Replies to post #2601 on Biotech Values

[DewDiligence]

King Pharma replies to FDA’s surprise action on generic Levoxyl:

[I can attest from personal knowledge that Synthroid and Levoxyl are *not* equivalent drugs despite the FDA’s approval of new generics which are A/B substitutable for both of them. King Pharma may have a valid case against the FDA here. Ditto for Abbott, but the issue is much more economically consequential for King.]

http://biz.yahoo.com/prnews/040624/nyth147_1.html

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King Pharmaceuticals Reports FDA Approval of Two Products as Bioequivalent for Levoxyl(R)

Thursday June 24, 9:36 pm ET

BRISTOL, Tenn., June 24 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG - News) reported today that the Food and Drug Administration ("FDA") has approved supplemental New Drug Applications (sNDA) which provide that Unithroid® (levothyroxine sodium tablets, USP) and Levo-T® (levothyroxine sodium tablets, USP) are bioequivalent and therapeutically equivalent to Levoxyl® (levothyroxine sodium tablets, USP). Despite the Company's expectation to the contrary, the FDA granted these approvals without requiring certification against King's patent number 6,555,581 ("the '581 Patent") which pertains to Levoxyl® and is listed in the FDA's publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the "Orange Book". King is currently evaluating the appropriateness of such approvals and considering potential legal recourse.

Brian A. Markison, acting President and Chief Executive Officer of King, noted, "The American Thyroid Association (ATA), The Endocrine Society (TES), and the American Association of Clinical Endocrinologists (AACE) issued a joint release today regarding their concerns with respect to the methodology used by the FDA to determine bioequivalence. In their release these organizations indicate that there is the potential for health issues that may arise from this action which is of great concern to our Company, healthcare professionals, and ultimately patients who utilize levothyroxine sodium products." A copy of the joint release issued by the ATA, TES, and AACE may be found at http://www.thyroid.org/professionals/advocacy/04_06_24_fda.html.

King also reported today the receipt of the FDA's denial of the Company's Citizen Petition challenging the appropriateness of the FDA's bioequivalence methodology for levothyroxine sodium tablets.

The '581 Patent is a utility patent that covers the Company's novel Levoxyl® product. The '581 Patent extends through February 15, 2022.

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
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