C&EN, February 12, 2018
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
|Noxafil (posaconazole)||Schering Plough||500||III|
|Alvesco (ciclesonide)||sanofi-aventis||480||Filed US, Approved UK|
|Yentreve (duloxetine)||Eli Lilly||400||Approvable|
|Asmanex (mometasone)||Schering Plough||300||III|
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.