Press Room

Press Release / Aug 01, 2005

Hovione Group sales grow 8% for fiscal year 2004/05

Hovione announces that the consolidated sales volume for the fiscal year ended 31st March 2005 amounted to US$81.4 million, representing a growth of 8% over the previous year.

Hovione announces that the consolidated sales volume for the fiscal year ended 31st March 2005 amounted to US$81.4 million, representing a growth of 8% over the previous year.

Guy Villax, CEO of Hovione noted that "Hovione's sales have shown continuous growth over the past 4 years, an increase of 50% over that period. Although our results are unsatisfactory with an EBITDA of US$16m (against US$18m in 2003), this is still a good performance when the harsh environment we face is considered. We continue to be affected by the strength of the dollar – over the same period our major invoicing currency has weakened 41%. Our sector has seen much red ink – a recent presentation by Peter Pollak shows that the seven largest players in the pharma fine chemicals sector have had, between 2002 and 2004, an average 14% negative sales growth. In Generics, both in the USA and in Europe, companies are facing aggressive price-cutting from new entrants, mainly from India. Our success is primarily due to the increasing differentiation of the products Hovione offers – a value proposition centered around high service, R&D and compliance."

The results in Portugal were affected by the depreciation of the US dollar that has weakened the company’s competitiveness by a further 5% this year. Exports from Portugal decreased by 4.2%. On the other hand, supported by our New Jersey Technology Transfer Center, sales of R&D process development were very positive. The income from such services almost doubled over 2003.

Capital expenditure was reduced to US$4.3m, a substantial reduction when compared to US$13.3m invested last year, reflecting the Company’s objective to improve its returns on assets and taking a prudent position as a result of the negative exchange rate climate.

This year was also positive in terms of results of the technology investments Hovione has done in the past 3 years. Hovione has chosen to become a leader in the field of particle design. Spray-drying and spray-congealing at very low temperatures have taken us to near nano-scale particles. Hovione now offers this technical expertise at its Portugal site at every scale - lab, pilot and industrial – all within a GMP compliant environment and will soon be offering similar services from Technology Centre in the USA.

In terms of geography, Hovione sales mirror the world pharma market, with the USA accounting for almost half its sales, Europe and Japan with even shares, and about 10% going to other markets such as Australia and Singapore.

Hovione’s Technology Transfer Centre (TTC) in the USA has had a leading role in the Group’s activities, contributing not only to consolidate Hovione’s presence in the US market, but also to contracting an ever increasing number of new projects from US and European Biotechs. The TTC currently employs 37 people.

 

About Hovione
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 galenically enhanced APIs.

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Pharmaceutical Technology® spoke with David Basile, VP Technical Operations, Americas, Hovione, about how companies can meet these requirements for GMP facilities and equipment and some of the common mistakes made when working toward compliance. PharmTech: Which department is responsible for evaluating GMP equipment and facilities? Basile (Hovione): The primary groups that participate in the evaluation of GMP equipment and facilities are engineering, maintenance, while quality assurance (QA) oversees compliance and approval. The best companies keep a few dedicated roles focused on maintenance planning and equipment reliability to drive best practices and implement the concepts of reliability centered maintenance. Do regulatory inspectors request proof of maintenance? If yes, how should this be compiled and presented to the agency? Yes, it's fairly standard for regulators to request proof of maintenance during GMP audits to verify compliance and confirm that we document all our activities related to the manufacturer and release of our products. You didn't do it, if you didn't document it. We compile detailed electronic records, including preventive maintenance schedules and calibration certificates. These should be presented in a clear and organized manner. In our recent inspections, we've seen that inspectors appreciate being able to get these records in a digital format for portability, and in case they'd like to reference them at their convenience. Another element here is using what we call our computerized maintenance management system, or CMMS. This is a central repository for all of our maintenance-related activities. This is a key system in the efficient execution of any strong, compliant maintenance program. It provides detailed work order history, preventative maintenance instructions, asset specifications, scheduling, data and spare parts inventory, so we can see trends and pick up drift, for example, to clearly demonstrate that our assets remain in a state of high performance and quality operation. We'd really be flying blind without a CMMS. It's a tool that you can't live without in today's world of pharmaceutical maintenance. What are the most common mistakes that manufacturers make when it comes to maintaining GMP equipment and facilities? Failing to do a comprehensive criticality assessment and a risk-based approach, [which can result] in over or under maintenance [is one mistake]. Solely relying on time-based preventative maintenance versus proactive maintenance approaches such as precision alignment or lubrication [is another]. Today's teams need to incorporate conditions-based maintenance using technologies such as vibration analysis. 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