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Purpose To present a new screening methodology intended to be used in the early development of spray-dried amorphous solid dispersions. Methods A model that combines thermodynamic, kinetic and manufacturing considerations was implemented to obtain estimates of the miscibility and phase behavior of different itraconazole-based solid dispersions. Additionally, a small-scale solvent casting protocol was developed to enable a fast assessment on the amorphous stability of the different drug-polymer systems. Then, solid dispersions at predefined drug loads were produced in a lab-scale spray dryer for powder characterization and comparison of the results generated by the model and solvent cast samples. Results The results obtained with the model enabled the ranking of the polymers from a miscibility standpoint. Such ranking was consistent with the experimental data obtained by solvent casting and spray drying. Moreover, the range of optimal drug load determined by the model was as well consistent with the experimental results. Conclusions The screening methodology presented in this work showed that a set of amorphous formulation candidates can be assessed in a computer model, enabling not only the determination of the most suitable polymers, but also of the optimal drug load range to be tested in laboratory experiments. The set of formulation candidates can then be further fine-tuned with solvent casting experiments using a small amount of API, which will then provide the decision for the final candidate formulations to be assessed in spray drying experiments.   Read article here

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Screening Methodologies for the Development of Spray-Dried ASDs

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

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 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.    

Press Release

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  

Press Release

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. 

Press Release

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

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