Press Room

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

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

PharmaChemical Ireland is the leading representative body for the pharmaceutical and chemical manufacturing sectors in Ireland. A major business association within the Irish Business and Employers Confederation (IBEC), PharmaChemical Ireland has access to IBEC’s core support and research facilities, and has a full-time executive staff. We represent the manufacturers and distributors of pharmaceutical products and ingredients, and general chemical materials. Our membership is composed of leading global corporations and indigenous Irish companies. Nine of the top ten pharmaceutical corporations in the world have manufacturing plants in Ireland. Read article here

Article
PharmaChemical Ireland Presentation, April 2009

Why Ireland should be your location of choice

Apr 01, 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

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