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2015-05-21

ThromboGenics NV: ThromboGenics Q1 2015 Business Update

REGULATED INFORMATION

New clinical studies for
JETREA®
confirm positive OASIS results:
28 days post injection resolution rates ranging from around 40% to 58%

New JETREA®ready-diluted formulation received final EU approval

Philippe Vlerick nominated Non-Executive Director ThromboGenics NV

Highlights

JETREA®in the US

* ThromboGenics reported positive top-line results from the OASIS study. This
randomized controlled study met its primary endpoint with 41.7% of patients
treated with JETREA®achieving VMA resolution at day 28 post injection
compared with only 6.2% of patients who received a sham injection
(p<0.001). This was a positive result which is in line with the
JETREA®real-world experiences of the retina community and more favourable
than the results of the pivotal Phase III program where VMA resolution was
seen in only 26.5% of patients. The study also showed that the
JETREA®safety profile in this 24 month follow-up study was consistent with
the drug's overall safety profile as known from the approved label
* ThromboGenics, and its partner Alcon, presented a number of new data
posters on JETREA®at the ARVO (The Association for Research in Vision and
Ophthalmology) meeting in Denver May 3-7. The majority of these posters
showed additional positive real world data on JETREA®, which provided
further important insights into the value that this novel medicine
provides, reinforcing the findings of the OASIS study

* ThromboGenics' sales team is focused on key accounts. These accounts
comprise retina specialists who have already achieved experience and
satisfactory clinical or real-world results with JETREA®. This approach is
designed to allow ThromboGenics to capitalize on the real-world data that
has and will continue to emerge during the course of 2015 to drive the
adoption of JETREA®

JETREA®outside the US

* A new ready-diluted formulation of JETREA®(ocriplasmin), which is easier to
use as it eliminates a dilution step in the product's preparation by
physicians, received a positive opinion from the CHMP in Europe in March.
This new formulation gained its final EU approval at the end of April.

* ThromboGenics' partner Alcon continues to gain new marketing and
reimbursement approvals and to execute commercial launches of JETREA®across
Europe and Rest of the World (RoW).
* JETREA®is now approved in 52 countries globally. Patients are being treated
and reimbursed in over 20 countries

Research&Development

* ThromboGenics is on track to recruit the first patient in its Phase IIa
clinical study assessing JETREA®for the treatment of diabetic retinopathy
(DR) before the end of 2015. DR is the second indication that ThromboGenics
is developing JETREA®for
* ThromboGenics has also announced the start of the evaluation and
development of JETREA®for the treatment of Retinal Vein Occlusion (RVO).
RVO is the third indication the Company will develop JETREA®for. The
Company has received an IWT grant to conduct pre-clinical research related
to this indication. RVO is known to be the second most common retinal
vascular disease, and thought to negatively impact the quality of life of
16 million patients worldwide

Corporate

* ThromboGenics' spun out its oncology research activities into a new company
Oncurious NV of which ThromboGenics is the majority shareholder. This
company has been created in conjunction with theVIB (Flanders Institute for
Biotechnology). This new venture is initially focusing on developing TB-403
for the treatment of medulloblastoma, the most common form of brain cancer
in children

Appointments

* Dominique Vanfleteren was appointed as ThromboGenics Chief Financial
Officer (CFO) in January 2015
* Emmanuèle Attout was appointed Independent Non-Executive Director of the
Board of ThromboGenics NV on May 5, 2015
* Philippe Baron Vlerick was nominated as a Non-Executive Director of the
Board of ThromboGenics NV. It is expected that he will be appointed by an
extraordinary shareholders' assembly in June/July

Financial

* Cash and investments of €121.4 million as of the end of March 2015,
compared with €127.1 million at the end of December 2014
* On May 19, Philippe Baron Vlerick informed ThromboGenics that on May
14thhis ownership interest in ThromboGenics' share capital has exceeded the
3% threshold.

Leuven, Belgium - 21 May 2015 -
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic
medicines, today issues a business and financial update for the three months
ending 31 March, 2015.

ThromboGenics developed JETREA®, the first and only pharmacological treatment
indicated for an important sight-threatening condition, symptomatic
vitreomacular adhesion (VMA)/vitreomacular traction (VMT) as known in the US
and Europe respectively. Symptomatic VMA/VMT is a progressive,
sight-threatening condition that may lead to visual distortion, decreased
visual acuity and central blindness.

