Press Room

Loures, Portugal, September 29th, 2009 – Hovione's API plant in Loures, Portugal has just successfully passed a pre-approval inspection by FDA. The inspection, carried out by Mr. Mark Parmon, Inspector of Cincinnati District lasted 5 days as initially planned, starting on 21st September and concluded on the 25th, covering 5 ANDAs and 1 NDA. No Form 483 was issued. At the closing meeting the inspector informed that he was happy with what he had seen and congratulated our GMP System and the knowledge of team members. Luisa Paulo, Hovione's Compliance Director, said "The inspection focused on the documentation system, especially on how we record and manage OOS, deviations, change control, batch production records and analytical procedures. The Inspector focused on looking for deviations in consistency of the application of procedures”. Hovione plants have been the object of 17 FDA inspections, with 10 at the Loures site since 1982. The thoroughness of inspections and the ability to make an assessment of the maturity of GMP system is far greater than before. The main objective of this inspection was to evaluate how the “guidelines and internal procedures” are followed in day-to-day plant operations. Special emphasis was given to: 1) root cause determination; 2) preventive and corrective actions implementation and follow-up; 3) impact analysis of the changes and 4) production and analytical operation. The Loures plant has a total workforce of about 500 professionals and produces both generic products, as well as APIs and bulk formulated products manufactured under exclusivity for both clinical trials and for commercial sale. The facility exports to the most demanding markets such as North America, EU, Japan and Australia. About Hovione. Hovione is an international company with 50 years’ experience in active pharmaceutical ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on the most demanding customers in the most highly regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications, Isabel Pina, + 351 21 982 9362, e-mail: mailto:hello@hovione.com.    

Press Release

Successful FDA inspection at Hovione’s API manufacturing plant in Loures, Portugal

Sep 29, 2009

Welcome speech by Guy Villax, Chief Executive, to the attendees of the 6th Hovione Seminar. Estoril, 17th September 2009 Ladies and Gentlemen – Good Morning and Welcome, I am delighted that you all came from far away to be here with us to celebrate the 50th anniversary of Hovione. Thank you. I am so glad to see so many faces – from so many moments – recent relationships and very long standing ones. Only a moment ago Gerold Stamm was telling me my father supplied him with doxycycline in 1979. In 2007, I was a witness before a sub-committee of Congress and I said that for 40 years I had had a front seat watching the growth and evolution of the pharmaceutical industry. There have been endless changes, but what I feel is most important is to do with people. For a long time careers would last a shorter time than the lives of companies, today it is the other way around. Most careers last far longer than companies. Among many stories that shaped Hovione, the one about us supplying Agouron with Viracept stands out as a good example. When the original 10 tons per year forecast became a 100 ton per year challenge, Hovione rose to the occasion. We were trusted to do the impossible, we committed to do our best, and together we came though and delivered a $500m sales product in the 1st year. Agouron was so successful it was bought by Warner Lambert, then by Pfizer. But still today many of the people that worked with us then to do the impossible -and made sure the market was never short of product- are now working in many other biotechs across California and they have great memories of what collaborations can achieve. The Agouron story was -to me- the first evidence that the outsourcing model not only worked, reduced risk and cost but that it was also robust and able to meet the toughest challenge. Viracept at some stage mobilised 1000m3 of reactor capacity. So business is about networks, people that trust each other and work together to achieve great things. Second listening to customers is not easy. In addition to listening carefully one has to really understand the client’s context. Unless we are familiar with the driving forces that shape decisions within a customer we will never be able to be proactive and truly become aligned with it. The most challenging aspect of the future way of working in the pharmaceutical industry is how to work collaboratively. The “procurement” model will soon be dead because the Parma Industry is now facing for the first time ever strong Darwinian pressures. The need to survive will drive evolution and only the fittest will succeed, the issue here is not being the best among equals – the winner will be of a new shape, working in a new way. But it takes two to tango, so a new shape of supplier to emerge we need a new shape of customer. Third – again people, people make things happen. At the top big decisions get taken, but the outcome is to do with execution, Getting it done, right first time – every time is a matter for everyone in the company – and it is especially at the operations level, whether in the lab or operating reactors, that actions are taken that result in good yields or not, in deviations or not, in surprises – better good than bad. You can only procedurise so far, you need to count on the human side – to do this you need great people. This does not happen by chance, it is not determined by culture, or nationality, or even by education – it is a matter of leadership, of somehow providing everyone in the company with a sense of belonging, making work meaningful. Nothing gives our work more sense than when we are told what our products do for patients. Yesterday a customer told me he has a desk full of letters from parents of children that suffer from cystic fibriosis. This is a terrible illness, these kids probably never had a good night’s sleep in their life. Peter was telling me that after 3 weeks on the new drug, they sleep – their life is changed. Hovione is part of that effort, this is why we are here. There are many people that should be mentioned as key in our first 50 years. Whether as customers giving us business and opportunities to make a difference, or as team members developing the solutions and manufacturing the products. The way we will show our appreciation is by focusing on the work ahead, making sure Hovione continues to do a good job. Thank you Guy Villax Chief Executive Hovione

Article
The event that marked the start of the celebrations of Hovione's 50th anniversary.

