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Primex Pharmaceuticals Appoints Jostein Davidsen and Angelo Colombo as Board Members

Jostein Davidsen brings over 30 years of experience from the international pharmaceutical industry, most recently serving as CEO of Acino Pharmaceuticals in Switzerland.

“I am delighted that we can attract experienced pharmaceutical professionals to our board, at a time when Primex is progressing to a new and exciting stage of strong and sustainable growth.”

Mr. Davidsen was the founder of Nycomed Russia-CIS which he built up to be one of the leading pharmaceutical companies in the region, until being sold to Takeda Pharmaceuticals in 2011. Davidsen then became Corporate Officer and Head of the Emerging Markets at Takeda in Zurich. He was named the world’s second most influential pharma-industry leader in Emerging Markets by pharma news service Scrip.

Angelo Colombo has 25 years of experience from the pharmaceutical sector. Recently, he was Managing Director at Corden Pharma Spa with extensive experience in the manufacture of pharmaceuticals, especially injectables.

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Primex’ CEO Kari Sarvanto on Pharmaboardroom

Kari Sarvanto introduces Primex, an innovative fast-growing company spearheading a new pharmaceutical business model, strongly focusing on anesthesiology. He talks about entrepreneurship, innovation and new ways of achieving success in the pharmaceutical business today.

“For big pharma, pediatric patients only become of interest at the end of the life cycle with extension to patent times: we see them as a core customer, innovating and developing new formulations and packs specifically for children.”

Primex calls itself ‘an innovative and fast-growing company spearheading a new pharmaceutical business model’. What exactly does that mean?

As a young company, we were able to create a strategy that does not have to carry any past legacy, but rather focus on quickly changing the pharmaceutical landscape based on interaction with the clinicians. Big pharmaceutical companies are very dominant, but are often disconnected from the market. We recognized this, and focused on understanding market realities through our interaction with people. We are close to our customers, that is for example our partners, hospitals and patients. The first thing we do is go to clients in a new market and simply ask them what they lack. Our focus is on anesthesia and other demanding products. We have just submitted the first pediatric anesthetic to the EU and Swiss authorities for marketing authority. For big pharma, pediatric patients only become of interest at the end of the life cycle with extension to patent times: we see them as a core customer, innovating and developing new formulations and packs specifically for children.

Why did you decide to focus your business on this area in particular?

In 2011 we acquired Recofol from Bayer.

It was the first propofol after the originator, and the first advanced lipids version, thus leading us to become involved in the anesthesia market. Since the first propofol arrived decades ago, there have not been many new products in anesthetics, but today we are bringing a new pediatric anesthetic to the market; a product that, once registered, will become the first sedative for children in Europe. As a pediatric product, it has been developed and studied for children, and we have already gained experience with some 10 000 pediatric patients during the last years of clinical use in the University Hospital of Amiens in France.

Could you give us an overview of your current product portfolio? Over the last few years Primex has demonstrated extremely strong revenue growth. What products account for such growth?

Recofol has been our key revenue driver, together with our intravenous acute heart failure therapy, Dobuject. Everything in this business takes time, but in anesthesia we have an exciting upcoming pipeline of products. To define our portfolio strategy, we use the metaphor of the triad of anesthesia: which is associated with hypnosis, or sedation, or being unconscious; but there are also the two other corners that the anesthesiologist needs daily: the analgesics, or pain management, and the third corner of muscle relaxants and their reversants. All these need to be considered when working in anesthesia.

When we go to new markets, in particular undeveloped ones, we recognize that the greatest products, together with a sales force, will not do the job alone.

Therefore, we focus on unlocking markets through interaction with policy makers and hospital buyers, and delivering European quality to the standards appreciated by the local authorities. For example, in Indonesia, we work with a major local player –

it is our strategy to be local. On the other hand, there are the subsidiaries of big multinationals run by foreigners and, as a result, there is often a lack of dialogue with the local stakeholders. In the past, we needed to knock on doors around the world and introduce Primex, but now it is easier, as we are receiving brand name recognition through our products and global marketing efforts.

Click here to read the full article.

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Primex Pharmaceuticals Acquired Italian Leader OGNA, Expands to Dental Surgery and Anaesthetics

Zug, Switzerland, November 22, 2016 – Swiss pharmaceutical company Primex Pharmaceuticals AG announces acquisition of OGNA. The acquisition expands the company’s product portfolio to the full dental surgery range, from local anaesthetics to dental products.

