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Israel: Import of generic antiviral Kaletra approved to treat coronavirus

For the first time since the Patent Law was enacted in 1967, the Attorney General has approved the use of a generic alternative to a patented drug before the expiration of its patent.

The drug concerned, Kaletra, is an antiviral that was originally developed by AbbVie pharmaceuticals to treat the HIV virus. It was singled out by the Health Ministry as a possible treatment for the coronavirus, but its Israeli patent only expires in 2024. However, Section 104 of the Patent Law allows the government to override the provisions of the law in specific circumstances and to permit the import and sale of generic alternatives. Since Kaletra’s patent has already expired in several countries, generics can be imported from these locations, for example from India.

Regardless of patent issues, AbbVie and its official importer in Israel are not capable of meeting the current demand for the drug, which is soaring world-wide. All the same, AbbVie will still be entitled to retrospective royalties, and the company’s interests are further protected by a stipulation that the generic drugs imported will only be used to treat coronavirus, and not the HIV virus it was originally developed to treat.

Kaletra is one of a number of antiviral drugs currently being tested for efficacy against coronavirus. A trial on Kaletra recently conducted in Wuhan, China on 199 adults severely ill with coronavirus yielded disappointing results, however. “No benefit was observed,” the researchers wrote in The New England Journal of Medicine. The trial compared standard treatment (the usual treatments for pneumonia along with supportive care) with Kaletra plus standard treatment, and researchers concluded that Kaletra neither decreased the duration of the illness nor did it reduce fatalities. However, they also stressed that one failed trial was not sufficient to discount the drug’s usefulness, which they would continue to investigate.

There is as yet no proven treatment for coronavirus, although a number of antiviral drugs have shown some promise, such as remdesivir, which was originally developed to treat Ebola. Tamiflu, an antiviral developed to treat influenza, has also been used to treat coronavirus in some countries, and another drug being used with cautious optimism is hydroxychloroquine, an old antimalarial drug that lab studies indicate could prevent coronavirus from invading cells. Another drug, the immunosuppressant tocilizumab, is also being used to treat those patients suffering from intense inflammatory reactions to coronavirus, based on its use in treating rheumatoid arthritis.

Despite the lack of conclusive evidence, doctors across the world are pulling out all the stops to find new approaches to treat the rapidly advancing epidemic, while vaccine trials are already underway in several locations.

Note: Lopinavir/ritonavir (LPV/r), sold under the brand name Kaletra among others, is a fixed dose combination medication for the treatment and prevention of HIV/AIDS. It combines lopinavir with a low dose of ritonavir.

In the United States it is not available as a generic medication and costs more than US$200 for a typical month supply as of 2016.

As of 2006, lopinavir/ritonavir forms part of the preferred combination for HIV first-line therapy recommended by the US United States Department of Health and Human Services in 2006.

Lopinavir/ritonavir was approved by the US Food and Drug Administration (FDA) on 15 September 2000, and in Europe on 19 March 2001. Its patent was scheduled to expire in the US on 26 June 2016.