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Finasteride + Doxazosin

Benefits at a glance

  • Combination of  drugs from the two substance classes with the highest recommendation grade in urology guideline
  • Increased patient compliance
  • EU production site

Product details

Indication

BPH (Benign Prostatic Hyperplasia)

Strengths

5 mg + 4 mg

Dosage form

Film-coated tablet

API

Finasteride
Doxazosin

Regulatory approach

Substitution (of mono substances)

Dossier available

Q3/2022

Turnover

239 Mio. € (IQVIA 2020 – EU sum of monos in 5 mg / 4 mg)

Development by

Midas Pharma

Status

  • Development Kick-off
  • Formulation Development
  • Prototype
  • Pilot BE
  • Scale Up
  • Pivotal BE
  • 6 M Stability
  • Dossier
  • EU-Approval

Summary

With our new fixed dose combination, we have combined two well established molecules and widely used substances for the treatment of BPH (5α-reductase inhibitor + alpha blocker). The treatment guidelines recommend the combination of Finasteride and Doxazosin and with the results of the MTOPS study providing good clinical evidence for the combination, this new fixed dose combination will be an innovative and patient friendly new treatment option, with the possibility to unlock a large market potential.

Thereby we reduce the number of individual tablets the patient has to be prescribed, while providing the required medication, leading to a long-term improvement in patient satisfaction through improved quality of life.

Your Contact

Heike Sagi

Heike Sagi

Business Development & Licensing
Senior Director

Midas Pharma GmbH
Rheinstraße 49
55218 Ingelheim
Germany
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    The exploitation, including the development, sale and offer for sale of products and related processes is performed by Midas only in those territories where permissible by applicable patent law in particular, but not limited to EC Directive 2001/83 EC, Article 10, as amended by EC Directive 2004/27 EC. This document, therefore, does not and shall not constitute an offer for sale for the product in territories where an offer for sale or sale is not permissible by law. Midas expressly disclaims any liability for the information provided in this document as well as for damages resulting from or arising out of the use of the product and related process for purposes other than research and development in compliance with applicable laws.

     

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