FDA Advisory Panel endorses approval of Solesta(TM)
(Thomson Reuters ONE) -
Q-Med AB submitted in April, 2010, together with its partner Oceana
Therapeutics, a Premarket Approval (PMA) application for Solesta(TM) in the US.
Solesta is a product indicated for the treatment of fecal incontinence.
Representatives from Q-Med AB, Sweden, and Oceana Therapeutics met December
2(nd) with the FDA's Gastroenterology and Urology Devices Panel to discuss
clinical evidence for the use of Solesta in the treatment of fecal incontinence.
The FDA Advisory Panel voted 5-0, with one abstention, that the benefits of
Solesta outweigh its risks. The vote by the Advisory Committee essentially
endorses approval of Solesta for patients who have failed conservative therapy.
The FDA is expected to take the panel's recommendation into consideration during
the continued review process of the Solesta PMA.
Oceana and Q-Med have an exclusive partnership for the worldwide
commercialization rights to Solesta and Deflux®. Q-Med will continue to develop
and manufacture all products under this agreement. Oceana will focus on
continued global commercialization.
Queries should be addressed to:
Alexander Kotsinas, Vice President and CFO
Tel: +46 73 500 1111
Per Langö, Senior Director Corporate Development
Tel: +46 73 387 1521
Medical queries should be addressed to:
Dr Cindy Wong, Chief Medical Officer and Head of Medical Affairs
Tel: +46 73 387 1450
The information in this report is such as that which Q-Med is required to
disclose in accordance with the Swedish Securities Market Act. The information
was submitted for disclosure at 7.30 am CET on December 3, 2010.
Q-Med AB is a medical device company that develops, manufactures, markets, and
sells high quality medical implants for esthetic and medical use. The majority
of the products are based on the company's patented technology, NASHA(TM), for
the production of stabilized non-animal hyaluronic acid. The product portfolio
today contains: Restylane® for filling lines and folds, contouring and creating
volume in the face, Macrolane(TM) for body contouring, Durolane(TM) for the
treatment of osteoarthritis of the hip and knee joints, Deflux® for the
treatment of vesicoureteral reflux, VUR, (a malformation of the urinary bladder)
in children, and Solesta® for the treatment of fecal incontinence. Sales are
made through the company's own subsidiaries or distributors in over 70
countries. Q?Med today has about 650 coworkers, with almost 400 at the company's
head office and production facility in Uppsala, Sweden. Q-Med AB is listed in
the Mid Cap segment of the NASDAQ OMX Nordic.
Q-Med AB (publ), Seminariegatan 21, SE-752 28 Uppsala, Sweden. Corporate
identity number 556258-6882.
Tel: +46 18 474 90 00. Fax: +46 18 474 90 01. E-mail:info(at)q-med.com Web: www.q-
med.com
[HUG#1468522]
Press release PDF:
http://hugin.info/130306/R/1468522/406053.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Q-Med AB via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 03.12.2010 - 08:00 Uhr
Sprache: Deutsch
News-ID 49370
Anzahl Zeichen: 3752
contact information:
Town:
Uppsala
Kategorie:
Business News
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