American drug company Akorn Inc has signed a Letter of Intent with Indian pharmaceutical giant Cipla to develop and supply an oral anti-infective drug in the United States.
The oral anti-infective drug would be distributed primarily in the US hospitals and has a current market size of approximately 100 million dollars, the two companies said in New York on Tuesday.
This generic drug comes under the ANDA (Abbreviated New Drug Application) category, which needs the approval of US Food and Drugs Administration.
"We are excited to enter into this agreement with Cipla. Over the years, Cipla has demonstrated its ability to successfully develop and manufacture drug products for the United States market," Arthur S Przybyl, Akorn's president and chief executive officer said.
The LoI anticipates executing a definitive agreement within ninety days upon terms and conditions agreeable to both Akorn and Cipla, the companies said.
Cipla will be responsible for the development and manufacturing of the drug, and Akorn for the ANDA regulatory submission and clinical development.
Akorn will pay Cipla product development milestone fees, purchase the product from Cipla and will own exclusive marketing rights in the US.
"This product is an excellent fit for Akorn's distribution channel strategy because the product sales are primarily driven by hospitals," Przybyl added.