K-V Pharmaceutical Company Announces Comprehensive Patient Assistance Program for Makena™
Makena available for prescribing week of March 14
St. Louis, March 8, 2011 – K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company"), a specialty pharmaceutical company, along with its branded subsidiary, Ther-Rx Corporation, today announced the details of its patient assistance program for Makena™ -eligible patients. Makena will be available for prescribing the week of March 14.
“Prior to FDA approval of Makena, women who could benefit from therapy may have faced barriers to access due to the absence of a commercially-available, FDA-approved product,” said Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation. “We established this comprehensive patient assistance program as part of our commitment to ensure that all eligible women have access to FDA-approved Makena.”
The patient assistance program for Makena covers both uninsured and insured patients, and is based on income eligibility requirements. The program has been designed with the following guidelines in place:
The patient assistance program is available as part of the services provided by the Makena Care Connection™, a comprehensive program for patients and healthcare providers that provides administrative, financial, and treatment support for Makena in one single point of contact. Because specialty injectable products like Makena are not typically carried by retail pharmacies, the prescription process for Makena will be managed by this dedicated customer support center. The services designed to support therapy for patients include:
“Ther-Rx recognizes the importance of ensuring that the process of prescribing and obtaining Makena be as easy as possible for healthcare providers and patients,” said Divis. “We look forward to providing our customers with an outstanding level of support for Makena.”
The Makena Care Connection is available by calling 1-800-847-3418. Hours of operation are 8 a.m. to 9 p.m. EST, Monday-Friday.
Makena was granted orphan drug designation by the FDA, which is given to treatments that target conditions with an estimated patient population of fewer than 200,000 patients per year.To view the Makena Prescribing Information, please visit http://www.kvpharmaceutical.com/pdf/Makena_PI.pdf.
About Ther-Rx Corporation
Ther-Rx Corporation is committed to advancing the health of women across all the stages of their lives. To help ensure patients are educated about their health care, Ther-Rx collaborates with leading patient advocacy groups and professional organizations who share this common mission of advancing women’s health.
About KV Pharmaceutical Company
K-V Pharmaceutical Company is a fully-integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded prescription pharmaceutical products. The Company markets its technology-distinguished products through Ther-Rx Corporation, its branded drug subsidiary.
For further information about K-V Pharmaceutical Company, please visit the company’s corporate Web site at www.kvpharmaceutical.com.
Cautionary Note Regarding Forward-looking Statements
This press release contains various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 (the “PSLRA”) and that may be based on or include assumptions concerning the operations, future results and prospects of the Company. Such statements may be identified by the use of words like “plan,” “expect,” “aim,” “believe,” “project,” “anticipate,” “commit,” “intend,” “estimate,” “will,” “should,” “could,” “potential” and other expressions that indicate future events and trends.
All statements that address expectations or projections about the future, including without limitation, statements about product development, product launches, regulatory approvals, governmental and regulatory actions and proceedings, market position, acquisitions, sale of assets, revenues, expenditures, resumption of manufacturing and distribution of products and the impact of the recall and suspension of shipments on revenues, and other financial results, are forward-looking statements.
All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the PSLRA’s “safe harbor” provisions, the Company provides the following cautionary statements identifying important economic, competitive, political, regulatory and technological factors, among others, that could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions.
Such factors include (but are not limited to) the following:
All forward-looking statements attributable to the Company are expressly qualified in their entirety by the cautionary statements in this “Cautionary Note Regarding Forward-Looking Statements” and the risk factors that are included under Part I, Item 1A – “Risks Factors” in the Form 10-K , as supplemented by the Company’s subsequent SEC filings. Further, any forward-looking statement speaks only as of the date on which it is made and the Company is under no obligation to update any of the forward-looking statements after the date of this release.
New factors emerge from time-to-time, and it is not possible for the Company to predict which factors will arise, when they will arise and/or their effects. In addition, the Company cannot assess the impact of each factor on its future business or financial condition or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.