Patients Making a Difference:

Several weeks ago the US Food and Drug Administration announced the intent to remove midodrine from the marketplace because of a lack of clinical studies.  However, the more than 100,000 patients who rely on this medication to prevent disabling conditions including many types of autonomic dysfunction, and their doctors were in disbelief that the medicine would be withdrawn. Large numbers of patients contacted the FDA with complaints about their actions, and the FDA later reconsidered their decision and now says that Midodrine will be allowed to remain on pharmacy shelves.

“In a different situation, we might act differently,” said Dr. Joshua Sharfstein, principal deputy commissioner. “But in this case, it does not make sense to pull access to the drug while we get better data.”

Dr. Janet Woodcock, director of the agency’s drug center, agreed.

“Patients are out there thinking doom is about to fall, and they can’t go about their normal business,” she said.

A press release from Shire Pharmaceuticals released on September 13, 2010 follows:

Shire Update on ProAmatine® (midodrine HCl) FDA posts clarifying statement on its website Philadelphia, PA – September 13, 2010 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the United States Food and Drug Administration posted an update on its website on September 10, 2010  related to ProAmatine (known generically as midodrine), a medicine approved for the treatment of symptomatic orthostatic hypotension.

Notably, the FDA clarified that the FDA’s prior announcement related to midodrine “did not represent the actual withdrawal of the medication from the market.” Rather, the FDA stated that it “represented a step in the regulatory process.” To view this FDA statement, visit: http://www.fda.gov/Drugs/DrugSafety/ucm225444.htm

“Shire is very pleased that FDA has stated that ‘continued patient access to midodrine is a key agency priority’ and that the FDA has taken action allowing midodrine to remain accessible to patients and their families who rely on this medicine,” said Jeffrey Jonas, M.D., Senior Vice President of Research & Development for Shire. “We look forward to continuing our ongoing discussions with FDA related to the efficacy of this medicine.”

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. Press Release www.shire.com SHI-00059 09/10/10

SHIRE PLC 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 (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases 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.