Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

SMITHKLINE BEECHAM/ONO TO FILE IND FOR ONO-1078 LEUKOTRIENE ANTAGONIST

Executive Summary

SMITHKLINE BEECHAM/ONO TO FILE IND FOR ONO-1078 LEUKOTRIENE ANTAGONIST for treatment of asthma "later this year" under a cross-licensing agreement. Under the agreement announced March 31, SmithKline Beecham has been granted "the option to acquire exclusive development, manufacturing and marketing rights" to ONO- 1078 in all countries except Japan, South Korea and Taiwan. In exchange, the Japanese firm will receive rights in those three countries to SB's Phase III 5-alpha reductase inhibitor epristeride for treatment of benign prostatic hyperplasia. Leukotriene antagonists are in the clinic for several firms, including SmithKline Beecham which has oral and aerosol compounds in Phase II. Ono filed a licensing application for ONO-1078 in Japan last year, SB said, indicating that the drug "could be the first leukotriene antagonist to be used as an asthma drug." Merck has said it expects its lead leukotriene product, MK- 591, to begin Phase III clinicals this year ("The Pink Sheet" Nov. 9, 1992, p. 4). Merck's initial attempt in the class, Venzair, was dropped after Phase II trials showed poor tolerance ("The Pink Sheet" April 29, 1991, T&G-6). Rhone-Poulenc Rorer also has reported signs of "unusual toxicity" with its leukotriene antagonist ("The Pink Sheet" Feb. 17, 1992, p. 4). The Ono cross-licensing deal was one of three R&D agreements announced by SmithKline Beecham March 31 to coincide with a meeting with the financial community. SB also disclosed deals with Ciba-Geigy and TheraTech. SB and Ciba-Geigy have signed an agreement in principle to develop and market CGP 57701, an oral penem antibiotic. The agreement covers rights to all markets except Japan and certain Far East territories, where Takeda has rights. CGP 57701 has entered Phase II in Japan, SB noted. "This new type of antibiotic has a very broad spectrum of activity and is effective against certain pathogens that are resistant to existing anti-infectives," SB said. The firm expects to begin U.S. clinical trials of CGP 57701 by the end of the year. SmithKline Beecham will market TheraTech's TheraDerm-LRS testosterone transdermal patch for hypogonadism in North America. TheraTech retains future U.S. copromotion rights and manufacturing rights. TheraDerm-LRS is in Phase III, and TheraTech has said it expects to file an NDA by mid-1994 ("The Pink Sheet" Jan. 4, T&G- 2). As part of the deal, SB's S.R. One venture capital arm has upped its equity stake in TheraTech by $1.5 mil. S.R. One invested $1 mil. in November. Also on March 31, the health care consulting firm Scott-Levin declared SmithKline Beecham number one in terms of physician "impressions" of sales forces in the consulting firm's annual survey. "With quality and familiarity as key criteria...the new edition of Sales Force Structures & Strategies shows SmithKline Beecham, Merck, Wyeth-Ayerst, Pfizer and Upjohn as the five top-rated companies among physicians overall," Scott-Levin said. Merck held the top spot in each of the four previous surveys.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS022448

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel