Press Room

In this article, João Ventura Fernandes, PhD, Director of Technology Development and Licensing, and Peter Villax, Chief Executive Officer, both of Hovine Technology, look at the trends shaping the development of dry powder inhalers. Inhaled drug delivery is established as the primary choice for airway disease treatment and continues to hold high potential for systemic drug delivery. Since its invention in the 1950s, the pressurised metered dose inhaler (pMDI) has been the inhaled therapy “gold standard” for airway diseases such as asthma, as a result of being easy to use, multi-dose and inexpensive to manufacture. However, its drug delivery performance remains dependent on patient co-ordination – often leading to high drug losses – and environmental concerns have emerged with respect to the use of propellant-driven pMDI technology. Although initial chlorofluorocarbon (CFC) propellants have been discontinued due to their impact on the ozone layer, their hydrofluoroalkane (HFA) replacement propellants are unfortunately potent greenhouse gases – 2,000 times more potent than carbon dioxide. The global battle against climate change arising from greenhouse gas emissions may drive regulators to subject pMDI technology to carbon emission restrictions. Without major technological breakthroughs in finding alternatives which are not greenhouse gases, pharmaceutical companies may lean towards the use of alternative inhaler technologies.   Read the entire article      


Hovione Technology: Dry powder inhalers towards effective affordable sustainable respiratory healthcare

Nov 01, 2019

Hovione is nominated for CPhI awards 2019 being shortlisted in two categories:   1. “API Development”, for its PRIME tool - Process Ranking of Inputs from Manufacturing.         “It is an honour to have been selected for the finalists’ panel, which is already by itself an achievement. The PRIME tool enables to grow our collective knowledge on chemical processes and being able to visualize how each project is evolving along the lifecycle according to several metrics; additionally, we can establish thresholds for different metrics according to our past knowledge and develop our process to meet those targets. We can also start to build automatically databases for e.g. the most frequent reaction conditions per type of reaction. The tool not only helps managing better our knowledge on chemical processes but also adds a lot of value for our customers” said Filipe Ataíde, PhD, one of Hovione’s scientists responsible for PRIME.   2. “Analysis, Testing, and Quality Control” for its Accelerated dissolution methods for extended release drug product.     ​“Extended release formulations provide many advantages to patients and greatly simplify treatment but carry a heavy burden in terms of quality control. The methodology presented here aims at reducing the burden on the quality control lab, by developing accelerate dissolution methods that shorten the API release duration from several months to a few days. This accelerates the analysis timing and still guarantees the quality of the drug product since a good correlation with the long-term API release is the base of this development. Most importantly, this development poses a very significant advantage in terms of patient compliance, particularly for drugs where administration is complex such as those administered through the ocular route, or when the risk of missing a dose is high, and also regarding drugs with a frequent administration for extended periods. Above all, it contributes to the patients’ well-being” said Mafalda Paiva, MsC, one of Hovione’s scientists responsible for this innovation.    


Hovione’s innovative solutions nominated for CPhI awards 2019

Oct 30, 2019

Cork, Ireland, 20th September 2019 – Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea. At a recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Hovione received guidance for the design and clinical endpoints for HY01, topical minocycline gel 3%. Based on the review of the Phase 2 clinical trial which enrolled 270 subjects across 3 treatment arms (HY01 Gel, 1%, HY01 Gel, 3%, and vehicle), FDA has supported advancement to Phase 3. The two, US based, pivotal studies will enroll 750 subjects each with the primary endpoints of absolute reduction in inflammatory lesions at week 12 compared to baseline and the achievement of “clear” or “almost clear” and a 2-grade reduction on the Investigator Global Assessment. Additionally, Hovione will complete a maximal use study in subjects with papulopustular rosacea. Assuming replication of the clinically significant improvements in subjects with moderate to severe papulopustular rosacea observed in Phase 2, Minocycline Topical Gel may offer a safer alternative to modified-release doxycycline, which is the only tetracycline approved for the treatment of inflammatory lesions of rosacea1. If approved, Minocycline Topical Gel will provide an important alternative treatment option targeted to the site of action and as thus avoiding the systemic side effects of oral doxycycline. Hovione’s topical minocycline is the only program under development that uses a proprietary, crystalline form of the drug as minocycline base, conferring differentiated properties of potentially lower skin irritability based on its lower acidity and superior stability, as compared to its generic alternative. Hovione has secured patents for both the drug substance and the drug product globally with exclusivity through 2033. Hovione’s topical minocycline uses a novel proprietary excipient that reduces Trans-Epidermal Water Loss (TEWL) and provides a moisturizing, skin-barrier effect, potentially conferring relief to dry cracked skin of some rosacea patients. Minocycline is proven to have a potent anti-inflammatory effect,2 potentially superior to other tetracyclines.  Guy Webster, M.D. Ph.D., dermatologist at the Sidney Kimmel School of Medicine of Thomas Jefferson University stated: “Approximately two-thirds of oral antibiotic prescriptions written by dermatologists are for doxycycline and minocycline for either acne or rosacea. Both compounds are only available for oral delivery and carry a risk of side effects. Hovione’s topical minocycline has a systemic exposure 1000 times lower than oral minocycline and provides a topical alternative with a moisturizing formulation. “ Hovione anticipates initiating the Phase 3 trial subject to entering into a strategic collaboration with a commercial partner, by fourth quarter of 2019, aiming at filing the NDA during 2021.   About Rosacea Papulopustular Rosacea (PPR) is a chronic facial skin disease presenting most commonly in adulthood, with an estimated 16 million patients in the United States. PPR is characterized by inflammatory lesions (papules, pustules) on the nose, cheeks, chin and forehead.  PPR has been shown to have a negative impact on quality of life. Surveys conducted by the National Rosacea Society have shown that approximately 70% of rosacea patients experience lower self-confidence and lower self-esteem. Forty-one percent stated they avoid public contact and cancel social engagements during an exacerbation2.  Strategic Partnership Hovione is seeking strategic partners with proven regional or global commercial expertise in dermatology capable of maximizing the value of the First Topical Minocycline Gel for Rosacea.   About Hovione Hovione is an international company with 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and cGMP-compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.   Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. Del Rosso, James Q. et al. Journal of the American Academy of Dermatology, Volume 56, Issue 5, 791 – 802   Minocycline: far beyond an antibiotic. Garrido-Mesa N. et al. British Journal of Pharmacology. 2013;169(2):337–352. doi:10.1111/bph.12139    

