• Abbott Laboratories, of Abbott Park, Ill., said the European Medicines Evaluation Agency granted a positive opinion for a label extension of Humira (adalimumab), used in combination with methotrexate to reduce progression of joint damage, as measured by X-ray, and to improve physical function in adults with rheumatoid arthritis (RA). The European Commission approved Humira last year for RA. The FDA approved it in December 2002 for reducing the signs and symptoms of RA and inhibiting the progression of structural damage. In October, Abbott submitted a supplemental biologics license application to the FDA seeking approval of Humira to improve physical function in RA patients. Humira has been approved in 41 countries. In addition to RA, it is being studied for psoriasis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease.

• Akorn Inc., of Buffalo Grove, Ill., entered an agreement with Aero Pharmaceutical Inc., of Boca Raton, Fla., to provide contract manufacturing services. The companies intend to begin development of a manufacturing protocol that will lead to a commercialized product. Akorn manufactures and markets sterile specialty pharmaceuticals, while Aero is a private specialty pharmaceutical company with knowledge in respiratory health.

• Axonyx Inc., of New York, said a blinded data review of the company's ongoing Phase IIb beta-amyloid trial with Phenserine confirmed the original power requirements and the study's ability to achieve its objectives. The company expects results to be available at the end of the year. The six-month, randomized, placebo-controlled, double-blind trial is evaluating the effects of two different dosages of Phenserine in Alzheimer's disease patients. It will evaluate Phenserine's ability to lower the levels of the beta-amyloid precursor protein and amyloid beta in the plasma and cerebrospinal fluid of patients. The trial is expected to include 65 patients, all of whom could participate in the open-label extension study.

• Caliper Life Sciences Inc., of Hopkinton, Mass., and Amphora Discovery Corp., of Research Triangle Park, N.C., entered a definitive agreement for Caliper to acquire certain technology for cell-based screening assays. Amphora, which has developed assays for a number of target classes, will transfer to Caliper its cell culture techniques, and hardware and software upgrades that Amphora has implemented on Caliper's microfluidic screening system. In exchange, Caliper will compensate Amphora through a combination of cash, its products and royalties based on future sales of cell-based assays.

• CeMines Inc., of Evergreen, Colo., appointed Roger Attick president and CEO. He also was elected to the board. Previous CEO Bailey Dotson assumed the title of vice chairman, while CeMines' co-founder, Richard Cavalli, will continue in his role as chairman. Attick has been a venture partner with Artiman Ventures since 2000. Prior to that, he was senior vice president of business markets at Quest Communications International. CeMines' Molecular FingerPrinting products are designed for early stage diagnostics and optimized treatments for cancer.

• CytoGenix Inc., of Houston, said a second round of preclinical animal studies demonstrated that its DNA antibacterial compound is effective in controlling the growth of wild strains of bacteria, including those that cause infection and sepsis in humans. The company said the study showed that the compound is capable of killing wild-type bacteria in a living animal. The next steps involve pharmacological studies to determine safe dosage and toxicology studies in larger animals.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., said the FDA requested it begin a new clinical trial to provide additional safety and efficacy data on oxymorphone extended-release tablets (oxymorphone ER) in support of the company's new drug application. Last fall, the agency issued an approvable letter for the NDA, but also requested that Endo address certain questions and provide additional information, including another clinical trial to further confirm safety and efficacy. The product employs delivery technology from Penwest Pharmaceuticals Co., of Danbury, Conn. Endo's stock (NASDAQ:ENDP) dropped 18 cents Thursday to close at $24.88.

• The Endocrine Society in Chevy Chase, Md., said that women who suffer from polycystic ovary syndrome (PCOS) have a higher chance of developing cardiovascular diseases, according to two new studies published this month in The Journal of Clinical Endocrinology & Metabolism. PCOS, which affects 5 percent to 10 percent of reproductive-aged women, is linked with several serious health conditions, including diabetes, obesity, cardiovascular disease and metabolic syndrome. A retrospective, cross-sectional study of 116 PCOS patients and 94 body mass index-matched controls was conducted to determine whether levels of C-reactive protein are increased in PCOS patients. Tests indicated that 36.8 percent of PCOS patients had extremely high levels of CRP, compared to only 9.6 percent of control women (p<0.001).

