Akorn and Fidia to develop four ANDA drugs

US firm Akorn says that it has signed a definitive agreement with Fidia Farmaceutici SpA, a privately-held pharmaceutical company located in Abano Terme, Padova, Italy, to develop four Abbreviated New Drug Application products. The two companies had previously signed a letter of intent in October 2005 to develop these four drugs.

The products include one ointment and one cream for topical application, and two tablet formulations used in the immuno compromized antiviral market. The combined current market size of the four drugs is around $1.0 billion. Fidia will be responsible for product development and manufacturing, including clinical development of the two tablet formulations, while Akorn will be in charge of the clinical development of the ointment and cream formulations along with sales and marketing efforts. According to the signed agreement, Akorn will make milestone development fee payments to Fidia and have exclusive rights to market these four drugs in both the USA and Canada. Further terms were not disclosed.

Arthur Przybyl, Akorn's chief executive, stated: "these drug products represent an important future revenue opportunity for Akorn. Fidia has the expertise and capabilities to develop these four drugs."