Press Release

Hovione announces successful end-of-phase 2 meeting with the FDA and outlines phase 3 program for minocycline topical gel

Sep 20, 2019

Portugal-based Hovione Technology, a company developing inhalation devices, announced it has entered a collaboration agreement with the Kiel University’s Institute of Pharmacy in Germany. The agreement will see scientists from the institution utilize Hovione’s portfolio of large dose dry-powder inhalers (DPIs) to conduct research on advanced formulation approaches for high-dose inhalation applications. João Ventura Fernandes, Hovione’s director of technology, development and licensing, told us that the collaboration started in July 2019 and will continue during the course of the next three years. Specifically, researchers will use Hovione’s TwinMax and 8Shot inhalation devices, which enable administration of powder doses of up to 400mg to patients lungs through multiple inhalations manoeuvres. The devices are suitable for inhaled delivery of antibiotics, peptides, anti-virals, vaccines, pain or rescue treatments. Using Hovione’s devices, the researchers will work on formulations containing softpellets and nanocrystals for high-dose administration via dry powder inhalation, and with antibiotics including clarithromycin and rifampicin as model drugs. "In high dose drug delivery, the key in inhaled formulation development is to create an active pharmaceutical ingredient (API)-rich formulation, i.e. with as little as possible excipients, to deliver the required therapeutic dose with the smallest amount of material as possible,"​ Regina Scherließ, director of the Institute of Pharmacy, told us. Scherließ added that, in order to achieve this goal, while concurrently maintaining handling and dispersion properties, the Institute develops two advanced formulation approaches: Softpellets, which can be produced from pure API, i.e. 100% API in the formulation, and provide improved powder handling and aerodynamic dispersion properties when compared to the traditional approach of micronizing the material​ Nanoparticles, which may decrease the dose needed due to higher dissolution rate, and can be formulated to API rich microparticles for inhalation by particle engineering technologies, such as spray drying. This combination is called Trojan particle and also provides improved powder handling and dispersion properties.​ Fernandes said that Hovione aims to answer market needs, after the introduction of new drugs requiring delivery of large lung doses, often within the range of 50 to 150mg. Indications of such drugs include cystic fibrosis, pulmonary arterial hypertension, idiopathic pulmonary fibrosis or lung infections. Earlier this year​, Hovione acquired from Med & Tec the rights to the design of Papillon, a reusable, cost-effective, dry powder inhaler suitable for administration of treatments for chronic or acute pulmonary conditions. Find more about Hovione Technology   You might be interested in: DPI's formulation development Inhalation development services    

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Kiel University and Hovione to develop high-dose inhalation formulations

