ST. LOUIS, May 15 KV Pharmaceutical Company(NYSE: KVa/KVb), a fully integrated specialty pharmaceutical company thatdevelops, manufactures, acquires and markets technology-differentiated brandedproducts and generic/non-branded prescription pharmaceuticals, announced todaythat it has received final approval from the U.S. Food and Drug Administration(FDA) of its Abbreviated New Drug Application (ANDA) to market its 50 mgstrength of metoprolol succinate extended-release tablets. The Company expectsto begin shipping immediately. This product is a generic version ofAstraZeneca's branded product, Toprol-XL(R) and the 50 mg strength recordedtotal branded and generic dollar volume in 2007 of $585 million according toIMS America. The 50 mg strength is the largest of the four strengths in bothunits sold and dollar volume.
As a result of the 50 mg approval, KV is now offering the complete line ofall four dosage strengths of metoprolol succinate extended-release tablets --200 mg, 100 mg, 50 mg and 25 mg. KV currently has a 77.8% and 77.4% marketshare for the 200 mg and 100 mg strengths, respectively. Based on theCompany's first-to-file status on its ANDA for these two strengths, KV wasaccorded the benefit of a 180-day generic exclusivity period for the marketingof these two dosage strengths. Even though KV was not granted an exclusivityperiod for the 50 mg or 25 mg dosage strengths, the Company currently has a23.5% market share for the 25 mg strength which was only approved by the FDAon March 20, 2008.
Marc S. Hermelin, Vice Chairman and Chief Executive Officer of KVPharmaceutical stated, "Following today's approval, KV is now able to offerall four dosage strengths of metoprolol succinate extended-release tablets. Wehave achieved remarkable results marketing the 100 mg and 200 mg strengths ofmetoprolol succinate extended-release tablets and have demonstrated successmarketing the 25 mg strength since we began shipping in March. With the 50 mgdosage strength now available, we expect the complete product line to continueto be a solid contributor to our growth in fiscal 2009 and beyond."
Metoprolol succinate extended-release tablets are indicated for thetreatment of hypertension used alone or in combination with otherantihypertensive agents, for the long-term treatment of angina pectoris andfor the treatment of stable, symptomatic (NYHA Class II or III) heart failureof ischemic, hypertensive, or cardiomyopathic origin.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceuticalcompany that develops, manufactures, markets and acquirestechnology-distinguished branded and generic/non-branded prescriptionpharmaceutical products. The Company markets its technology-distinguishedproducts through ETHEX Corporation, a national leader in pharmaceuticals thatcompete with branded products, and Ther-Rx Corporation, its brandedprescription pharmaceutical subsidiary.
For further information about KV Pharmaceutical Company, please visit theCompany's corporate website at www.kvpharmaceutical.com .
The information in this release may contain various forward-lookingstatements within the meaning of the United States Private SecuritiesLitigation Reform Act of 1995 ("PSLRA") and which may be based on or includeassumptions concerning KV's operations, future results and prospects. Suchstatements may be identified by the use of words like "plans", "expect","aim", "believe", "projects", "anticipates", "commit", "intend", "estimate","will", "should", "could" and other expressions that indicate future eventsand trends.
All statements that address expectations or projections about the future,including without limitation, statements about the Company's strategy forgrowth, product development, product launches, regulatory approvals, marketposition, market share increases, acquis