Relief Therapeutics Receives Notice of Allowance for European Patent Covering RLF-TD011 for Epidermolysis Bullosa Wound Treatment

GENEVA (OCT. 21, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today reported that the European Patent Office (EPO) has issued a Notice of Allowance under Rule 71(3) EPC for Relief’s patent application No. 20737588.2, titled “Therapeutic Uses of Oxidizing Hypotonic Acid Solutions.” This Notice of Allowance signifies the EPO’s intention to grant a patent covering Relief’s proprietary, highly pure hypochlorous acid solutions, including its investigational drug RLF‑TD011 intended for the treatment of wounds caused by epidermolysis bullosa (EB).

Upon completion of the grant procedure, the patent will protect RLF-TD011 in key European countries until 2040. Corresponding applications in other major markets, including the U.S. and China, are currently under review. RLF-TD011 previously received orphan drug designation (ODD) from the U.S. Food and Drug Administration for EB, providing potential incentives such as market exclusivity upon approval.

Giorgio Reiner, chief scientific officer of Relief, said: “We are very pleased with this news. The anticipated grant of this patent represents an additional validation of our efforts to develop novel treatments for rare and devastating diseases like EB. This patent will strengthen the protection of our innovation as we continue advancing RLF-TD011’s development, with the ultimate goal of reaching patients who need it most.”

ABOUT RLF-TD011
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief’s proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has shown efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. Currently under clinical development, RLF-TD011 has the potential to offer an innovative solution for EB wound care management. The U.S. Food and Drug Administration granted it orphan drug designation for EB, and Relief plans to seek qualified infectious disease product (QIDP) designation for extended market exclusivity.

ABOUT EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus. EB affects approximately 1 in 20,000 births in the United States, while the global prevalence of epidermolysis bullosa simplex (EBS) ranges from 1 in 85,000 to 1 in 500,000.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Hamburg, Germany, October 19, 2024 – The CXCR4 targeting compounds developed clinically by Pentixapharm in a number of diagnostic and therapeutic indications are subject of 17 abstract presentations at the 37^th Annual Congress of the European Association of Nuclear Medicine (EANM) which takes place in Hamburg from 19 – 23 October 2024. The presentations feature the company’s ongoing theranostic development efforts and CXCR4 targeting research initiatives in areas such as primary aldosteronism, high-grade gliomas, muscle invasive bladder cancer, multiple myeloma, as well as in cardiovascular disease and inflammation. On the economic side, there is an assessment of the economic implications of CXCR4-directed molecular imaging.

Dr. Dirk Pleimes, Pentixapharm’s Chief Medical Officer, commented, “We are excited about the opportunity to highlight the many applications of CXCR4 targeting compounds and the work of our collaborators at one the largest gatherings of nuclear medicine professionals globally. The abstracts accepted from investigator-initiated studies supported by Pentixapharm and others also demonstrate the ongoing interest of academia in CXCR4 and the still untapped potential. We look forward to welcoming friends and collaborators at Pentixapharm’s booth in Hall H, stand H19 for updates and discussions”.

A list of abstracts presentations featuring CXCR4 targeting compounds can be found here.

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and in the United States in 2025.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

aap Implantate AG (the “Company”) announces with reference to the ad hoc release published on October 15, 2024 at 11:25 p.m. regarding a possible cyberattack that the company’s IT systems are being restarted step by step. Production was resumed after a short interruption and was almost unaffected. The ad hoc announcement on October 15, 2024 was directly preceded by information provided to the Company by the relevant investigating authorities regarding investigations initiated ex officio on suspicion of a cyberattack on the Company. According to the ongoing internal investigation of the incident by IT specialists and the latest information provided to the Company by the investigating authorities, it can be assumed at this point in time that no irregularities, in particular data outflows, have occurred. The Company expects to be able to resume normal operations by the end of next week.

Contact:

If you have any questions, please contact:

aap Implantate AG; R. Di Girolamo; Chairman of the Management Board/CEO; Lorenzweg 5; D-12099 Berlin

Tel.: +49/30/750 19 – 170; Fax: +49/30/750 19 – 290; r.digirolamo@aap.de

Würzburg and Berlin, Germany, October 18, 2024 – The European Medicine Agency (EMA) has granted PRIME Status to Pentixapharm’s lead candidate Ga68-PentixaFor, thereby granting an early and proactive support for the development of the radiodiagnostic and the possibility of an accelerated approval. The benefits of PRIME status include an early appointment of CHMP or CAT rapporteurs, iterative scientific advice on development plans, introductory meeting on regulatory requirements, and potentially a total fee exemption for scientific advice. The status also confirms that PentixaFor has the potential to address, in primary aldosteronism (PA), an unmet medical need to a significant extent.

