Sun Pharma open to exploring acquisitions in global specialty portfolio

Sun Pharma has net cash position of $2.4 bn at end of FY24; 6 new specialty products in R&D pipeline

The country’s largest drugmaker by market share Sun Pharmaceutical Industries says it is open to exploring acquisitions in the global specialty portfolio as it closed financial year 2023-24 (FY24) with a strong net cash position of $2.4 billion.

In the 2023-24 annual report, Chairman and Managing Director Dilip Shanghvi said: “Sun Pharma had a strong net cash position of approximately $2.4 billion, which enables us to explore inorganic opportunities, including but not limited to strengthening our global specialty portfolio.”

He added that the firm made critical hires in several functions, and the focus has been to improve in-house clinical development capabilities for which the firm is building a clinical organisation, globalising specialty assets beyond the US, and deepening business development capabilities.

 

The specialty research and development (R&D) spend has continued to increase to strengthen the innovation pipeline, rising to $148 million in FY24 compared to $65 million in FY20. It accounted for 78 per cent of the total R&D increase during the period.

The contribution of global specialty increased from 7 per cent of consolidated revenues in FY19 to 18 per cent in FY24. In FY24, the firm’s R&D spend stood at $32 billion or 6.7 percent of overall sales.

“During the year, we filed approximately 250 formulation dossiers globally. In FY24, the company took steps to improve study enrolment for our global specialty pipeline candidates, including creating a clinical organisation within Sun and hiring key talent to lead the same. Sun Pharma also continues to scout for external R&D assets to strengthen the pipeline. R&D spending is expected to increase as clinical trials for specialty products gain traction,” Shanghvi said.

Some of the key products in Sun Pharma’s specialty portfolio include Ilumya (psoriasis drug), Winlevi (acne drug), Cequa (ophthalmic drug for dry eye disease), Odomzo (locally advanced basal cell carcinoma) and Levulan (keratosis of face and scalp).

Sun Pharma’s specialty R&D pipeline has six candidates undergoing clinical trials.

Deuruxolitinib’s new drug application (NDA) was filed with U.S. Food and Drug Administration (USFDA) for the treatment of moderate to severe alopecia areata during FY24. The FDA has assigned the Prescription Drug User Fee Act (PDUFA) date of July 2024 for the firm’s application. Open Label Extension studies for deuruxolitinib are ongoing. Its Partner product Nidlegy is expected to be filed with the European Medicines Agency (EMA) for locally advanced fully resectable melanoma during H1CY24. It is currently being investigated in Phase 2 trials for locally advanced melanoma and other non-melanoma skin cancers. Currently marketed drug Ilumya is undergoing Phase-3 clinical trials for additional indication of treatment of psoriatic arthritis. Topline data for the studies is expected during the H2CY25. Another drug MM-II has completed Phase-2B trial as a potential treatment for knee pain in patients with symptomatic knee osteoarthritis. Phase-3 for the candidate is expected to begin during the H1CY25.

SCD-044 is in Phase-2 clinical trials as a potential oral treatment for atopic dermatitis and moderate to severe plaque psoriasis. Topline data for the indication of atopic dermatitis is expected to be available during the H2CY24. Topline data for the indication of psoriasis is expected to be available during the H1CY25.

The much awaited GLP-1R (Glucagon-Like Peptide-1 Receptor) agonist has completed Phase-1 clinical trials. Early clinical data demonstrated marked weight loss in single and multiple ascending dose studies. The drug was well tolerated, and we expect to start enrolling patients for Phase-2 trials during the H2CY24.