Press Room

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.

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

Hovione stands behind 3 NCE launches

Apr 07, 2005

Interview with Hovione's CEO, Guy Villax. “Many of the new compounds in development present significant challenges. For example, they may be very fragile, and in simple terms, galenic techniques enable the chemist to isolate the API already in a preformulated more stable form. We call these Enhanced APIs.” There is much talk about the convergence of disciplines in the life-sciences area. Hovione has been involved in manufacturing APIs under current cGMP for nearly 50 years. Many development candidates present an increasing set of challenges: complexity of the molecule, poor bioavailability yet highly potent, very high purity, poor stability, etc.....often simultaneously. Meeting these demands has opened opportunities for the “top-of-the-line” Contract Manufacturing Organizations to develop strengths in new disciplines and to combine capabilities never before found on the same campus, let alone within a validated commercial scale GMP environment. Hovione has traditionally been a CMO of small molecules and is now adding new skills and capabilities that address the special needs of large molecules, peptides, and antibodies. Hence, Hovione now offers a range of galenic enhancements that contribute decisively to making certain APIs into viable industrial propositions, in purpose-designed containment areas built to uncommon standards, to serve projects managed with multidisciplinary staff. Drug Delivery Technology recently interviewed Mr. Guy Villax, Hovione’s CEO, to discuss his company’s philosophy and business strategy, a vision based on an intimate understanding of client needs and technology trends. APIs of the 21st century present increased difficulties not only in their traditional fields (chemistry, engineering, analytical chemistry), but in new areas of technology as well as management.     Small-molecule chemistry      

Article
Drug Delivery Technology, March 2005

Hovione: More Than Just Very Good

Mar 01, 2005

Hovione's active pharmaceutical ingredients plant in Macau underwent a pre-approval inspection by FDA; this was triggered by a filing by a US customer. The inspection, carried out by Ms. Karen Moksnes, Compliance Officer at the U.S. FDA Center for Drug Evaluation and Research (CDER) and by Ms. Susan Ting, Chemist at the U.S. FDA Office of Regulatory Affairs (ORA), lasted 3 days, and resulted in a Form 483 with two minor points. Mr. Luis Gomes, General Manager of the plant, said "the inspection was concluded one day early, and by the closing meeting the two points had been satisfactorily addressed". Hovione plants have been the object of 13 FDA inspections, with 5 at the Macau site since it started to operate in 1986. This inspection reflected the "Risk-Based Management Plan" described in its Pharmaceutical Quality for the 21st Century: The emphasis is on the design and operation of the quality system and on the competence and understanding of the operators and analysts. The thoroughness of the inspection and its ability to make an assessment of the maturity of "GMP mindedness" is far greater. The obvious objective is to be able to determine the plants', and the plant management's, "credibility and reliability" rating that is used in FDA's Risk-Based calculations. The Macau plant has today a total workforce of 133 professionals and produces both Hovione catalogue generic products and commercial APIs manufactured under exclusivity and has been increasingly used by Hovione customers to produce on an exclusive basis clinical trial quantities of compounds for Phase I and II testing. The facility is responsible for one third of Hovione’s total production, and exports to the most demanding markets such as the USA, EU, and Australia.   About Hovione Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and eAPIs for the Pharmaceutical Industry. With a 40-year track record of quality standard and advanced particle design technologies, such as micronization, jet milling and spray drying, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support your API development from gram scale to commercialization. Hovione's capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards. Hovione has process capabilities in the areas of particle design and inhalation drug delivery.

