News Release
Mallinckrodt plc Responds to FDA’s Expected Reclassification of Methylphenidate ER
DUBLIN--(BUSINESS WIRE)--Nov. 13, 2014--
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Draft Guidance for determining bioequivalence of methylphenidate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Draft Guidance has an open comment period through January 5, 2015, the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.
ABOUT MALLINCKRODT:
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
FORWARD-LOOKING STATEMENTS
Statements in this press release that are not strictly historical,
including statements regarding, future financial condition and operating
results, economic, business, competitive and/or regulatory factors
affecting our business and any other statements regarding events or
developments that we believe or anticipate will or may occur in the
future, may be “forward-looking” statements within the meaning of the
Private Securities Litigation Reform Act of 1995, and involve a number
of risks and uncertainties. There are a number of important factors that
could cause actual events to differ materially from those suggested or
indicated by such forward-looking statements and you should not place
undue reliance on any such forward-looking statements. These factors
include risks and uncertainties related to, among other things: general
economic conditions and conditions affecting the industries in which we
operate; the commercial success of our products, including H.P. Acthar®
Gel ("Acthar"); our ability to protect intellectual property rights; our
ability to maintain important business relationships; the lack of patent
protection for Acthar, and the possible United States Food and Drug
Administration ("FDA") approval and market introduction of additional
competitive products; our reliance on certain individual products that
are material to our financial performance; our ability to continue to
generate revenue from sales of our products to treat on-label
indications and to develop other therapeutic uses for them; our ability
to receive procurement and production quotas granted by the U.S. Drug
Enforcement Administration; our ability to obtain and/or timely
transport molybdenum-99 to our technetium-99m generator production
facilities; customer concentration; cost containment efforts of
customers, purchasing groups, third-party payors and governmental
organizations; our ability to successfully develop or commercialize new
products; competition; our ability to achieve anticipated benefits of
price increases; our ability to successfully integrate acquisitions of
operations, technology, products and businesses generally and to realize
anticipated growth, synergies and cost savings; the reimbursement
practices of a small number of large public or private issuers; complex
reporting and payment obligations under healthcare rebate programs;
changes in laws and regulations; conducting business internationally;
foreign exchange rates; material health, safety and environmental
liabilities; product liability losses and other litigation liability;
information technology infrastructure and restructuring activities.
Additional information regarding the factors that may cause actual
results to differ materially from these forward-looking statements is
available in (i) our SEC filings, including our Annual Report on Form
10-K for the fiscal year ended September 27, 2013 and our Quarterly
Reports on Form 10-Q for the quarterly periods ended December 27, 2013,
March 28, 2014 and June 27, 2014; (ii) the SEC filings of Cadence
Pharmaceuticals, Inc., which was acquired by Mallinckrodt on March 19,
2014, including its Annual Report on Form 10-K for the fiscal year ended
December 31, 2013; and (iii) the SEC filings of Questcor
Pharmaceuticals, Inc.’s, which was acquired by Mallinckrodt on August
14, 2014, including its Annual Report on Form 10-K for the year ended
December 31, 2013 (and the amendment thereto on Form 10-K/A), its
Quarterly Reports on Form 10-Q for the quarterly periods ended March 31,
2014 and June 30, 2014, and its Current Report on Form 8-K filed with
the SEC on July 10, 2014. The forward-looking statements made herein
speak only as of the date hereof and neither Mallinckrodt nor any of its
affiliates assume any obligation to update or revise any forward-looking
statement, whether as a result of new information, future events and
developments or otherwise, except as required by law.
1 Source, IMS Health
Source: Mallinckrodt plc
Mallinckrodt
Investor Relations:
John
Moten, 314-654-6650
Vice President, Investor Relations
john.moten@mallinckrodt.com
or
Kekst
and Company
Media Relations:
Jeffrey
Taufield, 212-521-4879
or
Daniel Yunger, 212-521-4879
jeffrey-taufield@kekst.com
daniel-yunger@kekst.com