Regulatory News:
OSE Pharma SA (Paris:OSE)(ISIN: FR0012127173; Mnémo: OSE), a
biotechnology company based in France, developing T specific
immunotherapy treatments against invasive and metastatic cancers,
is pleased to announce that it has signed an exclusive long term
agreement with RAFA laboratories in Israël for the registration,
marketing, distribution and sale of Tedopi®, today in phase 3
status in lung cancer.
“This collaboration represents a significant step as first
licensing and distribution agreement in the business development
strategy for OSE Pharma with pharmaceutical companies well
established in specific countries. RAFA has obtained a leading
position, long history in the pharmaceutical sector particularly in
orphan respiratory diseases and in oncology/supportive care The
long-standing relationships with Israeli key opinion leaders made
them an ideal partner for Israel and this substantial agreement has
been facilitated by our advanced clinical stage in NSCLC ” said
Dominique Costantini, Chief Executive Officer.
OSE Pharma is launching its phase 3 in Non-small cell lung
cancer in 2015 in the USA (Orphan status obtained in NSCLC patients
HLA-A2 Positive) and in Europe (product considered as personalized
medicine) and plan to have the results in 2018. The company plans
other phase 2 clinical trial for other cancers alone or in
combination with other immunotherapy or targeted therapy.
“We are delighted of this first licensing and distribution
agreement with a renowned pharmaceutical company, validating the
potential of Tedopi® in NSCLC and other cancer indications”, adds
Alexis Peyroles, OSE Pharma’s Chief Financial Officer.
Under the terms of the distribution agreement, RAFA will
submit the drug for approval in Israel, market and distribute it in
the territory for a long term period. RAFA will pay an upfront and
milestone payments based on the future development of the product
in addition to equally sharing the profit of Tedopi®’s sales in
Israel.
ABOUT OSE PHARMA
OSE Pharma is a European cancer immunotherapy company with a
multi-epitope technology named Memopi® that directs the body’s
immune system to generate a specific cytotoxic T response to
prevent cancer cell growth.
OSE Pharma’s lead product, Tedopi®, combines 10 “neo-epitopes”
directed against five tumour associated antigens. In its most
advanced application, it is about to enter a pivotal Phase III
study in patients with advanced non-small cell lung cancer (NSCLC)
who express HLA-A2 and failed first line therapy. Tedopi® has
orphan drug status in the USA and is considered as personalized
medicine in Europe in HLA-A2 positive patients.
OSE Pharma is also planning a new Phase II clinical trial in
combination with another immunotherapy treatment in NSCLC.
Tedopi® targets five tumour associated antigens (TAA), selected
because their presence is linked to a poor prognosis and the
severity of various cancers. Tedopi® contains ten optimized
epitopes, or “neo- epitopes”, designed on the binding of HLA-A2 and
TCR. These neo-epitopes generate strong specific T cytotoxic
responses that fight cancer and prevent tumour escape.
ABOUT RAFA Laboratories
RAFA Laboratories, Ltd. is a pharmaceutical company specializing
in the manufacture and marketing of medicines in the Israeli
market since 1937. The company strives to supply Israeli patients
and physicians with state of the art quality medicines and medical
devices for the improved treatment of medical conditions and a
better quality of life for patients.
The company manufactures and/or markets a wide variety of
medication from Over-the-Counter medicines (OTC) to treatments for
rare pulmonary diseases like pulmonary arterial hypertension,
treatment of pain especially chronic and cancer pain and
supportive care treatment through international pharma corporation
agreements.
RAFA markets its products to the entire Israeli health market
including the health funds (health maintenance organizations),
hospitals, the government and private pharmacies.
RAFA is proud to be a pharmaceutical manufacturer operating in a
competitive market that includes other local manufacturers and
multinational corporations.
Today RAFA Laboratories, Ltd. employs about 260 employees,
more than half of whom are academically qualified.
OSE PHARMA: a new T specific immunotherapy weapon against
advanced cancers
- Immunotherapy in oncology is
becoming a clinical reality and raises hope for patients by
mobilizing their own immune defence to fight against cancer.
- For OSE Pharma’s lead product
Tedopi®: the Phase 3 clinical programme is scheduled in 2015
and will be active in Europe and in the USA, in order to obtain
registration in non-small cell lung cancer. The study will recruit
patients with invasive/metastatic non-small cell lung cancer
(NSCLC), expressing the HLA-A2 receptor (45% of the NSCLC
population).
- Tedopi® is a patented combination of 10
epitopes. The epitopes (small peptides triggering immune response)
are optimized. They have been selected and modified for a stronger
binding with immune response receptors (HLA-A2 and TCR). These
neo-epitopes trigger a stronger immune response and target 5 tumor
associated antigens expressed in several cancers.
