FrostPharma och Abboxia går samman

FrostPharma och Abboxia går samman under namnet FrostPharma och blir ett av Specialistläkemedelsbolagen med det bredaste sortimentet av sjukhusläkemedel i Norden.

FrostPharmas kommersiella styrka och förmåga att bygga strategiska allianser, kombinerat med Abboxias portföljutvecklingsförmåga skapar möjligheter att leverera betydligt fler viktiga sjukhusläkemedel till nordiska vårdgivare vid behandling av patienter med kritiska tillstånd.

Genom att gå samman med Abboxia har FrostPharma blivit ett av de ledande Specialistläkemedelsbolagen i Norden.

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Om FrostPharma och Abboxia

FrostPharma grundades i slutet av 2016 och har en framgångsrik historik av att bygga strategiska partnerskap med andra läkemedelsföretag, och att effektivt tillhandahålla och kommersialisera ett brett spektrum av specialistläkemedel på de nordiska marknaderna.

Abboxia grundades 2017 och har framgångsrikt utvecklat ett flertal egna specialistläkemedel inom sjukhussegmentet för den nordiska marknaden.

FrostPharma receives the distribution rights for Efmody® in the Nordics in May 2024

Press release, May 2024

FrostPharma was founded late 2016 and have since grown significantly, the vision is to become a leading specialty pharma company. We are now happy to announce that FrostPharma take another step towards their vision by receiving the distribution rights from Diurnal Limited, a Neurocrine Biosciences company, in the Nordics for Efmody® (hydrocortisone modified-release hard capsules). Efmody is the second endocrinology product in addition to Alkindi (hydrocortisone granules in capsules for opening) that FrostPharma distribute in the Nordics.

Efmody® (hydrocortisone modified-release hard capsules) provides a treatment option for adult and adolescent patients suffering from the rare condition congenital adrenal hyperplasia (CAH). CAH is caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels.

Alkindi® (hydrocortisone modified-release hard capsules) is designed for children suffering from adrenal congenital insufficiency and allows for age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age.

With the addition of Efmody® in the FrostPharma portfolio we have now a broader range of opportunities to provide treatments for patients in need.

Fredrik Anders, CEO FrostPharma

“We are very proud of our cooperation with Diurnal, that we now expand to include Efmody. Efmody has excellent strategic fit with Alkindi and fit well with the FrostPharma business model of providing niched hospital pharmaceuticals within areas of identified unmet needs."

Contact

For further information please contact

Fredrik Andersch, CEO FrostPharma Fredrik.andersch@frostphama.com

Rebecka Grund, COO FrostPharma rebecka.grund@frostpharma.com

More information

Congenital Adrenal Hyperplasia (CAH)

Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal hormones which are essential for life. Approximately 95% of CAH cases are caused by a mutation that leads to deficiency of the enzyme 21-hydroxylase (21-OHD). Severe deficiency of this enzyme leads to an inability of the adrenal glands to produce cortisol and, in approximately 75% of cases, aldosterone. If left untreated, CAH can result in salt wasting, dehydration, and even death.

Efmody®

Efmody® (hydrocortisone modified-release hard capsules) is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US.

Alkindi®

Alkindi® (hydrocortisone modified-release hard capsules) is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and CAH. AI requires life-long treatment and Diurnal’s novel approach to product development has the potential to significantly improve these young patients’ lives.

Diurnal Ltd.

Diurnal Ltd., a Neurocrine Biosciences company, is dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. Neurocrine Biosciences acquired Diurnal Group plc. in November 2022.

For further information about Diurnal, please visit www.diurnal.co.uk

About FrostPharma

FrostPharma is an entrepreneurial Swedish Specialty Pharma company specializing in the commercialization of value-adding medicines. FrostPharma signed its first product distribution agreement in 2017, and since then +40 products have been added to the therapy agnostic portfolio through a strong agreement deal-flow, as well as through the development of proprietary products. The company has an established specialty pharma platform across the Nordics, and now actively plan to expand to additional EU countries. The FrostPharma portfolio of products are primarily oriented toward hospital use, and hospital initiation. FrostPharma has also developed a separate division offering sustainable solutions to petroleum-based plastics across the Healthcare sector.

For further information please visit frostpharma.com

FrostPharma enters the hematology area in the Nordics

FrostPharma takes another step in its growth journey of becoming a leading European Specialty Pharma company, by being authorized by IDEOGEN as the exclusive Nordic representative to support patient access of Beleodaq (belinostat), a medicine that provide new hope for late-stage peripheral T-cell lymphoma patients.

