Press Room

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

Press Release

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

Feb 18, 2022

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

Press Release

Hovione announces New Pharma Campus expansion in New Jersey

Nov 22, 2021

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

Press Release

Hovione invests $170 million in new capacity and capabilities

Nov 11, 2021

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

Press Release

Hovione and iBET announce strategic collaboration

May 27, 2021

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

Mar 17, 2021

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

Press Release

Hovione Launches ASD-HIPROS

Jan 12, 2021

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

Press Release

Hovione Announces Partnership to Support Manufacturing of Antiviral Veklury® for COVID-19

Sep 23, 2020

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

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 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

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 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

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 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

Compliance at Hovione - Annual Inspection Review

Mar 08, 2018

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