Biogen Inc., of Cambridge, Mass., said an investigator reported at the annual meeting of the American Academy of Neurology in Denver four-year data on an Avonex dose-comparison study designed to see if doubling the approved 30-mcg weekly dose of Avonex would benefit patients with relapsing forms of multiple sclerosis (MS). Results from the randomized, double-blind, 802-pateint European trial showed no difference between the 30 mcg and 60 mcg treatment groups in the cumulative rate of sustained disability progression on the expanded Disability Status Scale, supporting the approved dose.
Carlsson Research AB, of Gothenburg, Sweden, completed Phase I studies with ACR16, and now plans to file an application with the Swedish Medical Products Agency for clinical studies in schizophrenia. The biological effects of ACR16 suggest the compound can be used to treat the full range of symptoms associated with schizophrenia, including positive and negative symptoms and symptoms not reached by current therapies, such as the impairment of cognitive and social functions.
Cohesion Technologies Inc., of Palo Alto, Calif., entered into a nonexclusive research and license collaborative agreement with Zycos Inc., of Lexington, Mass., for polyethylene glycol (PEG)-based drug delivery to develop hydrogel delivery systems for nucleic acid-based drugs, in return for future royalties on resultant products developed by Zycos. In addition, Zycos granted Cohesion nonexclusive rights to Zycos’ PEG-related technology for use in the field of human tissue repair and regeneration, in return for future royalties. Specific financial terms were not disclosed.
Connetics Corp., of Palo Alto, Calif., said its partner, Mipharm SpA, of Milan, Italy, filed a marketing authorization application for Olux with the UK’s Medicines Control Agency. Following marketing authorization, Connetics intends to submit the application to all additional EU states under the mutual recognition process. Connetics granted Mipharm commercial rights in Italy to Olux, a topical treatment for moderate to severe scalp dermatoses. Connetics will receive milestone payments and royalties on product sales. Connetics retains marketing and manufacturing rights for the rest of Europe and is seeking commercial partners.
Gilead Sciences Inc., of Foster City, Calif., reported at the 37th annual meeting of the European Association for the Study of the Liver in Madrid, Spain, results from an ongoing 48-week, randomized, double-blind, placebo-controlled, multicenter, 59-patient trial of its once-daily, oral antiviral agent adefovir dipivoxil 10 mg to treat chronic hepatitis B. Results demonstrated that treatment with adefovir dipivoxil as monotherapy or in combination with lamivudine was associated with significant reductions in both serum hepatitis B virus DNA and alanine transaminase (ALT, a measure of liver damage) levels through 16 weeks in patients infected with lamivudine-resistant HBV. Treatment with lamivudine monotherapy was not associated with statistically significant reductions in HBV DNA or ALT levels.
IDEC Pharmaceuticals Corp., of San Diego, reported Rituxan sales of $235 million for the first three months of the year, up from $168 million a year ago. The cancer product is shared through a joint business arrangement with Genentech Inc., of South San Francisco. IDEC reported total revenues for the quarter of $79.7 million and net income of $29.7 million, or 17 cents per share on a diluted basis.
Kosan Biosciences Inc., of Hayward, Calif., was awarded a $100,000 Phase I Small Business Innovative Research grant from the National Institutes of Health to support Kosan’s program to generate improved geldanamycin analogues for the treatment of cancer. Geldanamycin is a polyketide with antitumor activity in a variety of animal models. A derivative of geldanamycin, allylamino-geldanamycin (AAG), is undergoing Phase I evaluation by the National Cancer Institute.
Ligand Pharmaceuticals Inc., of San Diego, expects to receive $3 million this quarter from Royalty Pharma AG, of Schaffhausen, Switzerland, which said it intends to exercise its first option to purchase an additional 0.125 percent of potential future sales of three selective estrogen receptor modulator (SERM) products now in Phase III development. Last month, Royalty paid Ligand $6 million in exchange for a right to receive 0.25 percent of net sales of the three SERMs for 10 years. Royalty has remaining options, exercisable at its discretion, to purchase at escalating prices rights up to another 0.875 percent of the products’ net sales for up to another $8 million during 2002; an additional $12.5 million in 2003; and up to $26.5 million through the second quarter of 2004.
Rush-Presbyterian-St. Luke’s Medical Center, of Chicago, said a combination treatment of Pegasys (peginterferon alfa-2a 40KD), a pegylated interferon manufactured by F. Hoffmann-La Roche Ltd., of Basel, Switzerland, with ribavirin (Ribapharm Inc., of Costa Mesa, Calif.) has shown effective treatment rates for individuals with hepatitis C. The combination treatment yielded a 61 percent sustained virologic response (SVR), the highest SVR ever reported in a prospective trial for a pegylated interferon using an intent-to-treat analysis, the center said. Results of a recently completed Phase III study of the investigational hepatitis C therapy were presented at the European Association for the Study of Liver annual meeting in Madrid, Spain. The study also revealed evidence that, to achieve optimal results, treatment regimens should be based on hepatitis C virus genotype, rather than weight-based methodology.
Schering AG, of Berlin, and Chiron Corp., of Emeryville, Calif., said Betaseron (interferon beta-1b) was the subject of a presentation at the American Academy of Neurology meeting in Denver. Data from the 27-patient study showed relapsing-remitting multiple sclerosis patients with prolonged absence of clinical disease activity who were continually treated with high-dose interferon beta-1b had significantly fewer exacerbations and less disease activity than patients who reduced their dose by switching from interferon beta-1b to interferon beta-1a. The new data confirm the second-year final results from the Independent Comparison of Interferon (INCOMIN) trial, results also presented at the conference.