• The developer is a United Kingdom-based drug development and manufacturing company, providing integrated R&D and manufacturing capabilities to accelerate entry of PIP-101 in the U.S. market
• Shorla Oncology to receive the exclusive rights to commercialize PIP-101 in the U.S.

Shorla Oncology (‘Shorla’), a U.S.-Ireland pharmaceutical company, today announced it has entered into a licensing agreement and strategic partnership with a U.K.-based innovative drug development and manufacturing company. Under the terms of the agreement, Shorla will obtain an exclusive license from the developer to register and commercialize PIP-101, the first palatable oral solution of the related chemotherapeutic agent in the U.S.

PIP-101 is an oral solution treatment that slows or stops the growth of certain forms of leukemia, such as acute lymphoblastic leukemia and chronic myeloid leukemia.

“We are excited to partner with and leverage the developer’s oral oncology liquid manufacturing expertise,” said Sharon Cunningham, CEO and Co-founder of Shorla Oncology. “This commercial partnership is a strong endorsement of our commitment to bring to market differentiated oncology treatments to address key areas of unmet needs for patients.”

Under the terms of the agreement, the developer will continue to manufacture PIP-101. Once Shorla has obtained approval of its New Drug Application (NDA), the company will be responsible for the timely launch, commercialization and sales of PIP-101 in the U.S.

“We look forward to a long-term relationship with the developer with not only PIP-101, but other treatments that are in the pipeline,” said Orlaith Ryan, CTO and co-founder of Shorla Oncology. “We expect this partnership will take both companies to new heights and provide much-needed oncology treatments to patients with cancer.”

The U.S. Food and Drug Administration recently approved Shorla Oncology's Nelarabine Injection for the treatment of T-cell Leukemia, an aggressive blood and bone marrow cancer. Shorla also has plans to have three products on market and three or more in development by end of year 2024.

About Shorla Oncology

Established in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla Oncology is a privately held, Ireland- and U.S.-based 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

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