• Access Pharmaceuticals Inc., of Dallas, plans to file a new drug application with the FDA for OraDisc A within the next 15 days, it said. After filing, a copy will be forwarded to Access's European partner for reformatting and filing under the Mutual Recognition Procedure for the European Union. OraDisc A is a polymer disc that adheres to the disease site and slowly degrades, releasing drug locally. It is an improved delivery vehicle for the oral delivery of amlexanox, the active ingredient in Aphthasol, Access's FDA-approved product for the treatment of canker sores.

• AdipoGenix Inc., of Boston, received an undisclosed payment for screening compounds belonging to Pharmaceutical Research & Development LLC, a unit of Johnson & Johnson, of New Brunswick, N.J. AdipoGenix used its assay platform to complete the work that stems from an anti-obesity drug discovery collaboration that began in December 2002. Separately, AdipoGenix raised a Series A round of financing led by Boston University's CTF Venture Fund and Medinnova Partners Inc., an early stage technology investment company associated with the Canadian Medical Discoveries Fund, and MDS Capital Corp. The company also named MDS's Gerry Brunk to its board. Also, the company said it received two Phase I Small Business Innovation Research grants from the National Institutes of Health in Bethesda, Md., for obesity research.

• Archemix Corp., of Cambridge, Mass., provided an exclusive worldwide license for the discovery and development of antidote-controlled aptamers to Regado Biosciences, of Durham, N.C. The latter plans to develop them to control fibrin deposition and platelet adhesion and aggregation. Financial terms were not disclosed.

• Ardais Corp., of Lexington, Mass., appointed Donald Hawthorne president and CEO and member of its board. He has worked in the health care industry for more than 20 years, Ardais said. He replaces Gregory Phelps, who left Ardais to pursue other opportunities. The company uses actual human disease as the discovery model in pharmaceutical research and development.

• Avanir Pharmaceuticals Inc., of San Diego, said it would report Phase III data at this week's international symposium on amyotrophic lateral sclerosis/motor neuron disease in Milan, Italy. The data show Neurodex's ability to treat the pseudobulbar affect, a central nervous system disorder in such patients. The product is in development for pseudobulbar affect in neurodegenerative diseases including Alzheimer's disease, multiple sclerosis, Lou Gehrig's disease, Parkinson's disease, traumatic brain injury and stroke.

• Avecia Biotechnology Inc., of Billingham, UK, said its DNA medicines production facility in Grangemouth, Scotland, received European Union certification to produce DNA-active pharmaceutical ingredients for clinical trials and commercial products.

• AVI BioPharma Inc., of Portland, Ore., said two preclinical studies evaluating the potential of AVI's Neugene antisense compounds in prostate cancer models were published in two peer-reviewed journals. The first study, conducted in collaboration with Oregon Health & Science University, demonstrated that a Neugene antisense agent inhibited cell growth, tumor vascularization and metastasis of human prostate cancer cells grafted into mice. The article was published in the November 2003 issue of Cancer Gene Therapy. The second study was published in the Nov. 15, 2003, issue of Clinical Cancer Research. Results demonstrated the effectiveness of AVI's antisense compound, AVI-4451, against human prostate cancer in animal models by targeting the androgen receptor. Analysis of tissue distribution of AVI-4451 showed significant drug levels in both the mouse prostate and in tumor tissue, AVI said.

• Biosyn Inc., of Huntingdon Valley, Pa., said the FDA granted fast-track designation for its development program of 1 percent C31G vaginal gel for the reduction of HIV transmission. The product is entering Phase III trials to study its use in preventing the transmission of HIV and chlamydia, and for contraception.

• Biotique Systems Inc., of Emeryville, Calif., said new subscribers to its biological data integration, analysis and visualization products and services include The Monsanto Co., of St. Louis; Vertex Pharmaceuticals Inc., of Cambridge, Mass.; and the National Yang-Ming University of Taiwan. The company also introduced expanded security and consortia management tools for the Biotique Local Integration System to allow customers to better integrate and share data across research groups and geographical sites.

