Press Room

Transformative investments, and capacity expansions abound at CPhI North America Pharmaceutical services firms attending the CPhI North America trade show in Chicago earlier this month were virtually unanimous in reporting another year of strong growth in a business that has seen no direction other than up for nearly a decade. Investment continues apace, as do acquisitions, with many firms claiming their manufacturing assets are at or near full capacity. Tied as it is to the drug industry, the sector has long defied traditional economic cycles. Contract manufacturers of active pharmaceutical ingredients (APIs) have also added services, developed expertise in complex chemistry, and generally taken risks to grow businesses in the direction required by customers developing the drugs of the future. Results this year indicate that many of these risks have paid off. And ongoing investments hint at another round of risk taking on new technologies and service models. "Business is buoyant, the strongest it's been on record," said Denis Geffroy, vice president of business development for the Northern Irish firm Almac Sciences. "We are approaching 20% growth this year, which is really surprising because we've been growing 15-20% for the last 10 years." Several factors explain yet another year of strong results, Geffroy said. "First, I like to think we are doing a good job. But the market has improved, especially in the US," he said, citing a steady flow of venture funding for biotech start-ups. Meanwhile, customers continue to bring their outsourcing back to Europe from China, a shift that accelerated with a Chinese crackdown on environmental regulations starting in 2017. Almac Sciences is experiencing strong growth and is operating near full capacity. The firm plans a major expansion. Almac has also benefited from a commitment it made to biocatalytic services beginning in 2010. "We are staying ahead of the game, using enzymes not only for chiral molecules," Geffroy said. "About 20% of the compounds we make have got an enzyme somewhere, either in a final step or in an intermediate step." The 2015 acquisition of the Irish firm Arran Chemical was key to developing the service, he added. At the time, he told C&EN that Almac was "hitting the wall" on biocatalysis capacity. The company is hitting the wall again, according to Geffroy, this time in its core API business. "We are growing so quickly, we are at full capacity at the moment, which is a bit frustrating," he said. "We need more capacity, and we now have the approval from the board to start building an API plant next door to our current plant." The $20 million facility is expected to open in 2021, yielding a fivefold jump in the firm's capacity to make highly potent APIs. The Portuguese firm Hovione is also expanding. "We acquired a new piece of land in Portugal, a greenfield site, 10 times larger than the site we have," Marco Gil, senior director of commercial services, told C&EN. At the 40-hectare site, a half-hour drive from Hovione's headquarters plant in Loures, outside Lisbon, the firm will add API capacity while expanding in new areas such as flow chemistry and finished-drug production. The company is already expanding in Loures, where it recently established a continuous tableting line. Spreading out at the new site will give Hovione a chance to broaden its services and establish a full line from early-stage development to commercialization, all in the Lisbon area, according to Gil. In France, Minakem is building a lab for cytotoxics used in antibody-drug conjugates at its site in Louvain-la-Neuve, Belgium, where it is also installing a high-performance liquid chromatography column, according to Jean-Marie Rosset, vice president of sales and marketing. And the company, last year, completed and $11 million API-capacity expansion in Dunkirk, France. "We are facing capacity constraint," Rosset said, noting that Minakem is also pursuing an acquisition. "We have been looking for 18 months." The company may acquire R&D or pilot manufacturing assets in the US, he said. Rosset said that prospects look good for the year ahead. "We have a lot of stuff in the works that will require scale-up," he said. "The problem is where to put these products. But that's a good problem to have-better than empty capacity." Helsinn finds itself in similar straits, according to Sandra Moro, business development director. The company is in the midst of a $20 million project at its Biasca, Switzerland, headquarters to install large-scale cytotoxic manufacturing capability.                           