Press Room

Lisbon 23rd of August 2022, 四色AV and Zerion Pharma A/S (Zerion) today announced an extension of their collaboration on Zerion鈥檚 Dispersome庐 technology into the nutraceutical/dietary supplements field. Many dietary supplements suffer from low solubility. This results in poor bioavailability and consequently limits the physiological effect of the supplement. To overcome these limitations, the two companies will collaborate and apply the solubility enhancing Dispersome庐 technology for the development and commercialization of certain nutraceutical products.聽 聽 The first product candidate selected for joint development is an antioxidant with multiple health benefits and known for its extremely low solubility and bioavailability. By applying the Dispersome庐 technology, Zerion has been able to demonstrate significant solubility improvements of this antioxidant. Under their collaboration, 四色AV and Zerion will now upscale and develop commercial formulations of the antioxidant using the Dispersome庐 platform and make these products available for distribution by partners globally. Under the terms of the collaboration agreement, the two companies will share income from the commercialization of these products according to their respective contributions.聽 聽 In addition to the joint development projects, Zerion has granted 四色AV an exclusive license to exploit the Dispersome庐 technology for other nutraceuticals/dietary supplements. In return, 四色AV will pay Zerion license fees and royalties on sales of the licensed products.聽 聽 鈥淭he low oral bioavailability of some of the health-promoting nutraceutical compounds is a well-known challenge. The problem is compounded by the fact that some of the solutions used in pharma cannot be used in foods.鈥 says Jean-Luc Herbeaux, CEO of 四色AV. He adds: 鈥溗纳獳V is thrilled to be Zerion麓s exclusive partner for the application of Dispersome庐 to the fields of nutraceuticals and dietary supplements. The Dispersome庐 platform and its enabling ingredient 鈥 beta-lactoglobulin聽or BLG 鈥 afford formulators new options which address unmet needs of the industry.鈥澛犅 聽 鈥淚 am extremely pleased with this extension of our collaboration鈥, says Ole Wiborg, CEO of Zerion and continues: 鈥淭he Dispersome庐 technology is actually very well suited for use in dietary supplements because it employs BLG as its solubility enabling component. BLG is a sustainable natural material and in itself a beneficial nutritional product that we source in high quality from Arla Food Ingredients. Since we as a company only have limited resources to exploit these promising applications of the Dispersome庐 technology in the nutraceutical field, the collaboration with 四色AV is a win/win situation.鈥 聽 In February 2022, Zerion and 四色AV announced a strategic partnership aimed at commercializing the Dispersome庐 technology within the drug development field. Under this partnership, 四色AV and Zerion are offering pharma and biotech companies worldwide access to an innovative drug delivery platform combined with an unparalleled experience in formulation development, scale up and GMP manufacturing. This unique combination provides customers in the pharma industry with a line of sight over the entire drug development life cycle from the preclinical phase to commercial drug product. 聽 About 四色AV:聽四色AV is an international company with over 60 years of experience as a聽Contract Development and Manufacturing Organization聽(CDMO)聽with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. 四色AV provides pharmaceutical customers services for the聽development and compliant manufacture聽of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, 四色AV offers a complete range of services, from API, formulation development and devices. 四色AV麓s culture is based on innovation, quality and delivery. 四色AV was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. 聽 About Zerion Pharma ApS:聽Zerion develops proprietary drug formulations and offers the Dispersome庐 technology to established pharma companies as a means to solve their most challenging drug solubility problems. By applying the Dispersome庐 technology, the solubility of poorly soluble, oral drugs is greatly enhanced, which improves their bioavailability and therapeutic outcomes for the patients. Zerion was established in 2019 as a spinout from the University of Copenhagen based on almost a decade of research.聽(Dispersome庐聽is a trademark of Zerion Pharma A/S) 聽 Learn more about Dispersome庐聽technology 聽

Press Release
四色AV today announced an extension of collaboration on Zerion鈥檚 Dispersome庐 technology into the nutraceutical/dietary supplements field.

Zerion Pharma and 四色AV extend partnership to cover use of the Dispersome庐 technology platform in nutraceuticals

Aug 23, 2022

Lisbon, Portugal and Shanghai, China, 9 May 2022 鈥 四色AV, the leader in spray drying and particle engineering, announced today an exclusive license agreement for a preclinical ophthalmology program, JX08, with Ji Xing Pharmaceuticals Limited (JIXING).聽 JIXING is a biotechnology company headquartered in Shanghai and backed by RTW Investments, LP (RTW), a leading life sciences investment firm, that is focused on advancing innovative medicines for patients with ophthalmic and cardiovascular diseases. Under the license agreement, JIXING will receive global rights to JX08 and lead the full life cycle of development from preclinical through commercialization.聽 鈥淲e are excited to partner with 四色AV and today鈥檚 agreement further strengthens JIXING鈥檚 ophthalmology pipeline beyond its current focus on presbyopia and dry eye disease,鈥 said Peter Fong, PhD, board executive director, JIXING. 鈥淚n addition, this agreement marks a significant step for the company as it highlights its development from a China focused, late clinical-stage biotech to an innovation pioneer with full life cycle development capabilities to reach customers and patients globally.鈥 鈥淲e are extremely pleased to enter into this partnership with JIXING and help the company build upon its existing ophthalmology pipeline while further enhancing 四色AV鈥檚 leadership position in spray dried dispersions鈥 said Marco Gil, VP Sales at 四色AV adding 鈥淥ur highly experienced and committed teams can support pharma and biotech companies worldwide on their path to clinical success and commercialization, offering the best scale-up science, extensive manufacturing capacity and an excellent approval track record.鈥 This Global License Agreement is aligned with 四色AV鈥檚 strategy to offer integrated product solutions for drug delivery that co-create value with its partners and enable the development of innovative medicines that maximize patient benefit.聽 Destum Partners acted as business development and licensing transaction advisor to 四色AV.聽 聽 聽 About JIXING:聽JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in Greater China. For further information about JIXING, please visit www.jixingbio.com聽 聽 About 四色AV:聽四色AV is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization聽(CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. 四色AV provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, 四色AV is the only independent company offering a complete range of services, from API, formulation development and devices. 四色AV is a company with a culture based on innovation, quality and delivery. 四色AV was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. 聽 聽

Press Release
四色AV, the leader in spray drying and particle engineering, announced today an exclusive license agreement for a preclinical ophthalmology program, JX08, with Ji Xing Pharmaceuticals Limited (JIXING).

