aaiPharma Inc., of Wilmington, N.C., enrolled and dosed the first group of patients in its pivotal Phase III trials for its ProSorb-D (diclofenac) pain product. The Phase II/III studies are examining the reduction of pain in 75 subjects administered a single 100-mg dose of ProSorb-D, a single 100-mg dose of Cataflam, or a placebo, after the removal of more than two impacted third molars. The results of the study indicated that 50 percent of the subjects taking ProSorb-D had an onset of analgesic activity within 18 minutes, with an average duration of analgesia of 302 minutes.
AlphaRx Inc., of Richmond Hill, Ontario, completed the Canadian marketing registration of Flexogan, a series of over-the-counter pain relieving products using the company’s Bioadhesive Colloidal Dispersion delivery technology. Flexogan formulations suppress induced inflammation several times more effectively than currently marketed topical NSAID products, based on a non-infective inflammatory carrageenan experimental model, the company said.
AMDL Inc., of Tustin, Calif., authorized a study with Lung-Ji Chang at the University of Florida to develop a targeted immunogene therapy for breast cancer using a tumor antigen identification approach coupled with AMDL’s immunogene therapy technology. The technology will be tested in a breast cancer mouse model. Also, AMDL said AcuVector Group Inc., of Alberta, Canada, the former licensee of the combination immunogene therapy technology acquired by AMDL in August 2001, claims it has rights to the technology under a terminated license agreement AcuVector executed with Chang in 1998. AMDL responded to AcuVector’s claim by filing an action in the United States District Court for the Central District of California for a determination that its ownership of the technology is free of claims by AcuVector and that AMDL is the sole owner of the U.S. patent application and intellectual property rights in question.
American Biogenetic Sciences Inc., of Copiague, N.Y., updated information contained in its Nov. 26 press release in connection with its negotiations related to distribution agreements on vaccines for human and livestock diseases with manufacturers of such vaccines in the Russian Federation. ABS entered an agreement, effective Nov. 30, with the All-Russian Research Institute of Veterinary Virology and Microbiology that grants ABS rights for at least 10 years to act as the institute’s exclusive distributor outside of Russia for certain biological products related to animals, including livestock vaccines. Separately, the company said it is voluntarily delisting from the Nasdaq SmallCap Market, effective at the close of business on Jan. 8. Thus, the trading halt imposed by Nasdaq on the company’s common stock since Nov. 26 is no longer applicable. ABS said it intends to file an application for quotation of its stock with the Nasdaq’s OTC Bulletin Board as soon as possible.
Atugen AG, of Berlin, signed an agreement with Novo Nordisk A/S, of Copenhagen, Denmark, to validate novel genetic targets associated with diabetes and related diseases. After the first year, Novo Nordisk will have the option to enter into a long-term target validation and license agreement. Atugen will develop GeneBlocs that inhibit expression of specific genetic targets selected by Novo Nordisk. Atugen will receive up-front and annual payments, as well as potential future milestone and royalties. Atugen also will have the option to license certain intellectual property generated during the agreement and to develop antisense therapeutics against targets that Novo Nordisk declines to investigate further.
BioMS Medical Corp., of Edmonton, Alberta, received proceeds of about C$9 million (US$5.6 million) from the exercise of approximately 3 million share purchase warrants. Approximately 3.8 million warrants remain unexercised and are exercisable at C$4 before Dec. 31, 2002. Including the proceeds from this recent warrant exercise, BioMS has approximately C$25.2 million in cash and short-term investments. The company is developing a peptide technology for multiple sclerosis.
Boston Life Sciences Inc., of Boston, said its lead anticancer compound, Troponin I, when administered by constant infusion in extremely low doses to mice, suppressed growth of melanoma metastases in the lung. These results, part of the company’s finalization of dosage protocol for upcoming clinical trials, continue to suggest that Troponin has potential as a anti-angiogenic product for the prevention of tumor metastases in high-risk cancer patients, the company said.
