ThromboGenics Confirms JETREA® US Launch Date of Monday January 14th, 2013
LEUVEN, Belgium, January 4, 2013
LEUVEN, Belgium, January 4, 2013 /PRNewswire/ --
JETREA® US Price Set at USD 3,950 per Vial
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic
medicines, confirms its JETREA® US launch date of Monday January 14 ^th ,
JETREA® (ocriplasmin) Intravitreal Injection is a proteolytic enzyme indicated
for the treatment of symptomatic vitreomacular adhesion (VMA). The US
price for a single-use glass vial of JETREA® is set at USD 3,950.
Next week, Dr. Patrik De Haes, Chief Executive Officer of ThromboGenics , will
present during the 31st Annual J.P. Morgan Healthcare Conference from January
7 ^th to 9 ^th , 2013 in San Francisco, USA.
The ThromboGenics presentation will be held on Wednesday, January 9 ^th at
11.00 am PST (20.00 CET) at the Westin St. Francis Hotel in San Francisco. It
will include the Company's plans for launching JETREA® (ocriplasmin) in
January through its own U.S. commercial organization, which will mark a major
milestone for transforming ThromboGenics into a fully operational
biopharmaceutical company that provides innovative ophthalmic medicines.
JETREA® represents a paradigm shift and for the first time offers a
pharmacological treatment option to patients suffering with symptomatic VMA.
The U.S. Food and Drug Administration (FDA) approved JETREA® in October 2012
as the first pharmacological agent for the treatment of symptomatic VMA.
Symptomatic VMA is a progressive, sight-threatening condition that, when left
untreated, frequently leads to retinal distortion, further deterioration in
vision, and irreversible damage to eyesight. The recommended dose of JETREA®
is 0.125 mg (0.1 mL) of the diluted solution administered by intravitreal
injection to the affected eye once as a single injection.
The approval was based on the data from ThromboGenics' Phase III program where
JETREA® was shown to be superior to placebo for the treatment of symptomatic
VMA (26.5% versus 10.1%; p<0.01). Treatment with JETREA® was associated with
some, mainly transient, ocular adverse events.
Important safety and prescribing information about JETREA ® is available at
About JETREA ® (ocriplasmin)
JETREA ^® (ocriplasmin) is a truncated form of human plasmin that has been
approved by the U.S. Food and Drug Administration (FDA) for the treatment of
symptomatic VMA. JETREA ^® is a selective proteolytic enzyme that cleaves
fibronectin, laminin and collagen, three major components of the vitreoretinal
interface that play an important role in vitreomacular adhesion.
JETREA ^® has been evaluated in two multi-center, randomized, double-masked
Phase III trials conducted in the U.S. and Europe involving 652 patients with
vitreomacular adhesion. Both studies met the primary endpoint of resolution of
VMA at day 28. JETREA ^® 's Phase III program found that 26.5% of patients
treated with ocriplasmin saw resolution of VMA, compared with 10.1% of
patients receiving placebo (p<0.01). The Phase III program also showed that
JETREA ^® was generally well tolerated with most adverse events being
transient and mild in severity.
ThromboGenics is an integrated biopharmaceutical company focused on developing
and commercializing innovative ophthalmic medicines. The Company's lead
product, JETREA ^® (ocriplasmin), has been approved by the FDA for the
treatment of symptomatic VMA. The Marketing Authorisation Application (MAA)
for ocriplasmin is under review in Europe.
In March 2012, ThromboGenics signed a strategic partnership with Alcon
(Novartis) for the commercialization of JETREA ^® outside the United States.
Under this agreement, ThromboGenics could receive up to a total of €375
million in up-front and milestone payments. It will receive significant
royalties from Alcon's net sales of JETREA ^® . ThromboGenics and Alcon intend
to share the costs equally of developing JETREA ^® for a number of new
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor),
formerly referred to as TB-403, for the treatment of ophthalmic indications.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin,
NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext
Brussels exchange under the symbol THR. More information is available at
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking".
Such forward-looking statements are based on current expectations, and,
accordingly, entail and are influenced by various risks and uncertainties. The
Company therefore cannot provide any assurance that such forward-looking
statements will materialize and does not assume an obligation to update or
revise any forward-looking statement, whether as a result of new information,
future events or any other reason. Additional information concerning risks and
uncertainties affecting the business and other factors that could cause actual
results to differ materially from any forward-looking statement is contained
in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or
purchase of securities or assets of ThromboGenics in any jurisdiction. No
securities of ThromboGenics may be offered or sold within the United States
without registration under the U.S. Securities Act of 1933, as amended, or in
compliance with an exemption therefrom, and in accordance with any applicable
U.S. state securities laws.
For further information please contact:
ThromboGenicsWouter Piepers, Global Head of Corporate Communications
+32-16-75-13-10 / +32-478-33-56-32 email@example.com Dr. Patrik
De Haes, CEO +32-16-75-13-10 Patrik.firstname.lastname@example.org Chris Buyse, CFO
+32-16-75-13-10 Chris.email@example.com Citigate Dewe Rogerson David
Dible/ Nina Enegren/ Sita Shah +44-20-7638-9571 firstname.lastname@example.org The
Trout Group (US investor relations)Todd James/ Simon Harnest +1-646-378-2926
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