FDA turns down King’s NDA for CorVue (binodenoson)

The FDA has issued a completed response letter in response to King Pharmaceuticals NDA for CorVue (binodenoson). The company has not disclosed the content of the letter. Binodenoson is a pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) cardiac imaging.

The FDA response is not entirely unexpected, as the FDA’s cardiorenal advisory panel failed to recommend the agent in July. Here are links to our earlier coverage:

Here is the press release from King Pharmaceuticals:

FDA Issues Complete Response Letter for Corvue™

October 21, 2009

BRISTOL, TENNESSEE, October 21, 2009 –King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for CorVue™ (binodenoson) for injection. CorVue™ is a cardiac pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) cardiac imaging intended for use in patients with or at risk for coronary artery disease (CAD) who are unable to perform a cardiac exercise stress test.

King is currently evaluating the FDA’s complete response letter and expects to respond to the Agency’s questions as quickly as possible.

About Coronary Artery Disease

Coronary artery disease is a condition in which plaque builds up inside the coronary arteries, thereby narrowing or blocking the arteries and reducing blood flow to the heart. CAD is one of the most common forms of cardiovascular disease and is the leading cause of death globally. In the United States, it is estimated that CAD affects 16 million adults and kills more that 450,000 annually – about one every five deaths.

About CorVue™

CorVue™, a selective adenosine A2A receptor agonist, is being developed as an alternative to exercise prior to cardiac perfusion imaging for the diagnosis of coronary artery disease. CorVue™ is designed to minimize side effects such as dyspnea, flushing, heart block and chest pain. For ease of administration, CorVue™ is being developed for dosing as a single IV injection. CorVue™ has a fast onset while providing a sufficient duration of coronary blood vessel dilation for flexibility in diagnostic imaging.

About King Pharmaceuticals, Inc.

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 and technologies that complement the Company’s focus in specialty-driven markets, particularly the neuroscience and hospital markets. King’s wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacturing and marketing of pharmaceutical products for food producing animals.

About Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Act”). When used in this press release, the words “estimate,” “project,” “anticipate,” “expect,” “intend,” “believe,” and similar expressions are intended to identify forward-looking statements. King Pharmaceuticals, Inc. disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risk factors include, but are not limited to, our ability to gain FDA approval of the CorVue™ NDA, and the timing of any such approval; King’s ability to gain FDA approval of product labeling for the proposed indication for CorVue™; and the market acceptance and sales potential for CorVue™. You are encouraged to review these and other risks and uncertainties detailed in King’s Annual Report on Form 10-K for the year ended December 31, 2008, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, each of which is on file with the U.S. Securities and Exchange Commission.

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