Handa Therapeutics Acquires FDA-Approved Leukemia Drug PHYRAGO

In a recent announcement from Taipei, Taiwan, Handa Pharmaceuticals, Inc., through its U.S. subsidiary Handa Therapeutics, LLC, has expanded its portfolio with the acquisition of PHYRAGO™ (dasatinib) tablets. This pharmaceutical innovation marks a significant advancement in the treatment of chronic myeloid leukemia as it represents the first and only improved formulation of SPRYCEL® that can be safely taken alongside gastric acid-reducing agents. This development was made possible by Nanocopoeia, LLC, and has gained the approval of the U.S. Food and Drug Administration (FDA).

PHYRAGO™ is a unique dasatinib product crucial for patients who concurrently require gastric acid-reducing agents, which include proton pump inhibitors and H2 receptor antagonists. Studies indicate that about one-third of patients prescribed with SPRYCEL® might need these additional agents. However, combining them with standard dasatinib treatments can lead to a significant reduction in drug exposure—by over 40% and 60%, respectively. Therefore, PHYRAGO™ offers a new solution by maintaining effective drug levels in these patients.

The FDA has recognized PHYRAGO™’s distinct benefits by granting it Orphan-Drug Designation, alongside three years of data exclusivity, which will lapse in December 2026. There is potential for an extension to seven years of exclusivity if Orphan-Drug Exclusivity is secured, extending protection until December 2030. Furthermore, PHYRAGO™ is protected by multiple patents, some of which are listed in the FDA’s Orange Book, with expiry dates reaching into the early 2040s.

Handa Pharmaceuticals is in the process of identifying a partner for the U.S. commercialization of PHYRAGO™, anticipating its availability in the first quarter of 2025. This medication is designated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase and for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who have exhausted the benefits of other treatments.

Bill Liu, Chairman and CEO of Handa, expressed that PHYRAGO™ embodies a groundbreaking formulation that parallels the efficacy of SPRYCEL® while offering the capability to use it with gastric acid-reducing medications. This is a noteworthy improvement over SPRYCEL®, which explicitly advises against such combinations due to the risk of reduced dasatinib concentrations and subsequent loss of efficacy. The new FDA label for PHYRAGO™ states there are no clinically significant pharmacokinetic differences when co-administered with omeprazole or famotidine, although it advises against using antacids concurrently unless separated by a two-hour window before or after PHYRAGO™ administration.

The significance of PHYRAGO™ is highlighted by the sales performance of SPRYCEL®, which generated $1.44 billion in net sales in 2023, according to Bristol Myers Squibb's annual report. This underscores the potential market impact and patient benefits that PHYRAGO™ may offer as it enters the competitive landscape, providing a viable alternative for patients requiring complex treatment regimens.