Although the Turkish pharmaceutical market has grown significantly in recent years R&D investment remains comparatively low. However, the expertise and capabilities exist for growth in this sector. Turkish companies and international affiliates are also beginning to innovate, especially in combination products for which there is high demand.
Multinational R&D investment in Turkey, particularly investment in clinical trials, has been quite limited relative to the size of the Turkish pharmaceutical market. Turkish R&D spending totaled TRY 14.8 billion (USD 7.77 billion) in 2013, just 0.95 percent of GDP according to TurkStat; President Erdogan’s ‘Vision 2023’ includes the target to increase this ratio to three percent of GDP by 2023. R&D spending on all healthcare related topics has grown at a CAGR of 8.3 percent per year since 2009, reaching TRY 2.217 billion (USD 1.16 billion) in 2013, with pharmaceutical investment on pharmaceutical clinical trials accounting for only TRY 85 million (USD 45 million).
One of the major limiting factors for pharmaceutical R&D investment in Turkey is the small number of certified clinical trial research centers capable of carrying out early phase trials; in a country of 75 million, there are only six such centers, with one of them only being opened in May 2015. As such, Turkey is not particularly competitive in R&D when compared to countries with robust, often government funded, research infrastructure, and as such the ratio of pharmaceutical R&D spending to pharmaceutical expenditures in Turkey is low relative to many other countries.
According to AIFD chairman and GSK VP and Area GM Emin Fadıllıoğlu, “our level of investment in R&D is USD one billion lower than it would be if our R&D share matched our share of [global] expenditures.” At present, the Tenth Development Plan includes targets to increase the number of clinical trial centers to 13 by 2018, and “to increase the number of clinical trials by 25 percent each year until 2023,” according to TITCK president Özkan Ünal.
Turkey plans, “to increase the number of clinical trials by 25 percent each year until 2023.”
Özkan Ünal – President, TITCK
Lundbeck Turkey general manager Şebnem Girgin indicates that the company has “been extremely satisfied with the quality of the neurology and psychiatry centers in Turkey when it comes to R&D cooperation, and we have identified a few as key centers for future global studies in this area,” demonstrating that expertise and capabilities do exist to support more investment in clinical trials.
Founded in 1997, the key player in the Turkish clinical trial industry is Omega CRO, the first Turkish CRO, and according to CEO Berk Özdemir, “the only truly full service CRO in Turkey; other local CROs have limited services and outsource work to us.” As he explains, “the Turkish clinical trial area has changed a lot since Omega CRO was founded; at the beginning we didn’t have a solid regulatory framework, then we had solid regulations but the timelines became too slow, and now we have optimal regulation with optimal timelines.”
Regarding the current clinical trial environment, Özdemir admits Turkey is “still not very competitive, it is difficult for us to substantially increase the number of global trials we can attract… [However], there are some very good projects underway in line with the Vision 2023 goals, and the Ministry of Health recently hosted a workshop in Izmir on how to attract more clinical trials.”
Yet, one multinational has taken a strong interest in bringing high value R&D activities to Turkey, going beyond clinical trials and bringing basic drug research to Turkey. “AstraZeneca has signed a collaboration agreement with Koç University, that gave us responsibility for preclinical testing and research for a few candidate molecules, as well as access to their broader open innovation chemical library,” according to Burak Erman, head of the Drug Research Center at Koç University.
AstraZeneca Turkey’s country president Pelin Eriştiren Incesu explains that “some of the projects have progressed very well, and the Turkish scientists involved have travelled to AstraZeneca HQ in Cambridge to present their findings, and we remain confident that one or two of these projects will proceed to the clinical development phase, and maybe become the first drug of Turkish origin in the coming years.” AstraZeneca’s support of this project demonstrates that the company is “on the right track to building scientific leadership,” one of the three pillars of AstraZeneca’s current global strategy, according to Incesu.
Apart from R&D efforts in the field of biosimilars, several locals and multinationals are taking strong innovative steps. Mehmet Pisak, one of the former owners of Mustafa Nevzat, which was sold to Amgen in 2012, and now CEO of Imuneks Farma, contends “supergeneric product development makes a lot of sense for Turkish companies.
Combination products are the starting point, which are very popular in Turkey right now, and we as Imuneks Farma have three of them with marketing authorization in Turkey. Further down the road, a few of the larger Turkish players might be able to develop a molecule from scratch.” Imuneks has four patents, two approved and two pending, for “a rare disease product… another is in ophthalmology, and two others are for antiviral products. The first two were just approved in the US and EU.” Pisak continues, “These are drug repositioning projects, where we took an existing molecule and targeted a new indication with a new formulation… We’re maybe three years away from bringing at least one of these products to market.”
Larger Turkish companies like Abdi Ibrahim and Nobel are also investing in innovation, with combination products being the best example of value-added products that have reached the market; as Hasan Ulusoy, chairman of Nobel describes, “most R&D in Turkey is done in the context of generic development, while there is some product innovation in terms of combination products and improved formulations.” Abdi Ibrahim fits this description. CEO Süha Taşpolatoğlu recounts that the company’s R&D unit has “developed several generic products which are the first generic versions of the molecule worldwide, and several of the products developed by our team are sold in Europe by our [multinational] partner companies,” and is beginning to make headway in “value-added product development, specifically in combination products; we have already launched our first [combination product] on the Turkish market and have others in development.”
Nobel is working to innovate on a higher level, as Ulusoy explains. “Nobel has started some elementary research for an original product, and in this respect I believe we are the only Turkish company to have invested so much in R&D. Currently this product is in a phase I clinical trial.”
According to CEO Ersin Erfa, Centurion is also working on “the development of a new orphan drug, a new molecule to treat pulmonary sarcoidosis… This new molecule is currently in phase III of clinical development, and we hope that it will become the first molecule to be developed by a Turkish company to reach the market, which should occur within the next two years.”