PentixaFor is a novel tracer for positron emission tomography (PET) imaging targeting the C-X-C receptor 4 (CXCR4). High expression of CXCR4 has been identified in aldosterone-producing tissue, which is responsible for the aldosterone over-secretion that causes PA. PentixaFor aims to be a non-invasive and accurate alternative to adrenal venous sampling (AVS), the current invasive and difficult Standard of Care procedure, offering the potential to transform diagnostic subtyping in PA.

PRIME is a status granted by the EMA for promising medicines that target an unmet medical need with the goal of optimizing these medicines’ development. The PRIME scheme is based on enhanced interaction and dialogue between EMA and Sponsor, to improve the development plans and speed up the evaluation, so that the medicines can earlier reach the patients. In particular, the PRIME scheme allows iterative scientific advice on the overall development plans and key issues, expedited follow-up scientific advice with shortened timelines, and potential accelerated assessment at the time of application for a marketing authorization. Since the start of the program in 2016, only 139 applications were granted, with Ga68-CXCR4 being the first radiopharmaceutical.

Primary aldosteronism, also known as Conn’s syndrome, is an adrenal gland disorder and the most common cause of secondary hypertension. However, it remains difficult to diagnose and to effectively treat with current methods. Pentixapharm is currently preparing a Phase III pivotal study to obtain marketing authorization in PA that will start in 2025.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

STRATEC POSTS PRELIMINARY RESULTS FOR FIRST NINE MONTHS OF 2024; TARGET CORRIDOR FOR ADJUSTED EBIT MARGIN CONFIRMED WITH ADJUSTMENT TO 2024 SALES GUIDANCE

Birkenfeld, October 17, 2024

Based on preliminary figures, STRATEC generated consolidated sales of € 176.3 million in the first nine months of 2024 (9M/2023: € 187.7 million). Its sales performance in the third quarter of 2024 therefore fell short of expectations. This is mainly due to deliveries being postponed to the fourth quarter of 2024 and the 2025 financial year respectively. Despite negative scale effects and the product mix still not being optimal, STRATEC managed to achieve a level of profitability consistent with the targeted pathway needed to meet its full-year margin guidance for 2024. Based on preliminary calculations, the adjusted EBIT margin for the first nine months of 2024 will amount to 8.4% and thus almost match the previous year’s level (adjusted EBIT margin 9M/2023: 8.6%). In this respect, the margin has benefited in particular from the earnings enhancement measures initiated eighteen months ago and since continually extended, as well as from the associated early steps to adjust capacities in line with the current market situation.

Furthermore, STRATEC is shortly due to sign further additional orders with customers, most of which were not included in the original financial guidance for 2024. As a result, sales and earnings are expected to improve significantly in the fourth quarter of 2024 compared with the first nine months of 2024. STRATEC accordingly expects to be able to make up for most of the shortfall in sales by the end of the year. Given the ongoing volatility in the market climate, STRATEC’s Board of Management has therefore decided to slightly adjust its sales guidance for 2024. STRATEC now expects its constant-currency sales to remain stable or decline slightly compared with the previous year (previously: constant-currency sales to remain stable or rise slightly). By contrast, the 2024 guidance for the adjusted EBIT margin has been confirmed at around 10.0% to 12.0%.

STRATEC will publish its final figures and its Quarterly Statement for the first nine months of 2024 as planned on October 25, 2024.

FURTHER INFORMATION IS AVAILABLE FROM:
STRATEC SE
Jan Keppeler, CFA | Investor Relations, Sustainability & Corporate Communications
Tel: +49 7082 7916-6515
ir@stratec.com
www.stratec.com

Publication of inside information pursuant to Article 17 of the Regulation (EU) No. 596/2014

APONTIS PHARMA and Zentiva enter into investment agreement – Zentiva will launch a voluntary public purchase offer

Monheim / Rhein, 16 October 2024. APONTIS PHARMA AG (“APONTIS PHARMA” or the “Company”, Ticker APPH / ISIN DE000A3CMGM5), Zentiva Pharma GmbH and Zentiva AG (the “Bidder”), both part of the Zentiva group (“Zentiva”), today signed an investment agreement with the aim of supporting the future growth of APONTIS PHARMA. The Bidder will launch a voluntary public purchase offer (the “Offer”) for all outstanding shares of APONTIS PHARMA (the “Shares”) at an offer price of EUR 10.00 per Share in cash.

