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news.Aceto Corporation, a global distributor of chemically derived products, has signed an agreement with generic drug maker Three Rivers Pharmaceuticals to bring three generic biopharmaceutical products to market.
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Under the agreement, Aceto will source the active pharmaceutical ingredients, manage the regulatory and quality control functions of production, and supply the final dosage form of the products to Three Rivers.
Three Rivers will file applications with the appropriate regulatory agencies and market the products in the US, Europe and Japan.
Aceto anticipates Three Rivers will submit regulatory applications within the next year, with commercialization of the products expected in 2007.
The agreement provides for revenue sharing between the two companies based on Three Rivers’ final selling prices, and will continue for a minimum term of ten years from the date of initial commercial sales.
Although the indications for the three products have not been disclosed, Aceto’s, chairman, CEO and president, Leonard Schwartz, revealed that one of the products will be competing with a brand-name market worth around $500 million wholesale in the US.
The agreement represents Aceto’s entree into the generic biopharmaceuticals business. The company has also expanded its Chinese headquarters and is increasing staffing levels in China as part of a strategic plan to facilitate the development of its biopharmaceuticals operations.
“We remain confident about our prospects in the emergent generic biopharmaceuticals segment as well as other biopharmaceuticals markets, and look forward to reporting on future developments,” Schwartz said.