Akorn, Cipla strike deal to develop, manufacture anti-infective ANDA drug

By E. Janene Geiss

Philadelphia, Nov. 8 - Akorn, Inc. announced Tuesday that is has signed a letter of intent with Cipla, Ltd. to develop and supply an oral anti-infective ANDA drug product.

A definitive agreement with Akorn and Cipla, a Mumbai, India-based pharmaceutical company, is expected within 90 days upon agreeable terms and conditions, officials said in a company news release.

Officials said the oral ANDA anti-infective drug product is distributed and used primarily in U.S. hospitals and has a current market size of about $100 million.

Cipla will be responsible for the development and manufacturing of the drug and Akom will be responsible for the ANDA regulatory submission and clinical development, officials said.

Akorn will pay Cipla product-development milestone fees, agrees to purchase the product from Cipla and will own the ANDA with exclusive marketing rights in the United States. No other details about the deal's financial terms were disclosed.

"Over the years, Cipla has demonstrated its ability to successfully develop and manufacture drug products for the United States marketplace. This product is an excellent fit for Akorn's distribution channel strategy because the product sales are primarily driven by hospitals," Arthur S. Przybyl, Akorn's president and chief executive officer, said in the release.

Buffalo Grove, Ill.-based Akorn manufactures and markets sterile specialty pharmaceuticals.

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