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To address a significant market interest in Advanced APIs (aAPI®), Hovione has increased its range of services and multi-scale facilities in cGMP Spray Drying, an advanced particle design technology. Building on its accumulated expertise in all major areas of API development and cGMP manufacture, a full range of cGMP Spray Drying facilities operating at lab, pilot and industrial scale have now been installed at Hovione's API manufacturing plant in Europe and are currently being installed at Hovione’s Technology Transfer Centre in New Jersey, USA. Building on the state-of-the-art spray drying industrial facility installed in 2004, Hovione now operates three additional units at lab scale and two others at pilot scale. All units comply to the most stringent cGMP requirements, allowing production from just a few grams for feasibility studies to full scale commercial production. Offering process scale-up throughout all phases of product development, Hovione's multi-scale spray drying facilities further widen our ability to provide customized solutions. Designed to support both Custom Synthesis and Generic Product customers, Hovione’s spray drying technology is complemented by complete R&D and analytical studies on particle properties as per specific product requirements, thus offering all expertise and capabilities for successful product development. All Hovione spray dryers operate with nitrogen as the drying gas and are designed to support both aqueous and organic feeds. 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, can improve product stability and bioavailability. Spray drying also overcomes micronization issues associated with conventional grinding and jet milling processes. The industrial unit has the versatility of operating as a conventional spray dryer or as a fluidized spray dryer. In conventional spray drying operation the process involves continuous atomization of solutions, suspensions and emulsions to generate from ultra-fine particles (below 5-10 micron) up to large particles (100 micron) either in amorphous or crystalline form. In fluidized spray drying, the unit produces dustless free flowing agglomerated powders (up to 400 microns) 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. Moreover, complementing Hovione’s growing suite of cutting-edge capabilities, the Company is investing in other state-of-the-art technologies, which will further enhance our particle engineering capabilities.   About Hovione Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and aAPIs® for the Pharmaceutical Industry. With a 45-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
To address a significant market interest in Advanced APIs (aAPI®), Hovione has increased its range of services and multi-scale facilities in cGMP Spray Drying

Hovione expands its range of services in Particle Design technology

Aug 17, 2005

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.

Press Release
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 Group sales grow 8% for fiscal year 2004/05

