ThromboGenics Q1 2015 Business Update
(Thomson Reuters ONE) -
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 the VIB (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 14(th)
his 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
with JETREA(® )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 a post-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 patients with focal VMA and an absence of Epiretinal
Membrane (ERM), two criteria which have been shown to lead to better treatment
outcomes with JETREA(®).
It is known that an ERM adversely impacts the efficacy of JETREA(®).
Approximately 20% of the recruited patients in the OASIS study had an epiretinal
membrane (ERM) (despite it being one of the exclusion criteria), suggesting that
the 41.7% overall resolution rate at day 28 post-injection could have been even
higher. This underscores the message that proper patient selection will lead to
better treatment outcomes.
Further analysis of all of the OASIS data, which will be interpreted with the
help of retina physicians, is ongoing. The results from these analyses are
planned to be shared with the retina community at the American Academy of
Ophthalmology conference of November 14 - 17, 2015.
ORBIT study
In March 2014, ThromboGenics launched the "Ocriplasmin Research to Better Inform
Treatment" (ORBIT) study.
This prospective, observational study is designed to assess clinical outcomes
and the safety of JETREA(® )administered in a real-world setting for the
treatment of symptomatic VMA by assessing both anatomical and functional
outcomes.
The study is looking at a number of parameters including resolution of VMA, full
thickness macular hole (FTMH) closure, changes in visual acuity (VA) and
occurrence and time to vitrectomy. It will also monitor adverse drug reactions
(ADRs) and changes from baseline in ocular signs and symptoms over time, such as
metamorphopsia. These data will further characterize the efficacy and safety
profile of the product.
Patients will be followed for up to 12 months following a single treatment with
JETREA(®). The ORBIT study is due for completion in mid-2016.
Six month data from the ORBIT study, were presented in a poster at the
Association for Research in Vision and Ophthalmology (ARVO) meeting May 3-7 in
Denver, Colorado.
The study showed that 58.1% of patients experienced 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.
More JETREA(® )real-world data was the subject of several scientific posters
presentations that were delivered at the recent (ARVO) 2015 meeting, which took
place in Denver from May 3-7.
The results outlined in these posters were consistent with those from previous
real world analyses and with the top line data from the OASIS study.
The posters showed VMA resolution 28 days post injection with JETREA(®) ranged
from around 40% to as high as 58.1% demonstrating that physicians have started
using criteria such as focal VMA and an absence of ERM when selecting patients
for treatment with this novel medicine.
All of the JETREA(®) posters that were presented at ARVO can be accessed using
the following link: http://www.arvo.org/webs/am2015/abstract/166.pdf
Education of the Wider Ophthalmic Community on Symptomatic VMA
ThromboGenics has begun implementation of a new program to educate general
ophthalmologists and optometrists about symptomatic VMA. Patients who first
notice the symptoms of VMA often have the initial discussion about their
condition with their general ophthalmologist or optometrist, and this program is
intended to help these front-line eye care practitioners decide whether
symptomatic VMA patients should be considered for referral to a specialist
retina clinic with JETREA(®) experience.
A number of seminars in this program have already taken place with a total of
more than 1,000 ophthalmologists and optometrists participating.
JETREA(®) in Europe and RoW
ThromboGenics' partner Alcon is continuing to commercialize JETREA(®) across
Europe using a similar commercial approach to that being used by ThromboGenics
in the U.S. - i.e. a focus on key retinal accounts.
In March 2015, the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion for a new ready-
diluted formulation of JETREA(®).
Meanwhile, the new JETREA(®) ready-diluted formulation gained final EU approval
in late April.
The forthcoming introduction of the new formulation of JETREA(®) will eliminate
the preparatory dilution steps prior to injection. At the point of
administration into the eye, the strength, potency, composition and
pharmaceutical form of the ready-diluted formulation remain identical to the
currently available formulation after dilution.
Regulatory Update
In February, JETREA(®) was granted approval in Argentina, Israel and the
Philippines.
In April, JETREA(®) was granted approval in New Zealand. This was the product's
52(nd) approval globally.
Research & Development Update
Diabetic Retinopathy - 2(nd) Indication for JETREA®
ThromboGenics remains on track to start its planned Phase IIa trial with
JETREA(® )in diabetic retinopathy. This study is designed to assess the utility
of the product in this significantly underserved patient population.
ThromboGenics intends to enroll the first patient into this study in the second
half of 2015.
Retinal Vein Occlusion - 3(rd) Indication for JETREA®
In April, ThromboGenics announced that it would be evaluating and developing
JETREA® for the treatment of retinal vein occlusion. RVO is the third indication
ThromboGenics has underway for JETREA® (ocriplasmin).
With this new vitreo-retinal project, ThromboGenics aims to demonstrate the
potential of using locally delivered ocriplasmin for lysing the blood clots (in
the retinal veins) that are responsible for this sight threatening condition.
