The audit documents’ of Ukrainian manufacturers of the drug “Alfapeg” showed that the drug did not pass clinical trials on patients who might buy it. Thus, on the basis of the documents provided by “Valartin Pharma” to the State Expert Center of MoH of Ukraine it was found that the drug has not passed clinical trials on the most common variety of hepatitis C in Ukraine – genotype 1. Now, if the company doesn’t provide within one month documents confirming that clinical trials on genotype 1 have been passed, the license will be denied.
The examination of medicines began after the call of NGOs to the Ministry of Health of Ukraine with appeal to provide documents proving that the drug, which could be bought for hepatitis C patients in Ukraine, have passed all necessary clinical trials.
“We have been asked the company for a long time to give the results of clinical trials of drugs which are going to participate in tenders to patient organizations, – says Dmytro Sherembey, Head of CF “Patients of Ukraine.” – We have rejoiced after knowing about the entry of Ukrainian substitute of pegylated interferons into the market, because it can significantly reduce the price of drugs that are very expensive. However, we suspected manipulations after having realized that there are no available data from clinical trials at any international website where companies always publish clinical trials results. As we can see, our suspicions appeared to be true, because it is not for nothing the company has concealed trials’ results from those people whose lives depend on the quality of their medicine. The company didn’t have it.”
The drug “Alfapeg” was registered in late 2012. The name of the company that registered the drug and wanted to sell it this year on public procurement to Ministry of Health is – LLC “Valartin Pharma”, which was registered the same 2012 year by the company «Valartin Holding LTD», an offshore company registered in Cyprus.
According to NGOs’ data 9% Ukrainians are infected with hepatitis today. In 2013 the first national program of the hepatitis C treatment was adopted.
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