ANI Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, announced that it has acquired the exclusive rights to distribute 1 per cent and 2.5 per cent hydrocortisone cream for rectal use and the exclusive rights to distribute the authorised generic of Lipofen (fenofibrate capsules 50mg and 150mg USP) from H2-Pharma, LLC. In addition, ANI also acquired an early stage development project for an undisclosed generic injectable drug product.

Topical corticosteroids such as 1 per cent and 2.5 per cent hydrocortisone cream are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Lipofen (fenofibrate capsules) is a peroxisome proliferator receptor alpha (PPARa) activator indicated as an adjunct to diet: to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and for treatment of adult patients with severe hypertriglyceridemia.

In 2015 the combined market for 1 per cent and 2.5 per cent hydrocortisone cream for rectal use was $73 million, according to IMS Health. ANI intends to launch both strengths during the second quarter of 2016 and will retain a portion of net profits from its sales of these products.

In 2015 the authorised generic for Lipofen (fenofibrate capsules 50mg and 150mg USP) generated $21.9 million in revenues. According to the distribution agreement with Kowa Pharmaceuticals America, Inc., ANI will retain 7.5 per cent of net profits from its sales of the authorised generic for Lipofen. Following a transition period, ANI intends to launch the authorised generic for Lipofen (fenofibrate capsules 50mg and 150mg USP) under its own label during the second quarter of 2016.

Arthur S. Przybyl, ANI’s president and CEO stated, “We are excited to add these products to our growing portfolio of commercial generic drugs. We continue to pursue opportunities to expand our generic business and mature brand portfolio.”

Bryce M. Harvey, president of H2-Pharma, stated, “This transaction resonates with our primary goal at H2, which is to bring value to our partners' existing product portfolios by utilizing our extensive industry experience and knowledge. Our commitment is and will continue to be to foster innovation within our industry by developing new ideas and programs which will benefit each and every one of our partners.”