- BL-8030 is a pre-clinical, second-generation NS3 protease
inhibitor -
- CTTQ receives development and commercialization rights in China
and Hong Kong -
JERUSALEM--(BUSINESS WIRE)--Jun. 10, 2013--
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development
company, announced today that it has signed an out-licensing agreement
with Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), the
leading Chinese pharmaceutical company in the liver disease therapeutic
area, for the development and commercialization of BL-8030, an orally
available treatment for the Hepatitis C virus (HCV).
Under the terms of the agreement, BioLineRx will grant CTTQ exclusive
rights to develop, manufacture and commercialize BL-8030 in China and
Hong Kong. CTTQ will pay BioLineRx an upfront license fee, plus future
development, regulatory and commercialization milestones, for a total
potential deal value of approximately $30 million. In addition,
BioLineRx has the right to receive high single-digit royalties on future
sales of the drug. BioLineRx will retain the right to develop and
commercialize BL-8030 in other parts of the world. CTTQ will adhere to
FDA and EMA guidelines in pre-clinical development and manufacturing of
BL-8030. BioLineRx will have access to all development and regulatory
data generated by CTTQ, as well as the right to use this data for
commercialization and regulatory purposes in all areas of the world
outside of China and Hong Kong.
“We look forward to developing and commercializing BL-8030 with CTTQ,
the leading pharmaceutical company in China in the field of liver
diseases,” said Kinneret Savitsky, Ph.D., Chief Executive Officer of
BioLineRx. "We are proud that since in-licensing this promising
pre-clinical asset just over one year ago, we have found a strong
partner for the further development of BL-8030 in China, which is a
significant market in the HCV field. We believe that given CTTQ's
extensive experience in the liver disease area, it will swiftly advance
the development of BL-8030 at the highest global standards. In parallel
to collaborating with CTTQ to advance the drug, we intend to continue
discussions with relevant partners for this project in other parts of
the world.”
"We are excited to include BL-8030 as a new asset in our pipeline," said
Mr. Jian Sun Emba, President of CTTQ. "Unfortunately, the prevalence of
HCV is relatively significant in China, with reports of 3.2% of the
population (amounting to approximately 43 million individuals) suffering
from this chronic and debilitating disease. Thus there is a clear and
urgent need to develop new, safe and effective treatments for HCV
patients in China. After conducting a thorough due diligence process, we
sincerely believe that BL-8030, even though still in pre-clinical
development, has the potential to become an important addition to HCV
combination therapies."
Professor Philippe Halfon, world-renowned scientist for his work on HIV,
HPV (human papilloma virus causing cervical cancer) and Hepatitis, and a
co-inventor of BL-8030, said, "BL-8030 has shown promising results in
pre-clinical studies, and may become an important part of combination
therapies for HCV. Current treatments are only partially effective and
adverse effects are common, so there is a clear need for new drugs that
will be both safe and effective."
About BL-8030
BL-8030, an orally available treatment for Hepatitis C, is a potent and
selective second generation NS3 protease inhibitor. The NS3 protease is
essential for replication of the Hepatitis C virus and is an important
target for HCV therapies. BL-8030 has been shown to have excellent
antiviral activity, in the low nanomolar range, against a wide range of
HCV genotypes. Pre-clinical studies have demonstrated an improved
resistance profile against common protease inhibitor mutants, resulting
in a lower probability that the virus will develop resistance to
treatment. In addition, BL-8030 has demonstrated a good safety profile
in pre-clinical studies, exhibiting specificity only to the viral
protease and lack of activity against a relevant panel of human
proteases, as well as a clean profile versus human liver enzymes, which
is expected to lead to less drug-drug interactions. PK studies in
animals indicated the BL-8030 has good oral bioavailability, suggesting
the potential for once-daily dosing in the clinic.
In February 2012, BioLineRx signed a worldwide, exclusive license
agreement with Genoscience and RFS Pharma, LLC to develop and
commercialize BL-8030. BL-8030 was invented by Professor Philippe Halfon
and his team at Genoscience, and co-developed with scientists at RFS
Pharma, LLC. Prof. Halfon, Co-Founder and President of Genoscience, is a
specialist in molecular virology and infectious diseases, especially
HIV, HPV and Hepatitis. In addition he is the founder of several
biotechnology companies focusing on antiviral drug discovery and
development, including ACTgene, Alphabio and Genoscience. RFS Pharma was
founded in 2004 by Professor Raymond Schinazi; he currently serves as
the Frances Winship Walters Professor of Pediatrics at Emory University.
He is also a principal founder of Pharmasset Inc., Idenix Inc. and
Triangle Pharmaceuticals.
About Hepatitis C
Hepatitis C is a blood borne infection of the liver caused by the
Hepatitis C virus which becomes chronic in about 85% of cases. According
to the World Health Organization, up to 170 million people worldwide are
chronically infected with HCV. In addition, HCV infection is the leading
cause of liver transplantation and is a risk factor for liver cancer.
The Hepatitis C market is growing rapidly and is forecasted to reach $16
billion in 2015 in the seven major markets (US, France, Germany, Italy,
Spain, UK and Japan).
About CTTQ
Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), headquartered
in Nanjing and Lianyungang, Jiangsu Province, China, is a large
pharmaceutical manufacturer, integrating research, production and sales.
The company is one of the top 50 companies in China’s pharmaceutical
industry. CTTQ’s products are in a wide array of therapeutic areas,
including hepatitis, cancer, cardio-vascular, anti-virus, digestion,
respiratory and diabetes, with a particular emphasis on liver diseases,
where it is the leading Chinese company in that field. CTTQ is a
subsidiary of Sino Biopharmaceutical Ltd., a publicly traded company on
the Hong Kong Stock Exchange.
About BioLineRx
BioLineRx is a publicly-traded biopharmaceutical development company.
BioLineRx is dedicated to building a portfolio of products for unmet
medical needs or with advantages over currently available therapies.
BioLineRx’s current portfolio consists of seven clinical stage
candidates: BL-1040, for prevention of pathological cardiac remodeling
following a myocardial infarction, which has been out-licensed to Ikaria
Inc., is currently undergoing a pivotal CE-Mark registration trial;
BL-5010 for non-surgical removal of skin lesions has completed a Phase
1/2 study; BL-7040 for treating inflammatory bowel disease (IBD) has
successfully completed a Phase 2a trial; BL-8040 for treating acute
myeloid leukemia (AML) and other hematological cancers has commenced a
Phase 2 study; BL-1021 for neuropathic pain is in Phase 1 development;
BL-8020 for hepatitis C (HCV) has commenced a Phase 1/2 study; and
BL-1020 for schizophrenia. In addition, BioLineRx has five products in
various pre-clinical development stages for a variety of indications,
including central nervous system diseases, infectious diseases,
cardiovascular and autoimmune diseases.
BioLineRx’s business model is based on acquiring molecules mainly from
biotechnological incubators and academic institutions. The Company
performs feasibility assessment studies and development through
pre-clinical and clinical stages, with partial funding from the Israeli
Government’s Office of the Chief Scientist (OCS). The final stage
includes partnering with medium and large pharmaceutical companies for
advanced clinical development and commercialization. For more
information on BioLineRx, please visit www.biolinerx.com,
the content of which does not form a part of this press release.
Various statements in this release concerning BioLineRx’s future
expectations, including specifically those related to the development
and commercialization of BL-8030, constitute “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements include words such as “may,”
“expects,” “anticipates,” “believes,” and “intends,” and describe
opinions about future events. These forward-looking statements involve
known and unknown risks and uncertainties that may cause the actual
results, performance or achievements of BioLineRx to be materially
different from any future results, performance or achievements expressed
or implied by such forward-looking statements. Some of these risks are:
changes in relationships with collaborators; the impact of competitive
products and technological changes; risks relating to the development of
new products; and the ability to implement technological improvements.
These and other factors are more fully discussed in the “Risk Factors”
section of BioLineRx’s most recent annual report on Form 20-F filed with
the Securities and Exchange Commission on March 12, 2013. In addition,
any forward-looking statements represent BioLineRx’s views only as of
the date of this release and should not be relied upon as representing
its views as of any subsequent date. BioLineRx does not assume any
obligation to update any forward-looking statements unless required by
law.
Source: BioLineRx
KCSA Strategic Communications
Garth Russell / Todd Fromer
1
212-896-1250 / 1 212-896-1215
grussell@kcsa.com / tfromer@kcsa.com
or
BioLineRx
Tsipi
Haitovsky
Public Relations
+972-52-598-9892
tsipih@netvision.net.il