Press Room

Hovione will be in at the 1st BioFine event in Berlin, so yes we did feel there was space for another show. In fact our thoughts are that some shows may have become too large and far too expensive, trying to be all things to all people, and with their gigantic size working against some of their users. Many of us, tired and with sore feet, wonder why we have to stand in queues waiting for expensive average food. We are looking at Bio-fine as a differentiated show - one that focuses away from commodities and is sensitive to pairing customers with suppliers eager to provide service and know-how. In giving our best wishes to the managers of BioFine, we would remind them that this is a global industry where English is the lingua franca and the outlook is international. We all have full agendas and tight schedules so please do choose venues where foreigners are welcome, taxis cheap and plentiful, airports near-by and hotels at the convention centre and not a wet 5 (in fact 15) minute walk away! Please time your shows away from other well-established and popular industry events, do consider traditional holidays of the key nations involved, keep away from locations in seasons that are predictably wet and cold. A great show was CPhI 1997 in London in Earl´s Court - everyone spoke English, the walk to the tube was 2 minutes, it was sunny September, and close to all the hotels. If Bio-fine wants to do really well look to how organisers of US shows do it. Food is free, no queues, no wet walks - and it is inexpensive. Charging attendees makes sure the quality stays high; keeping it small and with a smart market positioning makes sure the right people show up, business is done and time is not wasted. Going forward, security concerns are also a factor, keeping away from big crowds or major cities may be a plus. At BioFine we will be offering our customers the latest technology we have added to our capabilities: particle size design, from lab to large-scale, with a focus on reproducibility of physical characteristics. Our customers tell us that the galenic interface is where most of our competitors fail. We are doing for particle size and crystal form what we did for injectable grade APIs in the 90´s, becoming a leader and defining bench-marks. Guy Villax CEO Hovione Loures, 4th May 2004

Article
BioFine Berlin, 4 May 2004

Do we really need more trade-shows

May 04, 2004

Hovione for CPhI 2003 Sticking to your knitting... When the going gets tough, Guy Villax, CEO of Hovione, argues the importance of keeping your business focused Business conditions are tough. The pharmaceutical fine chemicals sector is now heading South, the largest players -even the Rolls-Royces of the industry- have announced lay-offs and issued profit warnings. Two years have not elapsed since CPhI was throbbing with the excitement of billion dollar acquisitions: BTP, Catalytica, Chirex... A time when the exuberant optimism of the stock-markets made anything possible. This was a period of major re-structuring not just for the fine chemical sector but also of the pharma sectors. Relentless focus on their core-business of prescription medicines led Pharma Giants to spin-off a number of big businesses: non-prescription medicines, chemicals, fragrances, etc… and overnight new multi-billion dollar companies appeared. Large pharma concentration was driven by both a desire to grow sales forces and to address R&D pipeline issues (whether for lack of innovation or to address a block-buster patent expiry calendar). During this time the Biotech sector had a tough time getting funding, the IPO markets dried up and the private equity firms, unfairly, looked at drug development with the biased look of someone who just got burnt by a dot.com. Generics were quietly booming. As a result for those making APIs the short term horizon looks grim, except for those that serve the generics industry. Over the past 5 years most fine chemicals company invested in GMP facilities. In addition to billions spent in mergers and acquisitions, there was also a genuine expansion in capacity. If there is now a cycle in this business, then 2003 is clearly in the downward slope. No one talks of growth. Those with empty vessels offer very aggressive, and in my mind unsustainable, prices - this is particularly noticeable of smaller firms that were taken over by chemical giants. In exclusive manufacturing - is the problem structural or cyclical? There is certainly a structural part to the issue: in the past 7 years the number of compounds in Phase I and II have grown at a CAGR of 9 and 6% respectively - whereas Phase III compounds are unchanged at 500, with zero growth. Approved genuine NCEs numbered only 17 last year, but averaged about 30 in the previous years. Sir Michael Rawlins who chairs the UK government body that monitors the cost-effectiveness of medicines recently told a conference that the cost of development of new medicine was becoming “unsustainable”, and that unless regulators backed-off "by the year 2015 we will not have any new NCEs". There is also a cyclical component - capacity has to adjust. In addition to the lay-offs there will be plant closures. At least one European based multinational is looking to close half its primary plants in its home country. On the other hand we can be sure that capital expenditure will be dramatically cut this year and for the next few years, and we all know that without investment a GMP primary plant goes out of compliance in just a few years. Indeed nothing causes obsolescence faster than GMP design. Where does this leave us? I think that those that are totally dedicated and committed to pharmaceutical APIs will plough through. These are usually private companies, well capitalized and well-entrenched in preferred supplier lists. But especially they are not subjected to the pressure of quarterly reports or stock-markets, as such they will weather the storm better than those that have to tack to short term winds. Customers know only too well that cut-throat pricing is not a good indicator of long-term survival, and although they will take advantage of it, they will not burn bridges with the suppliers that were there over time, solved problems and delivered the occasional miracle. The other advantage that the private firms have is that they walk on two legs - they serve both the exclusive manufacturing sector as well as the generic sector, and they benefit from the manufacturing synergies offered by the combination. Generics are up - a significant number of products will come off patent from over the next few years. Now to the companies that discovered that getting into exclusive manufacturing was an expensive mistake, I would say they should be just as careful if they think they will find a quick fix in the generic API business. Hovione's generic development methodology sets as rule Nº1 to start early - this means that from the start of a development program you will have to wait at least 7 years for your first invoice. About the same time as going from Phase I to launch - and in generics there are no development fees! It is all a question of sticking to your knitting; a question of focus. Guy Villax Chief Executive

Article
CPhI 2003, 23 September 2003

Sticking to your knitting...