Sep 13, 2019

Pictured above were Gillian Chamberlain, BT with Maarten Schuuruman, MD, HEINEKEN Ireland, Bernard Sheridan, Corporate Affairs Director, Central Bank of Ireland and Paul Downing, General Manager, Hovione.   The 2019 Edelman Trust Barometer recently revealed that 75% of Irish people expect CEOs to take the lead on social change issues. Business in the Community Ireland has developed the Business Working Responsibly mark, the only independently audited standard for CSR and Sustainability in Ireland. The Mark can put your CEO and company at the forefront of social change, pioneering best practices in human rights and other social areas, and enabling others to follow suit. To date, 33 of the largest organisations operating in Ireland are certified to the Mark, and testimonials from their CEOs speak to the many benefits associated with certification. “We want to attract the best talent and having the Mark is a clear demonstration of our responsible business practices and signals to existing and potential staff that we are serious about our corporate social responsibility” – Clive Bellows, Country Head, Northern Trust  “For our businesses in Ireland, being certified with the Business Working Responsibly Mark helps to convey to employees, customers, local communities and stakeholders that we are fully committed to managing our operations in a socially responsible and sustainable manner “- Oliver Mahon, Senior Vice President – CRH Europe North So what are some of the benefits of achieving Mark certification? 1. Employee Engagement and Retention In the last decade the workforce has changed, and with it the culture of the workplace. Together Millennials and Gen Zs make up more than half the world’s population and account for most of the global workforce[1]. This new generation of workers places a much larger focus on social and environmental responsibility. Policies around diversity and inclusion, flexible working and rewards and recognition are being put under the spotlight, as the new workforce wants to work for companies that offer them a socially responsible purpose, without “sacrificing the flexibility to be who they are at work and live a fulfilling life outside of it”[2]. This flexibility doesn’t just mean flexible work hours or locations, but a more inclusive workplace and fair and transparent opportunities for progression. The Mark takes a focus across all of these workplace indicators and assesses company policies, practices and performance in achieving objectives. Achieving the independently verified certification can enhance your employer brand and help attract and retain employees. [1] [2]   2. Customer Relationships Not only is flexibility in the workplace becoming an essential part of any recruitment package, but so is the impact that a business has on both society and the environment. Research shows that millennials are the most socially conscious generation since the 1960’s[1] and climate change is topping their list of concerns[2] . They are expressing these values both in the demands they make as employees and in the demands they made as consumers. Present day consumers are making socially conscious choices and choosing products that meet their ethical requirements. According to the recent Deloitte Millenial Survey[3], “42% of millennials have begun or deepened a business relationship because they perceive a company’s products or services to have a positive impact on society and/or the environment. Further, 37 percent said they have stopped or lessened a business relationship because of the company’s ethical behaviour.” The Mark looks at the value chain of companies, and assesses whether their products and service are both socially and environmentally responsible. The certification process also examines the company’s environmental footprint, including waste reduction and carbon emissions amongst much more.   3. CEOs as Leaders of Change Mark certification gives you access to Leaders’ Group on Sustainability, a collaboration between the CEOs of some of Ireland’s largest organisations, addressing pressing social, economic and environmental challenges. This year the Leader’s Group has produced the Low Carbon Pledge, with 49 of Ireland’s largest companies committing to lowering their scope 1&2 emissions by 50% by 2030, and the Social Inclusion Blueprint, a practical guide to create inclusive workplaces and reduce inequality in Ireland. What does the Mark certification involve? The Mark can help your company to raise your brand’s CSR profile and better recruit, retain, and engage your employees. Audited by the National Standards Authority of Ireland (NSAI), and based on ISO 26000, The Mark will assess your responsible and sustainable business practices and provide your organisation with an assessment of how well positioned it is to address CSR risks and opportunities in the current business environment. The assessment addresses policies, practices and company performance across five pillars (Governance, Marketplace, Workplace, Environment, and Community which encompass 22 indicators, including Employee Engagement, Responsible Products and Services, Carbon Management and Climate Change Adaptation, and Community Engagement. Achieving the Mark Certification provides independent verification that will enhance your employer brand, help attract and retain employees, support your corporate responsibility and sustainability credentials and support your organisation in leveraging investment potential.   Read article  

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The Mark of a Great Company

Sep 09, 2019

  Hovione is a pharmaceutical company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. Hovione was established in Portugal in 1959 and today employs 1,742 people worldwide. The Cork site was established ten years ago and currently employs over 210 full-time team members. “I’m delighted to see the Cork site playing such an important part in the success of this impressive company,” said Simon Coveney TD, Tánaiste and Minister for Foreign Affairs and Trade speaking at the celebration event for Hovione’s 60th anniversary. “Hovione has seen steady growth over the last few years and I’m confident that the coming years will be equally successful for the Cork team.” “Our Cork site plays a significant and strategic role within the Hovione network,” said Hovione CEO, Guy Villax, who was in Cork for the anniversary celebrations. “With two Active Pharmaceutical Ingredient facilities alongside a Drug Product Intermediate facility that houses the largest commercial pharmaceutical spray dryer in operation, the Cork site boasts both extensive manufacturing capacity and people capability.” Over the last five years, the Hovione Cork site has invested close to $30 million in new processing equipment, new analytical equipment, upgrading the facility to contemporary standards, re-instatement of a third production building and the installation of new technologies.  “Hovione is a fast, challenging, dynamic environment and the team here in Loughbeg are the reason for our continued success,” said Dr. Paul Downing, General Manager at Hovione Ireland. “Since 2014, we have undergone a significant change in terms of increased volume output and increased capacity utilisation. Along the way, we have further diversified our portfolio, increased complexity, transferred products from sister facilities and increased the number of customers we serve.”    Hovione is a proud member of the Ringaskiddy and Loughbeg communities in which it is based and maintains strong links with the local community and sporting organisations. Hovione is an active member of Business in the Community and holds the Business Working Responsibly mark. The Cork site is also a signatory to the Business in the Community Low Carbon Pledge.   About Hovione Hovione has almost 60 years of experience as a Specialist Integrated CDMO (Contract Development and Manufacturing Organization) offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services.  

Press Release

Hovione celebrates its 60th Anniversary in Cork

Sep 05, 2019

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