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With exceptional entrepreneurship, solid functional skill sets and capabilities fostered by a strong ‘can-do’ attitude, the team have time after time proven that we can overcome any obstacle together and achieve great things.
Anders Edvell, CEO
The Immedica team is one of the best that we have encountered in a space that we have been following for some time. We are deeply impressed by the accomplishments of Immedica under Impilo’s ownership and the establishment of a rare disease player with a highly promising pipeline. We look forward to working with the management team alongside Impilo to accelerate growth further
Kugan Sathiyanandarajah, Partner and Head of KKR’s Health Care Strategic Growth business in Europe
KKR, with its experience in rare disease and specialty pharma in Europe and the U.S., as well as its global presence and network, is an ideal strategic partner for the next stage of Immedica’s evolution. We are excited to continue our engagement in Immedica, together with KKR, supporting management to realize our joint vision of becoming a leading ultra-rare disease platform and making medicines available to patients with high unmet medical needs
Magnus Edlund, partner at Impilo
I am excited to continue our partnership with Impilo and welcome KKR as a new strategic partner for the next step in Immedica’s journey, Since our inception in 2018 backed by Impilo, Immedica has made significant strides towards becoming a leader in the rare disease sector, providing innovative therapies to patients with severe unmet medical needs. I look forward to working alongside both KKR and Impilo as we further our mission, continue to build our organisation, and expand our reach globally"
Anders Edvell, CEO of Immedica.
"We are extremely proud to be recognized as one of Sweden's Best Workplaces™ by Great Place to Work®. It is a testament to our commitment to creating an inclusive and enjoyable work environment for all our employees,"
Anders Edvell, CEO
We raise awareness for Rare Disease Day, since it’s crucial to address the widespread issue of underdiagnosis and misdiagnosis, notably in conditions like ARG1-D. These rare diseases often remain overlooked, leaving patients and families to confront their challenges alone.
Anders Edvell, CEO
"This is a very important approval for the people living with ARG1-D and their families across the whole of United Kingdom and proof of the huge unmet medical need in this ultra rare disease. We will now focus on getting Loargys available to patients in the UK as soon as possible."
Mark Bell, General Manager UK & Ireland
Today’s approval marks a major milestone for Immedica, but an even greater one for the people living with ARG1-D and their families.
Anders Edvell, CEO
Today’s announcement demonstrates significant progress towards providing the first disease modifying treatment for ARG1-D. The unmet medical need in this vulnerable patient population is huge and we look forward to the decision by the European Commission
Anders Edvell, CEO
“This approval by ANMAT is an important milestone for the people living with UCDs in Argentina and addresses the significant unmet medical need in this patient population”
Anders Edvell, CEO
We are very pleased with this new agreement with Aeglea, giving us the global rights to pegzilarginase. People with arginase 1 deficiency lack sufficient treatment options today and we believe that pegzilarginase, where awarded marketing authorizations, has the potential to benefit these patients as the first disease modifying treatment
Anders Edvell, CEO
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Immedica announces publication of 2023 Business Review and Annual & Sustainability Report

Stockholm, April 26, 2024 – Immedica is proud to announce the release of our Business Review and Annual & Sustainability Report for the year 2023. This year marks the most successful period in our history since the company's establishment in 2018, highlighting our substantial progress and achievements. In 2023, Immedica strengthened its position as an emerging leader in the rare disease sector across Europe and the MENA region. Through strategic initiatives and a dedicated focus on our core mission, we have taken significant strides toward becoming a frontrunner in this important field.

Leading global investment firm KKR and Nordic healthcare investment firm Impilo enters strategic partnership together with Immedica management

Stockholm, April 23, 2024 –Investment funds managed by KKR, a leading global investment firm, have agreed to acquire Immedica Pharma. Existing owner, Nordic healthcare investment firm Impilo, will reinvest to become an equal owner alongside KKR. The transaction is subject to customary regulatory and closing conditions. KKR and Impilo will work together with Immedica’s management team to support Immedica’s continued growth, including the launch of the recently approved ultra-orphan drug Loargys, additional pipeline assets, continued in-licensing, M&A and expansion into new territories.

