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Primex Pharmaceuticals with the support of TheSi Farma, launch OZASED® in Italy

Zug, 16th April 2020, Swiss company Primex Pharmaceuticals is working with the contract sales company TheSi Farma to launch OZASED to the Paediatric Anaesthesia community in Italy.

OZASED® (oral midazolam) is indicated for children from 6 months to 17 years for moderate sedation before therapeutic or diagnostic procedures, and as premedication prior to anaesthesia. OZASED® comes ready to use and requires no preparation unlike the current practice of manipulating intravenous midazolam for oral administration in paediatric patients given the lack of alternative licensed oral solutions in the indication.

Alan Knox, CEO of Primex, comments: “Our collaboration with TheSi Farma allows Primex to enter the Italian market directly by managing the whole marketing and sales process through the promotion of OZASED® to the Paediatric Anaesthesia medical community. TheSi Farma also support Primex in the management of the process of distribution through an Italian wholesaler and into the Hospital pharmacies ensuring we are on the IHS national hospital platform. TheSi are a well-established company in the Italian market with significant expertise.”

For further information, please contact: www.primexpharma.com
For further information, please contact: www.thesifarma.it

OZASED® is called OZALIN® in some countries

© Primex Pharmaceuticals AG, Zug, Switzerland. All rights reserved

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OZALIN® continues to receive marketing authorization approvals across EU

Zug, 25th February 2020, Swiss company Primex Pharmaceuticals announces it has received international approval of the repeat use procedure for OZALIN® (ADV6209) involving the following 8 countries: Germany, Austria, Spain, Portugal, Ireland, Belgium, Greece and Poland.

This follows the decentralised regulatory approval and marketing authorization approval in France, UK, Italy, Netherlands, Finland, Norway and Denmark at the end of 2018 for children from 6 months to 17 years for moderate sedation before therapeutic or diagnostic procedures, and as premedication prior to anaesthesia. OZALIN is commercialized in the above countries.

Alan Knox, CEO of Primex, comments: “This is another milestone for Primex in paediatric anaesthesia. This will allow us to expand the availability of OZALIN across Europe. Initially developed by Amiens Hospital in France, very few companies are developing medicines in paediatric anaesthesia and we are happy to offer a palatable oral solution developed by clinicians for children’s needs. The sales potential is over 100 million euros in Europe alone, but more importantly, we can really make a difference here.”

For further information, please contact:

Primex Pharmaceuticals AG
Mr. Alan Knox, Group CEO
Mobile : +41 791762420
Email : alan.knox@primexpharma.com

About Primex Pharmaceuticals :

Primex Pharmaceuticals is a leading global innovative anaesthesia company, expanding in paediatric pharmaceuticals.

Primex brings a portfolio of anaesthesia products helping patients undergo a wide range of medical procedures, including a novel, oral solution for paediatric sedation now approved in several markets in the European Union.

Primex Pharmaceuticals will continue to identify and bring to the market new medications that complete the Triad of Anaesthesia.

Primex Pharmaceuticals is headquartered in Switzerland.

For further information, please visit www.primexpharma.com

© Primex Pharmaceuticals AG, Zug, Switzerland. All rights reserved

OZALIN® is called OZASED® in some countries

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Primex Pharmaceuticals and Nordic Group sign a strategic partnership to commercialise OZALIN® in France

Paris and Zug, 20th March 2019 – Nordic Group, a pharmaceutical company focusing on the development and commercialisation of hospital and orphan products, and Primex Pharmaceuticals AG, an innovative global Anaesthesia pharmaceutical company, announced a strategic agreement today to launch OZALIN® in France.

One of the challenges facing paediatric anaesthetists in treating children, either for premedication prior to surgery or during procedural sedation, is the lack of acceptable approved medications. An innovative oral solution for children older than 6 months, OZALIN®, has been approved in several markets in the EU including France, to improve the palatability and acceptability for children.

“The partnership with Nordic Group represents an important achievement for Primex Pharmaceuticals and underscores our commitment to making OZALIN® available across all EU member states,” said Alan Knox, Primex’s Group CEO. “We are confident that Nordic Group with their experience in the hospital sector, will further support their portfolio in Anaesthesia in France.”

Vincent Leonhardt, Managing Director of Nordic Pharma in France said: “Nordic Pharma is delighted to have the opportunity to commercialize OZALIN®, a product initially developed at Amiens hospital in France, and that will make a fundamental difference to children and their acceptability toward treatment.”

About Primex Pharmaceuticals:

Primex Pharmaceuticals is a leading global innovative anaesthesia company, expanding in paediatric pharmaceuticals. Primex brings a broad portfolio of anaesthesia products helping patients undergo a wide range of medical procedures, including a novel, oral solution for paediatric sedation now approved in several markets in the European Union. Primex Pharmaceuticals is headquartered in Switzerland.

www.primexpharma.com

About Nordic Group:

Nordic Group is a privately-owned pan-European pharmaceutical company with a presence in 17 countries. It focuses on the development and commercialisation of hospital and orphan products to respond to unmet medical needs. Nordic Group expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development.

https://www.nordicpharma.fr/

News

Primex Pharmaceuticals and POA Pharma sign a strategic partnership to commercialise OZALIN in the Nordic region.

