• aaiPharma Inc., of Wilmington, N.C., appointed an independent committee of its board to conduct an inquiry into unusual sales in its Brethine and Darvocet product lines during the second half of last year. The committee has retained King & Spalding LLP, an independent law firm, to assist in the investigation. The specialty pharmaceutical company said it expects such matters to materially affect its previously announced guidance for the first quarter and full year of 2004 and is withdrawing its guidance for those periods. An adjustment to the 2003 financial results also might be necessary. aaiPharma's stock (NASDAQ:AAII) dropped $5.51 Monday, or 36 percent, to close at $9.77.

• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix subsidiary launched its CustomArray DNA Microarray platform, offering researchers the ability to order fully customizable arrays on demand.

• Active Biotech AB, of Lund, Sweden, said it planned to lay off 98 of its 176 employees as part of a shift in strategic focus toward its clinical-phase projects. All discovery activities will be discontinued, though a number of mature discovery projects will be retained in the portfolio to possibly be pursued at a later stage. Key capabilities required to support clinical and late preclinical development projects will be reinforced. The company said its operating costs would be reduced by about SEK100 million (US$13.5 million) per year, compared to 2003.

• Agencourt Bioscience Corp., of Beverly, Mass., said findings published in this month's edition of Nucleic Acids Research point to its use of a bacterial two-hybrid system to determine a genome-wide protein-protein interaction map of virulence-related genes in Rickettsia sibirica.

• Biobase GmbH, of Wolfenbuttel, Germany, licensed its Transpath signal transduction database to GPC Biotech AG, of Martinsried, Germany. The database is designed to be used as an encyclopedia for general or specific information about signal transduction, for analysis of biological networks and gene-expression data, as well as for searching for target molecules of new agents.

• CancerVax Corp., of Carlsbad, Calif., said an independent data and safety monitoring board recommended that the company continue as planned its Phase III trial of Canvaxin for Stage III melanoma, following a scheduled interim analysis of the randomized, double-blinded, international study. The analysis was conducted on data from 842 patients enrolled in the trial, for which CancerVax expects to complete enrollment this year. If successfully completed, the trial would serve as a pivotal study for the submission of a biologics license application for the approval of Canvaxin to treat patients with advanced-stage melanoma. The board also recommended the continuation of another Phase III trial of Canvaxin, for Stage IV melanoma.

• Charter Venture Capital, of Palo Alto, Calif., formed and closed on its early stage life sciences venture capital fund, Charter Life Sciences, with offices in Palo Alto and Cincinnati. The fund completed its first closing of $30 million in committed capital directed by C.M. Capital Corp., also of Palo Alto. Targeting $100 million in total committed capital, Charter said the fund has several additional institutional investors committed to join its next closing. It will invest in early stage biotechnology, specialty pharmaceutical and medical device companies, with a particular focus on cancer, cardiology and women's health. With typical initial investments ranging between $500,000 and $2 million, the fund will typically invest $4 million to $8 million over the life of a portfolio company. Portfolio companies will be split between device companies and biotech/specialty pharmaceutical companies.

• Compugen Ltd., of Tel Aviv, Israel, expanded its pipeline to include CGEN-40, a soluble splice variant of CD40, a member of the tumor necrosis factor receptor family with potential applications in treating autoimmune diseases, cancer, organ transplantation and inflammation. The company disclosed its discovery at the R&D Leaders' Forum in Coral Gables, Fla., at which it described the use of its discovery process that combines predictive mathematical modeling with hypothesis-driven experimentation.

• Cypress Biosciences Inc., of San Diego, said its stock began trading on the Nasdaq National Market with the same ticker symbol, "CYPB," under which its shares traded on the Nasdaq SmallCap Market. Cypress is focused on providing treatments for functional somatic syndromes.

• DMI BioSciences Inc., of Englewood, Colo., said a Phase IIa study of DMI-7958, its investigational drug for premature ejaculation, demonstrated a substantial effect against placebo in male volunteers suspected of having primary physiological premature ejaculation. The trial was conducted in Europe by an international contract research organization using a randomized, double-blinded crossover design. The product was well tolerated with no serious adverse events reported. DMI-7958 is being co-developed with Enhance Biotech Inc., of New York.

