Futura Medical Plc (LON:FUM) has advanced transdermal technology which can be incorporated into formulations of well characterised drugs to improve performance and extend their uses. 2015 was expected to be a busy year for the company and three recent announcements show that management is delivering on these expectations. Clarity of the EU regulatory pathway for the pain portfolio products is an important milestone, and rapid recruitment in the pivotal MED2002 trial, both add to the de-risking of the prodcuts and enhance the prospects of securing commercial partners.
► Pain portfolio: FUM announced that a positive meeting with an EU regulatory authority has clarified requirements for regulatory submission of FUM’s pain products and indicated that no further clinical trial are likely. This further derisks the portfolio and should spur the interest of potential commercial partners.
► MED2002: FUM is undertaking a pivotal phase III in 192 patients for EU regulatory approval. Recruitment has been at a rapid rate and 118 (61.5%) have been recruited in London alone. Importantly, no adverse events have been observed. Results are due by the end of 1H 2016.
► Commercialisation: All these announcements are associated with a further derisking of the products which increases the prospects of identifying and signing commercial partners. Clarity of requirements for regulatory submission is a major step.
► Risks: Clinical trials always carry risk, but considerable clinical experience with the underlying drug, these risk have been minimised. Greatest risk is the timing of licensing deals and commercial, where any delay impacts the time to cashflow breakeven and profitability.
► Summary: Regulatory clarity for EU approval of the pain portfolio represents a major achievement. In addition, rapid recruitment for the MED2002 trial augurs well for its regulatory pathway and making the product available as a ‘Special’ on a ‘Named Patient’ basis in the UK via Quantum Pharma is helping to maximise shareholder returns. Management is making steady progress on all fronts.
