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

HEM’s AMPLIGEN AIDS ANTIVIRAL CLINICALS SET TO RESTART

Executive Summary

HEM's AMPLIGEN AIDS ANTIVIRAL CLINICALS SET TO RESTART shortly at four to six medical centers, pending approval of the Philadelphia-based firm's IND. The company expects that the Phase II trials will be initiated in September. Ampligen's earlier Phase III trials on patients with AIDS-related complex were terminated in 1988 due to insufficient evidence of efficacy. HEM Research attributed lack of efficacy data to the use of plastic I.V. bags in administration, which, it said, rendered the drug (poly(1)poly(C[sub 12],U) inactive. The firm is now packaging Ampligen in glass vials. The apparent lack of efficacy found in the 300 patients then in the Phase III trials led to the dissolving of a joint venture between HEM and DuPont two years ago ("The Pink Sheet" Aug. 22, 1988, T&G-1). The joint venture to develop Ampligen (a mismatched, double-stranded RNA) was signed in October 1987. Under the contract, DuPont planned to manufacture and market the drug once approved. In May 1987, DuPont had acquired rights to Ampligen and a small equity stake in the R&D firm HEM ("The Pink Sheet" June 1, 1987, T&G-4). The loss of its primary project was a major blow to HEM, but the resolution of a bitter legal battle with DuPont and the anticipated restart of human clinicals for Ampligen signal brighter days for the firm. On July 16, HEM announced that it had reached a settlement with DuPont in which DuPont agreed to drop a lawsuit against the company and pay HEM a $2.7 mil. cash settlement. DuPont also agreed to sell 2.7 mil. shares of HEM stock back to the company. In the lawsuit, filed in April 1989, DuPont had sought more than $30 mil. from HEM, alleging that the company misrepresented data from its original 10-patient Ampligen study. That study, published in the Lancet, was the impetus for the formation of the joint venture. HEM countersued, claiming that DuPont owed it more than $7 mil. for numerous charges, including breach of contract. In the ensuing months, HEM nearly went bankrupt, and its board fired CEO and chief scientist William Carter, who subsequently sued the firm. However, HEM then found a new group of investors, led by Paul Charlap, who is the current chairman and CEO. In addition to the AIDS studies, Ampligan is in Phase II studies for chronic fatigue syndrome, renal cell carcinoma, and hemophilia.

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

LL1135495

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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