Abeille Pharmaceuticals Inc., of Princeton, N.J., completed a $1 million Series A financing round. The company said proceeds will go toward advancing its lead products, enhancing the product pipeline, building its intellectual property portfolio and expanding Abeille's management and advisory teams. Abeille focuses on applying delivery technologies to create new formulations of existing products.

Aerogen Inc., of Mountain View, Calif., received fast-track designation from the FDA for the combination product Amikacin pulmonary delivery system for ventilator-associated pneumonia. It is Aerogen's lead drug/device combination product incorporating Aerogen's OnQ Aerosol Generator technology adapted for high efficiency aerosol delivery to patients on mechanical ventilators. Aerogen's stock (NASDAQ:AEGN) increased 47 cents Tuesday, or 28.5 percent, to close at $2.12.

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and its collaborators at the Ludwig Maximilian University Munich said the online publication of an article in Nature identifies specific immunostimulatory motifs of short interfering RNAs. The identification of those motifs enables the design of siRNAs that avoid interferon induction. In connection with the publication, Alnylam has licensed certain intellectual property relating to that work from Ludwig.

Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner Boston Scientific Corp., of Natick, Mass., completed enrollment in the ATLAS clinical trial, which uses Boston Scientific's new Liberte coronary stent as a platform for its paclitaxel-eluting coronary stent system. Taxus Liberte is the next generation to Boston Scientific's first paclitaxel-eluting coronary stent system, Taxus Express2. The trial has enrolled 872 patients and is assessing the safety and efficacy of a slow-release dose formulation for the treatment of coronary artery disease.

Argonaut Technologies Inc., of Redwood City, Calif., entered an agreement to sell stock and certain assets of its consumables and flash chromatography business to Uppsala, Sweden-based Biotage AB for about $20 million in cash, subject to approval by Argonaut's stockholders. The transaction includes Argonaut's consumables business segments, which include synthesis and purification, bioanalytical sample and flash chromatography systems.

Arrowhead Research Corp., of Pasadena, Calif., launched a new majority-owned subsidiary, Calando Pharmaceuticals Inc., which will focus on developing and commercializing exclusively licensed technology for the therapeutic use of RNA interference. Calando intends to combine novel RNAi delivery technologies, developed at the California Institute of Technology, with a scientific leadership team experienced in the areas of non-viral nucleic acid delivery and RNAi. The name "Calando" derives from a musical term that means to play slower and softer, and ultimately to die away.

AtheroGenics Inc., of Atlanta, said the FDA approved its proposed amendment to the ARISE Phase III trial protocol, which is testing AGI-1067 for the oral treatment of atherosclerosis in research centers throughout the U.S., Canada, the UK and South Africa. The changes approved by the FDA include the company's plan to increase the trial's patient enrollment from 4,000 to 6,000. With that increase, the study will accumulate 10,000 patient-years of exposure. AtheroGenics expects that ARISE will achieve full patient enrollment by mid-2005.

AVAX Technologies Inc., of Philadelphia, established a collaboration with Joseph Friedberg, chief of the division of thoracic surgery at Presbyterian Medical Center, to conduct a clinical trial of its AC Vaccine in patients with non-small-cell lung cancer. Presbyterian Medical Center and Hospital of the University of Pennsylvania will be the exclusive partner and be the clinical sites for the trial. AVAX and the university plan to submit an investigational new drug application for the treatment of patients with Stage I or II non-small-cell lung cancer to the FDA by March 31.

Avidex Ltd., of Milton Park, UK, and Anosys Inc., of Menlo Park, Calif., announced the completion of a collaboration using Avidex's soluble T-cell receptors to validate T-cell antigen expression on Anosys' Dexosome cancer vaccines. The companies said that is the first direct measurement of the levels of antigen expression on a vaccine particle. Anosys' Dexosomes are a vaccine approach that use small vesicles derived from immune cells that contain the components to trigger immune response.