Welcome speech by Guy Villax at the 6th Hovione Seminar

Sep 17, 2009

Cork, 10th September 2009 – Hovione announced today that Terry Lambe, Ph.D., has been elected to the Board of Directors of Hovione Ltd. Hovione acquired earlier this year an important API manufacturing site located in Cork. This is a key element of the Hovione strategy to become a leading manufacturer to the pharmaceutical industry. “We are delighted to welcome Terry Lambe to Hovione. We want to build our Cork site into the ideal, preferred, launch facility for new product introductions. In the context of the emerging business model based on outsourcing, our Cork site provides innovator pharmaceutical companies with all the benefits of a top manufacturing facility without the costs of ownership. Terry has a good understanding of what Large Pharma requires and brings to Hovione a wealth of international experience in manufacturing activities. We also feel that to do this right it is important to have on the board of our subsidiary company in Ireland someone familiar with the local culture and with strong links into the Irish pharmachem industry” said Guy Villax, Hovione’s Chief Executive. In addition Terry also becomes a member of the Hovione Manufacturing Committee that sets out the longer-term production strategy for the group. “I am enthusiastic about joining a successful and dynamic company like Hovione and I hope to be able to make a significant contribution to its profitable growth”, said Dr. Lambe. Dr. Terry Lambe joins Hovione following his retirement from Pfizer Inc. in 2008. Dr. Lambe worked at Pfizer for 30 years, during this time he held roles of increasing responsibility in manufacturing and was responsible for the construction of several API facilities, in Puerto Rico, in Groton, Connecticut and later in Singapore. In 1999, Dr. Lambe assumed his role as Vice President, Global Drug Substance. In 2000, he was appointed Team Leader / Vice President, Ireland / Singapore Manufacturing Area, a position he held until 2008. In 2004, Dr. Lambe was awarded the Bio-Link USA - Ireland Life Science Award for his contribution to the Pharmaceutical Industry. He holds a B.S. and a Ph.D. in Chemistry from University College Cork and completed a post-doctoral fellowship in Electro-Fluorination Chemistry at the University of Manchester. About Hovione Hovione is an international company with 50 years’ experience in active pharmaceutical ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on the most demanding customers in the most highly regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area Hovione is the only independent company offering such a broad range of services. For further information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release

Hovione Appoints Terry Lambe to its Board of Directors

Sep 13, 2009

Loures, Portugal, 8th September, 2009. Hovione is pleased to announce that its TwinCaps® inhaler licensees Daiichi Sankyo Co. Ltd. (Tokyo, Japan) and Biota Holdings Ltd (Victoria, Australia) have both announced successful Phase III trials for CS-8958, a new long-acting neuraminidase inhibitor for treatment of influenza (known as a prodrug of laninamivir).  CS-8958, co-owned by Daiichi Sankyo and Biota, is delivered by TwinCaps®, a patented dry powder inhaler which Hovione specifically designed for the treatment and prevention of influenza infections in both seasonal and pandemics situations. The device was designed to be used across a broad range of patients’ inspiratory flow rates and requires a single priming action prior to use.  In the Phase III trials conducted by Daiichi Sankyo, a single inhaled dose of CS-8958 was shown to be as effective as oseltamivir (TamifluⓇ) administered orally twice daily for 5 days (total of 10 doses). A parallel Phase II/III trial of CS-8958 in paediatric patients also met the primary and secondary endpoints compared to oseltamivir.  CS-8958 is an important new treatment against influenza as current neuraminidase inhibitors for influenza require daily or more frequent dosing, compared to CS-8958 which requires one dose for treatment and possibly once-weekly dosing for prophylaxis). The ability to dose patients on a weekly, or even less frequent, basis offers numerous benefits. Firstly, the volume of product stored in stockpile reserves may be smaller and secondly, a single-dose treatment will offer better patient compliance and convenience.  TwinCaps®, for which patent applications were filed world-wide in 2006, is an innovative inhaler, delivering a significant dose of drug to the lung, in a simple device comprising only two plastic components. Daiichi Sankyo and Biota have a worldwide exclusive license to use TwinCaps® for the treatment and prevention of influenza infections. TwinCaps® is available for licensing for use in other indications including antibiotic and vaccine delivery.  Hovione is now planning for large-scale manufacturing of the TwinCaps® devices. Daiichi Sankyo is intending to submit its market authorization application for Japan by March 2010, while Biota continues to advance the clinical development program required to support registration in the United States and UK.  About Hovione Hovione is a leading developer of inhaled drug products, with experience in anti-virals and proteins delivered by inhalation, as well as inhaler development. It is an international company with 50 years’ experience in Active Pharmaceutical Ingredient integrated development and compliant manufacture, from molecule to unit dose. In the inhalation area, Hovione is the only independent company offering such a broad range of services.  For further information about Hovione, please visit the Hovione site atwww.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release

