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Article / Oct 09, 2001

Article published in the CPhI Show Daily Newsletter

Show Daily CPhI, 9 October 2001

Dear Friends,

When the organisers of CPhI asked us to write an article about Hovione for the CPhI Show Daily, we accepted but the words that follow are probably not what they expected.

Last year we were basking in the sun-shine, it had been a golden time for the fine chemicals industry. The El-dorado was nigh, everyone was investing, the brave ones were buying plants, and some, driven by consultants were spending hundreds of millions of dollars on merging and acquiring other companies. The folly of the stock-market still had everyone in a frenzy. Life seemed sweet, easy and money was plentiful. The bankers in their excitement even decided that those making fine chemicals for the Pharma industry deserved some attention, they organised conferences and issued reports.

What a difference 12 months make. We are now in a recession, and the atrocities of September 11th are fresh in our minds. Everywhere one looks, it seems the colours have gone and the World is now in black and white. The articles one reads in the industry magazines talk of over-capacity, slowing growth, withdrawn drugs, unapprovable letters, cancelled projects. In some cases, the extent of the excess-enthusiasm was even given a number: a CHF1.3 billion goodwill charge on acquisition. The fascination with our business will now wane and the wave of interest will go elsewhere.

Quite a few of us will remain behind to pick the pieces left behind by this storm, tidy up the house and get it to move forwards. It will take a couple of years to get things back into balance, for the new-comers to find their direction, to establish with clarity who is a quality competitor and who has remained a trusted supplier. Those that expected to grow an API business in 4 or 5 years to $500 million in annual sales will be disappointed; those that have been at it for decades, focusing on compliance and excellence will continue to deliver work that satisfies customers. It is the repeat customer that drives growth; track record is not just the absence of recalls and warning letters, it is also the ability to consistently find solutions for customer problems - and in drug development there are plenty of tough surprises to solve.

Being in compliant manufacture is not just a question of dollars; being "cGMP" is not just a question of investment in new facilities. It needs time more than money, it requires having a team of dedicated technical people with many years of accumulated training. You do not "go fast" because of more resources or tougher deadlines; projects move fast well because your technical groups are trained and have done it together many times before, your people are aligned, and the range of skills is well covered and well balanced. Can a confederation of a dozen plants acquired through multiple mergers ever have a common culture, a same view of safety, let alone of quality? How do you manage all the site managers competing for the new project? Being successful in compliant manufacture is tough, it comes with years of nurturing and focus. Is it a surprise that the smaller independent companies do it better than the large giants ?

The divide is often the time-scale - some squeeze their people and business partners for their quarterly results, the annual budget takes precedence over customer satisfaction, available capacity is a dreaded cost - others look at available capacity as a positive thing enabling prompt service, and focus on what is in their control: sales in 2003 and 2004 (indeed the sales for the next 2 years were decided some time ago...).

The divide is often the choice of target: large companies look at sales and profits, they look at the share price and at how to cut costs, performance is judged on dividends. This is not so for all: some of us are motivated by customers that say thank you, some even compete for, and win, environment awards, but those that succeed, work as partners with their customers to develop new drugs; if they were lucky they started working together 5 year ago for the first 10 kilos; if they are statistically normal, they will have worked together on two failed projects well before they can claim to have put a new drug on the market.

Our industry is about saving lives. Though on occasion we are seen as polluters carrying out unsafe operations, and sadly accidents do occur, as in Toulouse only last week. Odd how energetic reactions, deadly reactants, explosives, corrosives and flammables all come together to make pills that cure disease, kill bacteria and destroy viruses. Safety First is not a negotiable item, chemistry and its engineering need competence and have priorities that business pressures must not be allowed to interfere with. Success in this business needs great leadership, the decisions are not easy - Bayer reminded us all how tough it can get.

At Hovione we did not participate in the Technicolor storm of the past few years. We had approved a medium term plan in 1994 and executed it with success; in 2000 we approved another medium term plan and we are taking it forward unchanged. It involved buying a field near Princeton to build a kilo lab and pilot plant to support early phase customers in the USA and to assist in the technology transfer to our larger plants when the projects so warrant it. The plan also aims to build additional capacity in our areas of strength: process chemistry, GMP manufacture, injectable grade APIs and corticosteroids. Some of this expansion is taking place in our plant in the Far East which is not encumbered with EINECS costs and speed limitations that slow the pace of drug discovery.

The companies that meet at CPhI play a critical role in the world economy. We are a key link in the worldwide health care system - without us the pharmacies would be empty. Ours is an important job, one we can be proud of. It is important that we should move ahead and get on with our business with professionalism, and keep distractions to a minimum.

