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

In Brief: Forest's Infasurf

Executive Summary

Forest's Infasurf: Lung surfactant for prophylaxis and treatment of respiratory distress syndrome in premature infants is "approvable" as of July 25. Some chemistry and labeling issues remain to be resolved prior to approval, Forest says. FDA must also make a final determination on whether Infasurf is chemically different or clinically superior to Abbott's Survanta, which has market exclusivity from orphan drug protection. Infasurf is calf lung surfactant extract and Survanta is calf extract-derived. Forest believes the data in the NDA (submitted March 13) show that Infasurf is both chemically different and clinically superior to Survanta. At a meeting with analysts in February, Forest CEO Howard Solomon asserted that Infasurf is more effective, lasts longer, and requires less supplementary oxygen and fewer installations than Survanta or Glaxo Wellcome's Exosurf ("The Pink Sheet" Jan. 15, T&G-12)...

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

ID005817

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