Life Extending Enfuvirtide Looks to Become a Successful Generic


enfuvirtideIn June of 1981 the first known cases of AIDS in the United States were reported. Currently there are over 1.7 million people in the United States infected with HIV-1, the virus which causes AIDS, and over more then 600,000 Americans have already died from this ultimately fatal disease. With 1.2 million Americans estimated to be living with AIDS in 2012 time is of the essence for researchers to continue to maintain treatments to help extend the life of these patients. Known as Fuzeon, which is marketed by Genentech/Roche, Enfuvirtide is an effectual treatment option for patients suffering from HIV/AIDS. While enfuvirtide is not a cure, it can prolong the life expectancy of patients, and ease the symptom burden. Enfuvirtide is available in a 90 milligram vial. Typical dosing involves a subcutaneous administration injected twice daily, or one milliliter. Enfuvirtide works well in conjunction with other AIDS medications, including Ritonavir, Saquinavir/Ritonavir, and Rifampin.

Belonging to a class of medications known as fusion inhibitors, enfuvirtide is unique in it’s ability to work on the outside of the cells, versus most of the other HIV drugs which work on the inside of cells. Essentially, by not allowing the outer coating, or cell membranes of the HIV virus and the human cell to fuse together, the virus is unable to enter the human cell, leading to it’s inability to reproduce itself. The most common side effects is a local injection reaction, ranging from mild swelling, some pain and discomfort and pruritis. Additional negative effects may ensue with treatment of enfuvittide, including diarrhea, nausea and fatigue. Ideal for patients with a detectable viral load and who have experienced treatment failure with previous drug regimens, enfuvirtide has been proven efficacious.

The initial patent for enfuvirtide, specifically the Synthetic peptide inhibitors of HIV transmission, expires on June 7, 2013. However, for the specific patent deemed for the treatment of HIV and other viral infections using combinatorial therapy, the patent will expire on June 7, 2015. This is exciting news for researchers, physicians and the pharmaceutical industry, as generic treatment options are sure to be an asset. With the increasing population in the U.S. as well as around the world with HIV infection, a generic option will certainly be welcome to both patients and practitioners alike.

LGM Pharma is a provider of the API enfuvirtide and enfuvirtide acetate for R&D purposes.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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