四色AV and JIXING Announce an Exclusive Global License Agreement for Ophthalmology Program

May 09, 2022

Lisbon, Portugal, 25 February 2022 鈥 四色AV today announced that the Board of Directors and the shareholders have approved the appointment of Dr. Jean-Luc Herbeaux as 四色AV鈥檚 Chief Executive Officer, effective 1st April 2022. 聽 聽 Guy Villax, who has been 四色AV鈥檚 CEO for the past 25 years will now serve as a Member of the Board and shareholder. During his tenure, 四色AV grew tenfold.聽 The company currently employs 2000 team members, serves the global market from four production sites in 3 regions, and is recognized as a leader in its field.聽聽 聽 聽 The Board of Directors expresses its thanks to Guy Villax for his dedication and outstanding achievements. During his career at 四色AV, Guy Villax was also involved with the EFCG and Rx-360 associations and contributed to legislation being passed on both sides of the Atlantic to fight fake medicines and to level the playing field for GMP manufacturing. 聽 聽 鈥淚t has been a privilege and honor to lead 四色AV over the last decades. 四色AV is a great company because of its people and its clients. It has been an amazing entrepreneurial and human journey with so many projects and unforgettable success stories. I have seen this company, founded by my parents, growing, evolving and constantly re-inventing itself鈥, said Guy Villax. 鈥淒r. Herbeaux joined 四色AV nearly two years ago as COO and from day 1 brought change and contributed to financial and business successes.聽 We have worked together both on the strategy which will take 四色AV to the next level and on making this transition smooth. I am certain that both the company and our Team-Members will continue to thrive under his leadership鈥, added Guy Villax.聽聽 聽 聽 鈥淚 am honored to be entrusted with the role of 四色AV鈥檚 CEO and I am deeply motivated to lead this team of talented professionals. Building on Guy Villax麓s legacy of innovation and customer intimacy, we will continue to work to drive long-term growth for both ourselves and our customers maintaining the 四色AV values. 四色AV puts customers and patients at the center of everything it does and this focus will not change. Our customers can expect us to continue to deliver on what we promise and to offer innovative approaches to their project needs.鈥, said Jean-Luc Herbeaux. 聽 聽 Before joining 四色AV in May 2020, Dr. Herbeaux held multiple high-level leadership positions at Evonik, where he last headed the Health Care Business Line Dr. Herbeaux holds both a Master of Science and a Ph.D. in Mechanical Engineering with a research focus on Rheology from the University of Houston. 聽 聽 聽 About 四色AV: 四色AV is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization聽(CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland, and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds and customized product solutions across the entire drug life cycle. In the inhalation area, 四色AV offers a complete range of and services, from API, formulation development and devices. 四色AV was the first Chemical/ Pharmaceutical Company to became a Certified B Corp, is a member of Rx-360, EFCG and participates actively in the industry standard setting process. 聽 聽 聽 聽 聽

Press Release
四色AV today announced the appointment of Dr. Jean-Luc Herbeaux as 四色AV鈥檚 Chief Executive Officer, effective 1st April 2022

Jean-Luc Herbeaux to become 四色AV CEO

Feb 25, 2022

Lisbon, 22nd February 2022 鈥 四色AV, the leader in spray drying and particle engineering, announced today a strategic partnership with Zerion Pharma to market and commercialize Dispersome庐, Zerion麓s proprietary solubility enhancement technology platform. 聽 Zerion麓s innovative Dispersome庐 technology builds on a new concept of increasing drug solubility by using natural protein-based excipients to formulate APIs into amorphous solid dispersions (ASDs) by spray drying. By combining Dispersome庐 technology with 四色AV鈥檚 unique spray drying capabilities, experience in development, scale-up and GMP manufacturing, 四色AV further strengthens its leadership in amorphous solid dispersions and shows its commitment to innovative solutions to overcome one of the most prevalent challenges faced by the industry: low drug solubility.聽 聽 鈥淲e are extremely pleased to have entered into this partnership with Zerion whom we recognize as a very innovative company in the field of oral drug formulations. By joining forces, Zerion and 四色AV will be able to bring Dispersome庐 to the market faster. We look forward to applying the technology in collaboration with our customers and partners in our effort to develop novel drugs with strong benefits to patients.鈥, comments Jean-Luc Herbeaux, 四色AV麓s Chief Operating Officer. 鈥溗纳獳V will continue to pursue opportunities to enhance its offering around core areas of expertise such as particle engineering and inhalation by partnering with companies and research institutions developing innovative drug formulation technologies, like Dispersome庐鈥. 聽 Zerion麓s CEO, Ole Wiborg, sees a strong synergy in the partnership and expects it to generate new pharma partnerships. 鈥淲e consider 四色AV the global leader in the field of producing amorphous solid dispersions by spray-drying. More importantly for us, this leadership has resulted in 四色AV being, over the last 5 years, the main commercial manufacturer of novel FDA-approved drugs formulated as amorphous solid dispersions. Incorporating these competencies in our offering to the pharma industry both validates the strength of our Dispersome庐 platform and provides us and our pharma partners immediate access to the highest quality in upscaling and commercial GMP manufacturing.鈥 says Ole Wiborg. 聽 The announcement of this partnership follows 四色AV鈥檚 communication on a further expansion with an expected investment of $170 million in assets worldwide and shows the company鈥檚 commitment to also expand its technology platforms. 四色AV is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing. 聽 About 四色AV:聽四色AV is an international company with over 60 years of experience as a聽Contract Development and Manufacturing Organization聽(CDMO)聽with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four聽FDA inspected聽sites聽in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. 四色AV provides pharmaceutical customers services for the聽development and compliant manufacture聽of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, 四色AV is the only independent company offering a complete range of services, from API, formulation development and devices. 四色AV is a company with a culture based on innovation, quality and delivery. 四色AV was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. 聽 About Zerion Pharma ApS: Zerion has pioneered the Dispersome庐 technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and therapeutic outcomes for the patients. The Dispersome庐 technology is based on preparing stable amorphous formulations by mixing high loads of the drug compound with beta-lactoglobulin, a sustainable and biodegradable by-product from cheese production. Zerion develops proprietary drug formulations and offers the Dispersome庐 technology to established pharma companies as a means to solve their most challenging drug solubility problems. Zerion was established in 2019 as a spinout from the University of Copenhagen based on almost a decade of research. 聽 聽 (Dispersome庐 is a trademark of Zerion Pharma A/S) 聽 聽 Learn more about Dispersome庐 technology 聽

