Aderis Pharmaceuticals Inc., of Hopkinton, Mass., set the price range for its initial public offering at between $12 and $14 per share and the number of shares at 5.5 million. At that range, the offering would raise between $66 million and $77 million. The company filed for its IPO in January, estimating in its prospectus a maximum amount to be raised of $100 million. Aderis focuses on small-molecule drugs to treat central nervous system, cardiovascular and renal disorders. (See BioWorld Today, Jan. 15, 2002.)
Axiom Biotechnologies Inc., of San Diego, extended its collaboration with UCB SA, of Brussels, Belgium, to discover drugs for the treatment of allergic diseases and asthma. Axiom is using its physiogenomics approach to characterize particular types of cellular receptors that are of interest to UCB’s programs, and to find drug candidates active at those receptors. The companies already had a bridging agreement. Financial terms include an unspecified up-front payment, research supports, milestone payments and bonuses. The one-year contract is extendable for a second year.
BioTransplant Inc., of Charlestown, Mass., presented further developments in the use of its Eligix TCell Separation Systems last week at the European Bone Marrow Transplant meeting in Montreux, Switzerland. Several presentations described the potential of the Eligix Systems in the reduction of graft-vs.-host disease, detailing its ability to remove T cells implicated in GvHD while allowing a patient’s immune system to recover. Other studies suggested that T-cell depletion using anti-CD8 antibody may retain the graft-vs.-leukemia effect and simultaneously decrease GvHD compared to conventional hematopoietic stem cell transplantation.
Cell Based Delivery Inc., of Providence, R.I., completed a $9 million private financing round. The round was led by TVM Techno Venture Management and included ABN AMRO and The Vertical Group. Cell Based Delivery is developing an implantable protein delivery system that provides long-term therapeutic levels of proteins. Called ImPACT, for Implantable Protein Factory, the company’s platform is based on human muscle and is designed to deliver proteins to such chronic diseases as hemophilia, anemia, cardiovascular disease and cancer.
CeNeS Pharmaceuticals plc, of Cambridge, UK, terminated its drug delivery and product development and license agreements Bioglan Pharma plc, of Hertfordshire, UK. All rights under these agreements are thereby returned to the original owners. Andersen, the administrators of Bioglan, has also agreed to discuss the orderly disposal of Bioglan’s 8.9 million CeNeS shares with CeNeS and its brokers.
Cypress Bioscience Inc., of San Diego, said its auditors, Ernst & Young, withdrew the “going concern opinion.” Since the auditors completed their audit of the consolidated financial statements and issued their report dated Feb. 21, which contained an explanatory paragraph regarding the company’s ability to continue as a going concern, Cypress completed an issuance of its common stock and warrants to purchase common stock resulting in net proceeds of approximately $15.5 million. The conditions that raised substantial doubt about whether the company will continue as a going concern no longer exist and the auditors revised their opinion accordingly, it said.
Durect Corp., of Cupertino, Calif., filed an investigational new drug application to investigate the delivery of cromolyn sodium for the treatment of asthma. This IND was filed as part of an ongoing program to develop a product for the treatment of asthma and allergic rhinitis (seasonal allergies) using one of Durect’s biodegradable drug delivery platforms. Cromolyn sodium, a non-steroidal anti-allergy medication, is FDA-approved for the management of mild to moderate persistent asthma and is recommended for early intervention and daily anti-inflammatory therapy.
Exhale Therapeutics Inc., of Belmont, Calif., completed a Phase I trial of its lead compound, ETX-100, a pulmonary therapeutic intended for a genetic disorder, alpha-1 antitrypsin deficiency. This initial study, launched Jan. 29, was designed to measure the safety and tolerability of ETX-100 in 18 normal volunteers, and results indicated that ETX-100 was well tolerated. Studies were conducted in collaboration with Inveresk Clinical Research Ltd., of Edinburgh, Scotland.
ID Biomedical Corp., of Vancouver, British Columbia, said a preliminary analysis of safety and serum immunogenicity data from its Phase I trial of FluINsure, a non-living, subunit vaccine for the prevention of influenza administered by nasal spray, achieved the desired immune response endpoints and found no safety concerns. As a result, ID submitted an application to proceed to Phase II. The double-blind, placebo-controlled study focused on the safety and immunogenicity of four escalating doses of FluINsure in 78 healthy adult volunteers. Phase I results will be presented April 17 at the 2002 World Vaccine Congress in Montreal.
Incyte Genomics Inc., of Palo Alto, Calif., entered into an agreement to license from LION bioscience AG, of Heidelberg, Germany, its SRS integration platform, to enable Incyte’s customers to optimize data access and analysis for faster research and development. Under terms of the three-year agreement, LION will develop a customized application powered by SRS technology that gives Incyte customers a user-friendly web-based interface to access and analyze genomic and proteomic data and technology that Incyte provides through its information product offerings. Although specific financial terms were not disclosed, LION will receive annual license fees and royalties for the portal from Incyte, as well as for each of Incyte’s customers that uses the SRS-based software platform to work with Incyte data on its Intranet.
Neurogenetics Inc., of San Diego, appointed Neil Kurtz as president and CEO, as well as naming him to the board. Previously, the position of CEO had been held on an interim basis by Chairman William Comer. Prior to joining Neurogenetics, Kurtz was the president of Ingenix Pharmaceutical Services Inc., of Parsippany, N.J., a division of United Healthcare Group. Neurogenetics is focused on developing small-molecule therapeutics for Alzheimer’s disease and related neurodegenerative disorders.
