Current Treatments / Competition

Currently, antibiotics are the only available method of treatment of PCP. The most frequently prescribed antibiotic and the benchmark for efficacy is Trimethoprim-sulfamethoxazole (TMP-SMX). Used in treating and preventing PCP in both HIV patients and transplant recipients, TMP-SMX is plagued with a high rate of adverse side effects including gastrointestinal disturbances (nausea and vomiting) and allergic skin reactions (such as rash and urticaria). In addition, use of the drug results in the possibility of antibiotic resistance, especially in patients who cease treatment because of allergies or adverse effects of the treatment. Many alternative antibiotics such as Dapsone and Atovaquone are currently available due to the severity of allergic reactions that some people have to TMP-SMX.

The high risk of side effects from antibiotics and the emergence of antibiotic resistant strains of PCP are driving demand for new product development. Some major factors in comparing current treatments include cost, toxicity, efficacy, and protection from bacterial infection. As such, a successful prophylactic treatment with minimal side effects could have a large effect on the market. While the initial market size may be modest, there are virtually no competing products that claim to enhance the body's immune response to PCP or provide effective treatment without side effects. This leaves a large market opportunity for alternative treatments. After considering the current treatment options for PCP, it seems highly likely that there is an opportunity to develop and market our vaccine, MVX504.

Antibiotics have been stable treatments for many bacterial and fungal diseases. However, due to the overuse of antibiotics over the last 20 years, many drug resistant pathogens have been reported recently. There is no effective treatment against such pathogens other than to induce the body's natural immune system to fight them. Also, with the advance in medical research, there is a trend towards preventative medicine i.e. finding alternatives to short-term approaches such as antibiotics and replace these therapies with longer term biologics such as antibodies and vaccines. Vaccines are the most effective preventative care since this approach allows for long-term protection at a fraction of the cost.

Besides the current treatments for PCP, there is little to no competition in the PCP prophylaxis market. A search of www.clinicaltrials.gov for "pneumocystis" results in nine studies that are recruiting, none of which are associated with a novel treatment for PCP. In addition, a detailed search of large pharmaceutical companies (i.e. Pfizer, Sanofi, GSK, Merck) product pipelines reveals that none of these companies have a vaccine for PCP in their pipelines. A few companies have anti-fungal vaccines for Candida and Aspergillus in their pipelines and a number of clinical trials are on-going for these fungal species. The fact that no companies are active in the Pneumocystis space, but are active in other fungal species creates a very promising argument for the success of MVX504 and MiniVax.