Novartis India Limited terminated its Distribution and Promotion Agreement with Dr. Reddy’s Laboratories Limited on August 7, 2026, ending a partnership that granted the latter exclusive rights to promote and sell certain products. The termination, which becomes effective on September 30, 2026, allows Novartis India to re-acquire exclusivity and secure direct market access for these products, marking a strategic shift in its go-to-market approach.

The decision was taken during a Board meeting held on Friday, August 7, 2026, which commenced at 06:50 P.M. (IST) and concluded at 07:08 P.M. (IST). The disclosures were made pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, read with relevant SEBI circulars.

Key Board Approvals

The Board considered and approved several strategic and governance matters:

• Termination of DRL Agreement: The agreement dated February 11, 2022, is terminated effective September 30, 2026. This move enables Novartis India to regain control over the promotion, distribution, and sale of products previously managed by Dr. Reddy’s Laboratories Limited.
• New Articles of Association: A new set of Articles of Association was adopted to align with Table F of Schedule I of the Companies Act, 2013. Shareholder approval is required at the ensuing Annual General Meeting (AGM).
• ESOP 2026: The "Employee Stock Option Plan 2026" was adopted, subject to shareholder approval at the AGM.
• AGM Notice: The notice for the 78th Annual General Meeting of Members was issued.

Agreement Details

Strategic Implications

The termination of the agreement with Dr. Reddy’s Laboratories Limited marks a shift in Novartis India’s go-to-market strategy for specific product lines. By reclaiming exclusivity, the company aims to directly manage market access and distribution, potentially allowing for more integrated promotional efforts and tighter control over supply chain dynamics. The alignment of the Articles of Association with the Companies Act, 2013, reflects ongoing governance modernization, while the new ESOP plan underscores the company’s focus on employee retention and incentive alignment.

The Company Secretary and Compliance Officer, Chandni Maru, signed the disclosure. Further details are available on the company’s website.

The US Food and Drug Administration (FDA) approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) on July 31, 2026, for use in combination with an androgen receptor pathway inhibitor (ARPI) for patients with metastatic hormone-sensitive prostate cancer (mHSPC). This regulatory milestone nearly doubles the eligible patient population by expanding the drug’s indication beyond metastatic castration-resistant prostate cancer (mCRPC), introducing a precision treatment option at an earlier stage of the disease journey. The approval is grounded in Phase III PSMAddition trial data, which showed a 33% risk reduction in progression or death in updated analysis.

The expansion addresses a significant unmet need in oncology. Approximately 186,000 men are diagnosed with mHSPC globally each year. Despite advancements, about one-third of patients do not achieve undetectable PSA levels with standard ARPI-ADT therapy, and half progress to castration-resistant disease within 20 months. The PSMA biomarker is present in more than 80% of prostate cancer patients, making it a viable target for early intervention. Michael Morris, MD, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center, stated that having a radioligand therapy available at this stage meaningfully expands options for physicians.

Clinical Efficacy and Safety

The PSMAddition trial evaluated Pluvicto combined with standard of care (SoC) against SoC alone. At primary analysis, the combination reduced the risk of progression or death by 28% (HR 0.72; 95% CI: 0.58–0.90). In a subsequent updated analysis, the risk reduction improved to 33% (HR 0.67; 95% CI: 0.55–0.82), with a positive overall survival trend favoring the Pluvicto arm (HR=0.80; 95% CI: 0.63–1.01).

The safety profile in the mHSPC setting was consistent with previous trials. Grade ≥3 adverse events were reported in 50.7% of patients receiving Pluvicto plus SoC compared to 43.0% in the SoC-alone group. Common all-grade adverse events included dry mouth, fatigue, nausea, hot flushes, and anemia.

Commercial Impact and Manufacturing

Novartis reported a 43% revenue increase for Pluvicto in the second quarter, reaching $651 million. To support the expanded indication, the company has operationalized five radioligand therapy manufacturing sites in the US, with additional facilities under construction. This infrastructure allows delivery to US treatment sites within five days. Victor Bultó, President of Novartis US, noted that the approval signals a shift toward targeted, early intervention in prostate cancer care.

In other developments, the FDA granted traditional approval in July for Novartis’ oral medication Fabhalta (iptacopan) to slow kidney function decline in adult patients with primary immunoglobulin A nephropathy. Novartis shares were down 1.74% at $153.43 at the time of publication.

What the Numbers Show

The expansion into mHSPC significantly alters the commercial landscape for Novartis’ oncology portfolio. By addressing a population where half progress to castration-resistant disease within 20 months, Pluvicto is positioned as a foundational pillar of early-stage metastatic care. The 43% revenue growth in Q2 suggests strong initial adoption, while the dedicated US manufacturing footprint reduces logistical barriers that have historically limited radioligand therapy uptake.