Handa Pharmaceuticals announced on January 1st that it will acquire Phyrago (Dasatinib), an FDA-approved oral kinase inhibitor, for $30 million (approximately NT$983.55 million). The drug is indicated for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). Handa’s CEO, Chen Chun-Liang, stated that following the acquisition of full ownership of the drug, the company plans to launch it in the market in the first half of this year, aiming to capture a share of the $900 million annual market opportunity.
Handa has been actively expanding its business recently. The company previously announced that its board of directors approved Taiwan’s ScinoPharm, a subsidiary of Uni-President Enterprises, as a strategic partner. ScinoPharm will acquire up to 22,000 private placement shares of Handa, holding no more than a 13.5% stake, making it Handa’s second-largest shareholder.
In its latest announcement on January 1st, Handa disclosed the $30 million acquisition of Phyrago’s ownership. The drug received final approval from the U.S. FDA on December 5, 2023, but has not yet entered the market. Upon completing the transfer of the drug license, Handa plans to generate market value through direct sales or by partnering with commercial distributors.
Handa noted that Phyrago has been designated as an orphan drug by the U.S. FDA. If it obtains Orphan Drug Exclusivity (ODE) certification in the future, it will gain seven years of market exclusivity in the United States.
Phyrago is an oral kinase inhibitor for treating chronic myeloid leukemia and acute lymphoblastic leukemia. It can be co-administered with certain antacids, such as PPIs and H2 blockers. The drug is currently considered a first-line treatment for these diseases.
Chen explained that Phyrago is a reformulated 505(b)(2) drug that competes with Handa’s in-house developed blood cancer drug HND-033, which shares the same indications. However, HND-033 received a Complete Response Letter (CRL) from the FDA in 2023, delaying its approval process. In contrast, the original developer of Phyrago faced financial difficulties, prompting Handa to acquire full ownership of the drug to secure an earlier market entry.
Chen emphasized that Phyrago’s original drug was developed by Bristol-Myers Squibb, with annual sales of approximately $900 million. Three biotech companies have pursued 505(b)(2) versions of the drug, but only Phyrago has successfully obtained U.S. market approval. Handa and a Swedish biotech company encountered setbacks in their application processes. With the $30 million acquisition of Phyrago’s ownership, Handa now leads its competitors and expects to launch the drug in the market within the first half of this year.
Resource: 漢達3000萬美金買下同業抗血癌口服藥 上半年將推進市場