Hovione’s TwinCaps® inhaler delivers successfully in Phase III clinical trials for influenza

Sep 08, 2009

Loures, Portugal, July 31st, 2009 - Hovione announced today that the consolidated sales for the fiscal year ended March 31st 2009 amounted to USD125.5m, representing a growth of 21% over the previous year. In 2008 Hovione invested significant amounts in particle design technologies and in new production lines, both at Hisyn, China and at Hovione Portugal. Also during the year Hovione negotiated the acquisition of a Pfizer manufacturing facility in Ireland. This facility, located in Cork, Ireland has a world-class production capacity of 427m3 and a state-of-the-art spray drying building. This acquisition is of strategic importance to Hovione. It will provide the Company with the necessary additional capacity to support the growing production requirements from our clients. In addition this plant will enable Hovione to capture the opportunities resulting from the outsourcing trend in Large Pharma, said Miguel Calado, Chief Financial Officer. “Another year of strong performance by the Hovione group, despite a very challenging economic environment. With the recent acquisitions, in China and Ireland, we have significantly strengthened the growth potential of our Company. We are in the right places, with the right capabilities supported by great Team Members.” adds Miguel Calado. 2009 will mark Hovione’s 50th anniversary. During this year we shall take the time to do two things: to look back with pride on what we have built and to take a hard look at what were the success factors of these 50 years of satisfied customers. About Hovione Hovione is an international company with 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on the most demanding customers, in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For further information about Hovione, please visit the Hovione site atwww.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release
Sales reach USD 125.5 million for the fiscal year ended March 31st 2009

Hovione’s sales grow 21%

Jul 31, 2009

Loures, Portugal, June 26th, 2009 – Hovione's API plant in Macau has just successfully passed a pre-approval inspection by FDA.  The inspection, carried out by Mr. Michael Charles, investigator of New York District office in Buffalo and Mr. ChunChang Fang, Chemist from California District initially planned to take 4 days lasted 2.5 days, starting on 22nd June and concluded on the 24th. A Form 483 with five points was issued. At the closing meeting the inspectors informed that they were happy with what they have seen and congratulated our GMP system and the knowledgeable of the team members.  Mr. Jorge Pastilha, General Manager of the plant, said "The inspection was focused on the execution side rather than the documentation system. Inspectors wanted to know “how we did in specific situations” rather than “how we should do in hypothetical situations” . I am glad that we continue to do well in compliance issues."  Hovione plants have been the object of 16 FDA inspections, with 6 at the Macau site since it started to operate in 1986. This inspection reflected that FDA is looking in far greater detail to aspects like "Quality by Design” and “Supply Chain Management”. The thoroughness of the inspection and its ability to make an assessment of the maturity of "GMP mindedness" is far greater. The obvious objective of this inspection was to evaluate how the “guidelines and internal procedures” are followed on the day-to-day activity by operators and analysts. Special emphasis was given to: 1) preventive and corrective actions implementation and follow-up; 2) water systems operation. The way inspectors look to the softened water system is probably a good example of the new “FDA Approach”. They look to basic aspects like the Design, Operational and Performance Qualification and to the last years Annual Report and concluded that the system has a good performance. But on top of this they expect permanent monitoring of several operational parameters of the system, Municipal Water quality and performance of the Municipal Water systems in order to assure reliability. The Macau plant has today a total workforce of 120 professionals and produces both Hovione catalogue generic products and commercial APIs manufactured under exclusivity and has been increasingly used by Hovione customers to produce on an exclusive basis clinical trial quantities of compounds for Phase I and II testing. The facility is responsible for one third of Hovione’s total production, and exports to the most demanding markets such as the USA, EU, and Australia.  About Hovione Hovione is an international company with 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on serving the most demanding customers in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.  For further information about Hovione, please visit the Hovione site atwww.hovione.com or contact Corporate Communications (Isabel Pina, +351 91 7507 462 or + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release

