Press Room

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

East Windsor, New Jersey, March 10, 2016 – Hovione today announced that it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals. The state-of-the-art facility will be installed in Hovione’s New Jersey location, and Hovione expects the project to be complete by the end of 2017 to support the future manufacturing of Vertex’s approved medicines. Continuous manufacturing represents an innovative shift from the traditional multi-step, multi-location batch production process, which can take up to four weeks or more to make commercial-ready medicines. With continuous manufacturing, raw materials used to produce oral medicines (tablets) are fed into a single, continuously running machine that includes real-time release testing and can create commercial-ready tablets in just one day. Continuous manufacturing is well suited for the production of precision medicines and those with breakthrough therapy designations where development timelines may be short and there are patients in urgent need of transformative new treatments. “This agreement enables Hovione to be at the forefront of an important evolution toward the use of continuous manufacturing and positions us as a reliable and innovative source for the production of new medicines,” said Filipe Gaspar, VP R&D at Hovione. “Like Vertex, we view continuous manufacturing as an important scientific advance and an important advance for patients, as the technology will allow us to run manufacturing and process development in parallel with clinical studies to more rapidly bring new medicines to those who need them.” “Hovione and Vertex have been strong collaborators for more than a decade and share a commitment to innovative science,” added Guy Villax, CEO of Hovione. “This agreement adds to a recently announced $24 million investment in our New Jersey facility. The entire expansion will double Hovione’s development and manufacturing capacity at that site.” The new facility will include all facets of the continuous manufacturing process, including continuous blending, wet or dry granulation, fluid bed drying, tableting and coating operations. Spare capacity will be offered to third parties who are interested in manufacturing medicines through this process.   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 today announced that it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals

Hovione and Vertex Partner in Continuous Manufacturing

Mar 10, 2016

Loures, Portugal, October 19th, 2015 – Hovione announced today that it is investing in specialized formulation capabilities. The first step of the plan was the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms. The facility will be engineered to enable to work with highly potent APIs and moisture sensitive compounds and will have dedicated rooms to allow for concurrent manufacture of these products. The facility will be capable to prepare a wide range of materials suitable for clinical trials as well as commercial batches meeting global regulatory requirements. “Over the last decade we have built great knowledge in developing final dosage forms in the area of dry powder inhalation and oral dosage forms and have installed state-of-the-art formulation equipment to support these activities. Adding to our drug substance and particle engineering capabilities this new plant expands our integrated offer and technological capabilities to provide the best service to our customers”, said Filipe Gaspar, Hovione’s Vice-President R&D. “ “With this investment we will be able to expand our offerings and provide our clients with new services. I am sure our customers will value the option of not having to ship the material that comes out of our reactors and spray dryers to outside the walls of our site and away from our trusted quality culture.  This is also a great way to speed up the entire CMC development to meet the needs of the growing number of accelerated programs that our clients ask us to deliver on”, said Guy Villax, Hovione’s Chief Executive. 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 U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. 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 announced today that it is investing in specialized formulation capabilities.

Hovione acquires a Formulation Plant

Oct 19, 2015

Loures, Portugal, October 12, 2015 – Hovione announced today the appointment of Ms. Kristine Senft as Vice President Sales and Marketing. Ms. Senft joined Hovione on the 1st October and will succeed Mr. Dave Hoffman Vice President Sales and Business Development when he retires in April 2016. Ms. Senft was most recently with DSM and brings a vast experience in Sales and Marketing. Based in East Windsor, New Jersey, Ms. Senft will report to Guy Villax, Hovione’s Chief Executive Officer. “Hovione is delighted to welcome Ms. Senft to our management team. I very much look forward to working with Kristine.  Kristine brings to Hovione exactly what we need as we enter this next phase of growth”, said Guy Villax. “I am delighted to join Hovione, a company with a dynamic team and a strong history that understands the nature of leading through innovation. I look forward to building on what has been achieved by Hovione to date in its creation of solutions for customers”, said Ms. Senft. Before joining Hovione, Ms. Senft previously served various roles as a Business Unit Director, DSM Biomedical and before that as SVP, Marketing and Sales, DSM Pharmaceutical Chemicals where she led both regional and global marketing and sales organizations while experiencing expatriate life in Vienna, Austria, working with many of the top global pharma and biopharma companies. She also worked for Albemarle Corporation for many years in mainly Sales and Business Management roles in their Fine Chemicals and Pharmaceutical API businesses. Ms. Senft was also Co-Chair of the Women’s Initiative Network at Albemarle and was an executive member of the DSM Diversity Council. During her career she served on the Society of Chemical Manufacturers Association (SOCMA) Communications Committee and Membership Committee for several years. She is an active supporter of the Drug, Chemical and Associated Technologies Association (DCAT), DCAT Week and has recently served on the DCAT Board of Directors. While residing in Europe she was also associated with the European Fine Chemicals Group (EFCG). Ms. Senft graduated from Eastern Illinois University with a BSc in Chemistry. She recently (2014) completed the Executive Leadership Program with DSM / Wharton, University of Pennsylvania. 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 U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. Hovione is a member of Rx-360, EFCG and APIC and is active in the standard setting process of our industry, this reflects its commitment to higher global industry standards.   