• Draximage Inc., the radiopharmaceutical subsidiary of Draxis Health Inc., of Mississauga, Ontario, received FDA approval for MDP-25, a new formulation of a diagnostic product for preparing a skeletal imaging agent. The product is a kit for the preparation of Technetium Tc 99m Medronate Injection, and the imaging agent is used in metastatic bone disease, Paget's disease, arthritic disease and osteomyelitis, and others.

• Entropin Inc., of Indio, Calif., reported progress regarding the preclinical development of its new chemical entity, ENT-103. Investigators have evaluated the effects of ENT-103 on neurogenic inflammatory pain, with ENT-103 delivered both by injection and topical application in a standard animal model. The studies have shown that when given by injection, ENT-103 reduces the severity of inflammatory neurogenic pain, produces longer-lasting effects compared to lidocaine, and exhibits analgesic activity in a dose-dependent fashion. When applied topically, ENT-103 reduces the severity of pain when formulated with an absorption enhancer. It also reduces the severity of pain in a penetration-dependent fashion comparable to EMLA, an FDA-approved topical anesthetic.

• Generex Biotechnology Corp., of Toronto, raised about $1.8 million through private placements of common stock and warrants to five accredited institutional investors. The financings were completed through the issuance of about 1.2 million common shares. Each transaction was priced based upon the closing bid price for Generex's common stock on the date immediately prior to signing definitive agreements, with additional consideration for each warrant. At the closings, additional investment rights to purchase up to the same number of units at the same price per unit were issued to investors. Generex expects to use the proceeds to accelerate clinical development activities and for working capital and other general corporate purposes.

• Genetronics BioMedical Corp., of San Diego, began treating patients with primary or recurrent squamous-cell carcinoma of the head and neck (SCCHN) in a post-approval study in Europe, designed to support the commercialization of its MedPulser Electroporation System in the European Union. Prior clinical trials established the safety and performance of the MedPulser System for the treatment of SCCHN leading to approval for sale in the EU. The European clinical study will, among other things, document the clinical and pharmacoeconomic benefits of the MedPulser and establish centers of excellence to facilitate early sales, the company said. The study will involve 100 patients with primary or recurrent SCCHN.

• Hudson Health Sciences Inc., of South San Francisco, licensed a radiosensitizer called IPdR from Yale University and The Research Foundation of the State University of New York. The company said it expects to begin Phase I trials this year for IPdR, an orally available, halogenated dThd analogue that initially is being developed as a radiation sensitizer for the treatment of certain types of brain cancers. A prodrug of IUdR, an intravenous tumor radiation sensitizer, preclinical studies showed that IPdR is a better radiosensitizer in terms of safety and efficacy with a significantly lower toxicity profile, including gastrointestinal and hematological side effects. Financial terms were not disclosed.

• Neurocrine Biosciences Inc., of San Diego, said a Phase III trial of its modified-release formulation of indiplon achieved highly statistically significant results in adults with transient insomnia. The randomized, double-blinded, placebo-controlled, parallel-group, multicenter study's primary objective was to assess the efficacy of two dose levels (20 mg and 30 mg) relative to placebo on sleep initiation in 325 healthy adult subjects. Its primary endpoint was latency to persistent sleep (LPS), or time to sleep onset, as measured by polysomnography. Indiplon modified-release demonstrated a statistically significant reduction in LPS at both dose levels (p<0.0001) as compared to placebo, with improvements over placebo of about 50 percent for both dose groups. Patient-reported latency to sleep onset, or the amount of time it took subjects to fall asleep, also was significantly reduced (p<0.0001) for both doses, with a more than 50 percent improvement relative to placebo. The product was safe and well tolerated, with no serious adverse events. Indiplon is the subject of nine Phase III studies.

• Orchid BioSciences Inc., of Princeton, N.J., said its shareholders approved a reverse split of the company's common stock. The resolution authorizes Orchid's board to amend the company's restated certificate of incorporation to implement a reverse split ranging from 1-for-3 shares to 1-for-7 shares at any time prior to the company's annual meeting of shareholders, which is scheduled for June 4.