We believe in the one-site shop with chemistry, particle engineering, and final product. Marco Gil, senior director of commercial services, Hovione The project will free up smaller-scale capacity, Moro said, allowing Helsinn to take on more of customers' early-stage work, such as oncology projects that have been fast-tracked by regulators. "We can go from Phase I to Phase III," she said, referring to stages of drug development, "but we currently have very few early-phase compounds-56% of our compounds are commercial." Tight capacity has not stifled growth, however. Helsinn's revenues increased about 20% for the second year in a row last year, Moro said. It's not only European firms that are investing. India's Hikal also has achieved 20% annual growth in recent years, according to Anish Swadi, head of business development and strategy. The company is also in need of capacity. "We are investing $55 million into assets and infrastructure," Swadi said; this investment will support the company's pharmaceutical chemical and crop protection divisions, which share core chemistries. The new capacity will expand continuous manufacturing and biocatalysis capabilities, he added. Some of the firms that disclosed expansions at CPhI did so on top of large acquisitions. Executives from such firms discussed integrating internal and external investments to create full-service offerings for their drug-industry customers. Catalent recently announced a $1.2 billion acquisition of the gene-therapy specialist Paragon Bioservices, setting itself up in an increasingly competitive new field in drug development. Separately, the company is investing more than $200 million to expand its monoclonal antibody (mAb) and other large-molecule production capabilities in Madison, Wisconsin, and Bloomington, Indiana. It's adding fill-and-finish and associated analytical and packaging capabilities as well, to "take your mAb from preclinical all the way to commercial," said Elliott Berger, vice president of global marketing and strategy. Although Catalent doesn't manufacture pharmaceutical chemicals, it is looking to bolster its presence in small molecules, where bioavailability-enhancing techniques are of increasing importance. Acquisitions over the past 5 years-including Micron Technologies in 2014, Pharmatek Laboratories in 2016, and Juniper Pharmaceuticals in 2018-have brought in spray drying, formulation, and other services downstream of API production. At the Chicago event, Catalent announced a $40 million expansion of oral-dose capabilities and the addition of spray drying in Winchester, Kentucky. And the company is also ready to invest heavily in its newest business, Berger said, noting that Paragon is building two commercial production facilities in Baltimore and expanding its relationship with Sarepta Therapeutics, a key customer for its adeno-associated virus vectors. "We have financing secured for larger than the acquisition to fund that," he said. At CPhI, Lonza announced what it calls a "first in human" service: a combination of API and finished-drug development, formulation, and manufacturing targeted at the 70% of compounds in development that have solubility challenges. According to David K. Lyon, a senior research fellow with Lonza, the service draws on both internal assets and those acquired in recent years, such as Micro-Macinazione, a Swiss micronization specialist that Lonza bought in 2017. Other assets are as far afield as Bend, Oregon, where Lonza does solubility work; Guangzhou, China, where it manufactures APIs; and Edinburgh, Scotland, where Lonza operates a liquid-drug formulation facility. Lonza is cuing up these assets to crack the bioavailability case at Phase I and expedite commercialization, especially of fast-tracked projects, Lyon said. It aims to reduce development time from 52 weeks to 32 weeks for customers seeking to file an investigational new drug application with the US Food and Drug Administration. The small-molecule specialist Cambrex is also putting recent acquisitions together. The company brought in early-stage API development when it bought PharmaCore in 2016 and added early-stage API capabilities and sites in the US and Scotland when it acquired Avista Pharma Solutions last year. It also bought Halo Pharma, a finished-drug producer, for $425 million last year. Cambrex is now better positioned to address the changing needs of innovative drug companies, according to Matthew Moorcroft, vice president of marketing. Meanwhile, Cambrex continues to invest in large-scale API production. It completed an expansion of its high-potency API plant in Charles City, Iowa, last year. The company is now ramping up continuous manufacturing capabilities at its Highpoint, North Carolina, facility-the former PharmaCore-and its factory in Karlskoga, Sweden. "To make a long story short, we are excited about what we've done over the last 6 months," Moorcroft said. "Now it's all about delivering."     Read the article      