Press Release
Ms. Senft joined Hovione on the 1st October and will succeed Mr. Dave Hoffman Vice President Sales and Business Development when he retires in April 2016.

Hovione Appoints Kristine Senft Vice President, Sales and Marketing

Oct 12, 2015

Loures, Portugal, September 29, 2015 – Hovione announced today the expansion of its New Jersey facility in East Windsor, USA. This investment is part of the company’s strategy to increase its global development and commercial capacity to meet the increasing demands of Hovione’s customers.  The expansion will add an additional 30,600 ft² (2,843 m²) to the 24,000ft² (2,211m²) facility. It will introduce a new commercial spray dryer unit to complement their existing pilot unit and this installation will be specifically designed to handle potent drug substances (APIs). In addition the expansion will more than double the drug substance capacity at the site to support the needs of the current and future customer base. The expansion is expected to add approximately 60 new jobs to the current workforce. “Expanding our manufacturing presence in USA highlights our commitment to our customers that want to manufacture their products in the US and to support the development needs of our ever expanding local customer base. The additional capacity will give us more flexibility and make us more agile to deal with our customer’s fast paced projects.” said Dr. Marco Gil, General Manager, Hovione New Jersey. “This investment pays a tribute to the excellent work that Hovione New Jersey team has done to create a sustainable business for the company in the US. We trust the team in New Jersey to be an integral part of Hovione’s overall expansion. ” said Dave Hoffman, President of the US Operations.  “The State and especially the local government have been extremely supportive of us in the past and in our growth plans for the future and we are excited to partner with them to create new jobs in the local community.” The official ground breaking should occur in the first quarter of 2016 and the doubling of capacity is expected to be fully operational in early 2017. This expansion will give our customers more options for spray drying manufacturing at Hovione. With commercial scale facilities in Portugal, Ireland and the U.S. we offer unmatched supply risk management through our vast internal network of compliant manufacturing capacity.    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 U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. 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 announced today the expansion of its New Jersey facility in East Windsor, USA.

Hovione announces the expansion of its New Jersey Facility

Sep 29, 2015

Loures, Portugal, July 6, 2015 – Hovione announced today the installation of a new large scale spray drying unit in Loures, Portugal. This new state-of-the-art unit is specifically designed to handle high potency APIs and to use a wide variety of organic solvent systems. The unit will be installed in compliance with the most stringent Quality and Safety Standards.  Spray drying is used in a multitude of pharmaceutical applications and is often the first technique used to enable poorly soluble oral drugs, to isolate biopharmaceuticals and for the production of inhalable dry powder formulations. The new large scale commercial facility will be in full operation by March 2016, and Hovione’s Senior Management is enthusiastic about the expansion of its offering and the new possibilities it entails. According to Dave Hoffman, Vice President of Sales & Business Development “The new unit has all state-of-the-art technological developments and, more importantly, unique features from an accumulated knowledge of more than 10 years of experience in commercial spray drying.” This additional commercial unit is the first phase of a broad expansion program designed to increase the scope of offering, address customer needs and expand capacity. “We installed this new spray dryer in response to growing customer demand for the technology. Hovione’s leading position in spray drying is built on the experience of over 200 development programs. Thanks to our Development by Design approach we can develop a process and scale it up to a commercial batch size in a matter of weeks using a minimum quantity of API” said Filipe Gaspar, Vice President of Research & Development. The new unit will add additional capacity to the spray drying facilities at Hovione. Currently, Hovione has spray drying facilities in Portugal, Ireland and the U.S. covering all of the requirements of the pharmaceutical market in terms of scale, bioburden control and ability to handle highly potent materials.   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 U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. 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 announced today the installation of a new large scale spray drying unit in Loures, Portugal.