Aug 01, 2005

Allos Therapeutics, Inc. (Nasdaq: ALTH) and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium. Under the agreement, Hovione is committed to manufacture and supply Allos with sufficient quantities of efaproxiral sodium to support Allos' anticipated requirements for both the pre-and post-commercialization phases of production. EFAPROXYN is currently the subject of a confirmatory Phase 3 trial, called ENRICH, designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without EFAPROXYN in women with brain metastases originating from breast cancer. This randomized, open-label study will seek to enroll 360 patients at up to 125 leading cancer centers across North America, Europe and South America. The trial began in February 2004 and is expected to complete enrollment during the second half of 2006. The manufacturing agreement is the most recent step in a relationship between the two companies that began in 1997. Under a prior agreement between the parties, Hovione manufactured a majority of the bulk drug substance used by Allos in its clinical trials of EFAPROXYN. Hovione has already manufactured four batches of efaproxiral sodium at commercial scale using a process that they successfully validated in 2001. Hovione is in good standing with the FDA, having passed recent inspections. "This manufacturing agreement is an important step in our preparation for the potential commercialization of EFAPROXYN," said Michael E. Hart, President and Chief Executive Officer of Allos. "We have benefited from Hovione's commitment to working with companies like Allos and feel that Hovione's expertise in production of APIs for injectable products makes them an ideal partner for us." About EFAPROXYN EFAPROXYN is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that EFAPROXYN has the potential to enhance the efficacy of standard radiation therapy. About Allos Therapeutics, Inc. Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos' lead product candidate, EFAPROXYN, is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to whole brain radiation therapy in a pivotal Phase 3 trial in women with brain metastases originating from breast cancer. Allos' other product candidates are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation as both a single agent and in combination therapy regimens in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced solid tumors. For more information, visit the company's website at www.allos.com About Hovione Hovione, based in 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, technical expertise and cGMP quality standards. Hovione focuses on finding scientific and industrial solutions for APIs of increased complexity and for Enhanced APIs(TM) having developed, among other, special process capabilities in the areas of injectable grade APIs, particle design and inhalation drug delivery. For more information, visit the company's website at www.hovione.com Safe Harbor Statement This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning Allos' projected timelines for completing enrollment in the ENRICH study, the potential safety and efficacy of EFAPROXYN, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that Allos may experience difficulties or delays in its clinical trials, whether caused by adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that clinical trials may not demonstrate the safety and efficacy of Allos' product candidates in their target indications. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of Allos' Annual Report on Form 10-K for the year ended December 31, 2004 and in Allos' other periodic reports and filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. Allos cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Allos on the date hereof, and Allos undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law. Note: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics, Inc. SOURCE: Allos Therapeutics, Inc.; Hovione Jennifer Neiman, Manager, Corporate Communications of Allos Therapeutics, +1-720-540-5227; or Isabel Pina, Corporate Communication Manager of Hovione, +351-21-982-9362   Allos Therapeutics and Hovione Enter Into Manufacturing Agreement for EFAPROXYN(TM) Bulk Drug Substance 16/06/2005 Allos Therapeutics, Inc. (Nasdaq: ALTH) and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium. Under the agreement, Hovione is committed to manufacture and supply Allos with sufficient quantities of efaproxiral sodium to support Allos' anticipated requirements for both the pre-and post-commercialization phases of production. EFAPROXYN is currently the subject of a confirmatory Phase 3 trial, called ENRICH, designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without EFAPROXYN in women with brain metastases originating from breast cancer. This randomized, open-label study will seek to enroll 360 patients at up to 125 leading cancer centers across North America, Europe and South America. The trial began in February 2004 and is expected to complete enrollment during the second half of 2006. The manufacturing agreement is the most recent step in a relationship between the two companies that began in 1997. Under a prior agreement between the parties, Hovione manufactured a majority of the bulk drug substance used by Allos in its clinical trials of EFAPROXYN. Hovione has already manufactured four batches of efaproxiral sodium at commercial scale using a process that they successfully validated in 2001. Hovione is in good standing with the FDA, having passed recent inspections. "This manufacturing agreement is an important step in our preparation for the potential commercialization of EFAPROXYN," said Michael E. Hart, President and Chief Executive Officer of Allos. "We have benefited from Hovione's commitment to working with companies like Allos and feel that Hovione's expertise in production of APIs for injectable products makes them an ideal partner for us."   About EFAPROXYN EFAPROXYN is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that EFAPROXYN has the potential to enhance the efficacy of standard radiation therapy. About Allos Therapeutics, Inc. Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos' lead product candidate, EFAPROXYN, is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to whole brain radiation therapy in a pivotal Phase 3 trial in women with brain metastases originating from breast cancer. Allos' other product candidates are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation as both a single agent and in combination therapy regimens in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced solid tumors. For more information, visit the company's web site at www.allos.com. About Hovione Hovione, based in 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, technical expertise and cGMP quality standards. Hovione focuses on finding scientific and industrial solutions for APIs of increased complexity and for Enhanced APIs(TM) having developed, among other, special process capabilities in the areas of injectable grade APIs, particle design and inhalation drug delivery. For more information, visit the company's web site at www.hovione.com.   Safe Harbor Statement This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning Allos' projected timelines for completing enrollment in the ENRICH study, the potential safety and efficacy of EFAPROXYN, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that Allos may experience difficulties or delays in its clinical trials, whether caused by adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that clinical trials may not demonstrate the safety and efficacy of Allos' product candidates in their target indications. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of Allos' Annual Report on Form 10-K for the year ended December 31, 2004 and in Allos' other periodic reports and filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. Allos cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Allos on the date hereof, and Allos undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law. Note: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics, Inc. SOURCE: Allos Therapeutics, Inc.; Hovione Jennifer Neiman, Manager, Corporate Communications of Allos Therapeutics, +1-720-540-5227, jneiman@allos.com ; or Isabel Pina, Corporate Communication Manager of Hovione, +351-21-982-9362, e-mail: )

Press Release
Allos Therapeutics, Inc. and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium.

