By combining two drugs, the incidence of labial herpes can be diminished. In a previous collaboration with Astra, Medivir produced an entirely novel treatment principle against labial herpes and simultaneously resolved a scientific problem. Medivir’s 609 has undergone a major phase II trial, and efforts to out license the project ahead of phase III trials have begun.

Many people carry HSV (herpes simplex virus) from childhood, and may have been infected by their parents’ kisses. The virus migrates to the trigeminal nerve, a facial nerve whose roots lie just under the eye. Once a carrier is subsequently exposed to any of a series off actors such as stress, bright sunlight, menstruation, a common cold, or compromised immune defence, the virus can be re-activated and migrates to the lips, causing cold sores.

The first infection goes unrecognized by the immune system. On subsequent occasions, when the infection migrates to the lips, the body’s defences can effectively de-activate it,but the immune system overreacts, in turn causing inflammation with the consequence being a sore ofvarying size.

The market’s current HSV drugs – acyclovir, valaciclovir, famciclovir and penciclovir – inhibit virus propagation but not the aforementioned immunological overreaction. Research has shown that traditional drugs reduce cold sore healing times by 10-15%.An untreated cold sore remains for seven days, its healing time is cut by a half or one day. This represents just a marginal improvement of little value to the average patient. However, having cold sores for six days is a lengthy period, particularly if they are frequent.

ME-609 – Dual Action
Research based on a model Medivir has developed demonstrates that a combination ofan antiviral and a substance that locally inhibits the immune system would achieve distinct benefits.

ME-609, Medivir’s combination treatment against labial herpes suppresses the virus while moderating the immune system’s reaction. Clinical trials demonstrated that cold sores become far smaller, and in a significant number of cases, do not arise. This concept is highly competitive since none of the market’s current pharmaceuticals can prevent the incidence of cold sores.

The results of a major phase II trial were published in the year and submitted for publication. This study revealed that one-third of patients treated with ME-609 did not incur any cold sores. These phase II trial discoveries were statistically supported, and provide unusually bright prospects of a successful phase III trial.

ME-609 is primarily oriented against cold sores, and subsequently, there is a possibility of extending the project to genital herpes, caused by a similar virus.

Market
The market for drugs against labial herpes remains undeveloped and in terms of sales value relatively small because of the currently marketed compounds’ insignificant effect. But because in many cases, cold sores become large and disfiguring, a fast and effective treatment would also be of major psycho-social and cosmetic value to the people affected.

Not everyone infected with HSV develops cold sores, and the frequency declines with age. However, 80% of the adult population is infected. The most heavily affected patients, comprising 7% of the global population, suffer three or more cold sores yearly. In terms of the Western population, this potential market comprises 56 million people. Even ifa product was to capture only 20% of this potential market, sales would be very sizeable. In 2001,US pharmacists advised on the purchase of the biggest-selling non-prescription labial herpes pharmaceutical on some 3.5 million occasions.

Long Patent Protection
Medivir’s patent covers labial and genital herpes; the patent for the combination concept extends to 2016. The patent on the actual cream extends to 2019. Having such a long patent life when the product is so near to market and is unusual, would benefit Medivir when the substance goes to market.