• Abgenix Inc., of Fremont, Calif., will receive a milestone payment from Emeryville, Calif.-based Chiron Corp., after Chiron filed an investigational new drug application for the oncology compound CHIR-12-12, a human antagonist antibody targeting CD40. Chiron created the antibody using XenoMouse technology licensed from Abgenix.

• Amarin Corp. plc, of London, reported positive data analysis from two exploratory Phase IIa studies using Miraxion to treat depression. In a recent exploratory Phase II study, Miraxion was used as monotherapy in 77 patients with a new episode of depression in a six-week trial. In the study, it was specified that the presence of specific depression symptomology (patients with melancholic, vegetative symptoms) at the time of entry to the study would predict response. Amarin filed a patent covering the associated intellectual property in late 2004 and intends to publish full results from the monotherapy trial later this year.

• AtheroGenics Inc., of Atlanta, completed the sale of $200 million of its 1.5 percent convertible notes due 2012, which includes the exercise by initial purchasers of their entire option for an additional $25 million principal amount. The notes are convertible into AtheroGenics common stock at a rate of 38.6 shares per $1,000, reflecting a 35 percent premium relative to the Nasdaq closing price of $19.20 on Jan. 6. The company has said it expects to use the proceeds to fund ongoing costs of the ARISE trial of AGI-1067 and other research and development activities.

• Avanir Pharmaceuticals Inc., of San Diego, and the FDA formed a special protocol assessment agreement for a Phase III trial of Neurodex in the treatment of diabetic neuropathy. The company expects to start the Phase III trial in the first half of 2005. Avanir began filing a rolling new drug application in December for Neurodex to treat pseudobulbar affect.

• Barrier Therapeutics Inc., of Princeton, N.J., reported positive Phase IIa data for both oral Rambazole in psoriasis and for oral Azoline in superficial fungal infections. Rambazole is a retinoic acid metabolism-blocking agent. A review of initial Phase IIa trial data from 10 patients with moderate to severe psoriasis demonstrated a reduction in the PASI score, a symptom-severity score in psoriatic patients, by an average of 50 percent in patients treated with 1 mg once daily for eight consecutive weeks. The study is ongoing and is expected to involve 17 patients.

• Bolder BioTechnology Inc., of Wheat Ridge, Colo., received a $303,204 Phase I Small Business Innovation Research grant from the National Institutes of Health's Institute of Allergy and Infectious Diseases. Bolder said the grant will be used to optimize the manufacturing process and perform preclinical toxicology and pharmacology studies of the company's growth hormone product aimed at treating growth hormone deficiency, short stature in children and HIV-associated wasting.

• ComGenex Inc., of Budapest, Hungary, completed an agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, in high-throughput medicinal chemistry. Roche used ComGenex platform technologies to support internal lead generation for drug discovery and development programs. ComGenex used in silico tools to expedite the design of targeted compound libraries and also synthesized and purified the compounds using its high-throughput synthesis and purification platforms for biological evaluation at Roche. Financial terms were not disclosed.

• Corgentech Inc., of South San Francisco, filed an investigational new drug application with the FDA to begin a Phase I/II trial of its NF-kappaB Decoy candidate to treat atopic dermatitis. The trial will evaluate the product in adult patients with mild to moderate eczema. A second trial to be conducted in Europe will be initiated in the first half of 2005.

• CoTherix Inc., of South San Francisco, filed a registration statement covering a proposed offering of 4 million shares of its common stock. The company intends to grant underwriters the option to purchase up to 600,000 additional shares to cover overallotments. Needham & Co. Inc. and Thomas Weisel Partners LLC will act as co-managers of the offering.

• Depomed Inc., of Menlo Park, Calif., received gross proceeds of $22.7 million after completing its previously announced direct public offering of 5 million shares of common stock at $4.50 per share. The company estimated proceeds would total $21.1 million, which is expected to fund upcoming clinical trials, regulatory submissions, research and development expenses, internal marketing and sales, general administration and working capital needs. (See BioWorld Today, Jan. 10, 2004.)

• Dragon Pharmaceutical Inc., of Vancouver, British Columbia, said its shareholders approved the acquisition of Oriental Wave Holding Ltd., of the British Virgin Islands. The companies agreed to merge in March; Dragon shareholders would own about 31.7 percent of the new entity and Oriental shareholders would own about 68.3 percent. The companies expect the acquisition to close within the next few days.

