Press Room

Loures, Portugal, December 11th, 2008 - Hovione announced today that it has agreed with Pfizer to acquire their Loughbeg Active Pharmaceutical Ingredients (API) site in Ireland. This site manufactures intermediates for Lipitor active pharmaceutical ingredient. The site has had a number of owners starting in 1984 with Angus Fine Chemicals, then Hickson & Welch, Warner Lambert, Pfizer and now Hovione. Over the last 10 years Pfizer has invested several hundred million dollars in plant and equipment there, making it a modern, well equipped site, meeting the highest standards in the industry. The deal is scheduled to be completed by early April 2009. Hovione Cork will employ 70-80 staff and will, over the next 24 months be transferring products from its Loures, Portugal site and validating processes for new compounds in expectation of drug approval. The terms of the transaction were not disclosed but Hovione will continue to provide manufacturing services for Pfizer. "We made clinical trial materials for over 40 drug candidates last year. We have been investing heavily in R&D for over 6 years and now have a strong development pipe-line but have not invested in manufacturing assets since 2001, so it was time that we expanded our manufacturing capacity. This site offers everything that our Customers might want: large scale capacity, the highest standards, in a location where tax benefits are available to them and a well trained, innovative work-force" said Miguel Calado, CFO. The plant adds 427m3 of capacity to Hovione's 810m3 - of which 400m3 are in Portugal and the remainder in China. The plant is multi-purpose and is able to address a large number of specialized chemistries such as hydrogenation and low temperature chemistry. The Cork site also provides Hovione with a new, €70m capability to produce spray-dried formulations. Hovione is the world's leading provider of GMP spray-drying services covering every scale (lab, pilot and several intermediate production scales) and is able to provide R&D support and commercial manufacturing. At a time when most fine chemical producers are investing in Asia, Hovione is turning to Ireland. Cork has the highest concentration of API production anywhere in the world, with a vast and deep talent pool, with an excellent cGMP record with the health authorities since the mid-nineties. These sites belong to Large Pharma, companies that are now embracing outsourcing as a key part of their long-term manufacturing strategy. Hovione believes that having the right kind of capacity in Cork will help it better serve its Innovator customers when it comes to making APIs for their new product introductions. "We have been manufacturing in China for over 25 years - we know very well what China can do for the Pharma industry, but we also know what it can't do - and it is for those reasons that we are now in Cork" said Guy Villax, Chief Executive, "The Cork site, the New Jersey Technology Transfer Centre, Loures in Portugal and Taizhou and Macau in China now provide Hovione with the right range of capabilities in the correct geographies - every site meets FDA requirements for APIs but every site is suited to a different and well defined mission" he added. Pharma manufacturing needs to become lean and cost-effective and this is always a challenge. The outsourcing business model gives manufacturers a head start, as contractors can provide their services to any Innovator company for any product and thus benefit from lower risk, better utilization of facilities and scale. In addition, the contractor can select those compounds that have a good fit with its plant's technical capabilities, in turn the pharma company can avoid the expensive plant modifications often required to manufacture these compounds. It is this ability to produce for anyone that will contribute to making compounds fast and less expensively to the benefit of all stake-holders. However achieving this goal requires the ability to produce multiple small production campaigns -many simultaneously-, the skill to do rapid change-overs with validated cleaning, multi-purpose equipment design and lay-out that operate within a quality system specially designed for high levels of compliance yet of simple execution. This is what Hovione will be able to bring to the Cork site. "The combination of Hovione's 50 years of experience in API manufacture and contract manufacturing and the capabilities of the existing plant and compliance tradition of the Cork colleagues are a winning combination", said Noé Carreira, VP Manufacturing.   About Hovione Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

Press Release

Hovione buys Pfizer’s Loughbeg API Facility

Dec 11, 2008

Loures, Portugal, October 9th, 2008 - Hovione announced today the signature of a protocol with The Budapest University of Technology and Economics (BME) regarding the Ivan Villax traineeship program. This ceremony will take place next October 10th, in Budapest. Following the suggestion of the Portuguese – Hungarian Chamber of Commerce, and in order to pay tribute to the University where Hovione’s founder trained and graduated, the Company decided to institute a bursary program for two annual traineeships to enhance and develop the bonds between Portugal and Hungary. We will never forget that Ivan Villax believed in merit and competition therefore these traineeships will be awarded along the same set of criteria, said Mrs. Diane Villax, president of Hovione’s Board of Directors. This traineeship program aims to create the conditions for an MSc organic chemistry student to work for a period of 4 to 6 months in an industrial R&D environment and to be part of a project team responsible for the development of a synthetic process for the preparation of an active pharmaceutical ingredient. The traineeship will include exposure to the preparation of the active ingredient under Good Manufacturing Practices for use in clinical trials or to its related analytical chemistry requirements. This will allow BME students to take part of a learning experience that will contribute to their knowledge and skills and will also help to create an important link between the two institutions.   About Hovione Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