• Geron Corp., of Menlo Park, Calif., filed a mixed shelf registration statement with the SEC to occasionally offer up to $150 million worth of common and preferred shares, debt securities and warrants. The company said it would use any resulting proceeds for general corporate purposes, which might include funding research and development, increasing working capital, reducing debt, capital expenditures and acquisitions or investments in complementary businesses, products or technologies.

• Hemosol Corp., of Toronto, said its ticker symbol on Nasdaq would be temporarily changed from "HMSL" to "HMSLV" following its recently completed reorganization. The change is a result of the reorganization, and the ticker symbol is expected to return to "HMSL" on or about May 14. Hemosol is developing biologics, particularly blood-related proteins.

• The Indiana Future Fund I, of Indianapolis, said it made an investment in the Indiana-based Spring Mill Venture Fund, an early stage fund focusing on life sciences and technology opportunities. The Indiana Future Fund I is a $73 million fund designed to attract more venture capital to life sciences opportunities in Indiana.

• Nektar Therapeutics, of San Carlos, Calif., entered an agreement under which GlaxoSmithKline plc, of London, will license Nektar's Advanced PEGylation technology for use in the formulation of a protein under preclinical investigation as a therapy for cancer. Nektar also reported an agreement with an undisclosed biotechnology company in which the technology will be used in the formulation of another preclinical product.

• NeoPharm Inc., of Lake Forest, Ill., said additional Phase I/II data support the company's Phase III study of IL13-PE38QQR, a tumor-targeting agent for glioblastoma multiforme. Data showed that Convection-Enhanced Delivery (CED), the method used to administer IL13-PE38QQR, could be safely used in functional human brain tissue and that catheter placement is related to improvement of patient survival. Data also showed that CED can cause mild, transient neurological deficits that resolve once treatment is completed. Other Phase I data indicated that infusion of IL13-PE38QQR using CED in tissue surrounding the main tumor mass or adjacent to the cavity more consistently led to a clinically significant volume of distribution than infusion into the main tumor mass. The agent appears to be well tolerated and has a favorable safety profile.

• Neurocrine Biosciences Inc., of San Diego, said findings from four Phase III studies reported at the American Psychiatric Association meeting in New York detailed the efficacy and safety of both immediate-release and modified-release indiplon in treating chronic and transient insomnia. The results also show that indiplon is effective across different patient populations, including the elderly. Among the trials, a study of 200 adult patients with chronic primary insomnia, immediate-release indiplon demonstrated a statistically significant improvement in the primary endpoint of latency to persistent sleep. Another showed that with modified-release indiplon chronic insomnia patients fell asleep more rapidly and stayed asleep longer. Results from two Phase I studies demonstrated that the modified-release formulation does not affect respiratory functioning in healthy subjects or those with mild to moderate chronic obstructive pulmonary disease. The company is in the process of filing new drug applications for both formulations. (See BioWorld Today, March 1, 2004.)

• Newron Pharmaceuticals SpA, of Bresso, Italy, and Zambon Group SpA, of Milan, Italy, signed a collaboration and license agreement aimed at discovering, developing and commercializing compounds active as sodium- and calcium-channel blockers to treat pain. Newron will contribute its experience in ion channels and will license selected structures to Zambon. Zambon will contribute its Swiss research facilities dedicated to drug discovery, with expertise in lead optimization and drug development.

• Orchid BioSciences Inc., of Princeton, N.J., said the Irish government authorized its Cellmark unit to provide genotyping services designed to help farmers breed sheep with reduced susceptibility to the prion disease scrapie. Transmissible spongiform encephalopathy is an untreatable, fatal disease that affects sheep worldwide. Orchid will provide genotyping for the National Genotyping Programme being launched by the Irish government.