Bruker AXS Inc., of Madison, Wis., said underwriters of its initial public offering exercised their overallotment option and purchased 1.35 million shares of stock at $6.50 per share, bringing the total shares sold in the offering to 10.35 million and its total take to about $62.7 million, after underwriter’s discounts and commissions. The IPO priced in December. (See BioWorld Today, Dec. 18, 2001.)
Cell Signaling Technology Inc., of Beverly, Mass., established a collaborative sponsorship of the Antibody Laboratory and the Protein Laboratory of the Alliance for Cellular Signaling (AFCS). CST will be a preferred provider of “smart,” or activation-state-specific, antibodies relevant to the research of the AFCS. Also, CST will be a preferred provider for the development of antibodies to any novel target identified by the AFCS. The overall goal of the alliance for Cellular Signaling is to understand how cells interpret signals in a context-dependent manner.
Cephalon Inc., of West Chester, Pa., acquired, through its subsidiaries, expanded rights to Gabitril (tiagabine hydrochloride) from Sanofi-Synthelabo, of Paris, and Novo Nordisk A/S, of Bagsvaerd, Denmark, the developer of the product. The transactions, expected to close at the end of January, include an approximately $20.5 million cash payment to Sanofi-Synthelabo. Cephalon assumes rights to Gabitril worldwide, excluding Canada, Latin America and Japan, countries that were not included in Sanofi-Synthelabo’s territory under its 1997 license with Novo Nordisk. Cephalon France assumes French intellectual property rights and Cephalon’s Swiss subsidiary assumes rights in other territories included in the deal. Rights to Gabitril in the United States were acquired by Cephalon from Abbott Laboratories, of Abbott Park, Ill., in January 2001. Cephalon said U.S. sales of Gabitril, which is marketed in 23 countries, were expected to reach $27 million for 2001. Cephalon is initiating clinical studies to further develop Gabitril, with anxiety disorders and neuropathic pain as the first targets.
CombiMatrix Corp., of Seattle, a majority-owned subsidiary of Acacia Research Corp., of Pasadena, Calif., completed a milestone in its alliance with Roche Applied Science, a business area within Roche Diagnostics, of Basel, Switzerland. Roche will purchase and market the hybridization-reader instrument, flexible custom arrays and predesigned catalogue arrays in combination with its own matching labeling and hybridization reagents as well as bioinformatic tools. In phase two of the agreement, Roche will market CombiMatrix’s desktop synthesizers and will use production synthesizers for their own manufacturing of microarrays.
Corixa Corp., of Seattle, and Rhein Biotech NV, of Maastricht, the Netherlands, reported statistically significant preliminary results of an ongoing Phase III, randomized, controlled pivotal trial. The study tested the efficacy and safety of Corixa’s RC-529 synthetic adjuvant used in combination with Rhein Biotech’s yeast Hansenula polymorpha-based recombinant hepatitis B antigen (HBsAg). Results showed that there were significantly more patients seroprotected after two immunizations with Rhein’s hepatitis B vaccine plus RC-529 than with the vaccine alone (95.5 percent vs. 82.1 percent, p=0.001).
Cytokinetics Inc., of South San Francisco, reported that its Cytometrix Technologies Development Partner Program includes four pharmaceutical and biotechnology companies. Participants include Eisai Research Institute, of Tokyo; Novartis Pharma AG, of Basel, Switzerland; Tularik Inc., of South San Francisco; and Vertex Pharmaceuticals Inc., of Cambridge, Mass. Cytokinetics will work with each participant to conduct activities aimed at the extended validation and further development of its Cytometrix automated cellular phenotyping technologies. Specific terms were not disclosed.
engeneOS Inc., of Waltham, Mass., said scientists from the MIT Media Lab report in the Jan. 10 issue of Nature they can control biomolecules with radio frequency energy, selectively switching them from one state to another. The scientists include three authors who are key members of the engeneOS team. engeneOS is a sponsor of the Media Lab and has licensed the technology from MIT. engeneOS designs and fabricates biological systems to address high-value applications, the company said.
