Loures, Portugal, October 2nd, 2013 – Hovione's plant in Loures, Portugal has successfully passed a GMP and Postmarket Approval inspection by FDA. The inspection, carried out by Mrs. Yumi Hiramine, Inspector from CDER, lasted 5 days as initially planned, starting on 23rd September and concluded on the 27th. No Form 483 was issued. At the closing meeting the inspector informed that she was satisfied with what she had seen and complimented Hovione on its GMP System, inspection organization and the knowledge of its team members. “We are pleased to have another successful FDA inspection at our Loures plant completed," said Guy Villax, Hovione’s CEO. "Doing well in the eyes of an FDA inspector is always a motive of satisfaction and a good reason to congratulate one’s team – well done!; but with 65 client audits and inspections per year our sites are always inspection-ready”. Hovione’s 5 plants were the object of 12 inspections in the last 18 months. These inspections were performed by some of the world’s major Health Authorities:  Five by the US FDA in Portugal, Ireland Macau and New Jersey – 4 of them with no Form 483 issued;  Three by the Portuguese Health Authority (INFARMED) in Portugal, Macau and China, which led to GMP certificates granted to each of the sites;  One by the Irish Medicines Board (IMB) in our Cork plant, which ended with the issuance of GMP certificates; One by the Korean FDA in the Portuguese plant; Two by the CFDA in China. Luisa Paulo, Hovione’s Compliance Director said “the main objective of theses inspections was to evaluate how the guidelines and internal procedures are followed in day-to-day plant operations. Special emphasis was given to how the Company records and manages OOS, deviations, change control, batch production records, complaints, validation and product quality reviews. The Inspectors were always pleased to see consistency between daily practice and the quality system”. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate 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, formulation development and GMP 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 . Follow Hovione on Twitter @HovioneGroup and LinkedIn. 

Another successful FDA inspection at a Hovione site

  Lisbon, 11 September 2013. Hovione announced today that the European Patent Office has granted a patent for Hovione’s XCaps, a dry powder inhaler (DPI). XCaps addresses a pulmonary inhalation market need for a very inexpensive 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 as well as infection, which typically require very large dose delivery. 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. Hovione is offering XCaps as a part of its inhalation device portfolio, allowing its integration with a drug product development program, allowing business partners to take their candidate drugs from the API stage all the way to the unit dose, with a single partner. Peter Villax, Vice-President and co-inventor of the device, said “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. Granting of the European Patent on the XCaps inhaler, within 30 months after initial filing, underpins Hovione’s capabilities in innovation and intellectual property management, to successfully design, develop and deliver innovative products, namely, a quality inhalation device, addressing a market need”. “The XCaps addresses a gap for a simple, easy to use, cost effective, multiple use, capsule based inhalation device. This allows our business partners to take advantage of additional patent protection for their inhalation drug product and effective drug product life cycle management” said Gonçalo Andrade, Business Development Manager. Hovione is currently executing inhaled drug development projects for multiple pharmaceutical companies, involving API process development, particle engineering, formulation and clinical supplies and is looking for partners willing to incorporate the XCaps into their inhalation drug development. Find more about XCaps.   About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate 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, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Hovione: EPO grants a new inhaler patent

Loures, Portugal, 7 June 2013 – Hovione today announced the appointment of Dr. Justin Hughey to lead the Particle Design sciences at our site in New Jersey. With over 30 publications, posters and book chapters Dr. Hughey is an acknowledged expert in the field of solubilization including the creation of amorphous solid dispersions with emphasis on Hot Melt Extrusion. Dr. Hughey most recently served as the Director of Research for Austin-based Enavail.  To complement its spray drying capabilities and other technologies to improve bioavailability, Hovione is investing in both lab and mid-scale Hot Melt Extruders to enable the efficient development of particles with improved solubility with seamless scale up and transfer to clinical manufacture.  “I am delighted to announce the appointment of Dr. Hughey. With his experience and deep scientific knowledge in developing traditional and non-traditional dosage forms with a strong emphasis on Hot Melt Extrusion and other novel processing techniques, I believe he will help speedily solve bioavailability challenges brought to us by our customers”, said Dr. Colin Minchom, Vice President Particle Design. “I am excited about the opportunity to lead the scientific efforts of the Particle Design team at Hovione New Jersey. I have always admired Hovione’s capabilities in the area of spray drying and was pleased to hear that they were adding Hot Melt Extrusion to their portfolio. I am looking forward to making significant contributions to this area and offering customers a range of solubility enhancement options, thus improving the probability of success for their molecule” said Dr. Hughey. Dr. Hughey earned his Ph.D. in Pharmaceutics from The University of Texas at Austin under the supervision of James W. McGinity and also holds B.S. degrees in Chemical Engineering and Chemistry. His pharmaceutical development experience extends to particle engineering technologies for pulmonary delivery as well as controlled and immediate release solid oral dosage forms.  About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate 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, formulation development and GMP 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 . Follow Hovione on Twitter @HovioneGroup and LinkedIn.    