Press Release
四色AV, the leader in spray drying and particle engineering, announced today a strategic partnership with Zerion Pharma to market and commercialize Dispersome庐, Zerion麓s proprietary solubility enhancement technology platform.

四色AV and Zerion Pharma announce a strategic partnership to market the Dispersome庐 technology platform

Feb 22, 2022

Lisbon, Portugal, 18th February 2022 鈥 四色AV announced today that effective March 1st, or as existing contracts allow, it will increase prices for its Products and Offerings for the global pharmaceutical industry, such as Minocycline, Doxycycline, Ivermectin, Fluticasone, and Mometasone. The necessity of price adjustments stems from increases in the costs of raw materials, labor, energy, transportation, packaging, equipment, and maintenance. Price increases of up to 40% for off-patent Active Pharmaceutical Ingredients and Portfolio Products are required to offset these effects and continue to provide products sustainably to the market. For Development and Manufacturing Services, price increases will be applied to recalibrate the price to cost ratios based on the specific conditions of each program. 四色AV is dedicated to supporting the global pharmaceutical industry and patients around the globe with consistent and reliable supply meeting the most stringent technical, quality, and compliance requirements. We continue to invest in our people, sites, technologies, and products to ensure we meet this commitment. In case you have any questions about these price increases, please contact your account manager. 聽 About 四色AV:聽四色AV is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization聽(CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA聽inspected sites聽in the USA, China, Ireland, and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds and customized product solutions across the entire drug life cycle. In the inhalation area, 四色AV offers a complete range of and services, from API, formulation development and devices. 四色AV was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. 聽

Press Release
News release, 18 February 2022

四色AV increases prices for its off-patent Active Pharmaceutical Ingredients, Portfolio Products as well as Development and Manufacturing Services

Feb 18, 2022

New Jersey, USA, 22nd November 2021 - 四色AV, the global leader in spray drying and particle engineering announced that it is expanding its New Jersey site in East Windsor, laying the foundations for a state-of-the-art 四色AV Campus. This expansion in New Jersey will create up to 100 jobs over the next few years is part of a global expansion strategy representing an investment of $170million in increasing its capacity at its sites in the USA, Ireland and Portugal and was recently announced by Guy Villax, Chief Executive Officer, and Jean-Luc Herbeaux, Chief Operating Officer at 四色AV. In New Jersey, 四色AV will add a 31,000 sqft building next to its current facility in East Windsor, New Jersey, laying the foundations for a state-of-the-art 四色AV Campus. This investment will bring additional commercial spray drying capacity online by 2023. The expansion will allow the company to respond to the needs of customers who favor US-based manufacturing through their development cycles all the way to commercial. Additionally, it will solidify the 四色AV鈥檚 integrated offer: API - Particle Engineering - Drug Product in the region. 鈥溗纳獳V has set the goal of becoming the leading company provider of innovative and integrated solutions for the global pharmaceutical industry by 2028. Given its dimension and above all, the extremely high regulatory requirements, the US market is fundamental for the company and this investment represents a key step in our expansion strategy鈥 says Filipe Tom谩s, General Manager at 四色AV in New Jersey. He adds that 鈥溗纳獳V was established more than 60 years ago in Portugal and the company鈥檚 sustainable organic growth has allowed us to strive for excellence, rigor, innovation and quality. Present in the US since 2002, we have ensured that these values remain at the forefront of what we do at the New Jersey site鈥.聽 About 四色AV:聽四色AV is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. In the inhalation area, 四色AV is the only independent company offering a complete range of services.聽四色AV is a company with a culture based on innovation, quality and delivery. 四色AV is a member of聽Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.聽 聽 聽

Press Release
This expansion in New Jersey will create up to 100 jobs over the next few years is part of a global expansion strategy

