Following formal sign-off from the FDA, Handa Pharmaceuticals’ branded drug reformulation strategy has paid off for a third time.
On Friday, the U.S. and Taiwan-headquartered company announced final FDA approval for its Omcazio capsules, a laurylsulfate salt formulation of Exelixis’ cancer med Cabometyx that uses cabozantinib, the same tyrosine kinase inhibitor active ingredient.
The novel formulation of Exelixis’ patent-protected med was devised by the company’s Handa Oncology subsidiary and shifts a prior tentative approval into a formal green light, clearing the way for the drug to be marketed in the United States.
Omcazio now joins two other branded reformulated medicines in Handa’s portfolio, Phyrago, a modified version of Bristol Myers Squibb’s oncology medicine Sprycel (dasatinib) that can be used alongside proton pump inhibitors and H2 receptor antagonists, and Tascenso ODT, an orally disintegrating tablet formulation of Novartis’ relapsing multiple sclerosis therapy Gilenya (fingolimod).
Both of those products are being commercialized in the U.S. under licensing agreements with Cycle Pharmaceuticals.
As for Omcazio, Handa said Friday that it plans to provide additional information on the drug’s U.S. commercial availability in a forthcoming announcement. The capsule’s key advantage, according to a statement from Handa CEO Bill Liu, is that it can be taken with or without food, which he said gives both doctors and patients “added flexibility in treatment.”
The medicine can be used in adults with advanced renal cell carcinoma and as a first-line treatment in those patients in combination with BMS’ Opdivo, as well as in hepatocellular carcinoma patients previously treated with Bayer’s Nexavar and in adults and children 12 and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors.
Meanwhile, the 60-, 40- and 20-mg once-a-day doses of Cabometyx correspond to 34.5-, 23- and 11.5-mg daily doses of Omcazio, respectively, Handa noted.
Cabometyx, which won its first approval more than a decade ago, is among the most commonly used oral targeted therapies in cancer treatment, per Handa. Last year, Exelixis reported a 17% sales bump for the medicine to $2.11 billion in the U.S.
As for what Handa’s nod means for Exelixis, analysts at William Blair wrote to clients Friday that they don’t view the full approval of Omcazio as a threat. They cited the apparent gap between approval and commercial availability and further asserted that they believe Handa’s drug is “not equivalent to Cabometyx.”
Omcazio was approved using bioavailability and bioequivalence data via the FDA’s 505(b)(2) pathway, the William Blair team pointed out. This pathway enables developers to rely in part on existing data supporting a previously approved drug, and is often used when a company is developing a new formulation or novel combination of an already-approved medicine.
Nevertheless, Omcazio’s labeling specifically states that the drug is not substitutable on a milligram-to-milligram basis with other cabozantinib products. The William Blair analysts said they therefore believe Handa will “likely have to build a sales force to fully commercialize Omcazio,” adding that the lack of data also leads them to suspect “minimal” uptake of Omcazio in the U.S.
The reformulation game has been picking up traction of late, as multiple developers look to retool versions of already-approved medicines in hopes of delivering a new, patent-protected product that fills some lingering unmet need.
One prominent example is Veradermics, the buzzy hair-loss biotech that has continued to generate positive data—and investor excitement—around its lead candidate VDPHL01, which is an extended-release oral formulation of minoxidil.
Minoxidil is likely better known by most as the topical hair loss treatment Rogaine, first approved in 1988. Meanwhile, an oral version of the drug was approved in the late 1970s as a blood pressure medicine, but it has not been approved in that format for hair loss.