Bavarian Nordic A/S, of Copenhagen, Denmark, intends to extend production for its Imvamune smallpox vaccine program, and expects to initiate several clinical trials this year, including three Phase II studies to test the vaccine in more than 2,000 people. With this expansion, Bavarian Nordic said it will make significant investments to increase the company's international marketing function and add a vaccine filling line to ensure the security of supply for customers. The company also reported it was on schedule to begin commercially manufacturing the Imvamune vaccine at the Kvistgard site in Denmark, set to begin this summer.

Benitec Ltd., of Mountain View, Calif., entered a cross-licensing and collaboration agreement with the CombiMatrix group, one of two operating groups with Newport Beach, Calif.-based Acacia Research Corp. Under the agreement, CombiMatrix non-exclusively licensed to Benitec intellectual property related to the use of siRNAs as therapeutic agents against viral diseases. Benitec also receives a coexclusive sublicense to two specific sequences targeting key genes of HIV that CombiMatrix previously licensed from its partner, irsiCaixa, of Barcelona, Spain. In return, Benitec nonexclusively licensed to CombiMatrix its portfolio of 10 issued and 60 pending patents for the development of RNAi therapeutics for the treatment or prevention of injuries or diseases in humans resulting from exposure to biological, chemical, radioactive and other weapons. Separately, Benitec formed a collaboration with City of Hope in Duarte, Calif., to develop a T cell-based therapy for AIDS patients. The collaboration will be funded through Phase I trials by a portion of a $7.5 million federal grant awarded to City of Hope by the National Institute of Allergy and Infectious Diseases.

Carrington Laboratories Inc., of Irving, Calif., said the Southern Research Institute transferred its responsibilities under a one-year renewal of two agreements with Carrington's wholly owned subsidiary, DelSite Biotechnologies Inc., to Brookwood Pharmaceuticals Inc., of Birmingham, Ala. Brookwood, formed in January as a spin off of Southern Research Institute's drug delivery group, will continue the agreements with DelSite, which involve the development, formulation and commercialization of DelSite's patented drug delivery technology that is based on the natural polymer GelSite.

Cougar Biotechnology Inc., of Los Angeles, said that Phase I results on Cougar's investigational drug, CB7630 (abiraterone acetate) as a new therapeutic approach for patients with prostate cancer were presented at the 3005 Prostate Cancer Symposium in Orlando. The results were published in the British Journal of Cancer in June. The results from the first Phase I trial showed that a single dose of 500 mg of abiraterone acetate given to six castrate men achieved suppression of testosterone to less than 0.14nM or by 75 percent when baseline testosterone levels were greater than 0.6 nM.

Cryptome Pharmaceuticals Ltd., of Melbourne, signed an agreement with the University of Virginia at Charlottesville, giving the company sole option to an exclusive license over a class of protein-derived compounds with anti-inflammatory action. The agreement gave Cryptome an exclusive license for the U.S., and the company has up to 12 months to exercise the option. However, it said that it expects to begin work on the molecule under a material transfer agreement in the immediate future.

Cubist Pharmaceuticals Inc., of Lexington, Mass., said all of the enrolled patients in the Phase III trial of Cubicin have completed the treatment phase. An Independent Data Monitoring Committee reviewed data from 191 patients in the international trial examining Cubicin's efficacy in treating infective endocarditis and complicated bacteremia caused by Staphylococcus aureus. Cubist expects to report results from the trial in the middle of the year.

Curis Inc., of Cambridge, Mass., said its scientists have demonstrated that its compound can induce hair growth in a preclinical model. The compound is a small-molecule agonist of the Hedgehog signaling pathway, and it may be useful in treating male pattern baldness and female pattern hair loss. The data were presented at the annual meeting of the American Academy of Dermatology in New Orleans.

Dendreon Corp., of Seattle, said results from its National Cancer Institute-sponsored Phase II study of Provenge, in combination with Avastin (bevacizumab, Genentech Inc.), increased prostate specific antigen doubling time in patients with prostate cancer. The trial enrolled 22 patients with androgen-dependent prostate cancer who had undergone prior surgical and radiation therapy. The data were presented in Orlando, Fla., at the 2005 Multidisciplinary Prostate Cancer Symposium.

