Chronic therapy brands never die, they keep increasing in scale and size, said Cipla’s MD and Global CEO Umang Vohra, explaining the rationale behind its agreement with Novartis on diabetes therapy Galvus.
Last month, Cipla had inked a perpetual license agreement with Novartis, as part of its strategy to grow the One India franchise towards a higher share of chronic therapies. Galvus and its combination brands had clocked sales of ₹270 crore, upto March 2023, and would strengthen the company’s diabetes portfolio, Vohra told analysts recently, outlining Cipla’s push in the diabetes segment, besides its strategies in key markets like India, South Africa, and the United States.
Further on the Galvus agreement, he said, “This is a relatively large brand in the diabetes segment and Cipla has historically always been a big respiratory player but not that big in the diabetes area.” In December 2019, Cipla had acquired the brand name and trademark rights for Vysov and Vysov M (Vildagliptin + Metformin) of the anti-diabetic drug, Vildagliptin for the Indian market. The company had been co-marketing Vildagliptin in agreement with Novartis under brand names, Vysov and Vysov M.
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Cipla also entered into an alliance to market and distribute Scapho, a human IgG1 monoclonal antibody used for the treatment of psoriasis. And under Cipla Health, the company acquired Endura MASS, a nutritional supplement. The company has invested in growing its field force by 800 people in the last two years, besides investing in research, including the initiation of trials in complex products, he said. “We have three differentiated products undergoing clinical trials with filings targeted in FY24,” he added.
Derisking for the US
The company has also been on the path to derisk its portfolio in the United States. “Our US supply continues to be well diversified across all our sites and partner sites…,” Vohra said. On regulatory compliance, he added, the audit had been completed at its Fall River, Massachusetts sites, with zero ‘483 observations. “We have the approval to produce our respiratory assets in this facility. Respiratory assets are being derisked to this in-house facility,” he said.
Meanwhile, he added, “For Indore, we expect classification by mid-May. However, we do not see any risk to commercialise product portfolio. Generic Advair is already being derisked to another in-house facility. Remediation efforts are ongoing for our Goa facility, and we expect a CAPA (corrective and preventive actions) completion by the end of Q1.”
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He also added, “Reinspection is required for plant clearance, which is being targeted for Q3. Our generic Advair file is now solely dependent on the facility approval, having cleared all other questions from the agency. We have already commenced the derisking process for this product, … to our other in-house facility. The value stays intact as no new generic is expected before we launch.”
On nano-paclitaxel (generic Abraxane), he added, “We expect to be able to supply from two sites by FY25. We don’t see any change to the value of this product and there are clearly no generic launches till date.”