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Press Release / Apr 07, 2005

Hovione stands behind 3 NCE launches

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

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.

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The investment includes both continuous and batch tableting capabilities, as well as connect spray drying with tablet production at its East Windsor campus. Hovione, a Portugal-based contract development and manufacturing organization (CDMO), plans to install a continuous tableting line at its East Windsor, New Jersey campus, adding drug product manufacturing capacity and an integrated pathway from amorphous solid dispersion production through commercial tablet manufacturing. The $35 million investment will bring the first ConsiGma CDC Flex system to Hovione’s recently opened 89 Twin Rivers facility. The line is expected to be commissioned in late 2027 and will support both continuous and batch operation at throughputs ranging from 1 to 200 kilograms per hour, according to the announcement. The system will allow customers to use the same equipment for development, clinical, and commercial production, with formulation development possible using as little as 1.5 kilograms of material. Hovione said the line will also be equipped for containment to 1 microgram per cubic meter to support the handling of highly potent compounds. The new capability will also connect Hovione’s spray-drying operations with tablet manufacturing at the East Windsor campus. The company recently opened a 31,000-square-foot facility at the campus with two commercial-scale spray dryers for manufacturing amorphous solid dispersions (ASDs), completing a $100 million investment in its New Jersey operations. Hovione said the integrated setup will allow customers to move from formulation and particle engineering through tablet production under one quality system, reducing technology transfer requirements and eliminating traditional scale-up between development and commercial production. The ConsiGma CDC Flex platform was jointly developed with GEA as part of a collaboration that began in 2022, the company said. The system incorporates automated process controls and process analytical technology for real-time monitoring during production. Hovione already operates continuous tableting technology at its Loures, Portugal site. In August, the company completed a more than €40 million expansion of its tablet development and manufacturing center there, adding a second commercial-scale tableting line and increasing the center's manufacturing area by 25%. The East Windsor installation will extend Hovione’s continuous tableting capabilities to the U.S. and expand its integrated drug development and manufacturing services for oral solid dosage products. Read the full article at Pharma Manufacturing 

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Hovione to add $35M continuous tableting line at New Jersey site

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Hovione, a globally integrated pharmaceutical contract development and manufacturing organisation (CDMO), will commission the world’s first ConsiGma CDC flex – a next generation continuous tableting line – at its East Windsor, New Jersey (USA) campus in late 2027. The line will be installed at 89 Twin Rivers, Hovione’s recently opened facility, expanding the company’s drug product capabilities and strengthening its integrated pharmaceutical development and manufacturing hub in the US. CDC ConsiGma flex system The project represents an investment of $35 million. Once installed it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production. The new flex will operate in continuous or batch modes across a very broad throughput range (from one to 200 kg/h). Customers will be able to develop a formulation using small quantities of material, down to 1.5 kg, and then run from very small clinical batches to large commercial batches using the same equipment. This is enabled by specialised design within the flex to effectively switch between continuous blenders of various sizes. Additionally, the line will be installed for containment to 1 µg/m³, supporting highly potent compounds. Continuous tableting is reshaping manufacturing of oral solid dosage medicines and is well suited to programmes in which speed, supply resilience and efficient use of high-value active pharmaceutical ingredients (APIs) are priorities. Inline process analytical technology (PAT) and automated controls also provide real-time quality monitoring. In parallel, the 2022 adoption of ICH Q13 regulatory framework, guidance specifically for continuous manufacturing of drug substances and drug products, provides harmonisation across the US, Europe and Japan. As of 2024, 17 products manufactured under the international guidance have been approved by the US Food and Drug Administration (FDA) alone.  Developed jointly with GEA, the ConsiGma CDC flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply. Designed for versatility and ease of use, these innovative developments simplify operation, improve efficiency and containment, and enhance operator safety. Read the full article at Pharma Press UK 

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Hovione to commission world’s first ConsiGma CDC flex, bringing next-generation continuous tableting to the US

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Key Takeaways Commissioning a US-based ConsiGma CDC Flex line enables end-to-end spray drying-to-tablet manufacture within a single site and quality system, reducing comparability and technology-transfer burdens. Elimination of conventional scale-up is enabled by using the same equipment from early development through commercial supply, minimizing engineering runs and conserving scarce API. Operational flexibility spans batch or continuous modes and 1–200 kg/h throughput, with scale adjustment achieved by switching continuous blenders rather than replatforming processes. High-containment design to 1 µg/m³ expands suitability for highly potent oral solid-dose programs while maintaining integrated development-to-commercial workflows. Regulatory momentum for continuous manufacturing is supported by ICH Q13 harmonization, increasing FDA approvals, and platforms leveraging inline PAT and automated control suites for real-time quality assurance. Hovione announced on Oct. 5, 2026, that it will commission the ConsiGma CDC Flex, a next-generation continuous direct compression tableting platform jointly developed with GEA. The investment is designed to link amorphous solid dispersion manufacturing via spray drying with commercial tablet production at a single US site operating under one quality system. The line will run in either continuous or batch mode at throughputs from 1 to 200 kg/h. Formulation development can begin with as little as 1.5 kg of material, and the same equipment can then support everything from very small clinical batches to large commercial runs, enabled by a design that allows the system to switch between continuous blenders of different sizes. The installation will also be contained to 1 µg/m³ to accommodate highly potent compounds. "Hovione will be the first company in the world to offer the ConsiGma® CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs, Hovione, said in a press release. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." What Does a Single Development-To-Commercial Line Change? For formulators and process engineers, the most consequential claim is the removal of traditional scale-up. Moving a process from development equipment to commercial equipment typically requires engineering runs, bridging work, and consumption of scarce API, all of which weigh heavily on early programs with limited material. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated US development and manufacturing workflow," said David Basile, Vice President of Technical Operations, Hovione, in the press release. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Co-locating spray drying and tableting is also significant because amorphous solid dispersions remain a primary solubility-enhancement route for poorly soluble molecules, and transferring intermediates between sites or vendors adds technology transfer and comparability burdens. The new line builds on the company's earlier US expansion; Hovione recently completed a $100 million investment to bolster US capacity in particle design, amorphous solid dispersions via spray drying, and batch and continuous tableting. How Is the Regulatory Environment Shaping Continuous Tableting Adoption? The company points to the 2022 adoption of ICH Q13, which provides harmonized guidance for continuous manufacturing of drug substances and drug products across the US, Europe, and Japan. Hovione reports that, as of 2024, FDA alone had approved 17 products manufactured under the guidance. Speaking on ICH Q13, FDA's Kelley Burridge, PhD, "Perceived barriers to continuous manufacturing have been falling one by one," and noted an FDA publication showing faster approval times for products with continuous manufacturing elements than for comparable batch products. The platform incorporates inline process analytical technology and automated controls for real-time quality monitoring, along with SimpleCT, an automation and control suite intended to support a single process from development through commercial supply. For sponsors weighing supply resilience and regional sourcing, the East Windsor installation extends a capability that Hovione says only it currently offers as a contract development and manufacturing organization.   Read the full article at PharmTech.com  

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