Loures, Portugal, June 21st, 2012 – Hovione announced today that the consolidated sales for the fiscal year ended March 2012 amounted to USD 180m, the sixth consecutive year of sales growth, representing a growth of 24% in relation to last year. “Another year of continued strong performance by the Hovione group. During the last five years Hovione has doubled its sales and has made bold strategic steps to both strengthen its ability to serve Innovators and to consolidate its leadership in off-patent contrast agents. Looking forward, and despite the difficult economic environment, we remain confident that 2012 will be another year of solid growth”, said Miguel Calado, Chief Financial Officer. In addition to the financial results, which reflect the quality of the Team’s performance, overall 2011 represented a year of great achievements, namely: Hovione stood behind 3 NDA approvals, these were all major NMEs – and in two cases the approvals were full QbD filings in which Hovione was central to the design and data generation. All Hovione plants underwent several successful GMP inspections by one or more of the major Medicines’ Agencies – a reflection of the large flow of filings and the high standards of compliance. “Getting multiple NDA approvals every year is becoming a habit at Hovione, this reflects well both on our customers, on our team and on the CMO model. Our patient investment in capacity, new technologies and development methodologies is paying off.” said Guy Villax, Chief Executive Officer. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Intermediate Drug Product 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. Hovione 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 www.hovione.com  or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail:ipina@hovione.com     

Hovione’s sales grow 24%

Hovione Announces the Appointment of Colin Minchom

HOVIONE, a worldwide pharmaceutical manufacturing firm and BEND, OR – Bend Research Inc. (www.bendresearch.com), a leading independent drug-formulation development company, announced today that they have entered into a nonexclusive, cooperative relationship. The collaboration will give Bend Research clients access to Hovione’s commercial-scale pharmaceutical manufacturing facilities worldwide and give Hovione clients access to Bend Research’s oral drug-delivery, formulation, and engineering expertise. “Hovione has world-class commercial-scale spray-drying capabilities—both staff and facilities. We’re excited about this collaboration because Hovione will expand the range of manufacturing options available to our clients,” said Bend Research Chief Executive Officer Rod Ray. In addition to manufacturing, the collaboration builds upon both companies’ expertise in many types of specialized formulations, including engineered particles for inhaled delivery. Dave Hoffman, VP Exclusives and Particle Design, said, “Hovione is very pleased to work collaboratively with Bend, a company with such extensive expertise in early and mid-stage development. Leveraging on their capabilities, this collaboration will allow both companies to provide a comprehensive and integrated solution from development to commercial scale. ”  The collaboration will allow seamless technology transfer between the two companies, leveraging Bend Research’s clinical-trial-scale manufacturing facilities and scale-up and transfer expertise with Hovione’s wide range of capabilities, which includes cGMP manufacturing facilities in the U.S, Ireland, Portugal, and China.  In addition, the agreement gives Hovione clients access to Bend Research’s expertise in oral drug delivery, formulation, and process engineering, including its proprietary drug-delivery technologies.  “This effort is a key part in our commitment to getting our clients’ best new medicines to market as quickly and efficiently as possible, and with the highest quality,” Ray said. About Hovione Hovione is an international company with over 50 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. Hovione employs 1,100 people worldwide.  About Bend Research Inc.  For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies. The firm’s innovative drug-delivery solutions grow from a solid base of scientific and engineering fundamental understanding. Bend Research provides formulation and dosage-form support, assists in process development and optimization, manufactures clinical-trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. Bend Research is a leader in novel drug formulations, including those based on solubilization (e.g., spray-dried dispersions), hot-melt extrusion, inhalation, controlled-release, and biotherapeutic technologies. Bend Research has more than 240 employees based in four state-of-the-art facilities in Bend, Ore., USA. For more information about Bend Research Contact Phoenix Ivers by email at Phoenix.Ivers@BendResearch.com,  by phone at 541-382-4100 and  visit www.bendresearch.com For more information about Hovione Isabel Pina Corporate Communications ipina@hovione.com +351 21 982 9362    

Hovione and Bend Research Enter Into Collaboration To Advance Clients’ Best Medicines

