Sun Pharma's Leqselvi faces legal challenges in US launch

Sun Pharmaceutical Industries Ltd’s alopecia drug Leqselvi (Deuruxolitinib) approved by the US Food and Drug Administration (USFDA) earlier this month could see immediate legal hurdles when it comes to its launch.

A motion seeking a preliminary injunction has been filed in a US court to prevent the product’s launch. The management cannot comment on the timeline for when they will be able to launch Leqselvi in the US due to the ongoing legal proceedings.

The company reported double-digit growth in its branded generics segment in the US, which saw an 11% increase. Additionally, global speciality sales reached $266 million for the quarter versus $271 million the previous quarter.

Investment in research and development continues to be a priority as per analysts. Speciality R&D accounts for 45% of the total R&D expenditure. It is expected that there will be a step up in R&D costs in subsequent quarters as the company reaches the 8 to 10% of sales guidance provided in earlier quarters.

In other significant developments, Taro, the company’s US arm is now a wholly-owned entity of Sun Pharma after the company successfully delisted the company from the US stock exchanges. Integration efforts between Taro and Sun Pharma are actively underway as per the company and they are aiming to streamline operations and leverage synergies between the two companies.

The company also addressed the status of its Halol manufacturing plant, which has had an import alert since 2022. A request will be made to the US FDA for a re-audit of the Halol plant, but only once the company is completely confident in its compliance and readiness for inspection.