BIOTIME ANNOUNCES REGULATORY APPROVAL OF HEXTEND (R) IN sOUTH KOREA; RECEIVES SECOND LICENSE FEE FROM CJ CORP.
BERKELEY, Calif., July 7 -- BioTime, Inc. (Amex:
BTX) today announced that its South Korean licensing partner CJ Corp. has
received regulatory approval from the Korea Food and Drug Administration
(KFDA) for Hextend(R), the Company's physiologically balanced blood plasma
volume expander. BioTime also announced that it has received the second of
two license fee installments from CJ Corp. The $300,000 license fee was paid
to BioTime in connection with CJ Corp.'s filing for regulatory approval to
manufacture and market Hextend in South Korea. CJ Corp. will now seek Korean
National Health Insurance pricing, which is necessary to commence marketing
Hextend. That process is expected to take approximately six months.
"CJ Corp. is a valued partner with deep marketing resources and
established pharmaceutical leadership," said Judith Segall, BioTime Vice
President of Operations, Office of the President. "We are pleased that CJ
Corp. has successfully concluded the regulatory approval process for Hextend,
and we are confident they will optimize sales and marketing initiatives for
the product in South Korea.
"Hextend's registration in South Korea marks a major step forward for
Hextend's entry into overseas markets," Ms. Segall added. "We chose South
Korea as our first overseas target market because of its strong trade
relationship with the U.S. and neighboring Asian countries. We have been
focusing a good deal of our attention to the Asian market as we seek to
fulfill the need in that region for safer and more effective plasma volume
expansion solutions."
CJ Corp. holds the exclusive license to manufacture and sell Hextend and
PentaLyte(R) in the Republic of Korea (South Korea) for human therapeutic
uses. The first license fee installment of $500,000 was paid to BioTime by CJ
Corp. during April 2003. Under the licensing agreement, BioTime will receive
a royalty on Hextend sales ranging from $1.30 to $2.60 per 500 mL unit,
depending upon the price approved by Korea's National Health Insurance.
Hextend is BioTime's proprietary physiologically balanced blood plasma
volume expander for treating the loss of blood volume during major surgery.
Hextend is manufactured and marketed in the U.S. and Canada by Hospira, Inc.
under an exclusive licensing agreement. The product is used in leading
hospitals, teaching universities, hospital chains and HMOs in North America,
and is the preferred resuscitation fluid of the U.S. Special Operations
Command.
PentaLyte is a pentastarch-based blood plasma volume expander similar in
formulation to Hextend. PentaLyte is more quickly metabolized than Hextend,
and is designed for use when short lasting volume expansion is desirable.
BioTime has completed a Phase I clinical trial of PentaLyte in the U.S. and
expects to commence a Phase II trial this year.
About BioTime, Inc.
BioTime, headquartered in Berkeley, California develops blood plasma
volume expanders, blood replacement solutions for hypothermic (low
temperature) surgery, organ preservation solutions and technology for use in
surgery, emergency trauma treatment and other applications. BioTime's lead
product Hextend(R) is manufactured and distributed in the U.S. and Canada by
Hospira, Inc. under an exclusive licensing agreement. Information about
BioTime can be found on the web at www.biotimeinc.com.
Forward Looking Statements
The matters discussed in this press release include forward-looking
statements which are subject to various risks, uncertainties and other factors
that could cause actual results to differ materially from the results
anticipated. Such risks and uncertainties include but are not limited to the
ability of BioTime and its licensees to obtain additional FDA and foreign
regulatory approval to market BioTime products; competition from products
manufactured and sold or being developed by other companies; the price of and
demand for BioTime products and the results of clinical trials of BioTime
products. Other risk factors are discussed in BioTime's Annual Report on Form
10-K filed with the Securities and Exchange Commission.
CONTACT: BioTime, Inc.
Judith Segall, 510-845-9535
or
Financial Relations Board
Kristen McNally, 310-407-6548
(Investor/Analyst Information)
kmcnally@financialrelationsboard.com