Biotech Values

[DewDiligence]

Speaking of generics…
This is kind of odd:

[Novartis’ generic thyroid hormone, Levothyroxine, is generically substitutable for either Abbott’s Synthroid or King’s Levoxyl. The odd part is that Synthroid and Levoxyl are not substitutable for each other! In other words, this arrangement violates the mathematical principle knows as “transitivity.”]

http://biz.yahoo.com/prnews/040623/nyw196_1.html

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Sandoz Inc. Launches AB-Rated Levothyroxine

- Generic Treatment for Hypothyroidism Provides Lower Cost Alternative for Patients -

PRINCETON, N.J., June 23 /PRNewswire/ -- Sandoz Inc., a Novartis company and one of the leading generic pharmaceutical companies in the world, announced today it began commercially shipping its version of generic Levothyroxine sodium tablets. On June 23, 2004, the United States Food and Drug Association (FDA) approved the Sandoz Levothyroxine Sodium tablets as AB-rated (bioequivalent) to both Synthroid® and Levoxyl®. The Sandoz product is now shipping to all classes of trade, including retail chain drugstores, wholesalers and distributors, and managed care customers.

Levothyroxine is indicated for the treatment of hypothyroidism. The Sandoz tablets are manufactured in all 12 dosage strengths: 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200 and 300 mcg. Sandoz becomes the first generic pharmaceutical company to launch AB-rated versions of Synthroid® and Levoxyl® with an approval for all dosage strengths.

John Sedor, President and CEO of Sandoz North America, stated, "We are extremely pleased to launch our version of Levothyroxine sodium tablets. This product is fully substitutable for Synthroid® and Levoxyl®. Patients deserve a lower cost alternative in their treatment for hypothyroidism. Sandoz is pleased to provide this high quality, fully bioequivalent product. Additionally, our product maintains 25-months of expiration dating. This longer expiration dating is excellent news for our customers and patients as it ensures greater product availability when needed."

Sandoz Levothyroxine Sodium tablets were developed through a partnership between Sandoz Inc. and MOVA Pharmaceutical Corporation, who will manufacture this product for Sandoz.

Sales of Synthroid® for 2003 were $818M and sales of Levoxyl® for 2003 were $256M, according to IMS data.

The thyroid gland regulates metabolism and organ function. Hypothyroidism is a condition whereby the thyroid gland fails to produce enough thyroid hormone. According to the American Association of Clinical Endocrinologists, an estimated 13 million Americans have thyroid disorders, with more than half undiagnosed. Those most likely afflicted with a thyroid condition are women and the elderly. Treatment replaces the deficient thyroid hormone.
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