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

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

DUBLIN, January 17, 2023 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) right now introduced that nemvaleukin alfa (nemvaleukin), the corporate’s investigational, novel engineered interleukin-2 (IL-2) immunotherapy variant, has obtained an Innovation Passport for the therapy of mucosal melanoma underneath the Revolutionary Licensing and Entry Pathway (ILAP) of the Medicines and Healthcare merchandise Regulatory Company (MHRA), the regulatory physique United Kingdom (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 severely debilitating situations, or situations for which there’s a big affected person or public well being want. Advantages of ILAP embrace entry to a spread of growth instruments, akin to the flexibility for a 150-day accelerated advertising and marketing utility evaluation (MAA), ongoing evaluate and steady benefit-risk evaluation.

“We consider within the potential of nemvaleukin to assist tackle the continuing unmet want going through sufferers with mucosal melanoma,” he mentioned. Craig Hopkinson, MD, Chief Medical Officer and Government Vice President of Analysis and Growth at Alkermes. “The award of the Innovation Passport represents an thrilling step within the medical growth program for our IL-2 candidate and we stay up for working intently with the MHRA and ILAP companion businesses in our efforts to convey nemvaleukin to individuals 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 therapy of mucosal melanoma.

Concerning the Innovation Passport and ILAP

ILAP was launched by the MHRA in January 2021 with the purpose of accelerating growth and facilitating sufferers’ entry to 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 Middle (AWTTC) and the Nationwide Well being Service (NHS) England. It is step one within the ILAP course of and is awarded to corporations growing therapies with the potential to supply vital profit to sufferers with situations which might be life-threatening or severely 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 means of selective binding to IL-2 medium affinity receptor advanced. Nemvaleukin selectivity is designed to reap the benefits of the confirmed antitumor results of current IL-2 remedy whereas mitigating sure limitations. Nemvaleukin is at the moment probably the most superior IL-2-based immunotherapy in medical 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 medical growth program

ARTISTRY is an Alkermes-sponsored medical growth program evaluating nemvaleukin as a possible most cancers immunotherapy. The ARTISTRY program consists of a number of medical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, each as monotherapy and together with the anti-PD-1 remedy KEYTRUDA® (pembrolizumab) in sufferers with superior strong 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 industrial merchandise focusing on alcohol dependence, opioid dependence, schizophrenia and bipolar I dysfunction, and quite a few product candidates in growth for neurological issues and most cancers. Headquarters in Dublin, EireAlkermes has a analysis and growth middle in Waltham, Massachusetts; analysis and manufacturing facility in Athlone, Eire; and manufacturing plant in Wilmington, Ohio. For extra info, go to the Alkermes web site at www.alkermes.com.

Observe relating to forward-looking statements

Sure statements contained on this press launch represent “forward-looking statements” inside the which means of the Personal Securities Litigation Reform Act of 1995, as amended, together with however not restricted to statements regarding therapeutic and industrial 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 could differ materially from these expressed or implied by forward-looking statements as a consequence of 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 medical research for nemvaleukin will probably be predictive of future or last outcomes of such research, outcomes of future medical research or real-world outcomes; whether or not future medical trials or future phases of ongoing medical trials for nemvaleukin will probably be initiated or accomplished on time or in any respect; adjustments in prices, scope and period and medical trial operations for growth actions for nemvaleukin, together with adjustments associated to the influence of the novel coronavirus (COVID-19) pandemic; and people dangers and uncertainties described underneath the heading “Danger Components” within the Firm’s Annual Report on Type 10-Okay for the 12 months then ended December 31, 2021and in subsequent filings by the corporate with the US Securities and Alternate Fee (SEC), together with the corporate’s Quarterly Report on Type 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 traders are cautioned to not place undue reliance on these forward-looking statements, which converse 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, NJNOW.

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

SOURCE Alkermes plc

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