Immedica recognized as one of Sweden’s Best Workplaces 2024 by Great Place To Work®

Stockholm, April 19, 2024 – Immedica has made the list of Sveriges Bästa Arbetsplatser™ (Sweden's Best Workplaces). Ranked number 11 among medium sized organizations with 50-249 employees and best pharma company over all categories, Immedica demonstrates a strong dedication to creating a positive workplace culture. The award is organized by Great Place to Work®, which compiled the rankings based on the results of the world's largest employee survey. Great Place to Work®, the global expert in workplace culture, conducts the largest employee survey in the world each year, asking millions

Immedica’s partner Actinium announces Iomab-B phase 3 SIERRA trial results in patients with a TP53 mutation presented in an oral presentation at the 50th EBMT annual meeting

Stockholm, April 18, 2024 – Immedica’s partner Actinium Pharmaceuticals, Inc. presented results from the Phase 3 SIERRA trial of Iomab-B in patients with a TP53 mutation in an oral presentation at the 50th Annual meeting of the European Society for Blood and Marrow Trasnplantation (EBMT) held April 14 – 17, 2024, in Glasgow, Scotland. Iomab-B is a targeted radiotherapy agent comprised of an anti-CD45 monoclonal antibody conjugated to Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients with active relapsed or refractory acute myeloid leukemia (r/r AML) and

Ravicti® (glycerol phenylbutyrate) approved by the Taiwan Food and Drug Administration (TFDA) for the treatment of Urea Cycle Disorders

Stockholm, March 21, 2024 – Immedica and its partner WinHealth Pharma announce that the Taiwan Food and Drug Administration (TFDA) has granted marketing authorization for Ravicti® (glycerol phenylbutyrate) for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH)

From anonymity to recognition: The challenge of underdiagnosis and misdiagnosis in rare diseases

As we highlight Rare Disease Day, it’s crucial to focus on the often-overlooked issue of underdiagnosis and misdiagnosis in conditions like Arginase 1 Deficiency (ARG1-D), a progressive genetic metabolic disorder characterized by elevated plasma arginine levels, leading to serious health issues. ARG1-D presents with progressive neurological impairment, developmental delay, progressive spasticity and intellectual disability. The invisibility of rare diseases like ARG1-D in both public awareness and medical practice results in delayed interventions or even the omission of relevant treatments,

Immedica’s partner Actinium presented four abstracts of Iomab-B at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMTR®

Stockholm, February 27, 2024 – Immedica’s partner Actinium Pharmaceuticals, Inc. presented four abstracts at the 2024 Tandem Meetings | Transplantation & Cellular Therapy (TCT) Meetings of ASTCT® (American Society for Transplantation and Cellular Therapy and CIBMTR® (Center for International Blood and Marrow Transplant Research) on February 21 – 24, 2024 in San Antonio, Texas. Two oral presentations and two poster presentations highlighted results from the positive Phase 3 SIERRA trial of Iomab-B ([131]I-Apamistamab). Altogether 10 oral presentations of the SIERRA results have been

Loargys® (pegzilarginase) approved in Great Britain for treatment of arginase 1 deficiency (ARG1-D)

Stockholm, 21, 2023: Immedica today announces that the Medicines & Healthcare products Regulatory Agency in the UK has granted marketing authorization of Loargys® (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininaemia, in adults, adolescents and children aged 2 years and older. Orphan Designation in Great Britain was also granted. Anders Edvell, CEO of Immedica commented “This has indeed been an exciting week for Immedica with the approval in the EU on December 15 and now this approval in Great Britain, being one of the major markets in

Immedica intends to re-submit the BLA seeking approval of Loargys® (pegzilarginase) for treatment of arginase 1 deficiency (ARG1-D) in the US