Allos Therapeutics and Hovione Enter Into Manufacturing Agreement for EFAPROXYN(TM) Bulk Drug Substance

Jun 16, 2005

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

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 is pleased to announce that it has installed a new state-of-the-art Spray Drying facility to address the latest technology in particle design. The unit, installed at Hovione's API manufacturing plant in Portugal, operates under the most stringent cGMP conditions both as a conventional spray dryer for very fine particles (< 5 - 10µ) and as a fluidized spray dryer for agglomerated, free-flowing dustless materials (100 - 400µ). Supplied and designed by Niro A/S to the most advanced specifications, this multipurpose unit is capable of evaporating 35 to 90 Kg of water per hour and is equipped with two atomizer systems (a pressure nozzle and co-current two-fluid nozzle). The spray dryer is fit to deliver injectable grade APIs and is configured to be "cleaned-in-place", discharging into a classified clean-room. The facility 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 enables continuous production, at low-cost and with a high degree of precision over particle design; it allows control of particle size over a wide range of sizes (< 5 to 400µ), as well as control over bulk density and degree of crystallinity. When operating as a fluidized spray dryer, the unit produces free-flowing dustless materials, which are uniform and can be used directly in tableting. The system meets the most stringent explosion-proof requirements and can therefore spray-dry out of most organic solvents in a safe and compliant environment. It uses nitrogen in a closed cycle as the drying gas thus enhancing its safety and economical production aspects. The spray drying facility is the result of a close collaboration between Hovione and Niro; the supplier of the equipment has described the unit as one of the most flexible and versatile GMP compliant spray-dryers that they have ever built. Hovione will be presenting its new technology and facility at Biofine in Berlin, on May 5th and 6th, stand nr. E3. In its programme to expand scientific know-how in advanced technologies, Hovione is actively developing expertise in other particle design techniques: Supercritical Crystallization - this technology 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.   Ultra Sound Assisted Crystallization- this technology uses ultrasound to influence crystallization behavior 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. 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. Note: please be informed that we have photos of the spray dryer available, contact us.

Press Release
Hovione is pleased to announce that it has installed a new state-of-the-art Spray Drying facility to address the latest technology in particle design.

Hovione launches new Particle Design technology and state-of-the-art Spray Drying facilities