Beleodaq (belinostat) belong to the class of drugs known as histone deacetylase (HDAC) inhibitors. It works by affecting gene expression and the growth and division of cells. It is used to treat relapsed, refractory peripheral T-cell lymphoma. Beleodaq is approved by the FDA, and in Europe it is now available as an un-licenced pharmaceutical2.

The FDA approval was based on the phase 2-study, BELIEF, which included 120 patients in a single-arm study. The included patients had previously received between one to eight treatment regimens (median two regimens) and were at inclusion not responding to treatment or in relapse. Previous treatments included multiagent regimens, single-agent regimens as well as stem-cell transplantation.

Beleodaq was administered as a daily 30-minutes intravenous infusion for 5 days every 3rd week. The primary endpoint, overall response rate, was reached by 31 patients (25,8%) including 13 complete (10,8%) and 18 partial responses (15%). Median duration of response was 13,6 months. Twelve responding patients underwent stem-cell transplantation.

Beleodaq was well tolerated in this heavily pretreated population with few patients requiring dose reductions (12,4%). There was a low incidence of severe (grade 3 and 4) hematologic toxicities (thrombocytopenia 7%, neutropenia 6,2%, anaemia 10,9%)3.

A phase 2/3, randomized, open-label study in newly diagnosed patients with peripheral T-cell lymphoma is planned to start recruitment in a multinational trial. This study compares the efficacy and safety of the combination of Beleodaq-CHOP or Folotyn-COP to CHOP regimen alone4.   

As Beleodaq is now available as an additional option for severely sick T-cell lymphoma patients in the Nordics, FrostPharma keeps its promise to the patients, which is identifying unmet needs among patients within the hospital setting and based on that search for and provide solutions for those needs. FrostPharma is active within many different therapeutical areas, and Beleodaq serves as the pharmaceutical within haematology/oncology, hence provide the foundation for a new step in our expansion journey. 

About Beleodaq

Beleodaq (belinostat) is a histone deacetylase inhibitor (HDAC). It is approved by the FDA and is provided in the Nordics as an unlicensed pharmaceutical for patients with late stage peripheral T-cell lymphoma.

Beleodaq (belinostat) for injection, 500 mg lyophilized powder in single-dose vials for reconstitution. Given to patients during 30 minutes intravenous infusion day 1 to 5 in a 3 week cycle.

About T-cell lymphoma

Peripheral T-cell lymphomas (PTCL) is a rare and heterogeneous group of highly aggressive non-Hodgkin lymphomas (NHL). With a 5-year survival rate of approximately 30%, they are associated with poor treatment outcome.1

About FrostPharma

FrostPharma is an entrepreneurial Swedish Specialty Pharma company specializing in the commercialization of value-adding medicines. FrostPharma signed its first product distribution agreement in 2017, and since then +40 products have been added to the therapy agnostic portfolio through a strong agreement deal-flow, as well as through the development of proprietary products. The company has an established specialty pharma platform across the Nordics, and now actively plan to expand to additional EU countries. The FrostPharma portfolio of products are primarily oriented toward hospital use, and hospital initiation. FrostPharma has also developed a separate division offering sustainable solutions to petroleum-based plastics across the Healthcare sector.

About Ideogen

The Swiss pharmaceutical company IDEOGEN holds the exclusive license for the Managed Access Program for BELEODAQ® (belinostat) and FOLOTYN® (Pralatrexate) in Europe, MENA & CIS. Ideogen commences their strategic partnership with FrostPharma, a preeminent presence in the Nordic region known for its multifaceted commitment to multiple therapeutic areas.

Contact

For further information please contact

Rebecka Grund, COO

rebecka.grund@frostpharma.com

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References:

1.        T-cellslymfom, nationellt vårdprogram Sverige, 2021-02-16, version 2.0

2.        FDA Prescribing Information. h https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206256s003lbl.pdf

3.        O´Connor et al. Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Result of the Pivotal Phase II BELIEF (CLN-19) Study. J Clin Oncol 2015, 33:2492-2499

4.     A phase 2/3, randomized, open-label study comparing the efficacy and safety to the combination of Beleodaq-CHOP or Folotyn-COP to the CHOP- regimen alone in newly diagnosed patients with peripheral T-cell lymphoma. Clinicaltrials.gov. Identifier: NCT06072131