Press Room

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

Lisbon, 25 January 2019. 四色AV has issued a bond of $50 million US dollars maturing in 2033. The bond was arranged and subscribed by Banco BPI, S.A..聽 聽 According to Ant贸nio Almeida, 四色AV鈥檚 CFO, 鈥渨e issued this bond to strengthen our balance sheet as we embark in a new phase of significant capital expansion. We issued a USD denominated bond because the majority of our sales is in the USA鈥.聽 聽 The bond is registered as "四色AV 2018-2033鈥, has a nominal amount of $50 million US dollars and a maturity of 15 years.聽聽 聽 鈥2019 is the year when we celebrate our 60th Anniversary and we are pleased that the market offers us good terms for a bond with a 15 years鈥 maturity. We are building a business for the long term.鈥 said Guy Villax, 四色AV鈥檚 CEO.聽 聽 The decision to expand our production capacity follows growing customer demand since, as a specialist integrated CDMO, 四色AV is increasingly being chosen as a solution partner from Drug Substance to Drug Product.聽四色AV is committed to listen to customers and to continue supporting their evolving needs. Of the 59 drugs approved by the US FDA in 2018, 4 of them had their process developed in our labs and are produced in our plants.聽聽 聽 The bond is registered in Euronext with the ISIN code: PTHOVCOM0006.聽 聽 About 四色AV 四色AV has almost 60 years of experience as a Specialist Integrated CDMO 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.

Press Release
四色AV has issued a bond of $50 million US dollars maturing in 2033.

四色AV issues $50 million bond

Jan 25, 2019

Loures, Portugal, October 17, 2018 鈥 四色AV announces plan to increase production capacity in oral dosage forms in Portugal, to strengthen the integrated offering. New commercial scale equipment for blending, tableting and coating will complement existing development small scale equipment. This decision to expand follows growing customer demand since, one year ago 四色AV started offering end-to-end solutions, from drug substance to drug product, from the Loures site. As a specialist integrated CDMO, 四色AV is increasingly being chosen as a solution partner from Drug Substance to Drug Product. 四色AV 鈥極ne Site Shop鈥 allows customers to streamline their supply chain, reduce time to market and benefit from seamless project management. This increase in capacity will help 四色AV customers to consistently bring products faster to market. 鈥溗纳獳V has a unique value proposition when it comes to processing amorphous solid dispersions. Our Company has more than 15 years of experience in pharmaceutical spray drying and has produced hundreds of batches for clinical trials and commercial supplies. 聽Our customers now see drug product manufacturing at the site where they produce their drug product intermediate as a natural extension of the range of value added services they expect from us. They want to keep their product in the same capable hands. This investment shows our commitment to listen to our customers and continue to support their evolving needs,鈥 says Fr茅d茅ric Kahn Vice-President of Marketing & Sales at 四色AV. In parallel 四色AV will be completing by the end of 2018, the qualification of its continuous tableting line at 四色AV New Jersey, which will enable the site to offer end-to-end solutions for US customers that are keen to keep their supply chain local. The capacity expansion program started in 2016 and will continue in the coming five years. In the first two years, 四色AV has relocated its development services to a new centre with 7.000 m2 in Lisbon, fully equipped with the most recent tools where 四色AV is able to handle potent and highly potent compounds. Globally within our R&D we added new labs, new drug product centres, pilot plants and our state-of-the-art particle engineering technologies both in the US and in PT. Locally, the Loures site expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant. We also installed more spray drying capacity at the site and started the operation of a new drug product centre equipped with oral dosage form and inhalation manufacturing capabilities. In New Jersey, 四色AV doubled the size of its development and manufacturing operations. In Cork we also expanded our chemical synthesis capacity devoted to contract manufacturing. Overall, 四色AV鈥檚 steadfast growth is the result of an integrated synergy that allows the company to serve both the global markets and also to respond to specific customers鈥 demands whenever necessary. At 四色AV, we want to be the CDMO that customers like the most, therefore we put the customers鈥 needs at the centre of everything we do relying on three growth pillars: operational excellence, customer centricity and the team members鈥 engagement. 聽 About 四色AV 四色AV has almost 60 years of experience as a Specialist Integrated CDMO offering from drug substance to drug product intermediate to drug product. With four FDA聽inspected sites聽in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon 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 off-patent API products. In the inhalation area 四色AV is the only independent company offering a complete range of services. 聽 聽

