The pharmaceutical company Starpharma saw an 8% increase in its share, following approval of Vivagel by the FDA, a new formulation, believed to prevent transmission of HIV. // The company even signed a $20 million (US) contract with the US National Institute of Allergy and Infectious Diseases, an integral part of the National Institute of Health.
'There are currently no approved products for the prevention of HIV infection. The FDA recognizes the potential of Vivagel to address this unmet medical need. Vivagel's new drug application will now receive priority review, which has a shorter assessment time. The early review is expected to shorten FDA's approval time significantly', said John Raff, Chief executive of Starpharma.
It is further hoped that the FDA’s initiative to accelerate the approval process would contribute to the development of the company, in the opinion of Jackie Fairley, Chief operating officer, Starpharma.
It was anticipated that the approval and commercial use of the drug would take about 13 months. With this green signal from the FDA, it could be materialized in less than 6 or 7 months according to official reports.
The product is primarily targeted at women, and would help them prevent contracting sexually transmitted diseases such as genital herpes, HIV and so on. The drug, a vaginal formulation has to be topically applied prior to intercourse and would function as a chemical barrier against various infections.
'Vivagel is not a treatment for HIV. The gel is used topically prior to sexual intercourse to prevent the women from becoming infected with HIV, genital herpes and other sexually transmitted diseases', said Dr Fairley.
AIDS is increasingly becoming a global burden, with nearly 40 million people afflicted with the disease worldwide. The number of genital herpes and AIDS/HIV in Australia is estimated to be 3.4 million and 15, 000 respectively. This is of great importan
ce as individuals with genital herpes have an increased risk (5 to 7 times greater risk) of contracting the AIDS virus.
A Phase I clinical trial involving the new drug is expected to be launched soon. If the results are satisfactory, the drug would be approved for use in the US, Australia and Europe by the end of 2008.
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