Sun Pharmaceutical Industries Limited has entered into an agreement to acquire Checkpoint Therapeutics, Inc. for $355 million, adding the first FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma (cSCC) to its global oncology-dermatology franchise.
The Mumbai-based pharmaceutical giant announced on March 9, 2025, that it will pay $4.10 per share in cash for all outstanding Checkpoint shares, representing a 66% premium over Checkpoint's closing price on March 7. Stockholders will also receive a non-transferable contingent value right (CVR) worth up to an additional $0.70 per share if cosibelimab receives regulatory approval in the European Union or major European markets.
Strategic Acquisition Enhances Onco-Dermatology Portfolio
Checkpoint Therapeutics, a Nasdaq-listed commercial-stage company headquartered in Waltham, Massachusetts, recently received FDA approval for UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation.
"Combining UNLOXCYT, an FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma, with Sun Pharma's global presence means patients with cSCC may soon have access to an important, new treatment option," said Dilip Shanghvi, Chairman & Managing Director of Sun Pharma. "The acquisition further bolsters our innovative portfolio in onco-derm therapy."
The transaction strengthens Sun Pharma's specialty portfolio, which already accounts for over 18% of company sales across dermatology, ophthalmology, and onco-dermatology products.
Addressing a Significant Unmet Need
Cutaneous squamous cell carcinoma is the second most common type of skin cancer in the United States, with approximately 1.8 million new cases diagnosed annually according to the Skin Cancer Foundation. While most cases can be treated with surgery, approximately 40,000 cases become advanced each year, and an estimated 15,000 Americans die from the disease annually.
Advanced cSCC represents a significant treatment challenge, particularly when tumors arise in the head and neck region where they can invade blood vessels, nerves, and vital organs, causing functional impairments and cosmetic deformities.
UNLOXCYT offers a new immunotherapy option for these patients, targeting the PD-L1 pathway to help the immune system recognize and attack cancer cells.
Transaction Details and Timeline
The acquisition, expected to close in the second quarter of 2025, is subject to approval by Checkpoint's stockholders and other customary closing conditions. Fortress Biotech, Inc., which holds a majority of Checkpoint's outstanding voting power, has agreed to vote in favor of the transaction.
As part of the agreement, Fortress will receive royalty payments based on future sales of cosibelimab during a specified term, replacing royalty rights previously granted when Fortress founded Checkpoint.
James Oliviero, President and Chief Executive Officer of Checkpoint, expressed pride in his team's achievement: "I am proud of the dedication and passion of our team at Checkpoint that allowed us to achieve the first and only FDA-approved anti-PD-L1 treatment for patients with advanced cSCC, and we are excited to enter this transaction with Sun Pharma as the next step to bringing UNLOXCYT to cSCC patients in need of a differentiated immunotherapy treatment option."
Financial Context
For the nine-month period ending September 2024, Checkpoint reported minimal revenue of $0.04 million and a net loss of $27.3 million, with R&D expenses of $19.3 million. As of September 30, 2024, the company had a cash balance of $4.7 million and outstanding accounts payable and accrued expenses totaling $17.6 million.
The acquisition provides Checkpoint with financial stability while giving Sun Pharma an FDA-approved asset that complements its existing portfolio.
Global Expansion Plans
Sun Pharma, the world's leading specialty generics company and the largest pharmaceutical company in India, plans to leverage its presence in over 100 countries to accelerate patient access to UNLOXCYT globally.
The company's vertically integrated operations and manufacturing facilities across six continents position it well to scale production and distribution of the novel immunotherapy treatment.
Checkpoint's Pipeline
In addition to UNLOXCYT, Checkpoint is evaluating olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (EGFR) inhibitor, as a potential treatment for patients with EGFR mutation-positive non-small cell lung cancer. This investigational compound will also become part of Sun Pharma's development portfolio following the acquisition.
Market Impact
The transaction represents another significant move in the consolidation of the oncology therapeutics market, particularly for targeted treatments addressing specific cancer types with high unmet needs.
For Sun Pharma, the deal expands its specialty portfolio with a novel immunotherapy that has potential applications beyond its current approved indication, while providing Checkpoint's innovative treatment with the global commercial infrastructure needed to reach patients worldwide.
