Anaconda Pharma

A new era in HPV therapeutics

• Technology
• Background to HPV
• Markets for HPV treatments
• Anaconda’s approach

Markets for HPV treatments

Diseases caused by Human Papillomaviruses

HPV Infection
Genital HPV is the most frequent sexually transmitted infection diagnosed in developed countries – 20 million infected persons in the United States. The prevalence of HPV infection ranges from 3% to 42% (Southern Africa), and affects 10-20% of the sexually active population in industrialized countries. HPV infections are responsible for local epithelial hyperproliferations that lead to various external lesions such as condylomas, recurrent respiratory papillomatosis, dermal warts, or to subclinical lesions diagnosed by cytology or colposcopy such as internal condylomas, and pre-malignant anogenital dysplasias that can evolve into cervical or anogenital cancer.

 
Condylomas

Condylomas are sexually transmitted and affect about 1% of the sexually active population in developed countries, i.e. 3.5 million patients (1.5 million in the United States & 28 million worldwide).  They can be found on vulva, anus, vagina, cervix, or the penis.  Condylomas represent a distressful condition for social and sexual life, especially in the cases of external condylomas.

Current treatments lack efficiency, are associated with a high recurrency rate and posses significant toxicity. Despite these drawbacks, the latest marketed treatment, Aldara (imiquimod, 3M), currently generates in the region of US$300m revenues in sales.

Dermal Warts

Dermal warts are mainly caused by HPV types 1 and 2. They represent a huge market in volume terms: 7-10% of the worlwide population is affected, including 60 million in developed countries.  Common warts usually are asymptomatic, but may cause cosmetic disfigurement or tenderness. Plantar warts usually are painful and extensive involvement on the sole of the foot may impair ambulation.

Recurrent Respiratory Papillomatosis

Recurrent Respiratory Papillomatosis (RRP) is a rare disease associated with HPV, which affects mainly children with vertical viral transmission from contaminating mothers. It is estimated that 25,000 persons are affected with RRP in developed countries.  Its symptoms are hyperproliferation of the mucosal tissue of the respiratory tract.  It is a highly recurrent disease that requires multiple painful surgery or laser treatments costing up to US$400,000 per patient.  There is a significant therapeutic need to diminish recurrence and costs.

Dysplasia

Genital HPV infections can induce severe dysplasias called HSIL (high-grade squamous intraepithelial lesions) and LSIL (low-grade squamous intraepithelial lesions).  These lesions are more frequently found on the cervix (CIN) in the female population and on the anus (AIN) - especially in the male homosexual HIV+ population.  High-risk HPV dysplasias have a high probability of progressing to cancer.

Cancer

Although representing only a small percentage of all HPV infected cases, cervical cancer is the most common cancer in women in many developing countries with 80% of total cancer cases; worldwide, it is the second most common cancer among women after breast cancer. In the United States, 55,000 women suffer from cervical carcinoma; 15,000 new cases of cervical cancer are diagnosed each year; and nearly 5,000 women die of cervical cancer annually.

Recently, it has been demonstrated that more than 99% of cervical cancers have detectable HPV DNA sequences, with the majority of cancers associated with specific HPV types such as HPV16 and 18.

Upon discovery of the role of HPV in the ethiology of cervical cancer, it was assumed that a vaccine to prevent oncogenic HPV infection (or pre-malignant cervical lesions) from progressing to cancer would clearly offer a cost effective long-term strategy to reduce the cervical cancer burden, particularly for developing countries where effective screening programs are not available.

Prophylactic vaccines aim to prevent HPV infection in order to decrease the occurence of cervical cancer.  Merck/Sanofi (Gardasil) and GlaxoSmithKline (Cervarix) have prophylactic vaccines against HPV that rely on virus-like particle (VLP) technology - carrying recombinant viral capsid proteins - for producing a structurally identical, non-infectious form of the virus. The long-term protection offered by these vaccines is unknown at present.

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