Navigation Links
Hovione's TwinCaps(R) Inhaler Delivers Successfully in Phase III Clinical Trials for Influenza
Date:9/8/2009

LOURES, Portugal, September 8 /PRNewswire/ -- Hovione is pleased to announce that its TwinCaps(R) 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(R), 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(R)) 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(R), 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(R) for the treatment and prevention of influenza infections. TwinCaps(R) 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(R) 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 more information about Hovione, please visit the Hovione site at http://www.hovione.com or contact Corporate Communications, Isabel Pina, +351-21-982-9362, e-mail: ipina@hovione.com.


'/>"/>
SOURCE Hovione
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients
2. New Analysis of Study Data Shows That Asacol(R) (Mesalamine) Delivers Rapid Symptom Relief for Ulcerative Colitis Patients
3. PARIs eFlow Delivers Alnylam RNAi Therapeutic in Phase II Study
4. VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma
5. VivoMetrics(R) Introduces Next Generation LifeShirt Prototype, a Smart Garment That Delivers Real-time Vital Signs Remotely to Healthcare Providers
6. Vtech(R) Delivers Todays Hottest Trends to Tech-Savvy Kids
7. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
8. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
9. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
10. YMed, Inc. Successfully Completes First Clinical Cases With Innovative VascuTraK(TM) II PTA Dilatation Catheter
11. New Study Shows LEVITRA Successfully Treats Erectile Dysfunction (ED) in Men with Dyslipidemia, Including High Cholesterol
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... 2016 , Net Sales of $1.90 billion ... the prior year period, and an increase of 1.2% on ... EPS for the first quarter were $0.52 reported, a decrease ... an increase of 29.9% over the prior year period ... guidance for 2016 Zimmer Biomet Holdings, Inc. (NYSE ...
(Date:4/28/2016)... , April 28, 2016 Oramed ... a clinical-stage pharmaceutical company focused on the development of oral ... in the upcoming PIONEERS 2016 conference, presented by Joseph ... 2016 in New York . Nadav ... at the conference. Presentation Details:   ...
(Date:4/28/2016)... April 28, 2016  ValGenesis, Inc., the ... Solutions (VLMS) today announced that a prominent ... sufferers of chronic kidney failure has selected ... their corporate validation process. The global medical ... solution to manage their validation processes electronically. ...
Breaking Medicine Technology:
(Date:4/30/2016)... , ... April 30, 2016 , ... ... Studios. With inMotion3D Abstract users can distort and manipulate three-dimensional shapes with ease ... rotation, columns, rows, ranks, point, lines, polygons, polygon texture animation, opacity texture animation, ...
(Date:4/30/2016)... ... April 30, 2016 , ... ... News on April 4th, 2016 questioned the use of the HyProCure sinus ... as “a controversial procedure.” EOTTS-HyProCure is a minimally invasive procedure performed, when ...
(Date:4/29/2016)... ... ... In an article published April 16th on the New York ... injections, which she underwent in order to feel more at home at this year’s ... article explains that Ms. Mirmelli’s situation is not unique; many plastic surgeons say they’ve ...
(Date:4/29/2016)... ... ... On Tuesday, April 26, 2016 members of the HomeTown Health network, a network ... on SB 258, the “Rural Health Care Relief” Bill. , The bill, which was ... individuals and corporations which donate directly to a “rural hospital” in Georgia, and goes ...
(Date:4/29/2016)... ... April 29, 2016 , ... Coast Dental Fort Stewart ... at its new location in the Exchange Furniture Mall at 112 Vilseck Road in ... 50-inch Samsung Smart TV. Plus attendees will have the opportunity to meet general dentists ...
Breaking Medicine News(10 mins):