Eos Biotechnology Inc., of South San Francisco, signed a manufacturing and licensing agreement with ICOS Corp., of Bothell, Wash. ICOS will produce Eos’ lead monoclonal antibody candidate to clinical specifications for use in Phase I/II trials for the treatment of cancer. The licensing agreement provides Eos with nonexclusive rights to ICOS’ CHEF1 enhanced mammalian protein expression technology. Financial details were not disclosed.
Epimmune Inc., of San Diego, and Rhein Biotech NV, of Maastricht, the Netherlands, entered into a research agreement under which Epimmune’s Padre technology will be evaluated in connection with technology from Rhein Biotech for the development of certain vaccines. Epimmune and Rhein will evaluate the combination of their technologies to determine potential efficacy in several vaccines, with a goal of entering into a further commercial agreement for products developed under this collaboration. Financial terms were not disclosed.
GenOdyssee SA, of Les Ulis, France, and Transgenomic Inc., of Omaha, Neb., entered into a service provider agreement in which Transgenomic will market and sell nucleic acid analysis services that will be performed by GenOdyssee Genetics, the service division of GenOdyssee. Transgenomic will leverage the customer relationships it has developed as a provider of tools and consumables used in the synthesis, separation, purification and analysis of nucleic acids to market the services.
Illumina Inc., of San Diego, signed a commercial agreement with Johns Hopkins Medical University, Institute of Genetic Medicine, of Baltimore, to provide single nucleotide polymorphism genotyping services on a sample collection provided by the institute. Illumina will use its BeadArray technology to determine the frequency of specified SNPs in the sample set. Illumina also will design functional assays for most of the SNP loci provided by the institute. Further details were not disclosed.
Immune Network Ltd., of Vancouver, British Columbia, reported the publication in The Journal of Medical Virology results with its 1F7 antibody in tests designed to find out whether it may be able to improve the response of the immune system to infection. The 1F7 antibody is thought to have specific reactivity with antibodies from both HIV and the hepatitis C virus, and has the potential to boost the human immune system when either or both infections are present.
Geron Corp., of Menlo Park, Calif., and the Wisconsin Alumni Research Foundation, of Madison, resolved a federal lawsuit and have entered into a new license for the commercialization of human embryonic stem cell technology. The new agreement supersedes the earlier license, and resolves all issues related to the lawsuit filed by WARF against Geron in August 2001. In the new license, Geron holds exclusive rights for therapeutic and diagnostic products from hESC-derived neural, cardiomyocyte and pancreatic islet cells. Geron also has nonexclusive rights to develop therapeutic and diagnostic products from hESC-derived hematopoietic, chondrocyte and osteoblast cells. Geron was granted nonexclusive rights to develop research products in hepatocytes, neural cells, hematopoietic cells, osteoblasts, pancreatic islets and myocytes. Geron and WARF further agreed to grant research rights to existing hESC patents and patent filings to academic and government researchers at no charge. WiCell Research Institute, a WARF subsidiary, will distribute the cell lines. Third-party for-profit companies may form collaborations with Geron or obtain licenses to Geron’s intellectual property on market terms.
Maxim Pharmaceuticals Inc., of San Diego, said that the results from its Phase III trial of Ceplene and interleukin-2 in the treatment of advanced metastatic melanoma have been published by the leading clinicians from the trial in this month’s edition of the Journal of Clinical Oncology. Results of the 305-patient, open-label, parallel group, controlled, multicenter U.S. trial showed that use of Ceplene (histamine dihydrochloride) as an adjunct to IL-2 is safe, well tolerated, and associated with a statistically significant prolongation of survival compared with IL-2 alone in metastatic melanoma patients with liver involvement.