Stockholm, December 21, 2023: Immedica today announces its intention to re-submit the biologics license application (BLA) seeking approval of Loargys® (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D) in the US during 2024. The decision was taken following the recent approval of Loargys by the European Commission on December 15 and after a dialogue with the FDA. About Loargys®Loargys (pegzilarginase) is a novel recombinant human enzyme and has been shown to rapidly and sustainably lower levels of the amino acid arginine and its toxic metabolites in plasma

Loargys® (pegzilarginase) approved in the EU for treatment of arginase 1 deficiency (ARG1-D)

Stockholm, December 18, 2023: Immedica today announces that the European Commission has granted marketing authorization of Loargys® (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older. The approval follows the positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use on October 12. Anders Edvell, CEO of Immedica comments: “Today’s approval marks a major milestone for Immedica, but an even greater one for the people living with ARG1-D and

Immedica’s partner Actinium announces oral presentation at ASH annual meeting on Iomab-B outcomes data for TP53 gene mutation from the SIERRA trial

Stockholm, November 14 , 2023 – Immedica’s partner Actinium Pharmaceuticals, Inc. has announced that three abstracts detailing results from the completed Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) have been accepted for presentation at the 65th Annual American Society of Hematology Annual Meeting & Exposition (ASH) being held in San Diego on December 9-12, 2023. Outcomes of patients with a TP53 gene mutation enrolled in the SIERRA trial have been accepted for an oral presentation and results detailed in

Glycerol phenylbutyrate granted orphan drug designation for treatment of STXBP1 developmental and epileptic encephalopathy

Stockholm, October 20, 2023 – Immedica today announces that the European Commission has granted an orphan designation for glycerol phenylbutyrate in STXBP1 developmental and epileptic encephalopathy (STXBP1-DEE), following positive opinion from EMA’s Committee for Orphan Medicinal Products (COMP). Orphan designation is granted to medicines that treat, prevent, or diagnose a life-threatening or chronically debilitating rare disease, with a prevalence in the EU of below 5 in 10,000, and with either no satisfactory method of diagnosis, prevention or treatment or with significant benefit to

Loargys® (pegzilarginase) receives positive opinion by the CHMP for treatment of arginase 1 deficiency

Stockholm, October 13, 2023: Immedica today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization of Loargys® (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D) in patients two years and older. The positive opinion from the CHMP is now referred to the European Commission for a decision. Anders Edvell, CEO of Immedica commented: “Today’s announcement demonstrates significant progress towards providing the first disease modifying treatment for ARG1-D.

Ravicti® (glycerol phenylbutyrate) approved by the National Administration of Drugs, Food and Medical Devices in Argentina for treatment of urea cycle disorders

Stockholm, September 29, 2023 – Immedica and its partner Innovative Medicines AS announces that the National Administration of Drugs, Food and Medical Devices (ANMAT) in Argentina has granted marketing authorization for Ravicti® (glycerol phenylbutyrate) for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), Citrullinemia type 1, argininosuccinuria, argininemia and hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein

Immedica to present new pegzilarginase data at the SSIEM Annual Symposium 2023

Stockholm, August 28, 2023 Immedica today announces the presentation of new data at the SSIEM (Society for the Study of Inborn Errors of Metabolism) annual symposium taking place in Jerusalem, Israel. The presentation highlights important long-term patient-level data on pegzilarginase, a potential first disease modifying treatment for arginase 1 deficiency (ARG1-D). Anders Edvell, Immedica CEO commented: “We are very pleased to be able to present this new patient-level data that demonstrates long-term clinical outcomes of pegzilarginase for the treatment of ARG1-D, a disease where the

I131-apamistamab SIERRA abstracts accepted for oral and poster presentation at the European Association of Nuclear Medicine 2023 Congress