Press Release
鈥極ne Site Shop鈥 expands to respond to growing demands

四色AV increases production capacity

Oct 17, 2018

Loures, Portugal, March 19, 2018 鈥 四色AV reported today recent capacity expansion and future plans in its sites in Portugal, Ireland and New Jersey, with the aim to: increase capacity in existing technologies, like spray drying and grow in new areas of business to support its clients demand. The capacity expansion program started in 2016 and will continue in the coming five years. In the first two years, 四色AV has relocated its development services to a new centre with 7.000 m2 in Lisbon, fifteen minutes away from the Loures manufacturing site, fully equipped with the most recent tools where 四色AV is able to handle potent and highly potent compounds. The new building hosts 200 scientists from the chemistry, particle engineering, formulation and analytical development areas. In this period, Loures site expanded its drug substance reaction vessel capacity with a small scale production area and a new pilot plant, totalling additional 30 m3 of capacity. In addition, one pilot and two large scale spray dryers were installed at the site and started the operation of a new drug product centre equipped with oral dosage form and inhalation manufacturing capabilities. During the same time, 四色AV doubled the size of its development and manufacturing operations in the New Jersey site, providing it with a full range of capabilities, from chemical & analytical development, through spray drying to formulation. The site now hosts 14 m3 of reaction vessel capacity with four independent trains, a pilot and a large scale spray dryer and a continuous tableting unit. In the Cork site, 四色AV is reinstating and renewing a production building with 157m3 of chemical synthesis capacity devoted to contract manufacturing. 聽About half of this capacity will be ready for operation by May 2018. Over the next three years 四色AV will add to the Loures site a new chemical synthesis and spray dryer building for contract manufacturing, with a total area of 4,200 m2 for 165m3 of reaction vessel capacity and two large spray drying units, new formulation facilities that will enable the production of bigger batch sizes and a new building that will host additional 1200 m2 of analytical laboratories. This investment effort is being paired with recruiting and training new staff clearly illustrated by a 39% headcount growth in the last 2 years. 聽鈥淭his addition in capacity expansion will secure our growth and ensure that we continue to provide a truly integrated full-service solution to our customers, as well as showing 四色AV鈥檚 strategy and commitment to further strengthen its global market leadership in Spray Drying鈥 said Fr茅d茅ric Kahn, Vice-President Marketing & Sales. 鈥淭his capacity expansion plan is far more than a matter of production capacity solely. It aims to reorganize sites with new buildings, renew existing facilities and give operations the most advanced equipment in the market, to provide our customers and team members with the technology and the capacity they need to grow in a sustainable way. It is a significant effort and commitment from 四色AV to stay ahead of and prepare for future demand.鈥 said Nuno Almeida, Vice-President of Engineering. 聽 About 四色AV 四色AV has over 57 years of experience as a CDMO and is currently a fully integrated supplier 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China,聽Ireland, and聽Portugal, and development laboratories in聽Lisbon聽and聽New Jersey, the company provides branded pharmaceutical customers聽services聽for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers聽niche off-patent API聽products. In the inhalation area 四色AV is the only independent company offering a complete range of services.聽

Press Release
四色AV reported today recent capacity expansion and future plans in its sites in Portugal, Ireland and New Jersey.