Article

In the drug services industry, growth has no end in sight

May 20, 2019

The Fire Services Bureau held an emergency drill at the Hovione pharmaceutical plant in Taipa, to better strengthen the resilience and coordination of the bureau, and about 150 personnel from both parties participated. Macau (MNA) – The Fire Services Bureau (CB) on Thursday held an emergency drill at the Hovione PharmaScience Ltd Plant (Hovione) in Taipa, to better strengthen the resilience and coordination of the bureau. According to a release by the CB, the drill simulated an accident occurring when a worker operating a forklift at the pharmaceutical plant pierced a methanol solvent storage tank and caused a fire. During the evacuation process of the drill, workers pretended to be injured while the remainder of the staff took safety measures in accordance with the internal contingency plan of the plant, and evacuated all relevant personnel to their emergency meeting point. When informed of the ‘accident’, the CB dispatched nine emergency vehicles and 37 firefighters to the scene who carried out fire fighting, evacuations, search and rescue, as well as caring for the injured, according to an established plan. The exercise lasted for about an hour, and a total of 150 personnel from both Hovione and the CB participated in the exercise. The release states that the drill went smoothly and achieved its intended purpose, and after its completion, a meeting took place between both parties to discuss future exercises in testing their responses.   Read complete article at MNA    

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Fire Services Bureau holds emergency drill at Hovione plant in Taipa

Jan 25, 2019

Lisbon, 25 January 2019. Hovione has issued a bond of $50 million US dollars maturing in 2033. The bond was arranged and subscribed by Banco BPI, S.A..    According to António Almeida, Hovione’s CFO, “we issued this bond to strengthen our balance sheet as we embark in a new phase of significant capital expansion. We issued a USD denominated bond because the majority of our sales is in the USA”.    The bond is registered as "Hovione 2018-2033”, has a nominal amount of $50 million US dollars and a maturity of 15 years.     “2019 is the year when we celebrate our 60th Anniversary and we are pleased that the market offers us good terms for a bond with a 15 years’ maturity. We are building a business for the long term.” said Guy Villax, Hovione’s CEO.    The decision to expand our production capacity follows growing customer demand since, as a specialist integrated CDMO, Hovione is increasingly being chosen as a solution partner from Drug Substance to Drug Product. Hovione is committed to listen to customers and to continue supporting their evolving needs. Of the 59 drugs approved by the US FDA in 2018, 4 of them had their process developed in our labs and are produced in our plants.     The bond is registered in Euronext with the ISIN code: PTHOVCOM0006.    About Hovione Hovione has almost 60 years of experience as a Specialist Integrated CDMO 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 issues $50 million bond

Jan 25, 2019

On January 22nd Mrs. Diane Villax, Founder Chairman, received the Officer’s Cross of the Order of Merit of Hungary. The decoration was handed to Mrs. Villax by the Hungarian Ambassador to Portugal, Madame Klára Breuer, conferred on her by the President of the Republic of Hungary in recognition of the contribution to the development of education of Chemical Engineers through helping students of the Budapest Technical University financially and professionally. The ceremony took place at the Hungarian Embassy in Lisbon and was attended by representatives of the Embassy, the Portuguese Government, Hovione, friends and members of the Villax family. Since 1993, Hovione has received graduate students from the Faculty of Chemical Technology and Biotechnology of the Budapest University of Technology and Economics, alma mater of Dr. Ivan Villax. In 2008, a protocol was signed between the University and Hovione, which pledges to annually receive one to two students in the area of R&D, giving them financial and professional support. It was an intimate ceremony and Mrs. Villax expressed her appreciation of the award saying “this is the story of how the traineeship program came about and which is the basis of the honour I have received today. All I have to say is thank you very much and we intend to continue, our tag line "In it for Life" with many interpretations”.   Learn more about the Ivan Villax Traineeship      

