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



Executive Summary

BURROUGHS WELLCOME AZT TREATMENT IND PROTOCOL WAS SUBMITTED TO FDA SEPT. 26, the firm said. The protocol was submitted exactly one week after HHS and Burroughs Wellcome announced the compound would be made available on a treatment IND basis to AIDS patients who have had pnuemocystis carinii ("The Pink Sheet" Sept. 22, p. 3). The protocol, which is being evaluated by FDA's Division of Anti-Infective Drug Products, defines the precise group of AIDS patients eligible to receive the drug. FDA has reportedly taken an active role in advising Burroughs Wellcome of the appropriate eligibility criteria for the protocol to facilitate a speedy review of the application. Burroughs Wellcome said it will not disclose the proposed eligibilty criteria for the treatment IND until FDA clears the application. FDA recently announced that it has classified AZT (azidothymidine) as a 1AA drug, to indicate that it has "absolute top priority" for agency review. FDA normally classifies a new chemical entity with important therapeutic gain as a 1A drug. Reporting on the status of AZT, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD, told the Institute's advisory council Sept. 25 that the proposed dosage tentatively agreed to by FDA and Burroughs Wellcome is 200 mg every four hours for the first month of treatment and 100 mg every four hours thereafter. Noting that the dose is lower than that used in Burroughs Wellcome's clinical trial, Fauci said "different doses will be studied in protocols that are now being designed or being modified." Discussing distribution plans for the antiviral, Fauci said that Rockville, Maryland-based Biospherics will, upon request, send doctors, patients, and pharmacies information packets on the procedure for receiving treatment. Doctors, for example, will be sent entry criteria and the necessary information for enrolling a patient. Fauci said that physicians would then submit the applications to an "authorizing committee" made up of a panel of physicians which would determine whether or not patients meet the entry criteria of the treatment IND. If the patient is approved, "then the authorizing committee notifies the doctor that the patient is approved, notifies Burroughs Welcome, identifying the patient, [and] Burroughs Wellcome ships to the appropriate pharmacy the drug for that patient," Fauci said. The NIAID director noted that only registered hospital pharmacies would be handling the drug so as to "cut down, as best as possible, the black market potential."

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




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