• Cell Signaling Technology Inc., of Beverly, Mass., released its SignalSilence siRNA Kits for signal transduction research. The products are designed to allow researchers to specifically inhibit and monitor protein expression.

• DeCode Genetics Inc., of Reykjavik, Iceland, acquired an exclusive worldwide license to an investigational cardiovascular therapeutic called DG031 from Bayer AG, of Leverkusen, Germany. The small molecule is active against a key target, located within an inflammatory pathway, made by a gene isolated at DeCode that predisposes to myocardial infarction. Previous clinical work in a different indication has shown DG031 to be well tolerated with no major safety issues. DeCode plans to test it for efficacy in preventing heart attack in a Phase II trial, enrollment for which is expected to start at the beginning of next year. Bayer will receive milestones as the compound advances, as well as royalties on sales should the compound reach the market. More specific financial terms were not disclosed.

• Elan Corp. plc, of Dublin, Ireland, said the holders of its Liquid Yield Option notes due 2018 have the right to surrender their notes for purchase through Dec. 15. Pursuant to the indenture, each holder can require Elan to purchase the notes at a price equal to $616.57 per $1,000 principal amount at maturity. The aggregate principal amount due at maturity for all outstanding notes is about $801.2 million, and if all are surrendered for purchase, the aggregate cash purchase price would be about $494 million.

• EraGen Biosciences Inc., of Madison, Wis., designated the exclusive Japanese distributors of its integrated phylogenomics product, Master Catalog, to be Itochu Corp., of Tokyo, and CTC Laboratory Systems Corp., also of Tokyo. The informatics proteomics platform includes a software system that predicts protein function based on evolutionary analyses.

• Genaera Corp., of Plymouth Meeting, Pa., closed its previously disclosed registered direct offering. It sold about 2.1 million shares at $4.15 per share, for aggregate gross proceeds of approximately $8.5 million. Fortis Securities Inc. acted as placement agent. Genaera develops medicines for diseases using genomics and natural products.

• GeneMax Corp., of Blaine, Wash., said its wholly owned subsidiary, GeneMax Pharmaceuticals Inc., obtained nonexclusive worldwide licenses from the National Institute of Allergy and Infectious Diseases, of the National Institutes of Health in Bethesda, Md., for the use of modified vaccinia ankara. The technology and material will be used with the goal of developing a vaccine platform capable of generating superior protective immune responses against smallpox.

• Genmab A/S, of Copenhagen, Denmark, and ACE BioSciences A/S, of Odense, Denmark, said they would develop an antibody therapeutic product to treat fungal infections. The antibody will be directed against a target on Aspergillus fumigatus. The target discovered by ACE is the first in the collaboration between Genmab and ACE that covers four commercially promising disease targets in the area of infectious diseases. In the deal, ACE provides commercially promising disease targets and Genmab provides human antibody technology to create and develop antibody products. The two companies share development costs and commercial rights equally.

• Genta Inc., of Berkeley Heights, N.J., presented detailed scientific results from its 771-patient Phase III trial of Genasense (oblimersen sodium) plus chemotherapy in patients with advanced malignant melanoma at the sixth Perspectives in Melanoma meeting in Miami. Genasense is believed to inhibit the production of Bcl-2, a protein that is highly expressed in advanced malignant melanoma. By inhibiting Bcl-2, Genasense might improve the activity of anticancer therapy. Genta and Aventis SA, of Strasbourg, France, are collaborating on the development of Genasense. (See BioWorld Today, Sept. 11, 2003.)