四色AV announces New Pharma Campus expansion in New Jersey

Nov 22, 2021

Jean-Luc Herbeaux, COO, and聽Guy Villax, CEO at CPhI Worldwide, in Milan. 聽 Milan, 10th November, 2021 鈥 四色AV, the global leader in spray drying and particle engineering, today announced that it is expanding its industrial facilities around the world to support its ambitious growth objectives. The company has been on an expansion track since 2016 in Portugal, Ireland and New Jersey with the aim of continuing to increase its capacity and capabilities to address customer needs. 聽 The announcement of a $170 million investment in 四色AV units in Portugal, Ireland, and New Jersey, leading to a global capacity increase of approximately 25%, was made at CPhI Worldwide, in Milan, by Guy Villax, CEO, and Jean-Luc Herbeaux, COO.聽 聽 These investments will be used to support growth in the company麓s pharma custom development and manufacturing service business, fueled by strongly growing demand for 四色AV麓s integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing.聽The expansion will go hand-in-hand with a build-up of 四色AV麓s global team with the creation of more than 300 new jobs globally. This strategy will allow the company to continue to address difficult-to-meet client needs while reinforcing its commitment to the 四色AV values and standard of quality. 聽 In the USA, 四色AV will add a 2900m2 building next to its current facility in East Windsor, New Jersey, laying the foundations for a state-of-the-art 四色AV Campus. The upcoming cycle of investment will bring additional commercial spray drying capacity online by 2023. Further investments will follow with the aim to solidify the company麓s integrated offer: API - Particle - Drug Product in the region.聽This expansion will allow 四色AV to accompany existing and new customers favoring US-based manufacturing through their development cycles all the way to commercial. 聽 The capacity and capabilities of 四色AV麓s Cork site in the Republic of Ireland will also be upgraded to enable the production of Highly Potent Active Pharmaceutical Ingredients (HPAPI) and to facilitate onboarding of Drug Substance Manufacturing projects of all sizes.聽The investment will create an ecosystem in which large customer projects with unique technologies can find a home by connecting to the existing infrastructure and equipment. The site will also receive a new commercial size spray dryer to support the growing demand for particle engineering services.聽 聽 In Portugal, 四色AV is ready to start operations of its most recent facility with an increase in chemical synthesis capacity for High Potency Active Pharmaceutical Ingredients (HPAPI). The building is also prepared to receive a new commercial spray dryer to respond to the future needs of the global drug market. 聽 鈥溗纳獳V is in it for life and what better way to manifest this than through expansion of our global capacity and capabilities. Our sustainable organic growth strategy will allow us to keep true to those values that have been guiding us for more than 60 years鈥, says Guy Villax, Chief Executive Officer. 聽 鈥淭hese investments reinforce our integrated specialized offer globally, providing our clients with a line of sight for their projects.聽Focus is placed on facilitating and speeding up the drug development cycle and launch, by providing API manufacturing, Particle Engineering and Tableting services in each site.聽Our strategy continues to be to grow organically via investments in our existing sites, which are designed for purpose.聽This reduces the complexity associated with the growth journey and allows us to focus our management attention on what counts most, i.e. guaranteeing that our clients go to market with quality, safe and effective medicines for their patients鈥 says Jean-Luc Herbeaux, 四色AV鈥檚 Chief Operation Officer. 聽 About 四色AV:聽四色AV is an international company with over 60 years of experience as a聽Contract Development and Manufacturing Organization聽(CDMO)聽and is currently a fully integrated supplier offering services for聽drug substance,聽drug product intermediate聽and聽drug product. With four聽FDA inspected聽sites聽in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the聽development and compliant manufacture聽of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. In the inhalation area, 四色AV is the only independent company offering a complete range of services.聽四色AV is a company with a culture based on innovation, quality and delivery. 四色AV is a member of聽Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.聽 聽 聽

Press Release
四色AV, the global leader in spray drying and particle engineering, today announced that it is expanding its industrial facilities around the world to support its ambitious growth objectives

四色AV invests $170 million in new capacity and capabilities

Nov 11, 2021

Loures and Oeiras, May 27, 2021聽鈥 四色AV was a founding member of iBET in 1989 and has just re-joined the membership of the Instituto de Biologia Experimental e Tecnol贸gica. In order to increase the scope and strength of its research and development programs in the areas of novel and high potential pharmaceutical technologies, 四色AV has chosen to build on the existing knowledge and expertise of Portuguese academia. 四色AV is known worldwide for the process development, manufacture, and formulation of small molecules. Over the past 6 years, 四色AV was the key technical partner behind 24 of the 273 NDAs FDA approved, an 8% share. The partnership with iBET will take 四色AV to new technology frontiers. The Covid-19 pandemic has catalyzed an acceleration of scientific progress, outlining the power of new treatment modalities to fight diseases. The objective is to combine state-of-the-art knowledge from both partners to create strong industrial innovation in new therapeutic fields. The challenge is not trivial and will require more than the combined know-how, skills and capabilities of iBET and 四色AV. 鈥淲e are delighted with the return of 四色AV to the membership of iBET. Our goal is to strengthen the R&D capabilities of our members, this important partnership with 四色AV will allow to pull together complementary scientific competencies and power the development of biopharmaceuticals that are essential to patient health. To win in the area of biologics and novel therapies it is critical to have access to state-of-the-art competencies and support technologies鈥 said Paula Alves, CEO, iBET. 鈥淭he partnership with IBET opens a new chapter in 四色AV's history. We will bring together our knowledge in chemistry, in cutting-edge technologies, of the market and of the FDA regulatory process with iBET鈥檚 command of cell biology, viral biology and bioprocessing. If the twentieth century was the century of chemistry, the 21st century is the one of biology. iBET scientists have built deep knowledge in specific areas, we plan to work together to turn that knowledge into industrial innovation鈥 said Guy Villax, CEO of 四色AV. 鈥溗纳獳V was a founding member of iBET and I had the privilege to meet Ivan Villax, a remarkable scientist and entrepreneur open to the world stage where 四色AV plays a key role since its foundation. The experience in international collaborations and the complementary competencies that 四色AV and iBET have built over the past 25 years in a parallel fashion will now combine in what I expect to be a fruitful collaboration鈥 said Manuel Carrondo, Vice-President, iBET. 聽 About 四色AV:聽Founded in 1959, the multinational 四色AV has today laboratories and plants in Portugal, Ireland, Macau, and the United States of America. 四色AV researches and develops new chemical processes and produces active ingredients for the global pharmaceutical industry. Headquartered in Loures, the company employs 2000 people worldwide. Its research and development activity employs more than 420 technicians and scientists. For more information聽www.hovione.com 聽 About iBET:聽Founded in 1989 as a Research and Development (R&D) institution dedicated to establishing bridges between academia and industry, the Institute of Experimental and Technological Biology (iBET) is today the largest Portuguese private non-profit institution, dedicated biotechnology research, an area in which he was a pioneer. A global reference in the application of biotechnology and bioengineering to health, iBET invests in the development of vaccines, antibodies, recombinant proteins, stem cells, gene therapy and other innovative therapeutic products. In addition to the health sector, iBET also has a strong position in the areas of Clinical Nutrition, Food Industry and the Agroforestry sector. iBET simultaneously develops more than 70 R&D projects, carried out by approximately 215 researchers, including doctorates, engineers, technicians and scholarship holders. Its competencies are supported by a dynamic and multidisciplinary academic and business network, which, together with its structure geared to obtaining applied results, allows it to transfer the knowledge it creates to companies, helping them to innovate, create value, employment, and economic growth. For more information:聽www.ibet.pt For more information, please contact: iBET:聽Hugo Soares |聽hsoares@ibet.pt聽| +351 915 680 594 四色AV:聽Isabel Pina |聽ipina@hovione.com聽| +351 91 750 7462 聽

Press Release
A strategic partnership that will take 四色AV to new technology frontiers.

