PET500 is a topical spray developed for men who want greater levels of sexual control. It is designed to meet the requirements of men who suffer from occasional early ejaculation as well as those suffering from clinically diagnosed premature ejaculation. Applied directly to the penis, PET500 enables men to prolong their sexual experience and sexual enjoyment, increasing satisfaction for them and their partner.
PET500 combines Futura's highly effective DermaSys® delivery system with a mild anaesthetic. PET500's formulation is designed to provide extra control for a period of approximately eight minutes, after which time the effect of the mild anaesthetic dissipates.
In 2008, Futura announced positive results from a Phase I study which met all endpoints. The endpoints were devised following consultation with a number of leading medical experts in the field of premature ejaculation and on the basis of qualitative market research in patients. In this Phase I study of 20 healthy volunteers, PET500 was shown to give a rapid and controlled reduction in penile sensitivity, thereby having the potential to delay ejaculation. Penile sensitivity was measured in a clinical setting by the use of Von Frey microfilaments. No adverse events with the active product were recorded in the study.
The marketing positioning of the product will depend upon local regulatory requirements including the status of existing regulatory approvals for the active ingredients. A home use clinical study will be required for some markets including those in the EU. In considering how to market the product and subject to local regulatory requirements, we believe that 'enhanced sexual control' is a more attractive marketing positioning for the product.
The PET500 formulation has been successfully modified to comply with the current USA Food and Drug Administration monograph for male genital desensitisers. The product can therefore be marketed in the USA without any further regulatory approval or clinical data.
In 2011, we signed an exclusive worldwide agreement with Ansell Ltd for the distribution rights to our product for premature ejaculation PET500.
Under the terms of the agreement with Ansell, Futura will receive a significant royalty rate on sales. Ansell is responsible for the product's manufacture, distribution and marketing and for funding of all regulatory work. Futura will work closely with Ansell on the successful completion of any clinical work in territories where regulators require additional data.
Since signing the agreement, Ansell has developed the brand positioning and packaging for PET500 for initial sale in the USA where it will be sold under their well-known LifeStyles® brand.
We continue to work closely with Ansell, and we expect Ansell to carry out a soft launch of the product later this year in the US. In June 2012 Ansell showcased the product at the annual Marketplace meeting of the US National Association of Chain Drug Stores (NACDS) in Denver, Colorado. Presentations about the clinical performance and commercial prospects for PET500 were made to key retailers at Marketplace, which represents the largest conference of its type in the USA. Key US retail outlets only conduct a review on an annual basis culminating with a change to in-store listings generally in the first quarter of the year.
Ansell is finalising the details of its advertising strategy, which is expected to be designed to target existing users of sexual control products in the first instance. In the USA, PET500 is approved for sale under the current Food & Drug Administration monograph for male genital desensitisers and promotion of the product will be required to conform to the monograph.