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Pharma & Biotech

Futura Medical says shelf-life issue with condoms have been resolved

The CSD500 condom is close to regulatory approval for a longer shelf life and partner launch.

High-flying Futura Medical PLC (LON:FUM) was on the rise again on Tuesday after it said shelf-life problems with its CSD500 condom had been solved.

CSD500 condoms, which are designed to help men maintain an erection and maximise penile size, have had shelf-life issues, and these have delayed the launch of the product by its commercial partners, but in its interim results announcement the company said CSD500 was close to regulatory approval for a longer shelf life and partner launch.

Regulatory submissions to enable an extended shelf life of at least 18 months have been filed for both its European manufacturer and for TTK Protective Devices Limited, the Indian manufacturer with whom it has also signed a distribution agreement.

“In the past week we have heard from the regulators that there are no major outstanding issues on the TTK submission and we therefore anticipate the first approval of these submissions shortly,” the company said.

Meanwhile, the consumer healthcare company said it was becoming increasingly excited about the commercial prospects for MED2002, its gel for erectile dysfunction.

The shares shot up last week after the company announced a pivotal clinical trial had been a resounding success. Since then, the company has continued to analyse the data with the aim of releasing a full study report before the end of the year.

Meanwhile, work continued on preparing regulatory submissions for its topical pain relief candidates – that’s topical as in applied to the part of the body where the pain is, not as in featured on Have I Got News For You? - for territories within the EU.

The company said it is making progress with out-licensing talks for the topical pain relief gels, and it is now at the heads-of-terms stage with a number of potential partners.

The company said it ended June with £2.9mln in cash, down from £7.23mln a year earlier.

As for the profit & loss account, the numbers are not very meaningful for a company at this stage of its development, as evidenced by a fourfold increase in revenue from the year before that still only lifted the top line to £66,900.

Loss before tax narrowed to £2.26mln in the first half of 2017 from £3.02mln the year before, as research and developments costs reduced to £1.79mln from £2.48mln last year.

"We continue to make good progress in the clinical and commercial development of our portfolio of product opportunities. This was highlighted last week with the announcement of positive clinical study results for MED2002. We are increasingly excited about MED2002's commercial potential as well as the first partner launch of CSD500 later in the year and the first pain relief out-licensing deal," said Futura’s chief executive, James Barder.

Shares in Futura rose to 87.1p in early deals from 73.75p overnight before subsiding to 77.5p.

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