Zydus, Synthon enter into licensing, supply agreement for Palbociclib Tablets for US market

Ahmedabad: Zydus Lifesciences Ltd., a global healthcare company announced that its wholly owned subsidiary, Zydus Worldwide DMCC, has entered into an exclusive licensing and supply agreement with Synthon BV for Palbociclib Tablets (a generic version of IBRANCE) for the US market.

Under the terms of this agreement, Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets, and thereafter, for the manufacturing and supply of the product. Zydus will be responsible for commercialization of the oncology product in the US.

"Synthon was the first sole ANDA applicant for Palbociclib Tablets, 75 mg, 100 mg, and 125 mg, with a paragraph IV certification and therefore may be eligible for 180 days of generic drug exclusivity for all three strengths," the release stated.

IBRANCE, is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

• an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or

• fulvestrant in patients with disease progression following endocrine therapy.

Speaking on the development, Managing Director of Zydus Lifesciences Ltd., Dr. Sharvil Patel said, “We are pleased to partner with Synthon for the commercialization of this important drug product. The partnership will bring access to a high unmet need therapy area for patients in the US. We are certain that by pooling our resources and knowledge, we will meet critical needs of patients and stakeholders.”

Anish Mehta, Chief Executive Officer, Synthon BV commented, “As a leading global developer and manufacturer of high quality, complex generics, we are delighted to partner with Zydus on this significant first to market opportunity in what is the world’s largest pharmaceutical market. Bringing Palbociclib tablets to market represents another example of Synthon's global development, manufacturing and regulatory expertise. We are confident that working with Zydus will allow us to successfully commercialize Palbociclib while advancing our mission of enabling access to high quality, affordable medicines.”

The total addressable market opportunity of Palbociclib Tablets in the US is approximately $3.1 billion as per the IQVIA MAT Nov. 2023.

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