News

Diane Villax receives the Officer’s Cross of the Order of Merit of Hungary

Jan 22, 2019

Hovione Loughbeg supplies medium and large-scale manufacturing active pharmaceutical and drug product intermediates that are approved by European, US and Asian health authorities. Over the last four years, the site has continued to successfully transfer new products, acquire new business, achieve multiple regulatory approvals and attract key talent to the site, which now boasts close to 200 team members. Adding Capacity In May 2018, Hovione concluded the re-instatement of a second active pharmaceutical ingredient building on the site, adding further significant capacity, technical capability and expansion opportunities. This promising expansion creates career development opportunities for existing and new team members.  The site now has all three production buildings in operation for the first time in its history. This major investment in the Loughbeg facility will enable further diversity in the product portfolio and brings major additional capacity to the Hovione group, providing enhanced flexibility and agility to both existing and future customers. “We at Hovione Ireland are looking forward to celebrating our 10th year of operation in 2019,” explains Paul Downing, Hovione Ireland General Manager, “which is also the 60th anniversary of the founding of the company in Portugal.” In It For Life “Hovione is a pharmaceutical company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market,” Downing explains. “We do well what is difficult, to give our customers what they cannot find elsewhere.”

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Expansion at Hovione Ireland

Dec 10, 2018

2019 will be a very significant year for Hovione the contract pharmaceutical manufacturing company which helps bring new and off-patent drugs to market celebrates 10 years Irish-side. Hovione which took over Pfizer’s former Loughbeg site in Ringaskiddy in 2009 has seen rapid growth over the last 10 years. The company employs over 200 people in Cork and hundreds more at its other three sites spread over three continents with facilities in Lisbon (Portugal), Macau (China), New Jersey (USA). Hovione has over 55 years of experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. The Cork plant plays a significant and strategic role within the Hovione network and that was certainly proven earlier this year when Hovione expanded its production capacity. Having recommissioned a third production building at their site in Ringaskiddy Hovione went into production at this building in May of this year. “This is the first time in Cork’s history that all three buildings have been running at the same time”, said General Manager Paul Downing who said it is an exciting time in the company’s history as Hovione Cork now have extensive manufacturing capacity with two Active Pharmaceutical Ingredient facilities alongside a Drug Product Intermediate facility that houses the largest, commercial pharmaceutical spray dryer in operation. Dr Downing said he is optimistic about the future. 2019 he said is going to be a really big year for Hovione Worldwide as it celebrates its 60th Anniversary.  The company was founded by Ivan Villax with his wife Diane Villax in Lisbon in Portugal in 1959. “We have a very ambitious plan to be the Number 1 innovative, integrated pharmaceutical solution provider to the global pharmaceutical industry by 2028,” said Dr Downing.  Our mission is to passionately turn any challenge into a solution by collaboration with our partners to develop great medicines. "That is a company corporate goal so that requires all our facilities to grow and expand so this expansion plan is across the whole Hovione network including Lisbon, New Jersey, Macau and also obviously Cork. “In short we give our customers what they cannot find elsewhere”, says Dr. Downing, who explains that the company’s customers come from the sectors of biotechnology, medium, speciality and large pharmaceuticals as well as generics pharmaceuticals. “Hovione has a unique value proposition. We have more than 15 years of experience in pharmaceutical spray drying and have produced hundreds of batches for clinical trials and commercial supplies. “We have a very diverse workforce. We currently have 15 nationalities onsite here in Cork.  "Hovione is a fast, challenging dynamic environment and there are great opportunities for people with all skill sets at whatever age. “Because the market demands different products you can work on multiple products and multiple projects at the same time. That gives people a diversity of experience.  "We like to have a balance between promoting from within and recruiting from outside so therefore if someone has the desire to move within the organisation these opportunities arise.” Hovione is constantly developing its talent pool and is a big supporter of and encourages apprenticeships for young people where they get an opportunity to gain very substantial and important skills allowing them to take up roles as electricians, fitters, quality control analysts, instrument technicians as well as automation technicians. The Apprenticeship programme not only provides participants with the necessary technical and professional skills, it also provides valuable teamwork experience. Valuable teamwork experience “What we do find is that people can have very strong technical and academic skills but their team collaboration skills require us to invest in further training.  "These skills would be automatically instilled in participants in the Apprenticeships programmes.  