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


FDA Has Full Plate This Fall For Vaccines: More Than H1N1

This article was originally published in RPM Report

Executive Summary

FDA faces the massive task of facilitaing the development and distribution of H1N1 vaccine in the autumn of 2009, but the agency also has some important pending applications for other vaccines in the same timeframe: Prevnar-13, Cervarix, and Gardasil for boys. Wall Street is not showing much excitement about the upcoming decisions. The applicatins could present some pleasant surprises and positive events for the sponsors.

You may also be interested in...

Novartis Bets Big on Meningitis:Wall Street Awaits Blockbuster Vaccine Franchise

Two years after shaking up the vaccine field with its big entry-acquisition of Chiron, Novartis AG has identified a make-or-break pair of projects in the meningitis area. The meningitis vaccines will determine whether the Novartis bet on vaccines will turn into a smart long-term diversification or a low-return move into an unfamiliar and unfriendly segment of health care.

Why Wyeth's Talking Up Vaccines

Given the near-term generic threats to over a third of its US drug revenues and two late-stage set-backs last year, Wyeth's vaccines business--basically the $3 billion-and-growing pneumococcal vaccine Prevnar--matters more than ever before. So, then, does eliminating an imminent competitive threat from GlaxoSmithKline, and a swift switch to follow-on Prevnar 13 in 2010. Indeed, vaccine chiefs at the other four big players-Sanofi-Aventis, Merck & Co. Inc., GlaxoSmithKline PLC, and Novartis AG-are likely to become more prominent, too. Vaccines may still account for only a small minority of revenues at these Big Pharma, but most saw far healthier growth in their vaccines business in 2007 than in therapeutics. That's why Sanofi, according to recent media reports, is out looking for vaccine acquisitions.

How Wyeth Plans to Make Prevnar a $3 Billion Vaccine

Wyeth's conjugated pneumococcal vaccine continues to break records. The company boldly says there is a lot of growth left, enough to take the product through $3 billion a year and perhaps to $4.5 billion. No vaccine has ever reached those heights. Can Wyeth pull it off?

Related Content





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