ROTOP Pharmaka Invests Nine Million Euros in New Production Facility for Drug Manufacturing

Dresden-Rossendorf, June 29, 2020 – A reason to celebrate at ROTOP Pharmaka GmbH: The company’s largest investment in its history is nearing completion. “Over the past four years, we have invested more than nine million euros in building a new production facility for GMP manufacturing of Iodine-123 ready-to-use patient doses for targeted nuclear medicine diagnostics of Parkinson’s syndromes. In parallel, we have developed the corresponding radiopharmaceutical generically in close cooperation with the Helmholtz-Zentrum Dresden-Rossendorf (HZDR),” reports Jens Junker, Managing Director of ROTOP Pharmaka GmbH.

Financing Supported by Saxon Investment Company MBG

Last week, the company received official confirmation from the German Federal Institute for Drugs and Medical Devices (BfArM) of the successful completion of the approval process. This means the Iodine-123 radiopharmaceutical can soon be delivered to nuclear medicine specialists once routine production ramps up and the final approval formalities are completed. To finance this investment, ROTOP established ROTOP Radiopharmacy GmbH together with the Mittelständische Beteiligungsgesellschaft Sachsen (MBG). “We are delighted to be part of such a challenging project. The initiators, the on-site team, and the excellent location conditions in Rossendorf have made this project possible in and for Saxony. It requires equity and strong support—that is in our ‘DNA.’ From the start, it was clear that we wanted to be involved,” says Markus H. Michalow, Managing Director of Bürgschaftsbank Sachsen GmbH.

Saxony’s Minister for Regional Development, Thomas Schmidt, also sees the Saxon pharmaceutical company on a promising path: “I have followed the developments and successes of the Rossendorf institutions and companies for a long time. Dresden-Rossendorf is one of the Free State’s most important showcases, which many people in the region may not realize. The new production facility of ROTOP Radiopharmacy GmbH will help maintain the nationally and internationally recognized expertise developed here over many years, particularly in the use of radioactivity and radiation applications, and strengthen Saxony as a center for medicine and science. Investments in such innovative technology companies are money well spent!”

From Start-Up to Internationally Established Company in 20 Years

Since its founding in 2000, ROTOP Pharmaka GmbH has developed very successfully. The company produces a wide range of radiopharmaceuticals under GMP and FDA conditions in Dresden-Rossendorf to ensure the basic supply for nuclear medicine. ROTOP is currently the only manufacturer in Germany of Technetium-99m kits for classical SPECT diagnostics, playing a key role in guaranteeing supply security for doctors and patients. The product portfolio has been continuously expanded, and a worldwide distribution network has been established. Today, ROTOP is also internationally recognized: its radiopharmaceuticals are used in 30 countries as diagnostic agents in nuclear medicine. Over 100 employees now work at the Dresden-Rossendorf site, and annual revenue has grown to €18 million.

“At our company size, every investment is carefully considered, focusing not only on a reasonable return on investment but also on strategic potential for long-term growth,” says Jens Junker. Since its founding, ROTOP has consistently invested in expanding production capacities for radiopharmaceuticals and in research and development.

Benefits for Medical Practice and Patients

“From a clinical perspective, it is remarkable that ROTOP invests in GMP-compliant production of radiopharmaceuticals. Other companies are only interested in distributing externally produced drugs. While many diseases can be examined using Tc-99m kits, there are numerous biomolecules that cannot be easily labeled with Tc-99m but can be with iodine. Labeling in outpatient practice, however, is not feasible with iodide. Therefore, the new production expands diagnostic possibilities in medical practice. Thanks to the sufficiently long half-life, distribution beyond Saxony is also possible. Early diagnosis of Parkinson’s disease is crucial for initiating treatment and relieving symptoms because functional changes precede clinical complaints and structural changes. Nuclear medicine enables pathognomonic and early detection,” says Prof. Dr. Jörg Kotzerke, Director of the Clinic for Nuclear Medicine at the University Hospital Carl Gustav Carus Dresden (UKD).

Future Expansion and Strategic Partnerships

ROTOP continues to expand its product portfolio, with the Helmholtz-Zentrum Dresden-Rossendorf (HZDR) remaining an important partner. “Our collaboration goes back to ROTOP’s founding days,” says Prof. Sebastian M. Schmidt, Scientific Director of HZDR. “We have become a well-coordinated team in the development of drugs for cancer and Parkinson’s diagnostics. The recently approved radiopharmaceutical Ioflupan is a prime example. Our combined expertise—fundamental research on our side and ROTOP’s development of potential drugs to market readiness—allows us to achieve goals together that we could not accomplish alone.”

On the occasion of the official inauguration of ROTOP Radiopharmacy today, ROTOP thanks all partners from research, medicine, business, politics, and administration for their extensive support. “The new production facility of ROTOP Radiopharmacy GmbH is a major step in our investment program since we took over ROTOP in 2014. About €17 million have been invested so far, with additional projects totaling €9 million underway. This latest investment strategically opens up a promising new business field on our path toward personalized medicine,” says Dr. Wilhelm Zörgiebel, shareholder of ROTOP and Molecular Diagnostics Group (MDG).

A Message for the Industry

“The development and investment in drug manufacturing in Germany is worthwhile, even for smaller companies. We make an important contribution to the security of supply with ‘Made in Germany’ pharmaceuticals,” emphasizes Jens Junker.

Image Video of ROTOP Radiopharmacy:  Link