ThromboGenics Business Update - Q3 2015
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Regulated information
ThromboGenics Business Update - Q3 2015
US organization adapted for break-even from 2016 onwards
Since launch, 20,000 patients treated globally with JETREA(®)
Diabetic Eye Disease clinical/ pre-clinical programs on track
Cash to support current development plans for the next 3 years
Highlights
JETREA(® )in the US
* ThromboGenics has adjusted the commercial strategy and composition of its US
organization to current market demand for JETREA(® )and to ensure it is
cash neutral in 2016
* Organization is focused on providing medical and scientific data-driven
support to the retina community and is supporting physicians' efforts to
enhance patient awareness of the options available for treating symptomatic
VMA
* On track for break-even from 2016 onwards
JETREA(® )outside the US
* 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 53 countries globally and reimbursement is
secured in over 20 countries
Research & Clinical Development
* ThromboGenics remains on track to initiate the CIRCLE study, a Phase II
study assessing JETREA(®)'s ability to generate a posterior vitreous
detachment (PVD) in patients with advanced diabetic retinopathy (DR) around
the year end of 2015
* A recent report from the American Academy of Ophthalmology projects that by
2020 there will be 1.34 million people in the US with vision-threatening DR
* A pre-clinical toxicity study with multiple injections of JETREA(®)
concluded that multiple doses of the drug, given at one month intervals,
were well tolerated. This is an important finding as ThromboGenics intends
to use multiple doses of JETREA(®) in the upcoming CIRCLE study. A poster
reporting this preclinical study was presented at the European Society of
Retina Specialists (EURETINA) conference in Nice 17-20 September
* New compounds with distinct mechanisms of action are under evaluation for
treatment of diabetic eye diseases
* ThromboGenics plans to host an R&D Investor Event in early 2016 at which the
Company will provide a review of its clinical and preclinical development
pipeline - focused on Diabetic Eye Disease
Oncurious
* Oncurious plans to commence a Phase I/IIa study with TB-403 in early 2016.
The study will assess TB-403 for the treatment of medulloblastoma, the most
common form of brain cancer in children
Appointments
* Baron Philippe Vlerick appointed Non-Executive Director of the Board of
ThromboGenics NV at an extraordinary shareholders' assembly that took place
on 20 August 20, 2015
Financial
* Cash and investments were ?106.6 million as of the end of September 2015,
compared with ?113.3 million at end of June 2015 and ?127.1 million at the
end of December 2014
* The current cash resources are expected to enable ThromboGenics to support
its business and development plans for at least the next 3 years.
Leuven, Belgium - 5 November 2015 - ThromboGenics NV (Euronext Brussels: THR),
an integrated biopharmaceutical company focused on developing and
commercializing innovative medicines for the treatment of vitreo-retinal
disorders, today issues a business and financial update for the nine months
ending 30 September, 2015.
ThromboGenics' strategy is focused on:
* Extending the clinical utility of JETREA: Developing JETREA in a significant
new indication - Diabetic Retinopathy
* Building a pipeline of next generation treatments for diabetic-related
vitreo-retinal disorders
* Commercializing JETREA (in first approved indication, sVMA/ VMT) in the US
and in the rest of the world via partner Alcon (Novartis) to reduce the
burden of sVMA on society, and to generate cash to fund our research
activities
* Within Oncurious NV, further develop TB-403 for treatment of medulloblastoma
Dr Patrik De Haes, ThromboGenics' CEO, said: "In recent months we have made a
number of important changes that are designed to ensure ThromboGenics' future
success and to generate returns for our shareholders.
We have reduced the size of our US organization and changed our commercial
strategy for JETREA® to ensure that our US business will become cash flow
neutral from 2016 onwards. While we remain convinced that in time JETREA® could
play a key role in a changed standard of treatment for patients with sVMA, this
will take time given it will be driven by a combination of new medical data and
increasing clinical experience.
We are continuing to invest in the clinical development of JETREA(® )in diabetic
retinopathy, a very significant next indication where there is a clear need for
improved treatment options. Our Phase II CIRCLE trial in this indication remains
on track to initiate around the end of this year.
Given our current cash resources of over ?100 million, the anticipated royalty
income from Alcon and our US organization on track to become cash flow neutral
from 2016, we believe that we can support our research and development
activities, which are focused on next-generation ophthalmology products for the
treatment of diabetic eye disease, over the next 3 years. During this period, we
are confident that we will be able to generate the clinical and pre-clinical
data needed to demonstrate the value of a number of our pipeline projects."
Commercial Activities
JETREA(®) in the US
In recent months, ThromboGenics has aligned the size of its US organization with
the current market demand for JETREA(®). The company also adjusted its
commercial strategy. ThromboGenics Inc. is now a lean customer-centric
organization that is continuing to supply JETREA(® )via a well-established
distribution network. The Company's US team is focused on providing medical and
scientific data-driven support to the retina community and is supporting
physicians' efforts to enhance patient awareness of the options available for
treating symptomatic VMA.