• GenVec Inc., of Gaithersburg, Md., presented an update on the progress of the Phase I trial evaluating AdPEDF in patients with wet age-related macular degeneration at the American Academy of Ophthalmology annual meeting in Anaheim, Calif. The open-label, dose-escalating study was designed to determine the safety of GenVec's AdPEDF product candidate, which produces the pigment epithelium-derived factor protein, a natural anti-angiogenic inhibitor, administered locally to the eye. The study has enrolled six of eight cohorts and is expected to complete enrollment in the first quarter of 2004. In the 18 patients enrolled to date, AdPEDF was well tolerated with no dose limiting toxicities or severe adverse events, it said.

• Insmed Inc., of Richmond, Va., said data reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston showed that as a single agent, its recombinant human insulin-like growth factor binding protein-3 (rhIGFBP-3) product significantly inhibited the growth of breast and colorectal carcinoma cells by 55 percent and 49 percent, respectively (p<0.01). The cancer compound also significantly enhanced the effect of radiation by demonstrating a decrease in the survival fraction in both breast and colorectal carcinoma cells. Insmed's stock (NASDAQ:INSM) gained 43 cents Monday, or 15.5 percent, to close at $3.20.

• Kalypsys Inc., of La Jolla, Calif. and CV Therapeutics Inc., of Palo Alto, Calif., entered a collaboration to discover, develop and commercialize treatments for cardiovascular disease. CV Therapeutics will contribute assays and lead compounds to initiate the collaboration. Kalypsys will develop high-throughput screens, run them against its compound collection and then use its medicinal chemistry and informatics capabilities to optimize CV Therapeutics' existing leads and new leads identified at Kalypsys. CV Therapeutics will be responsible for pharmacological studies, preclinical development and human trials. Kalypsys will receive an up-front payment, research funding, equity investments and could receive milestone payments, and will have the option of co-funding and co-developing candidates that result from the partnership.

• Large Scale Biology Corp., of Vacaville, Calif., said an incorrect association made by a business reporter between phasing out of a proteomics fee-for-service contract and language in its third-quarter SEC Form 10Q resulted in the Nov. 14 depression of its share price - a 44.2 percent drop. The company noted that existing cash will cover six months' operation next year at the current burn rate, and that new government research contracts will provide an additional two months. Beyond that, it said sales and new licensing deals would cover operations for the remainder of the year. Its stock (NASDAQ:LSBC) gained 18 cents Monday, or 11.6 percent, to close at $1.73. (See BioWorld Today, Nov. 17, 2003.)

• Lilly ICOS LLC, a joint venture between Eli Lilly and Co., of Indianapolis, and ICOS Corp., of Bothell, Wash., said a study published in this month's issue of Clinical Therapeutics showed that men with erectile dysfunction who had previously used Viagra (sildenafil citrate, Pfizer Inc.) preferred to continue treatment with Cialis (tadalafil) after first receiving Viagra then Cialis 20 mg. Other data also published showed that 66 percent of men beginning treatment, most of whom had no prior experience with Viagra, preferred Cialis 20 mg over Viagra 50 mg after four-week treatment intervals with each. Additional findings, reported at the European Society for Sexual Medicine meeting, showed that up to 80 percent of erectile dysfunction patients attempted intercourse after four hours and up to 24 hours after they took Cialis over a 12-week period.

• Lorantis Ltd., of Cambridge, UK, closed a £25 million (US$42 million) Series C private financing round led by funds advised by Apax Partners. Apax Partners were joined by existing investors Abingworth Management, JP Morgan Partners, Quester Capital Management, Schroder Ventures, The Wellcome Trust and funds managed by Fleming Family and Partners. The investment will allow clinical development programs to begin on Lorantis' products for the treatment of immune diseases, such as allergy, arthritis and transplantation, as well as supporting new lines of research.

• Manhattan Pharmaceuticals Inc., of New York, said data published in Medical Clinics pointed to the weight reduction associated with its lead product candidate, oleoyl-estrone, given orally over a 27-month period in a morbidly obese patient without dietary restrictions. The company said it is using the findings in its ongoing Phase I trial designs.

