Akorn, Cipla sign 10-year agreement for an oral anti-infective aNDA product

By Lisa Kerner

Erie, Pa., March 7 - Akorn, Inc. and Cipla, Ltd. announced the signing of an exclusive 10-year drug manufacturing and supply agreement for an oral anti-infective aNDA drug product.

Cipla will manufacture the drug using Akorn's formulation and will supply the product to Akorn on an exclusive basis in the United States, according to a company news release.

Akorn will be responsible for the abbreviated New Drug Application (aNDA) regulatory submission, clinical development and the purchase of specialized manufacturing equipment.

Under the agreement, Akorn will pay Cipla milestone fees for Cipla's assistance with aNDA development and submission.

Akorn will own the aNDA in the United States.

The total market size for the oral aNDA anti-infective drug product is about $100 million, the release stated.

"Together with Cipla, we are strongly committed to expediting the clinical development activities necessary to introduce this product to the market," president and chief executive officer Arthur S. Przybyl said in the release. "The commercialization of this aNDA drug product is a top priority."

Cipla is a pharmaceutical company located in Mumbai, India.

Akorn manufactures and markets sterile specialty pharmaceuticals. The company is based in Buffalo Grove, Ill.

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