Guy Villax
Chief Executive - Hovione

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In an interview with Executiva, a portuguese media outlet focused on women´s leadership, Diane Villax, co-founder and long-standing leader of Hovione, reflects on her journey and the company’s development over more than six decades. Diane Villax’s career began at a time when few women worked outside the home. At 19, she joined a trading company as a foreign languages correspondent, where she developed essential business skills — including commercial correspondence, banking and export procedures — that later proved instrumental in helping her husband, Ivan Villax, establish Hovione in 1959. From its earliest days operating in the family home in Lisbon, Hovione adopted an international outlook. The company’s first major customers were in Japan, setting demanding quality standards that helped shape its long-term position in global markets. Over the following decades, Hovione expanded its footprint with the construction of its first manufacturing site in Loures (1969), followed by expansion to Macau (1986), the United States (New Jersey, early 2000s) and Ireland (Cork). The company grew into a global organization with more than 2,500 employees — including over 300 scientists — and a reputation as a preferred supplier to leading pharmaceutical companies worldwide. Throughout the interview, Diane highlights the values that have guided the company’s development: a commitment to excellence, a strong work ethic, and a focus on quality and long-term relationships. Although she did not have formal business training, she learned “on the job” and brought discipline, precision and structure to her role — particularly in the company’s early financial and administrative leadership. Now in her nineties and an active member of Hovione’s Board of Directors, Diane Villax remains engaged with the company’s evolution and governance, reflecting a continued commitment to its long-term development. Her story reflects entrepreneurial drive, resilience and long-term leadership — and offers insight into the values that have shaped Hovione’s trajectory for more than six decades. Read the full interview at Executiva.pt (in portuguese).    

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Márcio Temtem, vice president, Strategic Business Management, Hovione, addresses molecule complexity, speed, and regionalization via integrated manufacturing. The landscape of small molecule manufacturing is rapidly evolving, according to Márcio Temtem, vice president, Strategic Business Development, Hovione, who provides an expert look into how his firm is evolving their approach as the industry changes. With 17 years of experience at Hovione, a family-owned CDMO with a 66-year legacy, Temtem identifies three pivotal trends currently shaping the industry: increased complexity, accelerated development speed, and the regionalization of supply chains. Temtem observes that small molecules have grown significantly in size and complexity, often requiring multiple chemical steps and high-potency handling. This shift necessitates a specialized "toolbox" to overcome modern bioavailability challenges. Highlighting Hovione's technical approach to these hurdles, Temtem states, "We use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability.” This platform represents a core area in which Hovione maintains global leadership, utilizing innovative tools to scale processes efficiently while minimizing the use of APIs. Temtem also mentions the increased influence of AI in drug discovery and deployment, which requires CDMOs to bridge the gap from grams to tons at a much faster pace than in previous years. He further addresses the trend of regionalization, noting the rise of countries such as the US and China prioritizing regional supply chain strategies. He explains that Hovione is uniquely positioned to navigate these new challenges with supply chains through its FDA-inspected sites across three continents. Central to Hovione’s competitive advantage is their integrated manufacturing offer, which combines drug substance and drug product expertise at a single location. Temtem emphasizes the value of this model, stating, “The company… has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop.” To support this integration, the company continues to pioneer advanced manufacturing avenues, including continuous flow for drug substances and continuous tableting for drug products. Watch the full video interview or read the transcript at PharmTech.com  