Hovione Announces the Appointment of Justin Hughey, PhD to lead Particle Design in the USA

Lisbon, Portugal, 3rd April 2013 - Hovione today announced a co-promotion and collaboration agreement with Ligand to provide Hovione’s customers efficient access to Captisol® technology. Captisol, a chemically modified cyclodextrin, is proven to improve the solubility and stability of drugs and is currently used in six marketed products. Hovione offers innovative particle engineering technologies to improve the solubility of modern drugs. The agreement allows Hovione to use Captisol technology in its solubilization programs, which include amorphous solid dispersions, crystal design and size reduction and control of particle size. By adding this new technology, it increases the likelihood of solving the molecule’s bioavailability challenges. “Hovione is delighted to announce the ability to provide access to Captisol.There is no single solution to improving bioavailability and for a customer to access diverse options with a single supplier provides for greater probability of success and speedier outcomes,” said Dr. Colin Minchom, Hovione’s Vice President of Particle Design. “Hovione has manufactured Captisol for more than a decade, and we are very pleased to expand our partnership to help customers succeed. Providing for greater access to Captisol should efficiently enable the successful development of more poorly soluble molecules and further increase our Captisol partnership portfolio,” said Mr. Mathew W. Foehr, Ligand’s Executive Vice President and Chief Operating Officer. About Captisol®  Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis™, Baxter International's Nexterone® and Pfizer's Vfend® IV. There are currently more than 30 Captisol-enabled products in development, including Lundbeck’s carbamazepine IV, The Medicines Company's MDCO-157 and Rib-X's delafloxacin IV program. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate 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,formulation development and GMP 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 . Follow Hovione on Twitter @HovioneGroup and LinkedIn. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Please visit www.captisol.com for more information on Captisol or www.ligand.com for more information on Ligand. Follow Ligand on Twitter @Ligand_LGND.    

Hovione announces a co-promotion and collaboration agreement with Ligand for Captisol®

Lisbon, Portugal, 3rd April 2013 - Hovione today announced a co-promotion and collaboration agreement with Ligand to provide Hovione’s customers efficient access to Captisol® technology. Captisol, a chemically modified cyclodextrin, is proven to improve the solubility and stability of drugs and is currently used in six marketed products. Hovione offers innovative particle engineering technologies to improve the solubility of modern drugs. The agreement allows Hovione to use Captisol technology in its solubilization programs, which include amorphous solid dispersions, crystal design and size reduction and control of particle size. By adding this new technology, it increases the likelihood of solving the molecule’s bioavailability challenges. “Hovione is delighted to announce the ability to provide access to Captisol.There is no single solution to improving bioavailability and for a customer to access diverse options with a single supplier provides for greater probability of success and speedier outcomes,” said Dr. Colin Minchom, Hovione’s Vice President of Particle Design. “Hovione has manufactured Captisol for more than a decade, and we are very pleased to expand our partnership to help customers succeed. Providing for greater access to Captisol should efficiently enable the successful development of more poorly soluble molecules and further increase our Captisol partnership portfolio,” said Mr. Mathew W. Foehr, Ligand’s Executive Vice President and Chief Operating Officer. About Captisol®  Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis™, Baxter International's Nexterone® and Pfizer's Vfend® IV. There are currently more than 30 Captisol-enabled products in development, including Lundbeck’s carbamazepine IV, The Medicines Company's MDCO-157 and Rib-X's delafloxacin IV program. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate 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,formulation development and GMP 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 . Follow Hovione on Twitter @HovioneGroup and LinkedIn. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Please visit www.captisol.com for more information on Captisol or www.ligand.com for more information on Ligand. Follow Ligand on Twitter @Ligand_LGND.    

