¿ Aerogen Inc., of Sunnyvale, Calif., announced the results of its Phase II study using the Aerodose albuterol inhaler at the American College of Chest Physicians conference in Philadelphia. The results indicate the Aerodose albuterol inhaler, using one-tenth to one-fifth of the standard nebulized dose, provides comparable efficacy to that of the Pari LC Plus jet nebulizer in the delivery of albuterol to the lungs of moderate-to-severe asthmatic patients. Twenty-two patients each received four cumulative doses of albuterol delivered by each device on separate study days.
¿ Arena Pharmaceuticals Inc., of San Diego, said it completed its initial analysis of human G protein-coupled receptor gene expression in 80 normal human tissues. Utilizing a proprietary, custom-designed, oligonucleotide GPCR chip, Arena identified relative expression levels of more than 700 GPCRs across these human tissues. Results indicate a large number of previously unidentified GPCRs are expressed in tissues that Arena believes are of high therapeutic importance, including over 225 receptors within major systems of the central nervous system, approximately 180 GPCRs localized to various cardiovascular tissues and about 300 receptors in endocrine/metabolic systems.
¿ Auxilium Inc., of East Norriton, Pa., said it raised $28 million in a Series B equity financing. The financing round was led by Perseus-Soros Biopharmaceutical Fund L.P. and brings to $39 million the total funds raised since the company¿s founding in 1999. The latest funding will be used to complete the company¿s NDA filing for its androgen formulation for male hormone replacement and to further its commercialization plans.
¿ BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said it licensed its Bio-Vant vaccine adjuvant on a non-exclusive basis to Corixa Corp., of Seattle, for use in several potential vaccines to be developed by Corixa. This agreement is a result of Corixa¿s completion of feasibility studies using Bio-Vant with certain Corixa protein antigens and DNA. Corixa agreed to pay BioSante milestone payments upon the achievement by Corixa of certain milestones plus royalty payments on sales by Corixa if and when vaccines are approved.
¿ Celera Genomics Group, of Rockville, Md., said Immusol Inc., of San Diego, signed a multiyear subscription agreement with Celera. Immusol scientists will access the Celera Discovery System, an integrated, web-based platform that enables users to leverage Celera¿s computational tools, super-computing power and genomic and biological data to advance the discovery process for researchers. Financial terms were not disclosed.
¿ Generex Biotechnology Corp., of Toronto, said the results of gamma-scintigraphy studies indicate that there is no lung deposition associated with buccal administration of an Oralin formulation, the company¿s proprietary technology used to deliver oral insulin. The studies were completed with seven healthy volunteers to establish quantitative mouth deposition and the area of deposition for an Oralin spray formulation. The studies illustrated that the droplet size distribution of the formulation was too large to enter the deep lung region, and that the deposition of the formulation was located in the mouth, oropharynx and the gastrointestinal areas. There was no deposition of the formulation in the lungs.
¿ Genomic Solutions Inc., of Ann Arbor, Mich., said its internal proteomics research and development team successfully validated the use of its GeneTAC HybStation, G3, Ls IV and UC4 instruments for protein chip production, processing, imaging and analysis. The company said the technology will provide current and future GeneTAC customers with the ability to conduct research beyond standard DNA microarrays.
¿ Strategene Inc., of La Jolla, Calif., was issued a summary judgment in its favor by the U.S. District Court of the Western District of Texas, which held that Strategene¿s chemically competent cell products do not infringe San Diego-based Invitrogen Corp.¿s U.S. Patent No. 4,981,797. Invitrogen withdrew its infringement allegations against Stratagene¿s electrocompetent cells.
¿ Hollis-Eden Pharmaceuticals Inc., of San Diego, offered data from three separate presentations at the Cytokine Odyssey 2001 meeting in Maui, Hawaii. This includes results with the company¿s lead immune regulating hormone, HE2000, indicating that treatment with the compound in HIV patients significantly reduced elevated levels of a number of well-known inflammatory mediators throughout the five-month treatment period. The new clinical findings indicate that Hollis-Eden¿s immune regulating hormones have the potential to reduce inflammation while at the same time boosting immune responses and preserving bone. The findings support and expand upon data previously reported on the ability of HE2000 to reduce transcript numbers for key inflammatory mediators such as TNF-alpha, COX-2, IL-1-beta and IL-6.
¿ Interferon Sciences Inc., of New Brunswick, N.J., said William Sheremata presented a study comparing the brain magnetic resonance imaging scans of 40 multiple sclerosis patients treated with interferon alfa-n3 as well as 40 patients treated with interferon beta-1b, both before therapy and at least six months after the initiation of therapy. The study was presented at the 126th Annual Meeting of the American Neurological Association in Chicago. A control group of 39 untreated MS patient scans were also evaluated. The data showed a reduction in the volume of T2-weighted MS brain lesions in both the interferon alfa-n3 treated group (-10 percent) and the interferon beta-1b group (-7 percent), as compared to increased lesion volume in the untreated control group (12 percent).
¿ La Jolla Pharmaceutical Co., of San Diego, said it initiated a Phase I/II trial of LJP 1082 for the treatment of stroke, deep-vein thrombosis and other conditions associated with antibody-mediated thrombosis, an autoimmune disease in which disease-causing antibodies promote the formation of potentially dangerous blood clots. The study¿s objective is to evaluate the safety of LJP 1082 and its ability to reduce disease-causing antibody levels in patients with antibody-mediated thrombosis. The trial is a double-blind, placebo-controlled study evaluating multiple doses.
