Press Room

Press Release / Apr 15, 2009

TwinCaps® in Phase III clinical trials for influenza

Hovione’s TwinCaps® inhaler in Phase III clinical trials for influenza

April 15, 2009. Hovione is pleased to announce that its licensee Daiichi Sankyo (Tokyo, Japan) has informed that it intends to use Hovione’s TwinCaps® dry powder inhaler device in the launch of the compound CS-8958, an inhaled long-acting neuraminidase inhibitor active against the influenza virus. Daiichi Sankyo has completed patient enrollment for Phase III clinical trials in Japan and other Asian countries and results are expected to be released mid year, including data to confirm the device switching. TwinCaps® was specifically developed by Hovione for the indication and licensed to Daiichi Sankyo and Biota Holdings Ltd (Victoria, Australia). 



The announcement follows the recent publication [1] of data indicating that the compound is as effective as Relenza® and Tamiflu® against various influenza strains. Significantly this efficacy is achieved with a single dose, as opposed to a treatment over five days for the established drugs.



A 20 mg dose of CS-8958 is inhaled from powder compartments in the TwinCaps® inhaler, which is made of just two plastic parts. Hovione believes this is currently the simplest inhaler being tested in clinical trials and once approved, will be the simplest in the market and have the lowest cost of goods. TwinCaps® has no moving parts to deaggregate the dose of powder and only requires a low inspiratory airflow to achieve optimal delivery to the lung. This means that children and the elderly will find it easier to inhale the full dose. 



The design challenge for Hovione was to make TwinCaps® extremely simple to use, as in the case of a pandemic requiring immediate treatment of large populations, there is an obvious advantage for simple operation. The TwinCaps® DPI (to be manufactured in Japan and Europe) is a two-piece unit comprising body and shuttle components. The shuttle has two pre-filled dose chambers, left and right. In use, the shuttle is moved to one side by the patient to align one chamber of the shuttle with the mouth piece to allow the first inhalation, creating turbulence within the dose chamber and drawing the dry powder into the lung of the patient. The process is then repeated for the second dose chamber, as the shuttle is moved to the opposite side to permit another inhalation to take place.



Daiichi Sankyo has indicated that they are planning to file NDA in Japan in March 2010 and get approval within 2010, while Daiichi Sankyo and Biota are seeking licensees for the drug product collaboratively for the rest of world market. Hovione retains the right to commercialize TwinCaps® outside the field of influenza.



Peter Villax, Hovione’s Vice President Pharma Business Unit stated ”The unique design benefits of TwinCaps® including high dose capability, disposability and low cost are predicted to drive growth in Hovione’s inhalation business and further leverage our already proven track record in developing inhalation APIs, formulation development and manufacturing services.”

About Hovione

Hovione is an international company with 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on the most demanding customers, in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.



________________________________________

[1] Makoto Yamashita et al. “CS-8958, a prodrug of the new neuraminidase inhibitor R-125489, shows long-acting anti-influenza virus activity”, Antimicrobial Agents and Chemotherapy, Jan.2009, p.186-192

 

For further information about Hovione, please contact Corporate Communications (Isabel Pina, + 351 21 982 9362)

Also in the Press Room

See All

The latest from CDMOs, CMOs, and suppliers featuring Thermo Fisher Scientific, Lonza, SK pharmteco/Lotte Biologics, Hovione, Sai Life Sciences, BioCina, Alcami, Piramal Pharma/IntoCell and Roquette. Formulation Development/Drug Product Manufacturing: Hovione Completes Initial $100-M Investment Cycle in US Operations Hovione, a CDMO of drug substances and drug products, has completed an initial $100-million investment cycle at its site in East Windsor, New Jersey, as part of a strategy to increase its US operations and enhance its integrated drug-substance, drug-product intermediate, and drug-product capabilities. Upon completion, the site will cover more than 200,000 square feet.   The initial expansion phase includes a 31,000-square-foot building that will house two size-3 spray dryers (PSD-3) designed for production of amorphous solid dispersions (ASDs). This investment more than doubles Hovione’s spray-drying capacity in the US by expanding capabilities for ASD development and commercial manufacturing. Construction is underway at the New Jersey site, with GMP operations planned to start in the second quarter of 2026.  As part of this expansion, Hovione has also acquired additional adjacent land to enable future growth at the East Windsor site. The 125,000-square-foot greenfield will support large-scale production, including continuous and batch tableting capacity, and introduce the latest pharmaceutical technologies and digital innovation with enhanced quality control and R&D capabilities.    Read the full article at DCATvci.org  