OGNA manufactures and commercializes solutions for dental surgery needs, e.g. local anaesthetics, root canal irrigation and cementation, detergents and disinfectants. Constant search for innovative solutions within the dental market and the determination to guarantee excellence to customers has led OGNA to become a leader in Italy, and it is the first and sole full range dental products manufacturer in the country. Italy is the world’s third largest producer of dental supplies.

OGNA is a 100-year-old family company founded by Giovanni Ogna in Milan. In 1960, the company obtained the desired certification from the FDA to produce generic drugs in the USA. Today, OGNA has a full range of dental products and pharmaceuticals.

Primex is integrating the former OGNA companies into the Group and reorganizing its commercial functions under the original company name “Giovanni Ogna et Figli S.r.l.”, which is now a wholly-owned subsidiary of Primex Pharmaceuticals AG.

Kari Sarvanto, CEO and Co-Founder of Primex Group, comments: “With the acquisition, Primex gets not only new anaesthesia products that can be equally applied for non-dental use, but also acquires a key distribution network. Via OGNA’s global expansion, this is especially potential for the novel procedural sedative we expect to launch soon.”

For further information, please contact:

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

About Primex Pharmaceuticals

Primex Pharmaceuticals is a fast-growing global specialty pharma company spearheading a new lean pharmaceutical business model.

Primex aims to become the leading global innovative anaesthesia company, helping patients undergo a wide range of medical procedures, and to expand in pediatrics and orphan pharmaceuticals. With a portfolio of strong, trusted anaesthesia products from propofol-based products acquired from Bayer to the recent novel oral solution for pediatric anaesthesiology and procedural sedation, Primex will continue to identify and acquire new medications that complete the ‘Triad of Anaesthesia’.

Primex Pharmaceuticals’ global partner network operates in over 40 countries and reaches a population of one billion. The company is headquartered in Zug, Switzerland; all Primex products are manufactured in the EU or Switzerland. Primex has proven underlying business operations and historically strong revenue growth.

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Primex Featured on Scrip, the Leading Pharma Management and Strategy Journal

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Primex Nears Market With Oral Pediatric Sedation Solution. Switzerland’s fast growing critical-care company has submitted for approval what it believes is the first oral solution for the mild to moderate sedation of anxious children undergoing surgical and diagnostic procedures, with a launch in Europe pencilled in for a year’s time.

Anesthesiology is often overlooked by pharma, and many believe there has been little innovation in the area since propofol was developed 30 years ago, but the fast-growing Swiss company Primex Pharmaceuticals AG wants to change that perception.

Primex has submitted a marketing authorisation in Europe for ADV6209, a new 0.2% oral solution of midazolam as a pediatric sedative, and expects the product to be launched in around a year’s time. It will market the product through its network of agents and distributors.

The indication being sought is use as premedication in anesthesia, although Primex is also aiming to seek approval for use in procedural sedation. The oral solution of the rapidly acting benzodiazepine has been formulated to mask its bitter taste, and global rights licensed from the French company Advicenne SA, that developed ADV6209 in collaboration with researchers at Amiens University Hospital, France, one of the leading pediatric hospitals in Europe.  Nearly 10,000 patients have used the drug in the hospital.

In many pre-surgery situations, and before diagnostic procedures like incredibly noisy MRI scans, there are few if any agents that can be used to reduce anxiety in children. “Children are being scared and traumatized every day, and this could lead to them avoiding hospitals when they become adults,” commented Primex’s president Kari Sarvanto, who co-founded the company in Finland eight years ago.

There are a number of sedatives available to clinicians, but mostly they have not been approved for use in children, do not have children-appropriate formulations, or have other drawbacks to their use in children, Sarvanto told Scrip in a recent interview. Propofol, for example, is widely used in young children, but its administration usually has to be monitored by an anesthetist, a time consuming and costly process when only mild sedation is required to reduce anxiety.

Primex considers the market for reducing anxiety in children via oral pediatric sedation to be worth Euro 100-350m annually. “There are no competitors in sight, and we are happy to be first to the market with the product,” Sarvanto added. The company is not using the EU’s pediatric-use marketing authorisation (PUMA) process because of that procedure’s complexities.

A review of Informa Pharma Intelligence’s Biomedtracker data base reveals there are only a handful of anesthesia-related agents in development worldwide; one of the most advanced is Cosmo Pharmaceuticals/Paion’s ultra-short acting intravenous benzodiazepine remimazolam that is in Phase III trials in the US for anesthesia during procedures.

An Open Phase II Study

At the 16th World Congress of Anesthesiologists, held in Hong Kong from Aug. 28 to Sept. 2, Hervé Dupont, head of anesthesiology at Amiens University Hospital, France, reported a Phase II open study in 37 children in which 78.4% of patients achieved satisfactory sedation within 30 minutes. There was no significant difference between response rates achieved with ADV6209 and historical studies in the literature involving other oral midazolam formulations.

