News Room

Celon Pharma has positively concluded the decentralised procedure (DCP) for Salmex on Scandinavian markets

November 30, 2017

Plexus Ventures would like to share successful news from Celon Pharma. Additional details are provided in Celon’s press release (Warsaw, 30.11.2017):

• Finalisation of the DCP opens new perspectives for the Company
in terms of export to the market as big as approx. 3 million inhalers
a year.
• The procedure included: Sweden, Finland, Norway, Denmark and
Iceland.
• The Company’s business partner in the scope of obtaining
marketing authorisation and product distribution in the markets
covered by the DCP is Glenmark.
• The commercialization of the product would depend on national
approval as well as substitution and pricing approvals.


The countries covered by the Scandinavian procedure have issued positive decisions on acceptance of the submitted marketing authorisation dossier.

Bogdan Manowski, Director for Business Development, Member of the Board of Celon Pharma S.A.: This is a very important market to us. The key issues in the following months will be: acceptance of product information, reimbursement and introduction into the market. After the concluded decentralised marketing authorisation procedure, the participating countries will verify product information documents and will issue national marketing authorisation decisions. We are cooperating closely with our partner to streamline this process.

Maciej Wieczorek, PhD, CEO of Celon Pharma S.A.: Generic drugs penetrate the market in Scandinavian countries very quickly due to a number of incentives provided for in the system; they make a streamlined and patient-friendly changeability of therapy possible. The fact that Salmex received marketing authorisation in those markets confirms he high quality of the dossier we submitted.

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Celon Pharma is an integrated biopharmaceutical company which designs, develops, manufactures and distributes pharmaceutical products. The company has its own research and development laboratories, which allow it to develop its own pharmaceutical technologies by using extensive laboratory equipment resources, as well as the experience and expertise of its staff. It also has a modern manufacturing facility where dry pharmaceutical forms are manufactured. In the past the Company focused on the production of traditional generic drugs i.e. drugs which are substitutes of original drugs, containing the same active substances and characterised by the same pharmacological action as the reference drugs. Over the last few years the Company has introduced products into the market in the following therapeutic areas: oncology, central nervous system diseases, cardiology, HIV treatment, respiratory diseases. The Company has been developing the technology for manufacturing inhalation drugs and several projects of innovative drugs since 2007.

ABOUT THE COMPANY

Celon Pharma S.A. is an integrated pharmaceutical company which conducts advanced research and manufactures modern drugs. It was founded in 2002 by Maciej Wieczorek, PHD. Celon Pharma S.A. has two fully equipped laboratories dedicated to research and development of medicinal products (R&D) for both generic and innovative drugs. Two of Celon Pharma S.A.'s production plants have appropriate GMP (Good Manufacturing Practice) authorisations. The main office and the laboratories are located within 30 km from the centre of Warsaw. The company currently has approx. 250 employees. It employs 62 scientists responsible for research and development, half of whom either have a PhD or are in the process of acquiring their PhD. The company operates more than a dozen projects for the development of innovative drugs with therapeutic groups such as oncology, neuro-psychiatry, autoimmunity and metabolism, 6 of which are planned to reach the clinical development stage in the years 2017-2018.

More information can be obtained by contacting:
Ma?gorzata Siewierska
519066531
media@celonpharma.com