NicOx SA, of Sophia Antipolis, France, reported positive clinical results of a Phase IIa study of HCT 1026, its nitric oxide-donating derivative of flurbiprofen in development for the treatment of lower urinary tract symptoms. In the study, designed to evaluate the efficacy and safety of HCT 1026 in the treatment of patients with symptoms of an overactive bladder, HCT 1026 showed statistically significant improvement compared to placebo (p< 0.05) in symptoms of urinary urgency and pain intensity (dysuria) and in the sensation of complete bladder emptying. The overall safety was excellent, it said, with no difference in both the total number of adverse events and the number of patients reporting adverse events for HCT 1026 and placebo.
Northwest Biotherapeutics Inc., of Bothell, Wash., said it will present favorable results from a Phase I glioblastoma multiforme (GBM) brain cancer clinical evaluation of its second dendritic cell-based immunotherapy, DCVax-Brain. The data will be presented this month during the 93rd annual American Association for Cancer Research Meeting in San Francisco. The company said it anecdotally experienced an encouraging overall 30 percent progression rate at one year follow-up for patients receiving DCVax-Brain vs. an 85 percent progression rate for GBM patients not receiving the dendritic cell-based therapy. Based on these results, Northwest received FDA clearance to begin a multisite, 90-patient Phase II evaluation of DCVax-Brain as a potential treatment for newly diagnosed and recurrent GBM brain cancer.
Novasite Pharmaceuticals Inc., of San Diego, was awarded a $2.4 million, two-year grant from the National Institutes of Health to support the development of anti-obesity drug candidates. Novasite plans to apply its Expanded Target Drug Discovery technology in an effort to discover novel anti-obesity drug candidates within the chemical libraries of a corporate partner.
Pacific Northwest Research Institute, of Seattle, said it created a method to make the immune system more powerful in destroying tumors, a method described in an April 1, 2001, Nature Medicine article. According to the study, tumors that were established from a highly malignant mouse melanoma were rejected in mice that were given a therapeutic vaccine. Such tumors were previously considered untreatable. Researchers inserted genes encoding artificially constructed antibody fragments into the tumor cells, creating ligands on the surface of the cancer cells, binding them to lymphoid cell molecules that can stimulate the immune system. Most of the treated mice became completely cancer free.
Paradigm Genetics Inc., of Research Triangle Park, N.C., and Bio-Technical Resources, of Manitowoc, Wis., a division of Arkion Life Sciences LLC, entered an agreement to co-market their technologies to the enzyme and microbial-based bioprocessing industry. Paradigm and BTR will jointly market services, such as biochemical profiling, metabolic engineering, strain improvement and process development, to improve the production of industrial enzymes and metabolites, such as vitamins, amino acids and pharmaceuticals. BTR will spearhead the sales effort by including Paradigm’s technologies in the portfolio it presents to customers. Paradigm will in turn market BTR’s technologies to its clients.
Progen Industries Ltd., of Brisbane, Australia, was named the exclusive distributor in Australia, effective May 1, for Pierce Chemical Co., of Rockford, Ill., covering both Pierce and Endogen brand products. Through its Life Sciences division, Progen will distribute the Pierce Endogen brand products throughout Australia.
Pharmacopeia Inc., of Princeton, N.J., said it earned a research milestone in its collaboration with Mitsubishi Pharma Corp., of Tokyo. Pharmacopeia is using its assay development experience, its compound sample collection and its ultra-high-throughput screening technology to identify compounds against a Mitsubishi target. Pharmacopeia received an undisclosed payment for achieving the milestone.
Prana Biotechnology Ltd., of Melbourne, Australia, requested an immediate trading halt pending release of material information regarding its Phase II trial results on Alzheimer’s disease patients. The news will coincide with an address Thursday at the seventh International Geneva/Springfield Symposium on Advances in Alzheimer Therapy in Geneva.
Provid Pharmaceuticals Inc., of Piscataway, N.J., licensed a portfolio of intellectual property from the University of Pennsylvania in the field of small-molecule peptide mimetics. Provid has exclusive worldwide rights to the technology and said it intends to develop drug candidates for multiple biological targets. Provid plans to focus its drug discovery efforts in the areas of autoimmune and infectious diseases and in programs established with partners.
Scios Inc., of Sunnyvale, Calif., said Natrecor net sales for the first quarter were $15.4 million, a 60 percent increase over the fourth quarter ended Dec. 31. Also, Natrecor received an Ambulatory Payment Classification passthrough code under the Hospital Outpatient Prospective Payment System from the Centers for Medicare and Medicaid Services. The code allows Medicare reimbursement for acutely decompensated heart failure patients with dyspnea at rest or with minimal activity treated with Natrecor in an outpatient setting.
Third Wave Technologies Inc., of Madison, Wis., said that Japan’s National Cancer Center (NCC) will use the Third Wave Invader products to genotype more than 100,000 different genetic variations in each of several hundred individuals in a large-scale study to discover the genetic foundations of cancer. Third Wave will provide it with access to a menu of products and collaborative support and, in turn, will receive an initial multimillion dollar payment from the NCC, follow-on product sales and access to licensing the discoveries arising from the study.
Xenova Group plc, of Slough, UK, began patient dosing in a Phase IIa dose-escalation trial for its therapeutic vaccine, TA-CD, under development for cocaine addiction. The open-label trial is designed to evaluate the safety and immunogenicity of TA-CD using a four- or five-dose vaccination schedule. The results of an earlier four-dose Phase IIa study found that TA-CD was well tolerated both systemically and locally, and was able to generate higher and earlier antibody titers than those seen in a Phase I trial using a three-dose vaccination schedule.