Press Release
Hovione's active pharmaceutical ingredients plant in Macau underwent a pre-approval inspection by FDA

FDA inspects Hovione's API manufacturing plant in Macau

Nov 11, 2004

Building on its accumulated expertise in all major areas of API development and cGMP manufactures, Hovione is expanding its scientific know-how and industrial production capabilities on a variety of technologies to widen its ability to provide customized solutions for advanced APIs (aAPI™). Hovione has recently installed the latest design of advanced technology spray-drying facilities. This industrial unit is able to operate under the most stringent cGMP conditions. Designed to support both Custom Synthesis and Generic Products customers, Hovione’s state-of-the-art equipment enables it to offer a full range of API production capabilities. From few grams for galenic feasibility testing in a lab-scale unit to full production scale, Hovione offers all expertise and capabilities for successful product development. The new industrial unit has the versatility of operating as a conventional spray dryer or as a fluidized spray dryer and is designed to isolate from either aqueous or organic solvent feeds. In conventional spray drying operation the process involve continuous atomization of solutions, suspensions and emulsions to generate ultra-fine particles (below 5-10 mm) either in amorphous or crystalline form. In fluidized spray drying, the unit produces dustless free flowing agglomerated powders (up to 400 mm) that can be directly compressible, have increased bulk/tap density, and demonstrate improved wettability /dissolution behavior. Operation in either mode can have applications for processing thermally labile APIs, co-processing APIs with inactive ingredients, as-well-as aid in the reduction of residual solvents and OVIs. The manipulation of the operational parameters during spray drying offers the possibility to control the design of the particle and it’s attributes to meet the requirements of final product. Optimal sizing and shaping of particles, together with a variety of encapsulation options, improves product stability and bioavailability. Spray-drying also overcomes micronization issues associated with conventional grinding and jet milling processes. Moreover, complementing Hovione’s growing suite of cutting-edge capabilities, the company has also acquired a freeze-dryer and invested in Supercritical Crystallization and Sonocrystallization (crystallization assisted by ultrasound), which further enhances its particle engineering credentials. In summary, Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and aAPIs for the Pharmaceutical Industry. With a 40-year track record of quality standard and advanced particle design technologies, such as micronization, jet milling and spray drying, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support your API development from gram scale to commercialization.

Press Release
Hovione is expanding its scientific know-how and industrial production capabilities on a variety of technologies to widen its ability to provide customized solutions for advanced APIs (aAPI™).

Hovione consolidates API expertise to provide advanced technologies in particle design

Sep 03, 2004

Hovione announces that the consolidated sales volume for the fiscal year ended 31st March 2004 amounted to US$75m, representing a growth of 9% over the previous year. Guy Villax, CEO of Hovione noted that “2003 was an excellent year. In the context of an adverse market environment sales grew and gross margins improved, but more significantly Hovione delivered on its goals in terms of strategy, cost cutting and productivity. During 2003 the sales evolution to the Innovator segment, to which Hovione supplies R&D and contract manufacturing was in its 3rd year of crisis with FDA approving half the usual number of new pharmaceuticals. On the other hand sales to the Generics segment presented vigorous growth. In terms of geography, our sales remained close to the proportion to the pharmaceutical market sizes with North America accounting for 48%, Europe 22% and Asia 21% – with Japan showing greater than usual growth. Small Pharma and the quality Generic Houses remain the Customers that best benefit from Hovione’s value proposition. Capital expenditure reached $13m, and the focus remains one of consolidation and of pay-back on the significant investments of the last 4 years: The Technology Transfer Centre in New Jersey, USA; the significant investments in IT and R&D capabilities in Loures and the doubling of the plant capacity and improved environmental protection systems in Macau. Equity and long-term debt remains 68% of our net balance sheet; and the net debt / EBITDA ratio remains at a low 2.2 multiple. Despite the focus on minimizing expense in capital items, Hovione remains keen to invest in process technology whenever this can provide further value to our Customers. During 2003 a $3.3m investment in particle design technology was again evidence of this technology early-adopter mentality that Hovione has demonstrated in its 40 years of pharmaceutical chemistry specialization. Hovione is now organized by profit centres and has extended its decade old process of continuous improvement to include balance sheet objectives. As a result good management of current assets released $11m over last year’s performance. Sofia Lee, responsible for Finance and Treasury at Hovione commented: “Unfortunately the strength of the Euro reduced Hovione competitiveness: For every 5 centimes of strength vis-a-vis the US $ Hovione loses about $1m of profitability in cash terms. This negative exchange environment together with important start-up-losses from the US operations were a drain on our EBITDA, this reached $18m or 24% of sales – a level we consider wholly unsatisfactory but which is justified under the current circumstances. … The 2005 deadline for the adoption of the IFRS is an issue we solved several years ago”. Hovione’s financial statements have been prepared according to the International Financial Reporting Standards since 2000. www.hovione.com includes additional information on quality, health, safety and environmental performance. Hovione is an international group dedicated to the process development and synthesis of APIs (active pharmaceutical ingredients) serving exclusively the pharmaceutical industry. 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. Hovione’s capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards.