Sep 23, 2003

Hovione for CPhI 2003 Cholesterol lowering agents (HMG CoA reductase inhibitors) recorded sales close to US$19 bil. in 2002 according to IMS Health figures. Atorvastatin from Pfizer and Simvastatin from Merck are the top two drugs of this therapeutic class, indeed they rank in the top two drugs in sales worldwide. They account for 71% of this market followed by Bristol-Myers Squibb’s Pravastatin. In the US alone the statins reached sales of nearly US$12 bil. in 2002 – well over one hundred tons of API. The generic versions of Merck’s Zocor®, the second biggest product in worldwide sales, entered the German and UK markets last May, after Merck’s patent expired, rapidly achieving sales of about Euro 30 mil. in Germany in the first month alone (IMS Health). The performance of the generic versions of simvastatin in the first quarter after launch already suggested that the impact of the generic entry may not stay confined to this molecule, but might affect the overall statins class market. Indeed recent price pressures have seen growth in generic lovastatin prescriptions; which might indicate that generic simvastatin is likely to cannibalise some of the sales of Lipitor, if not even Zetia… We are currently 2 years away from the simvastatin generic entry in the US, where approximately 40 tonnes of API were sold in 2002. Traditionally, after a US generic entry the volume of scripts more than doubles and the price more than halves. It should not come as a surprise that simvastatin might grow into a product of more than 100 tons of API. Capacity is very likely to be an enduring issue because simvastatin is technically difficult to make and the supplies of lovastatin limited. European pharmaceutical generic companies entered the market using registrations developed outside Europe by integrated houses able to make the API and the formulations. This is a normal course of action in Europe and enabled a very fast access to the market. As the quick entry focus looses ground to serving the market and expanding share – reliable supply will become a major concern. The competitive landscape looks to us to be as follows: * : The issue as to whether a supplier is a “partner or a competitor” is a very sensitive one. In the USA this is addressed earlier than Europe as most Generic firms usually develop their dossiers and source bulk. However given the high probability of a scenario of simvastatin API shortage it is very likely that an integrated player -both API producer and seller of formulations- will give preference to its own needs, to the detriment of supplying other generic firms. Choosing the right API supplier has significant long-term impact. Hovione is fully committed to supplying simvastatin bulk, and has no involvement in the dosage form business. This position, allied with a strong partnership with CKD that ensures the control and supply of the Lovastatin starting material, enables Hovione to present to customers a unique differentiation that guarantees a reliable supply of simvastatin API.

Article
CPhI 2003, 23 September 2003

Simvastatin - Supply Chain Reliability

Sep 23, 2003

Hovione for CPhI 2003 The service of an API manufacturer not only involves the development of the chemical process and the supply of high quality API, when and where required, but also paying close attention to those physical parameters which make up the necessary requisites for a successful formulation. Chemical skills must be complemented by a pharmaceutical culture. For a successful custom synthesis partnership it is imperative that the API contractor be both cognizant of the importance of having the correct particle size and morphology, and be able to develop a process that delivers consistently the required crystal form and size. This is key in many galenic forms; in the field of inhalation for instance it is absolutely critical; it can also be the source of many last-minute surprises and frustrations until the matter is well controlled. Traditional know-how includes: expertise in controlled crystallisation, micronization and jet milling. These are skills that Hovione has used for decades in its plants to achieve the desired crystal form and consistent particle size. All of this needs to be backed up with analytical techniques, including laser diffractometry and impaction, used in a manufacturing scenario, to assure the necessary QC controls. But technology moves on…. Hovione is pleased to announce it is installing a state of the art Spray Drying facility, capable of evaporating 35 to 90 Kg of water per hour under the most stringent cGMP conditions. The supplier of the Spray Drier, Niro A/S has designed this to the most advanced specifications. It is equipped with two atomizer systems (a rotary and co-current two-fluid nozzle) to deliver injectable grade APIs and is configured to be “cleaned-in-place” it discharges into a classified clean-room. This multipurpose unit was the result of a close collaboration with Niro and allows Hovione to produce dry solids in either powder, granulate or agglomerate form from liquid feedstocks such as solutions, emulsions and pumpable suspensions. This technology will enable continuous production, at low-cost and with a high degree of precision, over a wide range of particle sizes. The system meets explosion-proof requirements and can therefore spray-dry out of most organic solvents in a safe and compliant environment. Niro has described the unit as one of the most flexible and versatile GMP compliant spray-driers that they have ever built. Continuing its programme to expand scientific know-how in advanced technologies, Hovione is actively developing expertise in other particle design techniques: Supercritical Crystallization and Sono-crystallization. Supercritical crystallization offers a trouble-free separation of the product from the solvent and the capability to control the size and form of the crystals. The principle is based on replacing a conventional solvent with a supercritical fluid, which may act as a solvent or as an anti-solvent. This technique may be used to produce very small particles with narrow size distribution. Sono-crystallization uses ultrasound to influence crystallization behaviour by promoting cavitations within the liquid media, which serve as nuclei for new crystals to form. Benefits can include improved crystal habit, purity and the ability to manipulate crystal-size distribution and powder flow characteristics. It also offers a useful and more controllable alternative to seeding.

Article
CPhI 2003, 19 September 2003

Particle Design, New Technologies for Better Crystals

Sep 19, 2003

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