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

(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.      

Hovione Wins Flumethasone Patent Case

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)    

Aseptic Spray-Drying - Hovione’s latest offering

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)    

Hovione’s TwinCaps® dry-powder inhaler approved in Japan as part of Inavir® influenza treatment

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)    

Hovione’s sales grow 15%

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)    

Hovione scientists bring PAT and inhalation expertise to USP

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)    

Hovione’s TwinCaps® dry-powder inhaler filed in Japan for the treatment of influenza

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.    

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