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Amring Pharmaceuticals Inc. Announces Name Change to Nordic Pharma, Inc. Under New Nordic Group, B.V. Ownership
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Amring Pharmaceuticals Inc. (“Amring”) announces its name change to Nordic…

Company news

Amring Pharmaceuticals Inc. (“Amring”) announces its name change to Nordic Pharma, Inc. on March 4, 2024, following the change in ownership of the company from SEVER Life Sciences, B.V. to Nordic Group, B.V., a subsidiary of SEVER Life Sciences B.V., which occurred on June 1, 2023.

The change in the corporate name provides for better alignment strategically with the parent company headquartered in the Netherlands and its subsidiaries worldwide. Together, the companies look to expand the global footprint in Eye Care, Rheumatology, Woman’s Health, and Critical Care for branded products as well as strengthening their generic product business in the U.S.

As part of this growth strategy, Nordic Pharma recently acquired Visant Medical, Inc., a leader in medical technology innovation in Dry Eye Disease (DED). The acquisition included the FDA cleared hyaluronic acid derivative LACRIFILL® canalicular gel, which is intended to temporarily block tear drainage by the occlusion of the canalicular system. Nordic Pharma will be launching LACRIFILL in the U.S. in Q2 2024 followed by a global rollout.

Charlotte Phelps, CEO of Nordic Pharma said, “The strategic acquisition and merger of the US business unit is a cornerstone of Nordic Pharma's global expansion. With a range of ophthalmology products currently in phase II development, combining this with our existing assets and leveraging the expertise of our US leadership in ophthalmics is imperative for driving the success of these programs.”

“I'm excited to be leading Nordic Pharma U.S. at this dynamic stage of the company as we continue focusing on providing quality generics to our customers and their patients in the U.S. while building out an innovative proprietary ophthalmic business,” said Philip Gioia, President of Nordic Pharma U.S. “The timing could not be better as new ophthalmic innovations are becoming near-term ready for commercialization and I believe Nordic Pharma can capitalize and compete effectively as a newer specialty ophthalmic player in the U.S. and globally.”

NORDIC GROUP B.V. THROUGH ITS SUBSIDIARY AMRING PHARMACEUTICALS INC., ANNOUNCES JAI G. PAREKH, MD, MBA AS CHIEF COMMERCIAL OFFICER, EYE CARE U.S.
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BERWYN, PA — Amring Pharmaceuticals Inc. (Amring), a subsidiary of…

Company news
BERWYN, PA -- Amring Pharmaceuticals Inc. (Amring), a subsidiary of Nordic Group B.V. (Nordic Pharma), announces Jai G. Parekh, MD, MBA as Chief Commercial Officer, Eye Care U.S.

Nordic Pharma recently expanded its pharmaceutical expertise in the U.S. by acquiring
Visant Medical, Inc. (Visant), a leader in medical technology innovation in Dry Eye Disease (DED). This included the FDA-cleared hyaluronic acid derivative LACRIFILL®, a canalicular occlusive device, which is intended to temporarily block tear drainage by the occlusion of the canalicular system.

“With this exciting acquisition and our global plans for LACRIFILL, Dr. Parekh’s 25 years of eye care experience, strategic leadership, and deep understanding of eye care and the industry, make him the perfect choice to guide our commercial entry into the U.S. market,” said
Charlotte Phelps, CEO, Nordic Pharma. “As a practicing ophthalmologist, Dr. Parekh’s patient-driven focuswill also be invaluable for making a sustainable impact on the health of people with dry eye disease.”

Philip Gioia, President of the U.S. team that will launch LACRIFILL under the Nordic Pharma
brand said “I look forward to partnering with Jai in his new role. I’ve had the great opportunity to work with him while at other leading global Ophthalmology companies. He brings a world class, innovative, fresh perspective to eye care and his background, experience anarmamentariad reputation in our industry is second to none. In addition, having Andy Corley of Yelroc Consulting as a commercial advisor to Nordic Pharma following the Visant Medical acquisition, clearly sets us up for excellence as we prepare to launch LACRIFLL later this year.”

