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

On the 24th of November, the winners of the 5th Business Awards of Macau were revelead. The winners were picked by a jury panel composed by 30 members of the jury, who selected what they considered to be the 46 best examples of contributions to promote the local entrepreneurial spirit, while advancing and increasing awareness for best industry practices and standards. Hovione was awarded the Innovation Gold Award.

News
The winners of the 5th Business Awards of Macau were revealed at a ceremony held at the Grand Lisboa hotel

Hovione is a Winner of the 5th Business Awards of Macau

Nov 24, 2017

Frankfurt expo showcases a transformation in contract R&D and manufacturing of drug ingredients. The pharmaceutical chemical sector is experiencing a prolonged period of profitability and a wave of transformation as companies invest profits in new ventures and new capacity. A picture of how the sector is evolving came into focus last month when CPhI Worldwide, the annual pharmaceutical ingredients exhibition, came to Frankfurt. The event­—the largest of its kind in the world, attended by more than 40,000 people—followed a year and a half of robust merger and acquisition . . . Read full article  

Press Clipping
C&EN, November 13, 2017

Growth strategies for pharmaceutical chemical makers on display at CPhI

Nov 13, 2017

What is happening to the CMO industry (particularly the pharmaceutical fine chemical industry) looks pretty similar to what it did almost 20 years ago. The attached 13 articles written between 1998 and 2005 -half of which were written by me- recount a well-known story: exuberance and over-investment results in write-offs and losses. What happened then was crystal clear to me when in 1998 someone came with a large cheque book convinced that a $500m API business could be built in 3-5 years. Shortly thereafter a well-known Deutsche Bank analyst’s report made sure the herd mentality took over. By 2005 most of the $15bn or so spent in M&A deals were mostly written off and a number of wonderful brands and several major companies had vanished. It is interesting to note that at the time that some entered the CMO business Honeywell was exiting and said: “...pharmaceutical chemical manufacture is a highly capital intensive business plagued by over-capacity, clinical trial failures, limited new drug approvals, new drug marketing disappointments, and price wars…”  Maybe there is an opportunity to learn from history. The challenge today is to check whether what looks the same is indeed the same, and whether what is really different can contribute to a different outcome. What remains to be seen is whether outsiders understand what they are getting into, and one thing is certain: when the dust settles you will have the usual suspects picking up the pieces. If anything we should be concerned because as of today over $33bn have already been spent in CMO related M&A activity in the last 4 years – in exactly the same pattern as in 1995-7, 1998-2000. Yours, Guy # Title  Type Author Date 1 The API Solution Provider article Guy Villax 1998 2 Aggressive goals - $500m in 3-5 years ppt Solutia 1998 3 Deutsche Bank analyst's report on CMO article DB 1999 4 Hovione in the CPHI show daily 2001 article Guy Villax 2001 5 Pharma Fine Chemicals - Nothing has changed! article Guy Villax 2002 6 Outsourcing: The dust has now settled  article Guy Villax 2002 7 European producers face unique issues article Maureen Rouhi 2005 8 Why Fine Chemical Business Development has failed  ppt Peter Pollak 2005 9 GMP fraud - largest ever penalties in criminal pharma  web www.infojustice.com 2005 10 Clients, competitors and Consultants  ppt Guy Villax 2005 11 Fine Chemicals Revisited  article Guy Villax 2005 12 5 years after its buying spree…  article Clay Boswell 2005 13 The Gold Sheet  article  Bill Paulson  2006 View the full set of documents (PDF, 8MB)   Guy Villax Hovione +351 917 888 899

Article
Guy Villax, November 10, 2017

Learning From History: For CMOs the Cycle is Back

Nov 10, 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

Empowering employees with a strong sense of ownership can lead to improved outcomes and increased cost efficiency. Guy Villax, CEO of Hovione agrees. As a CEO, he says, it has to be established that everyone in an organization shares responsibility for the quality of their products and that everyone must be quality-minded. Villax encourages his employees to be open and transparent and notes he’s often the first to call FDA or order investigation/root cause analysis if something goes wrong, so his teams can learn from issues and fix them. Villax says it’s important to keep patients in mind… the medicine they’re creating literally saves lives.   Read the full article

Press Clipping
Healthcare Packaging, September 12, 2017

Live from PDA/FDA: Culture of Quality

Sep 12, 2017

With demand soaring, drug service and other firms are challenged to keep talented scientists in the lab The analytical chemistry business is booming. Contract manufacturers have significantly expanded their analytical labs in recent years to keep pace with regulatory requirements and customer demand for data. At dedicated analytical service firms, business is growing as drug companies and customers in other industries seek out backup resources for their in-house labs and manufacturing plants. That growing demand is creating lots of analytical chemistry jobs. The sometimes-repetitive nature of the work, however, often leads chemists...    

