Futura signs impotence gel deal with Glaxo
Last Updated: 2006-07-04 13:00:56 -0400 (Reuters Health)
LONDON (Reuters) - British sexual health specialist Futura Medical Plc signed a long-awaited agreement with GlaxoSmithKline Plc on Tuesday to develop its gel MED2002 as a non-prescription treatment for impotence.
If successful, Futura's MED2002 -- which is applied directly to the penis -- would be the world's first over-the-counter remedy for men with erectile dysfunction, offering an alternative to pills such as Pfizer Inc's Viagra.
The product is based on glyceryl trinitrate, or GTN, a vasodilator that has been used for the treatment of angina for more than 40 years.
Under the terms of the deal, Glaxo will pay 65 percent of the clinical development costs and Futura 35 percent.
The cost of the entire clinical programme is expected to be about 3.65 million pounds ($6.7 million), which would result in a contribution from Glaxo of about 2.4 million.
Futura said it intended to raise up to 2.5 million pounds, after costs via a placing of shares at a discounted price of 78 pence each to help fund its share of the project.
Its stock, which had risen recently on hopes of an imminent deal, ended 3.8 percent lower at 82-1/4 pence.
Around 1,500 men are expected to be recruited into three clinical studies of MED2002, the first of which will commence before the end of this year.
The goal is to have collected enough data on the safety and effectiveness of the gel for it to be filed for regulatory approval in 2008.
Futura and Glaxo have agreed in principle that Glaxo will become global distributor of MED2002, but the terms of this licensing deal are not yet legally binding.
Futura also plans to grant Glaxo first refusal rights on two other products in early-stage development -- a non-prescription treatment for female sexual dysfunction and a treatment for premature ejaculation.
For Glaxo, the agreement with tiny Futura is not material financially. But it highlights the commitment of the world's second-biggest drugmaker to over-the-counter medicines, one week after it lost out to Johnson & Johnson in a $16.6 billion battle for Pfizer's consumer health unit.