Primex was established in 2008, and quickly acquired several products from Bayer, including the anesthetic Recofol (propofol) and the acute heart failure therapy Dobuject (dobutamine). After the early years the company has been profitable, Sarvanto said. Investors in the company include two private investment funds as well as family and friends, and it has an aggressive growth strategy. “We want to be the leader in anesthesia, and we are keen to acquire new products,” Sarvanto said.

The company has also brought in several new executives. Ernesto Alegria joined last month as chief financial officer, having been CFO of the Acino Group and before that worked at Takeda Pharmaceutical International GmbH and Nycomed. Alan Knox became head of marketing in June, 2016, having previously been vice-president of global marketing at MSD International AG.

Source: https://scrip.pharmaintelligence.informa.com/SC097256/Primex-Nears-Market-With-Oral-Pediatric-Sedation-Solution
September 8, 2016

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Primex Announces Phase II Results of ADV6209 at the 16th World Congress of Anaesthesiologists

Hong Kong: Approximately 60% of children experience significant behavioural stress during perioperative or procedural sedation, making them anxious, frightened, phobic and non-cooperative. The ultimate goal is a safe and effective procedural sedation service. ADV6209 is an oral solution, and it will be the first paediatric sedative registered in Europe, expected to be on the market next year.

Professor Hervé Dupont, Head of the Anaesthesiology and Critical Care Medicine Department at Amiens University Hospital, presented the clinical results from the phase II study and his own experiences of ADV6209 in paediatric sedation. The results show the rapid sedative effect with excellent acceptability by paediatric patients in clinical practice as one of the main advantages of the novel formulation.

ADV6209 is an oral solution, and it will be the first paediatric sedative registered in Europe, expected to be on the market next year.

“We are excited to bring the next anaesthetic innovation to the market,” Mr. Alan Knox, Head of Global Marketing at Primex comments. “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 a huge unmet need for procedural sedation, e.g. in emergency and diagnostic procedures.”

Kari Sarvanto, President and Co-Founder of Primex Group, added: “Bringing this new solution to the market will be a major step towards making Primex Pharmaceuticals the leading global anaesthesia pharmaceutical company.”

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New acquisition brings an innovative oral solution for pediatric anesthesiology to the market

Zug and Nimes: Swiss pharmaceutical company Primex Pharmaceuticals AG and French pharmaceutical laboratory Advicenne SA announced today a deal where Primex will acquire global rights for an advanced oral pharmaceutical candidate for pediatric anesthesiology developed by Advicenne. The market potential is evaluated as hundreds of millions of euros.

This oral solution is dedicated to pediatric anesthesiology. Nearly 10,000 patients have already been successfully treated by the university hospital at Amiens, which collaborated with Advicenne.

With this acquisition, Primex Pharmaceuticals expands its anesthesiology portfolio with a unique product that will be distributed through Primex’s existing channels and new partners, which will be appointed in all other markets.

“This is a breakthrough in the area of pediatric anesthesia, and along with further applications, the annual market potential is between 100M€ and 350M€”, says Kari Sarvanto, President of Primex Pharmaceuticals. “We’re extremely enthusiastic about the cooperation with Advicenne and looking forward to bringing such a patient-friendly novel product to the market.”

“As one of the very first in-house developed products, this deal validates our strategy and capabilities in developing original pediatric-adapted drugs”, says Dr Luc-André Granier, CEO of Advicenne. “Primex Pharmaceuticals is probably the best partner for the commercial success of the product as its network is global and its commitment for anesthesiology is very strong.”

For further information, please contact:
Primex Pharmaceuticals
Mr Kari Sarvanto, President
Mobile: +41 796 162 694
Email: kari.sarvanto@primexintl.com

Advicenne
ComCorp, Ms Adélaïde Manester
Mobile:  +33 1 58 18 32 44, +33 6 70 45 74 37
Email: amanester@comcorp.fr

ComCorp, Ms Anne Hardy
Mobile: +33 1 58 18 32 51, +33 6 13 56 23 96
Email: ahardy@comcorp.fr

About Advicenne, www.advicenne.com

Advicenne, a fast-growing specialty pharma, focuses on innovative pediatric medications, targeting orphan or neglected diseases within the fields of neurology and nephrology and aims to become a world leader in those therapeutic areas.

The company has today a strong portfolio of products in late-stage development targeting critical unmet needs in nephrology and epilepsy, and has started its commercial activities late 2015 with its first product on the French market.