“We need a level playing field for pharmaceuticals in Europe!”
Interview with Irina Fedortsova, Finance and Administration Director of Gemini PharmChem Mannheim GmbH
Gemini PharmChem Mannheim GmbH, a company that originated in Ukraine prior to its relocation to the Southwest of Germany as a consequence of the ongoing war, produces highly potent active pharmaceutical ingredients which are used in drugs to treat cancer patients. While it continues to invest in the development of new synthesis routes of highly effective APIs, it is also currently seeking new partners who wish to take advantage of its currently underutilized production capabilities. Finance and Administration Director Irina Fedortsova spoke to European Business about the opportunities and challenges the future will hold for Gemini.
European Business: Almost 20 years after it first began operations in Ukraine, your company is looking back at an eventful corporate history – including its move to Southwestern Germany.
Irina Fedortsova: Originally, our production facilities were located in Eastern Ukraine which was invaded by Russian forces in 2014. Our former plant there now lies in ruins. The untenable security situation decided us to move elsewhere. Luckily, Synbias Pharma AG, the owner of 100% of our shares who also covers the business development and sales sides of our organization, found and acquired the production site of a former chemical company in Mannheim, Germany, which had gone into bankruptcy. The facilities there proved ideal for the production of our active pharmaceutical ingredients, as many measures for groundwater protection and pollution reduction were already in place.
European Business: What are some of the main products of Gemini PharmChem?
Irina Fedortsova: We produce highly potent active pharmaceutical ingredients which we supply to companies that use them to manufacture the final dosage forms of medicines administered to patients. In 2019, we started production of Doxorubicin hydrochloride, an anthracycline antibiotic which is now listed as an essential medicine by the World Health Organization. One year later, we began to produce another anthracycline antibiotic, Epirubicin hydrochloride. Both are used in a variety of cancer treatments, including soft-tissue sarcomas, childhood solid tumors, aggressive lymphomas and breast cancer. Since then, we have expanded our anthracycline antibiotics portfolio to include three more active pharmaceutical ingredients: Idarubicin hydrochloride which is used for treating multiple myeloma, non-Hodgkin’s lymphoma and breast cancer as well as Valrubicin for bladder cancer treatment and Pirarubicin which is used to treat a wide variety of tumors. Since 2021, we have also been producing Nelarabine, a nucleoside for treating T-cell lymphoblastic leukemia and lymphoma. All of these active pharmaceutical ingredients have since been granted GMP approval by the European Medicines Agency.
European Business: Where do you see the greatest potential for future growth?
Irina Fedortsova: Our dedicated research and development team is currently working on developing the synthesis routes for new molecules which may hold great promise for highly effective new cancer treatments. The development and approval processes in our industry are exceptionally long, however, and often take 4 or 5 years, which is a major obstacle for an innovative mid-sized company like Gemini. This is why we are currently also exploring additional business opportunities: On the basis of our proven track record of reliably producing highly complex active pharmaceutical ingredients at the highest quality standards in the world, we are currently seeking collaboration with other pharmaceutical companies, as our production capacities are currently underutilized and we could easily more than double our production output.
European Business: What was the greatest challenge you faced in recent years?
Irina Fedortsova: The Covid-19 pandemic was disastrous for our company, as not only the entire pharmaceuticals industry, but also virtually all regulatory bodies focused their complete attention on finding cures and vaccines for the disease that essentially shut down the world – and rightly so. For Gemini, however, this meant even longer delays in the market entry processes of our products, which in turn led to cash-flow gaps for our parent company Synbias. Luckily, FPP Asset Management, a venture capital firm with a clear focus on acquiring distressed assets with significant opportunities for future growth, saw the potential of our company and decided to invest.
European Business: What do you think are some of the drivers and obstacles for the future success of Gemini?
Irina Fedortsova: The standards we observe at our facilities in Germany are the highest in the world, and Gemini is proud of never having failed a single audit in the process after final receiving of GMP approval. However, this also means that we are being incessantly undercut by competitors from China and India who have far lower production costs and produce at much lower environmental and safety standards. We are not arguing for trade barriers or excessive subsidies. What we are asking for is a level playing field, so that innovative European pharmaceutical companies can thrive again and continue to produce and develop the cutting-edge medicines patients need.