The offer document (“Offer Document”) will be published on the internet at www.zentiva-offer.com. Since APONTIS PHARMA is not listed on the regulated market, the Offer is not subject to the German Securities Acquisition and Takeover Act (Wertpapiererwerbs- und Übernahmegesetz – WpÜG).

The Offer will be subject to customary conditions, such as the granting of regulatory approvals. It will also include a minimum acceptance threshold of 65% of all Shares. Zentiva has already secured a stake of approximately 37.5% of the Shares by entering into a share sale and purchase agreement with the main shareholder of APONTIS PHARMA.

The Executive Board and the Supervisory Board of APONTIS PHARMA welcome and support the Offer, subject to their review of the Offer Document and in compliance with their fiduciary duties. The members of the Executive Board and Supervisory Board intend to tender all Shares held by them.

In accordance with the investment agreement, APONTIS PHARMA will – subject to all fiduciary duties of the Executive Board – apply for the cancellation of the inclusion of the Shares in over-the-counter (OTC) trading on all stock exchanges on which the Shares are traded.

APONTIS PHARMA AG

Investor Relations
ir@apontis-pharma.de
T: +49 2173 89 55 4900
F: +49 2173 89 55 1521
Alfred-Nobel-Str. 10
40789 Monheim / Rhein
Germany
apontis-pharma.de

APONTIS PHARMA Press Contact

CROSS ALLIANCE communication GmbH
Sven Pauly
ir@apontis-pharma.de
T: +49 89 125 09 0330

Disclaimer – Legal notice

The information contained in this press release may include certain forward-looking statements that are based on current assumptions and forecasts made by the management of APONTIS PHARMA AG. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Such factors include those discussed in APONTIS PHARMA AG’s public reports. These reports are available on www.apontis-pharma.de. The Company assumes no obligation to update such forward-looking statements or to adapt them to future events or developments.

APONTIS PHARMA and Zentiva entered into partnership for future growth – Zentiva will launch a voluntary public purchase offer

• APONTIS PHARMA and Zentiva signed an investment agreement today
• Growth strategy of APONTIS PHARMA to be continued together with Zentiva
• APONTIS PHARMA to benefit from the European footprint, the existing research and production facilities, and the financial strength of Zentiva
• Zentiva will offer the shareholders of APONTIS PHARMA AG an offer price of EUR 10.00 per share which corresponds to a premium of 52.9% on the closing price on 15 October 2024 and a premium of 38.3% on the average XETRA closing price for the past three months
• The Executive Board and the Supervisory Board of APONTIS PHARMA fully support the offer
• Zentiva has already secured approximately 37.5% of the APONTIS PHARMA shares by entering into a share sale and purchase agreement with the main shareholder

Monheim / Rhein, 16 October 2024. APONTIS PHARMA AG (Ticker APPH / ISIN DE000A3CMGM5) (APONTIS PHARMA), a leading pharmaceutical company specializing in Single Pill combinations in the German market, and Zentiva, a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines, today signed an investment agreement. Under the terms of the agreement, Zentiva will support the future growth of APONTIS PHARMA.

Zentiva AG, a wholly-owned subsidiary of Zentiva Pharma GmbH, headquartered in Frankfurt / Main, Germany, and part of Zentiva group (“Zentiva”), will launch a voluntary public purchase offer (the “Offer”) for all outstanding shares of APONTIS PHARMA at an Offer Price of EUR 10.00 per share in cash. The offer document (“Offer Document”) will be published on the internet at www.zentiva-offer.com. Zentiva is seeking to acquire a majority stake and is setting a minimum acceptance threshold of 65% of the shares.

Zentiva strives for joint further development of APONTIS PHARMA

Zentiva is the largest supplier of generic drugs in Germany, selling over 100 million packages per year. The company has around 5,000 employees at its headquarters in Prague and in 7 subsidiaries. The business model is based on the provision of branded, specialty, OTC and generic drugs. Zentiva has two of its own research and four production sites for this purpose. With this acquisition, both companies aim to deepen their strategic partnership. In addition, increased investments in the APONTIS PHARMA pipeline and an expansion of the number of product launches, as well as collaboration on the potential international expansion of APONTIS PHARMA products and pipeline, are to be realized.