• MannKind Corp., of Danbury, Conn., and Novo Nordisk A/S, of Bagsvaerd, Denmark, signed an agreement on a feasibility study for potential development of a pulmonary formulation of a therapeutic protein. MannKind will use its patented Technosphere pulmonary drug delivery technology to develop an inhaleable form of one of Novo's biopharmaceuticals. Financial terms were not disclosed.

• Micrologix Biotech Inc., of Vancouver, British Columbia, said it achieved statistically and clinically significant efficacy results from its Phase IIb study of MBI 594AN, a topical drug candidate under development as a first-in-class prescription treatment for acne. The Phase II study was designed to evaluate acne lesion count reductions at various time points (three, six, nine and 12 weeks), comparing MBI 594AN (1.25 percent and 2.5 percent) with the alcohol vehicle.

• Miravant Medical Technologies Inc., of Santa Barbara, Calif., said Phase III efficacy data reported at the American Academy of Ophthalmology meeting in Anaheim, Calif., would form the basis of its planned new drug application, seeking marketing approval for a SnET2 treatment. The results show that, relative to placebo, 0.5-mg SnET2/kg stabilizes visual acuity in a statistically significant number of patients with wet macular degeneration, the leading cause of blindness in adults more than 50 years old. Safety data showed that the proposed clinical dose of SnET2-PhotoPoint photodynamic therapy was well tolerated and demonstrated a favorable profile in the study population.

• NeoPharm Inc., of Lake Forest, Ill., presented Phase I/II trial data on IL13-PE38QQR, its tumor-targeting agent for malignant glioma, from three clinical studies at the 8th annual meeting of the Society for Neuro-Oncology in Keystone, Colo. The findings suggest consistent evidence of tumor cytotoxic effects of IL13-PE38QQR against malignant glioma tumor cells and, although the trials were not designed to address efficacy, encouraging survival results continue to be observed beyond two years, NeoPharm said.

• Neoprobe Corp., of Dublin, Ohio, raised $2.8 million after completing a private equity placement of 12.2 million common shares at 23 cents apiece, as well as Series R warrants to purchase an additional 6.1 million common shares at 28 cents apiece. The warrants have a term of five years. Buyers included both institutional investors and high-net-worth individuals.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., signed a two-year extension of its herbicide discovery collaboration with Bayer CropScience, a unit of Bayer AG, of Leverkusen, Germany. The extension, which would take the partnership through September 2006, includes research funds and success fees for assay deliveries. Paradigm's herbicide partnership with Bayer began in October 1998 with the objective of discovering a portfolio of herbicide products to be developed and marketed by Bayer. The term of the original agreement was three years with an initial option to extend the relationship another two. The first extension was signed in September 2001. (See BioWorld Today, Nov. 3, 1998, and June 20, 2001.)

• Paratek Pharmaceuticals Inc., of Boston, and Families of Spinal Muscular Atrophy in Libertyville, Ill., formed an agreement to research Paratek's small molecules as a possible treatment for spinal muscular atrophy (SMA). Using a specific subset of Paratek's compounds that were identified through a previous collaborative effort between researchers at the University of Massachusetts Medical School and Paratek, investigators sponsored by Families of SMA will begin testing the compounds both in the laboratory and in animal models to evaluate their potential use in treating SMA. Financial terms were not disclosed.

• QLT Inc., of Vancouver, British Columbia, said limited Phase III data reported at the American Academy of Ophthalmology meeting in Anaheim, Calif., showed that Macugen does not appear to provide an improvement over QLT's Visudyne Therapy for patients with choroidal neovascularization due to age-related macular degeneration. QLT noted that although complete data were not presented, the anti-VEGF aptamer data appear no better than Visudyne's original TAP data in all lesion types. Macugen (pegaptanib sodium) is under development by Eyetech Pharmaceuticals Inc., of New York, and Pfizer Inc., also of New York, in a deal that could net Eyetech up to about $745 million. Eyetech registered for its initial public offering two months ago. QLT's stock (NASDAQ:QLTI) gained $1.51 Monday, or 9.8 percent, to close at $16.91. (See BioWorld Today, Dec. 19, 2002, and Sept. 16, 2003.)

