NATCO Pharma Limited has announced the launch of Pomalidomide Capsules, a generic version of Celgene's Pomalyst®, in the United States market. The launch is being executed in partnership with Breckenridge Pharmaceutical, Inc, marking a significant addition to the company's oncology portfolio.

Product Details and Market Opportunity

Pomalidomide Capsules is a thalidomide analogue with multiple therapeutic applications. The product is available in four different strengths and targets substantial market opportunities.

Therapeutic Applications

The medication serves critical treatment needs across multiple patient populations:

• Multiple Myeloma: Treatment for adult patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, with demonstrated disease progression on or within 60 days of completion of the last therapy
• AIDS-related Kaposi Sarcoma: Approved for use after failure of highly active antiretroviral therapy
• HIV-negative Kaposi Sarcoma: Treatment option for adult patients with this condition

Leadership Commentary

Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer of NATCO Pharma Limited, emphasized the strategic importance of this launch: "We are pleased to launch Pomalidomide Capsules in the U.S., this further strengthens our oncology and specialty portfolio in the U.S. The launch highlights our commitment to our mission of making specialty medicines accessible to all the patients worldwide."

Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, Inc, highlighted the patient access benefits: "Breckenridge's launch of Pomalidomide Capsules delivers a high-quality, affordable generic solution, supported by copay assistance for eligible patients to help reduce treatment delays and ensure continuity of care."

Strategic Significance

The launch represents a major milestone for NATCO Pharma's US operations, particularly in the specialty oncology segment. Based on FDA information, the company believes it has secured 180 days of shared exclusivity for this product. This exclusivity period, combined with the substantial market size of USD 3.2 billion, positions the launch as a significant revenue opportunity.

The partnership with Breckenridge Pharmaceutical demonstrates NATCO's strategy of collaborating with established US partners to enhance market penetration and patient access. The focus on specialty pharmacies and clinics as primary distribution channels aligns with the complex nature of oncology treatments and the need for specialized patient support services.

Natco Pharma Limited has issued a clarification to BSE Limited regarding the recent increase in trading volumes of its shares, attributing the surge to market-driven factors. The pharmaceutical company's response, dated February 25, 2026, addresses BSE's inquiry under reference L/SURV/ONL/PV/SG/2025-2026/935.

Regulatory Compliance and Disclosure

The company emphasized its adherence to regulatory requirements in its communication to the stock exchange. Key aspects of the clarification include:

Volume Movement Explanation

Natco Pharma stated that the increased trading volume in its shares is purely market-driven and results from prevailing market conditions. The company clarified that it has not withheld any material or price-sensitive information that could influence the volume behavior of its shares.

Corporate Communication Details

The clarification letter was signed by Ch. Venkat Ramesh, Company Secretary and Compliance Officer, on February 25, 2026. The response confirms that all disclosures pursuant to Regulation 30 of SEBI (LODR) Regulations, 2015, have been made, covering information that bears on the company's operations and performance.

Regulatory Framework

The communication falls under the standard regulatory framework where stock exchanges monitor unusual price or volume movements and seek clarifications from listed companies. Natco Pharma's response demonstrates its commitment to transparency and regulatory compliance in addressing market inquiries.