Alkermes has been granted Innovation Passport designation by the MHRA (UK) for Nemvaleukin Alfa for the remedy of mucosal melanoma

— The designation marks the entry level to the MHRA’s Revolutionary Licensing and Entry Pathway (ILAP) program in the UK —

DUBLIN , Jan. 17, 2023 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS ) right now introduced that nemvaleukin alfa (nemvaleukin), the corporate’s investigational, novel engineered variant of interleukin-2 (IL-2) immunotherapy, has been awarded an Innovation Passport for remedy of mucosal melanoma below the Revolutionary Licensing and Entry Pathway (ILAP) of the Medicines and Healthcare merchandise Regulatory Company (MHRA), the regulatory physique of the UK (UK). The Innovation Passport designation is the entry level for ILAP, which goals to hurry time to market and make it simpler for sufferers to entry medicines within the UK for life-threatening or critically debilitating situations, or situations for which there’s a major affected person or public well being want. Advantages of ILAP embrace entry to a variety of growth instruments, equivalent to the flexibility for a 150-day accelerated advertising and marketing utility evaluation (MAA), ongoing overview and steady benefit-risk evaluation.

“We consider within the potential of nemvaleukin to assist handle the continuing unmet want dealing with mucosal melanoma sufferers,” mentioned Craig Hopkinson, MD, chief medical officer and govt vice chairman of analysis and growth at Alkermes. “The award of the Innovation Passport represents an thrilling step within the scientific growth program for our IL-2 candidate and we look ahead to working intently with the MHRA and ILAP associate companies in our efforts to deliver nemvaleukin to folks residing with mucosal melanoma within the UK.”

The US Meals and Drug Administration beforehand granted orphan drug designation and Quick Observe designation to nemvaleukin for the remedy of mucosal melanoma.

Concerning the Innovation Passport and ILAP

ILAP was launched by the MHRA in January 2021 with the goal of dashing up growth and making it simpler for sufferers to entry medicines. The Innovation Passport is awarded by the UK ILAP Steering Group, which includes representatives from the MHRA, the Nationwide Institute for Well being and Care Excellence (NICE), the Scottish Medical Consortium (SMC), the All Wales Therapeutics and Toxicology Heart (AWTTC) and the Nationwide Well being Service (NHS) of England. It is step one within the ILAP course of and is awarded to firms growing therapies with the potential to supply vital profit to sufferers with situations which might be life-threatening or critically debilitating. One innovation passport can cowl a number of future indications for a similar molecule.

About Nemvaleukin Alfa (nemvaleukin)

Nemvaleukin is an investigational, novel, engineered fusion protein consisting of a modified interleukin-2 (IL-2) and a high-affinity IL-2 receptor alpha chain, designed to preferentially unfold tumor-killing immune cells whereas avoiding the activation of immunosuppressive cells by selective binding to IL-2 medium affinity receptor complicated. Nemvaleukin selectivity is designed to benefit from the confirmed antitumor results of present IL-2 remedy whereas mitigating sure limitations. Nemvaleukin is at the moment essentially the most superior IL-2-based immunotherapy in scientific growth, with two actively engaged, potential registration research, ARTISTRY-6 and ARTISTRY-7 in platinum-resistant mucosal melanoma and ovarian most cancers.

Concerning the ARTISTRY scientific growth program

ARTISTRY is an Alkermes-sponsored scientific growth program evaluating nemvaleukin as a possible most cancers immunotherapy. The ARTISTRY program consists of a number of scientific trials evaluating intravenous and subcutaneous dosing of nemvaleukin, as monotherapy and together with the anti-PD-1 remedy KEYTRUDA® (pembrolizumab) in sufferers with superior stable tumors. Trials within the ARTISTRY program embrace: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

About Alkermes plc

Alkermes plc is a completely built-in, world biopharmaceutical firm growing modern medicines within the areas of neuroscience and oncology. The corporate has a portfolio of proprietary business merchandise focusing on alcohol dependence, opioid dependence, schizophrenia and bipolar I dysfunction, and a variety of product candidates in growth for neurological issues and most cancers. Headquartered in Dublin, Eire, Alkermes has a analysis and growth middle in Waltham, Massachusetts; analysis and manufacturing facility in Athlone, Eire; and a producing facility in Wilmington, Ohio. For extra data, go to the Alkermes web site at www.alkermes.com.

Be aware concerning forward-looking statements

Sure statements contained on this press launch represent “forward-looking statements” inside the that means of the Non-public Securities Litigation Reform Act of 1995, as amended, together with however not restricted to statements regarding therapeutic and business potential of nemvaleukin as an immunotherapy, together with mucosal melanoma and platinum-resistant ovarian most cancers. You’re cautioned that forward-looking statements are inherently unsure. Though the corporate believes that such statements are based mostly on affordable assumptions inside the limits of its information of its enterprise and operations, forward-looking statements are neither guarantees nor ensures and are essentially topic to a excessive diploma of uncertainty and threat. Precise outcomes might differ materially from these expressed or implied by forward-looking statements attributable to varied dangers and uncertainties. These dangers and uncertainties embrace, amongst different issues, whether or not nemvaleukin could also be proven to be unsafe or ineffective; whether or not outcomes and knowledge from scientific research for nemvaleukin will probably be predictive of future or last outcomes of such research, outcomes of future scientific research or real-world outcomes; whether or not future scientific trials or future phases of ongoing scientific trials for nemvaleukin will probably be initiated or accomplished on time or in any respect; adjustments in prices, scope and period and scientific trial operations for growth actions for nemvaleukin, together with adjustments associated to the impression of the novel coronavirus (COVID-19) pandemic; and people dangers and uncertainties described below the heading “Threat Components” within the Firm’s Annual Report on Kind 10-Ok for the yr ended December 31, 2021 and in subsequent filings by the Firm with the U.S. Securities and Change Fee (SEC ), together with the Firm’s Quarterly Report on Kind 10-Q for the quarter ended September 30, 2022, which can be found on the SEC’s web site at www.sec.gov. Present and potential buyers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date hereof. Besides as required by regulation, the corporate disclaims any intention or duty to replace or revise any forward-looking statements contained on this press launch.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Alkermes contacts: For buyers: Sandy Coombs, +1 781 609 6377 For media: Sourojit Bhowmick, Ph.D., +1 781 609 6397

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