Loures, Portugal, 19 October 2011 – Hovione today announced the launch of its Rapid Proof of Concept Study for the development of dry powder inhalation (DPI) products. Building on Hovione's well established DPI development capability, the new service simplifies the development of formulations, producing a proof of concept formulation of a client's molecule in just a few weeks. Hovione has simplified DPI product development, reduced complexity and reduced the time required for completion by mastering, in concert, particle engineering, formulation technology and inhaler design, the three disciplines vital to the development of a successful product. Unlike other CROs, Hovione has all of this expertise under one roof, eliminating the coordination issues clients often experience in having to use multiple CROs. The results of this are reduced coordination costs, shortened development timescales and a stream-lining of the development process. Peter Villax, Hovione's Vice President of Pharma & Innovation commented “this new Rapid Proof of Concept service offers clients a low risk look at the feasibility of developing a DPI product and gives clients greater confidence about going into later stage development”. “Clients of the new service don't just get a report, they get their first DPI formulation” he added. In a short period of time and for relatively little investment, a drug developer can acquire a DPI formulation, potentially adding significant value to an early stage out-licensing opportunity or helping a company move into a stronger position in funding negotiations with venture capitalists. About Hovione Hovione is an international company with over 50 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. Contacts at Hovione Phil Nelson, PhD Business Development Manager pnelson@hovione.com +351 219 847 619 Isabel Pina Corporate Communications ipina@hovione.com +351 219 829 362    

Hovione´s Rapid Proof of Concept Dry Powder Inhalation Product Development

The Board of the European Fine Chemicals Group (EFCG) is delighted to announce that  today it agreed to ratify the proposal of the US Food and Drug Administration (FDA) to put  forward a legislative package, designed with the help of EFCG and US industry  representatives, to deliver into US law a new Generic Drug User Fees Act (GDUFA).    Read more:     

EFCG Ratifies FDA's Proposed Generic Drug User Fees Act

Hovione announced today the international filing of its latest patent covering a new, highly efficient dry powder inhaler (DPI), XCaps. XCaps fills a void in the pulmonary inhalation market, as a device which combines high efficiency in powder dispersion with ease of use. Lung fractions in excess of 70% have been achieved, from a device which only requires two steps to inhalation and which only has two components plus a dust cover. This makes XCaps highly suited for inhalation applications where minimal training of patients is desirable and has the versatility to treat almost all pulmonary diseases, including asthma, COPD and infection.  XCaps follows on the heels of another successful Hovione DPI, TwinCaps®, which was developed specifically for an influenza application and is licensed to Daiichi Sankyo and Biota for this application. Daiichi Sankyo launched Inavir® in the Japanese market in October 2010 and monthly sales in Japan of this TwinCaps®-delivered neuraminidase inhibitor since then have surpassed those of Roche’s Tamiflu® (1, 2). Hovione is offering XCaps in optional conjunction with its drug product development program, allowing potential licensees to take their candidate drugs from the API stage all the way to the unit dose, under one roof. “We give our customers an edge in speed of development because we are perhaps the only independent company developing DPIs with expertise in every aspect of the inhaled drug development process”, said Peter Villax, Vice-President and co-inventor of the device. Phil Nelson, Business Development Manager, said “Hovione has wide-ranging expertise in the field of inhalation products. With our core API process development and manufacturing expertise, we can manufacture pharmaceutical ingredients where the final crystallization step produces pulmonary delivery-friendly particles. Alternatively, we can use other particle formulation technologies, such as spray-drying and we are currently pioneering new particle technologies for stable, large dose delivery.” Hovione is currently executing inhaled drug development projects for 5 pharmaceutical companies, involving API process development, particle engineering, formulation and clinical supplies.   About Hovione Hovione is an international company with over 50 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.  More about XCaps at www.hovione.com  Sources: https://www.biota.com.au/uploaded/154/1021733_76openbriefing-ceoonoutlo.pdf   FY2010 Consolidated Financial Overview, Chugai Pharmaceutical Co. Ltd., February 2, 2011 Contacts at Hovione Phil Nelson, PhD Business Development Manager pnelson@hovione.com +351 219 847 619 Isabel Pina Corporate Communications ipina@hovione.com +351 21 982 9362    