Hovione installs a new Large Scale Spray Drying Unit

Jul 06, 2015

Loures, Portugal, January 12th, 2015 – Hovione today announced the appointment of Dr. Filipe Gaspar as Vice President of its Research and Development organization. Dr. Gaspar will lead teams based in Lisbon and New Jersey that serve our clients’ drug development projects; he will also be defining long-term product development strategies and collaborations. He will report to Guy Villax, Hovione’s Chief Executive. “We are very pleased to have Filipe running our R&D. Filipe brings great science and leadership skills. For the last 10 years Filipe has been the driving force behind our Particle Engineering, and if we have four new drugs today on the market it is because he and his team made sure we had the right capabilities, knowhow and ability to deliver” said Guy Villax. “I am honored to have the opportunity to lead this talented R&D team and help fulfilling our mission of serving our customers developing and delivering innovative medicines for patients”, said Filipe Gaspar. Dr. Gaspar is the co-author and co-inventor of numerous publications, scientific presentations and patents. He is a Chemical Engineer from Instituto Superior Técnico (Lisbon) and has a PhD in Chemical Engineering from the University of Birmingham.  Dr. Gaspar joined Hovione in 2003 as a Manufacturing engineer and later became responsible for the technical leadership of spray drying technology. In 2004 Dr. Gaspar moved to R&D to start the Particle Engineering group, there he was involved in more than 120 projects from preclinical stage to commercial. During that period he was the Lead Scientist in four projects that reached commercial stage, including the first at Hovione submitted under Quality by Design. He was instrumental in many of the projects that contribute to Hovione’s growing success in Particle Engineering.  In 2012 he moved to a Business Development role and spent a year based in New Jersey.   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 U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets.  In the last 5 years it stood behind 1-2 NDA approvals each year, and its DMFs and CEPs are referenced in dozens of ANDAs and marketing authorization that are approved each year. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs.  It is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Press Release

Hovione appoints Filipe Gaspar, PhD as Vice President R&D

Jan 12, 2015

  Loures, Portugal, December 17th, 2014 – Hovione today announced that the U.S. Food and Drug Administration (FDA) performed a Pre-Approval Inspection to its plant in Loures, Portugal, covering two NDA filings. At the conclusion of the inspection, the FDA issued a Form 483 with three inspectional observations.  The inspection carried out by the FDA Investigator Mr. Ramon Hernandez and by the Chemist, Mr. Jose A. Lopez Rubet, lasted 5 days as initially planned, started on 1st December and concluded on the 5th. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP). On the outcome of the inspection, Luisa Paulo, Hovione's Compliance Director, said "Addressing these observations is the top priority of the site management and the points raised will be replied to within 15 working days from the receipt of the Form 483. We are taking this result to improve our quality system both here and at our other sites.  The investigators spoke positively of many of our initiatives.  We have a strong pipeline of products under development with new NDAs being filed in the next 12 months, and we need to work diligently to continue to deserve our clients’ trust”. “We have a culture of quality that puts patient safety first. This shapes our behaviors and motivates us to improve. This is a Team effort, and I am very encouraged to see everyone so committed.” said Guy Villax, Chief Executive.   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 U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. 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 today announced that the FDA performed a Pre-Approval Inspection to its plant in Loures, Portugal, covering two NDA filings.

Successful FDA inspection at Hovione

Dec 17, 2014

Cork, Ireland, 27th of November 2014 – Hovione announced today it has filed its first Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA). This event represents a milestone in Hovione’s strategy of developing improved drug delivery options for established drugs. The IND was submitted for minocycline gel, a novel formulation using a new patented crystalline base form of minocycline, to administer topically one of the most widely prescribed oral antibiotics for acne. Currently, there are no approved topical formulations of minocycline for the treatment of acne. While oral administration of minocycline has a well-established efficacy and safety profile in acne, it is also associated with certain adverse events, due to systemic exposure. Pending FDA’s acceptance of the IND submission, Hovione plans to initiate human clinical Phase 1/2 studies in early 2015. “This filing represents a turning point in Hovione’s history.  It builds on 50 years of manufacturing Active Pharmaceutical Ingredients, Particle Engineering and Formulation” commented Carla Vozone, Hovione’s Senior Director of Product Development and Licensing. “This is a novel route of administration for a drug with proven safety and efficacy over more than 30 years of clinical use. We believe the targeted delivery to the site of action will reduce systemic exposure and thus potentially reduce the adverse events profile”.   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 U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

