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GSK licenses OTC erectile dysfunction product
 
 
  05/07/2006
http://www.pharmatimes.com
 
GlaxoSmithKline has licensed co-development rights to a topical formulation of the widely-used angina drug glyceryl trinitrate that could become the first over-the-counter product to treat erectile dysfunction.
 
MED2002 will be a "rub-on" gel applied directly to the penis for the treatment of male erectile dysfunction. The Directors believe this will become the first pharmaceutical treatment for erectile dysfunction without the need of a doctor's prescription.
 
If it proves successful in clinical trials, the gel product, developed by UK firm Futura Medical, could provide an alternative therapy for men who do not respond to treatment with oral phosphodiesterase 5 inhibitors such as Pfizer's Viagra (sildenafil). It could also shift some of the cost of managing ED from national health systems to patients' own pockets and, given that just 15% of men with ED seek prescription treatment, could actually increase treatment rates.
 
The local action of the product could also be an advantage as it avoids systemic exposure to medication, unlike the PE 5 inhibitors, said Futura. And glyceryl trinitrate, which is already available OTC for angina, has its own built-in safety valve to guard against over-dosing: apply too much and the first symptom to develop is a severe headache.
 
GSK has committed funding of around 2.4 million to the project, which will pay for the lion's share of Futura's clinical trial programme for MED2002, expected to cost around 3.65 million. The trials will enroll around 1,500 men and are scheduled for completion in time for regulatory filings for the product in 2008.
 
Under the terms of the agreement, GSK has global distribution and marketing rights for MED2002. In return, Futura receives a royalty on all MED2002 sales for the lifetime of the MED2002 patents, currently expected to run until around 2024. GSK also gets first refusal rights for two other OTC products in early-stage development at Futura, including a treatment for arousal and desire disorders associated with female sexual dysfunction and a non-prescription treatment for premature ejaculation.
 
From the Futura Medical Website
http://www.futuramedical.co.uk
 
MED2002 will be a 'rub-on' gel applied directly to the penis for the treatment of male erectile dysfunction.
 
MED2002 is based on the active compound GTN within a patented gel delivery system. GTN is a potent vasodilator and has been used for the treatment of angina and associated cardio-vascular defects for more than 40 years, where it has been determined to be a safe and effective drug with a known side-effect profile.
 
MED2002 is applied to the glans area of the penis with a single dose applicator. It has been designed to deliver an effective, rapid-onset, locally active dose with a low systemic uptake which will help to reduce unwanted side effects and minimize the potential for adverse interaction with other centrally acting drugs that may also be taken concomitantly by the patient, especially PDE5 inhibitors such as Viagra , Cialis or Levitra.
 
This is a less invasive method of application compared with other treatments and is consistent with sexual foreplay. The GTN is absorbed into the penile blood system and is converted to nitric oxide having the effect of relaxing muscles surrounding the corpus cavernosa and dilating the penile arteries. This allows the corpus cavernosa to engorge with blood and, following sexual stimulation, a natural erection occurs.
 
MED2002 is expected to become the world's first non-prescription pharmaceutical treatment for men with ED. By being available from pharmacies without the need for a doctor's prescription, MED2002 will be aimed at satisfying a large unmet demand from men with ED.
 
A joint development agreement has been signed with GlaxoSmithKline Consumer Healthcare, a division of GlaxoSmithKline plc the global pharmaceutical and healthcare group. Under the terms of the legally binding agreement, GlaxoSmithKline will pay 65% of the clinical development programme costs for MED2002 and Futura will pay 35%.
 
GlaxoSmithKline will provide complete global regulatory and technical support to maximise the chance of regulatory approval and launch of MED2002. The programme, to be run and managed primarily by GlaxoSmithKline, is expected to comprise of up to three studies involving approximately 1,500 men with ED and several small safety studies to support the existing studies already completed by Futura. The clinical development programme is already in an advanced stage of planning and is currently expected to complete in time for regulatory submissions in 2008.
 
The Agreement also includes licence terms that are intended to be incorporated into a global licence agreement to be executed by both parties for MED2002. Under these terms GlaxoSmithKline has global distribution and marketing rights for MED2002. In return, Futura receives a royalty on all MED2002 sales for the lifetime of the MED2002 patents, currently expected to run until around 2024. Negotiations of the detailed terms and conditions are continuing with the intention of executing the licence agreement as soon as practicable. The clinical development programme will run in parallel.
 
 
 
 
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