(MENAFN- ProactiveInvestors - UK) Futura Medical PLC (LON:FUM) is set to reap the benefit of all the research & development work on its pain relief and sexual health products.
Last year was a period of intense clinical activity during which it made "significant advances" in programmes in erectile dysfunction and pain relief.
This year, it expects research & development (R & D) outlay will be significantly lower, and the focus would be on commercial product development.
Futura chairman John Clarke''s AGM statement in June gave a round-up of progress made to date on the commercialisation of the company''s product pipeline.
Top of the bill was the CSD500 condom, which maintains a firmer erection, maximises penile size and gives women a longer-lasting sexual experience.
Monthly data reports from Futura''s extended shelf life product are giving the company confidence in the product''s ability to meet the requirements of its partners. Talks with regulatory authorities in India and Europe are taking place, and Futura expects regulatory approvals for CSD500 will be based on a shelf life of at least 18 months, thereby enabling a product launch in key commercial markets.
Production is underway for an anticipated launch in the second half of this year in certain territories in the Middle East and North Africa.
Moving on to its non-steroidal anti-inflammatory drug (NSAID) pain relief gels, following the positive clinical data announced last year, the company has received significant interest from a number of companies to in-license these products, currently known as TPR100 and TIB200.
"On MED2002, Futura''s topical gel for the treatment of erectile dysfunction, 137 patients have so far completed this pivotal clinical study and we expect the remaining 55 patients to complete by the end of July. If the current rate of completions is maintained, we would expect to announce the headline results of the study during September 2016,'' Clarke told shareholders at the AGM.
''With potential news flow from all of our pipeline projects during the remainder of the financial year, we believe that there is clear potential for value generation this year and beyond," Clarke''s statement concluded.
ABOUT THE COMPANY
Futura Medical looks to be overcoming problems with its innovative condom, which helps men and their partners to have better sex.
The CSD500 condoms, which are designed to help men maintain an erection and maximise penile size, have had shelf-life issues.
The company has been working on ways to allow the product to be stocked for two years rather than one year, and, as indicated above, Futura expects regulatory approvals for CSD500 will be based on a shelf life of at least 18 months.
Futura has also made significant advances in its clinical programmes in erectile dysfunction and pain relief.
The erectile dysfunction product MED2002 is aimed at addressing a need for an alternative to the current erectile dysfunction treatments.
People report side-effects such as headaches and heartburn from taking Viagra and Cialis, while for others the blue pill isn''t an option as it clashes with existing medication they are being prescribed.
Futura said a study of MED2002 began in June last year and recruitment of patients closed in May, with around 360 men having signed up.
RECENT NEWS FLOW
On 20 June, the company signed a five-year licensing agreement with a Zagreb-based firm that will see its CSD500 condoms distributed in seven territories in south-east Europe.
The deal with Milsing was the company''s second in seven days.
On June 13, the AIM-listed group said it had linked up with TTK Protective Devices, part of the conglomerate TTK Group and the maker of Skore, India''s biggest condom brand.
Futura said this Milsing tie-up is in line with strategy of licensing CSD500 to regional distributors in order to build a global distribution network. No financial details were given.
Chief executive James Bader told investors: ''We are delighted to sign this exclusive agreement with Milsing for the marketing of CSD500 in Southeast Europe.
''It marks further progress to our strategy to license CSD500 with leading regional distributors in order to build a global distribution network.
''Milsing is a dynamic company and is well placed to maximise the potential of CSD500."
Meanwhile, the TTK deal provides back-up to the European manufacturing deal the company already has.
The UK firm has also inked an exclusive licensing agreement for the marketing and sale of CSD500 in India for the lifetime of its patents.
Watch: TTK deal provides ''certainty of supply'', says Futura chief
"I am delighted to sign these two agreements for worldwide manufacturing and for distribution in India of our novel erectogenic condom, CSD500,'' said Futura chief James Barder.
''It has always been our manufacturing strategy to offer CSD500''s licensees the guarantee of supply by having dual sourced manufacture in Europe and in Asia.
''TTK is an ideal manufacturing partner as it is a highly experienced condom maker that has supplied the world''s largest condom brands.''
SHARE PRICE PERFORMANCE
Since the middle of May the shares have risen steeply from 14.5p to around 24p.
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