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Biopharmaceuticals Regulatory

 News Release - March 8, 2019

Positive Interim Analysis in Pivotal IsoConDa Phase III Study

STOCKHOLM, March 8, 2019 -- (Healthcare Sales & Marketing Network) -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced the results of the interim analysis for the company's pivotal phase III study aimed at getting the candidate drug IsoConDa (isoflurane) approved for inhalation sedation in intensive care in Europe. The interim analysis shows smaller variations in efficacy than anticipated and the study will therefore only need to cover a total of 300 patients instead of initially estimated 550 patients.

"This is very positive news. The interim analysis shows a low standard deviation in the primary variable, the proportion of time with adequate sedation, i.e. the effect of IsoConDa and propofol. This means that we will need to include fewer patients in the study to show the same effect than we initially anticipated. At the current rate of inclusion our estimation is that we can include the last patient in the study around the turn of the year 2019/2020, which means that we expect to submit an application for market approval in the summer of 2020 in 16 European countries in a first round of registration. If all goes well, we can have a European market approval in the second half of 2021," said Christer Ahlberg, CEO of Sedana Medical.

Sedana Medical has previously, for the German pharmaceutical agency BfArM, committed to include a minimum of 300 patients in the study in order to confirm the safety of IsoConDa. However, the company has estimated that up to 550 patients would be needed to show an equivalent effect to propofol. The interim analysis, which did not compare the groups but is a blinded analysis of the spread in the proportion of time with adequate sedation between the individuals in the study, has shown smaller variations in efficacy than initially calculated. The result is that only 300 patients will be needed to show efficacy in the primary endpoint of the study.

"The IsoConDa study is the world's largest study of inhalation sedation in intensive care. In addition to the European registration, the study will be a central part of the applications for registration in the US and other markets. The interim analysis is a milestone and we can now continue to work with the study at a rapid rate. Today, 201 patients are included in the study and we are working to add additional centers to ensure rapid progress of the study," said Peter Sackey, Medical Director of Sedana Medical.

Sedana Medical will hold a telephone conference at 10:30 am (CET) today Friday.

To participate, please dial: +46 8 566 427 03
Or join us at: https://tv.streamfabriken.com/2019-03-08-sedana-medical-press-conference

The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se.

This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, on March 8, 2019 at 8:00 a.m. (CET).

About the IsoConDa study

In 2017, Sedana Medical initiated a pivotal clinical phase III study aimed at getting IsoConDa (isoflurane) approved for inhalation sedation in intensive care in Europe. IsoConDa is Sedana Medical's trademark for the generic drug substance isoflurane which is currently only approved for use in general anesthesia. The study is now ongoing at approximately 20 centers in Germany.

The study is a noninferiority study which means that its primary purpose is to prove that IsoConDa administered with AnaConDa is not inferior to propofol in maintaining an adequate sedation level. This is determined by analyzing the proportion of time that adequate sedation depth is maintained with isoflurane compared to propofol. The study will include 300 mechanically ventilated intensive care patients in need of sedation. Patients are assigned to two equal groups, one of whom is treated intravenously with propofol and the other with IsoConDa administered with AnaConDa.

Sedana Medical's market in brief

Sedana Medical's market consists primarily of mechanically ventilated intensive care patients. The market for sedation of mechanically ventilated intensive care patients today consists of established drugs that are administered intravenously. The target group the company is focusing on are those patients who are ventilated for more than 24 hours, a target group that globally amounts to between two and four million patients per year. In total, the company consider this to be a market of SEK 10-20 billion per year, of which Europe accounts for about SEK 6 billion.

Sedana Medical AB (publ) has developed and sells the medical device AnaConDa, for the administration of volatile anaesthetics to mechanically ventilated patients. A major clinical registration study is currently ongoing to obtain market approval in Europe for inhalation sedation in intensive care units with the pharmaceutical IsoConDaŽ (isoflurane).

Sedana Medical has direct sales in the Nordic countries, Germany, France, Great Britain and Spain as well as external distributors in the rest of Europe, Canada, Australia, Japan and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.


Source: Sedana Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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