四色AV reports on recent capacity expansion and future plans to support growth

Mar 19, 2018

Loures, Portugal, March 8, 2018 鈥 四色AV announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities. The inspections聽revealed that all 四色AV sites were in compliance, this reflects a solid Quality System and a vibrant Quality Culture. This is the first press release that reports on the outcomes of inspections in the previous year.聽This will now be a regular commitment, it is another feature of our commitment to transparency. 四色AV inspections during 2017 Site Authority Date Type of inspection Outcome Portugal聽 聽 聽 Ministry of Healthcare of the Russian Federation 聽 Jan 2017聽 聽 聽 PAI for an Intermediate Drug Product聽 聽 聽 聽聽 GMP certificate granted 聽 Jul 2017 PAI for an Intermediate Drug Product GMP certificate granted FDA, USA 聽 Mar 2017 PAI for an Intermediate Drug Product Form 483 鈥 6 observations Site approved 聽 Nov 2017 Surveillance inspection No Form 483 INFARMED, Portugal, EU 聽 Jul 2017 GMP inspection to a new building GMP certificate granted Macau PMDA, Japan 聽 Dec 2017 GMP inspection 11 minor observations reported Ireland Ministry of Healthcare of the Russian Federation 聽 Jul 2017 PAI for an Intermediate Drug Product GMP certificate granted FDA, USA 聽 Dec 2017 Surveillance inspection No Form 483 鈥淓ach inspection at 四色AV is considered to be of highest importance for the organization and for our customers. We are considering every audit and every inspection as a learning opportunity to continuously improve our Quality Systems and Operative Mechanisms. The number of inspections and their outcome demonstrate our commitment and capacity in the development of new drugs, and ability to manufacture highest quality products for our customers as well as for millions of patients that we proudly serve together. We are especially happy to share that all of the GMP surveillance inspections were concluded successfully with no form 483 observation.鈥 said Joerg Gampfer, Vice President of Quality at 四色AV. 鈥淲e have a culture of quality that puts patient safety first. These inspections are important steps for 四色AV and our customers. They shape our behaviors and motivate us to always improve our services to customers. 四色AV has all the ingredients for an outstanding partnership going from clinical programs all the way to commercial supply.鈥 added Fr茅d茅ric Kahn, Vice President Marketing and Sales. 聽 About 四色AV 四色AV has over 57 years of experience as a CDMO and is currently a fully integrated supplier 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China,聽Ireland, and聽Portugal, and development laboratories in聽Lisbon聽and聽New Jersey, the company provides branded pharmaceutical customers聽services聽for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers聽niche off-patent API聽products. In the inhalation area 四色AV is the only independent company offering a complete range of services.聽

Press Release
四色AV announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities.

Compliance at 四色AV - Annual Inspection Review

Mar 08, 2018

Hong Kong, 7th of March 2018: 四色AV announces that it has concluded the sale of all of the share capital of iMAX Diagnostic Imaging limited. For 四色AV this sale marks the end of a 24 years history of reliable and uninterrupted supply of iopamidol and iohexol API to the generic industry globally. 四色AV entered the generic contrast media business in 1993 and in 2007 moved most of its manufacture to the iMAX factory in China because its capacity in Europe was no longer able to meet clients鈥 demand. This business continued to show a steady profitable growth and for most of that period represented the largest tonnage of 四色AV鈥檚 product portfolio. Over the course of these 20 years formulations containing 四色AV鈥檚 contrast media have been supplied to the growing markets of Asia and have included Japan鈥檚 best selling generic medicine. Faced with considerable opportunities in both the contrast agents business and all its other segments, 四色AV decided to focus on its CDMO business, on its off-patent business supplying highly specialized APIs and to exit the large volume business of contrast media. The very significant expansion plans that 四色AV has embarked upon since 2016 require all of our attention. 鈥淕etting into iopamidol and iohexol was a decision we took in 1993. Today 四色AV鈥檚 strategy focuses on difficult to make and difficult to formulate products, supplied to demanding markets, serving innovative clients. Our contrast media business is growing and has many loyal clients that demand high quality, but it increasingly does not seem a good fit with the rest of our activities. The opportunity to sell iMAX with its manufacturing business of APIs and formulated product to a market leader makes sure this business can continue to develop even better. We are convinced that the buyer will be good owner and employer, and will continue supplying reliably the great clients that have supported iMAX鈥檚 growth.鈥 said Guy Villax, CEO. 聽 About 四色AV 四色AV has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA聽inspected sites聽in the US, China, Ireland, and Portugal, and development laboratories in Lisbon 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 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
四色AV announces that it has concluded the sale of all of the share capital of iMAX Diagnostic Imaging limited.