Press Clipping
C&EN, June 5, 2017

Industry and academia rethink analytical chemistry

Aug 23, 2017

CMOs are embracing continuous manufacturing in several ways. Some (e.g., Patheon and Catalent) are investing directly in continuous lines that will be available to customers much like traditional lines. Other CMOs are collaborating with bio/pharma companies that have developed their own technology. In one widely reported example, Hovione is building a new suite at its East Windsor, NJ, site to house a continuous manufacturing line developed by Vertex Pharmaceuticals to produce its own products. Hovione will operate the line and will be able to sell any uncommitted capacity to third-party customers. The Hovione-Vertex collaboration is an example of another way that CMOs are responding to the need for flexibility in manufacturing: developing new types of collaborations with clients. The traditional CMO business model, with multiple clients sharing the same tightly scheduled production trains, is not adaptive; it is basically a one-size-fits-all. CMOs must be more innovative in their sourcing arrangements (i.e., they must offer manufacturing arrangements that can adapt to the market response as the new product is rolled out).   Read article

Press Clipping
PharmTech, August 1, 2017

CMOs Must Embrace Flexible Manufacturing

Aug 01, 2017

Hovione New Jersey welcomed a team of 8 FDA Reviewers for two days training in its facilities. The training was organized under the scope of a training program FDA has in place to provide insight on how does industry apply QbD (Quality by Design), how a facility looks like, which challenges industry faces during development phases up to registration/validation campaigns. The 8 FDA members are reviewers of drug substance section as part of the applications for DMF, NDA and IND. TRAINING TOPICS Introduction to Hovione and New Jersey site Hovione Quality System Hovione methodology for QbD and Risk Assessment Strategy QbD methodology: A Case Study Plant Tour Workshop on Risk Assessment

News
Hovione New Jersey welcomes a team of 8 FDA Reviewers for a training on Quality by Design (QbD)

FDA Training at Hovione New Jersey Site

Jul 10, 2017

The trend for school-leavers to prefer to automatically opt for college has resulted in a shortage of skilled workers in certain fields, warns Dr Paul Downing, Hovione general manager. “The single biggest challenge we have experienced is in the area of skills,” says Mr Downing. He says it’s believed the low number of skilled workers such as electricians, fitters, quality control analysts, instrument technicians as well as automation technicians, is a result of the fall-off in popularity of traditional Apprenticeship programmes and increased parental pressure on school-leavers to earn a degree. Yet, he points out, the traditional apprenticeship route offers all participants potentially excellent careers. "We would like to see more emphasis placed by second-level career guidance teachers on the option of apprenticeships in all of the different trades," he said, adding that the issue has become a "significant" problem in recent years. The focus of the Hovione pharmaceutical plant in Cork, at which just under 200 people are employed, is Contract Manufacturing, offering both drug substance and particle engineering capabilities and services. "Because of the shortage we are having to hire contract resources instead of being able to employ permanent staff members," Dr Downing explained. "We are trying to source laboratory technicians for example, who have become skilled through an Apprenticeship route rather than through a third level degree but it is difficult to find such personnel.   Read the full article

Press Clipping
Irish Examiner, 7 Jul 2017

Hovione keeps a keen focus on developing its talent pool

Jul 07, 2017

Diane Villax, Founder Chairman, received the Scientific Merit Medal, from the Portuguese Minister of Science, Technology and Higher Education of Portugal, Manuel Heitor, at the opening session of the National Science and Technology Meeting, Science 2017, in Lisbon, Portugal. The scientific merit medal rewards national or foreign individuals who, due to their outstanding professional qualities and the fulfillment of their duties, have made a valuable and exceptional contribution to the development of science or scientific culture in Portugal. «It is for me a great honour to represent Hovione on this occasion and to see that our original project has continued and grown and is today recognized at the highest levels. I would like to share and dedicate this moment to my family and to all of Hovione’s Team Members, and especially to the memory of my husband Ivan, who 58 years ago was a visionary and believed that it was possible to create in Portugal an innovative, research-based company» said Diane Villax after the ceremony.   Watch Diane Villax interview (in Portuguese):  

News
National Science and Technology Meeting, Science 2017, in Lisbon, Portugal

Diane Villax receives Scientific Merit Medal

Jul 03, 2017

Hovione is the first Chemical/Pharmaceutical Company integrating this innovative community of companies that use the power of business to solve social and environmental problems. As a Certified B Corporation Hovione wants to contribute to redefine success in business, meeting the highest standards of social and environmental performance, setting its team members for success and personal satisfaction and aspiring to use the power of markets to solve social and environmental problems. Hovione believe that B Corps, and especially those that are family businesses, through the power of their collective voice, are competing to be Best for the World® and through them society will enjoy a more shared and durable prosperity. To certify as a B Corp, a set of rigorous social and environmental standards must be met. This is achieved through the B Impact Assessment process that requires four principle areas to be assessed: governance model, workers, environment protection and community involvement, including the impact on its suppliers. Hovione's certification process began almost a year ago. During this period B Lab assessed Hovione's policies and procedures in all locations with its operations around the world (Portugal, Ireland, United States and Asia). They concluded that Hovione follows all the appropriate models and can thus be part of this movement. This is a global movement of people using business as a force for goodTM with a vision that one day all companies compete not only to be the best in the world, but the Best for the World®.    

News
Hovione became a Certified B Corp at the B Corp Summer Summit 2017, in Cascais, Portugal

Hovione receives B Corp Certification

Jun 22, 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

Contact Us

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