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Press Release / Sep 08, 2009

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

Loures, Portugal, 8th September, 2009. Hovione is pleased to announce that its TwinCaps® inhaler licensees Daiichi Sankyo Co. Ltd. (Tokyo, Japan) and Biota Holdings Ltd (Victoria, Australia) have both announced successful Phase III trials for CS-8958, a new long-acting neuraminidase inhibitor for treatment of influenza (known as a prodrug of laninamivir). 

CS-8958, co-owned by Daiichi Sankyo and Biota, is delivered by TwinCaps®, a patented dry powder inhaler which Hovione specifically designed for the treatment and prevention of influenza infections in both seasonal and pandemics situations. The device was designed to be used across a broad range of patients’ inspiratory flow rates and requires a single priming action prior to use. 

In the Phase III trials conducted by Daiichi Sankyo, a single inhaled dose of CS-8958 was shown to be as effective as oseltamivir (TamifluⓇ) administered orally twice daily for 5 days (total of 10 doses). A parallel Phase II/III trial of CS-8958 in paediatric patients also met the primary and secondary endpoints compared to oseltamivir. 

CS-8958 is an important new treatment against influenza as current neuraminidase inhibitors for influenza require daily or more frequent dosing, compared to CS-8958 which requires one dose for treatment and possibly once-weekly dosing for prophylaxis). The ability to dose patients on a weekly, or even less frequent, basis offers numerous benefits. Firstly, the volume of product stored in stockpile reserves may be smaller and secondly, a single-dose treatment will offer better patient compliance and convenience. 

TwinCaps®, for which patent applications were filed world-wide in 2006, is an innovative inhaler, delivering a significant dose of drug to the lung, in a simple device comprising only two plastic components. Daiichi Sankyo and Biota have a worldwide exclusive license to use TwinCaps® for the treatment and prevention of influenza infections. TwinCaps® is available for licensing for use in other indications including antibiotic and vaccine delivery. 

Hovione is now planning for large-scale manufacturing of the TwinCaps® devices. Daiichi Sankyo is intending to submit its market authorization application for Japan by March 2010, while Biota continues to advance the clinical development program required to support registration in the United States and UK. 

About Hovione

Hovione is a leading developer of inhaled drug products, with experience in anti-virals and proteins delivered by inhalation, as well as inhaler development. It is an international company with 50 years’ experience in Active Pharmaceutical Ingredient integrated development and compliant manufacture, from molecule to unit dose. In the inhalation area, Hovione is the only independent company offering such a broad range of services. 

For further information about Hovione, please visit the Hovione site atwww.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)

 

 

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Dear Customer, As you may be aware, Portugal and Spain experienced yesterday, April 28 (at approximately 11:30) a widespread power outage. This unexpected event, beyond our control, affected the normal activities at our sites in Portugal. In response, we promptly activated our contingency protocols for this type of situation, prioritizing the safety of facilities and personnel. All ongoing processes were taken to safe hold points, and no new processes were initiated. Our backup power generators ensured continuity of critical functions throughout the duration of the outage, which lasted approximately 11 hours, until the power from the grid was restored at the site. The site began resuming operations gradually through the night making sure all systems being restarted safely and verified to be in good working conditions. We anticipate that most activities will be fully resumed during today. Should you have any specific questions regarding your product or project, we kindly encourage you to contact your Account Manager or Project Manager, who will be glad to assist you. We sincerely appreciate your understanding and continued partnership.      

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In a recent appearance on CNN Portugal’s Pitch – Brand & Content program, Ilda Ventura, Senior Vice President of Human Resources at Hovione, highlighted a powerful reality: 55% of our employees in Science, Technology, Engineering, and Mathematics (STEM) roles are women. At Hovione, we’re proud to foster an environment where women in science thrive - leading innovation, driving progress, and shaping the future of healthcare. But our commitment goes beyond numbers - it’s about creating the right conditions for scientific talent to grow, equally and globally. “I am proud to say that, in our company, there is no gender pay gap between men and women. We empower everyone. Our female and male scientists are all working to find more sustainable, faster, and more productive ways to achieve victories over diseases.” - Ilda Ventura Watch the full edition to learn more about our commitment to women in science at CNNPortugal.pt  (Language: Portuguese)  

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We prioritize actionable improvements that resonate with our teams, engaging cross-functional and geographically diverse groups to implement meaningful change.  Across our sites, we’ve made significant investments tailored to each region while maintaining a unified approach to employee satisfaction. In the US, where employees value transparency, recognition, and growth opportunities, we’ve enhanced communication, feedback channels, and career development pathways. Similarly, in Portugal, Ireland, and Macau, we’ve introduced initiatives to promote collaboration, recognition, and personal growth, ensuring all employees experience a sense of belonging and purpose.  The actions we take are closely monitored, and every improvement is shared openly across all locations, fostering a culture of trust, transparency, and celebration that connects and empowers our workforce.  How are you working to attract and retain top talent in the competitive pharma industry?   We continuously strive to strengthen our reputation as an employer of choice. Participating in TEI allows us to have an independent assessment of our HR efforts and initiatives, ensuring that we are continuously improving and aligning with best practices. In addition, we have robust referral programs in place, supported by the fact that over 70 percent of our employees are strong promoters of the company. This is a testament to the positive culture we’ve built, and we are focused on leveraging this strength to attract and retain top talent.  In what ways does the company communicate and reinforce its core purpose and values among employees?   Our motto is “In it for life” – so, for example, every year we celebrate in each site our “Victory Over Diseases” by communicating the new products that we are manufacturing, as well as the new patents and innovative ideas that contribute to fighting diseases and improving global health. Contributing to saving the lives of billions of people worldwide is a way to motivate our people to challenge themselves and push the limits of innovation. By celebrating our achievements and their impact, we inspire our teams to think creatively, embrace new challenges, and contribute to solutions that make a real difference in the world. It´s an invitation to live our purpose.  Macau was the first site in the region to earn Top Employer certification last year and has renewed it this year. What unique challenges and successes have been experienced in achieving and maintaining this status in Macau?   Macau is unique. It’s the only site in this industry in the territory, so we have taken advantage of that to differentiate ourselves as an employer by collaborating with universities and local authorities to offer career opportunities and benefits that are a reference in the region.  What areas have you identified for continuous improvement in workplace practices and employee satisfaction in the future?   We will continue to strengthen our employee value proposition by mapping the employee journey and addressing every touchpoint to enhance the overall experience. Both people and business needs are constantly changing. It requires continuous adaptation of processes to meet evolving expectations. 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