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


MannKind files Afresa, downplays inhaled aspect of its insulin:

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Almost a year and a half after Pfizer admitted commercial defeat for the first inhaled insulin, Exubera, last-drug-developer-standing MannKind has filed the NDA for its inhaled insulin Afresa. The March 16 announcement continues MannKind's practice of downplaying the inhaled aspects of its insulin, stating that "the feature that distinguishes Afresa from all other insulin products is not the route of administration - it is the pharmacokinetic profile." Although the other manufacturers working on inhaled insulins abandoned the projects, MannKind persevered, arguing that the efficacy offered by the quick action (peak insulin levels in 12-14 minutes, mimicking the release of mealtime insulin in healthy people) - not convenience - is the rationale for the product. The firm also recently announced its plan to buy the German plant that produced Pfizer's Exubera. Having both the regulatory filing accomplished and the manufacturing capability should give the biotech a leg up in partnering talks - which had been put on hold after a lung cancer signal was detected in Exubera post-market data (1"The Pink Sheet" DAILY, Nov. 10, 2008)

You may also be interested in...

MannKind Says Inhaled Insulin NDA On Track, Resumes Search For Partner

Afresa Phase III studies are complete, though FDA wants bioequivalence trial to support new inhaler device.

CDER Pilot Program Offers Potential New Pathway For Approval Of Novel Pharmaceutical Excipients

After decades without an approval pathway for excipients, FDA pilot program paves the way for innovation.

Novartis Looks To Take Its Diversity Show On The Road

Head of clinical trial diversity and inclusion Kim Fookes spoke with Scrip about Novartis’s US trial diversity initiatives and early plans to expand them abroad.





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