Gothenburg and Zug, 21st February 2019 – POA Pharma Scandinavia AB, a market-oriented Boutique Healthcare Company, working in close contact with healthcare organizations, professionals and hospitals in Nordic countries and Primex Pharmaceuticals AG, an innovative Anaesthesia pharmaceutical company, today announced a strategic agreement to launch OZALIN® in Denmark, Finland, Norway and Sweden.

One of the challenges facing paediatric anaesthetists in treating children, either for premedication prior to surgery or during procedural sedation, is the lack of acceptable approved medications. An innovative oral solution for children older than 6 months, OZALIN®, has been approved in several markets in the EU to improve the palatability and acceptability for children.

“The agreement with POA Pharma represents an important achievement for Primex Pharmaceuticals and underscores our commitment to making OZALIN®available to Anaesthetists across all EU member states,” said Alan Knox, Primex’s Group CEO. “We are confident that POA Pharma expertise in the field of anaesthesia, coupled with their understanding of the Nordic countries, will greatly benefit children requiring premedication or procedural sedation.”

Tina Madsen Sandstrőm, CEO of POA, “POA Pharma is looking forward to launch OZALIN® to our patients and clinical customers in the Nordic markets. We are happy to once again having the opportunity to introduce new and innovative developments within the health care sector.”

About Primex Pharmaceuticals:

Primex Pharmaceuticals is a leading global innovative anaesthesia company, expanding in paediatric pharmaceuticals. Primex brings a broad portfolio of anaesthesia products helping patients undergo a wide range of medical procedures, including a novel, oral solution for paediatric sedation now approved in several markets in the European Union. Primex Pharmaceuticals is headquartered in Switzerland.
www.primexpharma.com

About POA Pharma:

POA Pharma is a market-oriented Boutique Healthcare Company present in 9 competence areas with offices in Denmark, Finland, Norway, Sweden and US. The home Market is the Nordic countries were POA represents 12 Pharmaceutical producers from 10 countries. POA Pharma contributes to better healthcare, better health and wellbeing and a higher quality of life.
www.poapharma.com

For further information, please contact:
Primex Pharmaceuticals AG
Alan Knox, CEO
Zug, Switzerland
Tel. +41 (0)79 1762420
alan.knox@primexintl.com

POA Pharma Scandinavia AB
Tina Madsen Sandstrőm
Gothenburg, Sweden
Tel. +46 (0) 31 788 05 99
tina.madsen@poaab.com

© Primex Pharmaceuticals AG, Zug, Switzerland. All rights reserved.

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Primex Pharmaceuticals AG announces it has received marketing authorization (MA) in the EU for OZALIN®

Primex Pharmaceuticals AG announces it has received marketing authorization (MA) in the EU for OZALIN® (ADV6209) for children from 6 months to 17 years for moderate sedation before therapeutic or diagnostic procedures, and as premedication prior to anaesthesia.

Primex Pharmaceuticals acquired the global rights for OZALIN from the French pharmaceutical development company Advicenne SA.

Dr. Luc-André Granier, CEO of Advicenne, comments: “As one of the very first in-house developed products, this MA validates our strategy and capabilities in developing original paediatric-adapted drugs.

Dr. Michael Brackhahn, from the Children’s Hospital in Hannover, Germany, presented results from the clinical studies and his own experience with OZALIN last week at the European Society of Paediatric Anaesthesia. “The results show the rapid sedative effect with good acceptability by paediatric patients in clinical practice.”

Alan Knox, Head of Global Marketing at Primex Pharmaceuticals, comments: “For children, there is a large unmet need for premedication prior to anaesthesia, and a huge unmet need for procedural sedation, such as in emergency and diagnostic procedures. OZALIN will reduce children’s fear and anxiety prior to surgical procedures.”

Kari Sarvanto, CEO of Primex,adds: “This is an important step for Primex in paediatric anaesthesia. The annual sales potential is between 100 million and 350 million euros, but more importantly, we can really make a difference here. This will pave our way to future new indications and products in anaesthesia and paediatrics.”

For further information, please contact:

Primex Pharmaceuticals AG
Mr Kari Sarvanto, CEO
Mobile: +41 796 162 694
Email:kari.sarvanto@primexintl.com

About Primex Pharmaceuticals

Primex Pharmaceuticals aims to become the leading global innovative anaesthesia company, and to expand in paediatric pharmaceuticals.

Primex Pharmaceuticals’ global partner network operates in over 40 countries. The company is headquartered in Switzerland and all Primex products are manufactured in Europe. Primex Pharmaceuticals has proven underlying business operations and historical strong revenue growth.

About Advicenne

Advicenne (Euronext: ADVIC) is a pharmaceutical company developing paediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases.

