Press Room

1st September 2020 – 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 Hovione Technology, a pharmaceutical specialist in the development of innovative pulmonary device technology, today unveiled a collaboration supporting Bilim Pharmaceutical’s 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’ 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 Hovione Technology.  “It’s a great pleasure for us to launch our new product Ventofor Combi Fix with a close collaboration with esteemed companies H&T Presspart and Hovione 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”, said Okan Oncel, Bilim Pharmaceuticals’s General Manager. “We 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 Hovione 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.” said Christian Kraetzig, H&T Presspart’s President. “We are delighted to have started an inhalation collaboration with Bilim Pharmaceuticals, one of Turkey’s largest pharmaceutical companies, and that they selected our PowdAir Plus DPI to bring Ventofor Combi Fix to patients’ 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”, said Peter Villax, Hovione Technology’s CEO.  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 Çerkezköy is one of Turkey’s most significant penicillin manufacturing facilities. Approved by EU GMP, Bilim Gebze is Turkey’s 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.  www.bilimilac.com.tr  About H&T Presspart H&T Presspart offers pharmaceutical customer’s 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.  H&T Presspart’s 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 Hovione Technology Hovione Technology offers access to a complete portfolio of innovative, cost-effective dry powder inhalation devices – disposable, capsule-based, blister-based and large dose DPIs. With over 20 years of expertise developing innovative inhaler technology, Hovione Technology’s 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 Hovione Technology’s innovative inhaler technology. For more information, please visit www.hovionetechnology.com  and contact info@hovionetechnology.com

Press Release

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

Sep 01, 2020

Loures, Portugal, May 4, 2020 – Hovione 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 Hovione a proven commitment to develop a successful and globally active business. Based in Lisbon, Portugal, Dr. Herbeaux will work directly with Mr. Guy Villax, Hovione’s Chief Executive Officer, in executing the company’s strategy and vision. “We are delighted to welcome Dr. Herbeaux to Hovione. Jean-Luc will oversee all aspects of Hovione’s 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 – patients, customers, and team members as well as shareholders. Our leadership team is now well positioned to accelerate our long-term growth plans”, said Mr. Guy Villax. “I am really excited to take on the COO role at Hovione. Hovione 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 Hovione Team to bring this already successful company to new heights”, said Dr. Jean-Luc Herbeaux. Prior to joining Hovione, 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.     About Hovione Hovione 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 inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon 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. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.

Press Release
Effective May 1st, 2020

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

May 04, 2020

Cork, Ireland, 20th September 2019 – Hovione 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), Hovione 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 “clear” or “almost clear” and a 2-grade reduction on the Investigator Global Assessment. Additionally, Hovione will complete a maximal use study in subjects with papulopustular rosacea. 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. Hovione’s 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. Hovione has secured patents for both the drug substance and the drug product globally with exclusivity through 2033. Hovione’s 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. Minocycline is proven to have a potent anti-inflammatory effect,2 potentially superior to other tetracyclines.  Guy Webster, M.D. Ph.D., dermatologist at the Sidney Kimmel School of Medicine of Thomas Jefferson University stated: “Approximately 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. Hovione’s topical minocycline has a systemic exposure 1000 times lower than oral minocycline and provides a topical alternative with a moisturizing formulation. “ Hovione 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.   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.  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.  Strategic Partnership Hovione 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.   About Hovione Hovione 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 inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon 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. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.   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 – 802   Minocycline: far beyond an antibiotic. Garrido-Mesa N. et al. British Journal of Pharmacology. 2013;169(2):337–352. doi:10.1111/bph.12139    

Press Release
Hovione 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.

