Press Room

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

Cork, Ireland, 22nd April, 2009 - Hovione held today the opening ceremony of its new active pharmaceutical ingredient manufacturing site in Cork. Hovione contracted with Pfizer last December to take over the site that had been manufacturing Lipitor® since 1997. The handover of the plant took place on April 6th and the transaction closed on the 8th; going forward Hovione will continue to perform a small amount of manufacture for Pfizer but will mostly make use of the available capacity to address its own production needs. Hovione is a specialist developer and manufacturer and the Cork site will be used to produce active pharmaceutical ingredients (APIs) for a large range of pharmaceutical companies both large and small worldwide. Many customers find it more cost effective and less risky to manufacture APIs externally by a specialist, and see a contractor as a more flexible option that transforms fixed into variable costs, reduces risk, provides added value and assured results. By being the manufacturing partner to a large number of Innovators, Hovione is able to make sure its capacity is more readily occupied than if it was limited to producing in-house products, and is also thereby able to reduce production costs and the investment risk of equipping itself with the latest technologies. Hovione's research centres -in New Jersey, USA and Lisbon, Portugal- assure the development and manufacture of clinical trial materials for a growing number of compounds, exceeding 40 last year alone. As these products progressed through clinical development, and some got ready for filing, Hovione felt it needed additional capacity to ensure it could continue to guaranty absolute assurance of supply to its customers. The Cork site addresses perfectly this need as it provides state-of-the-art manufacturing capacity and experienced staff precisely at the right moment. "This site has been the API engine behind Lipitor®, the most successful medicine ever. It is with this heritage that it joins the Hovione group and embraces the opportunities that come with a new business model. We will be transferring to the Cork site a number of compounds over the next 18 months – some were recently approved, others are growing fast and customers are looking for second sources, and finally Hovione’s rich pipe-line of Phase III compounds need to have registration batches done at their commercial site of manufacture” - said Lorcan MacGarry, Hovione Cork's General Manager. Over the last two years Hovione acquired two new, virtually empty, plants -Cork in Ireland, and Taizhou in China-. The latter is dedicated to serving generics with a high volume low cost strategy value proposition; the former is the ideal plant for a new product introduction for an Innovator that does not possess in-house API production. In this period Hovione has doubled manufacturing capacity to more than 1000m3 and now employs over 900 staff. Over the last 3 years Hovione sales have grown at 14% average per annum. “The combination of the Cork Site’s team and capabilities, with the custom synthesis business model is an unbeatable value proposition. This allows the pharma innovator company to have the best of both worlds – access to excellent facilities with best service and high levels of compliance without fixed costs and with capacity available on demand – and all this at the right address” said Guy Villax, Chief Executive. 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 at www.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release