Press Clipping

Supplier News: Thermo Fisher, Lonza, SK pharmteco, Hovione & More

Oct 30, 2025

Today marks the start of CPhI Frankfurt, a huge trade show in Germany focused on the supply of pharmaceutical ingredients and other services to the drug industry. C&EN editor in chief Nick Perkins, life sciences editor Laura Howes, and reporter Aayushi Pratap are all there to meet drug outsourcing executives and take the pulse of the sector. In advance of CPhI, Cambrex and Wilmington PharmaTech both just announced big investments in US plants that make active pharmaceutical ingredients. And the Portuguese pharmaceutical services firm Hovione says it has completed a $100 million investment in New Jersey (story below). (...) Hovione invests in spray-drying in New Jersey The pharmaceutical services firm Hovione says it has spent $100 million to expand its operation in East Windsor, New Jersey. The facility spray-dries drug ingredients to create amorphous solid dispersions, which improve solubility and bioavailability. The Portuguese company says the new spray dryers will begin operating in the second quarter of 2026. The New Jersey facility opened in 2002, making Hovione one of the longest-established European pharmaceutical services firms in the US, CEO Jean-Luc Herbeaux says in a press release. Hovione says it has purchased land adjacent to the East Windsor site on which it can add new facilities for services such as spray-drying and drug tableting. Hovione is also investing at its sites in Ireland and Portugal. —Michael McCoy   Read the full article at CEN.acs.org  

Press Clipping

Oct. 28 Business Watch: More plants closing in Europe, Novartis to pay $12 billion for biotech firm

Oct 28, 2025

Developing drugs with poor water solubility remains a major challenge for pharmaceutical manufacturers, because solubility impacts bioavailability and effective drug delivery. The vast majority of small molecule drug candidates have low water solubility. For more than two decades, the most successful particle engineering technology to improve drug solubility and bioavailability has been spray drying with an amorphous solid dispersion (ASD) platform. Spray drying improves the solubility of oral drugs, inhalable particles, and excipients, and increases the stability of heat-sensitive drug products. Hovione, recognized globally for its industry-leading spray drying capabilities, has recently completed a $100 million investment cycle to enhance its operations in New Jersey. This initiative has successfully doubled Hovione’s spray-drying capacity in the US, strengthening its position in the industry. Hovione’s Expanded U.S. Site in East Windsor, NJ  The first phase of the expansion in East Windsor, NJ, delivers a new 31,000 square foot facility and houses two size-3 spray dryers (PSD-3). This additional capacity allows Hovione to meet increasing customer demand for ASD development and good manufacturing practice (GMP) commercial production. GMP operations are scheduled to commence in the second quarter of 2026.  Hovione has also acquired 15 acres of neighboring land, strategically positioning itself for future growth and evolving customer needs for U.S. manufacturing. The newly acquired greenfield site will provide future support for PSD-4–scale commercial production as well as continuous and batch tableting production. It will also be a hub for centralized logistics, enhanced quality control laboratories, and next-generation research and development facilities.  A Global CDMO with a Growing U.S. Footprint  Hovione has operated in New Jersey for more than two decades, establishing itself with a strong U.S. presence for the production of drug substances, intermediates, and finished drug products. A continued emphasis on an integrated service offering, including spray drying, supports delivering innovative medicines to patients more quickly.  The expansion of the East Windsor site addresses the rising demand for U.S. manufacturing and is an integral part of the company's ongoing global growth strategy, with facilities in Portugal, Ireland, and Macau. The company continues to bolster a cohesive network for drug development and commercial manufacturing unified by a corporate quality system and governance framework.  The integrated offering enhances development speed and eases technology transfers by unifying the team's technical skills, proprietary technologies, and digital platforms to efficiently produce drug substance to drug products at a single-site, through Hovione’s “one site, one partner” vision. Furthermore, Hovione’s strategic partnership model offers customers exclusive access to advanced technologies and resources while aiding in the optimization of their development programs and ensuring sustained value creation.  End-to-End Spray Drying and Particle Engineering: From Grams to Tons Hovione is a global leader in spray drying and particle engineering. Services include solubility enhancement and controlled-modified release via development and production of ASDs of both small and large molecules, supporting various modalities. ASD-HIPROS, Hovione’s proprietary spray drying screening platform, identifies optimal formulations that offer optimal performance and stability. By increasing production volume in the US, Hovione will meet customer demand for spray drying services:  Development services in the laboratory (1 g – 1 kg batches)  Pilot scale production (0.5 – 25 kg batches)  Small-scale production (5 – 200 kg batches)  Large-scale commercial manufacturing (50 – 400 kg batches) A Commitment to Sustainability  Hovione’s core values include a commitment to sustainability at all facilities. This commitment is reflected in a business strategy that focuses on improving the communities where the company operates. Hovione’s sustainability policy and strategy align with the UN Sustainable Development Goals and include adherence to science-based targets in line with the Paris Agreement to address climate change. Meeting these goals has required a dedication to process intensification and ensuring sustainability of manufacturing processes. This has been possible through strategic planning and commitments from senior management to ensure sustainability is addressed throughout the drug development life cycle.  Partner with a Technology-Leading CDMO for U.S. Manufacturing   As demand for poorly water-soluble drug formulations continues to rise in the U.S., expanding spray drying throughput is essential to meet the need for innovative therapeutics. With proven leadership in spray drying to manufacture ASDs, Hovione is able to support pharmaceutical companies by solving their solubility challenges efficiently and reliably.  Partnering with a CDMO that combines global leadership, advanced technologies, and the necessary manufacturing capacity in the U.S., drug developers can expedite time to market, ensure quality, and deliver innovative medicines to patients faster.  If your company is seeking access to the latest spray-drying capabilities, expanded U.S. manufacturing capacity, and an accelerated path to regulatory filing and commercialization, contact our team today.     

News

Hovione is Expanding Spray Drying Capacity for U.S. Drug Manufacturing

Oct 27, 2025