Sun Pharmaceutical Industries Limited has announced the launch of LEQSELVI™ (deuruxolitinib) in the United States market, marking a significant milestone in the treatment of severe alopecia areata. This new drug offering represents an important addition to Sun Pharma's dermatology portfolio and addresses a critical unmet need in the alopecia areata community.

A New Hope for Alopecia Areata Patients

LEQSELVI, an oral selective inhibitor of Janus kinases JAK1 and JAK2, is now available for prescription nationwide in the U.S. The drug is specifically indicated for the treatment of adults with severe alopecia areata, an autoimmune disease that can result in partial or complete loss of hair on the scalp and body.

Rapid and Significant Results

Clinical trials have demonstrated LEQSELVI's efficacy, with notable results observed as early as 8 weeks into treatment:

• One-third of patients regained almost all of their hair by Week 24
• Some patients (3%) achieved 80% or more scalp coverage in as little as 8 weeks

Addressing a Significant Market Need

Alopecia areata affects up to 2.50% of the United States and global population during their lifetime. The launch of LEQSELVI provides a new treatment option for eligible patients and healthcare providers in a field with limited alternatives.

Richard Ascroft, CEO of Sun Pharma North America, emphasized the importance of this launch, stating, "The launch of LEQSELVI in the U.S. brings an effective, new treatment option for severe alopecia areata to eligible patients and the healthcare providers who treat them."

Expert and Patient Advocacy Support

The medical community has responded positively to LEQSELVI's introduction. Dr. Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital, commented on the drug's compelling clinical evidence and consistent efficacy.

Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), expressed optimism about LEQSELVI's availability, highlighting its potential to bring hope to the alopecia areata community.

Patient Access and Support

Sun Pharma has introduced the LEQSELVI SUPPORT™ Program to enhance accessibility for patients. This program offers eligible individuals the opportunity to receive their medication for as little as $0 for up to two years, along with dedicated support from Patient Access Liaisons.

Safety Considerations

As with any medication, LEQSELVI comes with potential side effects. The most common adverse events reported in placebo-controlled trials were headache, acne, and nasopharyngitis. Healthcare providers and patients are advised to review the full prescribing information, including boxed warnings, before starting treatment.

Settlement with Incyte Corporation

In a related development, Sun Pharma has reached a settlement and license agreement with Incyte Corporation regarding litigation related to LEQSELVI. The agreement includes a limited, non-exclusive license for Sun Pharma to use certain patents for oral deuruxolitinib in specific non-hematology-oncology indications, including alopecia areata, in the U.S.

The launch of LEQSELVI represents a significant step forward in Sun Pharma's commitment to addressing unmet medical needs and expanding its presence in the U.S. pharmaceutical market. As the drug becomes available to patients nationwide, it has the potential to make a meaningful impact on the lives of those affected by severe alopecia areata.

Sun Pharmaceutical Industries Limited has announced a significant development in its ongoing legal dispute with Incyte Corporation. The two pharmaceutical companies have reached a settlement and license agreement regarding the litigation related to LEQSELVI™ (deuruxolitinib).

Settlement Details

According to the press release issued by Sun Pharma, the settlement includes the following key points:

• Both parties will seek dismissal of the pending LEQSELVI™ litigation in the United States District Court for the District of New Jersey.
• Sun Pharma and Incyte will mutually release each other from all claims that were raised or could have been raised in the litigation.
• Incyte has granted Sun Pharma a limited, non-exclusive license to U.S. Patent Nos. 9,662,335 and certain other related patents.
• The license pertains to oral deuruxolitinib for specific agreed-upon non-hematology-oncology indications, including alopecia areata, in the United States.

Financial Terms

While the specific terms of the settlement remain confidential, Sun Pharma has disclosed some financial aspects of the agreement:

• Sun Pharma will pay Incyte an upfront amount.
• The company will also make ongoing royalty payments to Incyte until the expiry of the patents.

These payments are in exchange for the settlement and the granted license.

Impact and Outlook

This settlement marks a resolution to the legal dispute between Sun Pharma and Incyte Corporation, potentially paving the way for Sun Pharma to expand its presence in the U.S. market for certain indications of deuruxolitinib.

The agreement specifically mentions alopecia areata as one of the non-hematology-oncology indications covered by the license, suggesting Sun Pharma's interest in this therapeutic area.

Sun Pharma, known as the world's leading specialty generics company, continues to strengthen its position in the global pharmaceutical market. With a presence in specialty, generics, and consumer healthcare products, the company's settlement with Incyte aligns with its strategy to expand its high-growth global specialty portfolio.

As the largest pharmaceutical company in India and a leading generic company in the U.S. and global emerging markets, Sun Pharma's move to settle this litigation demonstrates its commitment to resolving intellectual property disputes and focusing on business growth.

The company's specialty portfolio, which includes innovative products in dermatology, ophthalmology, and onco-dermatology, accounts for over 18% of the company's sales. This settlement could potentially contribute to further growth in this segment.

Investors and industry observers will likely be watching closely to see how this settlement impacts the company's performance in the coming quarters.