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

Sep 20, 2019

  Hovione is a pharmaceutical company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. Hovione 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. “I’m delighted to see the Cork site playing such an important part in the success of this impressive company,” said Simon Coveney TD, Tánaiste and Minister for Foreign Affairs and Trade speaking at the celebration event for Hovione’s 60th anniversary. “Hovione has seen steady growth over the last few years and I’m confident that the coming years will be equally successful for the Cork team.” “Our Cork site plays a significant and strategic role within the Hovione network,” said Hovione CEO, Guy Villax, who was in Cork for the anniversary celebrations. “With 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.” Over the last five years, the Hovione 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.  “Hovione is a fast, challenging, dynamic environment and the team here in Loughbeg are the reason for our continued success,” said Dr. Paul Downing, General Manager at Hovione Ireland. “Since 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.”    Hovione 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. Hovione is an active member of Business in the Community and holds the Business Working Responsibly mark. The Cork site is also a signatory to the Business in the Community Low Carbon Pledge.   About Hovione Hovione has almost 60 years of experience as a Specialist Integrated CDMO (Contract Development and Manufacturing Organization) offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites 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 Hovione is the only independent company offering a complete range of services.  

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

Hovione celebrates its 60th Anniversary in Cork

Sep 05, 2019

Lisbon, 25 January 2019. Hovione has issued a bond of $50 million US dollars maturing in 2033. The bond was arranged and subscribed by Banco BPI, S.A..    According to António Almeida, Hovione’s CFO, “we 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”.    The bond is registered as "Hovione 2018-2033”, has a nominal amount of $50 million US dollars and a maturity of 15 years.     “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’ maturity. We are building a business for the long term.” said Guy Villax, Hovione’s CEO.    The decision to expand our production capacity follows growing customer demand since, as a specialist integrated CDMO, Hovione is increasingly being chosen as a solution partner from Drug Substance to Drug Product. Hovione 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.     The bond is registered in Euronext with the ISIN code: PTHOVCOM0006.    About Hovione Hovione 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 inspected sites 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 Hovione is the only independent company offering a complete range of services.

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

Hovione issues $50 million bond

Jan 25, 2019

Loures, Portugal, October 17, 2018 – Hovione 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 Hovione started offering end-to-end solutions, from drug substance to drug product, from the Loures site. As a specialist integrated CDMO, Hovione is increasingly being chosen as a solution partner from Drug Substance to Drug Product. Hovione ‘One Site Shop’ allows customers to streamline their supply chain, reduce time to market and benefit from seamless project management. This increase in capacity will help Hovione customers to consistently bring products faster to market. “Hovione 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.  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,” says Frédéric Kahn Vice-President of Marketing & Sales at Hovione. In parallel Hovione will be completing by the end of 2018, the qualification of its continuous tableting line at Hovione 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, Hovione has relocated its development services to a new centre with 7.000 m2 in Lisbon, fully equipped with the most recent tools where Hovione 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, Hovione doubled the size of its development and manufacturing operations. In Cork we also expanded our chemical synthesis capacity devoted to contract manufacturing. Overall, Hovione’s 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’ demands whenever necessary. At Hovione, we want to be the CDMO that customers like the most, therefore we put the customers’ needs at the centre of everything we do relying on three growth pillars: operational excellence, customer centricity and the team members’ engagement.   About Hovione Hovione 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 inspected sites 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 Hovione is the only independent company offering a complete range of services.    

Press Release
‘One Site Shop’ expands to respond to growing demands

Hovione increases production capacity

Oct 17, 2018

Loures, Portugal, March 19, 2018 – Hovione 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, Hovione 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 Hovione 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, Hovione 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, Hovione is reinstating and renewing a production building with 157m3 of chemical synthesis capacity devoted to contract manufacturing.  About half of this capacity will be ready for operation by May 2018. Over the next three years Hovione 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.  “This 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 Hovione’s strategy and commitment to further strengthen its global market leadership in Spray Drying” said Frédéric Kahn, Vice-President Marketing & Sales. “This 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 Hovione to stay ahead of and prepare for future demand.” said Nuno Almeida, Vice-President of Engineering.   About Hovione Hovione 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 inspected sites 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 Hovione is the only independent company offering a complete range of services. 