Zentiva will fully support the Executive Board’s growth strategy. The registered office and headquarters of APONTIS PHARMA in Monheim will be retained.

The business strategy of APONTIS PHARMA with its focus on the concept of Single Pill combinations in the cardiovascular area, as well as selective sales activities for third parties, is to be continued and the product pipeline is to be expanded with an increasing share of exclusive contracts or exclusively developed products. The various strong brands of APONTIS PHARMA are very well known in Germany and will continue to be used (including as trademarks on APONTIS PHARMA products).

The Executive Board and the Supervisory Board of APONTIS PHARMA support the Offer

The Executive Board and the Supervisory Board of APONTIS PHARMA welcome and support the Offer, subject to their review of the Offer Document and in compliance with all their fiduciary duties. The Executive Board and Supervisory Board intend to recommend that the shareholders of APONTIS PHARMA accept the Offer. The members of the Boards intend to tender any APONTIS PHARMA shares held by them into the Offer. The Executive Board and the Supervisory Board assume that the Offer is in the best interest of the Company, its shareholders, employees and other stakeholders.

The Management Board and Supervisory Board intend to disclose a joint, reasoned statement on the Offer, which will be published on APONTIS PHARMA’s website.

Steffen Saltofte, CEO of Zentiva: “We are delighted that the Executive Board and the Supervisory Board welcome the Offer as a long-term solution for the company. We firmly believe that under a unified ownership structure, APONTIS PHARMA will be able to provide high-quality and affordable products to even more customers across Europe, while this partnership is an important step towards achieving Zentiva’s long-term strategy and goals.“

Bruno Wohlschlegel, CEO of APONTIS PHARMA, added: “In the past few months, we have fundamentally reorganized the Company, changed structures, implemented cost-cutting measures and strategically realigned our market access. We have received the best possible support from our experienced Supervisory Board under the leadership of Matthias Wiedenfels. APONTIS PHARMA is now in a significantly better position, and we are seeing the first successes of these efforts. The Offer now on the table is proof of the positive development and market relevance of the Single Pill concept. We welcome Zentiva’s interest and support the Offer. We see the merger as an opportunity to enable more patients to benefit from better treatment in a shorter time.”

Dr. Matthias Wiedenfels, Chairman of the Supervisory Board of APONTIS PHARMA: “Bruno Wohlschlegel and his Executive Board team have developed APONTIS PHARMA into a profitable company with great growth potential. We are pleased that the value increases that have been achieved since Bruno Wohlschlegel took office are clearly reflected in Zentiva’s intention to acquire the Company.”

Transaction details

Zentiva offers the shareholders of APONTIS PHARMA AG EUR 10.00 per share in cash. This Offer Price corresponds to a very attractive premium of 52.9% on the XETRA closing price of APONTIS PHARMA shares on 15 October 2024, the last trading day prior to this publication, and 38.3% to the volume-weighted average stock market price (VWAP) over the past three months. Based on the Offer Price, the market capitalization amounts to approximately EUR 85 million.

The Offer will be subject to customary conditions, such as the granting of regulatory approvals. It will also include a minimum acceptance threshold of 65% of all shares. The acceptance period will begin with the publication of the Offer Document. Zentiva has already secured a stake of approximately 37.5% of the APONTIS PHARMA shares by entering into a share sale and purchase agreement with the main shareholder of APONTIS PHARMA.

Zentiva and APONTIS PHARMA have agreed in the investment agreement that APONTIS PHARMA ‘s Executive Board will, to the extent permitted by law and subject to its fiduciary duties, terminate the inclusion of APONTIS PHARMA’s shares in the trading on the open market (Freiverkehr) immediately following the settlement of the Offer. A separate delisting offer will not be required.

Further details and terms of the Offer will be set forth in the Offer Document. As APONTIS PHARMA is not listed on a regulated market, the Offer is not subject to the German Securities Acquisition and Takeover Act (Wertpapiererwerbs- und Übernahmegesetz – WpÜG). The Offer Document (in German and in a non-binding English translation) and other information relating to the Offer will be published on the following website: www.zentiva-offer.com.

About APONTIS PHARMA:

APONTIS PHARMA AG is a leading pharmaceutical company specializing in Single Pill combinations in Germany. Single Pills combine two to three generic active ingredients in a single dosage form administered once a day. Single Pill therapies have been scientifically proven to significantly increase adherence and thus improve the treatment prognosis and quality of life of patients while reducing complications, mortality, and treatment costs. Consequently, Single Pill combinations are the preferred treatment option in numerous international treatment guidelines, including in the EU and Germany. APONTIS PHARMA has been developing, promoting, and distributing a broad portfolio of Single Pill combinations and other pharmaceutical products since 2013, with a special focus on cardiovascular diseases such as hypertension, hyperlipidemia, and secondary prevention. For additional information about APONTIS PHARMA, please visit www.apontis-pharma.de.

APONTIS PHARMA AG

Investor Relations
ir@apontis-pharma.de
T: +49 2173 89 55 4900
F: +49 2173 89 55 1521
Alfred-Nobel-Str. 10
40789 Monheim / Rhein
Germany
apontis-pharma.de

APONTIS PHARMA Press Contact

CROSS ALLIANCE communication GmbH
Sven Pauly
ir@apontis-pharma.de
T: +49 89 125 09 0330

Disclaimer – Legal notice

The information contained in this press release may include certain forward-looking statements that are based on current assumptions and forecasts made by the management of APONTIS PHARMA AG. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Such factors include those discussed in APONTIS PHARMA AG’s public reports. These reports are available on www.apontis-pharma.de. The Company assumes no obligation to update such forward-looking statements or to adapt them to future events or developments.

Press Release // October 16, 2024
 

Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda^® in peer-reviewed journal Drugs in R&D
 

• The comparative analytical evaluation results indicate that the proposed Keytruda^®-biosimilar FYB206 is structurally and functionally highly similar to the reference product
• Strong analytical results provide a solid foundation for the ongoing clinical trials with FYB206 and underline Formycon’s excellent position in the leading group of pembrolizumab biosimilar developers
   

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the results of the comparative analytical evaluation of the proposed pembrolizumab biosimilar FYB206 and the immuno-oncology blockbuster drug Keytruda^®1 were published in Drugs in R&D, an international, peer-reviewed journal owned by Springer. The paper indicates that FYB206 is structurally and functionally highly similar to the reference product, thereby supporting the testing of the proposed pembrolizumab biosimilar in clinical trials to confirm the similarity between the two products.

To determine FYB206’s suitability to enter clinical trials, a comprehensive comparative analytical assessment was designed to demonstrate analytical similarity in clinically relevant quality attributes between the reference product and the corresponding biosimilar candidate. The analytical panel to evaluate similarity in the current study was designed on the basis of available information on pembrolizumab and knowledge gained during initial analyses of the reference product. The wide battery of qualified and fit for purpose analytical and functional tests was assigned to categories such as structural characterization, product-related variants, glycosylation, general properties, and biological function. All tested functional attributes with a potential impact on clinical performance (PD-1 binding, neutralization of PD-1, FcRn binding) of FYB206 were found to be highly similar to the reference product.

In summary, the results of the extensive data package from all assessments covering structure, purity, protein variants, binding and potency confirm the high similarity between FYB206 and Keytruda^®.

Dr. Andreas Seidl, Chief Scientific Officer (CSO) at Formycon, commented: “The remarkable results of this comparative analytical evaluation suggest that FYB206 has the characteristics to be a safe and efficacious alternative to Keytruda^®. With this solid foundation, obtained prior to the start of the pharmacokinetic equivalence and confirmatory efficacy and safety trials with FYB206 in June and July 2024, we are committed to continuously initiate new clinical centres and to work closely with the investigators to expand access for patients with high unmet medical needs.”

The full paper entitled “Comparative Analytical Evaluation of the Proposed Biosimilar FYB206 and its Reference Medicinal Product Keytruda^®” can be found here.

The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system to activate the body’s own cellular anti-tumor immune response and kill cancer cells. With its broad range of indications in oncology and the continuing high global demand, sales of this currently best-selling drug worldwide could rise to USD 30 billion by 2026.²

FYB206/pembrolizumab is currently being tested in the pharmacokinetic equivalence trial “Dahlia” to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda^® in patients receiving adjuvant treatment for malignant melanoma (black skin cancer). The parallel “Lotus” trial compares the efficacy and safety of FYB206 with Keytruda^® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

—————

¹ Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA

^2. https://www.reuters.com/business/healthcare-pharmaceuticals/merck-raises-2024-profit-forecast-strong-cancer-hpv-drugs-sales-2024-04-25/

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.