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  Loures, Portugal, December 17th, 2014 – Hovione today announced that the U.S. Food and Drug Administration (FDA) performed a Pre-Approval Inspection to its plant in Loures, Portugal, covering two NDA filings. At the conclusion of the inspection, the FDA issued a Form 483 with three inspectional observations.  The inspection carried out by the FDA Investigator Mr. Ramon Hernandez and by the Chemist, Mr. Jose A. Lopez Rubet, lasted 5 days as initially planned, started on 1st December and concluded on the 5th. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP). On the outcome of the inspection, Luisa Paulo, Hovione's Compliance Director, said "Addressing these observations is the top priority of the site management and the points raised will be replied to within 15 working days from the receipt of the Form 483. We are taking this result to improve our quality system both here and at our other sites.  The investigators spoke positively of many of our initiatives.  We have a strong pipeline of products under development with new NDAs being filed in the next 12 months, and we need to work diligently to continue to deserve our clients’ trust”. “We have a culture of quality that puts patient safety first. This shapes our behaviors and motivates us to improve. This is a Team effort, and I am very encouraged to see everyone so committed.” said Guy Villax, Chief Executive.   About Hovione Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. 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 branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

Press Release
Hovione today announced that the FDA performed a Pre-Approval Inspection to its plant in Loures, Portugal, covering two NDA filings.

Successful FDA inspection at Hovione

Dec 17, 2014

Cork, Ireland, 27th of November 2014 – Hovione announced today it has filed its first Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA). This event represents a milestone in Hovione’s strategy of developing improved drug delivery options for established drugs. The IND was submitted for minocycline gel, a novel formulation using a new patented crystalline base form of minocycline, to administer topically one of the most widely prescribed oral antibiotics for acne. Currently, there are no approved topical formulations of minocycline for the treatment of acne. While oral administration of minocycline has a well-established efficacy and safety profile in acne, it is also associated with certain adverse events, due to systemic exposure. Pending FDA’s acceptance of the IND submission, Hovione plans to initiate human clinical Phase 1/2 studies in early 2015. “This filing represents a turning point in Hovione’s history.  It builds on 50 years of manufacturing Active Pharmaceutical Ingredients, Particle Engineering and Formulation” commented Carla Vozone, Hovione’s Senior Director of Product Development and Licensing. “This is a novel route of administration for a drug with proven safety and efficacy over more than 30 years of clinical use. We believe the targeted delivery to the site of action will reduce systemic exposure and thus potentially reduce the adverse events profile”.   About Hovione Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. 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 branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

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Hovione files its first Investigational New Drug Application with the FDA

Nov 27, 2014

Loures, Portugal, July 31st, 2014 – Hovione today announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by the US Food and Drug Administration (FDA).   The inspection, carried out by the FDA Consumer Safety Officer, Ms. Britanny Terhar lasted 5 days as initially planned, started on 21st July and concluded on the 25th. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were 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.   On the outcome of the inspection, Luisa Paulo, Hovione's Compliance Director, said "The pre-approval inspection was triggered by a client NDA filing, it also covered the manufacturing of a commercial NDA and a generic antibiotic, doxycycline. It is an extremely satisfying result for our team and for our customers. The Hovione Team members have again demonstrated their commitment and ability to meet the highest quality standards in the manufacturing of APIs and pre-formulated drug products”.   Jim Harvey, Hovione’s General Manager at the Cork site, said “We are very proud of the result achieved during this flawless FDA inspection. I am very satisfied that the FDA inspector reported no observations and I want to congratulate the entire team. This is another important step for our site in Cork as it confirms our ability to comply with high engineering, manufacturing and quality standards across all of the Hovione 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 branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers all customers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Press Release
Hovione today announced that its API plant in Cork has successfully passed a pre-approval inspection by the FDA

Successful FDA inspection at Hovione’s API manufacturing plant in Cork, Ireland

Jul 31, 2014

Lisbon, 15th July 2014 – Hovione and Merrion Pharmaceuticals [ESM; MERR] announced today that they have concluded a strategic partnership directed to the use of Merrion’s patented GIPET absorption enhancing technology by Hovione clients. Hovione, an international contract formulation and manufacturing group, will add its commercial reach and technical expertise to generate new products where the use of absorption enhancement through GIPET is appropriate. Hovione and Merrion Pharmaceuticals have already established a cooperative relationship on technical issues relating to GIPET manufacture, and the agreement provides for the companies to collaborate on the feasibility assessment of GIPET with development compounds introduced by Third Parties. Subject to a decision to proceed, separate technology and manufacturing agreements may be negotiated with the Third Party. In this way Hovione is able to leverage its expertise and international manufacturing capability in order to supply new products from clinical trials to commercialization. In its turn Merrion Pharmaceuticals is positioned to add to its current licenses with external development and marketing partners while keeping operational overheads to a minimum. In a comment on the agreement, Merrion’s Chief Executive, Dr John Fox noted ‘I am delighted that Merrion Pharmaceuticals is working with a partner of such scale and reputation. Merrion and Hovione represent complementary offerings to companies seeking to develop tablet versions of compounds that otherwise may have been administered by injection or never reached patients at all.’ “We are very pleased to announce this collaboration with Merrion Pharmaceuticals, which extends our current expertise and capabilities in improving solubility of oral drugs by addressing the permeability limitations of BCS classes III and IV drugs. This adds value to our customers and benefits the patients. This agreement reinforces our strategy of combining strengths with other innovative companies like Merrion, to create better medicines,” said Dave Hoffman, Hovione’s Vice President of Sales and Business Development. 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 branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers all customers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. About Merrion Pharmaceuticals plc Merrion Pharmaceuticals plc is a publicly listed (ESM:MERR) pharmaceutical company focused on delivering innovation to the market by partnering with complementary companies to develop patented products. Established in 2003, Merrion is primarily engaged in facilitating the development of oral forms (tablets/capsules) of drugs that have suboptimal absorption, many of which can only be given by injection, through the use of Merrion’sproprietary drug delivery technology platform.