Press Release

Ivan Villax Traineeship Program

Oct 09, 2008

Loures, Portugal, June 27th, 2008 - Hovione announced today that the consolidated sales for the fiscal year ended March 31st 2008 amounted to USD103.7m, representing a growth of 11% over the previous year. This is Hovione’s first year beyond the USD 100 million mark. This sales increase reflects the drug approvals by our customers both in the Innovator as well as the Generic segment. Hovione’s offering also includes the fast growing particle design and inhalation formulation services. All of our 4 businesses have a growth outlook and present synergies between them. In 2007 Hovione invested significant amounts in particle design technologies, in new production lines and in the constant upgrade of our facilities worldwide. We have concluded the acquisition of a 75% stake in the share capital of Zhejiang Taizhou Hisyn Pharmaceuticals Co, Limited (Hisyn) in December 2007 and Hovione retains the right to acquire the remaining 25% at a future date. Hisyn provides us with an excellent opportunity to leverage our 25 years of operations in Hong Kong and Macau, and positions Hovione ideally for a low cost, high volume strategy in contrast agents. “Despite the negative economic environment, we face 2008 with optimism. In 2005 we set a goal to be selling $150m by 2010 with all the sales increase driven by organic growth. I expect us to be ahead of target this coming year.” adds Guy Villax, Chief Executive.   About Hovione Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

Press Release
Sales reach USD 103.7 million for the fiscal year ended March 31st 2008.

Hovione’s sales grow 11%

Jun 27, 2008

Loures, Portugal, March 6, 2008 - Hovione announces that it has purchased 75% of Hisyn Pharmaceutical Co. Limited. The Zhejiang provincial authorities have already issued the necessary business license and the joint venture (JV) is now operational. The acquisition provides Hovione with significant additional drug substance manufacturing production capacity and strengthens its 20 year presence in China. The acquisition includes both development labs in Shanghai and an active pharmaceutical ingredient (API) plant occupying 22,000 square meters. on a 22 acre plot employing 181 staff. Hovione's relationship with Hisyn started with the supply of intermediates, but this factory, which was commissioned in 2005 from a greenfield site, will now produce Hovione's two largest volume products. "Hisyn represents an opportunity to both increase our manufacturing capacity and ensure a sustainable cost advantage. We find it important to provide our current customers with an assurance of competitive supply over the long run; and in addition we want to have a strong presence in new markets, such as Brazil, India and China, where price is decisive" said Miguel Calado, CFO. The negotiation and the acquisition processes moved smoothly in part due to the experience Hovione has built in China over the last 3 decades. The Macau plant, with 5 previous FDA inspections and more than 10 years of contract manufacturing relationships in China, has enabled Hovione to effectively bridge cultures with China in every dimension: language, GMP, culture and business practices. Luis Gomes, Vice President of Generics, and responsible for the investment and integration process added: "When we first came to the Canton fair in 1979 we were buying raw-materials that would be processed in Macau or in Portugal. For many years we felt we'd be better off being an important client of Chinese plants through contract manufacturing deals, because at that time there many JVs going very wrong. Now is the right time for Hovione to acquire infrastructure in China and tap into a growing market and leverage China’s manufacturing abilities. We are planning to invest further monies in 2008 to effectively double Hisyn's manufacturing capacity".   About Hovione Hovione is an international group specializing in the development and compliant production of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. In 2006 it had sales of US$94 million (Euro 70 million). With almost 50-year in process development, quality standards and advanced particle design technologies, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and New Jersey, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry, Hovione offers services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product.

Press Release

Hovione buys drug manufacturing facility in China

Mar 06, 2008

Loures, Portugal, October 29, 2007 - Hovione's Technology Transfer Center (TTC) in New Jersey has just passed successfully a pre-approval inspection by FDA. The inspection was carried out by Ms. Joy R. Kozlowski-Klena Compliance Officer at the US FDA Center for Drug Evaluation and Research (CDER) and lasted 3 days, starting on October 9th and concluded on the 12th. No form 483 was issued. At the closing meeting, the inspector had several positive comments on our systems and indicated she would be recommending the approval of the site. This inspection covered the TTC's first commercial product - a high potency small molecule API for an injectable formulation. The NDA was filed last May and approval is expected in Q1 2008, with a launch foreseen later that year. Mr. Dave Hoffman, President of the US Operations said “This is an exciting milestone for our New Jersey Technology Transfer Center. This successful FDA compliance inspection gives a green light to an NDA compound - we look forward to further expanding small scale commercial manufacturing opportunities at our NJ site”. Hovione plants have been object of 15 FDA inspections. This inspection is the first at the New Jersey since it started to operate as an R&D facility in September 2002. In the Establishment Inspection Report issued by Ms. Joy R. Kozlowski-Klena it is stated “This inspection covered the NDA under evaluation, as well as limited GMP coverage of systems in place at this time, including Quality, Laboratory, Production, Facilities and Equipment. The inspection did not reveal any significant deficiencies.” The TTC site consist of process chemistry R&D labs, cGMP kilo and scale-up labs and a cGMP pilot plant. The TTC is also the home of Hovione’s commercial offices. The TTC offers Hovione´s US based customers’ process development and scale-up services, along with quality control/assurance and regulatory support. The cGMP facility is designed to prepare small quantity NCE’s to support customer's pre-clinical and early-phase clinical development, demonstrating the customer’s processes locally before transferring them to Hovione's full scale manufacturing plants, in Europe and Asia. About Hovione Hovione is an international group specializing in the development and compliant production of active pharmaceutical ingredients (APIs), serving exclusively the pharmaceutical industry. With a 48-year track record in process development, quality standard and advanced particle design technologies, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, Far East and New Jersey, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry, Hovione offers services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product.

