Cambridge, Mass. & Chicago - December 19, 2023 - 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 taste1,2*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_PI_Dec152023.pdf