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

Hovione reports on recent capacity expansion and future plans to support growth

Mar 19, 2018

Loures, Portugal, March 8, 2018 – Hovione announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities. The inspections revealed that all Hovione 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. This will now be a regular commitment, it is another feature of our commitment to transparency. Hovione inspections during 2017 Site Authority Date Type of inspection Outcome Portugal      Ministry of Healthcare of the Russian Federation   Jan 2017      PAI for an Intermediate Drug Product         GMP certificate granted   Jul 2017 PAI for an Intermediate Drug Product GMP certificate granted FDA, USA   Mar 2017 PAI for an Intermediate Drug Product Form 483 – 6 observations Site approved   Nov 2017 Surveillance inspection No Form 483 INFARMED, Portugal, EU   Jul 2017 GMP inspection to a new building GMP certificate granted Macau PMDA, Japan   Dec 2017 GMP inspection 11 minor observations reported Ireland Ministry of Healthcare of the Russian Federation   Jul 2017 PAI for an Intermediate Drug Product GMP certificate granted FDA, USA   Dec 2017 Surveillance inspection No Form 483 “Each inspection at Hovione 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.” said Joerg Gampfer, Vice President of Quality at Hovione. “We have a culture of quality that puts patient safety first. These inspections are important steps for Hovione and our customers. They shape our behaviors and motivate us to always improve our services to customers. Hovione has all the ingredients for an outstanding partnership going from clinical programs all the way to commercial supply.” added Frédéric Kahn, Vice President Marketing and Sales.   About Hovione Hovione 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 inspected sites 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 Hovione is the only independent company offering a complete range of services. 

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

Compliance at Hovione - Annual Inspection Review

Mar 08, 2018

Hong Kong, 7th of March 2018: Hovione announces that it has concluded the sale of all of the share capital of iMAX Diagnostic Imaging limited. For Hovione 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. Hovione 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’ demand. This business continued to show a steady profitable growth and for most of that period represented the largest tonnage of Hovione’s product portfolio. Over the course of these 20 years formulations containing Hovione’s contrast media have been supplied to the growing markets of Asia and have included Japan’s best selling generic medicine. Faced with considerable opportunities in both the contrast agents business and all its other segments, Hovione 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 Hovione has embarked upon since 2016 require all of our attention. “Getting into iopamidol and iohexol was a decision we took in 1993. Today Hovione’s 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’s growth.” said Guy Villax, CEO.   About Hovione Hovione 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 inspected sites 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 Hovione is the only independent company offering a complete range of services. 

Press Release
Hovione announces that it has concluded the sale of all of the share capital of iMAX Diagnostic Imaging limited.

Hovione sells the iMAX business

Mar 07, 2018

Loures, Portugal, January 24th, 2018 – Hovione announced that a new MG2 Tekna Precision Capsule filling unit is now online in its Portugal facilities. This investment reinforces Hovione’s 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. Hovione’s 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 Hovione 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, Hovione 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 Hovione, from API synthesis to final drug product. “We 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’s inhalation projects at all scales and contribute to accelerate drug development and manufacturing timelines,” said Filipe Gaspar, Vice President R&D.    “These investments are driven by significant client demand, since the market is looking for integrated inhalation product development solutions that reduce program risk and complexity. Hovione has all the ingredients for an outstanding partnership starting from clinical programs and into commercial supply.” Added Frédéric Kahn, Vice President Marketing and Sales. Based on more than 20 years of experience in inhalation, Hovione can speed up your inhalation drug development, from a very early stage to a late development stage. Working with Hovione 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.   About Hovione Hovione has over 58 years of experience as a CDMO and is currently a fully integrated supplier offering 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 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 Hovione is the only independent company offering a complete range of services.

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

Hovione strengthens Inhalation Services portfolio

Jan 24, 2018

Cork, Ireland – Hovione 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. “Enrolling the first patient into our first phase 2 clinical trial is a milestone achievement for Hovione”, said Carla Vozone, Vice President of Product Development and Licensing (PDL). “Hovione 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’s mission of developing innovative drugs that bring value to patients and our licensing partners.” HY01 uses a patent protected minocycline base, which exhibits properties that have the potential of improving safety and efficacy of minocycline administration. Hovione 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.  Subtype 2 rosacea (papulopustular) consists of constant erythema and transient inflammatory pustules and papules.  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’ non-antimicrobial bioactivity is known to be associated with the drug’s 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 Hovione’s 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.  Hovione has secured patents for both the API and the drug product across the US and the EU with exclusivity through 2033.  Minocycline is believed to have superior anti-inflammatory profile as compared to other tetracyclines. About Hovione                                           Hovione 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 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 cGMP-compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione 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