FDA inspects Hovione’s API manufacturing plant in Macau

Jun 26, 2009

Loures, Portugal, June 9th, 2009 – Hovione has won the prestigious 2009 Innovation Prize from COTEC, Portugal’s leading association of innovative businesses. The prize was awarded on June 3rd by the President of the Republic of Portugal, Anibal Cavaco Silva, for the company’s technical and commercial success in the field of spray-drying, to Filipe Gaspar, PhD, Hovione’s lead scientist in the project and Director of the Particle Science Discipline at Hovione and to Peter Villax, member of the Board. Hovione’s advances in this field have led to key enabling solutions for innovative pharmaceuticals.  President Cavaco Silva said: “This award, which I have had the pleasure to hand over to Hovione, aims to single out ambition and courage. It rewards the ability to think “out of the box”, to take original actions and to do better; to identify opportunities, to challenge risks and to win. I congratulate the Company for being selected by such a distinguished jury”. Spray drying today is used at Hovione to manipulate the physical attributes of particles in a controlled manner in three approved commercial APIs and in dozens of projects in various phases of development. Hovione is today the established world leader in this area of technology with extensive R&D capabilities and a wide range of production capacities under the highest standards of cGMP. The capabilities span across all scales; from inhalation and injectable grade of compounds, small and large molecules, with activity up to category 3 (Occupational Exposure Limit: 0.03 - 10 µg/m3). Hovione expects another two spray-dried compounds to see their NDAs filed at FDA in the next 12 months.  “We received this award for several reasons – first because its use impacts dramatically the bio-availability of compounds, it also allows to tailor the API to desired physical attributes, it is a perfect technique to combine excipients with API in a perfect blend; and secondly because we showed how a hundred year old technique -well known for making powdered milk- can be made to have innovative and successful commercial applications in new and sophisticated uses and turn dead drug candidates into approved drugs” – said Peter Villax, Hovione board member, who leads a number of inhalation projects in this field, including pulmonary delivery of proteins. Filipe Gaspar PhD concluded – “It is really on behalf of my team that I am delighted to receive this award – it is great to see our work recognized like this, we all work really long hours. Nothing beats a smiling client, but having the Head of State telling me “well done” really made my day ! ”. Innovative Product Award candidate project: The objective of the project was to develop and implement Spray Drying technologies to produce high quality pharmaceutical products. These technologies enhance the physical properties of the product and offer the possibility to precisely control the particle attributes to meet target requirements. Optimal sizing and shaping the particles, together with a variety of encapsulation options, can improve product stability and bioavailability and the possibility to simplify the formulation of the final product. Designed to support both Custom Synthesis and Generic Product customers, Hovione’s spray drying technology, out of water or organic solvents, is complemented by complete R&D and analytical capabilities studies on particle properties as per specific product requirements, thus offering all expertise and capabilities for successful product development. Hovione has installed lab and commercial scale pharmaceutical spray dryers able to handle high potency products in Portugal, New Jersey and Ireland. These units are located in segregated areas of the plant and meet Pharma GMP standards. About COTEC Cotec Portugal, the Business Association for Innovation, joined Cotec Europe in April 2003, following the initiative of the President of Portugal, with the mission of promoting the competitiveness of companies established in Portugal, through the development and the diffusion of a cultural and practice of innovation as well as of “resident” knowledge. Cotec Europe is a foundation, that includes the member states Spain, Portugal and Italy. Cotec Spain adopted the Foundation status in October 1992 in response to a suggestion made by His Majesty the King of Spain.  About Hovione Hovione is an international company with 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on serving the most demanding customers in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.  For further information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release

Cotec awards Hovione their Innovation Prize

Jun 09, 2009

Portuguese fine chemicals firm targets big pharma with a plant acquired from Pfizer April 8 was a big day for Hovione, the Portuguese pharmaceutical chemical manufacturer. The family-owned firm, based in the Lisbon suburb of Loures, marked its 50th anniversary and closed on the purchase of a Pfizer chemical plant in Cork, Ireland. Until recently, this plant manufactured the active ingredient in Lipitor, the top-selling drug in the world. Read article here

Article
C&EN, 8 June, 2009

At 50, Hovione Takes A Big Step

Jun 08, 2009

Hovione may have made itself a name as a first-class manufacturer of regulated active pharmaceutical ingredients (APIs), but it still needs to compete on price for some of its business. As in many industries, one of the best ways to lower cost is to have a manufacturing base in China. That is what Hovione did in March 2008 when it acquired a 75% stake in Hisyn Pharmaceutical, an API manufacturer in Taizhou, Zhejiang province. The site is a four-hour drive from Shanghai. Read article here

Article
C&EN, 8 June, 2009

Hovione Shapes China Manufacturing Site

Jun 08, 2009

Contrary to what some would have you believe, the use of substandard APIs in European medicines puts patient health and pharmaceutical manufacturers' reputations at risk. Most APIs destined for the EU come from Asian plants that have never been inspected by an EU official. To ensure a minimum level of quality, agencies and regulators from both sides of the Atlantic must work together to provide API compliance oversight. Read article here

Article
Pharmaceutical Technology Europe, June, 2009

Substandard APIs: we must tackle the problem together

Jun 01, 2009

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