These changes will result in ThromboGenics' US operations being cash-flow
neutral from 2016 onwards.
OASIS study - Positive Top-Line Results
ThromboGenics announced positive top-line results from its OASIS study
"Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion including
Macular Hole" with JETREA(®) (ocriplasmin) in March 2015.
The OASIS study (n=220 patients) 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 24-month follow-up data is 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.
The OASIS data illustrate the importance of improved patient selection in order
to generate higher rates of VMA resolution with JETREA(®). It is known that an
epiretinal membrane (ERM) often adversely impacts the efficacy of JETREA(®).
Approximately 20% of the recruited patients in the OASIS study had an ERM
(despite it being one of the exclusion criteria, indicating the challenge of
accurately diagnosing this condition), suggesting that the 41.7% overall
resolution rate at day 28 post-injection could have been even higher. This
underscores the message that careful patient selection will lead to better
treatment outcomes.
Further analysis of the OASIS data will be shared with the retina community at
the upcoming American Academy of Ophthalmology (AAO) conference, Las Vegas,
November 14 - 17, 2015.
ORBIT study
In May, 6-month interim data from the "Ocriplasmin Research to Better Inform
Treatment" (ORBIT) study were presented in a poster at the Association for
Research in Vision and Ophthalmology (ARVO) conference in Denver, Colorado.
The data showed that 58.1% of patients experienced sVMA/VMT resolution within
one month post-treatment. The study also showed that the safety of JETREA(®) was
consistent with the product's label and the data from the Phase III clinical
trials.
JETREA(®) in Europe and RoW
Alcon is continuing to commercialize JETREA(®) in its RoW territory.
Research and Development Activities
Diabetic Retinopathy - A Substantial Potential New Indication for JETREA(®)
The Company is developing JETREA(® )for DR as part of its strategy to maximize
the value-creating opportunities for this novel drug and fill unmet medical
needs.
Research has shown that the presence of a posterior vitreous detachment (PVD),
where the vitreous is separated from the retina, may prevent the growth of new
blood vessels that are responsible for proliferative DR (PDR). This finding has
been reinforced by the fact that PDR is rare in patients who have a posterior
vitreous detachment.
The Company and its clinical advisors believe that by using JETREA(®) to
generate a PVD, the development of the new blood vessels that cause PDR can be
prevented as they are no longer able to use the vitreous as scaffolding in order
to grow along the surface of the retina or into the vitreous.
ThromboGenics remains on track to recruit the first patient into its planned
study in Non-Proliferative Diabetic Retinopathy which will be called CIRCLE
around the end of 2015.
The CIRCLE study will be a Phase II, randomized, double-masked, sham-controlled,
multi-center study that will evaluate the efficacy and safety of ocriplasmin in
inducing total posterior vitreous detachment (PVD) in subjects with non-
proliferative diabetic retinopathy (NPDR).
As part of the preparation for the start of the trial, ThromboGenics has
undertaken pre-clinical work in animal models to confirm the safety of multiple
doses of JETREA(®). These data, which showed that multiple doses of the drug
appeared to be safe, were presented in a poster at the European Society of
Retina Specialists (EURETINA) conference in Nice, France 17-20 September 2015.
A recent report from the American Academy of Ophthalmology has projected that
the prevalence of individuals with any form of diabetic retinopathy in the
United States in the year 2020 will be 6 million people, of whom 1.34 million
persons will have vision-threatening DR.
Retinal Vein Occlusion - Lysing blood clots with JETREA(® )
In April, ThromboGenics announced that it would be evaluating JETREA(® )for the
treatment of retinal vein occlusion.
This new vitreo-retinal project with JETREA(® )aims to demonstrate the potential
of using locally delivered ocriplasmin for lysing the blood clots (in the
retinal veins) that are responsible for this condition.
The first RVO in vivo tests have been completed, and results are currently being
processed. The Company intends to work towards a scientific publication of these
findings.
Pre-clinical Research
The Company presented three scientific posters on its ophthalmology research at
the European Association for Vision and Eye Research (EVER) conference which
took place in Nice, France 7-10 October 2015.
Oncurious NV - TB-403 Trial to Start in Early 2016
In April, ThromboGenics announced the formation of Oncurious NV, a new oncology
company that will develop TB-403 for the treatment of pediatric brain tumors.
TB-403 is a humanized monoclonal antibody against placental growth factor
(PlGF). PlGF is expressed in several types of cancer, including medulloblastoma.
High expression of the PlGF receptor neuropilin 1 has been shown to correlate
with poor overall survival. Medulloblastoma is a rare, life-threatening brain
tumor that mainly affects children.
