Drug Delivery Technologies
LAURIAD®
Additional follow-on products being developed on the Lauriad®
drug delivery platform include acyclovir Lauriad®
for treatment of oral herpes as described below.
 Acyclovir Lauriad®
Rationale:
- Early and extended release of acyclovir at the site of infection for continuous pressure on the virus
- Systemic, buccal and lip site activity
- Once a day
Targeted Indications:
Development Status:
- Phase 1 PK study completed in EU in 3Q05
- Phase III Pivotal study Herpes Labialis ongoing
Epidemiology:
Herpes simplex virus (HSV) consists of two type of viruses, type 1 (HSV-1) and Type 2 (HSV-2). The prevalence of herpes simplex viruses is expected to increase as no effective drug to cure herpes has yet been developed. This represents a significant market opportunity since it is estimated that one billion people worldwide are infected with HSV.
HSV is the most widely spread virus in the herpes family. HSV-1 dominates in prevalence and primarily causes oral infections. HSV-2 represents the primary cause of genital herpes though HSV-1 is increasingly associated with primary genital herpes.
Many people have no symptoms but are still infected with
the virus and can spread the infection. Others infected with
herpes experience small, painful lesions that crust and heal
after about two weeks. Even though the symptoms may heal or
disappear, herpes can still come back. This is called a recurrence,
or outbreak. Herpes is most easily spread when lesions are
present and right before and after an outbreak. There is no
cure for herpes but certain medications can reduce the severity
and number of outbreaks. Herpes can increase the risk of becoming
infected with other STDs including HIV. Herpes may be severe
in people with weakened immune systems and may also be harmful
to a foetus in pregnant women.
HSV-1 is associated with "oral herpes" because this type of the virus is often found in lesions on the lips, mouth or face. These lesions are often called cold sores, canker sores, or fever blisters. HSV-2 is associated with "genital herpes" because this type of the virus is often found in lesions on the external genitals, anus, cervix, vulva, buttocks or thighs. However, HSV-1 and HSV-2 can cause herpes infections in either area. Between 1 and 30% of all genital herpes outbreaks are caused by HSV-1. In other words, HSV-1 has been found in lesions on the genitals and HSV-2 has been found in lesions on the lips, mouth or face, but when this happens infections tend to be less severe with fewer recurrences.
Over 80% of the adult world population is infected with HSV-1. This comprises 56 million people in developed western countries. In the US, about 40% of the population is infected with oral herpes. The most heavily infected patients comprise 7% of the global population and suffer three or more cold sores yearly
WHO estimates suggest that worldwide, about 21 million people are infected with genital herpes (mainly HSV-2) globally each year. In the US, 21% of adults are estimated to be HSV-2 positive while in Europe the average prevalence is around 15%. By 2007, the potential patient population infected with HSV is estimated at 110,900,000 with oral herpes and for genital herpes at 1,250,000
Clinical development:
BioAlliance completed a Phase I PK and dosage study of acyclovir
Lauriad® in 3Q 2005. A prompt and lasting elevated concentration
was obtained for 24 hours in the saliva, corresponding to
a continuous presence of the active pharmaceutical ingredient.
A very elevated concentration above minimum effective concentration
(MIC) levels was also found at the labial site for 24 hours.
A dossier applying to conduct a phase III clinical trial was
filed with the regulatory authorities in Europe in December
2006. In 1S07, the Company obtained the authorizations from
the relevant authorities in Australia, France, Germany, the
United Kingdom and the Czech Republic, enabling it to enter
Phase III clinical trials for this product.
The purpose of this trial is to compare acyclovir Lauriad®
with a placebo, with the anticipated recruitment of 640 patients
with recurrent labial herpes (estimate of 40 clinical centres).
The main criterion evaluation will be the time taken to heal
the herpes lesion observed for 15 days. The first results
are expected within an estimated time period of 24 months,
subject to any additional requests that may be made by the
supervisory authorities.
Medical Need:
To meet the need for a more effective topical treatment of
oral herpes, a mucocutaneour illness, BioAlliance has begun
clinical studies of acyclovir Lauriad®
as a buccal mucoadhesive product. Investigation of peroral
therapy of herpes labialis documented in the literature has
demonstrated efficacy of acyclovir particularly in reducing
healing time of HSV lesions. In this context, acyclovir Lauriad®
appears to represent a promising novel therapy, which may
provide a systemic and local effect with high concentration
at the site of infection. Taking into account the high efficacy
and selectivity of acyclovir against HSV, BioAlliance completed
a Phase I PK and dosage study of acyclovir Lauriad®
in 3Q 2005.
While the potential worldwide market for treatment of HSV is over €1B, much of it in the GP market. As the product moves into clinical development, we intend to further refine the market forecasts and appropriate patient populations accessible with this product, but the company intends to maintain its strategy of focusing on the cancer and HIV markets while out-licensing any larger opportunities to partners with a sufficiently large sales force.
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