Discovery Laboratories Inc., of Warrington, Pa., said its recent direct offering has been extended to include an additional commitment to purchase about $2.6 million of common stock. Discovery will sell about 450,000 shares to a select institutional investor at $5.76 per share. Added to the $26.5 million the company had expected to raise, the additional commitment brings gross proceeds to about $29.1 million. Some of the proceeds will go toward the anticipated launch of Surfaxin, a prophylaxis therapy for respiratory distress syndrome, which gained an FDA approvable letter last week. (See BioWorld Today, Feb. 15, 2005, and Feb. 22, 2005.)

Elan Corp. plc, of Dublin, Ireland, said the European Commission granted marketing approval for the orphan drug Prialt (ziconotide) to treat severe, chronic pain in patients who require intrathecal analgesia. The approval follows a positive opinion in November by the European Committee for Medicinal Products for Human Use. It was based on the treatment of more than 1,000 patients, including three pivotal clinical studies. The FDA approved Prialt in December. (See BioWorld Today, Dec. 30, 2004.)

Gene Logic Inc., of Gaithersburg, Md., launched ToxShield Suite 1.0, a Web-enabled software platform for assessing and rank ordering drug candidates based on potential toxicities.

Genentech Inc., of South San Francisco, presented final results from a long-term study that showed sustained improvement in psoriasis symptoms through three years of continuous treatment with Raptiva (efalizumab). The three-year, Phase IIIb open-label trial evaluated the long-term safety and efficacy of treatment with Raptiva in adults with moderate-to-severe chronic plaque psoriasis. After 33 months, of the 151 patients who remained in the study, 75 percent of patients showed a 75 percent or greater improvement on the Psoriasis Area Severity Index, while 41 percent of patients showed a 90 percent or greater improvement.

GenVec Inc., of Gaithersburg, Md., began the second part of the ongoing Phase I trial of its pigment epithelium-derived factor (AdPEDF) drug candidate for wet age-related macular degeneration. Twenty patients with less-advanced AMD will be enrolled at multiple centers in the U.S. The Phase Ib study will compare two doses of AdPEDF.

Helix BioMedix Inc., of Bothell, Wash., and American Global Health Group LLC (AGHG), of Seattle, Wash., entered a license agreement for the inclusion of certain Helix peptide technology in AGHG skin care products that are under development and will be sold in Asian areas. The launch of the initial product line is planned for later this year. Helix is entitled to receive royalties.

Insmed Inc., of Richmond, Va., said the law firm of Foley & Lardner LLP moved to dismiss a complaint alleging infringement of method of use and method of manufacture patents brought by South San Francisco-based companies Tercica Inc. and Genentech Inc. against Insmed in U.S. District Court for the Northern District of California. Insmed's motion asserts that all alleged activities fell within the statutory safe harbor, known as the clinical trial exemption, and is seeking immediate dismissal or summary judgment against the plaintiffs. The initial complaint, filed Dec. 23 and amended Feb. 16, challenged Insmed's right to commercialize SomatoKine, for growth hormone-insensitivity syndrome.

MedImmune Inc., of Gaithersburg, Md., said its board allocated an additional $100 million to MedImmune Ventures Inc., the company's venture capital subsidiary created in July 2002 to invest in early to late-stage, public or private therapeutic firms. To date, the fund has invested about $85 million in about a dozen companies.

Millennium Pharmaceuticals Inc., of Cambridge, Mass., said final results from a Phase I trial of MLN2704 in patients with advanced hormone-refractory prostate cancer indicated the molecule was well tolerated and produced sustained antitumor activity. One patient achieved a durable partial response in measurable disease for 11 months, as well as a sustained prostate specific antigen decline of more than 50 percent. The results were presented at the 2005 Prostate Cancer Symposium in Orlando, Fla.

Nautilus Biotech, of Paris, reached the first milestone in its collaboration with Serono SA, of Geneva, to develop a next-generation human growth hormone with an improved pharmacological profile. Nautilus has designed, generated and tested in vitro a series of variants of hGH. Nautilus will receive a milestone payment from Serono, which has the exclusive right to license variants of the hGH protein.

