Alfacell Corp., of Bloomfield, N.J., expanded its research collaboration with the National Cancer Institute of the NIH under which the NCI will evaluate Alfacell's Onconase as a radiation enhancer. Previous research showed Onconase causes an increase in both tumor blood flow and median tumor oxygen partial pressure. Alfacell develops ribonucleases for cancer and other diseases.
Alliance Pharmaceutical Corp., of San Diego, said it, Baxter Healthcare Corp., of Deerfield, Ill., and their joint venture, PFC Therapeutics LLC, have agreed to explore avenues to realize the value of PFC and to negotiate in good faith. PFC was created to oversee development and sales of Oxygent, an intravenous oxygen carrier intended to eliminate the need for donor blood in elective surgeries. Alliance last month told PFC it intended to terminate the exclusive license it granted PFC because the venture did not fulfill its obligations. (See BioWorld Today, Aug. 30, 2002.)
Amersham Biosciences, of Piscataway, N.J., said it signed licensing agreements with Pharmacia Corp., of Peapack, N.J., and Novartis Pharma AG, of Basel, Switzerland, enabling the companies to use Amersham's green fluorescent protein vectors in their drug discovery research. The license includes access to intellectual property associated with folding and red-shifted mutations. Financial details were not disclosed.
Atrix Laboratories Inc., of Fort Collins, Colo., said it submitted two abbreviated new drug applications to the FDA seeking approval of generic formulations of topical dermatology products. Atrix had submitted ANDAs for two other formulations in late 2001. Atrix specializes in non-oral drug delivery, providing parenteral, transmucosal and topical delivery of proteins, peptides and other organic molecules.
BioDelivery Sciences International Inc., of Newark, N.J., said it signed an agreement with a leading manufacturer of processed foods for companion animals, which grants the manufacturer a temporary exclusive license in the veterinary field to evaluate BDSI's nanocochleate delivery technology for applications in pet food. BDSI estimates the worldwide annual sales of companion pet food to be more than $25 billion. The manufacturer will conduct a clinical trial using BDSI's delivery technology to supplement pet food with an antioxidant. Following the trial, the manufacturer will have a period of exclusivity to negotiate a veterinary license.
BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said results of a study of its calcium phosphate nanoparticles (CAP) vaccine adjuvant showed it was a mucosal adjuvant capable of inducing mucosal immunity and protection against herpes infection. The study was published in the September issue of Clinical and Diagnostic Laboratory Immunology. In the study, a vaccine for herpes simplex virus Type II was combined with the CAP vaccine adjuvant, known as Bio-Vant, in a formulation developed by BioSante to determine its effectiveness as a mucosal adjuvant.
Cell Pathways Inc., of Horsham, Pa., said it entered binding agreements to sell about 6.2 million shares of stock at 70 cents per share for proceeds of about $4.4 million. The shares issued in the offering became effective through a shelf registration statement filed with the SEC and declared effective February 2001. Proceeds of $2.8 million have been received and the balance should be received by the end of the month, it said. Also, the company said it engaged J.P. Turner & Co. LLC, of Atlanta, in connection with potential future financings and other advisory services.
Cellectis SA, of Paris, granted Artemis Pharmaceuticals Inc., a Cologne, Germany, subsidiary of Exelixis Inc., a worldwide nonexclusive license under a patent family covering the use of homologous recombination. It allows use of the technology for gene activation and substitution in living organisms. Terms of the deal were not disclosed.
DNAPrint genomics Inc., of Sarasota, Fla., said it launched a "recreational genomics testing service" designed to give individuals information on their own genomic sequences and genetic heritage.
Cellegy Pharmaceuticals Inc., of South San Francisco, said peer-reviewed results were reported in the September 2002 issue of Diseases of the Colon & Rectum from its first Phase III trial of Cellegesic (nitroglycerin ointment) for the treatment of chronic anal fissure. The randomized, double-blind, placebo-controlled study included 304 men and women with chronic anal fissure, and was the first of two Phase III trials completed to date. Patients were randomized to one of eight treatment regimens for up to eight weeks. Improvement in pain was assessed using a visual analogue scale. Significant and rapid decreases in average pain intensity (p<.0002 worst pain and at defecation were reported for cellegesic headache was the most common side effect reported. class="text"> Connetics Corp., of Palo Alto, Calif., and DPT Laboratories Ltd., of San Antonio, said a state-of-the-art aerosol manufacturing facility was completed in San Antonio. The new 12,000-square-foot facility, built through a partnership between the companies, will provide an additional venue for commercial production of prescription and consumer health care products for Connectics' product lines. The companies anticipate the facility will receive its FDA license to operate in early 2003. Connectics develops and commercializes dermatology products. DPT is a developer, manufacturer and packager of prescription, over-the-counter and biotech products.
EntreMed Inc., of Rockville, Md., said it intends to reduce net operating expenses 60 percent to about $12 million in 2003, part of which will be accomplished by a further reduction in its work force, that will leave about 50 people. In August, the company said it was releasing about 30 of its 115 employees and narrowing its focus to three lead products: Panzem, Angiostatin and Endostatin. EntreMed said it has sufficient cash to meet obligations into the fourth quarter and is considering a range of options to assure continuation of the business, including financings and other business opportunities. EntreMed's focus in on angiogenesis therapies.
Flamel Technologies SA, of Lyon, France, said it received a $4 million payment for completion of a further technical milestone in its licensing agreement with France-based Servier Monde. Further information on the progress of the product, an ACE inhibitor, was not disclosed. Flamel's focus is on developing polymer-based delivery technologies.