Apr 12, 2004

Carla Vozone, business development manager for generics, and Manuel Lourenço marketing & sales director, of Hovione look at Simvastatin as a case study in the supply of off-patent APIs The supply chain of off-patent APIs has been through a number of changes in the past few years. Originally, independent API suppliers developed, manufactured and sold APIs to supply local generics houses in essentially national markets. Today, there are billion dollar multinational generic houses, vertically integrated into API manufacture and carrying out synthesis and/or fermentation. Sandoz, for example, has owned Biochemie, a world leader in fermentation, for some years. It recently acquired Lek, probably in part to access its fermentation capabilities and so strengthen its position in the generic Augmentin market. Teva recently bought Sicor, as well as some plants from Honeywell. These large groups have multinational distribution and manufacture APIs. Nevertheless, they also source active ingredients from independent producers in the product-by-product collaborations traditional in the generics industry. The selection criteria that the vertically integrated generic firms use for their API product development is unclear. What is certain is that an integrated strategy is only likely to succeed if it is implemented with above average capabilities in its execution along the whole value chain. Teva, for instance, is highly regarded for the way its management maximizes marginal returns; it can access the available production capacity that will make extra production possible for that extra tender at that borderline price and thus improve overall profitability. Another noteworthy trend is the growing business of registration dossiers in Europe. The key differentiators of the players in this field, like Synthon and Substipharm, are know-how in regulatory affairs, careful monitoring of patent situations and an early start. Because of the SPC legislation and the absence of Bolar exemption in Europe, registration houses do their validation lots with the help of Far Eastern API sources and/or formulators in patent-free locations (Iceland, Malta and Turkey have all been used) and sell their registration dossiers all over Europe, thereby gaining significant control over the supply chain. Undoubtedly, this type of business brings short-term gains to the generics houses, because it accelerates market access; companies can enter the market with a generic product one day after patent expiry with minimum resources and avoid the patent constraints that Europe-based producers face. However, the long-term gains are less certain, as multiple registrations lead to price erosion and margins are squeezed. There are cases, like simvastatin, glucophage or paroxetine, where formulation prices dropped by over 60% in only a few months. These vicious downward price spirals raise the question of the API supplier’s sustainability in that product. Traditional suppliers whose core business is the manufacture and supply of APIs, like Dipharma, Esteve, Hovione or Cambrex Profarmaco are not involved in the drug product business and focus on long-term relationships with customers, offering added value based on reliable service and technical expertise. These companies look for partnerships with pharmaceutical manufacturers rather than aiming to extend their control over the supply chain or making a quick buck. The original patent on simvastatin, the API of Merck’s Zocor, expired in May 2003 in most European countries. As one of the top cholesterol lowering agents (HMG CoA reductase inhibitors) with worldwide sales of $5.58 billion in 2002, it naturally attracted the interest of several API producers. It is a good example of industry trends. The generic versions of Zocor were launched in Germany and the UK last May. They rapidly achieved sales of about €30 million in Germany in the first month alone, according to IMS Health. Their performance in the first quarter after launch suggest that the impact of the generic entry may not remain confined to this molecule but might affect the overall statins class market.  Indeed recent price pressures have led to growth in generic lovastatin prescriptions. Generic simvastatin may well cannibalise some of the sales of Pfizer’s Lipitor, if not Merck and SP’s Zetia. We are currently two years away from generic simvastatin’s entry in the US, where some 45 tonnes of API were sold in 2002. Traditionally, the volume of scripts more than doubles and the price more than halves after a generic market entry, so simvastatin might well grow into a product of >100 tonnes/year. Capacity is very likely to be an enduring issue, because simvastatin is technically difficult to make and lovastatin supplies are limited.

Press Release
Carla Vozone and Manuel Lourenço look at Simvastatin as a case study in the supply of off-patent API

The APIs supply chain: A case study

Mar 02, 2004

New Generic Drug Developments Mometasone: Hovione’s DMF has been filed worldwide; it had been accessed and all deficiencies satisfactorily and promptly addressed. The relevant pre-approval inspection did not result in a Form 483 being issued. The product is now in routine manufacture   Fluticasone: Hovione filed a DMF for Fluticasone at the FDA in 2002. This product is currently in commercial manufacture addressing the needs of 3rd parties for early intermediates and API for use in clinical supplies and registration. Fluticasone was developed by Glaxo Wellcome and is currently marketed as Flonase®, Flovent® and Cutivate® by GlaxoSmithKline. Its worldwide sales amount to USD3bn.   Simvastatin: Validation for this new generic compound as been successfully completed and a DMF has been filed. Hovione and CKD Bio, a Korean Company with extensive experience in fermentation of APIs, have established a joint collaboration to produce and market Simvastatin. This collaboration guarantees an integrated supply chain for Simvastatin with CKD Bio producing lovastatin that Hovione further transforms into Simvastatin. This collaboration has as primary objective manufacturing capacity and reliability of supply. Availability of API and a challenging specification remain the key issues surrounding this block-buster generic – a matter Hovione has addressed. Simvastatin was developed by Merck and is currently marketed as Zocor®, by Merck & Co. and was the largest selling prescription drug in worldwide sales (USD6.67bn) in 2001. The markets of United States, France, Germany, United Kingdom and Japan account for 58 tons of API annual consumption. Capacity increase for production of Minocycline In order to meet market demands, a project to increase the production capacity of minocycline by 40% is currently underway. This increase in the production line installation represents a significant investment, improving solid handling conditions and increasing the hydrogenation, filtration and drying operations. The additional capacity will go on stream as of Q3 2004 in phases and we expect stepwise increases as from the end of this year. Sales: Hovione has announced sales for the year ended 31st March 2003 amounting to US$70. Generic products for multi-customer remain with the largest share, however custom synthesis business continues to grow at a faster rate. Hovione is committed to serving both segments of the pharmaceutical industry with equal priority. Commercial Products Simvastatin  Sancycline Roxithromycin  Ivermectin Methacycline hydrochloride Minocycline hydrochloride Doxycycline hyclate Doxycycline monohydrate  Beclomethasone dipropionate monohydrate Beclomethasone dipropionate Betamethasone dipropionate Betamethasone valerate Betamethasone acetate Betamethasone disodium phosphate Clobetasol propionate Dexamethasone dipropionate Mometasone furoate  Fluticasone propionate Halobetasol propionate  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. Note: Hovione does not sell or offer to sell products to countries where they are protected by patents.