Newron Pharmaceuticals SpA, of Milan, Italy, raised EUR 30 million, out of which EUR 23 million closed Monday. The remaining EUR 7 million will remain open to additional interested parties for a few weeks. Newron Pharmaceuticals is a research and development company focused on ion channel-based therapies.

NicOx SA, of Sophia Antipolis, France, said that its partner, Biolipox AB, reported that a new clinical study of NCX 1510, in development for the treatment of rhinitis, demonstrated an onset of action of only five to 10 minutes. The onset of action study had a randomized, crossover design in which 12 healthy volunteers received a single intranasal dose of either NCX 1510 or placebo.

Oncolytics Biotech Inc., of Calgary, Alberta, received total proceeds of $3.25 million from 813,533 warrants issued Aug. 21, 2003, as part of the company's private placement. Of the total proceeds, $178,244 was received prior to the end of September and was included in the quarterly reports. With the addition of the warrant proceeds, Oncolytics estimates it has adequate cash on hand to fund its operations for about three years without additional financing rounds.

Priority Healthcare Corp., of Lake Mary, Fla., was selected by CoTherix Inc., of South San Francisco, to be a full-service specialty pharmacy provider of Ventavis (iloprost) inhalation solution. The FDA approved Ventavis on Dec. 29 for the treatment of pulmonary arterial hypertension in patients with HYHA Class III or IV symptoms.

PTC Therapeutics Inc., of South Plainfield, N.J., was awarded $1.7 million from Cystic Fibrosis Foundation Therapeutics Inc. to fund the development of PTC124 to treat cystic fibrosis (CF) due to a nonsense mutation in the CF transmembrane regulator gene. Of the 30,000 people in the U.S. with CF, it is estimated that 10 percent have nonsense mutations. PTC124 is an orally administered drug in Phase I trials.

Santarus Inc., of San Diego, launched Zegerid (omeprazole) powder for oral suspension 40 mg in the U.S. for the reduction of risk of upper gastrointestinal bleeding in critically ill patients and the short-term treatment of active benign gastric ulcers. The product, which was approved by the FDA in December, is being promoted by sales forces from Santarus and Otsuka America Pharmaceutical Inc., of Rockville, Md. Zegerid 20 mg was approved in June.

Sigma-Aldrich Corp., of St. Louis, launched Panorama Human p53 Protein Functional Microarray, which is based on technology that ensures the protein is correctly folded and confers full functionality. The product was developed by Procognia Ltd., of Maidenhead, UK, and is exclusively distributed by Sigma-Aldrich.

Somaxon Pharmaceuticals Inc., of San Diego, licensed rights to a U.S. patent for use of the oral nalmefene hydrochloride in the treatment of nicotine dependence, and intends to begin proof-of-principal studies this year. Nalmefene, a specific and selective opioid receptor antagonist, is designed to interrupt neurochemical reward and reinforcement, leading to a reduction in nicotine craving. Somaxon licensed the North American rights in November to develop, manufacture and commercialize oral nalmefene from Turku, Finland-based BioTie Therapies Corp. as a potential treatment for impulse control disorders.

Targeted Genetics Corp., of Seattle, reported preliminary results from a Phase I trial of tgAAC09, an investigational recombinant adeno-associated viral vector-based HIV/AIDS vaccine candidate, enrolling health volunteers who are not infected with HIV. No safety concerns were seen and the product was well tolerated.

V.I. Technologies Inc. (Vitex) of Watertown, Mass., said the Nasdaq Stock Market granted the company an extension until March 15 to comply with the $10 million minimum stockholders' equity requirement for continued listing on the Nasdaq National Market. On Nov. 19, Vitex provided a plan to achieve and sustain compliance with its listing requirements. Vitex is developing anti-infective products.

VaxGen Inc., of Brisbane, Calif., said San Diego-based IT&E International Group agreed to expand a long-term, multimillion dollar agreement under the U.S. Department of Health and Human Services' BioShield project. IT&E was awarded additional long-term contracts to continue its relationship with VaxGen, in support of VaxGen's production of 75 million doses of anthrax vaccine. The U.S. government awarded VaxGen an $878 million contract in the fall to supply anthrax vaccine for civilian defense. (See BioWorld Today, Nov. 8, 2004.)