PharMerica Responds to K-V Pharmaceutical's Statements Regarding Makena(R) and Compounded 17P
LOUISVILLE, Ky., Nov 18, 2011 (BUSINESS WIRE) -- PharMerica Corporation today responded to statements issued by the U.S. Food and Drug Administration (FDA) and K-V Pharmaceutical citing information and an analysis provided to the FDA by K-V Pharmaceutical in October 2011 regarding samples of bulk hydroxyprogesterone caproate (17P) active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone products. The data provided by K-V Pharmaceutical to the FDA, which has not been made public, allegedly reported variability in the purity and potency of both the bulk APIs and compounded 17P products that were tested. PharMerica Corporation contacted K-V Pharmaceutical and inquired as to whether any of the purportedly questionable samples provided by K-V Pharmaceutical to the FDA were obtained from PharMerica or were compounded by PharMerica. K-V Pharmaceutical refused to provide any information to PharMerica.
PharMerica dispenses compounded 17P to Alere's patients through Alere Women's and Children's Health's 17P Administration Nursing and Care Management Service. Alere Women's and Children's Health is a subsidiary of Alere Inc. ALR -2.17% . PharMerica reaffirmed that all of the physician-prescribed, preservative-free 17P compounded by the Company and dispensed to Alere's patients over the last eight years meets or exceeds any and all applicable United States Pharmacopeia (USP) standards.
PharMerica tests the 17P it compounds through an independent laboratory that is Good Laboratory Practice compliant and is registered with the FDA. The laboratory tests for identity, potency, sterility, absence of fungus and absence of endotoxins. PharMerica compounds 17P following receipt of a physician's prescription utilizing hydroxyprogesterone caproate purchased from a FDA-registered supplier.
Given the rigorous quality standards that PharMerica has in place for the 17P formulation, the Company is confident that its compounded 17P meets all FDA requirements for ensuring that patient safety is protected. PharMerica has received no report of any adverse drug events or safety concerns with respect to the 17P it compounds. As noted above, the Company does not believe that any of the purportedly questionable samples provided by K-V Pharmaceutical to the FDA were obtained from PharMerica or were compounded by PharMerica, nor has the FDA to date requested an audit or sample of PharMerica compounded 17P.
PharMerica Corporation is a leading institutional pharmacy services company servicing healthcare facilities in the United States. As of September 30, 2011, PharMerica operated 92 institutional pharmacies in 44 states. PharMerica's customers are institutional healthcare providers, such as nursing centers, assisted living facilities, hospitals and other long-term care providers. The Company also provides pharmacy management services to long-term care hospitals.
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which reflect the Company's current estimates, expectations and projections about its future results, performance, prospects and opportunities. Forward-looking statements include, among other matters, the information concerning the Company's "guidance" and possible future results of operations, the strength of the Company's financial performance during 2011, the impact of the brand to generic drug conversions on the Company, the Company's ability to deliver outstanding value to its stockholders and the Company's continued pursuant of its strategic initiatives. Forward-looking statements include statements that are not historical facts and can be identified by forward-looking words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "plan," "may," "should," "will," "would," "project" and similar expressions. These forward-looking statements are based upon information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause the Company's actual results, performance, prospects or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. Important factors that could cause the Company's actual results to differ materially from the results referred to in the forward-looking statements we make in this press release are included in the Risk Factors section set forth in the Company's Annual Report on Form 10-K filed with the SEC and in other reports, including Quarterly Reports on Form 10-Q filed with the SEC by the Company, and also include the outcome of, or developments concerning, the tender offer by Omnicare, Inc.; other potential commercial or business combination proposals that have or may be received in the future; the outcome of any litigation related to the tender offer by Omnicare, Inc. or any other offer or proposal and the Board's recommendation to the stockholders concerning the tender offer by Omnicare, Inc.
You are cautioned not to place undue reliance on any forward-looking statements, all of which speak only as of the date of this press release. Except as required by law, we undertake no obligation to publicly update or release any revisions to these forward-looking statements to reflect any events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. All subsequent written and oral forward-looking statements attributable to us or any person acting on the Company's behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this press release and in the Risk Factors section set forth in the Company's Annual Report on Form 10-K filed with the SEC and in other reports filed with the SEC by the Company.
SOURCE: PharMerica Corporation
Thomas A. Caneris, 502-627-7530
Senior Vice President and General Counsel