Submission by partner Natco contains Paragraph IV certification.
Alvogen believes its India-based partner, Natco Pharma, has become the first firm to file a substantially completed ANDA filing containing a Paragraph IV certification, for a generic version of Roche’s flu drug Tamiflu®. If FDA approval for the drug is granted, Natco will team up with Luxemburg-based Alvogen IPCO for marketing and sales of oseltamivir in the U.S. “The ANDA filing of oseltamivir represents a significant milestone for Alvogen in the U.S. market,” comments Robert Wessman, Alvogen executive chairman. “We are confident that the filing will qualify for 180-day exclusivity upon FDA approval.”
Alvogen is focused on difficult-to-make and high-value drug formulations. Headquartered in Parsippany, NJ, Alvogen has offices in eight countries, and access to regulatory, development, and manufacturing capabilities in Asia, Europe, and North America. The firm currently has over 200 pharmaceutical products in development and registration, spanning a range of therapeutic fields. Its product pipeline is built from internal R&D candidates, in-licensed products, strategic partnerships, and targeted portfolio acquisitions. In 2009 Alvogen stated its goal was to become a top ten generic pharmaceuticals player by 2015.
A serious financial boost to the firm’s coffers was announced in November 2010, with the closing of a private placement and other committed funding totaling $200 millon. Alvogen said it aimed to use the funds to build and expand its product portfolio and marketing network in key global markets. In particular, it has identified over 20 emerging markets in Europe, Asia, and Latin America as priorities.
Roche admits that global spread of the A (H1N1) influenza virus during 2009 led to unprecedented demand for Tamiflu from the second quarter of that year, resulting in the drug achieving 2009 sales of CHF 3.2 billion (about $3.4 billion), an increase of 435% (or CHF 2.6 billion) compared with 2008. Of the overall sales figure for 2009, sales for pandemic stockpiling amounted to CHF 1.9 billion. Conversely, the passing of the influenza A (H1N1) pandemic, combined with the completion of most government stockpiling orders, meant that for 2010 global sales of Tamiflu declined to CHF 873 million.