• A.P. Pharma Inc., of Redwood City, Calif., filed a shelf registration statement with the SEC for the sale of up to $15 million of its common stock. Terms of the offering, not yet effective, will be made at the time of the offering. A.P. Pharma develops drugs using its polymer-based drug delivery systems.

• Advanced Biotherapy Inc., of Woodland Hills, Calif., and Innogenetics NV, of Ghent, Belgium, signed a cross-licensing agreement combining Innogenetics' humanized antibody to interferon-gamma, INNO 202, with Advanced Biotherapy's intellectual property in immune diseases involving interferon-gamma. The companies will target rheumatoid arthritis as part of their agreement. Proceeds would be shared. Both companies can license their intellectual property rights to third parties. Last year, Innogenetics reported positive preclinical results of INNO 202 in severe sepsis.

• Bavarian Nordic A/S, of Copenhagen, Denmark, said it would begin a Phase I study of Imvamune following FDA approval of an investigational new drug application for the third-generation smallpox vaccine candidate. The study, which will include 60 subjects suffering from atopic dermatitis, will be conducted in Europe. Final data are expected next year.

• BioLineRx Ltd., of Jerusalem, agreed to in-license compounds for treating neurological disorders including schizophrenia, neurodegenerative diseases and cancer. The worldwide exclusive license agreement was signed with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel Aviv University, and Bar Ilan Research & Development Co. Ltd., the technology transfer office of Bar Ilan University.

• Biota Holdings Ltd., of Melbourne, Australia, filed suit against GlaxoSmithKline plc, of London, claiming breaches of contract and fiduciary duties for failing to promote and support Relenza. The writ seeks unspecified damages for lost royalty revenues to date, as well as future losses through the life of the product's patents. Biota claims that the product failed not because of any inherent disadvantages or deficiencies, but because support for the product was withdrawn immediately after the launch year.

• ConjuChem Inc., of Montreal, said it received FDA clearance for a Phase I trial with its DAC:GRF compound for the treatment of growth hormone deficiency in children and adults. The Phase I trial dosed the first subject on April 29. The study will enroll a maximum of 48 subjects in six ascending-dose cohorts of six subjects followed by one group of 12 subjects administered the maximum tolerated dose as determined by the results of the earlier cohorts. The primary endpoint will assess the compound's safety and tolerability. Secondary endpoints will measure the pharmacokinetic and pharmacodynamic profiles of the compound based on an assessment of the growth hormone and insulin-like growth factor-1 (IGF-1) in plasma levels.

• Covalent Group Inc., of Wayne, Pa., signed a $1 million contract with DynPort Vaccine Co. LLC, of Frederick, Md., for a Phase I study to develop a recombinant vaccine against Yersinia pestis infection. Covalent will provide study design consultation, project management, clinical site management and monitoring, data management, biostatistics and medical safety surveillance. Covalent will recognize revenue on the 18-month study in the second half of 2004, with initial subject enrollment beginning in early 2005.

• Elusys Therapeutics Inc., of Pine Brook, N.J., said its antibody, Anthim (ETI-204), was selected by the Centers for Disease Control and Prevention in Atlanta for government evaluation. Anthim, an affinity-enhanced monoclonal antibody being developed for the prevention and treatment of infection and death caused by anthrax toxin, is designed to remove the toxin from the bloodstream.

• FemmePharma Inc., of Wayne, Pa., said Phase II findings reported at the American College of Obstetricians and Gynecologists meeting in Philadelphia showed that FP1096 reduced symptoms of endometriosis with minimal side effects. More specifically, the primary efficacy endpoint demonstrated a statistically significant decrease in such symptoms when treated with the intravaginally delivered investigational drug, as assessed by the Biberoglu and Behrman Symptom Score.

• Genetics Squared LLC, of Ann Arbor, Mich., reported a $1 million investment from regional venture capital firm CrystalPoint Partners in Ann Arbor and a private investor. The funding will be used to recruit management and new staff, invest in additional technology infrastructure and develop a sales operation for the company. Genetics Squared is focused on delivering personalized medicines by using analysis software to stratify patients for disease diagnosis.

• Genitope Corp., of Redwood City, Calif., filed a registration statement with the SEC to offer 4.5 million shares of common stock. Genitope also granted underwriters an option to purchase up to an additional 675,000 shares to cover overallotments. Underwriters are WR Hambrecht & Co., Punk, Ziegel & Co., Brean Murray & Co. Inc. and Stanford Group Co. Genitope is focused on developing immunotherapies to treat cancer.