In support of this research, ThromboGenics has secured a ?0.6 million grant from
the Flemish Agency for Innovation by Science and Technology (IWT). ThromboGenics
will use this grant to evaluate ocriplasmin's ability to lyse the clots that
cause RVO by local intravenous administration of this thrombolytic agent in pre-
clinical models of the disease. ThromboGenics will collaborate with the
Ophthalmology Department of the University Hospital UZLeuven in Belgium on this
study.
The IWT grant will also support a partnership with the Mechanical Engineering
Department of the KU Leuven. The Department is developing a robotics-assisted
system which has the ability to deliver the local administration of ocriplasmin
directly in the retinal veins.
At present, there are no treatment options for clearing clots from the retinal
veins of RVO-patients.
Corporate
Oncology R&D transfer into new company
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.
Oncurious is a joint venture between ThromboGenics and VIB, the leading life
sciences institute in Flanders (Belgium). ThromboGenics is the majority
shareholder.
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 tumour growth and survival.
The favourable safety profile of TB-403 has already been demonstrated in
clinical trials in patients with other diseases.
Oncurious will initiate a Phase I/IIa program with TB-403 in medulloblastoma
patients with the first patient expected to be enrolled by the end of 2015.
BioInvent International will act as a co-development partner.
Appointments
Philippe Baron Vlerick - Nominated Non-Executive Director
In May, Philippe Baron Vlerick has been nominated as a new Non-executive member
of the Board of ThromboGenics nv.
It is expected that Mr Vlerick will be appointed by an extraordinary
shareholders' assembly in June/July.
Philippe Vlerick is 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 (PUB) (Ghent, Vlerick School of Management -
1979). He also holds a Masters 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.
Emmanuèle Attout - Appointed Non-Executive Director
In January, ThromboGenics nominated Emmanuèle Attout to be its new Independent
non-executive director. Mrs. Attout was appointed during the ThromboGenics
Annual Shareholders Meeting of May 5, 2015. She will also join the Audit
Committee of the Company.
Mrs. Attout has been an audit partner at PricewaterhouseCoopers since 1994. She
has been in charge of the audits for a wide range of clients, including in
recent years being in charge of the audits of publicly listed pharmaceutical
companies and life sciences businesses.
Dominique Vanfleteren - Appointed Chief Financial Officer
Dominique Vanfleteren was appointed as ThromboGenics' new Chief Financial
Officer (CFO) in January 2015.
Dominique Vanfleteren has over 25 years of experience in senior finance,
operational, control and reporting roles with quoted international
biopharmaceutical companies. Before joining ThromboGenics, Mr. Vanfleteren
spent 12 years at UCB, where he held a number of international managerial
finance positions, the latest being the CFO of UCB's Asia Pacific Operations,
operating from Brussels and Shanghai. Prior to joining UCB, Dominique worked
for GSK for 16 years.
Financial review
At the end of March 2015, ThromboGenics had ?121.4 million in cash and
investments, compared with ?127.1 million at the end of December 2014.
Cash usage in the first quarter was far below the forecast of ?11 million per
quarter partly due to positive impact of a reduction in receivables and
favorable exchange rate effects which together amounted to ?2.9million.
ThromboGenics believes that it has the financial resources needed to sustain the
commercialization of JETREA(®) in the US, to research and develop new
indications and formulations of JETREA(®) for the US market, and to expand its
R&D pipeline as it delivers on its commitment to become a leading ophthalmology
company.
END
For further information please contact:
+---------------------------------------------+-------------------------------+
| | |
| ThromboGenics | Citigate Dewe Rogerson |
| | |
| Wouter Piepers, | David Dible/Malcolm Robertson |
| 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 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.
About ThromboGenics
ThromboGenics is an integrated biopharmaceutical company focused on developing
and commercializing innovative ophthalmic medicines. The Company's lead product,
JETREA(® )(ocriplasmin) was approved by the US FDA for the treatment of
symptomatic VMA and was launched by ThromboGenics in January 2013.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis,
for the commercialization of JETREA(®) outside the United States in 2012. To-
date JETREA(®) has been approved in over 50 countries globally.
JETREA(®) is currently being evaluated for two further indications, diabetic
retinopathy (DR) and retinal vein occlusion (RVO).
ThromboGenics is the major shareholder in Oncurious NV, a cancer focused company
that was formed in April 2015 in collaboration with VIB, a leading life science
institute in Flanders (Belgium). Oncurious was created to develop TB-403,
initially for medulloblastoma, the most frequent form of pediatric brain cancer.
ThromboGenics has retained the exclusive rights to use TB-403 for 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
www.thrombogenics.com.
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
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Datum: 21.05.2015 - 07:30 Uhr
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