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

___________________________________________________________________

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

WOODSAFE TOGETHER WITH THE SWEDISH DRUG MANUFACTURER APL - CONTRIBUTING TO A GREENER HEALTH AND MEDICAL CARE!

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

mnv@frostpharma.com

www.WoodSafe.green

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.

Priveq invests in FrostPharma

FrostPharma welcomes Priveq Investment (“Priveq”) as a new growth partner

FrostPharma signed its first product agreements in 2017 and has since then launched over 50 products. Through strategic partnerships with pharmaceutical companies from Europe, USA and Asia a significant pipeline of new products has been secured covering a broad range of disease areas. While building a pharmaceutical company with a hospital and specialty pharma focus, FrostPharma has also developed a proprietary portfolio under the tradename Woodsafe. Woodsafe is a risk waste product offering a 66% reduction of CO2 compared to the products currently used in the healthcare sector.

“FrostPharma has been successful in attaining new products proactively and fast delivered strong commercial results. We are impressed by the founders and management team and thrilled to enter this partnership to accelerate the development together with them. As an investor with a strong ESG agenda we also very much look forward to contribute to the success of Woodsafe, a product that has the potential to reduce CO2 emissions from the healthcare sector here and now“, says Karl-Johan Willén, Partner and Investment manager at Priveq.

With an established platform across the Nordic region and Baltics the plan is to continue investing in the organization and to further expand the product portfolio.

“We strongly believe that the partnership with Priveq will provide FrostPharma with opportunities for accelerated sustainable growth going forward. The Priveq team has confirmed a significant understanding of the FrostPharma business model throughout this process. They also bring a strong track-record of adding value in these partnerships. I very much look forward to working with Priveq and the entire FrostPharma team in this next exciting phase of the FrostPharma growth journey” says Fredrik Andersch, CEO at FrostPharma.

“From the start 2017 a pharmaceutical company with a strong commercial platform has been built from scratch, with all required pharma capabilities inhouse. FrostPharma now cover all Nordic markets and has effectively launched 50 products in just six years. We focus on hospital and specialty products that meet specific patient and healthcare needs, and the FrostPharma team is doing an extraordinary job in making this happen. It is now very exciting to take the next step for FrostPharma together with the support and knowledge of Priveq “, says Clas Lindbergson, Co-founder and Head of business development at FrostPharma.

EY Corporate Finance was advisor to FrostPharma’s shareholders throughout the process.

For more information, please contact:

Fredrik Andersch, CEO FrostPharma, +46 737 74 40 67, fredrik.andersch@frostpharma.com

Karl-Johan Willén, Partner Priveq, +46 709 50 88 25

karljohan.willen@priveq.se

About Priveq For 40 years, Priveq Investment has invested in profitable growth companies. The business concept is to generate value through long-term investments and active ownership in unlisted growth companies. Since 1983, approximately SEK 8 billion has been managed and Priveq Investment and its employees have carried out 135 investments and been involved in taking 29 companies to an IPO. The current portfolio will consist of 17 companies which has a total revenue of approximately SEK 7.7 billion and 2,650 employees. Some of the current portfolio companies are Ports Group, Metenova and Swemac. Behind Priveq Investment is essentially a number of long-term, institutional pension funds in the Nordics and Europe, for example Skandia Liv, Fourth AP fund, abrdn and Pantheon. Visit www.priveq.se for further information.