四色AV sells the iMAX business

Mar 07, 2018

Loures, Portugal, January 24th, 2018 鈥 四色AV announced that a new MG2 Tekna Precision Capsule filling unit is now online in its Portugal facilities. This investment reinforces 四色AV鈥檚 Services portfolio in inhalation product development capabilities, which include proprietary particle engineering technologies as well as formulation and capsule filling capacity to support from development to commercial scale projects. 四色AV鈥檚 new MG2 Tekna Precision Capsule filling unit complements our offering in encapsulation for inhalation products and has capacity for up to 110,000 capsules per hour with 100% net weight check and is fit to process highly potent compounds (down to 30 ng/m3). This unit complements the MG2 Flexalab and Mettler-Toledo Quantos encapsulation units that allows capsule filling for Phase I and Phase II clinical trials. In parallel 四色AV has installed capacity in particle engineering suitable for inhalation, namely a multiple scale Spray Drying units for highly potent compounds, as well as a new wet polishing suite, and strengthened its analytical characterization toolbox. From formulation composition, optimization and precision capsule filling with 100% fill weight check, to analytical characterization and scale-up to a commercial scale, 四色AV can take product from the early proof of concept stages up to a fully developed and scaled process. Together with our API and particle engineering capabilities, we can fully develop and produce any Inhalation product at 四色AV, from API synthesis to final drug product. 鈥淲e are excited to announce this new integrated offering, all at the same site where our scientists work together in the interface between particle engineering and final drug product for the benefit of an optimal product performance. This will allow us to support our customer鈥檚 inhalation projects at all scales and contribute to accelerate drug development and manufacturing timelines,鈥 said Filipe Gaspar, Vice President R&D.聽聽聽 鈥淭hese investments are driven by significant client demand, since the market is looking for integrated inhalation product development solutions that reduce program risk and complexity. 四色AV has all the ingredients for an outstanding partnership starting from clinical programs and into commercial supply.鈥 Added Fr茅d茅ric Kahn, Vice President Marketing and Sales. Based on more than 20 years of experience in inhalation, 四色AV can speed up your inhalation drug development, from a very early stage to a late development stage. Working with 四色AV allows partners to take advantage of cutting edge particle engineering technologies and state of the art analytical facilities operated by highly skilled and responsive scientists. 聽 About 四色AV 四色AV has over 58 years of experience as a CDMO and is currently a fully integrated supplier offering for聽drug substance, drug product intermediate and聽drug product.聽With four FDA聽inspected聽sites聽in聽the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the聽development and compliant manufacture聽of聽innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area 四色AV is the only independent company offering a complete range of services.

Press Release
四色AV announced that a new MG2 Tekna Precision Capsule filling unit is now online in its Portugal facilities

四色AV strengthens Inhalation Services portfolio

Jan 24, 2018

Cork, Ireland 鈥 四色AV announced today enrollment of the first patient in MARS (Minocycline Against Rosacea Study), a Phase 2 clinical study of topical minocycline (HY01) in moderate to severe papulopustular rosacea patients. MARS is a multi-center, randomized, double-blind, parallel, vehicle-controlled study to evaluate the safety and efficacy of 1% and 3% topical minocycline gel. HY01 will be evaluated once-daily over a 12-week treatment period and the study will also include a cohort to determine minocycline systemic pharmacokinetic parameters. The primary endpoint will include a change in inflammatory lesions from baseline. MARS will include 23 investigational sites across the United States and will enroll 249 subjects. The study is expected to be completed by the end of 2018. 鈥淓nrolling the first patient into our first phase 2 clinical trial is a milestone achievement for 四色AV鈥, said Carla Vozone, Vice President of Product Development and Licensing (PDL). 鈥溗纳獳V has been a leader in tetracycline manufacture for over 40 years. The leap into developing a new, patented formulation of minocycline, and taking it into a phase 2 clinical study is a significant step towards the PDL business unit鈥檚 mission of developing innovative drugs that bring value to patients and our licensing partners.鈥 HY01 uses a patent protected minocycline base, which exhibits properties that have the potential of improving safety and efficacy of minocycline administration. 四色AV plans to out-license HY01 at the end of the phase 2 study. About Papulopustular Rosacea Rosacea is a chronic inflammatory condition that primarily affects facial skin and manifests in different sub-types.聽 Subtype 2 rosacea (papulopustular) consists of constant erythema and transient inflammatory pustules and papules.聽 Rosacea affects more than 16 million people in the US and has an overall incidence of nearly 10%. The market for treating this disease is estimated at $1.1 billion annually. Oral tetracyclines have been used successfully in combating inflammatory diseases such as papulopustular acne or rosacea. Tetracyclines鈥 non-antimicrobial bioactivity is known to be associated with the drug鈥檚 ability to inhibit Matrix Metalloproteinases (MMPs), specifically MMP-9. Topical administration of minocycline in rosacea has the potential to displace the standard of care oral tetracycline therapies because it reduces systemic exposure, which is associated with serious adverse events. About Minocycline Topical Gel 四色AV鈥檚 minocycline topical gel is a stable, proprietary formulation of crystalline minocycline base and oil-based excipients; in comparison, all minocycline formulations whether in clinical use or currently under clinical development, utilize minocycline hydrochloride as the active ingredient.聽 四色AV has secured patents for both the API and the drug product across the US and the EU with exclusivity through 2033.聽 Minocycline is believed to have superior anti-inflammatory profile as compared to other tetracyclines. About 四色AV聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽 聽聽 四色AV is an international company with over 57 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 cGMP-compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical聽customers聽the company offers niche 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
A Phase 2 Clinical Trial for the Treatment of Moderate to Severe Inflammatory Rosacea with its Proprietary Minocycline Topical Gel