Press Release

FDA inspects Hovione’s Technology Transfer Center in New Jersey

Oct 29, 2007

Loures, Portugal, October 8, 2007 – Hovione announces that its Technology Transfer Centre (TTC) has been accepted for Star participation to the Voluntary Protection Program by the Occupational Safety & Health Administration – OSHA. The VPP Star plaque and Flag presentation ceremony will take place next 11th October in East Windsor, New Jersey at 3pm. At present, only 44 sites in New Jersey have obtained the VPP Star designation. Just to apply, the facilities need to have a minimum of 3 years of unblemished track record. The TTC started operations in 2001 and OSHA accepted our application less than 12 months after it was first submitted. This shows the commitment to worker safety and health that has existed at the TTC since its inception. Guy Villax, Hovione CEO said: “I am very proud of the achievement of my colleagues. This award takes our TTC to the next level, it is a status that the Team in New Jersey will have to work hard to maintain. Continuing to deserve this is central to building our company culture. Safe operations are the result of good management and dedicated people. This is what gets customers to come back for more. I think it is terrific that, just like all our other sites, the TTC in New Jersey continues the Hovione tradition of collecting awards for doing important things well - well done!”. Working with industry and labor, the federal Occupational Safety & Health Administration created the Voluntary Protection Program (VPP) in 1980 to recognize and partner with worksites that implement exceptional systems to manage worker safety and health. The management and employees at these sites voluntarily implement comprehensive safety & health management systems - that go far beyond basic compliance with OSHA regulations. The VPP process emphasizes holding managers accountable for worker safety & health through measurable goals, the continual identification and elimination of hazards and the active involvement of employees in their own protection. The process places significant reliance on the cooperation and trust inherent in a partnership. Sites choosing to apply for VPP recognition show their commitment to effective worker protection by inviting government regulators into their workplace. In return, OSHA removes them from programmed inspections and does not issue citations for violations that are promptly corrected. About Hovione Hovione is an international group specializing in the development and compliant production of active pharmaceutical ingredients (APIs), serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Center in New Jersey, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry, Hovione offers services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product.

Press Release

Hovione in New Jersey awarded VPP Star status by OSHA

Oct 08, 2007

Sales reach USD 93.7 million (EUR 70,2 million) for the fiscal year ended March 31st 2007 Loures, Portugal, July 31st - Hovione announced today that the consolidated sales for the fiscal year ended March 31st 2007 amounted to USD 93.7M, representing a growth of 16% over the previous year. According to Hovione’s CEO, Guy Villax, “This was a year of strong sales growth despite the continued strengthening of the Euro. The main contribution to this growth came from the business segments in which Hovione has been strategically investing over the last few years. We have recently developed two new business segments: particle design services and formulation development services for inhalation – both technically challenging areas that have limited offer in the market.” In 2006 Hovione invested approximately USD 12M in R&D, with 140 people working in R&D both in lab and pilot-scale. Hovione supported pharmaceutical research in Europe and in the USA, custom synthesizing the development of more than 40 different pharmaceutical ingredients used in clinical trials all over the world. Over the last 12 months, 7 new patent applications were filed as a result of the research conducted at Hovione. Geographically, Hovione’s sales in the USA market represented 46% of our total sales (43% in 2005), Europe 30% (29%), Japan 15% (18%) and ROW 5% (5%). “We face 2007 with optimism. Our goal for this year is very clear – surpass USD 100M. I am confident that we can reach this goal!”, adds Guy Villax.   About Hovione Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs for the Pharmaceutical Industry. With a 48-year track record in process development, quality standard and advanced particle design technologies, 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 API development from gram scale to commercialization.

Press Release

Hovione’s sales grow 16%

Aug 03, 2007

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

Contact Us

If you would like to learn more about Hovione, kindly fill in the form below and we will be revert to you soon.