• Genta Inc., Heights, N.J., is the defendant in a class-action lawsuit filed by Philadelphia-based Berger & Montague PC on behalf of those who purchased Genta securities between Sept. 10, 2003, and May 3. The complaint alleges that Genta and its officers issued false and misleading statements that inflated the market price of Genta's securities by misrepresenting the safety of Genasense in advanced melanoma. The defendants claim Genasense did not appear to be associated with serious adverse reactions in the Phase III trial, but Genta knew that the drug was associated with increased toxicity and discontinuations due to adverse events. An FDA panel has said the drug failed to demonstrate a survival benefit and showed signs of increased toxicity, resulting in Genta's stock dropping more than 40 percent that day. (See BioWorld Today, May 3, 2004, and May 4, 2004.)

• Guava Technologies Inc., of Hayward, Calif., launched its EasyCD4 system outside the U.S., Europe and Japan. The company, which plans to release a version for research use only in the U.S. later this year, said it allows laboratories to monitor direct, absolute CD4 and CD8 T-cell counts in HIV-infected patients, improving on established flow cytometry and manual microscopy methods.

• Helix BioMedix Inc., of Bothell, Wash., conducted the final closing of a private placement, raising about $2.4 million total. The company initially raised $1.1 million in March. It sold units comprised of 50,000 shares of common stock and a warrant to purchase 17,500 shares. Each unit was priced at $100,000, or about $2 per share of stock and a 0.35 warrant share. The company said it will issue about 1.2 million shares and associated warrants to purchase an additional 414,400 shares of common stock. The financing, plus Helix's existing cash, provides the company with enough money to conduct business into fiscal year 2005, it said.

• Illumina Inc., of San Diego, Calif., reported the availability of two universal Sentrix arrays: one that can genotype 384 single nucleotide polymerase loci per sample, and a second that can genotype 786 loci per sample. The two Sentrix Array Matrices use Illumina's existing Golden Gate custom genotyping assay and are supported on the company's BeadLab and BeadStation systems, it said.

• Immtech International Inc., of Vernon Hills, Ill., signed an agreement with CombinatoRx Inc., of Boston, to screen its lead aromatic cationic compounds, DB289 and DB75, for activity against various cancers. Immtech is studying DB289 in Phase IIa/IIb trials to treat malaria and African sleeping sickness. The company believes both compounds will demonstrate activity in oncology in CombinatoRx's studies, which will include in vitro assays and in vivo models to test the compounds alone and in combination with CombinatoRx's cancer technology.

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., submitted an investigational new drug application with the FDA to begin Phase I trials of AEOL 10150 to treat patients with amyotrophic lateral sclerosis (ALS). Incara expects to begin dosing before the end of the second quarter. The study would test the safety of AEOL 10150 in healthy volunteers and patients diagnosed with ALS. Incara also announced the resignation of its president and CEO, Clayton Duncan, who will remain a consultant to the company. Shayne Gad will take over as president, but the company is not filling the CEO position at this time.

• Incell Corp. LLC, of San Antonio, was awarded a contract from the U.S. Air Force to further develop an oral smallpox vaccine product and oral vaccine platform technology. The vaccine is based on the use of a mild smallpox vaccine, known as modified vaccinia Ankara, a weakened strain of cowpox that does not replicate in human cells but can induce an immune response in vaccinated experimental animals and humans.

• Invitrogen Corp., of Carlsbad, Calif., entered an agreement with the National Human Genome Research Institute and the National Cancer Institute to allow open access to its Gateway and SuperScript technologies for use with its Mammalian Gene Collection Program. Gateway technology is a method for cloning DNA sequences in order to study their function. In November, Invitrogen established a new policy to allow government and academic researchers to create and distribute Gateway entry clones and expression clones to any entity, without royalties or licensing fees.

• Janssen Pharmaceutica Products LP, a wholly owned subsidiary of Johnson & Johnson, of New Brunswick, N.J., said findings reported at the American Psychiatric Association meeting in New York showed that many people with schizophrenia, deemed symptomatically stable, experienced further improvements in symptom control when transitioned to treatment with Risperdal Consta (risperidone) long-acting injection from their previous medication. Supporting data include results of a 119-patient European study that showed an improvement in Clinical Global Impression-Severity levels, with 14 percent considered not ill at endpoint vs. 2 percent at baseline. Also, about 22 percent were considered very mild vs. about 11 percent at baseline, and about 16 percent were considered mild vs. about 21 percent at baseline. The product is partnered with Alkermes Inc., of Cambridge, Mass.