Hovione opens its new API plant in Cork

Apr 22, 2009

April 15, 2009. Hovione is pleased to announce that its licensee Daiichi Sankyo (Tokyo, Japan) has informed that it intends to use Hovione’s TwinCaps® dry powder inhaler device in the launch of the compound CS-8958, an inhaled long-acting neuraminidase inhibitor active against the influenza virus. Daiichi Sankyo has completed patient enrollment for Phase III clinical trials in Japan and other Asian countries and results are expected to be released mid year, including data to confirm the device switching. TwinCaps® was specifically developed by Hovione for the indication and licensed to Daiichi Sankyo and Biota Holdings Ltd (Victoria, Australia).  The announcement follows the recent publication [1] of data indicating that the compound is as effective as Relenza® and Tamiflu® against various influenza strains. Significantly this efficacy is achieved with a single dose, as opposed to a treatment over five days for the established drugs. A 20 mg dose of CS-8958 is inhaled from powder compartments in the TwinCaps® inhaler, which is made of just two plastic parts. Hovione believes this is currently the simplest inhaler being tested in clinical trials and once approved, will be the simplest in the market and have the lowest cost of goods. TwinCaps® has no moving parts to deaggregate the dose of powder and only requires a low inspiratory airflow to achieve optimal delivery to the lung. This means that children and the elderly will find it easier to inhale the full dose.  The design challenge for Hovione was to make TwinCaps® extremely simple to use, as in the case of a pandemic requiring immediate treatment of large populations, there is an obvious advantage for simple operation. The TwinCaps® DPI (to be manufactured in Japan and Europe) is a two-piece unit comprising body and shuttle components. The shuttle has two pre-filled dose chambers, left and right. In use, the shuttle is moved to one side by the patient to align one chamber of the shuttle with the mouth piece to allow the first inhalation, creating turbulence within the dose chamber and drawing the dry powder into the lung of the patient. The process is then repeated for the second dose chamber, as the shuttle is moved to the opposite side to permit another inhalation to take place. Daiichi Sankyo has indicated that they are planning to file NDA in Japan in March 2010 and get approval within 2010, while Daiichi Sankyo and Biota are seeking licensees for the drug product collaboratively for the rest of world market. Hovione retains the right to commercialize TwinCaps® outside the field of influenza. Peter Villax, Hovione’s Vice President Pharma Business Unit stated ”The unique design benefits of TwinCaps® including high dose capability, disposability and low cost are predicted to drive growth in Hovione’s inhalation business and further leverage our already proven track record in developing inhalation APIs, formulation development and manufacturing services.” 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. ________________________________________ [1] Makoto Yamashita et al. “CS-8958, a prodrug of the new neuraminidase inhibitor R-125489, shows long-acting anti-influenza virus activity”, Antimicrobial Agents and Chemotherapy, Jan.2009, p.186-192   For further information about Hovione, please contact Corporate Communications (Isabel Pina, + 351 21 982 9362)

Press Release
Hovione’s TwinCaps® inhaler in Phase III clinical trials for influenza

TwinCaps® in Phase III clinical trials for influenza

Apr 15, 2009

Loures, Portugal, December 29th, 2008 - Hovione announced today the appointments of Roger Viney, PhD as Director of Sales & Marketing Europe/Asia, Thomas Eisele, PhD as General Manager R&D and Mr. Steve Beagle as Director of Sales & Marketing, North America Dr. Viney leads Hovione’s Sales & Marketing outside North America and is based at Hovione in Loures, Portugal. Mr. Steve Beagle leads Hovione‘s Sales & Marketing for the North America territory and is based at our Technology Transfer Center in New Jersey, USA. Both Dr. Viney and Mr. Beagle are responsible for the development of Sales and Marketing strategies in line with the strategies of Hovione´s four Business Units, Exclusive, Particle Design, Generics and Pharma. Dr. Thomas Eisele is responsible for the Corporate R&D and reports to the CEO. The R&D group includes Process Chemistry, Analytical Chemistry, Particle Design, Project Management and Pilot Plant. “We are pleased to welcome Roger, Thomas and Steve to the Hovione team”, said Mr. Guy Villax, Chief Executive Officer. “All these three individuals have a distinguished track record in the industry and their extensive experience will be an invaluable resource to the Company and broadens the executive management team at an important stage in the growth of our business”. “I am delighted to join a successful and dynamic company like Hovione and I hope to be able to make a significant contribution to its profitable growth”, said Dr. Viney. “I’m excited to join a successful and highly appreciated Company like Hovione and will do my utmost to contribute to the further operational development and profitable growth of Hovione”, said Dr. Eisele. “It is of the utmost importance for me to select a best-in-class company poised for growth with a distinct job culture. This culture would encompass a passion for science specifically pharmaceutics, a robust management group of proven leaders, and a team approach to solving complex problems to the customers’ approval over and over again. For me only one company fit all this criteria, it is the Hovione Group,” said Mr. Beagle. “I am honoured to be part of this team”. Prior to joining Hovione, Dr. Viney held various positions at Rhone-Poulenc/Rhodia from 1993 to present, most recently in Global Business Management. Prior to that Dr. Viney worked in senior roles in Sales, Marketing and Technical Management. Dr. Eisele worked in Switzerland for 13 years in the area of Custom Research and Custom Manufacturing at CarboGen-Amcis, Rohner and SynphaBase. During that time Dr. Eisele held several positions in R&D, Marketing & Sales, Global Business Development, Shared Services and General Management. Prior to that, Dr. Eisele started his professional career at Nycomed in the area of Medicinal Chemistry. Mr. Beagle has a diverse 24-year history working in global roles within the pharmaceutical industry ranging from product management to sales & marketing. He is well known in the pharmaceutical manufacturing community and brings a wealth of knowledge to this position. Most recently Steve was at DSM where he was Senior Director of Business Development. Prior to this position Steve was at Stiefel Laboratories where he held management positions in Business Development and Technical Service. Steve has also worked for BASF, American Cyanamid, and R.W. Greeff.   About Hovione Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

