Shorla Oncology & EVERSANA Announce U.S. Commercial Launch of FDA-Approved JYLAMVO, the First and Only Oral Methotrexate Solution Approved in the U.S. for Adults

CAMBRIDGE, Mass. and CHICAGO, Dec. 19, 2023 /PRNewswire/ -- Shorla Oncology ('Shorla'), a U.S.-Ireland specialty pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults. JYLAMVO has been shown to have a sweet, palatable taste^1,2*and is approved to treat adults with acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen; mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen; relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen; rheumatoid arthritis; and severe psoriasis.

"We are delighted to introduce JYLAMVO as an alternative treatment option for patients who may have difficulty swallowing pills," said Sharon Cunningham, Chief Executive Officer of Shorla Oncology. "This is our second product launch in the U.S. Market in 2023, and today's announcement is another significant advancement in our pipeline and our mission to bring new therapeutic options to patients in need."

JYLAMVO received FDA approval in November 2022 and was acquired by Shorla Oncology in October 2023. JYLAMVO is the first and only oral methotrexate solution approved in the United States for use in adults, it has shown to have a sweet, palatable taste*, is stable at room temperature (68°F to 77°F) for 90 days and does not require refrigeration.

EVERSANA, the commercialization partner to Shorla, will provide comprehensive launch support including field deployment sales and training solutions, medical information, pharmacovigilance and quality services, revenue management, agency solutions, patient services, data and analytics, third-party logistics channel and trade relations support.

"We have immediately activated our full commercialization engine, combined with in-depth knowledge of the complex methotrexate market, to help patients who have waited far too long for other treatment options that can help meet their needs," said Jim Lang, CEO, EVERSANA. "Today's announcement showcases the partnership we have built with the Shorla team, and we look forward to continuing to support their growing portfolio of therapies for patients in need."

Founded in Ireland, Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With strong support from scientists and clinicians, the company has an advanced pipeline of oncology therapies to treat a number of unmet patient needs.

IMPORTANT SAFETY INFORMATION

JYLAMVO is a folate analog metabolic inhibitor indicated for the:

• Treatment of adults with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
• Treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen.
• Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen.
• Treatment of adults with rheumatoid arthritis.
• Treatment of adults with severe psoriasis.

For important safety information and full prescribing information, including boxed warning, please visit:

• https://shorlaoncology.com/pdf/JYLAMVO_HCP_Important Safety Information.pdf
• https://shorlaoncology.com/pdf/Jylamvo_PI_Dec152023.pdf

About Shorla Oncology
Established in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla Oncology is a privately held, Ireland- and U.S.-based specialty pharmaceutical company with an advanced pipeline of innovative oncology drugs for women's, orphan and pediatric cancers. The company concentrates on indications where existing treatments are limited, in shortage or inadequate for the target population. Shorla's growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care. For further information, please visit www.shorlaoncology.com or connect through LinkedIn.

About EVERSANA^®
EVERSANA^® is a leading independent provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X.

^*In 2 single-dose (10 mg and 2.5 mg) bioequivalence studies of the 2 mg/mL methotrexate oral solution  in 24 healthy male subjects, JYLAMVO has been shown to have a sweet, palatable taste.²

References:

• 1. JYLAMVO [prescribing information]. Cambridge, MA: Shorla Oncology; October 2023.
• 2. Penton J, Winslade J, Roberts D, Conroy S. AB1101 The development of a palatable, stable oral methotrexate solution. Ann Rheum Dis. 2018;77:1659. doi:10.1136/annrheumdis-2018-eular.4596

Media Contacts:

For Shorla Oncology
Rachel Ford Hutman
[email protected]
+1-301-801-5540

For EVERSANA
Matt Braun
[email protected]
+1-414-975-8831

SOURCE EVERSANA