Hovione Announces Enrollment of First Patient in MARS

Dec 04, 2017

        Loures, Portugal, September 27, 2017 – Hovione announced today the appointment of Mr. Frédéric Kahn as Vice President Marketing and Sales, as of 1st 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. Based in Lisbon, Portugal, Mr. Kahn will report to Mr. Guy Villax, Hovione’s Chief Executive Officer. “We are delighted to welcome Mr. Kahn to Hovione. He is an excellent addition to our management team as his diverse cross-functional experience in marketing and sales, business management and industry knowledge will help drive Hovione’s forthcoming growth. Mr. Kahn will be responsible for leading Hovione’s 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”, said Mr. Guy Villax. “I am very proud to join Hovione, 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 Hovione multi-functional teams of experts to develop the best solutions for our customers”, said Mr. Frédéric 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’ 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 Hovione 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.   About Hovione Hovione 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 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, 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. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.

Press Release
Hovione announced today the appointment of Mr. Frédéric Kahn as Vice President Marketing and Sales, as of 1st September, 2017

Hovione appoints Frédéric Kahn Vice President, Marketing and Sales

Sep 27, 2017

Cork, Ireland, 25th of May 2017 – Hovione today announced the launch of its first clinical trial.  Hovione 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.  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.  Hovione expects topline results by the end of 2017.  Carla Vozone, Vice President of Product Development and Licensing (PDL) at Hovione, expressed enthusiasm for Hovione’s first clinical study using a patent protected minocycline API and formulation developed by Hovione.  “Hovione has been a leader in tetracycline manufacturing for over 30 years.  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.  Moreover, we believe that local delivery will increase exposure to the affected area without the negative adverse events associated with oral delivery.” 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’ non-antimicrobial bioactivity is known to be associated with the drug’s 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.  This led Hovione to begin testing their novel ophthalmic product in this new indication. “Ophthalmologists 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.  Despite systemic side effects, oral Doxycycline and Minocycline are commonly prescribed for a wide variety ocular and cutaneous diseases,” stated Dr. John Sheppard, Clinical Investigator for Hovione’s Phase 1 trial.  “Ancillary anti-collagenolytic, anti-MMP9, anti-inflammatory, and lipolytic activities of this antibiotic class have proven beneficial for literally millions of patients.  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.” Hovione’s minocycline sterile ointment is a proprietary formulation of crystalline minocycline base and oil-based excipients.  Hovione has applied for and been granted issued patents for both the API and the drug product.  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.  With the current granted patents, Hovione has exclusivity through 2033.   About Hovione Hovione 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 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. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione 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

Hovione Announces Start of Phase 1 Clinical Trial of HY02

May 25, 2017

Loures, Portugal, June 15, 2016 – Hovione 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 ft² (2,843 m²) to the existing 24,000ft² (2,211m²) 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 Hovione New Jersey facility will more than double its capacity to manufacture drug substance. The expansion is expected to add approximately 60 new jobs to the current workforce over the next three years. “The 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” said Dr. Marco Gil, General Manager, Hovione New Jersey. “This investment is part of the company’s strategy to increase its global development and commercial capacity which will meet the increasing demands of Hovione’s 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” said Kristine Senft, Vice President Marketing and Sales.  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.   About Hovione Hovione is an international company with over 50 years’ 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 Hovione is the only independent company offering a complete range of services.

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

Hovione announces the groundbreaking expansion plans of its New Jersey Facility

Jun 16, 2016

The new office underlines the importance of Japan for Hovione’s business activities. Japan is a strategic market for Hovione where the company is growing both its off patent API and its contract manufacturing businesses. The new office will support customer relations and help in the development of new business within Japan, while reinforcing Hovione’s global position. “We are delighted to be opening our office in Osaka. Hovione’s 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” said Mrs. Kristine Senft, Hovione’s Vice-President of Marketing and Sales. “We 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.” 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.   About Hovione Hovione is an international company with over 50 years’ 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 Hovione is the only independent company offering a complete range of services.

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

Hovione opens a New Sales and Customer Support Office in Japan

Jun 06, 2016

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