Press Release
Press Release, 15 September 2003

Hovione generic product portfolio update

Sep 15, 2003

Hovione is pleased to announce that its new and latest facility, the Technology Transfer Centre (TTC) located in East Windsor, NJ, is now open and in full operation. The 30.000 sq.feet / 3000m2. state-of-the-art facility consists of process chemistry R&D labs and scale-up facilities to springboard pharmaceutical pipeline products into full commercialization. Headed by Dave Hoffman, the TTC is ideally located just off exit 8 of the New Jersey Turnpike, in close proximity to nine of the world’s major pharmaceutical companies. A Greenfield project, the site now employs 16 people with the capability of expanding up to 45. The TTC offers Hovione’s US based customers process development and scale up services, along with quality control/assurance and regulatory support. The cGMP kilo-lab and pilot plant, aimed at preparing small quantity NCE’s to support customer’s pre-clinical and early phase clinical development, demonstrate processes locally before transferring them to Hovione’s full scale manufacturing plants, in Europe and Asia. The development labs, staffed with multi-disciplinary project teams, allow fast turn around in producing small quantity pre-clinical APIs and investigate emerging technologies for scale-up for incorporation into Hovione’s core capabilities. Process R&D and scale-up studies, carried out in glassware to 22 lt, aim to identify potential problems arising with the industrialization of the synthetic process.   The kilo lab has a capacity to 200 lt in glass-lined reactors and 100 lt Hastelloy® C-22 cryogenic reactors. The kilo-lab develops the industrialization of the process and produce pre-approval quantities for clinical studies in compliance with strict cGMP procedures.   The Pilot Plant, equipped with a 400 lt Hastelloy® C-22 cryogenic reactor and 800 lt glass-lined vessels, produces kilo quantities of API under cGMP. From the pilot plant, a seamless technology transfer of industrial scale quantities is in place for full-scale commercialization. The Finished Goods storage guarantee local stocking in compliance with cGMP of all Hovione APIs for US customers.   Sales, Marketing and Administrative offices communicating via a global IT connection provide a permanent presence and service to US customers, a market that already represents over 60% of Hovione Group sales. The technical capacity of the TTC mimics that of Hovione’s fully commercial quantities for seamless transition to commercial scale production. The TTC is fully integrated into Hovione’s global quality network offering US customers real time data and regulatory support for ongoing production in the manufacturing plants. Operating under the same procedures, company culture and team management, TTC benefits customers with efficient, seamless and cost-effective technology transfer. “The unique design and equipment of our TTC compliments Hovione’s existing facilities in Europe and Asia and allow us to expand upon our core capabilities,” says Dave Hoffman. “Those of us with Hovione in the US are proud to carry on the tradition of excellence in service to the pharmaceutical industry, first established by Ivan Villax over 40 years ago.” Hovione is an independent, privately held, European-based producer of Active Pharmaceutical Ingredients. Hovione is dedicated to the process development, quality and synthesis of APIs, serving exclusively the Pharma industry, Hovione is a specialist in manufacturing difficult to make APIs and Regulated Intermediates under the most stringent controls of safety, quality and environmental protection. Hovione has more than 40 years of experience in chemical processes and, with 500 m3 of reactor capacity, has produced industrially more than 40 APIs.