“I am honored to be a part of Nordic Pharma, a company known for its commitment to innovation and improving patient outcomes,” said Dr. Parekh. “I look forward to contributing to the growth and success of the organization by helping lead impactful commercial strategies. There are many ways to take care of dry eye patients and with this huge market opportunity, we believe LACRIFILL will be a significant part of the armamentaria.”
 
In addition to Dr. Parekh’s appointment, Nordic Pharma has formed its U.S. Medical Advisory Board which includes Richard Lindstrom, MD (Minnesota), Vance Thompson, MD (South Dakota), Preeya Gupta, MD (North Carolina), Paul Karpecki, OD (Kentucky), Lisa Nijm, MD, JD (Illinois), and Selina McGee, OD (Oklahoma). Dr. Parekh continued, “I’m excited to have many of the top eye care leaders on our Medical Advisory Board. Together, we will help serve the unmet needs of so many ophthalmic patients in a state-of-the-art fashion.”
To start their new roles, Dr. Parekh and Andy Corley are representing Nordic Pharma at the Hawaiian Eye and Retina 2024 meeting this week. During the meeting they will be sharing LACRIFILL’s benefits with physicians and leaders in ophthalmology while also providing select pre-order opportunities.   About Jai G. Parekh, MD, MBA Dr. Parekh has been a long contributing member of the industry, most notably as former Chief Medical Officer at Allergan Eye Care. He sits on many advisory boards, societies and foundations including non-profits and serves as a serial advisor to many eye care organizations. Dr.Parekh is currently CEO/Co-Founder of Eyecare Consultants of NJ, a practicing ophthalmologist, and most recently hired by Inizio Engage as Chief Commercial Officer. He earned his MD at the early-acceptance medical program at the Boston University School of Medicine. A dual-trained internist and board-certified ophthalmologist, he completed his ophthalmology training/chief year at Boston University Medical Center and then went on to the New York Eye & Ear Infirmary where he completed a fellowship in cornea/anterior segment/refractive surgery and still remains as an active Clinical Associate Professor. Dr. Parekh also completed an MBA at the Fuqua School of Business at Duke University.   About Nordic Group B.V.
Nordic Group B.V. is a privately owned, medium-size international pharmaceutical company which focuses on the development and commercialization of specialty products. Portfolio enhancement has been accomplished through targeted developments and focused acquisitions to build a foundation in Eye Care, Rheumatology and Women’s Health. Nordic Pharma has established deep roots throughout Europe, and more recently, expanded outside of Europe with increased acquisitions worldwide.

Nordic Pharma is a part of SEVER Life Sciences, a holding company created in 2019 that
brings together three diverse but complementary companies that offer a wide range of products, pharmaceutical development services and delivery technologies.
 
About Amring Pharmaceuticals Inc.
Amring Pharmaceuticals Inc., subsidiary of Nordic Group B.V., is partnered with well- established global biopharmaceutical companies and is uniquely positioned to leverage its expertise in bringing biotechnology derived medicines, sterile manufacturing and other state-of-the-art technologies to the marketplace.
 
About Visant Medical, Inc.
Visant Medical is a clinical-stage medical device company. It received FDA 510(k) clearance in 2022 for LACRIFILL® cross-linked hyaluronic acid-based canalicular occlusive device. LACRIFILL is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
Symatese SAS, a French company based in Lyon, was instrumental in the development of LACRIFILL, significantly enhancing the product's design and performance, by leveraging its expertise in tissue regeneration, reconstruction and related delivery systems. SYMATESE specializes in injectable crosslinked HA gels for many markets including Aesthetic, Rheumatology, Ophthalmology. With more than 40 researchers, SYMATESE designs the most advanced medical device solutions thanks to their technology portfolio in hyaluronic acid, collagen, thermoplastics and silicone.
 
