Press Room

(Lisbon, Portugal and New York, NY)—Hovione and Dickstein Shapiro LLP are pleased to announce that the U.S. Patent and Trademark’s Board of Patent Appeals and Interferences has reconfirmed Hovione's patent claims to a method of making flumethasone and its 17-carboxyl androsten analogue, two key intermediates on the synthesis of fluticasone, an important corticosteroid used in asthma medications, reversing a rejection by the reexamination examiner. The inter parties reexamination appeal decision, which found in favor of each of the firm’s arguments, was issued on October 26, 2010. “We are pleased that the board agreed with our demonstration that the method claimed in Hovione’s patent was not obvious, despite the attempt by a competitor to show otherwise,” said Edward Meilman, partner in Dickstein Shapiro’s Intellectual Property Practice. Mr. Meilman handled the reexamination proceeding on behalf of Portugal-based international pharmaceutical company, Hovione. Reexamination is a procedure in which a patent is reconsidered in light of prior art not previously considered during the original patenting procedure. Competitors often use this procedure in an effort to eliminate the patent entirely or limit it to a procedure which can be avoided. U.S. Patent Office statistics indicate that about half of reexamined patents do not meet the statutory requirement that a patented invention be unobvious. The board here found that the determination that Hovione’s method was not obvious at the time the patent was first issued was not changed by new prior art. A competitor filed for inter parties reexamination in April 2005 based on prior art which was not considered during the prosecution of the patent. The reexamination examiner used that new art to find the patent claims were obvious and should be cancelled. When the examiner could not be persuaded to change that viewpoint, Dickstein Shapiro appealed on behalf of Hovione. An oral argument, at which the competitor also presented arguments, was held in September 2010. The patented method involves complex steroid chemistry—an area in which Hovione has led since the 1960s—and a primary issue on the appeal was whether a particular compound was inherently formed in the course of performing the same process as previously as the result of using a stereoisomer of the compound used by the art in one step. A stereoisomer is a compound which is identical to another compound except that one group in the molecule has a different orientation in space when the three dimensional configuration is considered. The examiner advanced several scientific reasons to show Hovione’s compound was inherently produced, and the firm countered with several scientific arguments that the examiner was wrong, including statements made by the competitor in its own patent which it had not brought to the attention of the U.S. Patent Office. The appeals board accepted all of the firm’s arguments, found that inherency had not been established, and rejected the arguments advanced by the examiner and the competitor. Guy Villax, Hovione Chief Executive, commented as follows, “This outcome is a victory. One of the authors of this patent was Ivan Villax, my father and founder of Hovione—so we’d fight this one in any case. Fluticasone is a product where we believe we will continue to have a central role going forward. Our company believes in picking winners and not letting go.” Dickstein Shapiro’s nationally ranked Intellectual Property Practice has more than 80 attorneys who work with clients to develop strategies that capitalize on their intellectual property assets and achieve their business objectives. The firm is ranked by Chambers USA, Managing Intellectual Property and Intellectual Property Today magazines as a top firm for intellectual property work. Dickstein Shapiro has the experience, skill, and knowledge to successfully solve intellectual property problems for clients striving to succeed in this ever-changing, highly competitive arena. About Dickstein Shapiro LLP  Dickstein Shapiro LLP, founded in 1953, is internationally recognized for its work with clients, from start-ups to Fortune 500 corporations. Dickstein Shapiro provides strategic counsel and develops multidisciplinary legal solutions by leveraging its core strengths—litigation, regulatory, transactions, and advocacy—to successfully advance clients’ business interests. 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 U.S., 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 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: ipina@hovione.com.      

Press Release

Hovione Wins Flumethasone Patent Case

Nov 03, 2010

Loures, Portugal, 23rd October, 2009 - Hovione announced today that it has acquired an aseptic spray-drying production line, vial filling and back up utilities from Acusphere, a company located in Boston. The equipment includes sterile filtration, aseptic spray drying, secondary drying and vial filling, as well as terminal sterilization systems, lyophilisation, WFI and clean steam production utilities. This acquisition is a great business opportunity, as it now provides Hovione access to equipment and knowhow for the production of sterile drug substance and sterile drug product. “This is a very exciting move for Hovione, we are adding aseptic production -a tough new area of pharmaceutical manufacturing- to our offering. We have been considering aseptic production for some time and today we took the first step.” said Dave Hoffman, Head of Hovione’s Exclusives and Particle Design Business Units. This acquisition adds to Hovione’s already impressive cGMP spray-drying facilities, which includes lab, pilot and various commercial scale production installations in Portugal, US and in Ireland. The range and versatility of the production equipment means Hovione can spray dry milligrams as well as deliver 400 tons/year from its Irish facility, spray drying HPAI’s (Highly Potent Active Ingredients) and now sterile compounds. Hovione’s in-house mathematical models, in combination with PAT and a QbD mindset, Hovione can solve the most complex solubility challenges. About Hovione. Hovione is an international company dedicated to the cGMP development and manufacture of APIs and Intermediate Drug Products via particle design, serving exclusively the pharmaceutical industry. With four FDA inspected sites in the US, China, Ireland and Portugal, the company focuses on the most demanding projects, 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

Aseptic Spray-Drying - Hovione’s latest offering

Oct 23, 2010

Loures, Portugal, September 13, 2010. Hovione is announcing the approval in Japan of Inavir®, Dry Powder Inhaler 20mg, for treatment of influenza. This approval has been granted to Daiichi Sankyo Company Ltd, a licensee of Hovione for the TwinCaps® inhaler which delivers the drug to the lungs. Hovione developed the TwinCaps® inhaler specifically for this indication. Inavir® directly delivers the drug to the infected airways of influenza patients, and a single inhaled dose has proven to be as effective as a five-day course of oseltamivir for treatment of influenza. Daiichi Sankyo has announced it is confident that Inavir® will be an important alternative for treating influenza. According to Hovione, the low cost of the device means the inhaler can be disposable and is thus ideally suited for the treatment of lung infection. As bacteria or viruses are present in the airways, a disposable inhaler may be safer than a re-usable one. Peter Villax, TwinCaps® inventor and Hovione Vice-President said “This approval will boost visibility for TwinCaps®, an inhaler designed for extreme ease of use, as would be necessary in the case of a pandemic.”  Jason Suggett, Hovione Director of Pharma Operations said “We have a number of inhaled drug product development projects ongoing, and our in-house particle engineering expertise means that we can deliver large doses of powder from inhaler devices.” 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 51 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 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 approved in Japan as part of Inavir® influenza treatment

Sep 13, 2010

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
Sales reach USD 144 million for the fiscal year ended March 31st 2010.

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

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

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