Stockholm, August 25, 2023 – Immedica’s partner Actinium Pharmaceuticals, Inc. has announced that two abstracts have been accepted for oral and poster presentation at the upcoming European Association of Nuclear Medicine (EANM) 2023 Congress, which will be held in Vienna, September 9-13, 2023. The EANM oral presentation represents the fifth oral presentation at prestigious medical conferences globally in 2023 including TCT, EBMT, SNMMI, and EHA. The presentation reflects that I131-apamistamab increases access to allogeneic hematopoietic stem cell transplant for patients with relapsed or

Immedica acquires global rights to pegzilarginase from Aeglea

Stockholm, July 27, 2023 – Immedica announces that it has signed an agreement to acquire the global rights to pegzilarginase and related assets from Aeglea BioTherapeutics, Inc. The acquisition means that the previously entered exclusive license and supply agreement from 2021 of the rights to pegzilarginase in Europe and the Middle East will be superseded. Anders Edvell, Immedica CEO commented: “We are very pleased with this new agreement with Aeglea, giving us the global rights to pegzilarginase. People with arginase 1 deficiency lack sufficient treatment options today and we believe

Zepzelca® (lurbinectedin) approved by the Ministry of Health in Oman for the treatment of metastatic Small Cell Lung Cancer

Stockholm, July 21, 2023 – Immedica’s product Zepzelca[®] (lurbinectedin) has received approval by the Ministry of Health in Oman for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Anders Edvell, CEO of Immedica commented: “SCLC is a type of lung cancer that tends to grow and spread fast. The medical need for these patients is huge and lurbinectedin has the potential to benefit the SCLC patients in Oman. We will work with our partner PharmaMar to support access of Zepzelca to these patients”.

Glycerol phenylbutyrate approved by the National Medical Products Administration in China for the treatment of Urea Cycle Disorders

Stockholm, June 21, 2023 – Immedica’s partner Hongkong WinHealth Pharma Group Co.Ltd has announced that glycerol phenylbutyrate oral liquid has gained approval for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), Citrullinemia type 1, argininosuccinuria, argininemia and hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate must be used with

Iomab-B SIERRA trial results accepted for oral presentation at the European Hematology Association 2023 Congress

Stockholm, May 15 , 2023 – Immedica’s partner Actinium Pharmaceuticals, Inc. has announced that an abstract on the Iomab-B SIERRA trial results has been accepted for an oral presentation at the upcoming European Hematology Association 2023 Congress (EHA) which will be held in Frankfurt, Germany, June 8-11, 2023. The abstract includes data from Actinium's controlled phase 3 study, SIERRA , comparing the efficacy of Iomab-B based conditioning, a first-in-class targeted radiotherapy, versus physician's choice of conventional care in patients ≥55 years of age with relapsed/refractory acute

Immedica publishes Business Review and Annual & Sustainability report 2022

Stockholm, April 26 , 2023 - Immedica has today published its Business review and Annual & Sustainability report 2022. This is the first report for Immedica in this format. Immedica is a young  and still relatively small company, but our ambitions are nothing but high. “At Immedica, we believe we have an important role to fill in society in bringing new innovative treatments to patients with rare diseases for whom there are currently no viable treatment options.”comments Anders Edvell CEO. The integrated report is attached to his announcement. About Immedica Pharma

Immedica’s partner OrphanPacific initiates phase 3 trial with glycerol phenylbutyrate for treatment of urea cycle disorders in Japan

Stockholm, April 21 , 2023 - Immedica’s partner OrphanPacific Inc. (Tokyo, Japan) has enrolled the first patient in the phase 3 clinical trial with glycerol phenylbutyrate for the treatment of urea cycle disorders (UCD) in Japan. Immedica’s CEO Anders Edvell commented: “There is a significant medical need for better treatment options for people living with urea cycle disorders around the world. The initiation of this trial is a significant step towards expanding access to glycerol phenylbutyrate for patients in Japan.” This phase 3 clinical trial is planned to enroll 15 pediatric and

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