DUBLIN--(BUSINESS WIRE)--Mallinckrodt plc (NYSE: MNK) has been informed by the U.S. Food and Drug Administration (FDA) that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release (ER) tablets, USP (CII) may not be therapeutically equivalent to the category reference drug Concerta®. As a result, the agency indicated that it has reclassified Mallinckrodt’s ANDA 202608 for methylphenidate ER dosage strengths of 27mg, 36 mg and 54 mg from AB (freely substitutable at the pharmacy level) to BX (presumed to be therapeutically inequivalent). The agency said that this change was based on the application of its new Draft Guidance for determining bioequivalence of methylphenidate hydrochloride products just published on November 6, 2014. Although the Draft Guidance has an open comment period through January 5, 2015, the agency nevertheless confirmed that this change would be reflected on November 13, 2014 in the on-line Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
Mallinckrodt strongly believes its methylphenidate ER products are safe and effective when used in accordance with the approved labels.
“We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients,” said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA, and in the 21 months since launch more than 88 million1 doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug (Concerta) to the company’s methylphenidate ER products. “We believe this very low reporting rate is in line with response rates recorded for patients switching between different formulations of existing products,” continued Trudeau. “Based on our review of Mallinckrodt’s safety data base and the conclusions FDA has shared with the company, we remain confident in the safety of our methylphenidate ER products.”
“In the face of the agency’s precipitous decision, Mallinckrodt will continue to defend the safety and efficacy of our methylphenidate products,” said Trudeau. “We are considering all of our options to persuade the agency to engage in a meaningful dialog with us regarding the science, including potential legal action.” In Mallinckrodt’s view, the FDA’s recent unilateral decision, and apparent reluctance to engage with the company in a thorough scientific discussion and evaluation of these issues, could result in a variety of negative impacts including patient anxiety and uncertainty, potential disruption to effective therapy in vulnerable patients, possible market shortages, and unfavorable changes in the economics for ADHD patients and providers. “We have expressed to the FDA our earnest desire to have a robust scientific dialog about these important issues,” Trudeau concluded, “and it is our hope that this dialog will take place soon.”
This action by the agency was not contemplated on October 14, 2014 when Mallinckrodt provided financial guidance for fiscal 2015. The company plans to update its guidance at some point in the future once it has had time to fully assess this impact. As previously announced, Mallinckrodt will report its fiscal 2014 results on Wednesday, November 19, 2014. Mallinckrodt has an established toll-free information line (800-778-7898) to answer any questions that patients or providers may have.
ABOUT METHYLPHENIDATE ER:
On December 28, 2012, the FDA approved Mallinckrodt’s methylphenidate ER drug for marketing in three strengths as therapeutically bioequivalent to Concerta. In December 2012, Mallinckrodt launched the product as the first generic alternative to Concerta, which was first approved in August 2000. Since its launch, the company’s product has provided a cost-effective alternative to hundreds of thousands of patients suffering from attention-deficit hyperactivity disorder (ADHD).
Mallinckrodt’s formulation was approved as AB rated (readily substitutable at the pharmacy level) based on evidence that the product demonstrated bioequivalence in terms of (a) the same extended-release pharmacokinetic profile as Concerta; and (b) was, until November 13, 2014, AB-rated to (i.e., therapeutically equivalent to or substitutable for) Concerta because it met established FDA regulatory approval requirements.
Mallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology along with analgesics and central nervous system drugs for prescribing by office- and hospital-based physicians. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Pharmaceuticals segment includes branded and specialty generic drugs and active pharmaceutical ingredients, and the Global Medical Imaging segment include contrast media and nuclear imaging agents. Mallinckrodt has more than 5,500 employees worldwide and a commercial presence in roughly 65 countries. The company's fiscal 2013 revenue totaled $2.2 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
CONCERTA® is a registered trademark of ALZA Corporation
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1 Source, IMS Health