(Reuters) – Apricus Biosciences Inc said on Monday it was considering options for the company and looking to sell the U.S. rights to its erectile dysfunction cream Vitaros, after the Food and Drug Administration asked it to make a new formula for the product.
Shares of the company fell 24 percent to 32 cents in premarket trading, valuing the company at $ 7.5 million. Up to Friday’s close, Apricus has lost about $ 65 million in market value since the FDA declined to approve Vitaros in February.
Apricus said it did not have the money to develop a new version and fund two new late-stage studies to meet FDA requirements. The FDA has rejected Vitaros twice in 10 years.
“We have initiated discussions with interested parties for the U.S. Vitaros rights to enable its continued development and potential approval,” Chief Executive Officer Richard Pascoe said in statement.
“The cost and timeline associated with a reformulation effort … exceeds our current resources and our ability to raise additional capital.”
The FDA wanted Apricus to reduce the concentration of an ingredient that facilitates the absorption of Vitaros through the skin, citing concerns that it could cause cancer in patients or their sexual partners.
Although approved in several countries, Vitaros’ rejection in the U.S. gave Pfizer’s Viagra a dominant position as the main treatment for male impotence.
Apricus was hoping to sell Vitaros, possibly through commercial partner Allergan Plc, to patients unable to use oral medications and looking for less invasive existing options.
The company said its board determined it should evaluate options or other business combinations.
Reporting by Tamara Mathias in Bengaluru; Editing by Anil D’Silva, Bernard Orr