Safe Harbor
This press release contains forward-looking statements, including, without limitation, statements related to Amring/Nordic Pharma’s business developments and the implementation of Amring/Nordic Pharma’s strategic initiatives. Because these statements reflect Amring/Nordic Pharma’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties that could cause actual developments and results to differ materially from Amring/Nordic Pharma’s expectations. These factors include, but are not limited to, general market conditions, regulatory trends, changes in the financial conditions of third parties dealing with Amring/Nordic Pharma, and other factors that could affect Amring/Nordic Pharma’s business and financial performance. Amring/Nordic Pharma does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information,
future developments or otherwise.
 
Contact
Amring Pharmaceuticals Inc.
Kate Popova

Contracts Administration Lead

Phone : 610-285-1699

ekaterina.popova@amringpharma.com
Gail Feerrar
Director Sales and Marketing
Phone: 610-285-7152
gail.feerrar@amringpharma.com
 
NORDIC PHARMA GROUP B.V. THROUGH ITS SUBSIDIARY AMRING PHARMACEUTICALS INC., COMPLETES ACQUISITION OF VISANT MEDICAL TO LAUNCH NOVEL THERAPY FOR DRY EYE DISEASE IN THE UNITED STATES
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BERWYN, PA — Amring Pharmaceuticals Inc. (Amring), a subsidiary of…

Company news

BERWYN, PA -- Amring Pharmaceuticals Inc. (Amring), a subsidiary of Nordic Group B.V. (Nordic Pharma), announced today the completion of its acquisition of Visant Medical, Inc. (Visant), a leader in medical technology innovation in Dry Eye Disease (DED). This acquisition unites Nordic Pharma's pharmaceutical expertise, with Visant's FDA-cleared hyaluronic acid derivative LACRIFILL® canalicular occlusive device, which is intended to temporarily block tear drainage by the occlusion of the canalicular system. Nordic Pharma will launch and
commercialise LACRIFILL in the U.S. and has been chosen because of its focus on Ophthalmology.

This acquisition will enhance Nordic Pharma’s impact on the global ophthalmology market starting with the U.S. launch of LACRIFILL, the patented therapy for DED. “Visant is thrilled to be joining the Nordic Pharma group,” said Vartan Ghazarossian, Ph.D., Visant co-founder and CEO. “Our team has been passionate about bringing a truly innovative solution to patients suffering from DED and we are excited to be joining the Nordic Pharma team as we begin our commercialization efforts.”

This is the second branded medical device Nordic Pharma will introduce in the U.S. and is a complementary fit to the lead brand. Following the anticipated 2024 U.S. launch of LACRIFILL, Nordic Pharma intends to seek regulatory approval to make the product available globally.

“We’re ecstatic Visant Medical selected Nordic Pharma as their partner and for the opportunity to introduce LACRIFILL to the ophthalmologists and optometrists treating the over 16 million people diagnosed with DED in the U.S.,” said Philip Gioia, President of the U.S. team that will launch LACRIFILL under the Nordic Pharma brand. “LACRIFILL representsan innovative and elegant form factor to occlude that should become the gold standard for preoperative patient care for those with DED.”

LACRIFILL is indicated for dry eye conditions and provides relief for the symptoms of dry eye. It has received FDA 510(k) clearance and has an established CPT reimbursement code. These benefits make LACRIFILL appealing to both patients and providers.

Richard Lindstrom, MD, Founder and Attending Surgeon Emeritus at Minnesota Eye Consultants said, LACRIFILL is set to play a useful role in treating patients with the signs and
symptoms of dry eye, especially prior to refractive corneal or cataract surgery. LACRIFILL will provide the Eye Care Professional with a new and attractive option to treat patients with Dry Eye Disease within their practice.

