Solvay Pharmaceuticals has signed a license agreement with Lipocine to acquire exclusive rights to develop and commercialise an oral formulation of testosterone.

The company further plans to start a development programme to examine the investigational product as an oral treatment for male hypogonadism, also known as low testosterone. It is estimated that hypogonadism affects more than 13 million men in the US aged 45 and older.

The deal sees Solvay make an upfront payment and future milestone payments to Lipocine. Lipocine will also get royalties based on product sales. In addition, Solvay will fund Lipocine development expenses associated with this programme.

Solvay President Stephen Hill said that the compound holds great potential.

“As the market leader in the field, we will apply our expertise in the treatment of low testosterone to the development of an oral testosterone replacement therapy. This compound has the potential to be the next major innovation in the management of low testosterone,” Hill said.