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Hovione files its first Investigational New Drug Application with the FDA

Nov 27, 2014

Loures, Portugal, July 31st, 2014 – Hovione today announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by the US Food and Drug Administration (FDA).   The inspection, carried out by the FDA Consumer Safety Officer, Ms. Britanny Terhar lasted 5 days as initially planned, started on 21st July and concluded on the 25th. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued. At the closing meeting the inspector informed that she was satisfied with what she had seen and complimented Hovione on its GMP system, inspection organization and the knowledge of its team members.   On the outcome of the inspection, Luisa Paulo, Hovione's Compliance Director, said "The pre-approval inspection was triggered by a client NDA filing, it also covered the manufacturing of a commercial NDA and a generic antibiotic, doxycycline. It is an extremely satisfying result for our team and for our customers. The Hovione Team members have again demonstrated their commitment and ability to meet the highest quality standards in the manufacturing of APIs and pre-formulated drug products”.   Jim Harvey, Hovione’s General Manager at the Cork site, said “We are very proud of the result achieved during this flawless FDA inspection. I am very satisfied that the FDA inspector reported no observations and I want to congratulate the entire team. This is another important step for our site in Cork as it confirms our ability to comply with high engineering, manufacturing and quality standards across all of the Hovione sites.”   About Hovione. Hovione is an international company with over 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers all customers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Press Release
Hovione today announced that its API plant in Cork has successfully passed a pre-approval inspection by the FDA

Successful FDA inspection at Hovione’s API manufacturing plant in Cork, Ireland

Jul 31, 2014

Lisbon, 15th July 2014 – Hovione and Merrion Pharmaceuticals [ESM; MERR] announced today that they have concluded a strategic partnership directed to the use of Merrion’s patented GIPET absorption enhancing technology by Hovione clients. Hovione, an international contract formulation and manufacturing group, will add its commercial reach and technical expertise to generate new products where the use of absorption enhancement through GIPET is appropriate. Hovione and Merrion Pharmaceuticals have already established a cooperative relationship on technical issues relating to GIPET manufacture, and the agreement provides for the companies to collaborate on the feasibility assessment of GIPET with development compounds introduced by Third Parties. Subject to a decision to proceed, separate technology and manufacturing agreements may be negotiated with the Third Party. In this way Hovione is able to leverage its expertise and international manufacturing capability in order to supply new products from clinical trials to commercialization. In its turn Merrion Pharmaceuticals is positioned to add to its current licenses with external development and marketing partners while keeping operational overheads to a minimum. In a comment on the agreement, Merrion’s Chief Executive, Dr John Fox noted ‘I am delighted that Merrion Pharmaceuticals is working with a partner of such scale and reputation. Merrion and Hovione represent complementary offerings to companies seeking to develop tablet versions of compounds that otherwise may have been administered by injection or never reached patients at all.’ “We are very pleased to announce this collaboration with Merrion Pharmaceuticals, which extends our current expertise and capabilities in improving solubility of oral drugs by addressing the permeability limitations of BCS classes III and IV drugs. This adds value to our customers and benefits the patients. This agreement reinforces our strategy of combining strengths with other innovative companies like Merrion, to create better medicines,” said Dave Hoffman, Hovione’s Vice President of Sales and Business Development. About Hovione Hovione is an international company with over 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers all customers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. About Merrion Pharmaceuticals plc Merrion Pharmaceuticals plc is a publicly listed (ESM:MERR) pharmaceutical company focused on delivering innovation to the market by partnering with complementary companies to develop patented products. Established in 2003, Merrion is primarily engaged in facilitating the development of oral forms (tablets/capsules) of drugs that have suboptimal absorption, many of which can only be given by injection, through the use of Merrion’sproprietary drug delivery technology platform.

Press Release
Hovione and Merrion Pharmaceuticals Announce Strategic Partnership on Use of Merrion’s GIPET Technology

Hovione and Merrion Pharmaceuticals Strategic Partnership

Jul 15, 2014

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