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Do-it-yourself hep C therapy emerges in China as cutting-edge approvals lag
by EJ Lane | Jun 30, 2016 10:41pm
At least one of China's estimated 30 million hepatitis C infected patients found a way to make a bootleg cocktail of hepatitis C therapies by patching together ingredients via online shopping, bypassing a frustrating wait for the country's approval of drugs that can cure the disease.
Bloomberg reported on the case of Steven Wang who searched online for the active pharmaceutical ingredient (API) daclatasvir, Bristol-Myers Squibb's ($BMY) Davlinza,and having found a supply bought empty pill capsules the same way and made up a pill regimen combined with generic versions of Gilead's ($GILD) Sovaldi (sofosbuvir) made in India.
Wang told Bloomberg the cocktail worked and that at the end of three months he was cured.
The anecdote fills in a broader picture of patients from China heading to Hong Kong to buy hepatitis C therapies. These are coming via drug stores that sell supplies without prescriptions to medical tourists as the China FDA weighs a pending application from Gilead with at least three companies--Ascletis, Bristol and Johnson & Johnson ($JNJ)--in the late stage of clinical work, or on the approval pathway.
At the same time, China has held talks with Gilead on pricing terms for hepatitis C therapies as it stands apart, along with Russia, from a developing country licensing deal by the U.S. biopharma with nearly a dozen firms, mainly in India, to manufacture and/or market C treatments at sharply lower prices in around 100 developing countries.
Bloomberg reported that talks on pricing have seen China seeking a guarantee that therapies sold in China would use a reference point not higher than that seen in 6 surrounding markets including India.
China's National Health and Family Planning Commission (NHFPC) has successfully negotiated price-for-volume deals earlier this year on oncology and hepatitis B patented therapies that likely serves as a model for any agreement on hepatitis C.
But it remains unclear when a cutting-edge hepatitis C therapy may be approved in China, with Gilead and Bristol not commenting on a timeline to Bloomberg.
In the case of Wang, Bloomberg said the cost for his homemade cocktail reached RMB8,000 ($1,204) for the API and another RMB15,000 for the generic Sovaldi--still well below the $84,000 cost for a treatment regimen in the U.S.
- here's the Bloomberg story
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发表于 2016-7-6 15:48