Ther-Rx Corporation Commits to Take Action Regarding Makena™ Pricing
St. Louis, March 30, 2011 – Ther-Rx Corporation takes very seriously the public concerns raised regarding the list price of Makena. We are committed to ensuring that this significant, FDA-approved medication is covered at an affordable cost and accessible to all women who are prescribed Makena. We are finalizing solutions to the concerns, and will announce them by the end of the week.
We share the Food and Drug Administration’s (FDA) long-standing position to ensure that patients have access to FDA-approved medications. We also believe having available an FDA-approved medication is in the best interest of patients. Makena is closely controlled by FDA regulations to monitor safety, efficacy and quality. As an FDA-approved drug, Makena is manufactured in an FDA-regulated and FDA-compliant sterile facility. The manufacturing process is tightly controlled to ensure quality and consistency from dose to dose. This includes follow-up testing and reporting requirements that continue for the lifecycle of the medication.
Prior to FDA approval of Makena, women who could benefit from therapy faced potential barriers to access due to the absence of a commercially-available, FDA-approved product. A survey of obstetricians/gynecologists published in the American Journal of Perinatology in March 2009 highlights concerns about availability in the absence of an FDA-approved product. More than one in three OB/Gyns were “very concerned” about availability.
To address these unmet needs, Ther-Rx took important steps to bring Makena to market and ensure access to therapy upon FDA approval of Makena. Ther-Rx has invested or committed over a quarter of a billion dollars to-date to bring Makena to market, including more than $50 million in research and clinical trial costs, including those associated with conducting major, multi-year follow-on health studies of Makena involving 1,700 mothers and more than 500 infants.
To remove financial barriers to access, Ther-Rx established and has activated a patient financial assistance program (PAP) that not only reduces the total out-of-pocket costs for qualified patients, but eliminates out-of-pocket costs entirely for patients whose financial need is greatest. The level of assistance already exceeds many federal program guidelines for healthcare subsidies. Based on the feedback the company has received, we are currently exploring additional ways to help provide affordable access for all patients who are prescribed Makena. This includes the expansion of the existing patient assistance program.
Specialty injectable products like Makena are not typically carried by retail pharmacies. To make the process of prescribing and obtaining Makena as easy as possible for healthcare providers and patients, Ther-Rx established the Makena Care Connection™, a comprehensive program for patients and healthcare providers that provides administrative, financial, and treatment support for Makena patients in one single point of contact. The Makena Care Connection is actively processing prescriptions for Makena, and is already facilitating access to the financial assistance program for patients in financial need.
It is our commitment that every woman who is prescribed Makena will have affordable access to this FDA-approved and FDA-monitored therapy.
For more information about Makena, please visit www.makena.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:
This discussion is not exhaustive, but is designed to highlight important factors that may impact the Company’s forward-looking statements. Because the factors referred to above, as well as the statements included under the captions Part I, Item 1A—“Risk Factors,” Part II, Item 7—“Management‘s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the Form 10-K, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by the Company or on the Company’s behalf, you should not place undue reliance on any forward-looking statements.
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.