Futura Medical PLC (LON:FUM) continues to receive “significant commercial interest” in MED2002, its gel for erectile dysfunction, chairman John Clarke will tell the company’s annual meeting later Wednesday.
Last month the company received a boost in the form of “constructive feedback” from regulators in both the UK and US reviewing the clinical trial requirements for MED2002.
Crucially, written responses from America’s Food & Drug Administration and the Medicines & Healthcare products Regulatory Agency (MHRA) here in Britain support its timeline, which sees marketing approval for the product in the second-quarter of 2019.
It has been recommended Futura evaluates higher dosing regimes “to optimise efficacy across the spectrum of all ED patients”. The group has also been asked to obtain “limited additional safety data”.
“As a result of this feedback we expect our phase-III programme of MED2002 to proceed as planned, with the first patient dosed in the fourth-quarter this year,” Clarke will say.
“We continue to receive significant commercial interest in MED2002 from potential licensing partners and negotiations are ongoing.”
The chairman said Futura is assisting EU licensing partners where needed with launch plans for CSD500, its erectogenic condom.
“In addition, we have in production two manufacturing orders from our licensing partner for the Middle East and North Africa, following its launch of CSD500 in Saudi Arabia earlier this year,” Clarke added.
The company is also in discussions to out-licence its two pain relief products, TIB200 and TPR100.
“We look forward to providing an update on these discussions, and on other corporate developments, in due course,” Clarke will tell the annual meeting.