MED2002: Regulatory, Clinical and Commercial Update
29 November 2017
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, announces the following update on the regulatory and commercial progress of MED2002, Futura's novel gel for the treatment of erectile dysfunction ("ED").
The Company has recently received written correspondence following discussions with regulators in the UK and the Netherlands (the Medicines and Healthcare products Regulatory Agency and the Medicines Evaluation Board respectively) in connection with the Phase III clinical development programme for MED2002. The Netherlands is likely to be the reference member state for any EU regulatory filing for MED2002 following Brexit.
These regulatory agencies have signalled their broad approval of the Company's planned development programme, which includes a pharmacokinetic ("PK") study followed by two Phase III studies in line with guidance received earlier in 2017 from the US regulator, the Food and Drug Administration. Data from the PK study will assist in determining the dosages to be used in the two Phase III studies, in particular to exclude unacceptably high doses in the Phase III studies. The initial Phase III study, which is of an adaptive design to enable selection of the two most appropriate dose strengths. The selected two dose strengths will be used in the second Phase III study.
The agencies endorsed the inclusion of patients on nitrate medication in the Phase III programme to assess safety of MED2002 in those patients who are contra-indicated to PDE5 inhibitors, such as Viagra®. MED2002 potentially addresses an unmet medical need for this group of patients, who represent at least one in ten patients that suffer from ED, a significant market opportunity. MED2002's rapid onset of action and topical delivery, which helps restore spontaneity and sexual intimacy between partners, were also seen as highly relevant by physicians and an improvement over current ED therapies in recent research completed by Futura and announced in October 2017.
In addition, the regulatory agencies were supportive of a proposed potential switch of MED2002 from a prescription only to an over-the-counter ("OTC") medicine at the appropriate time, subject to the requirements being met for an OTC product.
As announced separately this morning, the first healthy subjects have already been recruited in the PK study designed to inform the optimum doses to be used in the two Phase III studies. The PK study is expected to be completed by the end of Q1 2018 with the first Phase III study commencing as soon as practicable thereafter.
Futura is making good progress in commercial discussions in connection with the out-licensing of MED2002 and discussions are at an advanced stage with a number of potential commercialisation partners. It is expected that an out-licensing agreement will be finalised during the first half of 2018 before the commencement of the first Phase III study.
James Barder, Futura's Chief Executive, said: "The further regulatory endorsement of our Phase III clinical programme for MED2002 in erectile dysfunction now enables us to move forward as fast as possible with the remainder of our clinical studies. As announced separately today, recruitment is now underway in the PK study, which begins the Phase III programme and will determine the dosage strengths in the initial Phase III study. Discussions are at an advanced stage with a number of potential out-licensing partners for MED2002 and we now expect to be able to announce commercial terms to shareholders during the first half of next year."
For further information please contact:
Aubrey Powell / Liz Yong
Tel: +44 (0) 20 7496 3000
For media enquiries please contact:
Mark Court / Sophie Wills /
Stephanie Watson / Tilly Abraham
Tel: +44 (0) 20 7466 5000
This announcement is released by Futura Medical plc and contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 ("MAR"), encompassing information relating to the regulatory, clinical and commercial update described herein, and is disclosed in accordance with the Company's obligations under Article 17 of MAR.
For the purposes of MAR and Article 2 of Commission Implementing Regulation (EU) 2016/1055, this announcement is being made on behalf of the Company by James Barder, Chief Executive.
Notes to Editors
Futura Medical plc
Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.
Data from the PK study, which represents the initial step in Futura's Phase III programme for MED2002, will assist in determining the dosages to be used in two Phase III studies, which will begin next year, as soon as practicable after the completion of the PK study.
A total of 40 subjects will participate in the PK study. The study will check the tolerance of subjects to a range of doses of MED2002 including higher doses than the dose used in the earlier efficacy study, the results of which were announced on 7 September 2016, and also compare MED2002's safety against an approved angina treatment that uses the same active pharmaceutical ingredient.
The PK study will help avoid the inclusion of unacceptably high doses in the Phase III studies and provide additional safety data to support the proposed US regulatory pathway of a 505 (b) 2 filing. Subject enrolment in the PK study is expected to be completed in early Q1 2018 and the results are expected to be available by the end of Q1 2018.
Regulatory endorsement of the design of the two Phase III studies is well advanced and includes feedback from the US FDA, the MHRA in the UK and MEB in The Netherlands. A formal investigational new drug ("IND") submission has been made to the US FDA.