Press Release

Hovione Announces New Appointments

Dec 29, 2008

Loures, Portugal, December 11th, 2008 - Hovione announced today that it has agreed with Pfizer to acquire their Loughbeg Active Pharmaceutical Ingredients (API) site in Ireland. This site manufactures intermediates for Lipitor active pharmaceutical ingredient. The site has had a number of owners starting in 1984 with Angus Fine Chemicals, then Hickson & Welch, Warner Lambert, Pfizer and now Hovione. Over the last 10 years Pfizer has invested several hundred million dollars in plant and equipment there, making it a modern, well equipped site, meeting the highest standards in the industry. The deal is scheduled to be completed by early April 2009. Hovione Cork will employ 70-80 staff and will, over the next 24 months be transferring products from its Loures, Portugal site and validating processes for new compounds in expectation of drug approval. The terms of the transaction were not disclosed but Hovione will continue to provide manufacturing services for Pfizer. "We made clinical trial materials for over 40 drug candidates last year. We have been investing heavily in R&D for over 6 years and now have a strong development pipe-line but have not invested in manufacturing assets since 2001, so it was time that we expanded our manufacturing capacity. This site offers everything that our Customers might want: large scale capacity, the highest standards, in a location where tax benefits are available to them and a well trained, innovative work-force" said Miguel Calado, CFO. The plant adds 427m3 of capacity to Hovione's 810m3 - of which 400m3 are in Portugal and the remainder in China. The plant is multi-purpose and is able to address a large number of specialized chemistries such as hydrogenation and low temperature chemistry. The Cork site also provides Hovione with a new, €70m capability to produce spray-dried formulations. Hovione is the world's leading provider of GMP spray-drying services covering every scale (lab, pilot and several intermediate production scales) and is able to provide R&D support and commercial manufacturing. At a time when most fine chemical producers are investing in Asia, Hovione is turning to Ireland. Cork has the highest concentration of API production anywhere in the world, with a vast and deep talent pool, with an excellent cGMP record with the health authorities since the mid-nineties. These sites belong to Large Pharma, companies that are now embracing outsourcing as a key part of their long-term manufacturing strategy. Hovione believes that having the right kind of capacity in Cork will help it better serve its Innovator customers when it comes to making APIs for their new product introductions. "We have been manufacturing in China for over 25 years - we know very well what China can do for the Pharma industry, but we also know what it can't do - and it is for those reasons that we are now in Cork" said Guy Villax, Chief Executive, "The Cork site, the New Jersey Technology Transfer Centre, Loures in Portugal and Taizhou and Macau in China now provide Hovione with the right range of capabilities in the correct geographies - every site meets FDA requirements for APIs but every site is suited to a different and well defined mission" he added. Pharma manufacturing needs to become lean and cost-effective and this is always a challenge. The outsourcing business model gives manufacturers a head start, as contractors can provide their services to any Innovator company for any product and thus benefit from lower risk, better utilization of facilities and scale. In addition, the contractor can select those compounds that have a good fit with its plant's technical capabilities, in turn the pharma company can avoid the expensive plant modifications often required to manufacture these compounds. It is this ability to produce for anyone that will contribute to making compounds fast and less expensively to the benefit of all stake-holders. However achieving this goal requires the ability to produce multiple small production campaigns -many simultaneously-, the skill to do rapid change-overs with validated cleaning, multi-purpose equipment design and lay-out that operate within a quality system specially designed for high levels of compliance yet of simple execution. This is what Hovione will be able to bring to the Cork site. "The combination of Hovione's 50 years of experience in API manufacture and contract manufacturing and the capabilities of the existing plant and compliance tradition of the Cork colleagues are a winning combination", said Noé Carreira, VP Manufacturing.   About Hovione Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

Press Release

Hovione buys Pfizer’s Loughbeg API Facility

Dec 11, 2008

Loures, Portugal, October 9th, 2008 - Hovione announced today the signature of a protocol with The Budapest University of Technology and Economics (BME) regarding the Ivan Villax traineeship program. This ceremony will take place next October 10th, in Budapest. Following the suggestion of the Portuguese – Hungarian Chamber of Commerce, and in order to pay tribute to the University where Hovione’s founder trained and graduated, the Company decided to institute a bursary program for two annual traineeships to enhance and develop the bonds between Portugal and Hungary. We will never forget that Ivan Villax believed in merit and competition therefore these traineeships will be awarded along the same set of criteria, said Mrs. Diane Villax, president of Hovione’s Board of Directors. This traineeship program aims to create the conditions for an MSc organic chemistry student to work for a period of 4 to 6 months in an industrial R&D environment and to be part of a project team responsible for the development of a synthetic process for the preparation of an active pharmaceutical ingredient. The traineeship will include exposure to the preparation of the active ingredient under Good Manufacturing Practices for use in clinical trials or to its related analytical chemistry requirements. This will allow BME students to take part of a learning experience that will contribute to their knowledge and skills and will also help to create an important link between the two institutions.   About Hovione Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

Press Release

Ivan Villax Traineeship Program

Oct 09, 2008

Loures, Portugal, June 27th, 2008 - Hovione announced today that the consolidated sales for the fiscal year ended March 31st 2008 amounted to USD103.7m, representing a growth of 11% over the previous year. This is Hovione’s first year beyond the USD 100 million mark. This sales increase reflects the drug approvals by our customers both in the Innovator as well as the Generic segment. Hovione’s offering also includes the fast growing particle design and inhalation formulation services. All of our 4 businesses have a growth outlook and present synergies between them. In 2007 Hovione invested significant amounts in particle design technologies, in new production lines and in the constant upgrade of our facilities worldwide. We have concluded the acquisition of a 75% stake in the share capital of Zhejiang Taizhou Hisyn Pharmaceuticals Co, Limited (Hisyn) in December 2007 and Hovione retains the right to acquire the remaining 25% at a future date. Hisyn provides us with an excellent opportunity to leverage our 25 years of operations in Hong Kong and Macau, and positions Hovione ideally for a low cost, high volume strategy in contrast agents. “Despite the negative economic environment, we face 2008 with optimism. In 2005 we set a goal to be selling $150m by 2010 with all the sales increase driven by organic growth. I expect us to be ahead of target this coming year.” adds Guy Villax, Chief Executive.   About Hovione Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

Press Release
Sales reach USD 103.7 million for the fiscal year ended March 31st 2008.

Hovione’s sales grow 11%

Jun 27, 2008

Loures, Portugal, March 6, 2008 - Hovione announces that it has purchased 75% of Hisyn Pharmaceutical Co. Limited. The Zhejiang provincial authorities have already issued the necessary business license and the joint venture (JV) is now operational. The acquisition provides Hovione with significant additional drug substance manufacturing production capacity and strengthens its 20 year presence in China. The acquisition includes both development labs in Shanghai and an active pharmaceutical ingredient (API) plant occupying 22,000 square meters. on a 22 acre plot employing 181 staff. Hovione's relationship with Hisyn started with the supply of intermediates, but this factory, which was commissioned in 2005 from a greenfield site, will now produce Hovione's two largest volume products. "Hisyn represents an opportunity to both increase our manufacturing capacity and ensure a sustainable cost advantage. We find it important to provide our current customers with an assurance of competitive supply over the long run; and in addition we want to have a strong presence in new markets, such as Brazil, India and China, where price is decisive" said Miguel Calado, CFO. The negotiation and the acquisition processes moved smoothly in part due to the experience Hovione has built in China over the last 3 decades. The Macau plant, with 5 previous FDA inspections and more than 10 years of contract manufacturing relationships in China, has enabled Hovione to effectively bridge cultures with China in every dimension: language, GMP, culture and business practices. Luis Gomes, Vice President of Generics, and responsible for the investment and integration process added: "When we first came to the Canton fair in 1979 we were buying raw-materials that would be processed in Macau or in Portugal. For many years we felt we'd be better off being an important client of Chinese plants through contract manufacturing deals, because at that time there many JVs going very wrong. Now is the right time for Hovione to acquire infrastructure in China and tap into a growing market and leverage China’s manufacturing abilities. We are planning to invest further monies in 2008 to effectively double Hisyn's manufacturing capacity".   About Hovione Hovione is an international group specializing in the development and compliant production of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. In 2006 it had sales of US$94 million (Euro 70 million). With almost 50-year in process development, quality standards and advanced particle design technologies, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and New Jersey, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry, Hovione offers services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product.

Press Release

Hovione buys drug manufacturing facility in China

Mar 06, 2008

Loures, Portugal, October 29, 2007 - Hovione's Technology Transfer Center (TTC) in New Jersey has just passed successfully a pre-approval inspection by FDA. The inspection was carried out by Ms. Joy R. Kozlowski-Klena Compliance Officer at the US FDA Center for Drug Evaluation and Research (CDER) and lasted 3 days, starting on October 9th and concluded on the 12th. No form 483 was issued. At the closing meeting, the inspector had several positive comments on our systems and indicated she would be recommending the approval of the site. This inspection covered the TTC's first commercial product - a high potency small molecule API for an injectable formulation. The NDA was filed last May and approval is expected in Q1 2008, with a launch foreseen later that year. Mr. Dave Hoffman, President of the US Operations said “This is an exciting milestone for our New Jersey Technology Transfer Center. This successful FDA compliance inspection gives a green light to an NDA compound - we look forward to further expanding small scale commercial manufacturing opportunities at our NJ site”. Hovione plants have been object of 15 FDA inspections. This inspection is the first at the New Jersey since it started to operate as an R&D facility in September 2002. In the Establishment Inspection Report issued by Ms. Joy R. Kozlowski-Klena it is stated “This inspection covered the NDA under evaluation, as well as limited GMP coverage of systems in place at this time, including Quality, Laboratory, Production, Facilities and Equipment. The inspection did not reveal any significant deficiencies.” The TTC site consist of process chemistry R&D labs, cGMP kilo and scale-up labs and a cGMP pilot plant. The TTC is also the home of Hovione’s commercial offices. The TTC offers Hovione´s US based customers’ process development and scale-up services, along with quality control/assurance and regulatory support. The cGMP facility is designed to prepare small quantity NCE’s to support customer's pre-clinical and early-phase clinical development, demonstrating the customer’s processes locally before transferring them to Hovione's full scale manufacturing plants, in Europe and Asia. About Hovione Hovione is an international group specializing in the development and compliant production of active pharmaceutical ingredients (APIs), serving exclusively the pharmaceutical industry. With a 48-year track record in process development, quality standard and advanced particle design technologies, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, Far East and New Jersey, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry, Hovione offers services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product.

