EXHIBIT 9.4
APPROVED PRESS RELEASE
Neose Signs R&D and Licensing Agreement with Wyeth-Ayerst First Commercial Use
of GlycoAdvance(TM) -- Novel Protein Glycosylation Technology
HORSHAM, Pa., Dec. 19 /PRNewswire/ -- Neose Technologies, Inc. (Nasdaq: NTEC -
news) today announced that it has entered into a research, development and
license agreement with Wyeth-Ayerst Laboratories, the pharmaceutical division of
American Home Products Corporation (NYSE: AHP - news), for the use of Neose's
GlycoAdvance(TM) technology to develop an improved production system for Wyeth's
biopharmaceutical compound, rPSGL-Ig (P-selectin glycoprotein ligand). rPSGL-Ig
is a P-selectin antagonist that is being developed to treat inflammation and
thrombosis associated with acute coronary syndrome and reperfusion injury. It is
currently being evaluated in Phase II clinical trials in patients being treated
for heart attack. Wyeth is evaluating the use of GlycoAdvance in the production
of rPSGL-Ig for Phase III clinical trials and commercial launch.
Neose will develop processes for the commercial-scale manufacture of proprietary
enzymes and sugar nucleotides to be used in the production of rPSGL-Ig, and will
license GlycoAdvance to Wyeth for commercial production of the drug. During
commercial production of Wyeth's current rPSGL-Ig, Neose will receive ongoing
payments tied to yield improvements achieved using GlycoAdvance in the
production of rPSGL-Ig. In addition, Wyeth has the option to use GlycoAdvance to
develop a next generation rPSGL-Ig, in which case Neose would receive royalties
on product sales.
Under the agreement, Neose will receive license, research, and milestone
payments that would total up to $17 million if all milestones are met. In
addition to ongoing product payments, Neose and Wyeth will also enter into a
supply agreement for the long-term supply of GlycoAdvance process reagents.
"We welcome Wyeth as our first commercial partner for GlycoAdvance and look
forward to contributing to the success of rPSGL-Ig," says Stephen Roth, Ph.D.,
Neose's Chairman and CEO. "Wyeth and Neose have worked together extensively to
show that GlycoAdvance can be applied to a drug in late stage clinical
development. We are particularly excited to be working with Wyeth, given their
significant investment in biopharmaceutical drug development, and their
commitment to being a world leader in biologics manufacturing."
"GlycoAdvance gives us an important competitive advantage that complements our
substantial and growing capital investment in manufacturing capacity," says L.
Patrick Gage, Ph.D., President, Wyeth-Ayerst Research. "Using GlycoAdvance with
rPSGL-Ig will help us launch the drug with manufacturing capacity in place to
supply the projected needs of our initial indication, while giving us the
flexibility to supply additional indications as they are developed."
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Background on GlycoAdvance
There are more than 360 biotechnology drugs in development for more than 200
diseases. Many of these drugs are glycoproteins -- proteins and antibodies that
include complex carbohydrates, or sugar chains, as an integral part of their
structure. In 2000, worldwide sales of protein and antibody drugs were about $20
billion. By 2010 worldwide sales are expected to exceed $90 billion. Many of
these drugs will be glycoproteins and may be appropriate candidates for
GlycoAdvance.
GlycoAdvance is Neose's proprietary enzymatic technology for completing the
carbohydrate chains on glycoproteins after they have been produced in a
biological expression system such as Chinese hamster ovary (CHO) cells.
GlycoAdvance uses a class of enzymes, glycosyltransferases, to add individual
sugar units onto the carbohydrate structures on glycoproteins. GlycoAdvance can
be used with glycoprotein therapeutics, including fusion proteins and monoclonal
antibodies, to extend half-life, increase effectiveness and improve
manufacturing efficiency.
Glycoproteins contain complex carbohydrate structures attached to the protein
portion of the molecule. These carbohydrates are integral to the structure and
function of a glycoprotein and help determine how long the drug stays active in
the body. Incomplete carbohydrate structures can result in the drug being
cleared from the body too quickly, or may result in the drug being less
effective. This means that a greater amount of the drug may be required to
achieve the intended effect.
Achieving and maintaining the proper carbohydrate structures on glycoproteins is
a major challenge in biotechnology manufacturing. Recombinant therapeutic
glycoproteins are produced in living cells, usually CHO cells. The use of cell
systems to produce glycoproteins requires balancing the cells' ability to
produce protein with their ability to put on the required carbohydrates. As the
cells' protein output increases, they do not maintain the proper level of
carbohydrates. This often results in low yields of usable product that adds to
the cost and complexity of producing these drugs. These low yields are a
significant contributor to the critical worldwide shortage of biologics
manufacturing capacity.
Background on rPSGL-Ig
Wyeth's rPSGL-Ig is a recombinant version of the human PSGL-1 glycoprotein,
linked to the Fc portion of a human antibody. PSGL-1 glycoprotein extends from
the surface of white blood cells, or leukocytes, and helps the cells bind to the
blood vessel wall in a process known as cell adhesion. PSGL-1 plays a critical
role in the migration of these cells from the bloodstream to the site of tissue
damage. This is an essential process in helping the body heal itself after an
injury. However, in some instances, it can be harmful. Immediately following a
heart attack, the leukocytes that attach to the damaged blood vessels exacerbate
local inflammation that causes additional tissue damage.
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rPSGL-Ig protects the site of tissue damage by preventing leukocytes and
platelets from adhering and causing inappropriate inflammation and/or
thrombosis. rPSGL-Ig is in Phase II clinical trials evaluating its ability to
help accelerate clot dissolution and prevent reperfusion injury following a
heart attack. rPSGL-Ig may also have use in solid organ transplantation and
arterial vascular diseases including stroke.
About Neose Technologies
Neose develops proprietary technologies for the synthesis and manufacture of
complex carbohydrates. The company uses its broad technology platform in the
following programs: GlycoAdvance for correcting incomplete or incorrect
glycosylation encountered in the manufacture of recombinant glycoproteins;
GlycoTherapeutics to develop and produce novel carbohydrate-based therapeutics;
and GlycoActives to develop and produce novel carbohydrate-based food
ingredients.
Conference Call/Webcast
A conference call and webcast will be held for the investment community on
Thursday, December 20, 2001, at 8:30 a.m. EST. The dial-in number for domestic
callers is 800-967-7140. The dial-in number for international callers is
719-457-2629. A replay of the call will be available for 7 days beginning
approximately four hours after the call's conclusion. The replay number for
domestic callers is 888-203-1112 using the passcode 421599. The replay number
for international callers is 719-457-0820, also using the passcode 421599. Live
audio of the conference call will be simultaneously broadcast over the Internet
through World Investor Link's Vcall website, located at http://www.vcall.com. To
listen to the live call, please go to the web site at least fifteen minutes
early to register, download, and install any necessary audio software. For those
who cannot listen to the live broadcast, a replay will be available shortly
after the call.
For more information, please visit http://www.neose.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of
1995: Statements in this press release that are not historical facts are
"forward-looking statements" that involve risks and uncertainties. Among the
risks are that the development of rPSGL-Ig using GlycoAdvance may not succeed,
or rPSGL-Ig may not receive regulatory approval or be commercialized
successfully. For a more detailed discussion of these risks and uncertainties,
any of which could cause the Company's actual results to differ from those
contained in any forward-looking statement, see the "Risk Factors" section of
Item 1 of the Company's Annual Report on Form 10-K for the year ended December
31, 2000.
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