Taking Charge of Your Health

Hello, I’m Dr James Freeman from FixHepC and today I’m here in Egypt with Dr Sherine Helmy from European Egyptian Pharmaceutical Industries, Sherine I hear there’s quite a lot going on with Hep C Generics in Egypt yes luckily Egypt. Yes, luckily Egypt in two years was transformed from the highest burden worldwide with Hep C infection to be the first country to treat all waiting list patients which is more than one million patients so if we cured in the past two years a million and a half worldwide out of which 1 million from Egypt and more than 600,000 from Pharco So can you tell me how Pharco became involved in making these generic medications? It started with the meeting years ago with Raymond Schinazi, the one who worked in Pharmasset and discovered Sovaldi and he came to a trip to Egypt with some visitors and friends whom they asked that we work together in producing something new for virus C other than Sovaldi and he asked us to build an API factory because the cost of the API is so high. I remember the first quotation we got for sofosbuvir was $1 million dollars per kg now it’s coming less than $2000 with very high good quality so what we did is we checked how can we start this and we had some Italian friends whom they made the design for a pharmaceutical API factory in Alexandria and also during that time we checked whether Sovaldi is patented in Egypt or not and we found that the patent was rejected because of the dates of applications and so on, so the product was not patented yet the process and the polymorph might be still pending so we also got another consultant to produce sofosbuvir with a non-proprietary process or non-infringement process and also the new polymorph shape so we would not be infringing any of the parents and starting from then we started some sort of collaboration a Saudi company for API production, till our factory now is ready and we’re producing our sofosbuvir here, so generally speaking we found it very challenging to find the solution because if you don’t look don’t see and the prices of medicine nowadays are very unaffordable so we thought how can we go with patent laws and at the same time solve the problem of people so to “P” or not to “P” that’s the question to Patent or not a Patent. In the United Nations secretary-general high-level panel for access to medicine last March in or to March before in Johannesburg South Africa, a hundred participants each were pulling inside you have activists, you have US government representatives, WTO, WHO Everybody was looking for his side so I started it to “P” or not to “P” that the question. To Patent or not to Patent? Life gains versus trade gains and how can we go with the law and at the same time find solutions for people worldwide to get affordable medicine especially for the non-communicable diseases or long-term chronic diseases like hypertension diabetes and so on, so we thought of making a team work and that’s why we starting with drugs for neglected diseases initiative (DNDi) working together in Malaysia, Thailand, South Africa in finding a pan-genotypic solution for Hep C worldwide and we’re now conducting some clinical trials in the far-east, also we’re interacting with the Medicine Patent Pool and I think by the EASL of the 20th April this month we’re gonna announce in a press release, Pharco joining the medicines patent pool in licensing out it’s Ravidasvir produced by or innovated Presidio San Francisco to peoples so that the can get it affordably. So with generics one of the big questions that comes ip is how do I know that I’m getting the same thing? Can you tell me more about that? You know in pharmaceuticals there’s lots of research, development and many things that assures the company first that this drug is bioequivalent or according to standards and if the patients uses it he will get the good effect, second is the patient may choose that this medicine which was released while the quality control or the quality assurance department of this company has the same medicine which is sent to you so you have to make sure of the authenticity and the company has to make sure that its product is bioavailable and a quality product So can you tell me about how you actually go about that bio-equivalence testing? Yes sure, for us to apply for pre-qualification for WHO which we did a couple of years ago we have to make bio-equivalence and the product was bio-equivalent and also the center was audited by the WHO and approved so the center of bio-equivalence to make sure that the study was accepted so all this is in the process we do not have the prequalification yet but we’re waiting for the audit on the 8th of May for our finished dosage factory and the 2nd of May this year for the API factory So we are in the process, so having a pre-qualified product also would give trust to patients worldwide but we have to have it first then we can claim that we have it So do you see HCV generics following a similar course to what we saw with HIV generics where we’ve now got half the world on treatment? A year and a half ago Stefan Wiktor he was responsible for HIV HCV in WHO he said was Pharco is doing for HCV reminds me what Cipla did in 1995 for HIV so I see lots of hope for patients as we are planning in Egypt to have Egypt almost free from Hep C on 2020, Africa 2025, and the world 2030, I think before this we can do it because our ravidasvir now is being in clinical trials multicenter multi countries it’s going inshallah إن شاء الله to show good results together with other helps so I think there is lots of hope for patients because every 45 seconds we lose one person in this world 700,000 deaths a year from Hep C so every 45 seconds you lose one person which we should save we can think of some sort of a fund or something to help others for not being affordable so we will make it happen if there is a will there is a way thank you very much I

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