Futura Medical Regulatory News (FUM)

9 Dec 2005 07:01

Futura Medical PLC09 December 2005 For immediate release 9 December 2005 Futura Medical plc in final discussions on global rights for MED2002 Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device groupthat develops innovative products for the sexual healthcare market, announcesthat it has extended the exclusivity period with the major global pharmaceuticalgroup (MGPG) with which it is negotiating global rights for MED2002*, theCompany's non-prescription topical gel for the treatment of erectiledysfunction. Heads of agreement are now being finalised, which are intended to be legallybinding. In addition, MGPG is providing extensive technical, regulatory andclinical resources to assist Futura in finalising plans for the Phase IIIclinical programme for MED2002, which is planned to start in 2006. The exclusivity period, which was initially entered into in March 2005, is beingextended by 45 days from 31 December 2005 in order to finalise the heads ofagreement and obtain MGPG's executive approval. James Barder, Chief Executive of Futura, said: "Both parties have worked veryclosely together during 2005 to conclude all the necessary evaluation work onMED2002, culminating in our recent announcements of positive pharmacokineticsand pharmacodynamic studies. An enormous amount of progress has been achievedover a short period of time since the results of the studies were made availablein early November, and we are happy to grant a short extension to theexclusivity period. By the end of the extended exclusivity period we expect toannounce the identity of our partner and highlights of the joint developmentprogramme and commercial arrangements after negotiations and approvals have beencompleted." *MED2002 is the term used by Futura to describe all of the Company's differentgel formulations for application directly to the penis for the treatment of maleerectile dysfunction. Futura may code certain formulations, for identificationpurposes, by altering the final digit. E.g. MED2001 or MED2004. For further information: Futura Medical plc James Barder, Chief Executive Tel: +44 (0) 1483 845 670 mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk Media enquiries: Buchanan Communications Mark Court / Tim Anderson / Rebecca Dietrich Tel: +44 (0) 20 7466 5000 Notes to Editors: Futura Medical plc Futura Medical is an AIM-listed pharmaceutical drug and medical device groupdeveloping innovative products for sexual health. The Company is developing aportfolio of products with the intention of licensing their manufacture anddistribution to major pharmaceutical and healthcare groups. Exclusiveworldwide distribution agreements have already been signed in respect ofFutura's two condom safety products, CSD500 and FLD500, with SSL Internationalplc, the makers of Durex(TM) condoms. Futura recently announced the results of pharmacokinetic and pharmacodynamicstudies which showed an excellent safety profile and statistically significantefficacy on the reformulated gel for erectile dysfunction, MED2003. Futura's primary focus is on Over the Counter (OTC) products with particularappeal to men and women who are reluctant to discuss potentially embarrassingsexual matters with their doctors. In March 2005 Futura announced it had entered into exclusive discussions until31st December 2005 with a major global pharmaceutical group on a proposedagreement for the worldwide development and marketing of MED2002 (MED2003,MED2004 & MED2005 are revised formulations of MED2002). This was to allow time for discussions, joint co-operation and certaindevelopment work on MED2002 to be completed with a view to entering into apotential global distribution agreement. Phase III trials are scheduled to commence in 2006. For further information please visit: www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange