Press Room

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

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

Hovione’s sales grow 11%

Jun 27, 2008

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