Hovione and Solvias announce a collaboration to provide for improved drug solubility

Loures, Portugal, 26 September 2012 - Hovione today announced the expansion of its solutions to solve issues of poor bioavailability, patient acceptability and the enabling of optimal delivery for non-oral routes of administration. Building on the experience of more than 100 projects and successful commercialization of spray dried dispersions, Hovione’s toolkit of solutions now includes crystal design, particle size reduction to the micro or nano-scale and amorphous solid dispersions. These services are offered from bench to commercial scale and are complemented with formulation development and clinical manufacture to Phase II. “We are very pleased to offer our customers these technologies. In response to customers’ needs, Hovione is investing in new technologies, many of them capable of handling highly potent compounds. These will help drive compounds with development challenges from early clinical to market”, said Guy Villax, Chief Executive. Colin Minchom PhD, who has been leading Hovione’s Particle Design business since March, stated: “More than the technologies, the quality of Hovione’s scientists, engineers and their experience in the application of 21st Century methodologies such as QbD, PAT and process modelling are outstanding.” Hovione will be presenting its new offering in detail during the AAPS Annual Meeting and Exposition at McCormick Place, Chicago USA. Hovione scientists and staff will be available to support your queries at booth 3936 from October 15-17. The company will also be exhibiting at Booth 3D39 at CPhI in Feria de Madrid, Spain (October 9-11). For those that are interested in the offering but are not able to attend either event, please visit hovione.com/pd or contact particledesign@hovione.com. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate 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, formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Hovione Expands Particle Design Solutions

Loures, Portugal, 30 August 2012 - Hovione today announced the appointment of Dr. Mike Ironside as General Manager, TTC in New Jersey. Dr. Ironside was previously with GSK in the UK and AMRI and most recently with Anacor Pharmaceuticals, both in USA, where he held the position of Vice President of Chemical Manufacture and Development. “This is a key appointment at an important time for Hovione. We are certain that Dr. Ironside’s leadership qualities combined with his relevant experience in chemical and analytical process development, scale-up from Pilot Plant to full commercial scale will enable us to further strengthen and enlarge our US operations in New Jersey and add new approaches to solve our customers’ most challenging problems.”, said Dr. Thomas Eisele, Vice President Corporate Research & Development. “I am excited and honoured about this new opportunity to lead the Hovione team in New Jersey. Throughout my career I have had a great respect for Hovione, a company that is recognized as world leader in pharmaceutical manufacture and particle design. I am looking forward to helping further enhance the TTC’s established reputation for offering our customers’ integrated solutions for any molecule “said Dr. Ironside. Dr. Ironside brings over 20 years of experience in the development and scale-up of APIs from lead candidate optimization through to NDA submission and commercialization. He also brings extensive experience in the management of scientific and operational teams in Biotech and Contract Research Organization (CRO) environments. Dr. Ironside is a member of the Royal Society of Chemistry in Great Britain and a member of the editorial board of the ACS Journal Organic Process Research and Development. He trained as an organic chemist at Dundee University, Dundee, UK, and holds a PhD in organic chemistry from the same University. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate 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 Announces the Appointment of Mike Ironside, PhD as General Manager TTC

Loures, Portugal, 23rd August 2012 - Hovione announced the appointment of Dr. Conrad Winters as Director, Drug Product Development. Dr. Winters was previously with Merck in USA and Canada and most recently with Xenon Pharmaceuticals Inc., where he held the position of Senior Director, Compound Properties Group. “We are very pleased to welcome Dr. Winters to Hovione. His experience in particle engineering, solubilisation, drug product development, scale up and commercialization will enable us to solve our customers’ most challenging problems”, said Dr. Thomas Eisele, Vice President Corporate Research & Development. “I am delighted to join the strong team at Hovione. Already the recognized world leader in pharmaceutical spray drying, I am looking forward to leading the team in developing complimentary technologies to enable Hovione to offer customers’ integrated solutions for any molecule”, said Dr. Winters. Dr. Winters is a Senior Director with 18 years experience in the pharmaceutical industry with a focus on managing the development of compounds from lead candidate optimization through to NDA submission and commercialization. He has much experience in rational formulation design, based on fundamental understanding of material properties and the adaptation of particle properties to effect improved bioperformance. Dr. Winters has led cross functional global teams charged with the development of priority new chemical entities. He has contributed to and prepared documentation in support of many successful regulatory submissions. Dr. Winters is a member of the American Association of Pharmaceutical Scientists and of the Royal Pharmaceutical Society of Great Britain. He is author of four patents, ten papers and is a frequent speaker at international conferences. He trained as a pharmacist at the Bradford University, Bradford, UK, and holds a PhD in Pharmaceutical Technology from the same University. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate 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.

Hovione Announces the Appointment of Conrad Winters

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