Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained its second US Food and Drug Administration (FDA) approval for a company’s Abbreviated New Drug Application (ANDA) within a week. The FDA granted tentative approval for Famciclovir tablets, 125 mg, 250 mg and 500 mg. Teva expects final approval of its application on August 24, 2007, upon expiry of the mandatory stay of approval associated with patent litigation related to the application.
Ethical Famciclovir, made by Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ), is used to treat herpes. The brand product had $190 million in sales for the twelve months through March 2007, based on IMS sales data.
Earlier this week, the FDA approved Teva’s ANDA for a generic version of GlaxoSmithKline's (NYSE:GSK) Zofran, used to prevent nausea and vomiting in patients undergoing chemotherapy, radiation therapy, or surgery. Ethical and generic zofran sales in US in the 12 months through March 2007 totaled $1.1 billion, based on IMS data.
Also this week, Wyeth (NYSE:WYE) asked the US District Court for the District of New Jersey for an injunction against Teva and India’s Sun Pharmaceutical Industries Ltd. (BSE:524715) from launching generic versions of its Protonix ulcer drug until the court reaches a final decision about related patent litigation. Protonix had $1.8 billion in global sales in 2006.
In a separate development, the US Senate Committee on Health, Education, Labor and Pensions passed the Biologics Price Competition and Innovation Act. The legislation includes standards for the FDA to approve follow-on biologics, a procedure designed to help resolve patents in an expedited way, and strong but responsible incentives to encourage innovation and the development of new therapies.
Teva has welcomed the legislation, but criticized the lengthy 12-year exclusivity period granted to ethical drug makers and the loophole which they can use to further extend the exclusivity period by making minor changes to their drugs.
Final approval of this bill is still a long way off, as it still has to be passed by the House of Representatives and signed by the president, and the road is filled with conflicting interests.
Published by Globes [online], Israel business news - www.globes.co.il - on June 28, 2007
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