• RetinaPharma Technologies Inc., of Jenkintown, Pa., said a preclinical study demonstrates that its chemopreventive drug called desmethyldeprenyl (DES) has the potential to facilitate repair of damaged nerve cells. DES is a metabolite of the drug deprenyl used to treat Parkinson's disease, and in previous published studies RetinaPharma has shown it to have a protective effect in preventing nerve damage in organotypic cell culture. The company is scheduled to present data on the study today at the Mid-Atlantic Venture Conference featuring BioVenture Forum East at the Pennsylvania Convention Center in Philadelphia.

• Sinovac Biotech Ltd., of Beijing, said it intends to raise $3 million through a private placement of 2.4 million units at $1.25 per unit. Each unit will consist of one share of common stock of Sinovac; one share purchase warrant to purchase one additional share of common stock of Sinovac at $1.50 per share until Nov. 14, 2004; and one piggyback warrant to purchase one additional share of common stock of Sinovac at $3 per share until Nov. 14, 2005, only if the holder thereof exercises the share purchase warrant. Proceeds will be used primarily for purchase of a plant and equipment for increased production of vaccines.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., began a Phase II study of EOquin in patients with superficial bladder cancer. Up to 10 European sites will participate in the trial, which is expected to be completed by the end of next year.

• SuperGen Inc., of Dublin, Calif., said long-term follow-up and independent review of results from its previously reported Phase III program of Orathecin (rubitecan) were presented at the Chemotherapy Foundation's symposium in New York, supporting the oral anticancer compound's activity in patients with refractory pancreatic cancer who have failed prior treatments. Response rate (6 percent vs. 1 percent), time to progression (58 days vs. 48 days) and median survival (109 days vs. 94 days) were all improved with Orathecin compared to "best choice," despite the fact that patients who failed best alternative therapy were allowed to crossover to Orathecin at disease progression.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, said University of Maryland School of Medicine researchers published data in this month's issue of the Journal of Neurological Sciences showing that Copaxone (glatiramer acetate injection), used to treat relapsing-remitting multiple sclerosis, stimulates anti-inflammatory T cells to produce a neuroprotective protein, brain-derived neurotrophic factor (BDNF). More specifically, results demonstrated that in cell lines originating from the same patients, Copaxone-reactive T cells produced significantly higher levels of BDNF than T cells reactive to other compounds (p=0.033).

• TranXenoGen Inc., of Shrewsburg, Mass., said results from animal model studies conducted with peptides derived from antineoplastic urinary protein (ANUP) demonstrate the ability of peptides to reduce tumor burden by up to 70 percent in nude mice implanted with human cervical cancer cells. The ANUP peptides appear to act on blood vessel formation inhibiting both angiogenesis and infiltration.

• Tularik Inc., of South San Francisco, said underwriters purchased another 900,000 shares of common stock through an option granted to the underwriters in connection with the company's common stock offering. Including the sale of the additional shares, the offering totaled 6.9 million shares of common stock, resulting in net proceeds of about $77.8 million. Goldman, Sachs & Co. is the book-running and lead manager for the offering. SG Cowen Securities Corp., UBS Securities LLC and SunTrust Robinson Humphrey, Inc. are the co-managers. The public offering priced earlier this month. (See BioWorld Today, Nov. 12, 2003.)

• Viragen Inc. and Viragen International Inc., of Plantation, Fla. entered an agreement with Pentafarma SA, of Santiago, Chile, to distribute Viragen's natural human alpha-interferon, Multiferon, exclusively in Chile. Pentafarma distributes health care products related to dialysis and nephrology. Pentafarma believes Multiferon may offer benefits to a segment of its dialysis patients and intends to initially evaluate the use of the injectable antiviral in dialysis patients diagnosed with chronic hepatitis C (HCV). Financial terms were not disclosed.