PHILADELPHIA, Sept. 22, 2011 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces an update on the approval status and availability of ProAmatine® (midodrine HCl), a medicine approved for the treatment of symptomatic orthostatic hypotension (SOH). Shire has engaged in consistent dialogue with the U.S. Food and Drug Administration (FDA) for the past 12 months in the hopes of either securing final FDA approval of this medicine based on the data submitted following two post-marketing clinical trials, or establishing an agreed development plan for conducting additional clinical trials.
ProAmatine remains available to patients today as discussions between FDA and Shire continue concerning the status of its NDA. Shire, the NDA holder for ProAmatine, remains committed to ensuring midodrine remains available for patients who critically need this medicine and who would be left without alternative treatments should it be withdrawn from the market.
"While we continue to work with the FDA to design trials that further confirm the clinical efficacy of ProAmatine, we've reached an impasse and we now believe the fastest way to get the final approval for this medicine is to present our data at a public hearing, thereby sparing patients the additional hardships of clinical trials," said Jeffrey Jonas, M.D., Senior Vice President of Research & Development for Shire. "This is a unique situation and we're doing everything we can to keep this medicine on the market so patients can continue to access it."
ProAmatine was approved in 1996 under Subpart H (an accelerated approval process) for the treatment of SOH, with a post-approval commitment to conduct two clinical trials to verify the clinical effect of midodrine. The initial approval was based on ProAmatine's demonstrated ability to significantly raise blood pressure in patients with SOH. In 2000, Shire acquired ProAmatine and completed two clinical post-marketing trials as required and submitted the results to FDA in 2005. FDA took the position that these trials were inconclusive and requested that additional trials be completed. Shire disagrees with the FDA and believes that these trials, together with 15 years of clinical experience, have established the clinical efficacy of ProAmatine and provide the necessary data to support the full approval of ProAmatine.
Shire has no financial interest in midodrine; Shire no longer manufactures, distributes or markets ProAmatine. Beginning in 2003 and continuing to today, midodrine has been manufactured and distributed by five (5) generic pharmaceutical companies. As the NDA holder, Shire has continued to invest in the needed processes to ensure this medicine remains available for patients and their families who rely on it, and Shire has worked diligently with FDA to develop a path forward that would allow the NDA to maintain its marketing authorization thus allowing the generic versions of ProAmatine to remain available for patients.
"We look forward to continuing our discussions with FDA related to either having the agency accept the current data submitted by Shire in 2005 that demonstrates the clinical efficacy of midodrine, or agreeing on new protocols for additional studies that further confirm the clinical efficacy of ProAmatine as a treatment for patients diagnosed with SOH," added Jonas.
Important Safety Information
Warning: Because ProAmatine® can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of ProAmatine® in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of ProAmatine®, principally improved ability to carry out activities of daily living, have not been verified.
CONTRAINDICATIONS ProAmatine® is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. ProAmatine® should not be used in patients with persistent and excessive supine hypertension.
Please see Full Prescribing Information
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Notes to editors
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website: www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.
SOURCE Shire plc