MedImmune Inc., of Gaithersburg, Md., said the SEC declared effective the registration statement, filed on Dec. 10 and amended Jan. 3, relating to MedImmune’s acquisition of Aviron Inc., of Mountain View, Calif. In early December, the companies announced they had entered a definitive merger agreement for MedImmune to acquire Aviron through an agreement in which Aviron stockholders will receive 1.075 MedImmune shares for each Aviron share. At the time of the announcement, the merger was valued at $1.5 billion. (See BioWorld Today, Dec. 4, 2001.)
Miravant Medical Technologies Inc., of Santa Barbara, Calif., began treating patients in a Phase II trial of PhotoPoint photodynamic therapy for plaque psoriasis. The open-label, drug- and light-dose-ranging study will assess the safety and efficacy of single topical PhotoPoint treatments in 54 patients. They will be treated at multiple U.S. centers and followed for up to 12 weeks. PhotoPoint uses Miravant’s light-activated drug MV9411, which is prepared in a topical formulation. In the two-step procedure, varying doses are applied directly to plaques followed by light treatment.
NeoTherapeutics Inc., of Irvine, Calif., said its oncology division, NeoOncoRx, started two Phase II double-blind, placebo-controlled studies of Neotrofin in patients with chemotherapy-induced neuropathy. The studies are expected to enroll about 50 patients each. The treatment study will evaluate the drug’s efficacy in treating neuropathy in cancer patients and the prevention study will look at Neotrofin’s ability to prevent the occurrence of neuropathy in patients with ovarian cancer treated with paclitaxel and carboplatin.
Onyvax Ltd., of London, began a Phase II trial with its lead product, Onyvax P, in 30 patients with prostate cancer who have failed hormone therapy. Onyvax P is a therapeutic vaccine designed to provoke the immune system to attack prostate cancer cells. The open-label study will provide patients active treatment via 12 monthly injections, after which they will be followed for 12 more months.
PerkinElmer Life Sciences Inc., of Boston, and Millipore Corp., of Bedford, Mass., reported a nonexclusive agreement to co-market total automated sample preparation solutions for life science applications, including genomics, proteomics and drug discovery. The agreement couples PerkinElmer’s Packard brand instrumentation with Millipore’s sample-prep platforms and validated software protocols for mid- to high-throughput research centers. Financial terms were not disclosed.
Procyon Biopharma Inc., of Montreal, entered into an agreement with Chiron Corp., of Emeryville, Calif., for an evaluation of its Prostate Secretory Protein (PSP94) technology being developed initially for the treatment of late-stage prostate cancer. Terms include an exclusive period of six months for the evaluation of the program, which encompasses applications of the recombinant PSP94 peptide as well as the synthetic peptide PCK3145. At any time, Chiron may exercise its right to negotiate a worldwide license for the PSP94 technology. Financial terms were not disclosed.
Seattle Genetics Inc., of Bothell, Wash., said its anti-CD40 monoclonal antibody for hematologic malignancies entered the clinical development portfolio of Genentech Inc., of South San Francisco. The product candidate, PRO64553, originated as part of a Seattle Genetics research program and was licensed to Genentech in June 1999. As part of the license terms for the CD40 program, Genentech purchased equity in Seattle Genetics in 1999 and 2001, and made an up-front payment. The agreement includes multiple milestone payments through development, as well as royalties on product sales to Seattle Genetics.
Trinity Medical Group USA Inc., of Rancho Santa Margarita, Calif., said the Thai FDA certified the Remune manufacturing facility operated by The Immune Response Corp., of King of Prussia, Pa., as being in compliance with Good Manufacturing Practices standards. As a result of the certification, the company believes a timely determination can be made by the Thai FDA concerning the commercialization of Remune in Thailand.
Valentis Inc., of Burlingame, Calif., entered a nonexclusive cross-license agreement with Genzyme Corp., of Cambridge, Mass., under which Genzyme receives rights to Valentis’ GeneSwitch gene regulation technology for research use and Valentis receives certain rights to Genzyme’s plasmid DNA manufacturing technology. Genzyme plans to use GeneSwitch for its internal product research. Financial terms were not disclosed.