Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs and Zhejiang Hisun Pharmaceutical Enter License Agreement for Protectan CBLB612 Hematopoietic Stem Cell Stimulator and Mobilizer in China
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - September 9, 2009) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) and
Zhejiang Hisun Pharmaceutical Co. Ltd. (SHSE : 600267 ), a leading
pharmaceutical manufacturer in the People's Republic of China, today
announced the execution of a license agreement granting Hisun exclusive
rights to develop and commercialize Protectan CBLB612 in the People's
Republic of China.
Under the terms of the license agreement, Cleveland BioLabs will receive
upfront product development payments of $1.65 million. Zhejiang Hisun will
be responsible for all development and regulatory approval efforts for
Protectan CBLB612 in China. In addition, Zhejiang Hisun will pay Cleveland
BioLabs a 10% royalty on net sales over the 20-year term of the agreement.
This royalty may decrease to 5% of net sales only in the event that patents
for CBLB612 are not granted. Cleveland BioLabs will retain all rights to
CBLB612 in the rest of the world.
Protectan CBLB612 is a proprietary synthetic agent that acts as a potent
stimulator of hematopoietic stem cell proliferation and mobilization to
peripheral blood in both mice and non-human primates.
Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland
BioLabs, commented, "We are very excited about the commercial validation
provided by this license agreement for CBLB612. Zhejiang Hisun is a
leading manufacturer of oncology products for the Chinese market. Our
access to pre-clinical and clinical data generated by Hisun for Chinese
State Food and Drug Administration approval will provide valuable insights
for our own developmental efforts."
"We have established Protectan CBLB612's activity as a mitigator of
myelosuppression caused by cyclophosphamide (Cytoxan, Neosar, CTX) in mice,
as well as its ability to protect lethally irradiated mice and non-human
primates from radiation-induced mortality. In fact, many of our studies
with CBLB612 in mice and non-human primates showed favorable comparisons of
a single injection of Protectan CBLB612 to multiple injections of
granulocyte-colony stimulating factor or G-CSF (Neupogen®, Granocyte®,
Neulasta®), a common therapeutic approach for increasing the amount of
hematopoietic stem cells in blood," continued Dr. Fonstein.
"Protectan CBLB612 may play a significant role in improving treatment
options for people with cancer," commented Hua Bai, President and Chief
Executive Officer of Zhejiang Hisun. "Preliminary demonstrations of
CBLB612's potential as a powerful modulator of the immune system and
inducer of hematopoietic stem cells warrant further clinical studies as
part of Zhejiang Hisun's growing oncology drug pipeline. We believe a drug
with these properties would be extremely valuable to physicians and cancer
patients in China."
About Zhejiang Hisun Pharmaceutical Co. Ltd.
Zhejiang Hisun Pharmaceutical Co. Ltd., located in Taizhou Zhejiang, a
coastal city in southeastern China, was founded in 1956. Hisun has become a
leading API -- Active Pharmaceutical Ingredient -- manufacturer in China.
Hisun has about 3000 employees, one third of them scientific and technical
personnel. In year 2000, Hisun was listed as a public company on the
Shanghai A Share Stock Exchange. As one of the biggest manufacturing bases
of antibiotics and oncology products, Hisun is devoted to providing better
service to global clients with its strong R&D resources. For more
information, please visit the Zhejiang Hisun Pharmaceutical website at
http://www.hisunpharm.com/en/.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company
leveraging its proprietary discoveries around programmed cell death to
develop treatments for cancer and protection of normal tissues from
exposure to radiation and other stresses. The Company has strategic
partnerships with the Cleveland Clinic, Roswell Park Cancer Institute,
ChemBridge Corporation and the Armed Forces Radiobiology Research
Institute. To learn more about Cleveland BioLabs, Inc., please visit the
company's website at http://www.cbiolabs.com.
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Forward-looking
statements reflect management's current expectations, as of the date of
this press release, and involve certain risks and uncertainties. The
Company's actual results could differ materially from those anticipated in
these forward-looking statements as a result of various factors. Some of
the factors that could cause future results to materially differ from the
recent results or those projected in forward-looking statements include the
"Risk Factors" described in the Company's Annual Report on Form 10-K filed
with the Securities and Exchange Commission on March 30, 2009.