Paul Karpecki, OD, Associate Professor, University of Pikeville, Kentucky College of Optometry; Kentucky Eye Institute; emphasized the benefits of using LACRIFILL, stating: "A  gel, consisting of cross-linked hyaluronic acid represents a significant impact in ocular health in tear conservation. The properties of the hyaluronic acid in a canalicular filler offer unique comfort and effectiveness in managing dry eye symptoms.”

Raymond James & Associates, Inc. served as exclusive financial advisor to Visant Medical, Inc. and Wilson Sonsini Goodrich & Rosati, Professional Corporation served as legal advisor. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal advisor to Amring Pharmaceuticals Inc.

About Nordic Group B.V.
Nordic Pharma is a privately owned, medium-size international pharmaceutical company which focuses on the development and commercialization of specialty products. Portfolio enhancement has been accomplished through targeted developments and focused acquisitions to build a foundation in Ophthalmology, Rheumatology and Women’s Health. Nordic Pharma has established deep roots throughout Europe, and more recently, expanded outside of Europe with increased acquisitions worldwide.Nordic Pharma is a part of SEVER Life Sciences, a holding company created in 2019 that brings together three diverse but complementary companies that offer a wide range of products, pharmaceutical development services and delivery technologies.

About Amring Pharmaceuticals Inc.
Amring Pharmaceuticals Inc., subsidiary of Nordic Group B.V., is a privately held pharmaceutical company that provides niche generics and value-driven brands to the market. Amring is partnered with well-established global biopharmaceutical companies and is uniquely positioned to leverage its expertise in bringing biotechnology derived medicines, sterile manufacturing and other state-of-the-art technologies to the marketplace.

About Visant Medical, Inc.
Based in Menlo Park, CA, Visant Medical is a clinical-stage medical device company. It received FDA 510(k) clearance in 2022 for LACRIFILL® cross-linked hyaluronic acid-based canalicular occlusive device. LACRIFILL is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
Symatese SAS, a French company based in Lyon, was instrumental in the development of LACRIFILL, significantly enhancing the product's design and performance, by leveraging its expertise in tissue regeneration, reconstruction and related delivery systems. SYMATESE specializes in injectable crosslinked HA gels for many markets including Aesthetic, Rheumatology, Ophthalmology. With more than 40 researchers, SYMATESE designs the most advanced medical device solutions thanks to their technology portfolio in hyaluronic acid, collagen, thermoplastics and silicone.

Safe Harbor
This press release contains forward-looking statements, including, without limitation, statements related to Amring/Nordic Pharma’s business developments and the implementation of Amring/Nordic Pharma’s strategic initiatives. Because these statements reflect Amring/Nordic Pharma’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties that could cause actual developments and results to differ materially from Amring/Nordic Pharma’s expectations. These factors include, but are not limited to, general market conditions, regulatory trends, changes in the financial conditions of third parties dealing with Amring/Nordic Pharma, and other factors that could affect Amring/Nordic Pharma’s business and financial performance. Amring/Nordic Pharma does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information,
future developments or otherwise.

Contact
Amring Pharmaceuticals Inc.
Kate Popova
Contracts Administration Lead
Phone Number: 610-285-1699
ekaterina.popova@amringpharma.com

Nordic Pharma joins the Pharmaceutical Supply Chain Initiative
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We are pleased to announce that Nordic Pharma has joined…

Company news
We are pleased to announce that Nordic Pharma has joined the Pharmaceutical Supply Chain Initiative (PSCI) as an associate member as of February 2023. Driving sustainable change in our supply chain is a key pillar of our Corporate Social Responsibility (CSR) strategy, and this marks an important step into this direction. By joining PSCI, we will join industry experts in collectively working towards better business conditions, ultimately driving our common goal of greener supply chains. We commit to uphold the responsible business principles and continue to grow ethically, always with a long-term vision.   Small steps, big impact. Our Sustainability journey continues ! If you’d like to find out more about the PSCI, click here.
Draupnir Holdings Ltd have officially merged with Nordic Group B.V
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We are pleased to announce that as of January 2023,…

