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M Pharmaceutical expecting very big things of C-103 and Extrinsa

Last updated: 13:50 17 Jul 2017 EDT, First published: 09:50 14 Jul 2017 EDT

Female sexual disorder
M anticipates Extrinsa will be extremely well tolerated and highly effective for a large number of women suffering from female sexual disorders

Having reduced the unwanted side-effects of weight loss drug Orlistat, M Pharmaceutical Inc (CNSX:MQ) is targeting US$500mln annual US revenues from its new formulation.

Orlistat blocks some of the fat that is consumed by users, keeping it from being absorbed by your body.

Once an US$800mln a year drug..

It was once an US$800mln a year drug, before socially unacceptable side effects - let’s just say it was advisable to have a change of underwear and an air freshener to hand when taking the drug - caused its popularity to wane.

M thinks it has cracked those unwanted side effects, and should the drug receive approval from the US Food and Drug Administration (FDA), its number crunchers came up with the US$500mln a year revenue projection - and that’s just based on the first year it goes on sale.

The projections were based on conservative patient prescription figures at a US$125 wholesale cost and adjustments for population growth and obesity rate growth.

The total estimated patient market (ages 17 to 65, with an obesity rate of 37.9%) is 83.38 million in 2017 compared with 58,633,200 in 2000, when the drug was launched with the Xenical brand name.

The opportunity for M is obviously enormous, but it did caution that substantial funds would be required for development costs, though these would be lower than the sort of money needed to develop a drug from scratch.

READ M Pharmaceutical shares surge as the drug developer outlines exciting future

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Meanwhile, the company has also been “bigging up” the market opportunity for Extrinsa, a form of the prescription drug tadalafil - the infamous Cialis mentioned in so many spam emails - that is applied to the skin.

M Pharma is targeting Extrinsa at the female market, primarily as a treatment for sexual arousal disorder with the possibility of it also working as a remedy for women unable to obtain orgasm.

M reckons this is a US$1bn opportunity..

M reckons this is a US$1bn opportunity; Addyi, the only drug currently approved for the treatment of female sexual desire disorder was purchased by Valeant Pharmaceuticals Intl Inc (NYSE:VRX) from Sprout for more than $1-billion in 2016.

Valeant had estimated that sales would ramp up to US$1-billion annually for this drug, and it makes no claims to treat orgasm disorders, so the potential market for Extrinsa should be higher still.

“The Extrinsa treatment is topical, local and non-systemic, with daily and on demand use, while being non-hormonal and not a central nervous system drug. Based on these core attributes, the safety profiles of the API and excipients in the drug product, and the dosage and delivery form, the company anticipates Extrinsa to be extremely well tolerated and highly effective for a large number of women suffering from female sexual disorders and has a great likelihood of approval by the FDA,” M Pharma said.

As with C-103, its reformulation of Orlistat, Extrinsa will require substantial funds for development.

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