News

Canada, March 29, 2022 - NORDIC PHARMA, a SEVER Life Sciences company, announced today the submission of a New Drug Submission to Health Canada for its methotrexate auto-injector, Nordimet® for the treatment of severe disabling active rheumatoid arthritis (RA) and symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy). Methotrexate is considered a cornerstone therapy for patients with rheumatoid arthritis (RA), with well-established safety and efficacy profiles and support in international guidelines.

For over a decade, NORDIC PHARMA has successfully built its therapeutic portfolio in Rheumatology around Europe. Its continuous collaboration with patient and physician associations has enabled it to focus its efforts closely on the expectations of patients and physicians for the past 10 years. A successful submission in Canada would mark the continued commitment of the Nordic group to address unmet medical needs.

Rheumatoid arthritis (RA) is the leading cause of pain and disability in North America.⁴ Its prevalence is estimated at 0.24% of the population globally¹. At present, patients still face unpredictable outcomes for their disease, with a gradual deterioration of their quality of life^1,2.

The past decade has brought about important advances in the understanding of RA, its management, and treatment. Methotrexate (MTX) has been used for RA treatment since the ‘80s. Today, MTX is known to be the anchor drug in RA treatment. MTX is a highly effective agent both as monotherapy and in combination with glucocorticoids, other conventional synthetic DMARDs, biological DMARDs, and targeted synthetic DMARDs.³ The subcutaneous route has been recognized to be the best treatment option from the outset, in terms of risk-benefit ratio, compared with the oral route.³ Subcutaneous administration of MTX is to be considered for optimizing RA treatment.

NORDIC PHARMA is a privately-owned pharmaceutical company created in 1995 in Sweden. With its pan-European presence and operations in over 17 countries, the group’s major corporate entity focuses on the development and commercialization of niche hospitals, retail, and orphan products to respond to unmet medical needs. Nordic Pharma Americas, Asia, Pacific (AAP) is the newest affiliate of NORDIC PHARMA and the first outside of Europe. With its establishment in 2020, Nordic Pharma AAP is seeking to establish its strong presence in Canada through the commercialization of its innovative products in rheumatology as well as in gynecology, anesthesia, hematology, and oncology.⁵

1. Cross M et al. The global burden of rheumatoid arthritis: estimates from the Global Burden of Disease 2010 Study. Ann Rheum Dis. 2014;73:1316-22.; 2. Rheumatoid Arthritis. Arthritis Research UK. www.arthritisresearchuk.org; 3. Smolen JS, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 2017;0:1–18. doi:10.1136/annrheumdis-2016-210715; 4. Canadian Chronic Disease Surveillance System (CCDSS) data, August 2019; 5.www.nordicpharma.ca

Paris, January 2022 – Nordic Pharma is pleased to announce that they have entered into an agreement with SANOFI to fully acquire the rights to ALTIM® (cortivazol), a legacy product in France.

ALTIM® contains a 3.75mg/1.5ml cortivazol suspension for injection, presented in a pre-filled syringe, and is approved in France in Rheumatology indications, where a local corticosteroid treatment is required. See prescribing information: Résumé des caractéristiques du produit - ALTIM 3,75 mg/1,5 ml, suspension injectable en seringue pré-remplie - Base de données publique des médicaments (medicaments.gouv.fr)

This acquisition supports Nordic Pharma’s strategy to grow its proprietary portfolio and to become a key player in Rheumatology in France and beyond.

ALTIM® was commercialized in France since the 70’s and subsequently withdrawn from the French market by Sanofi in 2018 due to manufacturing issues. It is the intention of Nordic Pharma to re-engineer the process and the manufacturing for both the active substance and the finished product to allow the product to be re-launched onto the French market at the earliest possibility as the product is still requested by clinicians.

Jean-Michel Quinot, CEO of Nordic Pharma stated:” We are very pleased to have reached an agreement with Sanofi allowing us to re-introduce ALTIM® into the French market. Nordic Pharma is dedicated to providing Patients and Physicians with innovative medications addressing significant unmet medical needs. We are very eager to further expand our successful collaboration with Sanofi.”

Veronique Rebours-Mory, CSO of Nordic Pharma stated: “Physicians are still demanding this unique treatment option for Rheumatology patients, and despite the challenge and investment needed, we are committed to solving the manufacturing issues that led to the discontinuation of the product.”

