J-Code for ThromboGenics' JETREA to Become Effective January 1, 2014
LEUVEN, Belgium, December 3, 2013
LEUVEN, Belgium, December 3, 2013 /PRNewswire/ --
Permanent J-Code J7316 will lead to streamlined reimbursement of JETREA® in
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic
medicines, announces that CMS (Center for Medicare and Medicaid Services) has
published the permanent HCPCS (Healthcare Common Procedure Coding System) code
for JETREA (ocriplasmin) J7316. The permanent J-Code for JETREA ^® will become
effective 1 January 2014.
The absence of a HCPCS code for JETREA ^® has meant that US physicians have
had to manually submit JETREA claims to payers following their use of this
novel treatment for symptomatic VMA (vitreomacular adhesion). This has led to
delays in reimbursement, and certain inefficiencies in use of financial
working capital at a retina practice management level. The permanent J-Code
will streamline the reimbursement process for retina practices and instil
higher reimbursement confidence. Recent market research conducted by
ThromboGenics has highlighted that the lack of a permanent J-Code is having an
adverse impact on the uptake of JETREA ^® .
Dr Patrik De Haes, CEO of ThromboGenics said, "We are extremely pleased that
the CMS has granted a permanent J-Code for JETREA ^® . We are confident that
the automation of the reimbursement process will be an important facilitator
in this novel product's uptake as US physicians will now be reimbursed for
JETREA ^® in a timelier and more efficient manner."
About JETREA ^® (ocriplasmin)
JETREA ^® (ocriplasmin) is a truncated form of human plasmin. In the US,
JETREA ^® is indicated for the treatment of symptomatic VMA. In Europe, JETREA
^® is indicated for the treatment of vitreomacular traction (VMT), including
when associated with macular hole of diameter ≤ 400 microns. 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 and oncology medicines. The
Company's lead product, JETREA ^® (ocriplasmin), has been approved by the US
FDA for the treatment of symptomatic VMA and was launched in January 2013.
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 vitreoretinal
In Europe, JETREA ^® is approved for the treatment of vitreomacular traction
(VMT), including when associated with macular hole of diameter less than or
equal to 400 microns. Alcon has launched JETREA ^® in the UK, Germany,
Finland, Denmark, Norway and Sweden. It has also recently introduced this
novel product in Canada.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor),
also referred to as TB-403, for the treatment of ophthalmic and oncology
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: Thrombogenics Wouter Piepers, Global
Head of Corporate Communications +32-16-75-13-10 / +32-478-33-56-32
Wouter.firstname.lastname@example.org Dr. Patrik De Haes, CEO +32-16-75-13-10
Patrik.email@example.com Chris Buyse, CFO +32-16-75-13-10
Chris.firstname.lastname@example.org Citigate Dewe Rogerson David Dible/ Sita Shah
Tel: +44-20-7638-9571 email@example.com The Trout Group (US
investor relations) Todd James/ Simon Harnest Tel: +1-646-378-2926
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