ThromboGenics' strategy is focused on:

* Driving the sales of JETREA®in the US
* Supporting Alcon to develop the sales of JETREA®outside the US
* Creating value by generating further real-world clinical data on the use of
JETREA®in its approved indication, confirming its efficacy and safety
profile.
* Evaluating and developing JETREA®in new indications: Diabetic
Retinopathy&Retinal Vein Occlusion.
* Progressing its pipeline in earlier stage projects focused on developing
treatments for diabetes-related vitreo-retinal diseases

Dr Patrik De Haes, ThromboGenics' CEO, said: "The positive top-line results
from the OASIS study and real-world data that have been reported in recent
months gives us great confidence that we can demonstrate to the broader
retina community the clear benefits and value of using JETREA®. With our
US sales and marketing organization now fully focused on key accounts we
believe we are well placed to drive the adoption of JETREA®for the treatment
of the many patients with symptomatic VMA who could benefit from
pharmacological intervention.

"We are also looking to expand the medium term potential of JETREA®by
evaluating and developing it for two further important retinal diseases, DR
and RVO. These are two conditions where there is a clear unmet need for
improved treatment options. We are convinced that by developing JETREA®for a
broader range of indications we will help the global retina community to gain
a deeper understanding of this novel medicine and its potential to treat a
number of important vitreo-retinal diseases".

JETREA®in the US

ThromboGenics' U.S. commercial team is focusing its efforts on key retinal
accounts, which are typically clinics that have successfully treated patients
withJETREA®
over a longer period of time (12 - 24 months). Longer term experience and new
data - both efficacy and safety - are critically important in shaping a
retinal physician's perspectives on this novel pharmacological treatment
option for symptomatic VMA.

This longer term experience has helped those specialists build their own
clinical data sets and develop a good understanding of JETREA®'s efficacy,
safety and side effects. This knowledge and experience ultimately leads to
improved patient selection and improved treatment outcomes and in turn to
more patients being treated with this novel medicine.

ThromboGenics' commercial strategy is to build on these experiences by
reaching out to the broader ophthalmic community near those retina centers
which are using JETREA®on a regular basis. At the same time, ThromboGenics
and its partner Alcon, are working to ensure that real world data that is
being reported is appropriately communicated to the global retina community.

The generation of real world data is designed to support/reinforce the
findings of apost-hoc
data analysis of the Phase III program with JETREA®which has shown that
certain patient characteristics, such as a focal VMA (<1,500 µm) or the
absence of an epiretinal membrane (ERM), are independently associated with
successful VMA resolution.

In clinical practice, many retinal specialists have started to use these
criteria to select the patients with symptomatic VMA whom they treat with
JETREA®, leading to higher rates of VMA resolution.

Generating real-world JETREA®
data

ThromboGenics has already and continues to generate real-world data with
JETREA®as part of its commitment to ensuring that the most suitable patients
with symptomatic VMA are treated with this novel medicine. In addition, many
retinal practices are generating and publishing their own real-world data,
leading to an increasing body of knowledge on the clinical outcomes that
JETREA®can deliver.

OASIS study - Positive Top-Line Results

In April, ThromboGenics announced positive top-line results from its OASIS
study "Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion
including Macular Hole" with JETREA®(ocriplasmin).

The OASIS study (n= 220) is a randomized, sham controlled, double masked study
that followed patients for 24 months post injection. The study was designed
to provide long term and well-controlled efficacy and safety data for
JETREA®in patients being treated for symptomatic vitreomacular adhesion
(sVMA).

The OASIS study is the first controlled study with JETREA®since the results of
the pivotal Phase III program were announced in 2011. The study includes 24
month follow up data, the longest period patients have been studied
post-treatment with this novel medicine.

The key findings of the OASIS study were as follows:

* 41.7% of patients treated with JETREA®achieved VMA resolution at Day 28
post injection compared with only 6.2% of patients who received a sham
injection (p<0.001); and
* The JETREA®safety profile in this 24 month follow up study was consistent
with the drug's overall safety profile as known from the approved label. No
new types of safety events were identified.

The OASIS data compare favourably with the results from the pivotal Phase III
program with JETREA®where VMA resolution was seen in 26.5% of patients at Day
28 post injection. In the Phase III program 10.1% of patients treated with a
placebo injection achieved VMA resolution (p<0.001).

The OASIS data show the importance of improved patient selection in order to
generate higher rates of VMA resolution with JETREA®. Recent real world data
confirm that access to more advanced diagnostic technology, such as SD-OCT,
enables retina physicians to improve patient selection. As a result they have
been able to select p...

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