In complex and large organisations like ourselves the interpersonal skills and an ability to work in small teams is important. Hovione works with Skillsnet and other local academic institutions to help build capabilities that can take advantage of the many career opportunities available. “We do College site tours and Master student placements. We work with the IDA on the IBEC EOP Programme which sees graduates spend six months with us and six months with our sister facility in Portugal mostly working as process engineers or QC analysts.  "We hope these graduates will come and join us in our new process in Cork in 2019. “We continue to work with the Portuguese Postdoctoral Graduate Placement Programme and with the Cork Education Training Board and this year we supported the IBEC Laboratory Apprenticeship Programme — we have the first two apprentices joining from that initiative this January in collaboration with CIT so we look forward to that as it has been a couple of years in the making.” Overall, Hovione’s steadfast growth is the result of an integrated synergy that allows the company to serve both the global markets and also to respond to specific customer demands when necessary. The company has a solid legacy of Corporate Social Responsibility — last year Hovione became a Certified B Corp – becoming the first facility in Ireland to have received this certification. The company’s ‘Safety First, Quality Always’ culture is also something staff are very proud of - “we nurture it each day so that we do not take it for granted”. “In the coming years we will continue to invest in additional capability and hire additional team members, launch and validate more new products”, says Dr Downing, who points out that the company is an active member of Biopharmachem Ireland, Cork Chamber as well as Business in the Community Ireland. Hovione sponsors and supports local community initiatives as well as establishing crucial links with the academic and training institutions through its support of STEM — initiatives to encourage take-up of subjects such as science, technology, engineering and mathematics — as well as CIT Student placements and the Cork Training Centre. Just last week, Hovione won the Corporate Citizen Responsibility Business in Community Ireland Mark. Carbon footprint commitment “We are one of 40 leading companies who have signed up to significantly reduce their carbon emissions between now and 2030”. The pledge was made at a summit organised in Dublin last week by Business in the Community in Ireland, which describes itself as a network for sustainability. “We are the first contact manufacturing organisation to win that award,” said Dr Downing.  “We see that things like corporate social responsibility, being ethical in the workplace and within the community, reducing our carbon footprint are all important very important issues going forward.” Hovione committed to engaging with its local communities Hovione holds annual corporate social responsibility days and each year a particular organisation is chosen. This year, the company supported SIMON Community — fundraising and giving practical support. Every Christmas, the company also facilitates food and gift appeals for the Society of St Vincent de Paul. Dr Paul Downing said: “We are the first chemical / pharmaceutical company integrating this innovative community of companies that use the power of business to solve social and environmental problems.  "As a Certified B Corporation, we want to contribute to redefine success in business meeting the highest standards of social and environmental performance, setting out Team Members for success and personal satisfaction and aspiring to use the power of markets to solve social and environmental problems. This is a global movement of people using business as a force for good, with a vision that one day all companies compete not only to be the best in the world but the best for the world. As well as expansion in Cork, Hovione is completing by the end of 2018 the qualification of its continuous tableting line at New Jersey (USA).  The capacity expansion program started in 2016 and will continue in the coming five years.  Hovione has relocated its development services to a new centre with 7,000 m2 in Lisbon — fully equipped with the most recent tools to handle potent and highly potent compounds. The Loures site expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant.  The company installed more spray drying capacity at the site and started the operation of a new drug product centre equipped with oral dosage form as well as inhalation manufacturing capabilities.  In New Jersey, Hovione has doubled the size of its development and manufacturing operations. The decision to expand follows growing customer demand since Hovione started offering end-to-end solutions from drug substance to drug product from the Loures site in 2017. Hovione increased production capacity in oral dosage forms in Portugal to strengthen their integrated offering.  New commercial scale equipment for blending, tableting and coating will complement existing development small scale equipment.  This ‘One Site Shop’ allows customers to streamline their supply chain, reduce time to market and benefit from seamless project management.  This increase in capacity helps Hovione customers to consistently bring products to market faster. Paul looks forward to a very exciting year ahead.  All these successes here at home, he says, would not have been possible without the continued support of the local businesses, IDA, Biopharmachem Ireland and the staff working at the Cork facility.   Read the full article  

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Life Sciences: Hovione increases production capacity while looking forward to its tenth year in Cork

