Press Room

Loures, Portugal, July 28th, 2010 - Hovione announced today that the consolidated sales for the fiscal year ended March 31st 2010 amounted to USD144m, representing an increase of 15% over the previous year. During 2009 Hovione celebrated its 50th Anniversary at everyone of its facilities. The Company acquired an API manufacturing facility from Pfizer, in Cork, Ireland, as well as a state-of-the-art Aseptic Spray Drying (ASD) manufacturing line. Hovione also expanded its production capacity of contrast agents at the Hisyn site in China. ASD capability is core to our strategy and Hovione is committed to remaining the global industry leader in spray drying. The plant in Cork doubled Hovione’s quality production capacity and will enable to capture new market opportunities. “This is proof of our commitment to providing our customers with assured continuity of supply and the highest standards”, said Guy Villax, Chief Executive Officer. “Another year of continued strong performance by the Hovione group. During the last five years Hovione has increased sales by 77%, has gone from three to five industrial plants and has passed the 1000 Team Members mark. Looking forward, and despite the difficult economic environment, we remain confident that 2010 will be another year of solid growth”, adds Miguel Calado, Chief Financial Officer.” About Hovione Hovione is an international company with 51 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’s sales grow 15%

Jul 28, 2010

Loures, Portugal, July 21, 2010. Hovione is announcing the nomination of two of its scientists to the United States Pharmacopeia (USP), for the period 2010-2015. Jason Suggett, PhD has been named to the General Chapters – Dosage Forms Expert Committee and Nuno Matos is joining the Chemical Analysis Expert Committee. Jason Suggett joins as an expert in the field of inhalation products and will contribute his knowledge in the area of new testing procedures for inhalation products. Nuno Matos is an expert in the field of process analytical technology (PAT), near-infrared spectroscopy and chemometrics. Peter Villax, Vice-President said “Hovione has been active in the standard setting process for three decades now. We are delighted that two of our scientists are joining USP committees, and hope that their work brings a significant contribution, particularly in the areas of PAT and inhalation.” The USP is a non-governmental, official public standards-setting authority responsible for overseeing standards for prescription medicines and other healthcare products manufactured or sold in the United States. USP's activities have a significant impact on promoting quality and protecting the public health worldwide. About Hovione Hovione is an international company with 51 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture, from molecule to unit dose. 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

Hovione scientists bring PAT and inhalation expertise to USP

Jul 21, 2010

Loures, Portugal, February 2, 2010. Hovione is announcing the filing of a New Drug Application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione’s TwinCaps® inhaler. Being pre-filled, disposable and low-cost, TwinCaps® was specifically developed for the influenza indication and may thus be used for inhaled drug delivery to the lung in other acute indications, such as bacterial or viral infections. Since the inhaler was designed for a primarily inhaler-naive population, ease of use was the most important design criterion. Patents for TwinCaps® were filed worldwide in 2006 and have already been issued in Japan, South Africa and Portugal. Hovione expects the case to proceed to grant in all jurisdictions. CS-8958 is a laninamivir prodrug, a long-acting neuraminidase inhibitor developed as an inhaled drug by Daiichi Sankyo for the Japanese market. Clinical studies performed with adults and children suffering from type A or B influenza viruses have proven that the delivery of CS-8958 by TwinCaps® is effective with a single treatment course. Daiichi Sankyo have also announced the start of a Phase III clinical trial to demonstrate efficacy in influenza prevention. Hovione has licensed its inhalation device patents to Daiichi Sankyo and Biota Holdings Ltd (Victoria, Australia) and collaborated on the formulation development. Peter Villax, Vice-President in charge of TwinCaps® development, said “This filing follows four years of great collaboration between Daiichi Sankyo and Hovione and we are very honoured to be part of this project”. 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’s TwinCaps® dry-powder inhaler filed in Japan for the treatment of influenza

Feb 02, 2010

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

Press Release

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

Sep 29, 2009

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

Article

Welcome speech by Guy Villax at the 6th Hovione Seminar

Sep 17, 2009

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