• Advancis Pharmaceutical Corp., of Germantown, Md., entered a commercial supply agreement with Ceph International Corp., a subsidiary of MOVA Pharmaceutical Corp., of Caguas, Puerto Rico, for its Keflex (cephalexin capsules) brand of products. Advancis acquired the products from Indianapolis-based Eli Lilly and Co. earlier this year. Advancis plans to begin clinical development of an enhanced Keflex using its once-a-day pulsatile-dosing technology. Keflex is indicated for respiratory tract infections, otitis media, skin and skin-structure infections, bone infections and genitourinary tract infections.

• Allos Therapeutics Inc., of Westminster, Colo., watched its stock (NASDAQ:ALTH) climb 37.9 percent Thursday, or 75 cents, to close at $2.73 on news that the company is presenting data today of its lead drug, Efaproxyn (RSR13; efaproxiral), at the 27th annual San Antonio Breast Cancer Symposium. The data include updated survival results of the randomized REACH study of efaproxiral as an adjunct to whole-brain radiation therapy in treating brain metastases originating from breast cancer. Preliminary data from REACH were reported in April 2003. The company received an FDA approvable letter in June, indicating the therapy could be approved if Allos has positive data from its ENRICH trial, which began in February. (See BioWorld Today, June 3, 2004.)

• Biosignal Ltd., of Sydney, Australia, was advised that early stage laboratory research led by Diane McDougald, a senior research associate in the Centre for Marine Biofouling and Bio-Innovation at the University of New South Wales, demonstrates the efficacy of Biosignal's furanones against bacteria that cause cholera. Among the conclusions of the research, the lab tests demonstrated that when the bacteria that cause cholera, Vibrio cholerae, are exposed to furanones, they cannot switch on the so-called virulence factors that trigger infection and disease development.

• BioVisioN AG, of Hannover, Germany, entered a service agreement to use its Differential Peptide Display technology to evaluate clinical samples provided by Novartis Pharma AG, of Basel, Switzerland, to find and identify clinically relevant peptides. Financial terms were not disclosed.

• Cellegy Pharmaceuticals Inc., of South San Francisco, and ProStrakan Group Ltd., of Galashiels, UK, entered an exclusive agreement for the commercialization of Rectogesic in Europe. The product is known as Cellegesic in the U.S., and it is a 0.4 percent topical nitroglycerin ointment indicated to treat pain associated with chronic anal fissures. The product was approved by UK authorities in September. Under terms of the agreement with ProStrakan, Cellegy could receive up to $5.6 million in up-front and milestone payments, including payments if the product later is approved to treat hemorrhoids. Cellegy also is entitled to an amount in excess of 25 percent of net sales of Rectogesic in Europe, including costs of goods. ProStrakan is responsible for additional regulatory filings, sales, marketing and distribution of Rectogesic throughout Europe.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, said an article published in Nucleic Acids Research described the use of its ACE (Artificial Chromosome Expression) System technology for biopharmaceutical protein production, transgenesis and gene-based cell therapy. The publication described each of the three components of the system, the Platform ACE, the ACE Targeting Vector and the ACE Integrase, and also shows the in vitro and in vivo gene expression of cells containing a gene expressing ACE.

• Cytokinetics Inc., of South San Francisco, said that four of the 11 poster presentations the company made during the week at the 44th annual American Society of Cell Biology meeting in Washington relate to its congestive heart failure program. The presentations provided further preclinical support for the mechanism of stimulating the activity of the cardiac myosin motor protein as a potential next-generation approach to managing acute and chronic congestive heart failure. Cytokinetics is planning to move a compound from that program into Phase I trials for congestive heart failure in 2005.

• GPC Biotech AG, of Martinsried, Germany, received Swiss regulatory approval to begin Phase I testing of a cancer product, 1D09C3. The study is designed to determine the safety and tolerance of escalating doses of the monoclonal antibody in patients with relapsed or refractory B-cell lymphomas, and to recommend a dose and schedule for Phase II. The product was generated using HuCAL technology from MorphoSys AG, of Munich, Germany. The commencement of clinical trials triggers a milestone payment from GPC to MorphoSys, due on the product's first administration. Specific financial details were not disclosed.

• Hemosol Corp., of Toronto, is expanding its efforts and resources directed to the commercialization of three therapeutic protein products: intravenous immunoglobulin, alpha 1 proteinase inhibitor and von Willebrand Factor/Factor VIII. All are to be isolated using the Cascade technology, for which Hemosol is the exclusive North American licensee. The company expects that investigational new drug applications for all three products will be prepared toward the end of next year, with clinical development activity and commercial scale-up of its manufacturing facility beginning thereafter.