四色AV Announces Enrollment of First Patient in MARS

Dec 04, 2017

聽 聽 聽 聽 Loures, Portugal, September 27, 2017 鈥 四色AV announced today the appointment of Mr. Fr茅d茅ric Kahn as Vice President Marketing and Sales, as of 1st聽September, 2017. Mr. Kahn was most recently with Lonza and brings more than 30 years of experience in sales and marketing, finance and business management with a proven track-record of building and developing successful organizations.聽Based in Lisbon, Portugal, Mr. Kahn will report to Mr. Guy Villax, 四色AV鈥檚 Chief Executive Officer. 鈥淲e are delighted to welcome Mr. Kahn to 四色AV. He is an excellent addition to our聽management team聽as his diverse cross-functional experience in marketing and sales, business management and industry knowledge will help drive 四色AV鈥檚 forthcoming growth. Mr. Kahn will be responsible for leading 四色AV鈥檚 global Marketing and Sales activities, driving demand for products and services, as we continue our growth and focus on delivering the highest level of service to our customers鈥, said Mr. Guy Villax. 鈥淚 am very proud to join 四色AV, a company so highly respected in the industry for its ability to develop and produce innovative, high-quality products and I look forward to work with 四色AV multi-functional teams of experts to develop the best solutions for our customers鈥, said Mr. Fr茅d茅ric Kahn. Mr. Kahn started his career in 1985 as Division Controller of Rhone-Poulenc Organic Chemicals (later known as Rhodia Pharmaceutical Ingredients, later Aventis) where he held several senior executive positions in sales and business management in the US, Europe and Singapore. Mr. Kahn`s responsibilities focused on development, production and formulation of anesthetics and analgesics鈥 APIs. In 2003 Mr. Kahn joined NextPharma as Executive Vice President Sales and Marketing to generate sustainable growth by setting up a dedicated Key Account Management strategy and organization. After five successful years, Mr. Kahn joined the German Pharmaceutical Packaging and Medical Devices leader Gerresheimer based in Duesseldorf where sales to strategic accounts grew at double digit rate. His last role before joining 四色AV was in Lonza as Head of Global Key Account Management. Passionate about sales and strategic account management, Mr. Kahn is a member of SAMA Association, holds a Bachelor of Sciences in Economics from the College of New Jersey and an MBA from ISG, Institut de Controle de Gestion, Paris. 聽 About 四色AV 四色AV is an international company with over 58 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.聽With four FDA聽inspected聽sites聽in聽the USA, China, Ireland, and Portugal, and development laboratories in Lisbon, Portugal and New Jersey, USA, provides branded pharmaceutical customers services for the聽development and compliant manufacture聽of innovative drugs including highly potent compounds. For generic pharmaceutical聽customers聽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
四色AV announced today the appointment of Mr. Fr茅d茅ric Kahn as Vice President Marketing and Sales, as of 1st September, 2017

