Press Room

Press Release / Apr 07, 2005

Hovione stands behind 3 NCE launches

Hovione's commitment to supporting the high risk business of drug development is paying off.

Hovione's commitment to supporting the high risk business of drug development is paying off. In the Goldman Sach's list of 19 new compounds to be approved by FDA during 2005, Hovione is involved in no less than 3 new chemical entities and may well become a second source supplier to another two - all for American clients.

The Portugal-based international company has a product range that includes 17 commercial phase active pharmaceutical ingredients, and supplies clinical trial materials for a further 30 compounds still in the various phases of drug development. "We have committed considerable people and resources to supporting the innovation efforts of both large Pharma and Biotechs for over a decade now. Our R&D is focused on process chemistry; we do it well, and can provide a fast and cost effective service to the pharmaceutical industry as a whole. Drug development is increasingly complex and certain technical areas are best outsourced to specialists, who have solved similar problems in the past. One of our customer's drug got approved by FDA last month, and we expect another 2 NCE approvals in the next year or so - it's a record for us. We are very excited but these days nothing is risk-free - drug development is not for the faint-hearted." says Guy Villax, Chief Executive.

The last decade has seen innovation shifting away from the exclusive preserve of the traditional pharma multinationals to the stock-market and venture capital driven Biotech sector. Hovione anticipated this and invested in a green-field tech-transfer centre in New Jersey, USA, in order to be closer to the science and the innovators. "We have been operating a kilo-lab and a pilot plant in New Jersey for two years now. Our Princeton location gives us proximity to customers and to the FDA and frees us from the frustrating bureaucracies that have handicapped us in Europe. Our 5 decades of experience and unblemished track record at the health authorities present great value for the smaller innovator companies. Business is good but the weak dollar hurts our financial results; in any case with these approvals we cannot complain. We had an exciting 2004 despite all the negative news, we have added 5 new clients and 9 new projects to our growing list of both customers and projects.", says Dave Hoffman, President US Operations.

 

Expected product launches for 2005 with peak sales >US$200mn

Drug Originator Peak sales estimate
($ mn)
Status
Boniva (ibandronate) Roche/GSK
 
950 Filed
Indiplon Pfizer 800 Filed
SU11248 Pfizer 800 III
nelarabine GSK 700 III
Entereg (alvimopan) GSK 700 Filed
abatacept Bristol Myers 600 III
capravirine Pfizer/Shionogi 600 III
Dynestat (parecoxib) Pfizer 660 III
exenatide Eli Lilly 500 Filed
Macugen (pegaptanib) Pfizer 500 Filed
Noxafil (posaconazole) Schering Plough 500 III
Alvesco (ciclesonide) sanofi-aventis 480 Filed US, Approved UK
entecavir Bristol Myers 400 Filed
Yentreve (duloxetine) Eli Lilly 400 Approvable
Asmanex (mometasone) Schering Plough 300 III
DV-7314 (clopidogrel) Daiichi 300 Filed
Tygacil (tigecycline) Wyeth 250 III
Vaprisol Yamanouchi 200 Filed
Exubera sanofi-aventis/Pfizer 200 III (US)
/Filed(EU)

 

 

Source: Company data, Goldman Sachs Research estimates.

Hovione is a fine chemicals company dedicated to the process development and compliant manufacture of APIs for the pharmaceutical industry, both on an exclusive basis and for the generics market. With FDA inspected plants in Europe and the Far East, and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service and quality. With more than 45 years experience in API development from gram scale to commercialization, Hovione´s capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex APIs under FDA and ICH cGMP quality standards. More recently, Hovione has added process capabilities in the areas of particle design and inhalation drug delivery, manufacturing enhanced APIs.