Press Release
Hovione announces that the consolidated sales volume for the fiscal year ended 31st March 2004 amounted to US$75m, representing a growth of 9% over the previous year.

Hovione Group sales grow 9% to reach USD75 million for the fiscal year 2003/04

Jul 20, 2004

Lisbon, Portugal and Lenexa, Kan. -14th June 2004 - Hovione, an international pharmaceutical fine chemicals company and CyDex, Inc., which is creating new pharmaceutical products through innovative drug delivery technologies, today announced an alliance to develop and commercialize improved formulations of drugs that are off-patent or soon will be off-patent. The collaboration will use CAPTISOL®, a proven technology from CyDex, to develop formulations offering advantages such as improved bioavailability, dissolution and stability. The companies agreed to develop Captisol-Enabled® formulations of six drugs initially but, for competitive reasons, did not announce the products. Hovione's CEO, Guy Villax commented "We are very pleased to add this further dimension to our collaboration with CyDex. Our companies have very complementary proprietary know-how and synergistic market presences - Hovione has a good understanding and a long-established presence in the generics market and Cydex's Captisol is well known to formulation development scientists at most innovative pharma companies". "Partnering with Hovione increases our capabilities and adds to our pipeline of proprietary drugs under development. Hovione already is manufacturing CAPTISOL for CyDex, and expanding the relationship unites our companies' complementary skills in a way that can create significant value for both," said John M. Siebert, Ph.D., Chief Executive Officer of CyDex. " CyDex also continues to make progress with pharmaceutical and biotech partners on developing several Captisol-Enabled® formulations of innovative drugs. The technology is proven, as two of these formulations already are approved and being marketed."     CAPTISOL is a rationally designed delivery system currently used in two prescription products developed and marketed by Pfizer Inc. in the United States and Europe, Vfend® and Geodon® . Additional Captisol-Enabled products are under development. CAPTISOL enables safe, effective delivery by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble. In oral and inhaled formulations, CAPTISOL can improve bioavailability by improving the solubility and dissolution of drug compounds. When given by injection or inhalation a Captisol-Enabled formulation helps carry a drug into the patient's bloodstream, where CAPTISOL and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect. Hovione, based in Loures, Portugal, is an international group dedicated to the process development and synthesis of active pharmaceutical ingredients serving exclusively the pharmaceutical industry. 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. Hovione's capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards. Hovione has process capabilities in the areas of particle design and inhalation drug delivery. CyDex, Inc. offers advanced drug delivery solutions to bring important new medications to patients by developing its own pipeline of Captisol-Enabled proprietary drug formulations and by partnering with the world's leading pharmaceutical and biotechnology companies. CyDex has agreements with Allergan, Inc.; Bristol-Myers Squibb Co.; Daiichi Suntory Pharma Co., Ltd., of Japan; Merck & Co., Inc.; OSI Pharmaceuticals, Inc.; Pfizer Inc.; PTC Pharma AG, of Switzerland; and Teva Pharmaceutical Industries Ltd., of Israel. CyDex is a privately owned company located in suburban Kansas City.

Press Release
Hovione and CyDex, today announced an alliance to develop and commercialize improved formulations of drugs that are off-patent or soon will be off-patent.

Hovione and CyDex announce drug development alliance for six potential new products

Jun 14, 2004

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

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