¿ Labopharm Inc., of Laval, Quebec, completed its bought-deal public offering of 5.2 million common shares at a price of C$6.75 per share for total gross proceeds of C$35.1 million (US$21.8 million).. This included 1.2 million shares that were issued as a result of the exercise of an option granted to the underwriters of the offering by Labopharm. The common shares were sold to a syndicate of underwriters led by Research Capital Corp. and included CIBC World markets Inc., National Bank Financial Inc. and TD Securities. The net proceeds from this financing will be used primarily to finance scientific research and experimental development of its technologies.
¿ MGI Pharma Inc., of Minneapolis, presented data on irofulven, the company¿s anticancer compound, at the Chemotherapy Foundation Symposium in New York City on Wednesday. As a result of impressive tumor shrinkage observed in a refractory pancreatic cancer patient treated in an initial Phase I trial of irofulven administered for five consecutive days every 28 days, a Phase II trial was conducted to evaluate the six-month survival rate in patients with pancreatic cancer who had failed treatment with gemcitabine. Results showed that eight, or 36 percent, of the 22 patients who received more than one course of treatment were alive at six months. (See BioWorld Today, Nov. 2, 2001.)
¿ NPS Pharmaceuticals Inc., of Salt Lake City, received a milestone payment from Janssen Pharmaceutica N.V. as a result of the selection of a preclinical compound for further development as a potential treatment for schizophrenia. The research, development and marketing agreement between Janssen and NPS began in 1998 and focuses on the identification and development of glycine re-uptake inhibitors selective for the glycine T1 transporter. The compound being advanced is from a class of small molecules that inhibit the uptake of glycine, which is implicated in schizophrenia.
¿ Nymox Pharmaceutical Corp., of Maywood, N.J., and its drug discovery and diagnostic technologies are highlighted in the latest issue of Science Magazine. The article, titled ¿Neuroscience: Unraveling and Repairing the Human Brain,¿ highlights Nymox¿s AlzheimerAlert technology, which helps in the diagnosis of Alzheimer¿s disease, and its spheron-based drug development program for Alzheimer¿s disease. Researchers believe spherons, which are tiny balls of densely packed proteins, ultimately burst as they grow. The bursting spherons, according to Nymox scientists, might lead to the senile plaques found in Alzheimer¿s disease. Nymox is testing several drugs that could prevent the conversion from spherons to plaques.
¿ Orphan Medical Inc., of Minneapolis, said the FDA cleared the company¿s contract manufacturer to produce certain classes of drugs, including Xyrem (sodium oxybate) oral solution. This action addresses one of the issued cited in the FDA¿s approvable letter issued to Orphan Medical on July 2, 2001. Other issues identified in the approvable letter were addressed in the company¿s response submitted to the FDA on Oct. 9. Orphan Medical is seeking approval of Xyrem as a treatment for the symptoms of cataplexy in narcolepsy before the FDA¿s action deadline of April 9, 2002.
¿ Proxgen Industries Ltd., of Brisbane, Australia, received a provisional hospital ethics committee¿s approval for the anticancer drug PI-88 to be investigated in a Phase II multiple myeloma trial at several sites in Australia. The objectives of this second Phase II trial will be to investigate the efficacy of PI-88 in patients with relapsed or non-responsive multiple myeloma. Latest results in preclinical studies show evidence of the effectiveness of PI-88 in hematological cancer, as well as in solid tumors.
¿ Sepracor Inc., of Marlborough, Mass., announced the private placement of $400 million of 5.75 percent convertible subordinated notes due 2006. This offering, made through an initial purchaser to qualified institutional buyers, is expected to close Nov. 14. Sepracor granted the initial purchaser a 45-day option to purchase an additional $100 million in aggregate principal amount of notes, convertible into Separator¿s common stock at $60 per share. Sepracor may elect to automatically convert the notes on or prior to maturity under certain conditions. The company expects to use the net proceeds of the offering for working capital and general corporate purposes.
¿ Sequenom Inc., of San Diego, received a more than $2.2 million grant from the National Institutes of Health to fund what Sequenom believes to be the largest genome-wide disease association study to date. Sequenom plans to use its MassARRAY platform and up to 100,000 assays for gene-based single nucleotide polymorphisms developed internally and through collaborations with the National Cancer Institute and GlaxoSmithKline to screen for genetic variations associated with disease severity in beta-thalassemia patients.
¿ SuperGen Inc., of Dublin, Calif., said data from an ongoing Phase II study of its anticancer compound pentostatin (Nipent) in combination with rituximab showed the regimen was remarkably well tolerated in patients with low-grade non-Hodgkin¿s lymphoma disease. The company said it has data on 40 of the 55 non-Hodgkin¿s lymphoma patients in its study, suggesting an overall response rate of 71 percent and an 80 percent response rate among patients who were chemo-naive coming into this study.
¿ Transmucosal Technology Ltd., a joint venture between Atrix Laboratories Inc., of Fort Collins, Colo., and Elan Corp. plc, of Dublin, Ireland, said it submitted an investigational new drug application to the FDA for BEMA-Fentanyl for evaluation of Atrix¿s BioErodable MucoAdhesive transmucosal drug delivery technology in clinical trials. BEMA-Fentanyl is designed to provide rapid delivery of the opiate, fentanyl, for management of cancer pain.