DGAP-News: CytoTools AG / Key word(s): Market launch
CytoTools partner Centaur Pharmaceuticals starts marketing the active substance DPOCL in India
Darmstadt, 3 September 2020 - CytoTools AG (ISIN DE000A0KFRJ1), a biotechnology holding company specializing in pharmaceutical and medical products, today received notification from its license partner Centaur Pharmaceuticals Pvt Ltd (Mumbai, India) of the start of marketing of its wound healing active substance DPOCL which is currently still in the approval process in Europe under the name DermaPro(R). Following the successful approval of the active ingredient by the India Central Drugs Standard Control Organization (CDSCO) and the GMP certification of the production in October 2019, the marketing of the drug will now start in the Indian market under the brand name WOXheal(R).
"The start of marketing of WOXheal(R), which was originally planned for the second quarter of 2020, has had to be postponed several times by Centaur due to the pandemic-related lock-down in large regions of India and the associated travel restrictions", explained Dr. Dirk Kaiser, Director of Research & Development at CytoTools AG. "In the end, preliminary talks with leading medical experts in the country have shown that the demand for a superior active substance for the treatment of the indication "diabetic foot" is so high in India, too, that the chances of a successful market entry are regarded as very good even in this difficult market environment". With more than 3.8 million confirmed cases, India is one of the countries most affected by COVID-19 worldwide, which is why extensive national travel and contact restrictions have been in place for several months.
The market launch of WOXheal(R) will therefore start primarily through video and telephone conferences with selected key opinion leaders in the field of diabetes. The conferences are held in cooperation with leading hospitals in the country. Depending on the extent of the applicable travel restrictions, opinion leaders will also be addressed personally via pharmaceutical representatives of the licensing partner. At market launch, Woxheal(R) will be distributed directly through the partner clinics' affiliated pharmacies. The connection of further clinics and pharmacies is currently being established and will be implemented consistently. Starting in mid-September, patient information on the effects and the use of the drug will also be made available online via the domain www.woxheal.com. Media marketing is also carried out via radio and advertising campaigns.
In India, the number of patients with the indication "diabetes" amounts to about 78 million people. In addition, around 15 percent of these patients have the indication "diabetic foot". The number of new cases of "diabetic foot" registered each year amounts to around 0.1 million people. Based on the results of the clinical studies carried out in the Indian approval process, the active substance developed by CytoTools in WOXheal(R) (DPOCL) has been shown to have a complete wound closure rate of over 75 percent. This means that WOXheal(R) has a success rate within a treatment period of three to eight weeks of well over 100 percent higher compared to the alternative treatment methods previously available on the market. "We have been able to prove in clinical studies that the active ingredient DPOCL leads to a significant improvement in the overall situation in almost all patients and to a much faster recovery," explains Shivanand D. Sawant, Managing Director of Centaur Pharmeceuticals. "We - and this applies especially also to the physicians involved in the studies - therefore attach great medical importance to this product and will consistently push ahead with marketing despite all the adversities caused by the pandemic. With our specially trained sales team, we have the ideal technical and organizational conditions to help the product achieve rapid market penetration."
WOXheal(R) is sold in India in packaging sizes that cover the daily requirements of a patient with average symptoms for about one week. Based on the clinical studies, full recovery with average symptoms occurs after three to eight weeks. The market price of the weekly package of WOXheal(R) is currently around 20 Euros.
The license agreement between CytoTools, DermaTools and Centaur Pharmaceuticals provides for a low double-digit percentage of sales. The level of the revenue share above all reflects the high level of financial involvement from the license partner Centaur for the approval, including the execution of all clinical studies and the development of product sales. "For CytoTools the market entry of our active substance in India represents a very central milestone in our company history which we have been working towards for many years", emphasized Dr. Mark-Andre Freyberg, CEO of CytoTools AG. "By the end of 2020 we should already have a clearer picture of how well the active substance will be taken up by the market despite all the limitations of COVID-19. And above all, we will have helped numerous people to overcome their health problems and to sustainably increase their quality of life again".
Further information about CytoTools AG, its affiliated subsidiaries and the active substance pipeline of the holding company is available on the company website at www.cytotools.de.
CytoTools AG is a German biotechnology holding company which translates results from basic cell biological research on cell growth and programmed cell death into new forms of therapy for the causal treatment of disease and healing. CytoTools' versatile product pipeline includes self-developed chemical compounds and biopharmaceuticals which have the potential to offer new treatment options in dermatology, cardiology, urology and oncology. CytoTools is structured as a technology holding and investment company and has holdings in the subsidiaries DermaTools Biotech GmbH (62 %) and CytoPharma GmbH (50 %).
About Centaur Pharmaceuticals:
Centaur Pharmaceuticals Pvt. Ltd. was founded in Mumbai, India, in 1978 and has since developed into a vertically integrated pharmaceutical company. The company has a matrix of capabilities across the entire pharmaceutical value chain, including API, formulations, contract research and manufacturing services, clinical research, R&D, regulation and marketing. Centaur exports its products to 96 countries on five continents and employs over 2,700 people. Further information about the company is available at www.centaurpharma.com.
This release contains certain forward-looking statements. These reflect the opinion of CytoTools as of the date of this release. The results actually achieved by CytoTools may differ considerably from the statements made in the future-oriented statements. CytoTools is not obliged to update forward-looking statements.
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