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The Turkish government plans to fix the country’s tamoxifen drug shortage problem by allowing a local company to manufacture the product.
The Minister of Health, Ahmet Demircan, said recently that a local company was being licensed to produce tamoxifen citrate from January 2018. The name of the local producer has not yet been disclosed but industry sources believe it is Kocak Farma, a fast-growing pharmaceutical company with a strong production infrastructure. Kocak Farma had not responded to a request for comment from the Pink Sheet at the time of publication.
There has been a tamoxifen shortage in Turkey for months now. Since around March, it has been difficult to find generic tamoxifen, which is produced and imported by Teva, as the company has not been able to meet demand.
Teva, for its part, told the Pink Sheet it is looking for a factory in Turkey to manufacture tamoxifen locally. It said that for months now it has been working hard to provide sufficient amounts of the product for Turkish patients.
Despite Teva’s efforts, the problem remains. The company said that some patients are buying more tamoxifen than they need due to the fear of not finding the product in future. It added that black market activities around the drug are increasing as many patients are willing to pay higher prices for the product.
Turkey’s tamoxifen drug shortage problem began after low prices for the drug prompted AstraZeneca to halt the importation of its original branded product Nolvadex, which held almost 70% of the market in Turkey. After AstraZeneca halted local sales – because of the low unit price of TRY11 (around $3) – Teva became the main importer of tamoxifen.
Low drug prices in Turkey and drug shortages are a recurring problem affecting multiple therapeutic areas. The country uses the exchange rate of TRY2.34 to the Euro to calculate drug prices. In the market today, the rate is around TRY4.15, meaning that some end prices end up too low to make imports commercially viable for manufacturers. Affected companies generally do not stop providing their drugs completely in Turkey so as not to lose their license to import their product, but they reduce the amount significantly.
Tamoxifen is used to treat hormone receptor-positive breast cancer and is a first choice in Turkey for premenopausal women with the disease. The estrogen-blocking drug is also used in postmenopausal women with breast cancer who cannot be treated with aromatase inhibitors.
Pink Sheet: global policy and regulatory coverage
02 Aug 2017
Long-term or open-ended treatment with PD-1/PD-L1 inhibitors is a burden for patients and the healthcare system and does not fit the biological paradigm of cancer immunotherapies, experts say; however, challenges to studying shorter durations include fears of undertreatment and patient objections to stopping a therapy that appears to be working.
Topics Clinical trials
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The Swiss major's pharma chief tells Scrip that its gene therapy for SMA offers much more than Biogen's Spinraza for both patients and payers, noting that the company is ready with alternative payment models for the pricey treatment as soon as approvals for Zolgensma are granted.
Topics Business strategies Drug approval Drug development landscape Drug review
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