四色AV and iBET announce strategic collaboration

May 27, 2021

Cork, Ireland, 17 March 2021 鈥 四色AV announced at the Ophthalmology Innovation Summit (OIS) Dry Eye Showcase the successful completion of its Phase 2 clinical trial in 270 patients with Dry Eye caused by Meibomian Gland Dysfunction (MGD). The well controlled and representative study was conducted across 26 clinical sites in the United States and tested 2 different strengths of minocycline against vehicle in a 1:1:1 randomization. This is the first dry eye therapy targeting MGD patients with ocular inflammation demonstrated by an MMP-9 based diagnostic and the first and only ophthalmic formulation of minocycline in clinical development, contingently named Meizuvo庐. The study observed superior clinical outcome in the 70% of patients with positive inflammatory biomarker at baseline, who achieved statistically significant (p=0.02) improvement of 25 points in the Visual Analogue Scale (VAS) discomfort after 2 weeks of treatment, dropping further to 35 points by the end of treatment (an improvement greater than 50%). The sign endpoint inferior Cornea Fluorescein Staining, which is a measure of corneal damage in dry eye, had a statistically significant improvement against vehicle in both active arms at day 57 (p=0.009). The product was safe and well tolerated with less than 3% of subjects reporting blurring vision or eye irritation. Carla Vozone, Vice President of the innovative proprietary portfolio at 四色AV commented: 鈥淭he correlation between the patients with a positive MMP-9 assay at baseline and the clinical improvement observed in both signs and symptoms of dry-eye was groundbreaking鈥. Ms. Vozone explained that investigational Meizuvo庐 not only has the potential of adding a much needed treatment specific for assay recognized inflammation, but could also reduce the risk of failure in the pivotal studies by inclusion of the patient sub-set most responsive to the drug. OIS panelists, who shared their Clinical Perspectives, consensually identified chronic inflammation as the underlying cause of Dry Eye Disease highlighting the relevance of diagnostics to recognize such inflammation. George Magrath, M.D., CEO of Lexitas Pharma Services stated 鈥淲e were thrilled with the opportunity to work on this exciting project.  Minocycline is a well-known molecule for ophthalmologists and there is significant excitement from the ophthalmology community regarding the potential for a topical alternative. The results in the overall population were encouraging in both signs and symptoms.  The results in the inflamed group of subjects were impressive with consistent statistically significant results in key dry eye signs and symptoms.鈥   About Minocycline Ophthalmic Meizuvo庐 (contingent brand name), is the first minocycline repurposed for ophthalmic administration, targeting a novel indication for inflamed MGD. It is a preservative-free formulation enabled by 四色AV鈥檚 proprietary minocycline base which is stabilized as a microparticle in a novel vehicle. The highly tolerable formulation maximizes bioavailability, efficacy and reduces systemic effects. Tetracyclines have been known to treat MGD through anti-inflammatory activity and inhibition of matrix metalloproteinases (MMPs). Minocycline is of particular interest due to its lipophilic nature and resultant affinity to the meibomian gland. Previous research also suggests lipase inhibition effect, which decreases meibomian gland lipid degradation and consequently avoids the release of fatty acids, a synergistic mechanism of downregulating the inflammatory process. As such, minocycline has the potential to address several of the mechanisms that lead to the chronic nature of MGD.   About Inflamed Meibomian Gland Dysfunction MGD is a highly prevalent, chronic condition in the eyelid glands which alters the lipid composition of the tears and triggers evaporation-induced tear hyperosmolarity. Evaporative Dry Eye, which affects 27 million people in the USA, constitutes approximately 80% of all Dry Eye Disease and is largely caused by MGD. The pathophysiological changes of the meibomian gland and tear film instability trigger an inflammatory cascade which results in increased matrix metalloproteinase (MMP-9). Left untreated, the MMP-9 activity in the tear will disrupt the corneal epithelial barrier and induce damage of the ocular surface causing ocular irritation and visual morbidity in dry eye patients. 四色AV鈥檚 presentation made by Courtney Smith, Director of Business Development & Licensing is accessible here     About 四色AV 四色AV is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche API products. 四色AV also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, 四色AV is the only independent company offering a complete range of services.    

Press Release
Showing promise in Dry Eye Disease associated with Inflamed Meibomian Gland Dysfunction

四色AV completes its Phase 2 clinical trial of the first minocycline ophthalmic

Mar 17, 2021

聽 Lisbon, Portugal, 12th January 2021 鈥 四色AV, the leader in Pharmaceutical Spray Drying, today announced the launch of ASD-HIPROS, a proprietary screening service for spray dried dispersions. This platform is the most advanced and most accurate tool to identify optimal and commercially viable Amorphous Solid Dispersions formulation by Spray Drying (ASDs). During drug development, it is crucial to quickly find the optimal formulation assuring fast progress to clinical supplies and minimal formulation changes till commercialization. 聽 ASD-HIPROS, the 四色AV Intelligent PROprietary Screening methodology, is able to rapidly screen for the best combination of polymers, drug loads, surfactants and solvents by using an advanced computational tool followed by producing scale-independent representative samples of the most promising formulations, which are evaluated for performance and stability. 聽 鈥淎SD-HIPROS is a multiple-step screening service that was perfected in the last 15 years and is able to provide an accurate assessment of Spray Dried Dispersion, in less than 2 months and requiring as little as 5-g of API.鈥 commented Dr. Filipe Gaspar, 四色AV鈥檚 Chief Technology Officer. 鈥淥ur accumulated experience and expertise in Spray Drying were used for the development of this platform. It offers a rational formulation definition using a combination of in silico computational modelling and high throughput formulation testing, maximizing the chances of identifying a winning formulation based on outputs obtained from Spray Drying prototypes鈥. 聽 鈥淲e offer a seamless experience, for our customers, and a secure path for their drugs to clinical supplies and commercialization, thanks to our unmatched experience, know-how and manufacturing capacity.鈥 stated Dr. Jean-Luc Herbeaux, 四色AV鈥檚 Chief Operating Officer. 聽 聽 About 四色AV 四色AV is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA聽inspected sites聽in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche API products. 四色AV also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, 四色AV is the only independent company offering a complete range of services. 聽 聽 Contact Isabel Pina | Director External Communications ipina@hovione.com |Tel.: 0035121 982 9362 聽 聽