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A mechanical engineering graduate, this Frenchman is the CEO of the Portuguese pharmaceutical contract manufacturer Hovione. Still owned by the founding family, the company was awarded the 2025 ‘Léonardo de Vinci’ Prize, which recognizes the innovative and successful succession planning of family businesses. With an international career behind him, Jean-Luc Herbeaux is almost more fluent in English than in his native language. At 58, this Frenchman with iceberg-blue eyes is the CEO of Hovione. Founded in the late 1950s, this Portuguese group, with 100% family ownership, has just received the ‘Léonardo de Vinci’ Prize, which highlights entrepreneurial successes tinged with family legacy. While this mid-sized company with a turnover of €500 million maintains a low profile, its pharmaceutical contract manufacturing business is just as obscure to the general public. "Yet, the market for contract manufacturers, or 'contract development manufacturing organizations,' is worth $200 billion", emphasizes the CEO, who has been working in this microcosm for two decades. 500 patents Aware of the stakes, he does not deny "the pharma industry's dependence on Indian and Chinese capabilities". "The fact remains that the trend is toward the regionalization of supply chains, with European manufacturers producing for the Old Continent, American manufacturers for their own market, and so on", he says. And to highlight the foresight of Diane and Ivan Villax, the founding couple, "who thought globally from the very beginning". As a result, the group, with its 500 patents, has factories in China, the United States, and Ireland, without neglecting its home territory. This is evident by the site currently under construction on the banks of the Tagus River, following a €200 million investment. "The heavy engineering and compliance aspects are being finalized, "he explains, emphasizing that this highly regulated sector "is under a microscope". He knows this all too well, as Hovione claims to be involved in 5 to 10% of the drugs approved each year by the FDA, the American drug regulatory agency. Professor from Houston to Japan “In this small world, having a good image is important: this is the case with Jean-Luc, passionate about his work, but who knows how to demystify things”, observes Elie Vannier, former chairman of the board of Hovione. He adds that having an international profile is a strength “in this ecosystem where talent and clients are international”. For his part, Jean-Luc retains from his numerous flights “a taste for films of all genres and from all countries”. The son of an administrative employee in secondary schools and an auto insurance expert, the youngest of three children moved around according to his parents' job transfers. He was born in Meaux, grew up in Chartres, and attended the University of Technology of Compiègne, “which already offered programs abroad”. Thus, he left a mechanical engineering internship at a Dior perfume factory to join the University of Houston in Texas, "carrying a 20 kg backpack". Despite his then-limited command of English, he earned a doctorate, became a professor, and met an American woman who would become his wife and the mother of their two children. Next came the University of Kanazawa in Japan. Alas! Disappointed by the academic world, "where you have to fight to get resources", he succumbed to the allure of industry and joined the American chemical company Rohm and Haas, which had fallen under the control of the German company Evonik. 80 million patients He spent twenty years there, in Germany and Singapore, before "accepting the offers from headhunters". He then accepted Hovione's offer, who appointed him Chief Operating Officer in 2020, then CEO two years later, making him the first CEO not from the founding family. The family remains the sole shareholder, which earned the company the ‘Léonardo de Vinci’ Prize, created by the Association Les Hénokiens and the Clos Lucé. Having settled near Lisbon, he substituted walking for combat sports, "having been burned by the injuries of some friends". He also mentioned that Hovione, whose clients include 19 of the world's 20 largest pharmaceutical companies, helps treat more than 80 million patients.   (Translated version)   Read the original and full article in French on LesEchos.fr  

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Jean-Luc Herbeaux aims to boost the growth of the pharmaceutical group Hovione

Dec 02, 2025

The CDMO’s New Jersey manufacturing site expansion will eventually cover more than 200,000 square feet. Portugal-based contract development and manufacturing organisation (CDMO) Hovione has completed an initial $100 million investment round in its East Windsor, New Jersey site. Once completed it will increase the facility’s footprint to more than 200,000 square feet and more than double its capacity for spray drying. Hovione CEO Jean-Luc Herbeaux said: “Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the US, we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.” Spray drying is an increasingly important particle engineering technology for improving drug bioavailability through the amorphous solid dispersion (ASD) that can address bioavailability or crystallisation challenges. The initial phase of Hovione’s expansion will include a 31,000-square-foot building to house two size-3 spray dryers (PSD-3) designed for ASD production. Construction at the New Jersey site is already underway and the company plans to start GMP operations in the second quarter of 2026. The initiative is part of Hovione’s long-term strategy to grow its US operations and enhance its integrated drug substance, drug product intermediate and drug product capabilities. Herbeaux said: “This investment addresses growing customer demand for US-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.” The company’s New Jersey expansion fits into its wider international growth plan that also includes capacity investments in Ireland and Portugal as it seeks to create a network of autonomous sites spanning the development and commercialisation of APIs, drug product intermediates and drug products.   Read the full article at EuropeanPharmaceuticalReview.com  

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