— Designation Marks Entry Point into MHRA's
Innovative Licensing and Access Pathway (ILAP) Program in the UK —
DUBLIN, Jan. 17, 2023 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced that nemvaleukin alfa
(nemvaleukin), the company's investigational, novel engineered
interleukin-2 (IL-2) variant immunotherapy, has been granted an
Innovation Passport for the treatment of mucosal melanoma under the
Innovative Licensing and Access Pathway (ILAP) by the Medicines and
Healthcare products Regulatory Agency (MHRA), the regulatory body
of the United Kingdom (UK). The
Innovation Passport designation is the entry point to the ILAP,
which aims to accelerate time to market and facilitate patient
access to medicines in the UK for life-threatening or seriously
debilitating conditions, or conditions for which there is a
significant patient or public health need. Benefits of ILAP include
access to a range of development tools, such as the potential for a
150-day accelerated Marketing Authorization Application (MAA)
assessment, rolling review and a continuous benefit-risk
assessment.
"We believe in the potential of nemvaleukin to help address
persistent unmet needs faced by patients with mucosal melanoma,"
said Craig Hopkinson, M.D., Chief
Medical Officer and Executive Vice President of Research &
Development at Alkermes. "The granting of the Innovation Passport
represents an exciting step in the clinical development program of
our IL-2 candidate, and we look forward to working closely with the
MHRA and the ILAP partner agencies in an effort to bring
nemvaleukin to people living with mucosal melanoma in the UK."
The U.S. Food and Drug Administration previously granted Orphan
Drug designation and Fast Track designation to nemvaleukin for the
treatment of mucosal melanoma.
About Innovation Passport and
ILAP
ILAP was launched by the MHRA in January
2021 with an aim to accelerate the development of and
facilitate patient access to medicines. The Innovation Passport is
granted by the UK's ILAP Steering Group, which consists of
representatives from MHRA, the National Institute for Health and
Care Excellence (NICE), the Scottish Medicines Consortium (SMC),
the All Wales Therapeutics and Toxicology Centre (AWTTC) and the
National Health Service (NHS) England. It is the first step in the ILAP
process and awarded to companies developing therapies with the
potential to offer significant benefit to patients who have
conditions that are life-threatening or seriously debilitating. A
single Innovation Passport can cover multiple future indications
for the same molecule.
About Nemvaleukin Alfa
(nemvaleukin)
Nemvaleukin is an investigational, novel, engineered fusion
protein comprised of modified interleukin-2 (IL-2) and the high
affinity IL-2 alpha receptor chain, designed to preferentially
expand tumor-killing immune cells while avoiding the activation of
immunosuppressive cells by selectively binding to the
intermediate-affinity IL-2 receptor complex. The selectivity of
nemvaleukin is designed to leverage the proven anti-tumor effects
of existing IL-2 therapy while mitigating certain limitations.
Nemvaleukin is currently the most advanced IL-2-based
immuno-therapy in clinical development, with two actively
recruiting, potentially registrational studies, ARTISTRY-6 and
ARTISTRY-7 in mucosal melanoma and platinum-resistant ovarian
cancer, respectively.
About the ARTISTRY Clinical
Development Program
ARTISTRY is an Alkermes-sponsored clinical development program
evaluating nemvaleukin as a potential immunotherapy for cancer. The
ARTISTRY program is comprised of multiple clinical trials
evaluating intravenous and subcutaneous dosing of nemvaleukin, both
as a monotherapy and in combination with the anti-PD-1 therapy
KEYTRUDA® (pembrolizumab) in patients with advanced
solid tumors. Trials in the ARTISTRY program
include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.
About Alkermes plc
Alkermes plc is a fully-integrated, global biopharmaceutical
company developing innovative medicines in the fields of
neuroscience and oncology. The company has a portfolio of
proprietary commercial products focused on alcohol dependence,
opioid dependence, schizophrenia and bipolar I disorder, and a
pipeline of product candidates in development for neurological
disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has a research and
development center in Waltham,
Massachusetts; a research and manufacturing facility in
Athlone, Ireland; and a
manufacturing facility in Wilmington,
Ohio. For more information, please visit Alkermes' website
at www.alkermes.com.
Note Regarding Forward-Looking
Statements
Certain statements set forth in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning the therapeutic and
commercial potential of nemvaleukin as an immunotherapy, including
for mucosal melanoma and platinum-resistant ovarian cancer. You are
cautioned that forward-looking statements are inherently uncertain.
Although the company believes that such statements are based on
reasonable assumptions within the bounds of its knowledge of its
business and operations, the forward-looking statements are neither
promises nor guarantees and they are necessarily subject to a high
degree of uncertainty and risk. Actual results may differ
materially from those expressed or implied in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others, whether nemvaleukin could be
shown to be unsafe or ineffective; whether results and data from
clinical studies for nemvaleukin will be predictive of future or
final results from such studies, results of future clinical studies
or real-world results; whether future clinical trials or future
stages of ongoing clinical trials for nemvaleukin will be initiated
or completed on time or at all; changes in the cost, scope and
duration of, and clinical trial operations for, development
activities for nemvaleukin, including changes relating to the
impact of the novel coronavirus (COVID-19) pandemic; and those
risks and uncertainties described under the heading "Risk Factors"
in the company's Annual Report on Form 10-K for the year ended
Dec. 31, 2021, and in subsequent
filings made by the company with the U.S. Securities and Exchange
Commission (SEC), including the company's Quarterly Report on Form
10-Q for the quarter ended September 30,
2022, which are available on the SEC's website at
www.sec.gov. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking statements contained in this press
release.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, NJ, USA.
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781
609 6377
For Media: Sourojit Bhowmick, Ph.D., +1 781 609 6397
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