Press Release
The Most Advanced Screening Service for Optimal Spray Dried Dispersions Formulation

四色AV Launches ASD-HIPROS

Jan 12, 2021

Lisbon, Portugal, 23rd September, 2020 - 四色AV today announced the signing of a partnership agreement with Ligand to significantly ramp up the production output of Captisol庐. Captisol庐, a Ligand product, is a chemically modified cyclodextrin proven to improve the solubility and stability of drugs.聽It is used in the formulation of Gilead鈥檚 Covid-19 treatment Veklury庐 (remdesivir). 四色AV is the sole producer of this key enabling excipient. The Covid-19 pandemic has to date killed one million people; studies show that in the next 3 months cumulative deaths may more than double. 鈥淭o meet Captisol庐 demand associated with Veklury庐, 四色AV will soon be producing per month the quantity it usually produces in one year. This sudden spike in demand has required unique mobilization efforts across the 四色AV network to secure additional raw material supply, execute major capital expenditure projects at our sites, maximize operational efficiency, hire additional talent聽and identify external partners to expand our overall capacity, The pharmaceutical supply chain is working together in an unprecedented fashion to treat patients and save lives.聽 四色AV is privileged to be part of this truly global response.鈥 said Jean-Luc Herbeaux, Chief Operating Officer. 鈥淟igand values its longstanding partnership with 四色AV,鈥 said Matt Foehr, President and Chief Operating Officer of Ligand.聽鈥淭heir excellent customer service, global commitment to quality and high pharmaceutical standards make them an ideal partner for Captisol庐, a critical component for a number of life-saving medicines. We commend them for responsibly and efficiently partnering with Ligand to manage the scale up and expansion of their operations to contribute to global health during the pandemic.鈥 聽 About Captisol庐 Ligand鈥檚 Captisol庐 technology is a patent protected, uniquely modified cyclodextrin, with a chemical structure that was rationally designed to enable the creation of new products by significantly improving solubility, stability, bioavailability and dosing of active pharmaceutical ingredients (APIs). It uses a green manufacturing process that uses water as process solvent. 聽 About Veklury庐 (remdesivir) Gilead Sciences鈥 Veklury庐 is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury庐 for the treatment of SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies. The U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury庐聽 to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. 聽 About 四色AV 四色AV is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA聽inspected sites聽in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. 四色AV also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, 四色AV is the only independent company offering a complete range of services. 聽 Contact Isabel Pina | Director External Communications Tel.: 0035121 982 9362

Press Release
四色AV today announced the signing of a partnership agreement with Ligand to significantly ramp up the production output of Captisol庐

四色AV Announces Partnership to Support Manufacturing of Antiviral Veklury庐 for COVID-19