Dec 10, 2018

This year, a further seven companies were recertified to the standard: Boots Retail, CRH, Deloitte, ESB, Gas Networks Ireland, Intel and KBC Bank Ireland. In all, 33 companies have now achieved the BWR mark, which is hosted by Business in the Community Ireland (BITCI), which assesses applicant companies’ sustainability and corporate social responsibility commitments. Significantly, this year’s event also saw 43 companies pledge to cut their carbon emissions between now and 2030. The signatories are in retail, manufacturing, agri-food, professional services, banks, transport and ICT. It is becoming increasingly important for Irish companies to measure and prove their commitments to sustainability, the environment and engagement with employees and local communities. And nudging those commitments on are their existing and prospective new employees, who are becoming increasingly insistent on working in a caring workplace. “We look at companies’ activities across the board, across their various management practices,” said BITCI’s CEO, Tomás Sercovich. The companies speak very highly of the mark, and that is because we are very thorough about the audit process. We have 22 auditors who conduct best-in-class audits. Companies find it useful to have a third party come in to observe their policies in practice “The truth is that companies are also very good at using this mark as a way of differentiating themselves in an increasingly complicated employment market. I know there are people working in life sciences who changing jobs, some just crossing the road to take work with a competitor.” In many cases, the employees are citing ethical grounds when changing jobs. Mr Sercovich said many new graduates are now asking companies policy questions about plastic, recycling and carbon footprint at interviews. In the case of Cork Harbour industries, would-be employees are asking about any impacts on the harbour. In retail, companies are also becoming more attuned to the ethical antennae of their employees. One Dutch supermarket recently introduced a plastic-free aisle. “Millennials in particular are looking to work with companies who have deep commitments across a range of issues,” Mr Sercovich said. “They’re digging deep with their questions. They won’t accept a box-ticking exercise, they want companies with real values integrated into their business models and their everyday activities.” This is where BITCI’s support is so important to companies. Going for the BWR mark is not without its risks. Attaining the mark is really demanding, so there is a very real risk of being embarrassed by falling short. Several recipients said they were relieved as well as delighted. “We’re extremely proud to have achieved the Business Working Responsibly mark,” said Maarten Schuurman, managing director, Heineken Ireland. “It’s wonderful to see the emphasis we place on sustainability and responsibility across all aspects of our business recognised and benchmarked independently. “The mark serves as a clear signal to our stakeholders and our customers and consumers that we are listening; that we know sustainability matters to them as much as it does to us; and that we are working every day to make Heineken Ireland a truly green brewer.” Kathryn D’Arcy, Heineken’s director of corporate affairs, added: “Our commitment to sustainability and the environment is a long journey. We need to make decisions today that will have a positive impact on the world for the people who are coming behind us. “Heineken has built up a proud heritage over 160 years. We’re producers of premium beers and ciders. Using only quality sustainable ingredients is at the heart of what we do. The Business Working Responsibly mark is a useful part of our journey. We want our heritage and commitments to be around for another 160 years.” Meanwhile, Hovione in Ringaskiddy is another of this year’s four new companies to achieve the Business Working Responsibly mark. It is also one of those to have signed up to BITCI’s dedicated pledge to significantly reduce their carbon emissions. “The award fits in well with our commitment to operating sustainably,” said Paul Downing, general manager of Hovione. “We have done a lot of work in managing our carbon footprint. Achieving the Business Working Responsibly mark is important to us, and we will be celebrating the award with our staff and the on-site team dedicated to managing this for us. The mark is also important in terms of attracting and retaining talented employees Dr. Downing said it is increasingly a feature for job candidates to ask about companies’ commitments to the environment, their employees and their local community. Membership of BITCI is one useful measure for demonstrating Hovione’s commitments. “People joining the company frequently ask questions about our corporate social responsibility programme,” said Mr Downing. “The Business Working Responsibly mark is a very useful measure of our environmental and community commitments.” Hovione is also the first chemical or pharmaceutical company to become B Corp certified. B Corp is a global community of companies committed to collectively solving social and environmental problems.   Read the entire article    

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Employee focus on ethical issues keeps firms on a righteous path

Nov 16, 2018

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