Myung In Pharm to lead registration, commercialization and manufacturing of P2B001 in South Korea
Myung In Pharm made a $5 million equity investment in Pharma Two B
REHOVOT, Israel, Nov. 18, 2021 (GLOBE NEWSWIRE) — Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation of previously approved drugs for neurological indications, today announced that it has entered into an exclusive licensing agreement with Myung In Pharm Co. Ltd (“Myung In Pharm”) to commercialize P2B001 for Parkinson’s disease (PD) in South Korea. In addition, Myung In Pharm invested $5 million of equity in Pharma Two B.
P2B001 is a novel fixed-dose combination of low dose extended release (ER) formulations of pramipexole (dopamine agonist) and proprietary ER rasagiline (monoamine oxidase-B inhibitor), both widely-prescribed drugs for PD. Based on the potential synergism of these two ER drugs working through different mechanisms, P2B001 was designed to address an unmet medical need, being highly effective with minimal side effects, especially for early-stage patients. It has been formulated in a convenient, once-daily pill, with no titration required.
“We are extremely pleased to enter this licensing agreement for P2B001 and look forward to building a long-term relationship with Myung In Pharm in South Korea,” said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B. “Myung In Pharm has an excellent track record of successfully launching and marketing pharmaceutical products in South Korea, and has particular expertise in CNS products, including treatments for PD.”
Under the terms of the agreement, Myung In Pharm will seek regulatory approval for P2B001 in South Korea and will manufacture, commercialize and distribute P2B001 in the region. Myung In Pharm will be responsible for all expenses related to the registration, sales, marketing and distribution of P2B001 in South Korea. In addition to the $5 million equity investment by Myung In Pharm, Pharma Two B is entitled to royalties on sales of P2B001 in the region.
Hang-Myung Lee, President of Myung In Pharm commented, “P2B001 has the potential to be a valuable new treatment for PD and the product is a strategic fit for Myung In Pharm. CNS is one of our core areas and we believe that P2B001 will strengthen our presence in the field, if approved. We look forward to working with Pharma Two B to bring this much needed treatment for PD patients in South Korea.”
Pharma Two B recently completed its multinational Phase III study of P2B001 in early PD. The pivotal study was conducted at 70 sites in North America and the EU. Top line results are expected by the end of the fourth quarter of 2021. For more information, refer to ClinicalTrials.gov Identifier: NCT03329508.
About Myung In Pharm Co. Ltd.
Myung In Pharm is a fully integrated pharmaceutical company established in 1985, in Seoul, Republic of Korea. The company’s line of business includes the manufacturing, fabricating, and processing of pharmaceutical drugs. Myung In Pharm is ranked number one in Korea in the CNS area. It has customer relationships with 1,200 neurologists and 98% of domestic neurology hospital departments. It operates state-of-the-art manufacturing facilities with the most advanced equipment to manufacture products to ensure drug quality. All its facilities are designed to meet cGMP standards.
About Pharma Two B
Pharma Two B is a clinical-stage pharmaceutical company that is developing differentiated and value-added products, based on reformulation and combinations of previously approved orally-administered drugs for neurological indications. The company aims to improve efficacy, safety and delivery profiles and address unmet medical needs while minimizing timelines to FDA approval via the 505(b)(2) regulatory pathway. The company’s lead product P2B001 is being investigated as a treatment for early-stage Parkinson’s disease (PD). Pharma Two B is led by a highly experienced team, supported by prominent scientific and clinical key opinion leaders, and backed by a dedicated group of investors. For more information, please visit: www.pharma2b.com.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as” “will,” “expect,” “could,” “if,” “expected”,” “anticipate”,” look forward”, “believe” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the company’s future expectations and plans. The company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Vice President, Commercial and Business Development
U.S. investor contact:
LifeSci Advisors LLC