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SYNTHETIC OXYGEN CARRIERS (Blood Substitutes):
Opportunity Assessment of Three Leading Hemoglobin-Based
Products
Hemopure (Biopure), PolyHeme (Northfield) and Hemospan (Sangart)
October 10, 2005
As an individual with a specific interest in oxygen carriers –
blood substitutes – I invite you to purchase this definitive
examination of the prospects of three leading players in the race
to commercialize one of the true “holy grails” of human
medicine.
The Marketing Research Bureau specializes exclusively in market assessments
of human blood and blood-derived products, with over 25 years of experience
in this unique environment.
As you review the enclosed table of contents enclosed, you will quickly
recognize that this assessment thoroughly addresses and answers
the most important questions on your mind. But beyond this, I can
assure you that you will learn much more to help guide your planning
or investment decisions.
The complete report is available for $1,750. Without additional charge
for up to one hour, we would be happy to address any special questions
you may have.
I welcome your call or e-mail to inquire further about this newly
released report. To order, please fax (or mail) the enclosed order
form, or you may confirm your order by e-mail. We can ship your report
by overnight mail, to arrive next morning.
Sincerely,
Patrick L. Robert
President
THE MARKETING RESEARCH BUREAU, INC.
284 Racebrook Road
Orange, CT 06477
Tel: (203)799-0298
Fax: (203)891-8855
Or (203)387-2700
e-mail: mrb_ibpn@earthlink.net
| SYNTHETIC
OXYGEN CARRIERS (Blood Substitutes):
Opportunity Assessment of Three Leading Investigational Hemoglobin-Based
Products:
Hemopure (Biopure Corporation)
PolyHeme (Northfield Laboratories)
Hemospan/MP4 (Sangart, Inc.) |
October 2005
Contents
| Executive Summary |
1 |
| |
Product Characteristics |
1 |
| |
Safety-Related Findings in
Animal and Patient Studies |
2 |
| |
Efficacy in Patient Studies |
5 |
| |
Projected U.S. Approval and
Commercialization Prospects |
7 |
| |
|
| Biopure
Corporation |
10 |
| |
Introduction and
Historical Overview |
10 |
| |
Technology |
12 |
| |
Preclinical Studies |
15 |
| |
Early Clinical
Studies |
16 |
| |
Recent Clinical
Development Prior to Phase III U.S. Trial |
18 |
| |
The Pivotal U.S.
Phase III Orthopedic Surgery Trial |
20 |
| |
The Economics of
Hemopure in Elective Surgery |
25 |
| |
Approval of Hemopure
in South Africa |
26 |
| |
A Word About the Veterinary
Product: Oxyglobin |
27 |
| |
Safety Concerns with Hemopure
|
29 |
| |
Manufacturing Site |
33 |
| |
Recent Activity: December 2003
Through September 2005 |
34 |
| |
Conclusions |
36 |
| |
|
| Northfield
Laboratories |
38 |
| |
Program Background |
38 |
| |
Technology |
40 |
| |
Product Characteristics |
41 |
| |
Preclinical and Early Clinical
Testing |
42 |
| |
Biologics License Application
(BLA) Filing and Rejection |
47 |
| |
Elective Surgery Trial (Abdominal
Aortic Aneurysm) |
48 |
| |
1998 PolyHeme Study in 13 Trauma
Patients |
53 |
| |
A Dissection of the Phase III
Prehospital Trauma Trial |
56 |
| |
Walter Reed Hypotensive Resuscitation
Study in Rat Model |
62 |
| |
Rationale for In-hospital Administration
In Lieu of RBCs |
63 |
| |
Conclusions |
66 |
| |
|
| Sangart |
68 |
| |
Introduction |
68 |
| |
Product Characteristics |
69 |
| |
Viral Inactivation |
75 |
| |
Manufacturing Issues |
75 |
| |
Preclinical Studies |
76 |
| |
Clinical Development of Hemospan/MP4 |
77 |
| |
Commercialization Strategy |
79 |
| |
Conclusions |
81 |
PRINTABLE
ORDER FORM
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