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Hovione’s historic site in Loures has been expanded to meet demand and is now operating at full capacity. This Lisbon-based flagship company has developed innovative production techniques to serve laboratories around the world On the outskirts of Loures, in the periphery of Lisbon, a maze of multicolored pipes covers the walls of the Hovione factory. This industrial site, where signs warn of an “explosive atmosphere,” houses the production of active pharmaceutical ingredients — the core business of this company with Portuguese origins generating annual revenues of more than half a billion euros. “The products that leave here are shipped to every continent,” explains Diane Villax, the family matriarch. At 91, her voice moves effortlessly between English, French, and Portuguese — a cosmopolitan streak inseparable from the history of Hovione and the Villax family, its founders. The epic began with an exile: that of Ivan Villax in 1948. With a toothbrush in one pocket and his chemistry degree in the other, the 23-year-old anti-communist fled his native Hungary with relatives hunted by the Soviet regime. After a stop in Clermont-Ferrand, he dropped anchor in Lisbon, where he met Diane, from a family of sugar industrialists. One year after their marriage, they co-founded Hovione in 1959 with two other Hungarian refugees. The early days were artisanal: the company’s laboratory was located in the basement of the family home. “One of my earliest childhood memories is of adults in white lab coats. I knew how to use a fire extinguisher at six!” smiles Peter Villax, son of Ivan and Diane, who worked for Hovione for more than thirty years. Very early on, the duo expanded internationally, notably into Japan. The 1980s were prosperous years: growth surged at 20% annually. Then transformation accelerated with the arrival of new technologies in the early 1990s. Today, “the time required to move from test tube to industrial scale has been reduced to a few weeks, compared with six months in the past,” notes Peter Villax. The American adventure Sixty-seven years after its creation, the company — now headquartered in Switzerland — employs 2,400 people. Through medicines incorporating its active ingredients, Hovione claims to treats around an estimated 80 million patients worldwide each year. The Loures site has been expanded, and production has spread to Ireland, the United States, and Macao. The cellar at 1 Travessa do Ferreiro, where the story began, is now a distant memory. Little known to the general public, Hovione is nevertheless a key link in the pharmaceutical value chain: it develops and manufactures molecules for 19 of the world’s 20 largest laboratories. Its expansion has been fueled by favorable market conditions. “Pharmaceutical manufacturers increasingly rely on outsourcing for the production of active ingredients,” notes Loïc Plantevin, a pharma specialist at Bain & Company. “Historically, major groups chose to allocate more capital to research than to manufacturing, while biotech companies — which now drive most of the market’s growth — are not designed to build factories.” Far from resting on its achievements, the company has transformed its offering. “While the founders initially focused on generic active ingredients, Hovione has evolved toward more complex molecules and formulations, produced within exclusive partnerships with its clients,” explains Jean-Luc Herbeaux, a French national and the company’s CEO since 2022. This shift reflects a deeper trend. “For several years now, active ingredients have become a more differentiated market and less sensitive to price,” adds Loïc Plantevin. “Competitiveness is now linked to know-how and advanced production technologies, which require substantial investment.” Hovione is the world champion of spray drying, a technology enabling the production of soluble powders. With the expansion of its New Jersey site, the company aims to double its U.S. capacity — a country that accounts for 60% of its sales. Despite Donald Trump’s attacks on the pharmaceutical sector, which he claims to have brought to heel by forcing price cuts, Hovione remains confident. “We are in the U.S. to grow, and that ambition goes beyond the momentum created by the American administration,” assures Jean-Luc Herbeaux. “Our customers there are asking us to help them produce in the United States over the long term.” Commitment to cutting-edge research and the search for talent are deeply rooted in the company’s DNA. “In his later years, my father collaborated with Nobel Prize–winning chemist Geoffrey Wilkinson. Together, they would go to the Hovione lab to run experiments — just ‘for fun,’ as they put it,” recalls Peter Villax. The group is the largest employer of PhD students in Portugal and has forged partnerships with several national universities. “In some ways, Hovione resembles a university,” he continues. “Despite the sensitive nature of our technologies, we publish many academic research papers.” In search of lost sovereignty To preserve cohesion, the Villax family adheres to strict governance. “Unlike many Portuguese family businesses, most members of the third generation do not work in the company,” notes Duarte Pitta Ferraz of consulting firm Ivens in Porto. “Several independent directors sit on the board. The family’s role is to define values and long-term vision, not to manage day-to-day operations.” This responsibility is fully embraced by Jean-Luc Herbeaux. Since joining the group in 2020 as chief operating officer, sales have doubled. “My priority was to refocus the group,” says the engineer, who previously worked for German chemical giant Evonik. “We developed spray drying, invested in a new tablet-manufacturing process, and increased production speed through a new model that allows our clients to access all our services at a single industrial site.” A member of the European Fine Chemicals Group (EFCG), Hovione is actively defending European pharmaceutical manufacturing — a sector under strain. According to a study by the French Union of Organic Chemical Synthesis Industries (Sicos), Europe’s share of global active ingredient production has fallen from 48% to 30% in ten years, to the benefit of India and China. The reasons include production cost gaps — raw materials, energy — as well as the burden of European administrative and regulatory procedures, explains Maggie Saykali, director at the EFCG. “If we start a price war with our Asian competitors, we will not win it,” she admits. “It is better to compete on quality, innovation, and sovereignty over our value chain.” It took the Covid-19 pandemic and severe shortages for Europe to awaken. Last March, the European Commission proposed legislation on critical medicines. But the race against time has already begun. “China is increasingly using pharmaceutical ingredients as a tool of geopolitical pressure,” warns Maggie Saykali. “It is urgent to preserve European players like Hovione, focused on process innovation — which allows medicines to be produced with higher quality and greater environmental responsibility.” With a new site under construction in Seixal, on the southern bank of the Tagus River, the Lisbon star has not finished shining in the orbit of the global pharmaceutical industry.   (This is a translation from the original article)   Read the original article on lexpress.fr  

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