• NaPro BioTherapeutics Inc., of Boulder, Colo., changed its name to Tapestry Pharmaceuticals Inc. to reinforce the company's strategy to build a portfolio of therapeutics to treat cancer and hereditary disease. The stock symbol on the Nasdaq SmallCap Market has changed from "NPRO" to "TPPH." Tapestry has six programs in preclinical development for oncology and hereditary disease.

• NexMed Inc., of Robbinsville, N.J., completed a three-month interim analysis of an efficacy and safety study conducted overseas. The trial enrolled 120 patients with various degrees of big toenail fungal infection treated with NM100060, NexMed's nail lacquer treatment for onychomycosis. Interim data suggest that all three tested doses were well tolerated. The primary efficacy rate, defined as simultaneous negative mycological test and healthy new nail growth greater than 3 mm after three months, was up 55 percent.

• OriGene Technologies Inc., of Rockville, Md., said that its TrueClone Kinase Collection of more than 560 nonredundant full-length human cDNA clones was acquired by the Cancer Drug Discovery Laboratory of the Translational Genomics Research Institute in Phoenix for use in high-throughput drug target discovery and development efforts. The institute develops and implements technologies designed to interrogate gene function. Financial terms were not disclosed.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., agreed to sell $125 million in principal amount of 3.5 percent senior convertible notes to qualified institutional investors. The notes, due April 15, 2011, will be convertible into Oscient common stock at $6.64 per share - a 25 percent premium to Tuesday's closing stock price. The notes can be redeemed by Oscient beginning May 10, 2010. Initial purchasers have a 30-day option to purchase up to an additional $18.75 principal amount of the notes. The company said it plans to use a portion of proceeds to acquire government securities to be used for the first six scheduled interest payments. Remaining proceeds would be used to support the launch and development of Factive and to push Ramoplanin, as well as for in-licensing and general corporate purposes.

• Phase 2 Discovery Inc., of Cincinnati, completed a Phase I trial of PD-6735, a melatonin analogue under development for sleep disorders. All doses between 20 mg and 100 mg were well tolerated in the 40-patient trial. Adverse experiences, excluding sleepiness, occurred with the same frequency as placebo.

• Pivotal BioSciences Inc., of Los Angeles, entered a collaboration to develop PB1 with ProteomTech Inc., of Emeryville, Calif. Pivotal acquired exclusive worldwide rights to the product, a low-toxicity analogue of interleukin-2, from the University of Southern California. ProteomTech will assist Pivotal with protein expression in E. coli and the development of processes that lead to competitive production costs.

• ProMetic Life Sciences Inc., of Montreal, and the American Red Cross said they completed screening efforts leading to the discovery of Mimetic Ligands, which selectively extract and purify seven plasma proteins, as part of their alliance to develop a plasma protein-extraction manufacturing platform. The team also identified a preferred sequence of capture steps using affinity chromatography technology called the cascade process.

• Salmedix Inc., of San Diego, began a second clinical study of SDX-105 (bendamustine hydrochloride) in the U.S. and Canada. The Phase II trial will enroll 60 patients and look at SDX-105 in combination with Rituxan in patients with relapsed, indolent or slowly progressing non-Hodgkin's lymphoma who are not refractory to Rituxan therapy. Salmedix also said its first Phase II trial for SDX-105 will be expanded by up to 50 additional patients.

• Sanofi-Synthelabo SA, of Paris, said it is continuing its dialogue with the FTC related to its offer for Aventis SA, of Strasbourg, France. Sanofi-Synthelabo filed a registration statement, including a prospectus/offer to exchange, and will file additional documents with the SEC. It expects its exchange offer to occur on or before the end of this quarter.

• Sirna Therapeutics Inc., of Boulder, Colo., closed its previously reported private placement financing of about 5.8 million common shares to institutional investors for aggregate gross process of about $18.7 million. The offering was based on a per-share price of $3.25. The company is advancing toward the clinic Sirna-027, an RNAi-based therapeutic that targets the vascular endothelial growth factor pathway for the treatment of age-related macular degeneration. (See BioWorld Today, May 3, 2004.)