Navigation Links
Sosei Announces Successful Completion of AD 923 Pharmacokinetic,Study in the USA

TOKYO, May 22, 2007 /PRNewswire-FirstCall/ -- Sosei Group Corporation , a biopharmaceutical company, today announces the successful completion of a study of its fentanyl sublingual spray (AD 923), an opioid analgesic for the treatment of cancer breakthrough pain.

This was a pharmacokinetic Phase I single centre, open-label, single dose, cross-over, randomised study of AD 923 versus Actiq(R) (oral transmucosal fentanyl citrate lozenge) and versus fentanyl citrate injection. The study was conducted in healthy human volunteers, under an IND in the United States. All of the primary and secondary objectives of the study were achieved.

The more rapid absorption of fentanyl from AD 923 compared with Actiq(R) was statistically significant, with substantial plasma exposure seen within 10 minutes. The median Tmax (time to maximum plasma concentration) for AD 923 was 40 minutes compared with 120 minutes for Actiq(R). In addition, the higher absolute bioavailability of AD 923 compared with Actiq(R) was also statistically significant. Both formulations were well tolerated with no significant safety issues identified.

Sosei has reached agreement with EU regulatory authorities to move AD 923 directly into Phase III trials and plan to file a CTA (clinical trial application) in the second half of 2007. Following the outcome of this pharmacokinetic study the company will continue its discussions with the FDA regarding the detailed requirements for the Phase III programme in the USA.

Mr Shinichi Tamura, President & CEO of Sosei, said: "These data demonstrate that AD 923 has the potential to provide significantly faster onset of analgesia compared with existing therapy. Additionally, the higher absolute bioavailability indicates more predictable pain relief across the patient population. These factors together with the ease of administration will provide an optimised product with a rapid onset of ac tion, which is generally recognised as being the most important attribute in the treatment of cancer breakthrough pain. We now look forward to moving this product into Phase III studies."

Notes for Editors:

About Sosei

Sosei Group Corporation is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.

For further information about Sosei, please visit www.sosei.com

About AD 923

AD 923 is an optimised, sublingual formulation of the strong opioid analgesic fentanyl. It has been specifically designed to provide rapid onset of analgesia in a device that is easy to use by either the patient or their care giver. An additional benefit is the lockout system that prevents inadvertent overdosing. Sosei has concluded a range of studies that confirm the potential of this novel product.

In June 2006, Sosei entered into an agreement with Mundipharma International Corporation Limited for the development and commercialisation of AD 923 in Europe and other international markets, excluding North America and Japan. Sosei is currently evaluating its commercialisation options for the un-partnered territories.

About Cancer Breakthrough Pain

Cancer breakthrough pain is characterised by temporary exacerbations of moderate to severe pain in cancer patients that "breakthrough" their around-the-clock opioid treatments. Each episode may be spontaneous or incidental to an activity. It is estimated that the condition is prevalent in approximately 60% of cancer pain patients across Europe, the US and Japan, representing a total population size of 2.3 millio n. Most current treatments for cancer breakthrough pain are considered sub-optimal. The market seeks products which have a rapid onset of action and are easy to use. The current worldwide market for cancer breakthrough pain drug treatment is estimated to be worth $1.5bn and represents a growing market opportunity.

CONTACT: Sosei Group Corporation: Ichiban-cho FS Bldg., 8 Ichiban-cho,Chiyoda-ku, Tokyo 102-0082 Japan; Hiroki MAEKAWA, Representative ExecutiveOfficer, E-mail: , Tel: +81-3-5210-3399, Fax:+81-3-5210-3291; Sosei R&D Ltd : Chesterford Research Park, Saffron Walden,CB10 1XL England, John DAFFURN, SVP Corporate Development, E-mail:, Tel: +44-1799-532-350, Fax: +44-1799-532-351; FinancialDynamics: Julia Phillips, Tel: +44-207-831-3113; The Trout Group : ThomasFechtner, Tel: +1-646-378-2931; Brandon Lewis, Tel: +1-646-378-2915 hmaekawa@sosei.com daffurnj@sosei.com

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
2. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
3. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
4. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
5. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
8. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
9. Protox Announces Positive Clinical Data from Prostate Cancer Study
10. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
11. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/25/2017)... April 25, 2017 Endo International plc (NASDAQ: ... 2017. Members of its senior management team will host a conference ... a.m. ET. The dial-in number to access the ... 509-7598, and the passcode is 6086379. Please dial in 10 minutes ... A replay of the call will be available from May ...
(Date:4/24/2017)... England , April 24, 2017 ... development, today announced the addition of a major ... ,Validated In-situ Plate Seeding,). The VIPS has been ... and 384 well microplates as part of the ... system offers a simple and more reliable solution ...
(Date:4/20/2017)... 20, 2017  Cogentix Medical, Inc. (NASDAQ: CGNT), ... the Urology, Uro/Gyn and Gynecology markets with innovative ... has joined the Company as Senior Vice President, ... position, Mr. Keswani will report directly to ... "Our organization is delighted that Ash has joined ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... April 28, 2017 , ... Beginning in 2017, Ridgecrest Herbals will be phasing ... the popular ClearLungs Extra Strength formula. To ensure that the effectiveness of Clear Lungs ... ways:, , Removal of the homeopathic element , ...
(Date:4/28/2017)... New York, NY (PRWEB) , ... April 28, ... ... Shiel Medical Laboratory to expanded distribution of the GlycoMark test throughout the Northeast ... indicates recent hyperglycemia in patients with diabetes. The GlycoMark test provides a clinically ...
(Date:4/28/2017)... Fairfax, VA (PRWEB) , ... April 28, 2017 , ... ... elected volunteer board members and officers for 2017-2018. The annual board election process has ... serving on a volunteer basis. , Thomas C. Dickerson, Ed.D., FACHE, succeeds Jim Hamilton, ...
(Date:4/28/2017)... ... ... The Texas Cord Blood Bank (TCBB), a program of nonprofit biomedical organization GenCure, ... at Renaissance in Edinburg for their outstanding efforts in collecting umbilical cord blood donations ... , “Women’s Hospital at Renaissance has been a collection partner for the TCBB since ...
(Date:4/28/2017)... ... April 28, 2017 , ... People are starting to accept that hearing aids ... doesn’t have the stigma it had when great-grandpa wore his hearing aids years ago,” ... a NALA North American Speaker Series (NASS) segment. “He probably wore an ...
Breaking Medicine News(10 mins):