Sep 23, 2020

1st September 2020 鈥 Bilim Pharmaceuticals, a Turkish company manufacturing and marketing pharmaceutical drugs, H&T Presspart, a global provider of respiratory drug-delivery devices and components to the pharmaceutical sector, and 四色AV Technology, a pharmaceutical specialist in the development of innovative pulmonary device technology, today unveiled a collaboration supporting Bilim Pharmaceutical鈥檚 launch into the Turkish market of Ventofor Combi Fix, a formulation of Budesonide Formoterol for Asthma and COPD management, delivered by the PowdAir Plus Dry Powder Inhaler (DPI). Worldwide over 500 million people suffer from Asthma and COPD. In Turkey, there is growing patient demand for effective, readily accessible and affordable respiratory treatments. Aiming at fulfilling these patient needs, the three companies have been collaborating in Bilim Pharmaceuticals鈥 development program to bring into the Turkish market Ventofor Combi Fix delivered by the PowdAir Plus DPI, an innovative capsule DPI providing maximum simplicity, ease of use and affordability. The PowdAir Plus DPI is exclusively manufactured and commercialized by H&T Presspart under patent license from 四色AV Technology.聽 鈥淚t鈥檚 a great pleasure for us to launch our new product Ventofor Combi Fix with a close collaboration with esteemed companies H&T Presspart and 四色AV Technology. As being one of the strong drivers of Asthma and COPD treatment area, Ventofor Combi Fix is and will be an important part of our portfolio for this treatment area. We are confident that Ventofor Combi Fix will be a remarkable product in its market and crown all the outstanding efforts of the collaborators鈥, said Okan Oncel, Bilim Pharmaceuticals鈥檚 General Manager. 鈥淲e are very happy to see that Bilim Pharmaceuticals has selected the PowdAir Plus DPI for their launch of Ventofor Combi Fix. Due to the strong collaboration of Bilim Pharmaceuticals with 四色AV Technology and H&T Presspart this milestone could be reached. The individual expertise in each of their fields has allowed us to develop a strong partnership in the design, development and manufacture of PowdAir Plus. We look forward to seeing Bilim Pharmaceuticals launch the product to the market and will continue to strongly support them with their inhalation strategy.鈥 said Christian Kraetzig, H&T Presspart鈥檚 President. 鈥淲e are delighted to have started an inhalation collaboration with Bilim Pharmaceuticals, one of Turkey鈥檚 largest pharmaceutical companies, and that they selected our PowdAir Plus DPI to bring Ventofor Combi Fix to patients鈥 hands. We are also happy to continue our partnership with H&T Presspart, a master of large-scale industrialization and distribution, to turn our patented inhaler technology into a commercial ready product that is now globally available to pharmaceutical companies鈥, said Peter Villax, 四色AV Technology鈥檚 CEO.聽 About Bilim Pharmaceuticals Founded in 1953, Bilim Pharmaceuticals is a 100% Turkish capital owned company that manufactures and markets drugs, a strategically important commodity. Ranked as the second largest Turkish Pharma Company in the Turkish pharmaceutical industry, Bilim Pharmaceuticals consistently continues to grow at a higher rate than the market with a marketing and sales team of app. 1000. Bilim Pharmaceuticals carries out its production activities at two separate plants. Approved by EU GMP, Bilim 脟erkezk枚y is one of Turkey鈥檚 most significant penicillin manufacturing facilities. Approved by EU GMP, Bilim Gebze is Turkey鈥檚 largest, most innovative and most environment-friendly drug manufacturing plant. Bilim Pharmaceuticals owns the largest R&D center of the Turkish pharmaceutical industry with a laboratory area of 4,500 square meters, where it develops new products, contributing significantly to the Turkish economy. Exporting to over 60 countries, Bilim Pharmaceuticals has representative offices in Moldova and Albania. In a sensitive sector which is directly related to human health, Bilim Pharmaceuticals prioritizes quality and adopts respect towards future generations as a corporate value.聽 www.bilimilac.com.tr聽 About H&T Presspart H&T Presspart offers pharmaceutical customer鈥檚 high-precision injection moulded plastic components and deep-drawn metal cans for respiratory drug delivery systems, with 50 years' experience and a worldwide reputation for competence, quality and innovation in the pharmaceutical market.聽 H&T Presspart鈥檚 New Product Development Center (NPDC) & Inhalation Product Technology Centre (IPTC) support new product developments and strategic initiatives with our customers. Founded in 1970 and acquired by the Heitkamp and Thumann group in 2002, H&T Presspart has 3 European manufacturing sites with additional sales offices in China, India, the U.S.A. and Uruguay. For more information, please visit www.presspart.com. About 四色AV Technology 四色AV Technology offers access to a complete portfolio of innovative, cost-effective dry powder inhalation devices 鈥 disposable, capsule-based, blister-based and large dose DPIs. With over 20 years of expertise developing innovative inhaler technology, 四色AV Technology鈥檚 team has been behind the first market approved disposable dry powder inhaler for influenza treatment, the TwinCaps DPI, and the new market approved capsule DPI for Asthma and COPD management, the PowdAir Plus DPI. Millions of patients are being treated every year with 四色AV Technology鈥檚 innovative inhaler technology. For more information, please visit www.hovionetechnology.com聽 and contact info@hovionetechnology.com

Press Release

Bilim Pharmaceuticals, H&T Presspart and 四色AV Technology unveil collaboration for new asthma product: Ventofor Combi Fix delivered by PowdAir Plus

Sep 01, 2020

Loures, Portugal, May 4, 2020 鈥 四色AV announced today the appointment of Dr. Jean-Luc Herbeaux as Chief Operating Officer (COO), effective May 1st, 2020. Dr. Herbeaux held, over the past 20 years, multiple high-level leadership positions at Evonik, bringing to 四色AV a proven commitment to develop a successful and globally active business. Based in Lisbon, Portugal, Dr. Herbeaux will work directly with Mr. Guy Villax, 四色AV鈥檚 Chief Executive Officer, in executing the company鈥檚 strategy and vision. 鈥淲e are delighted to welcome Dr. Herbeaux to 四色AV. Jean-Luc will oversee all aspects of 四色AV鈥檚 business operations and I see the creation of this position as another major steppingstone in our journey to become an even stronger company. Our new structure will develop synergies and increase operational efficiency, which will benefit the customers. I am sure this appointment will bring great things to all stakeholders 鈥 patients, customers, and team members as well as shareholders. Our leadership team is now well positioned to accelerate our long-term growth plans鈥, said Mr. Guy Villax. 鈥淚 am really excited to take on the COO role at 四色AV. 四色AV is a company with a great vision, great people and great science and it has an important role in the pharma industry. I look forward to working with Guy and the 四色AV Team to bring this already successful company to new heights鈥, said Dr. Jean-Luc Herbeaux. Prior to joining 四色AV, Dr. Herbeaux headed the Health Care Business Line of Evonik, where he repositioned the business by driving an intentional, sustainable, and profitable growth agenda. His earlier postings, which included senior positions in Europe and Asia, allowed him to develop strong experience in management of complex global organizations. 聽 聽 About 四色AV 四色AV is an international company with 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for聽drug substance, drug product intermediate and聽drug product. With four FDA inspected sites in the聽US,聽Macau,聽Ireland, and聽Portugal, and development laboratories in聽Lisbon聽and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and cGMP-compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche聽API products. 四色AV also provides proprietary product development and聽licensing opportunities聽for drug products. In the inhalation area, 四色AV is the only independent company offering a complete range of services.