Press Release
Hovione is pleased to announce that its new and latest facility, the Technology Transfer Centre (TTC) located in East Windsor, NJ, is now open and in full operation.

Hovione opens new Technology Transfer Centre in New Jersey

Sep 03, 2003

Hovione and CKD announce joint collaboration to produce and market Simvastatin1 Hovione and CKD Bio Corporation (CKD Bio) have signed an agreement to produce and market simvastatin on a worldwide basis. The joint collaboration will offer the active pharmaceutical ingredient (API) for simvastatin under cGMP to FDA and ICH requirements as well as the registration dossiers for simvastatin tablets for the European and United States markets. Both companies will be offering the product for sale only in countries where such does not represent an infringement of third party patent rights. The collaboration guarantees an integrated supply chain for simvastatin – CKD Bio produces lovastatin that Hovione further transforms into simvastatin. Hovione has exclusive rights to use CKD Bio´s patented process (WO 01/45484 A2) for simvastatin manufacturing. The process validation batches of simvastatin (API) have been concluded, the filings will be ready in Spring 2003 and are suitable for worldwide registration. The joint collaboration offers the market with probably the most competitive integrated manufacturing platform for the reliable supply of simvastatin API for the generic industry. CKD Bio has dedicated a portion of its fermentation capacity to the production of lovastatin. The new complete automated manufacturing building inaugurated in November 2001 in Macao by Hovione is dedicated to the synthesis of simvastatin. This integrated supply assures the generic industry with a reliable supply of simvastatin as well as a competitive price. The two Companies enjoy a long and fruitful business relationship, having collaborated in several projects involving semi-synthesis active ingredients over the last 30 years. The simvastatin project demonstrates the unique synergies, which the two companies benefit from. One with an unparalleled excellence in fermentation and the other with a long history of success in building synthetically on natural products and scaling the processes to industrial manufacture. This strategic integration puts Hovione and CKD Bio in a unique position to guarantee reliability of supply, competitive terms and complete customer support – for both API supply and/or final formulations including all registration requirements. Simvastatin was developed by Merck and is currently marketed as Zocor®, by Merck & Co. and was the largest selling prescription drug in worldwide sales (USD 6.67bn) in 2001. The markets of United States, France, Germany, United Kingdom and Japan account for 58 tons of API annual consumption.   Hovione is an international Group dedicated to the process development and synthesis of APIs, serving exclusively the Pharma industry. With FDA inspected plants in Europe and Asia and a Technology Transfer Centre in New Jersey, Hovione is committed to the highest levels of service and quality. Hovione is a specialist in manufacturing difficult to make APIs and regulated intermediates under the most stringent controls of safety, quality and environmental protection. Hovione has more than 40 years of experience in chemical processes and, with 500 m3 of reactor capacity, has produced industrially more than 50 APIs. CKD Bio is a Korean company established in 1941, with extensive research and production capabilities in the fermentation of active pharmaceutical ingredients. CKD Bio has a fermentation plant in Korea with a total fermentation capacity of 1.200m3. This plant is FDA inspected for several products. CKD Bio exports 30-40% of its production to the United States and Europe. CKD Bio has a division of Pharmaceutical Technology and New Drug Development of the Research Institute, located in Korea.   1 This announcement is not to be construed as a representation or as an offer to sell in those countries where such would constitute an infringement of third parties’ patent rights

Press Release
Hovione and CKD Bio Corporation (CKD Bio) have signed an agreement to produce and market simvastatin on a worldwide basis.