Advicenne is listed on the regulated market of Euronext in Paris (ISIN: FR0013296746; Euronext ticker: ADVIC). The Company, which was established in 2007, is headquartered in Nîmes, France.

www.advicenne.com

Primex-_News124

News

Primex Pharmaceuticals Appoints Tomaso Dameno as Head of Operations

Zug, Switzerland. Swiss pharmaceutical company Primex Pharmaceuticals AG announces the expansion of its leadership team with Mr. Tomaso Dameno, appointed as Head of Operations.

Mr. Dameno brings more than 15 years of experience in the pharmaceutical industry to Primex Pharmaceuticals. Most recently, he was Partner and Head of Global Pharma Compliance Operations at PQE Suisse. He has held various pharma line management roles at e.g. Zambon and Helsinn.

“I am excited to join Primex at this fast growth stage of its development and on the brink of such an important product launch on the pediatric anesthetic market. My extensive knowledge of the different aspects of the pharmaceutical business will help smooth the path to new markets,” says Tomaso Dameno.

Mr. Dameno’s key responsibilities are strategic and operative performance ensuring the development of the global supply chain, heading the regulatory, quality and pharmaceutical safety management functions, as well as contract manufacturing and logistics. He will be part of the Executive Team headed by CEO Kari Sarvanto in Zug, Switzerland.

Mr. Sarvanto comments: “I am pleased to see Primex is constantly able to attract top talent like Tomaso. The management is facing increasingly demanding challenges, not only due to the company’s fast growth, but also due to the exceptional novel anesthetic launch, as Primex aims to launch ADV6209 (OZALIN) in mere months.”

ADV6209 will be the first oral paediatric anaesthetic on the market in Europe, indicated for both premedication for anaesthesia and procedural sedation, and Primex is already preparing to launch it internationally, including the US market.

July 7, 2018
Primex-news-8

News

Primex Pharmaceuticals AG presents ADV6209* at Euroanaesthesia 2018

Approximately 60% of children experience significant behavioral stress during perioperative or procedural sedation. This leads to anxious, frightened, phobic and non-cooperative children.

Pre-medication may be administered to reduce the preoperative anxiety. However, one of the challenges facing paediatric anaesthesiologists is the lack of suitable medications, either due to their lack of acceptability, or their being unregistered and therefore used outside of their medical indication.

An innovative oral solution for children, ADV6209, has been developed to improve the management of paediatric sedation.

“ADV6209 is an oral solution and is currently under regulatory submission in the EU. We are excited to bring the next anaesthetic innovation to the market”, said Mr. Alan Knox, Head of Global Sales & Marketing at Primex Pharmaceuticals. “Anaesthesiologists have been asking for a paediatric sedative that is accepted by children and well tolerated to be used by non-anaesthesiologists. For children, there is a large unmet need for pre-anaesthesia and procedural sedation, such as in emergency and diagnostic procedures.”

Mr. Kari Sarvanto, CEO and Co-Founder of Primex, added: “Primex is proud to bring a patient-friendly oral solution to a market with such an unmet need. Primex Pharmaceuticals will continue to identify, acquire and bring to the market new medications that complete the ‘Triad of Anaesthesia’.”

http://euroanaesthesia2018.esahq.org/

Register to live stream Primex Pharmaceuticals industry sponsored symposium from here.

*ADV6209 has not yet received marketing authorization in any EU country
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Primex Pharmaceuticals at Euroanaesthesia 2017: Next Innovation in the Management of Pediatric Sedation

With a growing number of surgical and diagnostic procedures being performed globally, children are subjected to increased levels of anxiety that may occur before anaesthesia or thereafter, leading to behavioural stress and frightened, phobic and non-cooperative children with traumas.

“ADV6209 is an oral solution and is currently under regulatory submission in the EU. We are excited to bring the next anaesthetic innovation to the market”

Premedication may be administered to reduce the preoperative anxiety. However, one of the challenges facing paediatric anaesthesiologists is the lack of suitable medications, either due to their lack of acceptability, or their being unregistered and therefore used outside of their medical indication.

An innovative oral solution for children, ADV6209, has been developed to improve the management of paediatric sedation.

Dr. Michael Brackhahn from the Department of Anaesthesiology at the Children’s Hospital ‘Auf der Bult’ in Hannover, Germany, presented results from the clinical and PK studies along with his own experience of ADV6209 in procedural sedation. The results show the rapid sedative effect by paediatric patients in clinical practice as one of the main advantages of this formulation.

“ADV6209 is an oral solution and is currently under regulatory submission in the EU. We are excited to bring the next anaesthetic innovation to the market”, said Mr. Alan Knox, Head of Global Marketing at Primex Pharmaceuticals. “Anaesthesiologists have been asking for a licensed paediatric sedative that is well accepted by children, and would thereby evolve the management of procedural sedation, such as in emergency and diagnostic procedures.”

Mr. Kari Sarvanto, CEO and Co-Founder of Primex, added: “Primex is proud to bring a patient-friendly oral solution to a market with such an unmet need. We are committed to making Primex Pharmaceuticals the leading global anaesthesia pharmaceutical company, and we aim to expand further into paediatrics and into orphan pharmaceuticals.”