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

CONNAUGHT WILL MARKET BIKEN ACELLULAR PERTUSSIS VACCINE IN U.S. AND CANADA; JAPANESE BIVALENT PERTUSSIS VACCINE WAS SUBJECT OF SWEDISH EFFICACY TRIAL

Executive Summary

Connaught has licensed North American marketing rights for the Biken acellular pertussis vaccine in the race to get the first acellular vaccine to the U.S. market. Under a licensing agreement announced by Connaught on April 21, Connaught will have "exclusive marketing rights for an acellular pertussis vaccine, licensed and sold in Japan for the past five years and used in an NIH-sponsored trial in Sweden." The bivalent acellular vaccine was developed by the Research Foundation for Microbial Diseases of Osaka University, known as Biken. Tanabe Seiyaku markets the product in Japan. Both Connaught Laboratories Ltd., in Canada, and the U.S. subsidiary will "seek permission to begin a series of clinical trials in adolescents, which will lead to safety trials in infants in both countries," the April 21 release notes. Connaught said it will file "an application for licensure of the new vaccine with [FDA] after the conclusion of safety trials in the U.S." The acellular pertussis vaccine was tested in an 18-month National Institutes of Health efficacy study in Sweden that ended in August 1987. The results of the trial were disclosed at a Feb. 8 meeting sponsored by National Institute of Allergy and Infectious Diseases (NIAID), FDA, the Centers for Disease Control, and the U.S. Agency for International Development ("The Pink Sheet" Feb. 15, p. 6). NIAID noted at the meeting that the Swedish trial was the first well-controlled study to show that acellular pertussis vaccines can prevent pertussis, but that the study failed to present key correlates necessary to expedite ongoing efficacy trials in the U.S. of other cellular pertussis vaccines. In the randomized, double-blind Swedish trial, which involved about 4,000 infants, ages five to 11 months old, 25% of the infants received placebo, with the rest receiving either Biken's bivalent vaccine, called JNIH-6 in the trial, or the monovalent vaccine JNIH-7. Biken's bivalent pertussis vaccine achieved a protective efficacy of 69%, while the monovalent vaccine had a efficacy rate of 54%. Connaught noted that the currently available whole cell pertussis vaccine is 70% to 80% effective. Connaught's primary competitor in the DTP vaccine area, Lederle, reported at the Feb. 8 vaccine workshop the results from its two U.S. Phase II studies of an acellular pertussis vaccine in over 1,000 children. That preliminary study showed reduced adverse events. The pertussis component of the Lederle vaccine is manufactured by the Japanese firm, Takeda. Institut Merieux and the National Institute for Child Health and Human Development are also developing acellular vaccines. Separately, Connaught's parent company, CDC Life Sciences recommended on April 19 that shareholders reject Institut Merieux' offer for an additional 20% or 4.4 mil. shares of the companies stock at $ 32 a share ("The Pink Sheet" April 18, p. 5). The board asserts that the offer has been "constructed to unfairly benefit one shareholder, Caisse", the Quebec provincial government's pension fund manager, which holds 20% of CDC Life. Because of the "private agreement" with Caisse, CDC maintains that Merieux "is making a bid for control without paying a premium for all the shares." CDC's board further states that the Merieux offer is "unfair" to U.S. shareholders, who have been excluded from the offer. The tender offer, which is being made through the Montreal and Toronto stock exchanges, is scheduled to begin on April 28. On April 21, CDC filed a complaint with the Supreme Court of Ontario to obtain an injunction against Merieux to prevent the company from proceeding with the offer.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

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 Skin Infections Guidance Spurs Debate On Endpoint Relevance

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

Shire Hopes To Sow Future Deals With $50M Venture Fund

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

UsernamePublicRestriction

Register

ID1132090

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