¿ Advanced Tissue Sciences Inc., of La Jolla, Calif., and Smith & Nephew plc, of London, said Dermagraft human fibroblast-derived skin substitute received an ambulatory payment classification pass-through code under the Hospital Outpatient Prospective Payment System from the Centers for Medicare & Medicaid Services. The code covers Medicare patients with diabetic foot ulcers treated in a hospital outpatient setting and will be effective Jan. 1. This will allow each of the Medicare local carriers/fiscal intermediaries to begin developing coverage guidelines.
¿ Amerimmune Pharmaceuticals Inc., of Woodland Hills, Calif., said data from a Phase Ia trial with Cytolin, for HIV patients, found Cytolin to be safe and well tolerated. Also, a dose-dependent relationship was suggested, which demonstrated that at the higher concentration, Cytolin reduced HIV RNA concentration and increased CD4+ and CD8+ T-cell counts through the end of the 56-day study. The company said it would present data from the trial at the 9th Conference on Retroviruses and Opportunistic Infections, to be held in Seattle in February.
¿ Amgen Inc., of Thousand Oaks, Calif., presented data at the 24th annual San Antonio Breast Cancer Symposium suggesting the benefits of identifying subgroups of breast cancer patients at high risk for hospitalization due to febrile neutropenia so that Neupogen might be administered to patients to help decrease the incidence of side effects. The open-label study demonstrated that 95.3 percent of high-risk patients who received Neupogen compared to 79.9 percent in the control group were able to receive an effective regimen of chemotherapy on schedule.
¿ Atugen AG, of Berlin, signed a collaboration with Oxford GlycoSciences plc, of Oxford, UK, to validate high-priority disease-associated genetic targets of interest to OGS. OGS will provide novel high-priority drug targets to Atugen to enable validation in specific cell lines and in animal models of human diseases. Atugen will optimize its GeneBloc and cellular delivery technologies to knock down the expression of these targets, thus inhibiting protein production and validating biological function. Financial terms were not disclosed.
¿ AxCell Biosciences, a subsidiary of Cytogen Corp., of Princeton, N.J., signed a binding term sheet with Pluvita Corp., of Bethesda, Md., for a pilot program to research protein interactions. The principle goals of the pilot program will be to identify the full-length peptides that bind Pluvita¿s compound, and identify apparent consensus sequences and analyze the representation of those sequences within the human proteome. AxCell also will determine apparent affinities of compound binding observed with the isolated peptides. Financial terms were not disclosed.
¿ BioTransplant Inc., of Charlestown, Mass., filed a shelf registration statement with the Securities and Exchange Commission to sell up to 5 million shares of its common stock. BioTransplant plans to use the proceeds for working capital and other corporate purposes, including development and commercialization of existing and proposed products, expenses related to clinical trials, as well as for enhancing sales, marketing and manufacturing opportunities. The sale of 5 million shares would gross $40.5 million based on the company¿s opening price Tuesday of $8.10.
¿ Cephalon Inc., of West Chester, Pa., said the initial purchasers of its $500 million aggregate principal amount 2.5 percent convertible subordinated notes due 2006 have exercised in full their option to purchase $100 million of additional notes, bringing the total amount of the notes sold to $600 million. The notes are convertible into Cephalon common stock at $81 per share, subject to adjustment in certain circumstances. Cephalon expects to use the net proceeds of the offering to fund a portion of the purchase price of its previously announced acquisition of the French pharmaceutical company Group Lafon, and for general corporate purposes. The company expected to close the $600 million offering Tuesday. (See BioWorld Today, Dec. 4, 2001.)
¿ Epoch Biosciences Inc., of Bothell, Wash., was awarded a National Institutes of Health Small Business Innovation Research Phase II grant, titled ¿Rapid Genotyping with Minor-Groove-Binder-Containing Probes.¿ The two-year grant of $872,000 will fund development of a prototype kit for rapid, cost-efficient, high-throughput DNA fingerprinting using probes that contain Epoch¿s probe technologies.
¿ eXegenics Inc., of Dallas, said it has been named as a member of the federal interagency working group asked to focus on the production of vaccines to protect the United States against biological warfare agents. The objective of the group is to address vaccine requirements designated by the interagency group as national priorities. eXegenics has developed a suite of platform technologies to accelerate and enhance the discovery and creation of pharmaceutical products, the company said.
¿ Gen-Probe Inc., of San Diego, and Chiron Corp., of Emeryville, Calif., reached a negotiated resolution of all contractual disputes prior to arbitration, scheduled to begin early this month. The companies said they were ¿pleased to put these issues behind them.¿ The companies will continue to support the blood screening community in continuing collaborative development programs for the Triplex HCV/HIV-1/HBV assay and the fully automated instrument platform.
¿ Graffinity Pharmaceutical Design GmbH, of Heidelberg, Germany, delivered the first results in a collaboration with Celera Genomics Group, of Rockville, Md. The collaboration is aimed at using Graffinity¿s integrated technology platform to discover novel lead structures for selected Celera targets. Graffinity said several proteins have been screened against its chemical microarrays. Financial details and target information were not disclosed.
¿ Hybridon Inc., of Cambridge, Mass., said its board adopted a shareholders rights plan, which is designed to ensure all company shareholders receive fair and equal treatment in the event of a takeover proposal. Hybridon CEO Stephen Seiler said it is a safeguard against abusive takeover tactics. Seiler noted that the rights plan was not adopted in response to any current effort to acquire control of the company.
¿ ICN Pharmaceuticals Inc., of Costa Mesa, Calif., entered a plea agreement with the Office of the U.S. Attorney in Los Angeles to settle a six-year investigation. ICN agreed to plead guilty to a single felony account for securities fraud for omitting to disclose until Feb. 17, 1995, the existence and content of a letter received from the FDA in December 1994 regarding the status of ICN¿s 1994 application for Virazole as a monotherapy treatment for chronic hepatitis C. ICN will pay a $5.6 million fine and be subject to three years of probation.
¿ Inflazyme Pharmaceuticals Ltd., of Richmond, British Columbia, completed patient enrollment for its Phase II Allergen Challenge Trial with IPL576,092, being developed as a potential new oral asthma therapy in collaboration with Aventis Pharma AG, of Frankfurt, Germany. Results are expected to be available by the end of the first quarter of 2002. The trial is designed to provide an indication of the activity of two different doses of the product, when administered orally to mild asthmatic subjects with a known sensitivity to an allergen. IPL576,092 is from the class of anti-inflammatory compounds known as leukocyte-suppressing anti-inflammatory drugs.
¿ ISTA Pharmaceuticals Inc., of Irvine, Calif., said it will announce on Jan. 30 the preliminary efficacy results from its two Phase III studies of Vitrase, a drug under development for severe vitreous hemorrhage. A total of 1,190 patients were targeted for enrollment in the prospective, double-masked, randomized, placebo-controlled trials. In both studies, patient enrollment is complete. Patients with a vitreous hemorrhage for more than one month were eligible if it was severe and the patients¿ best corrected visual acuity was worse than 20/200 at the time of study entry.
¿ Microbiotix Inc., of Worcester, Mass., obtained an exclusive, worldwide license to a series of antiviral compounds, discovered through the research efforts of Jiri Zemlicka of Wayne State University and John Drach of the University of Michigan. Compounds in the licensed series have demonstrated activity against a variety of disease-causing viruses, including cytomegalovirus, hepatitis B and Epstein-Barr. Financial terms were not disclosed.
¿ Molecular Staging Inc., of New Haven, Conn., said a paper describing the application of its Rolling Circle Amplification Technology (RCAT) to detect nucleic acids on microarrays was published in the November issue of Nucleic Acids Research. The paper outlines the benefits of RCAT as an on-chip signal amplification method. RCAT allows for multiplexing, or the ability to perform many assays simultaneously, without interference between the products of the amplification for each assay.
¿ Neoprobe Corp., of Dublin, Ohio, completed a definitive acquisition agreement with the shareholders of Biosonix Ltd., of Hod Hasharon, Israel. At the closing, expected to be by the year¿s end, Neoprobe will issue about 9.7 million shares of stock for all of Biosonix¿s outstanding shares. Neoprobe¿s stock (OTCBB:NEOP) closed Monday at 35 cents, valuing the acquisition at about $3.4 million. About 2.1 million shares of Neoprobe stock will be issued to Biosonix shareholders upon the satisfaction of a milestone event involving Biosonix product development activity. Biosonix focuses on blood flow measurement technology.
¿ Pain Therapeutics Inc., of South San Francisco, said it saw positive results with PTI-801, a narcotic painkiller. The company said it believes PTI-801 is a safer version of oxycodone. Twenty-two volunteers or patients participated and results indicate that PTI-801 is a viable drug candidate that is well tolerated, the company said.
¿ PhotoCure ASA, of Oslo, Norway, was given the go-ahead by the FDA for its investigational new drug application for its photodiagnostic agent, Hexvix. PhotoCure is now able to start the final Phase III study in the U.S. with Hexvix for fluorescence cytoscopic detection of bladder cancer. The study, scheduled to begin shortly, will be performed in collaboration with about 20 hospitals.
¿ ProBioGen AG, of Berlin, entered an exclusive research and license agreement with Merck & Co. Inc., of Whitehouse Station, N.J., to explore the development of cell substrates with potential application in the production of biologicals. The agreement includes an up-front payment, potential success-driven milestones and royalties from net sales of any products developed by ProBioGen technology. Financial terms were not disclosed.
¿ Prolinx Inc., of Bothell, Wash., released its genomics product, RapXtract Fluorescent cDNA Purification Kit. RapXtract products are based on a superparamagnetic particle technology that allows for extraction of contaminating fluorescent dyes. The product expands the Prolinx RapXtract product offering into the DNA microarray market, the company said.
¿ Viral Genetics Inc., of South Pasadena, Calif., entered a $1.8 million purchase agreement for property in South Pasadena for its commercial-scale production facility. The 65,000-square-foot lot contains three permanent structures, one of which is a residential rental property. The company estimates the facility will have a monthly production capacity of 15,000 to 20,000 units of thymus nuclear protein.