Press Room

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

People from Pharmaceutical Business indicate this acquisition will assist to upgrade the Pharmaceutical business in TaiZhou. In 22nd February 2008 afternoon, Hovione FarmaCiencia SA completed the acquisition of the ZheJiang HiSyn Pharmaceutical Company Limited. This is the first Equity Joint Venture in Pharmaceutical field in ZheJiang Province Chemical and Medical Materials Base LinHai Park, showing a positive trend. “We have good expectation on the API manufacturers in TaiZhou, the cost and human resources advantage of the China API companies combined with our technical and marketing advantage will be a winning proposition. Our joint venture will produce a huge chemical reaction.” said by the CEO of Hovione, Mr. Guy Villax with smile. “Hovione” is a Portugal international company with 50 years of history, the main products are API manufacturing, and her products have higher market shares in EEC, USA and Japan. Hovione used 150 million to acquire 75% shares of HiSyn this time, and indicated that the management team will be kept unchanged after the acquisition and the increased investment will be to support HiSyn to meet the international standards. The development history of the TaiZhou pharmaceutical business is more than 40 years, is one of the key product line in our city. Since, the business structure; creative abilities; environment protection; utilities saving and the basic facilities investment of the pharmaceutical companies in our city are rather poor. So that, the development plan of the Taizhou pharmaceutical business (2007-2012) was indicated that until 2012 we will build up a pharmaceutical park with higher international competition, and emphasize to develop five big products during the period, starting the “139” project. As per people come from the pharmaceutical business, the entrance of the international pharmaceutical companies in TaiZhou, will provide direct, positive and incentive effect on the upgrading of the pharmaceutical business in TaiZhou. And as per the Administrative Committee, they will incent the current exiting companies to co-operate with the group companies both from China and international. Now, there have several companies are under negotiation with the foreign companies.

Article

An International Company of Portugal acquires a TaiZhou Pharmaceutical Company

Feb 24, 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

Speech by Guy Villax on the occasion of the presentation of VPP Star plaque and flag Mr. Ambassador [Mr. Joao Salgueiro, Ambassador of the Republic of Portugal to the UN] Mr. Roskoski, [Mr. Gary Roskoski, Director- Marlton Area Office. OSHA]  Mayor Mironov, [Ms. Janice Mironov, Mayor of the Township of East Windsor]  Mr. Consul General [Mr. Francisco Azevedo, Consul General of Portugal in Newark] Ladies and Gentlemen, Dear Friends I am very glad to be here with you. I would like to thank the kind words from Mr. Gary Roskoski, Director and Mr. Martin Davies both of OSHA, from Mayor Mironov. This is an important event for Hovione's Technology Transfer Center – we celebrate OSHA’s acceptance of our application to the VPP Star program. This acknowledgement of an impeccable HSE record is something that I see as a reflection of the TTC’s standards, of the quality of the management of this site, and in a way this marks the coming of age of the TTC. Indeed this site is only 5 years old – and this is the first time that we have the chance to stop, invite our guests and friends and take a moment to look back. It’s not been easy, but we’ve clearly moved to the next step. We have established the TTC as a member of an elite group – in the words of Edwin J. Foulke, Assistant Secretary of Labour – not just in HSE terms, but as a service provider of sophisticated R&D services to the pharma industry. This is the correct moment to say a few words of thanks. First to the East Windsor Township, its Mayor and Council – because they helped us decide to locate here, they welcomed us and told us “we’ll be as fast as you want provided you do it by the book!”. Then to CUH2A, our architects that turned a dream, Dave, Bill and I had into reality – or at least into a blueprint – many sushi lunches at figuring out how to make it the best. Turner and to Dion Hall of Eng Tech – for the hardware. Millennium BCP bank – supported us all the way, and together with BES, BPI and CGD financed this investment. The Consulate in Newark for endless stampings of endless papers. The universities – Rider, Rutgers and Princeton – that lend us a hand only too often, train our young people so they will lead us in the future. The Twin Rivers association – our neighbours… to whom we have tried very hard to be the opposite of a nuisance. Certainly our customers – because at the end of the day they are the reason why we exist and succeed – I will pick a few names – Neurocrine Biosciences – because they gave us our first business here; and CVT and Astellas because they bet on us for an important new product. I’d like to also thank all the Hovione people for their efforts and commitment in turning what back in 1999 and 2000 was but a dream – into a tangible reality that clients and competitors talk about, and journalists write about! Journalists have played an important role in our success - this is something we appreciate very much. All Hovione sites perform over and above the regulations, and all get awards and commendations – they work hard to be a welcome part of their communities; they are often picked as an example to follow. So when I saw the letter from OSHA in Washington I was particularly pleased, because it came as a surprise – I did not even know the TTC had made the application – and it shows that whether they be in China or in America – Hovione people have the same culture, and look to meet the toughest challenges, to meet the highest standards – not because it is mandatory, but because this is just the way we work. To achieve this means great team spirit, because Safety is everyone’s job – so cohesion and alignment are part of the whole process. This occasion is also a happy one because it marks an achievement, Diane and I are here, to share it with you – and to tell you how pleased we are to see after 50 years of hard work how we are able to get recognition for a job well done everywhere we go – and how this is the result of people that come from nearby, and from Macau, and from Portugal. Going forward we have a great challenge – to continue to meet the standard. We all want to retain the VPP Star status – but to keep it requires effort and commitment – one day of lost work will cause us to loose the status… so we need to work hard because from where OSHA has put us, we can only go down… so I count on you. Lastly I would like to give my congratulations to Dave that has led this project from its beginning and who should feel that all this is the achievement of a team he led, coached, pushed forward and got amazing results from. Congratulations to all of you for a great job well done – congratulations also to everyone else that worked here at the TTC, and may not be here to hear these words. Thank you – well done. Guy Villax  Chief Executive  East Windsor, 11th October 2007

Article

Speech by Guy Villax at the VPP Star Presentation

Oct 11, 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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