presented at the 19th annual meeting of the International Society for the Biological Treatment of Cancer in San Francisco, Nov. 4-7.

• Immtech International Inc., of Vernon Hills, Ill., said that enrollment was completed in the Phase II trial of DB289 for the treatment of Pneumocystis carinii pneumonia (PCP). PCP is a respiratory fungal infection common in immunosuppressed patients that can be fatal if not treated. The trial, conducted in Peru, involves AIDS patients chronically infected with PCP who have failed standard therapy.

• Introgen Therapeutics Inc., of Austin, Texas, said findings published in the online edition of Molecular Therapy identify a unique mechanism of action for INGN 241 contributing to its antitumor effects observed in clinical trials. The study, performed in melanoma, showed that INGN 241 is secreted during therapy resulting in the killing of injected target cancer cells, as well as neighboring cancer cells.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said Phase III results showed an equivalent median survival of about 10 months among non-small-cell lung cancer patients who took Affinitak in combination with Gemzar (gemcitabine HCl) and cisplatin, compared to those receiving the chemotherapy alone. That was the primary endpoint of the trial. Findings from the trial, which was sponsored by Eli Lilly and Co., of Indianapolis, are similar to the results of an initial Isis-sponsored Phase III study. The addition of Affinitak to Gemzar and cisplatin was adequately tolerated, which was consistent with observations in the previous Phase III trial.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., said the FDA determined that Istalol is not therapeutically equivalent to other commercially available timolol maleate solutions and granted the glaucoma product a "BT" rating, meaning that prescriptions for Istalol cannot be substituted legally at pharmacies with generic products. The company said it launched a campaign to notify retail pharmacists of the FDA's rating.

• Mymetics Corp., of Annapolis, Md., received a $5 million financial commitment from Cornell Capital Partners LP. Mymetics may, at its discretion, issue shares to Cornell at any time over the next two years. Subject to the $5 million limitation, Mymetics may draw down up to $175,000 per advance.

• NeoPharm Inc., of Lake Forest, Ill., said John Kapoor, the company's former chairman, sent a letter to CEO Greg Young asking him to confirm or deny rumors on whether he would resign if Kapoor was successful in his consent solicitation. Kapoor asserts he is looking forward to working with Young and would not replace him, should the consent solicitation be successful. Kapoor is soliciting, among other things, consent to elect three new independent directors and to remove incumbent directors.

• Onyx Pharmaceuticals Inc., of Richmond, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., said the FDA named sorafenib (BAY 43-9006) an orphan drug for renal-cell carcinoma. A similar designation has been granted in Europe. Currently in Phase III testing for metastatic renal-cell carcinoma, BAY 43-9006 is a RAF kinase and VEGFR inhibitor that is intended to prevent tumor growth by combining two anticancer activities: inhibition of tumor-cell proliferation and tumor angiogenesis.

• Peninsula Pharmaceuticals Inc., of Alameda, Calif., said that the FDA granted fast-track designation for Doripenem for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia. Doripenem, Peninsula's lead product candidate, is a broad-spectrum antibiotic and a new member of the carbapenem class of beta-lactam antibiotics. Peninsula is evaluating Doripenem in six Phase III trials.

• Pluristem Life Systems Inc., of Haifa, Israel, said that Shai Meretzki, founder of the company, assumed the position of acting CEO. Pluristem is dedicated to the development of stem cell expansion technology.

• Senetek plc, of Napa, Calif., and IGI Inc., of Buena, N.J., signed a letter of intent for Senetek to acquire IGI in a stock-for-stock transaction in which Senetek shareholders would receive 60 percent of the shares of a newly formed holding company and IGI shareholders would receive 40 percent. The holding company would be organized in the U.S. and would seek listing on either the Nasdaq SmallCap Market or the American Stock Exchange. Senetek is focused on the dermatological and skin care product markets. IGI's Novasome micro-encapsulation technology is used in cosmetics, skin care products, dermatological formulations and other consumer products.

• Senomyx Inc., of La Jolla, Calif., entered a five-year agreement with Nestle SA for novel flavor ingredients in the coffee and coffee-whitener fields. Nestle will be responsible for funding research and development, and Senomyx is eligible for milestone payments based on specified goals, as well as product royalties. Research funding and milestone payments could exceed $13 million. It is the second collaboration between the companies; the first, focused on novel food flavors and flavor enhancers, was signed in 2002.

• Thermo Electron Corp., of Waltham, Mass., launched an initiative for protein biomarker discovery and development. Known as the Biomarker Research Initiatives in Mass Spectrometry Center, the joint collaboration with investigators at Massachusetts General Hospital in Boston will focus on the development of mass spectrometry-based technologies dedicated to the discovery of protein biomarkers.

• Thromb-X NV, a division of ThromboGenics Ltd., of Dublin, Ireland, and Chemicon International, a division of Serologicals Corp., of Atlanta, signed an exclusive global agreement to market embryonic stem cell reagents developed by Thromb-X. At the center of the agreement is the commercialization of the TX-WES culture medium that was specifically developed to enable the derivation of new non-permissive strains and to rescue existing lines. Chemicon will offer products through its direct sales team in North America, Australia, the UK and much of Europe, as well as through its worldwide network of distributors.

• Vasogen Inc., of Toronto, said preclinical data reported at the Society for Neuroscience meeting in San Diego demonstrated the ability of VP025 to reverse a key measure of memory and learning impairment in aged animals and also to prevent such impairment in animals injected with beta-amyloid. VP025 also was shown to reduce activation of microglial cells and to abrogate both the age-related increase in concentration of the inflammatory cytokine IL-1(B) and the activation of JNK. Additionally, VP025 was shown to modulate a key cell-survival pathway involving TrkB and pERK, and also restored the age-related loss of synaptophysin, a measure of the density of synapses in the brain.

• Viventia Biotech Inc., of Toronto, said Phase I results showed documented tumor responses in several patients treated with its lead product candidate Proxinium, for advanced, recurrent head and neck cancer. The study, which completed enrollment in eight months, was primarily designed to assess the safety and tolerability of Proxinium monotherapy over an escalating dose range.