Company news
We are pleased to announce that as of January 2023, Draupnir Holdings Ltd which incorporates Altacor, ParaPharm Development & Transdermal have officially merged with Nordic Group B.V. The new merged company will operate under the name Nordic Pharma. With this merger comes exciting opportunities to strengthen the business: combined talents and competencies, territorial expansion and product portfolio development. The new Global Company will seek long term sustainable and profitable growth in our consolidated four main therapeutic areas: Rheumatology, Women’s Health, Ophthalmology and Critical Care.   Please rest assured that our teams have been and will continue to be in contact with their counterparts in the same way they have been in the past and that we commit to continue providing the highest quality products and services. We look forward to further delivering value to our shareholders whilst working together on our common purpose of making a sustainable impact on people’s health.
Nordic Pharma files submission to health Canada for the marketing authorization of methotrexate autoinjector for treating rheumatoid arthritis in Canada
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Canada, March 29, 2022 – NORDIC PHARMA, a SEVER Life…

Company 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 life1,2.

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.

  About Nordic Pharma Inc.

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

  Contact Corporate Media and Communication, Nordic Pharma AAP   References

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

Nordic Pharma has acquired ALTIM® (cortivazol) pre-filled syringe to strengthen their Rheumatology portfolio
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Paris, January 2022 – Nordic Pharma is pleased to announce…

Product acquisition

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.

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.”

  About Nordic Pharma

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).

https://www.nordicpharma.com/   About Sanofi

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.

https://www.sanofi.com/
European Commission approves Teysuno in metastatic colorectal cancer
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Nordic Pharma announces that on the 24th of January, the…

Company news

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.

Based on this approval, 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
  New fluoropyrimidine for patients with metastatic colorectal cancer nordic_pharma_thumbnail_green_colon

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.

  About Nordic Pharma 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. Email: oncology@www.nordicpharma.com

TEY-2022-01-016
Positive EMA opinion for the use of Teysuno in metastatic colorectal cancer
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Nordic Pharma has announced that on 16 December 2021, the…

Company news

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).
  New fluoropyrimidine for patients with metastatic colorectal cancer nordic_pharma_thumbnail_green_colon

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.

  About Nordic Pharma

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@www.nordicpharma.com

TEY-2022-01-002

Nordic Pharma present at CPhI !
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Nordic Pharma will be attending CPhI Worldwide in Milan, Italy from November…

Company news
Nordic Pharma will be attending CPhI Worldwide in Milan, Italy from November 9th-11th 2021. We are actively looking for late stage partnering opportunities ideally within our core therapeutic areas of Women’s Health, Rheumatology and Critical Care. If you would like to get in touch and possibly meet us there, please contact busdev@www.nordicpharma.com   Nordic-Pharma-present-at-CPhI
Nordixate® Methotrexate Pre-filled Syringe approved in Colombia
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Nordic Pharma AAP is pleased to announce that the Nordixate®…

Product launch
Nordic Pharma AAP is pleased to announce that the Nordixate® Methotrexate Pre-filled Syringe has been issued market authorization by Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or INVIMA, the Colombian National Food and Drug Surveillance Institute. With our local partner, Vitalis Laboratorio, we are working towards a launch early next year. Thank you to everyone who has been involved in achieving this approval. nordic-pharma-vitalis-expertos-en-inyectables
New Headquarters Offices
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Both of Nordic Pharma HQs, located in France and in…

Company news

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 1st, 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-New Headquarters Offices

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

 

Our second HQ in Paris, France, also relocated on March 1st, 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-New Headquarters-Offices-Paris
Nordimet® PFS and Pen are launched in Chile!
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Nordic Pharma Americas, Asia, Pacific are pleased to announce that…

Product launch
Nordic-Pharma-Nordimet-PFS-and-Pen-are-launched-in-Chile

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.

This exciting milestone represents the first launch of the Nordic Pharma methotrexate products in Latin America.

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