• Pharmacyclics Inc., of Sunnyvale, Calif., reported updated interim data from an ongoing Phase I trial evaluating the investigational drug Xcytrin (motexafin gadolinum) injection in combination with concurrent chemoradiation for the treatment of locally advanced head and neck cancer. Thus far, 12 patients received the regimen, and nine out of 10 evaluable patients remain in complete remission with a median follow-up of one year. The data were presented at the Opinion Leader Consortium on Novel and Targeted Therapies for Head and Neck Cancer.

• Point Biomedical Corp., of San Carlos, Calif., said it plans to submit a new drug application later this year after comparing two pivotal Phase III trials of Cardiosphere, a myocardial perfusion imaging agent used with ultrasound. The trials were designed to evaluate the performance of Cardiosphere imaging relative to radionuclide imaging for detecting obstructive coronary artery disease and identifying the anatomic location of perfusion defects. A total of 884 patients were enrolled. Using a clinically accepted definition of disease as having at least a 50 percent stenosis by angiography in one or more coronary vessels, results showed that sensitivity ranged from 63 percent to 75 percent for Cardiosphere, and 64 percent to 76 percent for radionuclide imaging, with all four readers demonstrating statistical non-inferiority. Specificity results ranged from 48 percent to 60 percent for Cardiosphere and 53 percent to 78 percent for radionuclide imaging.

• Quantum Dot Corp., of Hayward, Calif., said findings published in last month's issue of Nature Biotechnology showed that researchers at the Max Planck Institute in Germany used a new nanosized imaging tool to capture the first-ever movies of cells transmitting the messages that control genes. It is expected to help pharmaceutical companies speed and enhance the process of screening candidate cancer drugs. The researchers used quantum dots developed and manufactured by the company to provide prolonged, real-time visualization in living cells of the signaling mechanisms of the erbB family of receptors.

• Sepracor Inc., of Marlborough, Mass., received an approvable letter from the FDA for its new drug application for Estorra (eszopiclone) 2-mg and 3-mg tablets for the treatment of insomnia characterized by difficulty falling asleep and/or difficulty maintaining sleep during the night and early morning for adult and elderly patients, and a 1-mg tablet for elderly patients whose primary complaint is difficulty falling asleep. The agency did not request additional clinical or preclinical trials for final approval. The company said pre-launch activities are under way, and it is finalizing its plans to expand its sales force to about 1,250 to be ready for launch by mid-year. Sepracor's stock (NASDAQ:SEPR) gained $15.99 Monday, or 56.5 percent, to close at $44.30.

• Serono Inc., of Rockland, Mass., said data published in the current edition of the Journal of AIDS showed that Serostim (somatropin [rDNA origin] for injection) administered daily decreased visceral adipose tissue in patients with HIV-associated adipose redistribution syndrome (HARS). Some people with AIDS or HIV infection develop HARS, an excessive build up of visceral adipose tissue combined with metabolic abnormalities, for which no medical treatment is approved. Results from the multicenter, randomized, double-blinded, 239-paient study showed that the decrease in visceral adipose tissue was highly significant in the Serostim 4-mg daily group (p<0.001), as compared to placebo. The study also showed that the trunk-to-limb-fat ratio, another measure of fat distribution, was significantly reduced in both the Serostim 4-mg daily (p<0.001) and alternate day (p<0.001) groups, compared to placebo.

• Spectral Genomics Inc., of Houston, entered an agreement to gain a worldwide license to certain patents of Affymetrix Inc., of Santa Clara, Calif., to manufacture and sell spotted DNA arrays for use in the diagnostics market, upon regulatory approval of Spectral Genomics' products. The license supports the company's Constitutional Chip to be introduced this year, as well as anticipated specialty arrays to be used in cancer diagnostics.

• Symphogen A/S, of Copenhagen, Denmark, said it received a $2.5 million investment from Vaekstfonden, a government-backed venture fund. The company, which has raised a total of $25 million, said it is planning to initiate a second round of venture financing. Symphogen's technology is designed to produce target-specific recombinant human polyclonal antibodies, symphobodies, for the treatment or prevention of human disease.

• Wilex AG, of Munich, Germany, reported long-term survival data at the German Cancer Society meeting in Berlin, following a Phase II trial of the monoclonal antibody Rencarex (WX-G250) in 36 patients with metastatic renal-cell carcinoma. Clinical benefit, defined as objective response or stabilization of previously progressive disease for at least six months, was observed in 25 percent of the 32 evaluable patients.