CHUGAI G-CSF STILL AT "PRE-IND" STAGE IN U.S.
CHUGAI G-CSF STILL AT "PRE-IND" STAGE IN U.S., the Japanese company's deputy president, Osamu Nagayama, reported at an Oct. 3 press conference in Cambridge, Mass. Noting that the product will be developed in the U.S. for co-marketing by Upjohn and Chugai, Nagayama said "in Japan, we have already filed last year, and we hope to get approval from the Japanese government." The recombinant G-CSF, licensed from Genetics Institute, will "be a sort of blockbuster," Nagayama predicted. The company's recently released English-version annual report for 1989 notes that the Japanese submission was made in December 1989 and the product is in Phase II trials in Europe. Japanese approval could come in 1991. Japan's ninth largest pharmaceutical manufacturer, Chugai had $900 mil. in sales last year, up from $869 mil. in 1988. The company's largest current commercial presence in the U.S. is through the licensing of sucralfate to Marion Merrell Dow. Sucralfate export sales for Chugai accounted for almost 5% of the company's total sales in 1989. Chugai's 10-year objectives include carving a niche in the top 30 worldwide pharmaceutical firms and building annual sales to $3 bil. by the year 2000. Chugai would like to derive 30% of its volume from overseas sales by the beginning of the next century and rank in the top 40 worldwide drug companies by 1994. The company's annual report highlights nine products in clinical development. Awaiting approval in Japan are MC-838, an orally active ACE inhibitor that works as a long-lasting antihypertensive, and CU-083, a prostaglandin derivative for treating gastric ulcers. In Japanese Phase II trials are DWA 2214R, a platinum complex anticancer agent designed to shrink tumors, BY-1949, an anti-senile dementia compound, and CS-1433, an anti-allergy IgE inhibitor with potential in bronchial asthma, atopic dermatitis and rhinitis. The company is also working on a treatment for gout, and has begun testing in the U.S. for new indications for Nicorandil, a long-acting coronary vasodilator under development by Upjohn.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth