Bluepharma Indústria Farmacêutica SA

THIS PRESS RELEASE CONTAINS INFORMATION THAT NANOFORM IS OBLIGED TO MAKE PUBLIC PURSUANT TO THE EU MARKET ABUSE REGULATION. THE INFORMATION WAS SENT FOR PUBLICATION THROUGH THE AGENCY OF THE CONTACT PERSONS SET OUT BELOW, ON JANUARY 26, 2024, AT 11:20 FINNISH TIME / 10:20 SWEDISH TIME. HELSINKI , Jan. 26, 2024 /PRNewswire/ -- Nanoform Finland Plc ("Nanoform"), the medicine performance-enhancing company, today announced that one of its leading nanoformulation drug products had received promising clinical results. These were from a relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutamide) tablet formulation, an alternative to the amorphous solid dispersion (ASD) used in Xtandi®[1], the number one prescribed androgen receptor inhibitor[2] first approved by the FDA in 2012, and by the EMA in 2013 to treat prostate cancer. The nanoenzalutamide tablet formulation was developed in a partnership with the ONConcept® Consortium (Bluepharma, Helm, and Welding) whereby Nanoform's proprietary controlled expansion of supercritical solutions (CESS®) technology provides the opportunity for an improved and differentiated finished product. Tablet-burden and dysphagia are well-documented challenges for prostate cancer patients, and the development of a 160mg, single tablet per day regimen may be preferable for patients in need of reducing their total number of daily pills. The single-dose, randomized, comparative bioavailability study, which was performed by a contract research organization (CRO) in North America and completed on January 25, 2024, compared enzalutamide 160mg filmcoated tablets (Bluepharma) and Xtandi® 4x40 mg film-coated tablets (Astellas Pharma Europe B.V.). The clinical trial demonstrated promising results. Nanoform and ONConcept® will further analyze these results prior to moving ahead to enter the phase of process validation and pivotal clinical trials. A patent application for the nanoenzalutamide formulation has already been jointly filed by Helm and Nanoform. We aim for the product launch after the expiry of the enzalutamide substance patent in the respective territories. For the United States this patent expiry is expected in 2027, and in Europe in 2028. This unique IP position may allow the nanoenzalutamide product to enter the market prior to other generic competition based on the ASD formulation, which is currently patent protected in the US and Europe until 2033. "We are delighted to have achieved promising results from this clinical trial, bringing closer the prospect of making the lives of prostate cancer patients around the world easier in their daily struggle managing this common disease", said Dr. Edward Haeggström, Chief Executive Officer of Nanoform. "This program exemplifies the opportunity available to create novel and improved dosage forms of existing medicines and to ensure that those drugs in clinical development are patient-centric before they reach the market. Together with our ONConcept® Consortium partners, we look forward to executing licensing deals this year and in the future to commercialize nanoenzalutamide." [1] Xtandi is a registered trademark of Astellas Pharma Inc. [2] Source: xtandi.com Nanoform will present the conclusions in a live webcast presentation and conference call on Friday January 26, 2024, at 14:00 Helsinki time / 13:00 Stockholm time. Following the presentation there will be a question-and-answer session. Please note that you must dial in to present questions. The presentation will be broadcast live as a webcast available at: Teleconference dial-in numbers: Register using the link below to receive dial-in details and a conference ID for the webinar and conference call. For further information, please contact: Christian Jones, Chief Commercial Officer [email protected] +44 7804 474 771 For investor relations queries, please contact: Henri von Haartman, Director of Investor Relations [email protected] +46 7686 650 11 About Nanoform Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules' performance through its nanoforming technologies and formulation services, from pre-formulation to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. Nanoform's shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 744 1900. For more information, please visit . About ONConcept® Consortium The three independent and certified European pharmaceutical companies - Bluepharma, Helm and Welding - joined forces in 2019 after identifying a significant opportunity for a leading partnership that can develop and manufacture complex, differentiated and highly potent products for licensing to pharmaceutical companies operating in markets around the world. ONConcept® consortium develops a portfolio of more than 15 molecules and makes them available for licensing and distribution by pharmaceutical companies around the world. The consortium is based on a profound international network and global experience in value-added products, in-house scientific-, IP-, regulatory-, and commercial expertise to be in the position to offer services covering the entire value chain according to customer needs. Bluepharma (Portugal) operates as a contract development and manufacturing organization and has in-house all the capabilities needed to develop a medicine from scratch and, in the period before the formation of ONConcept®, began applying them to the development of complex products. Bluepharma has global regulatory approvals and experience filing submissions with authorities around the world. Helm AG (Germany) has a strong track record of collaborating with international partners to apply its scientific, IP, regulatory and quality expertise to the development of generic and differentiated pharmaceuticals. The work has turned Helm into an experienced coordinator of different stakeholders and an expert in handling active pharmaceutical ingredients. WELDING (Germany) has built an excellent reputation for leading projects from start to finish. Since its establishment in 1955, WELDING has been serving as a trusted global partner to companies worldwide. We distribute raw materials and offer a wide range of ready-to-use drug formulations to the healthcare community. Nanoform Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform's strategy, business plans and focus. The words "may", "will", "could", "would", "should", "expect", "plan", "anticipate", "intend", believe", "estimate", "predict", "project", "potential", "continue", "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform's business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks described in the Report of the Board of Directors and Financial Statements for the year ended December 31, 2022 as well as our other past disclosures. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The following files are available for download: SOURCE Nanoform

HELSINKI, Jan. 26, 2024. Nanoform Finland Plc ("Nanoform"), the medicine performance-enhancing company, today announced that one of its leading nanoformulation drug products had received promising clinical results. These were from a relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutamide) tablet formulation, an alternative to the amorphous solid dispersion (ASD) used in Xtandi [1] , the number one prescribed androgen receptor inhibitor [2] first approved by the FDA in 2012, and by the EMA in 2013 to treat prostate cancer. The nanoenzalutamide tablet formulation was developed in a partnership with the ONConcept® Consortium (Bluepharma, Helm, and Welding) whereby Nanoform's proprietary controlled expansion of supercritical solutions (CESS®) technology provides the opportunity for an improved and differentiated finished product. Tablet-burden and dysphagia are well-documented challenges for prostate cancer patients, and the development of a 160mg, single tablet per day regimen may be preferable for patients in need of reducing their total number of daily pills. The single-dose, randomized, comparative bioavailability study, which was performed by a contract research organization (CRO) in North America and completed on January 25, 2024, compared enzalutamide 160mg filmcoated tablets (Bluepharma) and Xtandi® 4x40 mg film-coated tablets (Astellas Pharma Europe B.V.). The clinical trial demonstrated promising results. Nanoform and ONConcept will further analyze these results prior to moving ahead to enter the phase of process validation and pivotal clinical trials. A patent application for the nanoenzalutamide formulation has already been jointly filed by Helm and Nanoform. We aim for the product launch after the expiry of the enzalutamide substance patent in the respective territories. For the United States this patent expiry is expected in 2027, and in Europe in 2028. This unique IP position may allow the nanoenzalutamide product to enter the market prior to other generic competition based on the ASD formulation, which is currently patent protected in the US and Europe until 2033. "We are delighted to have achieved promising results from this clinical trial, bringing closer the prospect of making the lives of prostate cancer patients around the world easier in their daily struggle managing this common disease", said Dr. Edward Haeggström, Chief Executive Officer of Nanoform. "This program exemplifies the opportunity available to create novel and improved dosage forms of existing medicines and to ensure that those drugs in clinical development are patient-centric before they reach the market. Together with our ONConcept® Consortium partners, we look forward to executing licensing deals this year and in the future to commercialize nanoenzalutamide." [1] Xtandi is a registered trademark of Astellas Pharma Inc. [2] Source: xtandi.com About Nanoform Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules' performance through its nanoforming technologies and formulation services, from pre-formulation to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. Nanoform's shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). About ONConcept Consortium The three independent and certified European pharmaceutical companies - Bluepharma, Helm and Welding - joined forces in 2019 after identifying a significant opportunity for a leading partnership that can develop and manufacture complex, differentiated and highly potent products for licensing to pharmaceutical companies operating in markets around the world. ONConcept® consortium develops a portfolio of more than 15 molecules and makes them available for licensing and distribution by pharmaceutical companies around the world. The consortium is based on a profound international network and global experience in value-added products, in-house scientific-, IP-, regulatory-, and commercial expertise to be in the position to offer services covering the entire value chain according to customer needs. Bluepharma (Portugal) operates as a contract development and manufacturing organization and has in-house all the capabilities needed to develop a medicine from scratch and, in the period before the formation of ONConcept®, began applying them to the development of complex products. Bluepharma has global regulatory approvals and experience filing submissions with authorities around the world. Helm AG (Germany) has a strong track record of collaborating with international partners to apply its scientific, IP, regulatory and quality expertise to the development of generic and differentiated pharmaceuticals. The work has turned Helm into an experienced coordinator of different stakeholders and an expert in handling active pharmaceutical ingredients. WELDING (Germany) has built an excellent reputation for leading projects from start to finish. Since its establishment in 1955, WELDING has been serving as a trusted global partner to companies worldwide. We distribute raw materials and offer a wide range of ready-to-use drug formulations to the healthcare community. Nanoform Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform's strategy, business plans and focus. The words "may", "will", "could", "would", "should", "expect", "plan", "anticipate", "intend", believe", "estimate", "predict", "project", "potential", "continue", "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform's business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks described in the Report of the Board of Directors and Financial Statements for the year ended December 31, 2022 as well as our other past disclosures. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Posted: January 2024 Related articles Pfizer and Astellas' Xtandi Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting - November 16, 2023 FDA Approves Xtandi (enzalutamide) for the Treatment of Metastatic Castration-Sensitive Prostate Cancer (mCSPC) - December 16, 2019 FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) - July 13, 2018 FDA Approves Xtandi for Late-Stage Castration-Resistant Prostate Cancer - August 31, 2012 Medivation and Astellas Announce Submission of New Drug Application for Enzalutamide for the Treatment of Castration-Resistant Prostate Cancer in Patients Previously Treated with Chemotherapy - May 22, 2012 Xtandi (enzalutamide) FDA Approval History More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

The investment totals €30million ($32million) which has provided the plant in Portugal, one of Europe’s largest for the production of medicnes, with these specifications. The new unit in Eiras, Coimbra, has created 100 mostly highly-qualified jobs. This production unit materializes the ONConcept project, which brought Bluepharma together in a partnership with two German companies in the pharmaceutical area - Helm and Welding. Bluepharma says the new unit represents an important role to Europe's reindustrialization strategy, while being an important contribution to the sustainability of the health systems and accessibility of life-changing medicines to oncology patients. The company operates as a CDMO and offers an integrated approach from development to commercial manufacturing. With Helm and Welding, the collaboration will use its scientific and regulatory knowledge, growing the active pharmaceutical ingredients (API) network offering its own intellectual property service, strengthening the individual market knowledge and a strong highly potent products portfolio of those made in Europe. The ONConcept project has built a basket of more than 20 products providing a stream of new opportunities to its partners, with some molecules open to off-patient competition now while others will have dates for later in the decade. The company saus that in the coming years, the strategic alliance wants to become known as a reputable European supplier of highly potent drugs with the capabilities needed to develop, register, and supply complex products, ensuring competitiveness across the product lifecycle. googletag.cmd.push(function () { googletag.display('text-ad1'); }); The launch ceremony was attended by a number of national and international dignitaries including the Portuguese Minister of Economy and Sea, António Costa Silva, the President of Medicines for Europe, Elisabeth Stampa, and the President of Bluepharma, Paulo Barradas Rebelo.