• Immunicon Corp., of Huntingdon Valley, Pa., launched its CellTracks Endothelial Cell Kit for research use only. The product is used in conjunction with the company's CellTracks AutoPrep System for blood-sample preparation and its CellSpotter Analyzer to capture, count and characterize circulating endothelial cells from whole blood.

• Introgen Therapeutics Inc., of Austin, Texas, said Phase II findings reported at the San Antonio Breast Cancer Symposium showed that the use of Advexin combined with neoadjuvant chemotherapy produced a greater than 50 percent reduction in tumor size in all patients. Complete tumor removal by subsequent surgery was achieved in 100 percent of the patients. The results of the therapy with the addition of Advexin are better than what would be expected from neoadjuvant chemotherapy treatment alone, the company said, adding that a new finding showed that the activation of a local immune response at the site of the tumor was observed. Treated tumors were infiltrated with cells of the immune system that are known to participate in immune responses against tumors, which may be useful in controlling local disease, as well as disease outside the breast. Introgen's stock (NASDAQ:INGN) gained $1.17 Thursday, or 15.3 percent, to close at $8.82.

• Invitrogen Corp., of Carlsbad, Calif., completed its offer to exchange up to $350 million of new 2 percent senior convertible notes due 2023 for an equal amount of currently outstanding 2 percent senior convertible notes due 2023. It also completed its offer to exchange up to $450 million of new 1.5 percent senior convertible notes due 2024 for an equal amount of currently outstanding 1.5 percent senior convertible notes due 2024. Invitrogen will make a cash payment of $2.50 per $1,000 in notes accepted in the offer.

• Myriad Genetics Inc., of Salt Lake City, filed an investigational new drug application with the FDA to begin a Phase I study of MPC-6827. The trial is designed to evaluate the safety and pharmacokinetic profile of the pro-apoptotic cancer drug candidate in patients with advanced solid tumors, in an escalating-dose regimen. The compound family from which the product was born was discovered by Maxim Pharmaceuticals Inc., of San Diego, through its live cell, high-throughput, caspase-3 screening technology.

• The National Cancer Institute, part of the National Institutes of Health in Bethesda, Md., said that SAIC-Frederick Inc., of Frederick, Md., made two awards under a competitive solicitation totaling $13.4 million to two research teams from 10 cancer research institutions. The NIH said the awards reflect a collaborative approach to develop the standard tools and resources needed to accelerate protein biomarker discovery to provide specific approaches to the early detection and diagnosis of cancer. The researchers will use transgenic mouse models of human cancers to study current proteomic technologies, compare results and provide reference data sets and biological resources.

• Plexxikon Inc., of Berkeley, Calif., and Phenomix Corp., of San Diego, selected PLX647 as a development candidate for inflammation. Preclinical testing of the compound, a dual c-Kit and FMS kinase inhibitor, has demonstrated safety and anti-inflammatory activity in several models of inflammation, including a collagen-induced arthritis model. It was discovered through a year-old research collaboration to discover and develop drugs targeting specific kinase pathways critical in inflammation. The partners expect to begin clinical trials in rheumatoid arthritis by the end of next year, and will seek a licensing partner for the program.

• Prospect Venture Partners, of Palo Alto, Calif., closed its third fund, Prospect Venture Partners III, at $500 million. The prior fund also was a $500 million fund raised in 2001, which invested in companies such as Cambridge, Mass.-based Gloucester Pharmaceuticals Inc. and South San Francisco-based Tercica Inc.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., said it completed a private placement with 14 accredited investors. The company sold 556,832 shares of common stock at 75 cents a share, for an aggregate purchase price of $417,624 pursuant to securities agreements with each investor. Provectus also issued warrants to investors to purchase up to 835,249 shares of stock at $1 a share. Provectus paid $41,762 to Venture Catalyst LLC, of New York, as placement agent for the transaction.

• Resverlogix Corp., of Calgary, Alberta, entered a preclinical research agreement with Naeja Pharmaceutical Inc., of Edmonton, Alberta, a preclinical drug discovery and contract research company, up to the investigational new drug application stage. The company said the agreement would help expedite and further validate its cardiovascular Nexvas clinical program.

• US LABS, of Irvine, Calif., launched its genomics testing methodology for the classification of tumors of unknown origin at the San Antonio Breast Cancer Symposium. Employing a technology called gene-expression profiling, it has demonstrated 86 percent accuracy in clinical studies, as reported at this year's American Society of Clinical Oncology meeting.

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