Treatment with TB-403 in relevant animal models for medulloblastoma has
demonstrated beneficial effects on tumor growth (containment) and survival.
The favorable safety profile of TB-403 has already been demonstrated in clinical
trials in patients with other diseases.
Oncurious intends to initiate a Phase I/IIa program with TB-403 in
medulloblastoma patients with the first patient expected to be enrolled in early
2016.
Investor R&D Day
ThromboGenics plans to host an Investor R&D Event in early 2016 at which the
Company will provide a detailed review of its clinical and development pipeline.
Appointments
Baron Philippe Vlerick - Appointed Non-Executive Director
In May, Baron Philippe Vlerick was appointed as a non-executive member of the
Board of ThromboGenics NV. His appointment was confirmed at an extraordinary
shareholders' assembly that took place on 20 August 2015.
Philippe Vlerick is the owner, Chairman and CEO of several businesses in Belgium
and abroad. He currently serves as the Chairman and Chief Executive Officer of
Vlerick Group (Belgium). He also serves as the Chairman and CEO of UCO Textiles
NV. In addition, he is the Vice-chairman of KBC Group, Corelio, smartphoto Group
and Durabilis. Baron Vlerick is also a member of the Board of Directors of
Exmar, Hamon & Cie, Besix Group and I.V.C. (Belgium).
Mr. Vlerick holds a Degree in Philosophy and Law from the University of Leuven,
and an MBA General Management degree (PUB) (Ghent, Vlerick School of Management
- 1979). He also holds a Master's degree in Business Administration from Indiana
University, Bloomington (USA - 1980).
He was elected 2006 Manager of the Year by Trends, a leading business magazine
in Belgium. He was granted the title of Baron in 2008, and became Commander of
the Order of Leopold in 2013.
Financial review
At the end of September 2015, ThromboGenics had ?106.6 million in cash and
investments, compared to ?113.3 million at the end of June 2015 and ?127.1 at of
the end of December 2014.
ThromboGenics believes that with this cash, the anticipated royalty stream from
JETREA(®) and a re-organized US business, it has the financial resources to
support its activities for at least the next 3 years.
In September, Baron Philippe Vlerick informed the Company that his ownership
interest in ThromboGenics' share capital had increased to 6.4%.
On 14 July, Biggar Ltd notified the Company that its shareholding in
ThromboGenics NV had dropped below transparency notification level.
END
For further information please contact:
+---------------------------------------------+------------------------------+
| | |
| ThromboGenics | Citigate Dewe Rogerson |
| | |
| Wouter Piepers, | David Dible/Sylvie Berrebi |
| Global Head of Corporate Communications/ IR | |
| +32 16 75 13 10 / +32 478 33 56 32 | Tel: +44 20 7638 9571 |
| wouter.piepers(at)thrombogenics.com | David.Dible(at)citigatedr.co.uk |
| | |
+---------------------------------------------+------------------------------+
About ThromboGenics
ThromboGenics is an integrated biopharmaceutical company focused on developing
and commercializing innovative treatments for diabetic eye disease.
The Company's first product, JETREA® (ocriplasmin), has been approved in 53
countries across the globe. In the US, ThromboGenics is commercializing JETREA®
via its subsidiary ThromboGenics Inc. ThromboGenics signed an agreement with
Alcon, a division of Novartis, for the commercialization of JETREA® outside the
United States.
ThromboGenics is planning a Phase II clinical trial with JETREA® in diabetic
retinopathy. In addition to JETREA®, the Company is evaluating drug candidates
that could potentially deliver a number of next generation treatments for eye
disease.
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
www.thrombogenics.com.
About JETREA(® )(ocriplasmin)
JETREA(® )(ocriplasmin) is a truncated form of human plasmin. JETREA(®) acts as
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.
In the US, JETREA(®) is indicated for the treatment of symptomatic vitreomacular
adhesion. In Europe, JETREA(®) is indicated for the treatment of vitreomacular
traction (VMT), including when associated with macular hole of diameter less
than or equal to 400 microns.
JETREA(® )was 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. This 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.
In March 2015, ThromboGenics reported top line results from OASIS, a Phase IIIb
study. This randomized, sham controlled, double masked study followed-up
patients for 24 months post injection. In this study, retina physicians were
able to use SD-OCT to select patients with focal VMA and without Epiretinal
Membrane (ERM), two criteria which have been shown to lead to better treatment
outcomes with JETREA®. Despite this, OASIS data showed over 20% of the patients
recruited into study had ERM.
The trial showed that 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 that the drug's safety profile in the
24-month follow period was consistent with the drug's overall safety profile as
known from the approved label.
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.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(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: ThromboGenics NV via GlobeNewswire
[HUG#1964701]
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Datum: 05.11.2015 - 17:40 Uhr
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News-ID 432379
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