Press Release

FDA inspects Hovione’s Technology Transfer Center in New Jersey

Oct 29, 2007

Loures, Portugal, October 8, 2007 – Hovione announces that its Technology Transfer Centre (TTC) has been accepted for Star participation to the Voluntary Protection Program by the Occupational Safety & Health Administration – OSHA. The VPP Star plaque and Flag presentation ceremony will take place next 11th October in East Windsor, New Jersey at 3pm. At present, only 44 sites in New Jersey have obtained the VPP Star designation. Just to apply, the facilities need to have a minimum of 3 years of unblemished track record. The TTC started operations in 2001 and OSHA accepted our application less than 12 months after it was first submitted. This shows the commitment to worker safety and health that has existed at the TTC since its inception. Guy Villax, Hovione CEO said: “I am very proud of the achievement of my colleagues. This award takes our TTC to the next level, it is a status that the Team in New Jersey will have to work hard to maintain. Continuing to deserve this is central to building our company culture. Safe operations are the result of good management and dedicated people. This is what gets customers to come back for more. I think it is terrific that, just like all our other sites, the TTC in New Jersey continues the Hovione tradition of collecting awards for doing important things well - well done!”. Working with industry and labor, the federal Occupational Safety & Health Administration created the Voluntary Protection Program (VPP) in 1980 to recognize and partner with worksites that implement exceptional systems to manage worker safety and health. The management and employees at these sites voluntarily implement comprehensive safety & health management systems - that go far beyond basic compliance with OSHA regulations. The VPP process emphasizes holding managers accountable for worker safety & health through measurable goals, the continual identification and elimination of hazards and the active involvement of employees in their own protection. The process places significant reliance on the cooperation and trust inherent in a partnership. Sites choosing to apply for VPP recognition show their commitment to effective worker protection by inviting government regulators into their workplace. In return, OSHA removes them from programmed inspections and does not issue citations for violations that are promptly corrected. About Hovione Hovione is an international group specializing in the development and compliant production of active pharmaceutical ingredients (APIs), serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Center in New Jersey, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry, Hovione offers services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product.

Press Release

Hovione in New Jersey awarded VPP Star status by OSHA

Oct 08, 2007

Sales reach USD 93.7 million (EUR 70,2 million) for the fiscal year ended March 31st 2007 Loures, Portugal, July 31st - Hovione announced today that the consolidated sales for the fiscal year ended March 31st 2007 amounted to USD 93.7M, representing a growth of 16% over the previous year. According to Hovione’s CEO, Guy Villax, “This was a year of strong sales growth despite the continued strengthening of the Euro. The main contribution to this growth came from the business segments in which Hovione has been strategically investing over the last few years. We have recently developed two new business segments: particle design services and formulation development services for inhalation – both technically challenging areas that have limited offer in the market.” In 2006 Hovione invested approximately USD 12M in R&D, with 140 people working in R&D both in lab and pilot-scale. Hovione supported pharmaceutical research in Europe and in the USA, custom synthesizing the development of more than 40 different pharmaceutical ingredients used in clinical trials all over the world. Over the last 12 months, 7 new patent applications were filed as a result of the research conducted at Hovione. Geographically, Hovione’s sales in the USA market represented 46% of our total sales (43% in 2005), Europe 30% (29%), Japan 15% (18%) and ROW 5% (5%). “We face 2007 with optimism. Our goal for this year is very clear – surpass USD 100M. I am confident that we can reach this goal!”, adds Guy Villax.   About Hovione Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs for the Pharmaceutical Industry. With a 48-year track record in process development, quality standard and advanced particle design technologies, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support API development from gram scale to commercialization.

Press Release

Hovione’s sales grow 16%

Aug 03, 2007

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