Genelabs Technologies Inc., of Redwood City, Calif., signed an agreement with Patheon Inc., of Mississauga, Ontario, for the commercial supply of Prestara, Genelabs' drug candidate for systemic lupus erythematosus. Patheon will manufacture and supply Prestara capsules for distribution in North America and Europe. The agreement has an initial term through Dec. 31, 2008, and is renewable for three-year terms thereafter. Genelabs said that, if approved, Prestara would be the first new lupus drug in more than 40 years. The company late last month received an approvable letter from the FDA. The company plans to commercialize Prestara in Europe and Japan through pharmaceutical companies and is in discussions for licensing rights in those territories. (See BioWorld Today, Sept. 3, 2002.)
Genmab AS, of Copenhagen, Denmark, said the FDA approved its investigational new drug application for the initiation of a Phase IIb study of HuMax-CD4 for psoriasis. The study, which will be the fifth for the antibody that targets the Cd4 receptor on T lymphocytes in psoriasis or rheumatoid arthritis, will involve about 300 patients with moderate to severe psoriasis and include 40 sites in the U.S. and Canada. Patients will be treated with one of three doses or placebo and evaluated for safety and efficacy, as assessed by PASI scores.
Genomic Solutions Inc., of Ann Arbor, Mich., said it received notice from Nasdaq that its bid price has been less than $1 over the previous 90 days and that the stock is subject to delisting. The company requested a hearing before a Nasdaq panel to review and appeal the determination.
Illumina Inc., of San Diego, signed a genotyping services agreement with GlaxoSmithKline plc, of London, to develop a set of single nucleotide polymorphism markers into validated SNP assays. Illumina will develop the assays into a whole-genome linkage disequilibrium-mapping product. The companies will jointly establish performance criteria, evaluate the candidate SNP markers and select a set for assay development. Financial terms were not disclosed.
Ligand Pharmaceuticals, of San Diego, said it expects to receive $3.5 million this quarter from Royalty Pharma AG, of Schaffhausen, Switzerland, which notified Ligand that it intends to exercise its Sept. 30 option to purchase an additional 0.125 percent of potential future sales of three selective estrogen receptor modulator products now in Phase III development. In March, Royalty Pharma paid Ligand $6 million in exchange for a right to receive 0.25 percent of new sales of the three SERMs for a period of 10 years from the first commercial sale of each product. In April, Royalty Pharma exercised its first option to purchase another 0.125 percent of net sales for $3 million. Upon the exercise of the Sept. 30 option, Royalty Pharma will have purchased for $12.5 million the right to receive 0.5 percent of the products' new sales for 10 years. Royalty Pharma has rights to purchase an additional 0.75 percent for $42.9 million at various times through mid-2004. The SERM products included in the transaction are lasofoxifene, bazedoxifene and bazedoxifene/Premarin.
LION bioscience AG, of Heidelberg, Germany, signed licensing agreements with Biogemma, a French crop science company, and RhoBio, a joint venture between Bayer Crop Science and Biogemma, for its SRS and bioScout technology, aimed at improving plant disease research. RhoBio will deploy LION's SRS technology for better integration of genetic data related to plant disease research. Biogemma will be using LION's bioScout application to analyze gene sequences to develop better crop protection strategies.
Maxygen Inc., of Redwood City, Calif., said its scientists created a series of novel molecules that could have application in cancer and autoimmune and infectious diseases, and a paper on the work was published in the online edition of the Journal of Biological Chemistry. The paper describes the creation of CD28 binding protein and CTLA-4 binding protein, molecules on the surface of T cells that play a role in immune system regulation. CD28BP, in combination with a cancer-specific antigen, is in preclinical development for colorectal cancer.
Oxford GlycoSciences plc, of Oxford, UK, entered a Cooperative Research and Development Agreement with the FDA's Center for Drug Evaluation and Research to identify serum protein biomarkers that could be useful in predicting and evaluating drug-induced toxicities. The FDA will begin a program to develop specific models of drug-induced histopathologic injury to the myocardium, vasculature and liver and will produce samples. OGC will use industrial-scale proteomics to analyze those samples.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., said it received correspondence from the FDA regarding its proposed Phase III trial of Cotara for brain cancer, and said it plans to meet with the FDA as "soon as practical" to negotiate several issues before approval is received for the trial. The company in December 2001 said it had agreed to a 24-month study design with the FDA and had planned to begin enrollment within months. Cotara, from the company's tumor necrosis therapy program, is a monoclonal antibody that carries iodine-131. (See BioWorld Today, Dec. 14, 2001.)
Symyx Technologies Inc., of Santa Clara, Calif., and Kurt J. Lesker Co., of Clairton, Pa., entered a worldwide, nonexclusive license agreement for selected Symyx patents and technology that may enhance the performance and capabilities of KJLC's CMS-A and CMS-18 thin-film deposition tools. KJLC will develop, manufacture and distribute the instruments worldwide, with Symyx receiving royalty payments on product sales.
The National Institutes of Health in Bethesda, Md., said grants totaling $19 million were awarded to the first two research centers in a network to focus on the biomedical and behavioral aspects of autism. The initiative, called STAART (studies to advance autism research and treatment) Centers Program, was established in response to the Children's Health Act of 2000, which calls for five new autism research centers by the end of fiscal year 2003. The grants, for five years each, were awarded to Fred Volkmar and Ami Klin at Yale University and Joseph Piven and James Bodfish at the University of North Carolina at Chapel Hill.