Glenmark Pharmaceuticals and Pfizer have inked a settlement involving Axitinib tablets, a generic version of the latter’s kidney cancer drug Inlyta.

Glenmark Pharmaceuticals Inc and Glenmark Pharmaceuticals reached a settlement with Pfizer Inc, PF Prism CV, and PF Prism IMB BV (Pfizer) for Axitinib tablets in the strengths of 1 mg and 5 mg, the generic versions of Pfizer’s drug in the same strength, a note from Glenmark said. Since details on the agreement were not divulged, industry observers say, the move could stagger or delay Glenmark’s launch of the product in the US.

Glenmark had received tentative approval from the United States Food and Drug Administration for its generic Axitinib tablets (1 mg and 5 mg) on November 30, 2020. This effectively set the stage for the Mumbai-based drugmaker to launch a less expensive version of the product in the US – once it got final approval. However, the latest agreement with Pfizer could change that timeline.

Industry estimates peg sales for the 12‐month period ending September 2022, for Inlyta tablets (1 mg and 5 mg) at $644.5 million.

Glenmark’s US portfolio has 177 products authorised for distribution, it said, besides 47 ANDA (Abbreviated new drug applications) pending approval with the USFDA. “Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio,” the company said.

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In a recent interaction with investors, the Glenmark management indicated that by FY27, they expected two-thirds of their consolidated revenues to come from branded products and markets. They expected to commercially launch one “innovative asset”, between the company or its US-based wholly-owned subsidiary Ichnos, either on its own or through partners. It targeted double digit growth in four years, and zero net debt by FY 26.

Glenmark closed FY22, with a consolidated revenue of Rs 12,304 crore. In its Q2 results, the company said net debt for the period ended September 30, 2022, was at Rs 2,715 crore, as against Rs 2,260 crore as of March 31, 2022. The increase in net debt was primarily on account of adverse forex exchange impact during the first half of FY’23, it added.

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