"The main aim of the company is to focus on specific product areas and especially products that are difficult to make. It was said that it was impossible to develop an inhaler drug delivery system and Arven decided to take on the challenge."
Can you give an overview of Arven Pharmaceuticals and the reasons behind the establishment of the company?
Arven is part of the Toksoz Group and was established in 2007 with a focus on developing inhalation and biotechnology products. Considering the rapidly changing dynamics of the global regulatory environment, in 2012, the Toksoz Group decided to start up Sanovel – the branded generic of the group - and Arven – a company dedicated to the development and manufacturing of inhalation products and biologics. Today, Arven strives to develop quality products for the global market and we are the first Turkish company developing biosimilars for global markets, including USA and EU.
Arven Pharmaceuticals, a 100% Turkish capitalized pharmaceutical company, succeeded in developing the first Turkish patented dry powder inhaler (DPI) “Sanohaler” as a result of long lasting R&D activities, which is a significant milestone in the Turkish pharmaceutical industry.
Moreover, as a result of investments in biotechnology, Arven Pharmaceuticals succeeded in creating Turkey’s “from cell to finished biosmiliar product”.
Can you elaborate on Arven’s core capabilities and product portfolio?
Our core capabilities include production of therapeutic proteins, determination of quality of therapeutic proteins, head-to-head comparison with reference products, analytical similarity studies, bioassay studies, and receptor binding studies. One of our main products we offer to the market is a DPI device. The DPI was not created as a generic product, but rather a new and more effective drug delivery system (DDS). In addition to DPI products, we continue to invest in the necessary equipment for the R&D of different types of inhalation products.
What is usually the process and timeframe from developing a product to taking the product to market?
The idea of developing a DPI device came back in 2006 and the Sanohaler product was launched in 2013. It took us seven years to go to the market from scratch and we are planning to launch the Sanohaler in the United States in 2023.
Why is Arven focussed on the development of inhalers and biosimilars?
The main aim of the company is to focus on specific product areas and especially products that are difficult to make. It was said that it was impossible to develop an inhaler drug delivery system and Arven decided to take on the challenge. The entire world is changing to biotechnologies. New products today are biologicals and the active ingredient is not through chemical syntheses, but the products extracted from a biological source. Biological products act more like antibodies. Realising that biologicals are the future of the industry, but without the capital to invest in developing new drugs we decided to focus on the biosimilar space.
How does Arven find the balance between being sustainable in the market and having the room to innovate?
From a regulatory perspective, Turkey is possibly one of the toughest markets as the country does not have its own regulation system, but adheres to regulations from the FDA, Europe and other countries in the world. The government does support manufacturing in Turkey, but this does not mean that we have any advantage of getting to market. Arven follows the highest quality standards and regulations to make sure that we take the best products to market. The products we currently have in our portfolio are compatible with global standards. We are not only focused on the Turkish market, but can export our products around the globe.
What is Arven’s vision and objectives moving forward?
Obtaining the investment needed to take our company global will take a significant amount of time in the Turkish market and thus we have made the strategic decision to become a CDMO. We have the knowledge, capacity and facilities to continue our activities as a company that produces biotechnology drugs as well as respiratory products for the international markets.