Hovione and CKD announce joint collaboration to produce and market Simvastatin

Sep 03, 2003

Hovione announces that sales for the year ended 31st March 2003 amounted to US$70m. This represents a growth of 27% on the previous year, and accounts for the Company´s best sales performance ever. Guy Villax, CEO of Hovione noted that “Hovione has successfully delivered on the business plan approved two years ago. In addition to the good performance of the financial indicators a good management of the product portfolio was successfully managed – Hovione now has two distinct business areas – generics and exclusive manufacturing – accounting, respectively, for 2/3 and 1/3 of sales”. The company forecasts an average annual sales growth of around 15% from 2003 to 2006 through organic growth. Over the past 7 years the company’s sales grew at 13% pa, a growth that was financed by the company’s cash flow and bank loans. During 2002, Hovione pursued on schedule its 3 year US$56m investment programme due for completion in 2003. The investment programme addresses a growth strategy directed at strengthening Hovione’s leading world position in the supply of active pharmaceutical ingredients to Pharma Multinationals, the emerging Biotechs and the Generic houses. - The new Technology Transfer Center in New Jersey, USA was concluded on time and budget in September 2002, suitably qualified to enable it to start taking on customer projects in the last quarter of the year. This greenfield project includes a kilo-lab and a pilot plant and provides a permanent presence in the market that already provides over 60% of Hovione Group sales. - At the Loures plant the construction of a cGMP compliant pilot plant started in 2002. This shall provide Hovione with the necessary facilities to be able to continue expanding its process chemistry R&D resources. A first-phase will enter into service before year-end 2003. - In the Taipa facility in Macau manufacturing equipment and validation is now in place for production of injectable grade APIs. This plant has been regularly inspected by the US FDA since 1987 and Hovione is now well equipped to address the growing outsourcing needs of the NASDAQ quoted Biotechs that operate under the virtual company business model. 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 sales for the year ended 31st March 2003 amounted to US$70m.