Nordic Pharma is a privately owned, medium-size, fully integrated Pharma company with a history of internal product development and acquisitions. We have established deep roots throughout Europe, and more recently, expanded in North America and Japan, with increased partnerships worldwide.

Nordic Pharma focusses on the development and commercialization of specialty products, which include, but are not limited to, niche hospital and orphan products, to address unmet medical needs. Today, Nordic Pharma has a range of highly specialized proprietary and in-licensed products in the following therapeutic areas: Rheumatology, Women’s Health and Critical Care (Anaesthesiology, Haematology, Oncology).

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. Sanofi prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. Sanofi stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Nordic Pharma announces that on the 24th of January, the European Commission (EC) approved the new indication for Teysuno® (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity.

Nordic Pharma received a positive scientific opinion recommending approval of the use of Teysuno in metastatic colorectal cancer from EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2021.

• for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
• as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting

In metastatic colorectal cancer the typical first-line chemotherapy consists of a fluoropyrimidine used in various combinations.

Teysuno is an oral fluoropyrimidine with similar efficacy, but improved specific safety profile compared with other fluoropyrimidines.

Jean-Michel Quinot, CEO of Nordic Pharma stated: ”This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication.”

Iris van Lakerveld, Global Oncology Lead added: “Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.

Nordic Pharma licences Teysuno from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011 Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide. The approval of the European Commission is an important step in providing patients with metastatic colorectal cancer access to Teysuno. Subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

Nordic Pharma’s focus is on the development and commercialization of specialty products, which include niche hospital and orphan products, to address unmet medical needs. Today, Nordic Pharma has a range of highly specialized proprietary and in-licensed products in the following therapeutic areas: rheumatology, women’s health and critical care (anaesthesia, haematology and oncology).

Find out more on www.nordicpharma.com. Email: oncology@nordicpharma.com

Nordic Pharma has announced that on 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion Teysuno: Pending EC decision | European Medicines Agency (europa.eu)] recommending the use of Teysuno (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity. The CHMP supports including patients who developed these toxicities in the adjuvant setting in addition to metastatic patients.

Teysuno® is an oral fluoropyrimidine with similar efficacy, but improved safety profile compared with other fluoropyrimidines.

Based on this positive opinion Teysuno will be indicated in adults:

• for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
• as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting (pending European Committee decision).

In metastatic colorectal cancer the typical first-line chemotherapy contains of a fluoropyrimidine used in various combinations.

Jean-Michel Quinot, CEO of Nordic Pharma stated: ”This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication.”

Iris van Lakerveld, Global Oncology Lead added: “Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.

Nordic Pharma has licenced Teysuno® from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011 Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide.

This positive CHMP opinion is a first step in providing patients with metastatic colorectal cancer access to Teysuno. EMA’s opinion needs to be adopted by the European Commission, and subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

Nordic Pharma is a medium-sized, fully integrated international pharma company.

Nordic Pharma’s focus is on the development and commercialization of specialty products, which include niche hospital and orphan products, to address unmet medical needs. Today, Nordic Pharma has a range of highly specialized proprietary and in-licensed products in the following therapeutic areas: rheumatology, women’s health and critical care (anaesthesia, haematology and oncology).

Find out more on www.nordicpharma.com. Contact: oncology@nordicpharma.com

TEY-2022-01-002

Both of Nordic Pharma HQs, located in France and in the Netherlands, have recently moved.

Nordic Pharma HQ NL has relocated to a new office in the Schiphol area as of June 1^st, 2021. You will find our new address and phone number below:​​​​​​​

Nordic Pharma B.V. Siriusdreef 41 2132 WT Hoofddorp The Netherlands Phone number: 085 – 48 35 871

Nordic Pharma B.V., our Dutch affiliate, is also located here. 

Our second HQ in Paris, France, also relocated on March 1^st, 2021 to the following address: 

Nordic Pharma 216 Boulevard Saint Germain 75007 Paris, France Phone number: +33 (0)1 70 37 28 02

Nordic Pharma Americas, Asia, Pacific are pleased to announce that as of the 15th of April, Nordimet® PFS and Pen are officially launched in Chile via our partner Gador.