Hovione announces filing of patent for new powder inhaler

Loures, Portugal, June 8th, 2011 – Hovione and Particle Sciences Inc (PSI) have today announced a collaboration agreement under which they will pool their technologies together to significantly speed development projects targeting poorly water soluble drugs. The companies expect to jointly be able to significantly reduce typical project times. Hovione and PSI are joining their solid solution technologies based on spray-drying capabilities and aimed at targeting ways to maximize the bioavailability of BCS Class II active pharmaceutical ingredients. Development will be fast-tracked at both companies, with PSI developing the solubilization process and resulting drug product for their clients and Hovione managing the scale-up and industrialization of the spray drying process. Dave Hoffman, President, Hovione US Operations, said “It is truly incredible how versatile and useful spray-drying technology is. We have used it from a gram scale to tons, with important time savings on the scale-up to manufacture products where other technologies failed. Teaming up with PSI will give their customers an integrated solution which will allow us to go from drug product and process design to feasibility and development to industrial application in record time”. According to Mark Mitchnick, Particle Sciences’ CEO, “We have a variety of drug delivery platforms, some of which are best scaled through spray drying. Our unique contribution is to develop products that maximize clinical effect, and after that Hovione takes over with their technological and industrial expertise and regulatory compliance. We will really be able to save our clients quite a lot of time.” Hovione is an international company with over 50 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. Particle Sciences Inc is an integrated provider of drug development services. Particle Sciences utilizes a broad suite of drug delivery technologies to address a diverse range of challenges. With special expertise in particulate based formulations and drug/device combination products Particle Sciences has become a leader in drug delivery development. Through a full range of formulation, analytic, bioanalytic, and sterile and non-sterile manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic. The company was founded in 1991 and is headquartered in Bethlehem, Pennsylvania. For more information about Hovione visit www.hovione.com  or contact Isabel Pina, Marketing & Communication, at + 351 21 982 9362 ipina@hovione.com For more information about PSI visit www.particlesciences.com  or contact Maureen Cochran at (610) 861- 4701mcochran@particlesciences.com    

Hovione and Particle Sciences Inc. ink deal to speed up drug solubilization projects

Loures, Portugal, June 6th, 2011 - Hovione announced today that its Technology Transfer Centre in New Jersey, USA, has achieved renewed membership in the prestigious "Star" Voluntary Protection Program (VPP) of the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA). In communicating this renewal Robert D. Kulick, Regional Administrator of OSHA, indicated: “VPP participants serve as models for other employers and workers by operating excellent safety and health management programs. Achieving a level of worker protection that goes beyond compliance with government regulations is commendable”. Being a Star participant in the Voluntary Protection Program means that the site is removed from the roster of OSHA inspections and that it opens its doors to others that may want to learn from the site’s practices. “Hovione’s strategy is to stay ahead of requirements in every area of compliance – we do this because we have a genuine quality culture, we adopt best practices and we aim high. Quality and GMP compliance, health, safety and the environment – all rank high in our priorities. Our compliance record is something we are proud of. I also believe this gives comfort to our customers that we are the right home for their products” said Guy Villax, Chief Executive. Hovione is a leading contract manufacturer that stands behind at least one NDA approval every year. In 2010 Hovione made clinical trial materials for over 60 different compounds, and supplied over 30 commercial APIs made in its sites. About Hovione Hovione is an international company with over 50 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:  Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail: ipina@hovione.com .    

OSHA renews Hovione’s VPP STAR Certification

Hovione today announced that in the past 8 months the Company has had a large number of GMP inspections by the major Medicines’ Agencies. The Japanese PMDA inspected our sites in China and Portugal. The US FDA inspected our sites 3 times: Loures twice and New Jersey once. The Portuguese authorities also performed an inspection in April. In the last week of April FDA inspected simultaneously both New Jersey and Loures, in both cases no Form 483 was issued. The PMDA inspections have also been closed successfully. On the outcome of the PAI in Loures Luisa Paulo, Director of Compliance at Hovione, commented: “This was the best pre-approval inspection ever by FDA. The investigators were very experienced and very well prepared; they had studied the file in great detail. This was a Quality by Design submission and a key element of it was a continuous process – so the discussions were really interesting. We definitely broke new ground.” The large number of inspections reflects the constant flow of submissions that Hovione clients make. Innovator drugs, generics, devices all make use of Hovione APIs or of its technologies that focus on particle properties in high performing formulations. “Our clients are thrilled. Successful outcomes at inspections is not an unusual event at Hovione, but to continue with this kind of stellar record in the current climate is something that makes us all really proud “ said Guy Villax, Hovione’s CEO. About Hovione Hovione is an international company with over 50 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 91 7507 462 or + 351 21 982 9362, e-mail: ipina@hovione.com.    

New Products at Hovione, 6 inspections in 8 months