Hovione Group financial results for the year ended 31st March 2003

Jul 30, 2003

Ivan Villax was fond of saying he had left his country aged 23 with a toothbrush in one pocket, a chemical engineering diploma in the other and the Russians at his heels. Born in 1925 in Magyaóvár, a small town in Hungary just East of Vienna, his mother was of Austro-Hungarian landowner stock and his father a Hungarian scientist. In 1948, while the family was in a displaced persons camp in Salzburg, a letter from Professor Victoria Pires, then Secretary of State for Agriculture in the Portuguese government, invited Ivan's father to come to Portugal. Ödon Villax was to help establish an agronomy research center into plant genetics in Portugal such as those he had run in Hungary. Ivan arrived in Lisbon a little later to join his family after working at the Centre de Recherches Agronomiques de Clermont-Ferrand in France. He knew then that antibiotics were to be his future and while in France he had isolated from soil samples some tetracycline producing strains that he later named Streptomyces lusitanus. He joined the Instituto Pasteur de Lisboa in 1952, then one of the leading pharmaceutical laboratories in the country. His first inventions were in the area of chloramphenicol preparation and tetracycline and penicillin fermentation. During this period he made good use of Prof. Maia Loureiro’s equipment, the inventor of submerged aerobic fermentation. This Portuguese technology had been instrumental in solving the industrial challenges of penicillin fermentation during World War 2. In 1958 he wed Diane Du Boulay; and together with two other Hungarians, Nicholas de Horthy and Andrew Onody, they founded Hovione in 1959. During the first 10 years the company was a research laboratory located in the basement of the family house in Lisbon, not far from the American and British embassies. As Ivan made chemistry in test tubes, Diane typed out invoices and for the next 45 years they made an amazing team. A close collaboration developed with Fermentfarma Spa, Milan - a company also run by Hungarian refugees - Villax became the technical director and a minority shareholder. Technology for the fermentation and isolation of tetracyclines was licensed to Imperial Chemical Industries of the UK, National Fermentation of South Africa, and to International rectifier of El Segundo, California among others. In 1967 Rachelle Laboratories bought out Fermentfarma and the proceeds of Ivan Villax’s share were used to build the first Hovione plant in Loures, just outside Lisbon. Growing tired of the unpredictability of fermentation processes, he directed his research efforts to chemical synthesis. In the Loures plant he developed and industrialized an 18 consecutive step process to produce betamethasone and its derivatives, and throughout the 70s Hovione enjoyed a privileged position in Japan, thanks to Villax's independent process patents. As the business grew, and Portugal went through some troubled times after the 1974 revolution, Ivan sent his children to finish their studies in England and started looking for a location for further expansion. A Hong Kong office was established in 1978, and in the same year Hovione's first purchasing visit to the Canton fair took place. One after the other his four children spent a few years working in the Far East; it was all part of giving them the best possible education. By 1982 the Loures plant had expanded and got organised to supply the US generic market with semi-synthetic antibiotics; the Macau plant went on stream in 1985 to provide additional capacity. This was prior to the Roche-Bolar amendment, and at FDA for several years people remembered how samples of doxycycline were provided at 9am at their Fishers Lane Rockville, Maryland offices, and not a minute too early, or too late, before the innovator’s patent expired. In Europe this product generated extensive patent litigation with Pfizer suing a number of Hovione customers in 8 different countries. True to his beliefs, Villax volunteered as co-defendant in every suit. His tenaciousness in the face of such adversity meant he did not give up and eventually the matter was settled out of court in 1992. This dispute diverted Villax’s efforts from following other creative pursuits much to his disappointment; though throughout this time the industry recognized in Hovione a fighting spirit that was a characteristic of its founder. Today the generic industry worldwide benefits from Hovione's efficient processes in the production of many other active ingredients: minocycline, roxithromycin, are products where Hovione retains a leading role in several countries. Ivan Villax was always grateful to the country that welcomed him and allowed him to make a new life. He was happy that in providing generic contrast media Hovione was somehow celebrating Prof. Egas Moniz, a Portuguese Nobel Laureate, the father of angiography. After the fall of the Berlin wall he made frequent visits to Hungary. The Technical University of Budapest, his Alma Mater, awarded him a PhD in recognition for his 40 years of work in pharmaceutical chemistry and he was made a member of the University's Senate. By then he had authored over 100 patents and scientific articles. In 1995 his health started to weaken and he made arrangements for an organised hand-over of his responsibilities. With the business in the hands of a professional management team led by his son Guy, Ivan Villax still came to the Loures plant on a daily basis, keen on being kept informed on the new chemistries and on the performance of the business, and quick to point out any slack in the rigour, discipline or housekeeping in either the labs or the manufacturing facilities. Every year, together with Diane, he visited the Macau plant keen to encourage the younger generation and to acknowledge the service of long-standing staff. In his last years he saw Hovione becoming an important producer of HIV protease inhibitors, a key medicine in the fight against AIDS, and taking an active role in many drug development projects as the provider of the active ingredient. In 2002 Hovione established a pilot plant in New Jersey, not far from Rahway where in the 50s Villax had turned down an offer for a position at Merck's research laboratories. He and Diane traveled the world, whereby he was able to satisfy one of his other passions, collecting plants from exotic locations, planting and nurturing them in his quinta outside Lisbon. This May, after a severe deterioration of his lung condition, Ivan, ever the fighter, ever determined to control his own fate, realized that hospitals and science could do no more for him and asked to be taken home. At his quinta in Manique surrounded by his flowers and his trees, with his children, grand-children and his wife Diane, his life-long partner, he lived another two happy weeks - he died on Friday June 6th. Church services will be celebrated at the Igreja Matriz of Loures at noon, and at the Basilica da Estrela, in Lisbon, at 7pm on June 12th.

Press Release

Ivan Villax, 1925-2003

Jun 06, 2003

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