• OxiGene Inc., of Waltham, Mass., said a research paper published in the online edition of the International Journal of Cancer explores the mechanism by which the company's lead preclinical compound, OXi4503, triggers the collapse of the chaotic network of blood vessels within a solid tumor. The study was conducted in conjunction with scientists from the University of Lund in Sweden and Baylor University in Texas. The effect of a single dose of OXi4503 on tumor blood flow in a mouse model was reduced to 50 percent one hour after drug administration and to less than 10 percent at six hours. Up to 72 hours following treatment, blood flow recovered to just 35 percent. Researchers also noted the potential of OXi4503 to selectively target tumor blood vessels and increase their permeability. Cancer Research UK plans to move the compound into a Phase I trial later this year.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., said its contract with the National Institute of Environmental Health Sciences (NIEHS) was expanded to include work using small interfering RNA technology as part of toxicogenomics research being performed for NIEHS. The company also is subcontracting with the Translational Genomics Research Institute to build a siRNA library for a better understanding of genes that appear to be involved in human response to environmental toxins. Paradigm expects to reach its 2004 revenue target as a result of the NIEHS contract modification. Paradigm and the NIEHS began their five-year, $23.8 million collaboration in September 2002 to study how toxicants work and cause liver damage at the cellular level.

• Samaritan Pharmaceuticals Inc., of Las Vegas, said its HIV drug candidate, SP-01A, exhibited a favorable safety profile in Phase Ib/IIa trials. Efficacy data demonstrated a decrease in viral load (HIV-1/RNA) and wellness improvements. The company said the product appears to work as an entry inhibitor.

• Sepracor Inc., of Marlborough, Mass., said six abstracts reported at the American Psychiatric Association meeting in New York detailed data from large-scale studies of Estorra (eszopiclone) for insomnia. Among the findings were results from a six-month study that showed statistically significant differences between patients taking eszopiclone and those on placebo in median wake time after sleep onset (WASO) in both the low-WASO (p=0.0035) and high-WASO (p=0.0055) groups. Also, the relative reduction from baseline was similar in both subgroups, demonstrating the therapeutic effect of eszopiclone on sleep improvement parameters irrespective of the degree of baseline impairment. Other findings showed that use of another product, eszopiclone, provided sustained improvement in sleep and daytime function over 12 months of treatment in chronic insomnia patients. The non-benzodiazepine also demonstrated consistent improvements in sleep and daytime functioning in both elderly and adult patients with chronic insomnia.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said it was approved for listing on the Nasdaq National Market. Its common stock, which trades on the Nasdaq SmallCap Market, will be eligible for trading on the national market today. The company, which develops drugs for cancer and related disorders, will continue to trade under the "SPPI" ticker symbol.

• System Biosciences, of Mountain View, Calif., launched its first two GeneNet siRNA Expression Libraries made using their pFIV Lentiviral siRNA Expression Vectors. The siRNA libraries are designed to allow researchers to see the effect of thousands of siRNA molecules on cell functions in one experiment.

• Tanox Inc., of Houston, began dosing patients in a Phase II trial of TNX-355 to treat HIV. The three-arm, double-blind, placebo-controlled study will enroll about 80 patients who have had antiretroviral therapy to evaluate TNX-355's safety and pharmacological activity in combination with an optimized background therapy as assessed by viral load reduction. TNX-355, a humanized, non-immunosuppressive, anti-CD4 monoclonal antibody, will be administered every two weeks during the 48-week trial.

• Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., acquired from F. Hoffmann-La Roche Ltd., of Basel, Switzerland, the rights to Tasmar (tolcapone) in the U.S. and certain non-European Union markets for $13.5 million in cash, plus royalties. Valeant gains the rights to manufacture, market and distribute Tasmar, a drug approved for Parkinson's disease. Manufacturing of the product will transition to Valeant over the next two years.

• VION Pharmaceuticals Inc., of New Haven, Conn., said that articles related to its clinical stage anticancer products, Triapine and Cloretazine, were published in a pair of scientific journals. Results of a Phase I trial of Triapine administered by continuous 96-hour intravenous infusion, reported in the May 1, 2004, issue of the Journal of Clinical Oncology, demonstrated that Triapine could be administered on an every-other-week schedule with tolerable and reversible toxicity. Prolonged stabilization of disease or decreases in serum tumor markers associated with stable disease was observed in four patients with advanced cancer. Findings from a Phase I trial of Cloretazine in patients with refractory leukemia, published in the May 1, 2004, issue of Clinical Cancer Research, demonstrated single-agent antitumor activity, including complete responses in a patient with myelodysplasia and a patient with relapsed acute myeloid leukemia.