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FROSTPHARMA MAGAZINE

For News and Media

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 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

 

___________________________________________________________________

References:

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

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


The WoodSafe hazardous waste containers reduce CO2 emissions by 66% compared to today's fossil-based plastic containers.



APL chooses WoodSafe® hazardous waste bins as part of its environmental and climate work.

Pharmacy Production & Laboratories (APL) is one of Europe's leading companies

within development, analysis and manufacture of extempore and stock preparations, as well as an established contract manufacturer in the Life Science industry. APL has now decided to start a collaboration with FrostPharma, which provides WoodSafe® hazardous waste container, to reduce its climate impact and contribute to a more sustainable society.



- For APL, it is an important step in our endeavor to reduce our climate impact and ta our responsibility for the environment. WoodSafe® hazardous waste containers are not only good for the climate, but also for our business where we must have secure supply chains. That which is particularly important to us is that the life cycle analysis carried out for WoodSafe® is according to ISO 14040 and 14044 and according to IPCC guidelines. This produces a heap credibility and transparency in our climate impact calculations. We look forward to

to start implementing WoodSafe® in our production and laboratories, says Erik

Haeffler, CEO of APL.


The healthcare sector with its suppliers accounts for over 4% of

the world's CO2 emissions. One of the reasons is that the sector generates large amounts hazardous waste. The hazardous waste is collected in fossil vessels which are incinerated, causing significant CO2 emissions. WoodSafe® is a hazardous waste bin that reduces CO2- emissions by 66% compared to today's fossil alternatives.


WoodSafe® is manufactured in Sweden from biocomposite, mainly from

residual products from the saw industry. This provides a safe supply of goods with short transport routes. An independently validated life cycle analysis verifies 66% CO2 reduction in accordance with the reporting requirements that follow the CSRD.


- We are very proud that a leading company like APL is switching to WoodSafe®

risk waste containers as part of its climate and sustainability work. It is also

very positive for everyone that a major state-owned company is stepping in to

reduce the use of fossil products in favor of renewables where possible.

From the day APL starts implementing WoodSafe®, they get an immediate

measurable reduction of CO2 emissions, which we look forward to reporting to

them continuously in ESRS format, says Fredrik Andersch, CEO at FrostPharma.


As a first immediate step, the smaller vessels are implemented in

the operations around the country. Then comes the routines regarding larger

containers also to be evaluated and the goal is to phase out all fossil-based ones

hazardous waste containers, explains Erik Haeffler, CEO of APL.



About the WoodSafe® needle container


WoodSafe® are innovative hazardous waste bins based on 80% renewable material from the forest. The material is designed to be able to replace several other materials because it is durable, malleable and flexible. By replacing today's

hazardous waste bins with biocomposite material can reduce the climate footprint 66%. WoodSafe® is a Swedish-made hazardous waste container designed for living up to today's sustainability thinking and contribute to a more environmentally friendly and climate-smarter future. The production takes place in close cooperation with Sweden Timber AB and Mälarplast AB.


For further information: www.WoodSafe.green


For more information and questions contact:

Magnus Nilsson Vall

Sustainable Solutions

Phone +46 735 18 60 67



FrostPharma AB, based in Danderyd, Sweden, a Swedish fast-growing

pharmaceutical company with a focus on commercialization and making it available of value-creating specialist and hospital medicine.


FrostPharma has also developed a separate business area that offers

healthcare, laboratory and pharmaceutical industry climate-smart

sustainable products as an alternative to the petroleum-based plastic products

health care uses today. These products are manufactured in Sweden from biocomposite and bioplastics and offers healthcare a significant reduction of

climate-affecting emissions.

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