- Tedopi® will enter in new therapeutic
combinations in Phase 2 studies with industrial partnerships (other
immunotherapy treatments or targeted therapies) to increase
clinical efficacy while maintaining high quality of life with
late-stage patients.
- Tedopi® has been granted “orphan drug”
status in the USA and is considered a personalised medicine in
Europe, enabling accelerated clinical development.
PIVOTAL PHASE 3 STUDY IN LUNG CANCER LAUNCHED IN 2015 IN
EUROPE AND IN THE USA
Tedopi® has been tested in a phase 2 study in patients with
non-small cell lung cancer1 (NSCLC- the most common form of lung
cancer). These patients were HLA-A2 positive, had an invasive or
metastatic disease and had received at least one previous line of
treatment. The results of this phase 2 trial showed that Tedopi®
generated a significant increase in the survival times of patients
with NSCLC, which correlates with immune response.
This study showed a one year survival rate of 59% for the group
treated with Tedopi®. This compares favourably with the 33% one
year survival rate in patients treated with currently approved
second line treatments2. The median survival in the group treated
was 17 months, compared with 12 months in the group of patients who
did not receive the treatment. In addition, 25% of patients treated
were still alive after 4 years, with a good quality of life, which
is important for patients suffering from principally metastatic
tumours3.
OSE Pharma is currently preparing to start a phase 3 study of
Tedopi®. The trial protocol is common to Europe and to the USA. The
launch of the Phase 3 study of Tedopi® is planned for the second
half of 2015.
It will look to enrol 500 patients with invasive/metastatic
non-small cell lung cancer (NSCLC), expressing the HLA-A2 receptor.
Tedopi® will be used as a second line treatment for patients for
whom first line treatments (such as chemotherapy) have not been
able to control their disease. Preparatory works and manufacturing
of the clinical supplies have started. An agreement has been signed
in January 2015 with Orion-Symbec, CRO based in Great-Britain for
this international Phase 3 study.
ADVANCED LUNG CANCER: A STRONG MEDICAL NEED
Lung cancer is the deadliest cancer in the world. In 2012, there
were 1.58 million new diagnosed lung cancer cases and 1.39 million
deaths from this disease globally4. Despite the different
treatments available today (surgery, radiotherapy, chemotherapy,
targeted therapy), the relative survival rates of these patients at
metastatic stage remains very low3.
Given the large incidence of NSCLC, OSE Pharma estimates that
the potential global sales at peak for Tedopi® for this single
indication could be about €2 billion4.
Disclaimer:
This press release may expressly or implicitly contain
forward-looking statements relating to OSE Pharma and its activity.
Although OSE Pharma’s management believes that the expectations
reflected in these forward-looking statements are reasonable,
investors are cautioned that such statements are related to known
or unknown risks, uncertainties and other factors that could lead
actual results, financial conditions, performance or achievements
to differ materially from OSE Pharma’s results, financial
conditions, performance or achievements expressed, projected or
implied by such information and forward-looking statements.
Other than as required by applicable law (article 223-1 et seq
of the General Regulation of the AMF), OSE Pharma issues this press
release at the date hereof and does not undertake any obligation to
update or revise any forward-looking information or statements.
These risks and uncertainties include among other things, the
uncertainties inherent in future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such
as the FDA or the EMA, regarding whether and when to approve any
drug, and other matters that could affect the availability or
commercial potential of such product candidates, the absence of
guarantee that the product candidates if approved will be
commercially successful, the future approval and commercial success
of therapeutic alternatives,
1 NSCLC– 88% of lung cancers2 (Cielanu T et al 2012) (Hanna N et
al 2004) (Garassino MC et al 2013)3 Overall survival rate after 5
years: 1% for metastatic cancers – American Cancer Society –
22/05/20134 Based on independent studies, source international
epidemiologic data, Globocan 2012
For a description of risks and uncertainties which could lead to
discrepancies between actual results, financial condition,
performance or achievements and those contained in the
forward-looking statements, please refer to Chapter 4 "Risk
Factors" of the company’s Documents de Base filed with the AMF
under number I. 14-056 on September, 17th 2014 and Chapter 2 "Risk
Factors related to the Offer" in the prospectus approved by the AMF
under number 15-078 on 6th March 2015, which can be found on the
websites of the AMF (www.amf-france.org) and of OSE Pharma
(www.osepharma.com).
Press
ContactsOSE Pharma saDominique Costantini,
CEOdominique.costantini@osepharma.comMob +33 6 13 20 77 49orAlexis
Peyroles, CFOAlexis.peyroles@osepharma.comMob : +33 6 11 51 19
77orCitigate Dewe Rogerson Laurence Bault / Lucie
Larguier+33 1 53 32 84 78laurence.bault@citigate.fr orHB
ComCorpFlorence Portejoie / Anne Hardy+33 6 88 84 81 74
-fportejoie@comcorp.fr
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