Press Release
Effective May 1st, 2020

四色AV Announces the Appointment of Jean-Luc Herbeaux as Chief Operating Officer

May 04, 2020

Cork, Ireland, 20th September 2019 鈥 四色AV announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea. At a recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), 四色AV received guidance for the design and clinical endpoints for HY01, topical minocycline gel 3%. Based on the review of the Phase 2 clinical trial which enrolled 270 subjects across 3 treatment arms (HY01 Gel, 1%, HY01 Gel, 3%, and vehicle), FDA has supported advancement to Phase 3. The two, US based, pivotal studies will enroll 750 subjects each with the primary endpoints of absolute reduction in inflammatory lesions at week 12 compared to baseline and the achievement of 鈥渃lear鈥 or 鈥渁lmost clear鈥 and a 2-grade reduction on the Investigator Global Assessment.聽Additionally, 四色AV will complete a maximal use study in subjects with papulopustular rosacea.聽Assuming replication of the clinically significant improvements in subjects with moderate to severe papulopustular rosacea observed in Phase 2, Minocycline Topical Gel may offer a safer alternative to modified-release doxycycline, which is the only tetracycline approved for the treatment of inflammatory lesions of rosacea1. If approved, Minocycline Topical Gel will provide an important alternative treatment option targeted to the site of action and as thus avoiding the systemic side effects of oral doxycycline. 四色AV鈥檚 topical minocycline is the only program under development that uses a proprietary, crystalline form of the drug as minocycline base, conferring differentiated properties of potentially lower skin irritability based on its lower acidity and superior stability, as compared to its generic alternative. 四色AV has secured patents for both the drug substance and the drug product globally with exclusivity through 2033.聽四色AV鈥檚 topical minocycline uses a novel proprietary excipient that reduces Trans-Epidermal Water Loss (TEWL) and provides a moisturizing, skin-barrier effect, potentially conferring relief to dry cracked skin of some rosacea patients.聽Minocycline is proven to have a potent anti-inflammatory effect,2 potentially superior to other tetracyclines.聽 Guy Webster, M.D. Ph.D., dermatologist at the Sidney Kimmel School of Medicine of Thomas Jefferson University stated: 鈥淎pproximately two-thirds of oral antibiotic prescriptions written by dermatologists are for doxycycline and minocycline for either acne or rosacea. Both compounds are only available for oral delivery and carry a risk of side effects. 四色AV鈥檚 topical minocycline has a systemic exposure 1000 times lower than oral minocycline and provides a topical alternative with a moisturizing formulation. 鈥 四色AV anticipates initiating the Phase 3 trial subject to entering into a strategic collaboration with a commercial partner, by fourth quarter of 2019, aiming at filing the NDA during 2021. 聽 About Rosacea Papulopustular Rosacea (PPR) is a chronic facial skin disease presenting most commonly in adulthood, with an estimated 16 million patients in the United States. PPR is characterized by inflammatory lesions (papules, pustules) on the nose, cheeks, chin and forehead. 聽PPR has been shown to have a negative impact on quality of life. Surveys conducted by the National Rosacea Society have shown that approximately 70% of rosacea patients experience lower self-confidence and lower self-esteem. Forty-one percent stated they avoid public contact and cancel social engagements during an exacerbation2.聽 Strategic Partnership 四色AV is seeking strategic partners with proven regional or global commercial expertise in dermatology capable of maximizing the value of the First Topical Minocycline Gel for Rosacea. 聽 About 四色AV 四色AV is an international company with 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA聽inspected sites聽in the聽US,聽Macau,聽Ireland, and聽Portugal, and development laboratories in聽Lisbon聽and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and cGMP-compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. 四色AV also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, 四色AV is the only independent company offering a complete range of services. 聽 Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. Del Rosso, James Q. et al. Journal of the American Academy of Dermatology, Volume 56, Issue 5, 791 鈥 802 聽 Minocycline: far beyond an antibiotic. Garrido-Mesa N. et al. British Journal of Pharmacology. 2013;169(2):337鈥352. doi:10.1111/bph.12139 聽 聽

Press Release
四色AV announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea.

四色AV announces successful end-of-phase 2 meeting with the FDA and outlines phase 3 program for minocycline topical gel

Sep 20, 2019

聽 四色AV is a pharmaceutical company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market.聽四色AV was established in Portugal in 1959 and today employs 1,742 people worldwide. The Cork site was established ten years ago and currently employs over 210 full-time team members. 鈥淚鈥檓 delighted to see the Cork site playing such an important part in the success of this impressive company,鈥 said Simon Coveney TD, T谩naiste and Minister for Foreign Affairs and Trade speaking at the celebration event for 四色AV鈥檚 60th anniversary.聽鈥溗纳獳V has seen steady growth over the last few years and I鈥檓 confident that the coming years will be equally successful for the Cork team.鈥 鈥淥ur Cork site plays a significant and strategic role within the 四色AV network,鈥 said 四色AV CEO, Guy Villax, who was in Cork for the anniversary celebrations.聽鈥淲ith two Active Pharmaceutical Ingredient facilities alongside a Drug Product Intermediate facility that houses the largest commercial pharmaceutical spray dryer in operation, the Cork site boasts both extensive manufacturing capacity and people capability.鈥 Over the last five years, the 四色AV Cork site has invested close to $30 million in new processing equipment, new analytical equipment, upgrading the facility to contemporary standards, re-instatement of a third production building and the installation of new technologies.聽 鈥溗纳獳V is a fast, challenging, dynamic environment and the team here in Loughbeg are the reason for our continued success,鈥 said Dr. Paul Downing, General Manager at 四色AV Ireland.聽鈥淪ince 2014, we have undergone a significant change in terms of increased volume output and increased capacity utilisation. Along the way, we have further diversified our portfolio, increased complexity, transferred products from sister facilities and increased the number of customers we serve.鈥澛犅犅 四色AV is a proud member of the Ringaskiddy and Loughbeg communities in which it is based and maintains strong links with the local community and sporting organisations. 四色AV is an active member of Business in the Community and holds the Business Working Responsibly mark.聽The Cork site is also a signatory to the Business in the Community Low Carbon Pledge. 聽 About 四色AV 四色AV has almost 60 years of experience as a Specialist Integrated CDMO (Contract Development and Manufacturing Organization) offering from聽drug substance聽to drug product intermediate to聽drug product. With four FDA聽inspected sites聽in the聽US,聽Macau,聽Ireland, and聽Portugal, and development laboratories in聽Lisbon聽and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche聽off-patent API products. In the inhalation area 四色AV is the only independent company offering a complete range of services. 聽

Press Release
Loughbeg, Co. Cork. Thursday, September 5th, 2019: 四色AV is celebrating its 60th Anniversary today in its site in Cork.

四色AV celebrates its 60th Anniversary in Cork

Sep 05, 2019

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