AstraZeneca Pharma India Limited and Sun Pharmaceutical Industries Limited have announced a strategic partnership to broaden access to an innovative Hyperkalemia treatment across India. This collaboration marks their second brand partnership, focusing on the distribution of Sodium Zirconium Cyclosilicate (SZC), a cutting-edge therapy for managing elevated potassium levels in the blood.

Key Partnership Details

Significance of the Partnership

This exclusive agreement aims to accelerate the availability of SZC to a broader patient base across India. Hyperkalemia, a condition characterized by high potassium levels in the blood, disproportionately affects patients with chronic kidney disease (CKD) and heart failure (HF). The prevalence of Hyperkalemia is significant, occurring in up to 50% of CKD patients and 42% of chronic HF patients.

Impact on Patient Care

The partnership between AstraZeneca and Sun Pharma is expected to have several positive outcomes:

1. Improved Access: Leveraging Sun Pharma's extensive distribution network and AstraZeneca's innovative treatment.
2. Enhanced Patient Outcomes: Providing a rapid and effective treatment option for Hyperkalemia management.
3. Addressing a Critical Need: In India, Hyperkalemia-associated mortality has been reported at 22.20%, underscoring the importance of accessible treatment.

Company Perspectives

Praveen Rao Akkinepally, Country President & Managing Director of AstraZeneca Pharma India Limited, emphasized the company's commitment to transforming care through early screening, diagnosis, and adoption of guideline-directed medical therapy.

Kirti Ganorkar, Managing Director of Sun Pharmaceutical Industries Limited, highlighted the partnership's alignment with Sun Pharma's focus on improving care for patients with chronic kidney disease.

Market Position

Sun Pharma, as India's largest pharmaceutical company with an 8.30% market share, brings significant reach to this partnership. The company leads in chronic therapies and maintains a strong presence in the acute segment, supported by a 15,000-strong field force.

This collaboration represents a significant step in improving Hyperkalemia management in India, promising enhanced availability of a crucial treatment and potentially contributing to better patient outcomes nationwide.

About the Companies

AstraZeneca India

A global, science-led biopharmaceutical company focusing on innovative medicines in Oncology, Cardiovascular, Renal & Metabolism, and Respiratory and Rare Disease therapies.

Sun Pharmaceutical Industries Limited

The world's leading specialty generics company with a presence in specialty, generics, and consumer healthcare products. It is the largest pharmaceutical company in India and a leading generic company in the U.S. and global emerging markets.

This partnership underscores both companies' commitment to addressing critical healthcare needs in India and improving patient outcomes through innovative treatments and expanded access.

Sun Pharmaceutical Industries Limited and its partner, Philogen S.p.A., have announced mixed results from the Phase III FIBROSARC clinical trial evaluating Fibromun in combination with doxorubicin for the treatment of advanced soft tissue sarcoma (STS). Additionally, Sun Pharma presented clinical trial results for its investigational obesity drug utreglutide (GLO034) at recent medical conferences.

Fibromun Trial Results

The FIBROSARC study, which compared Fibromun plus doxorubicin to doxorubicin alone as a first-line treatment, did not meet its primary endpoint of progression-free survival (PFS). However, the results showed trends favoring the combination therapy:

It's important to note that the overall survival data remains immature, with only 54 events recorded at the time of analysis.

Future Plans for Fibromun

Despite not meeting the primary endpoint, Philogen plans to:

1. Discuss the results with European and US regulatory authorities
2. Initiate a new Philogen-sponsored confirmatory Phase III trial with overall survival as the primary endpoint

Utreglutide Clinical Trial Results

Sun Pharmaceutical Industries presented clinical trial results for its investigational obesity drug utreglutide (GLO034) at recent medical conferences. The Phase 1b/2a studies showed:

• 13 weeks of treatment in individuals with obesity and MASLD demonstrated 6.8% body weight reduction and 6.8% waist circumference reduction at week 14.
• A separate 10-week study in overweight and obese individuals showed 6.8% body weight loss with 10% reductions in total cholesterol and LDL.
• In post-menopausal females with obesity, the drug achieved 8% weight loss at week 14 along with reduced liver fat content and blood pressure improvements.

The most common adverse events were gastrointestinal, including nausea, diarrhea, and vomiting, consistent with the drug class. GLO034 is a novel once-weekly GLP-1 receptor agonist being developed for obesity and type 2 diabetes treatment. Further clinical studies are planned to assess safety and efficacy.

Expert Commentary on Fibromun

Prof. Dr. Christoph Schliemann, the study coordinator and Principal Investigator from UK Münster, commented: "Fibromun is showing signs of activity in a very difficult-to-treat indication. We remain interested in future applications of this investigational study drug. We are eager to learn about the evolution of overall survival data."

Other Ongoing Studies

Philogen is also advancing other trials involving Fibromun:

• FLASH: A randomized controlled Phase II trial evaluating Fibromun with Dacarbazine in advanced or metastatic soft tissue sarcoma
• FIBROSARC US: A randomized controlled Phase IIb trial studying Fibromun with Doxorubicin in metastatic Leiomyosarcoma
• Multiple glioblastoma programs, including GLIOSUN, GLIOSTAR, and GLIOSTELLA

Market Implications

While the Fibromun trial results are mixed, the potential for the drug in treating difficult cancers remains. The outcome of these studies could have implications for Sun Pharma's oncology portfolio. Additionally, the results from the utreglutide trials position Sun Pharma as a potential player in the obesity drug market.

Investors and industry observers will be closely watching for the mature overall survival data for Fibromun and the results of the planned confirmatory Phase III trial. They will also be monitoring the progress of utreglutide as it moves through further clinical studies. These developments could impact Sun Pharma's future market position in both cancer treatments and obesity management.