Press Room

A breach in the pharmaceutical supply chain is only the tip of the iceberg. Innovators (Big Pharma and biotech companies) are today a minority player supplying only about 20% of the world’s medicines. At present, the vast majority of medicines are generic—the fruits of the best science of the 20th century can now be enjoyed for a few cents a pill.   Read article here

Article
Pharmaceutical Technology Europe, August 2014

Pharmaceutical Manufacturing and Supply-Chain Trends to 2020

Aug 01, 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.

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

Hovione and Merrion Pharmaceuticals Strategic Partnership

Jul 15, 2014

Here, Eunice Costa, PhD, Scientist, Drug Product Development; Filipe Neves, PhD, Senior Scientist, Group Leader, Drug Product Development; Gonçalo Andrade, PhD, Business Development Manager; and Conrad Winters, PhD, Director, Drug Product Development, all of Hovione, describe the strong position of inhalable products in preclinical and clinical pipelines and make the case for formulation-based approaches to enable and enhance pulmonary product development.   Spray-drying technology in particular is highlighted as a highly favourable, scalable manufacturing technique for inhalable composite particles.   Read article here

Article
ONdrugDelivery, 2014, June, pp. 3 - 8

Scale-up & QbD Approaches for Spray-Dried Inhalation Formulations

Jun 19, 2014

The quality metrics debate needs to recognize the paramount importance of quality culture over and above the mere compliance that results from meeting a quality system. What is needed is a simple reward system that identifies role models. An FDA’s Dean’s List will solve many problems: it will reward those producers that do the right thing for the patient, it will encourage innovation in pharmaceutical manufacturing, it will allow inspection resources to be applied wisely, it will make quality an effective differentiator at a time when the vast majority of manufacturing is done through outsourcing. This paper flags the responsibility of the CEO in driving the organization’s quality culture: the final safety net that assures patients only get good medicines.  

Article
Guy Villax Letter, June 2014

Why Dr. Hamburg Needs Her Dean’s List

Jun 01, 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.    

Press Release

USPTO grants a new inhaler patent to Hovione

Apr 07, 2014

The pulmonary route is gaining increasing popularity as a fast and effective way of delivering drugs to the lungs both locally and systemically. There are several reasons for this interest, noted Conrad Winters, PhD, director, and Filipe Neves, PhD, group leader, both from the Drug Product Development Group at Hovione. “Firstly, advances in device technology have made inhalation drug delivery more convenient and patient-friendly. Secondly, from a therapeutic angle, the lungs provide a high absorption area with extensive vascularisation, leading to rapid delivery of the drug. Moreover, because it circumvents first-pass metabolism, lower doses can be administered compared with the oral route.” Read full article

Article
Pharmaceutical Technology Europe, February 2014

Particle Engineering for Inhaled Therapeutics

Feb 01, 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  

Press Release

New inhalation capsule filling machine fills market gap

Dec 05, 2013

With an increasing number of relatively insoluble drugs in development today, there is a need to develop and use platform technologies capable of addressing solubility issues. Among the different alternatives, the use of stabilised amorphous solid dispersions is becoming increasingly popular, with pharmaceutical spray drying being one of the key technologies used in their preparation. In spray dried dispersions (SDD), the active pharmaceutical ingredient (API) is molecularly dispersed in a polymeric matrix. The polymer is used to stabilise the amorphous, metastable form of the drug and sustain supersaturation of the API in solution/biological fluids, thereby increasing bioavailability. Read article here

Article
European Industrial Pharmacy, December 2013

Scale-up of spray dried amorphous solid dispersions

Dec 01, 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. 

Press Release
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.

Press Release

Hovione: EPO grants a new inhaler patent

Sep 11, 2013

In this work, the potential of spray congealing in microencapsulation, taste masking and controlled release was explored and compared to other commonly used technologies, specifically spray drying and hot melt extrusion. The ability to control powder characteristics without the need of subsequent downstream processing methods is a marked advantage over other “particle-engineering” technologies. Moreover, spray congealing is an environmentally friendly process where high throughputs can be achieved. This technology involves some critical stages that should be thoroughly evaluated when establishing the process, namely the atomization, cooling and feed stages. Spray congealing represents a very attractive and promising platform to address some of the challenges related to drug development and drug life cycle management. Read article here

Article
Chemistry Today, September/October 2013

Spray congealing: applications in the Pharmaceutical Industry

Sep 01, 2013

The changing development paradigm resulting from the US Food and Drug Administration’s quality-by-design (QbD) initiative and International Conference on Harmonisation (ICH) guidelines requires increased process understanding of the drug substance and drug product throughout development and manufacturing. A lack of information can result in delays in regulatory approval and higher costs. Applying QbD principles leads to greater process understanding, facilitates regulatory approval and streamlines postapproval changes. Case studies on the manufacture of a bulk powder and the development of a tablet show the application of QbD principles, including defining critical quality attributes, implementing risk assessment, optimising process development, developing a design space and performing a criticality analysis. Read article here

Article
Pharmaceutical Technology Europe, September 2013

Optimising Quality by Design in Bulk Powders and Solid Dosage

Sep 01, 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.    

Press Release

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

Jun 07, 2013

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