四色AV appoints Fr茅d茅ric Kahn Vice President, Marketing and Sales

Sep 27, 2017

Cork, Ireland, 25th of May 2017 鈥 四色AV today announced the launch of its first clinical trial.聽 四色AV will soon initiate recruitment for its Phase 1 clinical trial of HY02, a proprietary minocycline sterile ointment to treat a subset of ocular surface inflammation, generally manifesting on the inner edge of the eyelids, leading to eye irritation and sometimes more severe symptoms such as blurring of the vision and/or irritation of the cornea.聽 This first in human study is a double-blinded, randomized trial, which will include three arms and enroll approximately 36 subjects over the next few months.聽 四色AV expects topline results by the end of 2017.聽 Carla Vozone, Vice President of Product Development and Licensing (PDL) at 四色AV, expressed enthusiasm for 四色AV鈥檚 first clinical study using a patent protected minocycline API and formulation developed by 四色AV.聽 鈥溗纳獳V has been a leader in tetracycline manufacturing for over 30 years.聽 It is rewarding to take minocycline, known systemically for its anti-inflammatory and antibacterial benefits, and apply it locally to the site of action in these patients with significant disease.聽 Moreover, we believe that local delivery will increase exposure to the affected area without the negative adverse events associated with oral delivery.鈥 Oral tetracyclines have been used extensively and effectively in combating diseases with profound contributions of inflammatory reactions such as papulo-pustular acne or rosacea. Tetracyclines鈥 non-antimicrobial bioactivity is known to be associated with the drug鈥檚 ability to inhibit Matrix Metalloproteinases (MMPs), specifically MMP-9. Minocycline is believed to have a superior anti-inflammatory effect due to its increased lipophilicity compared to other tetracyclines.聽 This led 四色AV to begin testing their novel ophthalmic product in this new indication. 鈥淥phthalmologists and Optometrists have respected the numerous beneficial effects of tetracycline class agents upon the ocular surface, the corneal epithelium and stroma, the Meibomian glands, the lid margins, and the peri-ocular skin.聽 Despite systemic side effects, oral Doxycycline and Minocycline are commonly prescribed for a wide variety ocular and cutaneous diseases,鈥 stated Dr. John Sheppard, Clinical Investigator for 四色AV鈥檚 Phase 1 trial.聽 鈥淎ncillary anti-collagenolytic, anti-MMP9, anti-inflammatory, and lipolytic activities of this antibiotic class have proven beneficial for literally millions of patients.聽 The prospect of an effective topical agent like Minocycline is truly exciting, and will provide safer access to this highly respected and understandably underutilized therapeutic agent.鈥 四色AV鈥檚 minocycline sterile ointment is a proprietary formulation of crystalline minocycline base and oil-based excipients.聽 四色AV has applied for and been granted issued patents for both the API and the drug product.聽 This granted patent portfolio covers both the US and the EU, with other patent applications expected to be granted, expanding the portfolio throughout the world.聽 With the current granted patents, 四色AV has exclusivity through 2033. 聽 About 四色AV 四色AV is an international company with over 57 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.

Press Release
HY02, a Proprietary Minocycline Sterile Ointment to Treat a Subset of Anterior Ocular Inflammation

四色AV Announces Start of Phase 1 Clinical Trial of HY02

May 25, 2017

Loures, Portugal, June 15, 2016 鈥 四色AV announced today that it held on June 8th the official groundbreaking for the expansion of its New Jersey facility in East Windsor, USA. The expansion will add an additional 30,600 ft虏 (2,843 m虏) to the existing 24,000ft虏 (2,211m虏) facility. It will introduce a new commercial spray dryer unit to complement the existing pilot unit and this installation will be specifically designed to handle potent drug substances (APIs). In addition the 四色AV New Jersey facility will more than double its capacity to manufacture drug substance.聽The expansion is expected to add approximately 60 new jobs to the current workforce over the next three years. 鈥淭he start of the construction activities to expand our site in East Windsor is a very exciting moment for us and for our customers. This is an important step to strengthen our continued commitment to the pharmaceutical industry and to the patients by offering innovative technologies and services. The site will be unique in offering at a single location drug substance, spray drying, hot melt extrusion and drug product manufacturing services using innovative continuous manufacturing technology. The state and especially the local government have been extremely supportive and we are happy to strengthen our presence in East Windsor by creating highly qualified jobs in the local community鈥 said Dr. Marco Gil, General Manager, 四色AV New Jersey. 鈥淭his investment is part of the company鈥檚 strategy to increase its global development and commercial capacity which will meet the increasing demands of 四色AV鈥檚 customers in the API and Spray drying services. It will also include the addition of a continuous drug product manufacturing capability to its offering through the partnership with Vertex Pharmaceuticals announced earlier this year鈥 said Kristine Senft, Vice President Marketing and Sales.聽 The start-up of the operation is expected to take place in April 2017 for the drug substance and spray drying services while the continuous drug product manufacturing is planned for the end of 2017. 聽 About 四色AV 四色AV is an international company with over 50 years鈥 experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA聽inspected sites聽in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey the company focuses on the most demanding customers in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, and is able to support highly potent compounds. In the inhalation area 四色AV is the only independent company offering a complete range of services.