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Hovione and Merrion Pharmaceuticals Announce Strategic Partnership on Use of Merrion’s GIPET Technology

Hovione and Merrion Pharmaceuticals Strategic Partnership

Jul 15, 2014

Lisbon, April 7th 2014. Hovione announced today that the United States Patent and Trademark Office (USPTO) has granted a patent for a capsule-based, low-cost dry powder inhaler (DPI) to Hovione. This happened less than three years after the patent was filed and after just one Office Action – unusual speed for an inhaler application. Hovione have designed this inhaler to have just two operating components, thereby achieving significant cost savings and giving the patient unprecedented ease of use. In use, the patient just needs two steps before inhaling. In terms of delivery performance, lung fractions in excess of 70% have been achieved. This makes this inhaler highly suited for inhalation applications where minimal training of patients is desirable and has the versatility to treat most pulmonary diseases, including asthma, COPD as well as infection, which typically requires very large doses. XCaps follows on the heels of another successful Hovione DPI, TwinCaps®, which was developed for the delivery of the anti-viral drug, laninamivir, to treat influenza and is now approved in Japan and marketed by licensee Daiichi-Sankyo as part of their Inavir® product. Hovione inhalers are offered for licensing, together with formulation and particle engineering services on a fee for service basis. The company has also developed a line of inhalation-grade APIs, including fluticasone, salmeterol, mometasone and tiotropium. 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. This patent grant in the US within 30 months of initial filing, underpins Hovione’s capabilities in innovation and intellectual property management, to successfully design, develop and deliver innovative products”. “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 5 pharmaceutical companies, involving API process development, particle engineering, formulation and clinical supplies and is looking for partners willing to incorporate Hovione inhalers into their inhalation drug product development. 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 branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers all customers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.    

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USPTO grants a new inhaler patent to Hovione

Apr 07, 2014

Lisbon, Portugal, 5th December 2013. Hovione announced today the expansion of its inhalation drug product development services with the introduction of a high precision MG2 FlexaLAB capsule filling machine. This investment is in response to market demand for high-precision, capsule filling services for inhaled products and is the last step in Hovione’s plan to offer development services in all quadrants of inhalation projects: from API to formulation to powder inhalers to final unit dose. This investment intends to support Phase II-Phase III clinical trials to Hovione’s business partners. “We give our customers an edge in inhalation capsule filling for drug delivery to the lung, by providing access to a machine capable of very high precision filling of low doses, down to 5 mg. We are perhaps the only independent company with expertise in every aspect of the inhaled drug development process and this acquisition strengthens our commitment to inhalation drug development”, said Peter Villax, Vice-President. Hovione is currently executing inhaled drug development projects for a number of pharmaceutical companies, involving API process development, particle engineering, formulation development and clinical supplies. Capable of filling up to 3,000 capsules/hour, the FlexaLAB is the first MG2 equipment fitted with the MultiNET system, which allows 100% net weight unit verification for increased precision and suitable internal process controls for supporting inhalation development activities. Gonçalo Andrade, Business Development Manager, said “Hovione has a proven track record in the field of inhalation product development. With our core API process development, particle engineering and manufacturing expertise, Hovione produces pulmonary delivery-friendly particles which can then be used to fill inhalation capsules. The acquisition of the MG2 FlexaLAB unit allows Hovione to support capsule filling activities in all stages of clinical development and even low volume commercial manufacturing of inhalation drug products. Customers can now partner with Hovione for a full service inhalation drug development manufacturing, all under one roof.” 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. More about Hovione at www.hovione.com Contacts at Hovione:  Gonçalo Andrade, PhD MBA  Business Development Manager  gandrade@hovione.com +351 219 847 619 Isabel Pina Director Corporate Communications  ipina@hovione.com +351 21 982 9362  

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New inhalation capsule filling machine fills market gap

Dec 05, 2013

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. 

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The 12th successful inspection in 18 months

Another successful FDA inspection at a Hovione site

Oct 02, 2013

  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.

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Hovione: EPO grants a new inhaler patent

Sep 11, 2013

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.    

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

Jun 07, 2013

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.    

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

Apr 03, 2013

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.    

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

Nov 28, 2012

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.

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Hovione Expands Particle Design Solutions to Solve Bioavailability and Other Drug Delivery Challenges

Hovione Expands Particle Design Solutions

Sep 26, 2012

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     

Press Release

Hovione Announces the Appointment of Mike Ironside, PhD as General Manager TTC

Aug 30, 2012

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.

Press Release
Hovione Announces the Appointment of Conrad Winters, PhD as Drug Product Development Director

Hovione Announces the Appointment of Conrad Winters

Aug 23, 2012

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     

Press Release
Sales reach USD 180 million for the fiscal year ended March 31st 2012

Hovione’s sales grow 24%

Jun 21, 2012

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