• Generex Biotechnology Corp., of Toronto, said an Oral-lyn research paper published in the December edition of Clinical Therapeutics showed that a study of healthy male subjects under euglycemic conditions indicated Oral-lyn was associated with a higher Cmax, shorter Tmax and faster time to peak glucose uptake, as compared with subcutaneous insulin. The paper was published by diabetes investigators Itamar Raz, Simona Cernea, Miriam Kidron and Jay Wohlgelernter, along with Generex consultant Pankaj Modi.

• GenVec Inc., of Gaithersburg, Md., said it received a $10 million, one-year contract extension on its HIV vaccine work with the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases. GenVec is working under a subcontract, issued and managed by SAIC-Frederick, that now totals up to $40 million and extends through 2008. The company first began working with the center three years ago. (See BioWorld Today, Jan. 11, 2002.)

• Geron Corp., of Menlo Park, Calif., received gross proceeds of $12.5 million for the exercise of warrants to purchase about 2 million shares of common stock. The warrants were issued to institutional investors in connection with the November financing. (See BioWorld Today, Nov. 12, 2004.)

• InNexus Biotechnology Inc., of Vancouver, British Columbia, entered a co-development arrangement for its TransMab Antibody Technology with Epitomics Inc., of Burlingame, Calif. Epitomics will supply humanized antibodies for certain intracellular targets that have been identified by the parties. InNexus then will modify those antibodies for intracellular delivery using its TransMab technology.

• Ista Pharmaceuticals Inc., of Irvine, Calif., plans to offer 4.5 million shares of common stock in an underwritten public offering as part of a shelf registration statement filed with the SEC. The company intends to grant underwriters an overallotment option for an additional 675,000 shares. Underwriters include Banc of America Securities LLC, Thomas Weisel Partners LLC, Lazard Freres & Co. LLC and C.E. Unterberg, Towbin LLC.

• Medicis Pharmaceutical Corp., of Scottsdale, Ariz., and BioMarin Pharmaceutical Inc., of Novato, Calif., amended their May agreement in which BioMarin purchased Medicis' subsidiary Ascent Pediatrics Inc., acquiring the children's asthma drug Orapred and a 66-person sales force. Under new terms, BioMarin will pay Medicis $159 million, instead of $175 million, in license payments for Orapred made by BioMarin after July 2005 and for the purchase of Ascent with the final payment due in 2009. Medicis also will make a $25 million convertible note available to BioMarin beginning July 1, 2005. (See BioWorld Today, April 22, 2004.)

• Neurocrine Biosciences Inc., of San Diego, will resubmit its new drug application for indiplon modified-release tablets to update its electronic formatting. Difficulties with the NDA, filed Nov. 22, were based on problems the FDA had navigating the electronic common technical document format and did not pertain to the content. The filing contains data from 68 clinical trials and more than 80 preclinical studies and includes safety and efficacy evaluations in about 7,500 subjects. The eCTD format contained 1,500 volumes, or 524,000 pages of data.

• OXIS International Inc., of Portland, Ore., said it intends to conduct research with selected scientists and university laboratories to design an oxidative stress paradigm to diagnose the early onset of human and animal diseases, such as bovine spongiform encephalopathy and Type II diabetes with associated cardiovascular morbidity. OXIS intends to develop diagnostic biomarkers that can identify at an early stage the presence of a disease state, distinguish which patients are most suited for a particular drug and provide feedback to the physician on how well the drug is working, it said.

• Protein Design Labs Inc., of Fremont, Calif., began a Phase II study of M200 for renal-cell carcinoma and expects to conduct an end-of-Phase I meeting with the FDA regarding Nuvion to treat ulcerative colitis at the end of the quarter or early in the second quarter. The product received fast-track status in September. PDLI also plans to begin a Phase I single-dose study this quarter and a Phase I multiple-dose study in the second half of the year for its asthma candidate daclizumab.

• Sinovac Biotech Ltd., of Beijing, received final approval for the marketing and sales of its combined hepatitis A and B vaccine, Bilive, by the Chinese drug regulatory body. The Bilive production license has been issued by the SFDA and sales of the vaccine will begin in China shortly, the company said.

• ViroPharma Inc., of Exton, Pa., received a $6 million payment from Kenilworth, N.J.-based Schering-Plough Corp. for existing inventory of pleconaril bulk drug substance. Schering-Plough will handle future development and commercialization of pleconaril. ViroPharma previously received a $10 million license fee and is eligible to receive up to $65 million in milestone payments, as well as royalties.

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