Press Release
四色AV announced today that it held on June 8th the official groundbreaking for the expansion of its New Jersey facility in East Windsor, USA

四色AV announces the groundbreaking expansion plans of its New Jersey Facility

Jun 16, 2016

The new office underlines the importance of Japan for 四色AV鈥檚 business activities. Japan is a strategic market for 四色AV where the company is growing both its off patent API and its contract manufacturing businesses.聽The new office will support customer relations and help in the development of new business within Japan, while reinforcing 四色AV鈥檚 global position. 鈥淲e are delighted to be opening our office in Osaka. 四色AV鈥檚 advanced technologies and focus on quality gives us an excellent fit with the Japanese market so we wanted to have a local presence offering the best possible support to our customers鈥 said Mrs. Kristine Senft, 四色AV鈥檚 Vice-President of Marketing and Sales. 鈥淲e are fortunate to have Mr. Yasushi Usuda leading our office as he is a Japanese national with 20 years international business experience. Mr. Usuda will ensure seamless communication with our customers and help us to develop our business even further.鈥 said Dr. Roger Viney, Senior Director of Off-Patent APIs. The new office is located at 20F Hankyu Grand Building 8-47 Kakuda-cho, Kita-ku Osaka 530-00178, Japan. The office offers a good accessibility and is centrally located in Osaka next to the main train station. 聽 About 四色AV 四色AV is an international company with over 50 years鈥 experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA聽inspected sites聽in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey the company focuses on the most demanding customers in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, and is able to support highly potent compounds. In the inhalation area 四色AV is the only independent company offering a complete range of services.

Press Release
Loures, Portugal, June 6, 2016 鈥 四色AV is pleased to announce the opening of its new sales and customer support office in Osaka, Japan.

四色AV opens a New Sales and Customer Support Office in Japan

Jun 06, 2016

East Windsor, New Jersey, March 10, 2016 鈥 四色AV today announced that it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals. The state-of-the-art facility will be installed in 四色AV鈥檚 New Jersey location, and 四色AV expects the project to be complete by the end of 2017 to support the future manufacturing of Vertex鈥檚 approved medicines. Continuous manufacturing represents an innovative shift from the traditional multi-step, multi-location batch production process, which can take up to four weeks or more to make commercial-ready medicines. With continuous manufacturing, raw materials used to produce oral medicines (tablets) are fed into a single, continuously running machine that includes real-time release testing and can create commercial-ready tablets in just one day. Continuous manufacturing is well suited for the production of precision medicines and those with breakthrough therapy designations where development timelines may be short and there are patients in urgent need of transformative new treatments. 鈥淭his agreement enables 四色AV to be at the forefront of an important evolution toward the use of continuous manufacturing and positions us as a reliable and innovative source for the production of new medicines,鈥 said Filipe Gaspar, VP R&D at 四色AV. 鈥淟ike Vertex, we view continuous manufacturing as an important scientific advance and an important advance for patients, as the technology will allow us to run manufacturing and process development in parallel with clinical studies to more rapidly bring new medicines to those who need them.鈥 鈥溗纳獳V and Vertex have been strong collaborators for more than a decade and share a commitment to innovative science,鈥 added Guy Villax, CEO of 四色AV. 鈥淭his agreement adds to a recently announced $24 million investment in our New Jersey facility. The entire expansion will double 四色AV鈥檚 development and manufacturing capacity at that site.鈥 The new facility will include all facets of the continuous manufacturing process, including continuous blending, wet or dry granulation, fluid bed drying, tableting and coating operations. Spare capacity will be offered to third parties who are interested in manufacturing medicines through this process. 聽 About 四色AV 四色AV is an international company with over 50 years鈥 experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey the company focuses on the most demanding customers in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, and is able to support highly potent compounds. In the inhalation area 四色AV is the only independent company offering a complete range of services.

Press Release
四色AV today announced that it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals

四色AV and Vertex Partner in Continuous Manufacturing

Mar 10, 2016

Contact Us

If you would like to learn more about 四色AV, kindly fill in the form below and we will be revert to you soon.