New Information on the Potential of Plasmin Shared at ISTH Congress

RESEARCH TRIANGLE PARK, N.C. & GENEVA--(BUSINESS WIRE)--Jul 11, 2007 - New information representing the continuing research and development program for Plasmin (Human), TAL-05-00018, was presented by Talecris Biotherapeutics, Inc. (http://www.talecris.com) this week at the XXIst International Society for Thrombosis and Haemostasis (ISTH) Congress in Geneva, Switzerland. The information included new data and updates on continuing research and development of Plasmin as a potential new thrombolytic to treat acute clotting disorders, such as peripheral arterial occlusion, deep vein thrombosis, and ischemic stroke.

Plasmin, which is derived from human plasma, is a unique locally-acting, fibrin-specific thrombolytic that can be infused directly into a clot via a catheter using minimally invasive techniques. "Plasmin, because of its local action and strong fibrin binding properties, has the potential to provide improvements when treating patients with acute clotting disorders," said Victor Marder, M.D., Chairman, David Geffen School of Medicine at University of California, Los Angeles (UCLA). "We look forward to plasmin's continued development as well as the continuing efforts to further characterize its possible advantages as a locally-acting thrombolytic."

Plasmin Posters Presented at ISTH 2007

1. PRIORITY Trial - Plasmin Revascularization of Acute Lower Extremity Native Artery or Bypass Graft Occlusion - Study Design (Abstract # P-S-691):

-- The Phase I/II PRIORITY trial has now enrolled three patients and is on target.

-- Data from the study will be used to select appropriate dosing to move into Phase III for treating patients with acute arterial peripheral occlusion (aPAO).

2. Safety results of the first clinical trial in humans of Plasmin to evaluate safety and establish effective dosing for Hemodialysis Graft Occlusion (Abstract #P-S-385):

-- Data from this study demonstrated a dose-related thrombolytic effect without an increase in dose-related adverse events. Specifically, no trend was seen for increased bleeding or thrombotic events with increasing Plasmin doses, and no trend toward a dose response was observed for adverse events. Additionally, there were no significant decreases in plasma fibrinogen.

3. New Animal Model Of Catheter-Selective Middle Cerebral Artery Thrombo-Occlusive Stroke: Demonstration Of Rapid Reperfusion By Local Plasmin Infusion

(Abstract # P-S-400):

-- Preliminary data utilizing a clinically-relevant animal model for human ischemic stroke will help guide clinical protocol development in this area.

4. Importance of Fibrin Binding for Therapeutic Efficacy of Direct Thrombolytics

(Abstract # P-S-383):

-- Valery Novokhatny, Ph.D., Research Fellow, Talecris Biotherapeutics, presented the company's ongoing biotechnology research efforts to develop a recombinantly-modified deletion mutant of plasmin, (delta) plasmin, ((delta)Pm), TAL-6003, working to optimize fibrin binding and fibrinolytic potency.

"As Talecris continues to develop Plasmin, we discover more about the diverse potential uses for this unique thrombolytic," said Alberto Martinez, M.D., President and COO of Talecris Biotherapeutics. "Plasmin represents another example of Talecris' R&D efforts to continue discovering and developing therapies that address unmet clinical needs."

Satellite Symposium: "Potential for Better Thrombolytic Therapy: Is Plasmin the Answer?"

Talecris also hosted a Satellite Symposium breakfast meeting at ISTH. "The symposium brings together recognized experts to discuss where we expect the next generation of thrombolytics to take us in terms of improved safety and effectiveness," said Program Chair of the Symposium, Gilbert C. White, M.D., Blood Research Institute in Milwaukee, Wisconsin. "Certainly Plasmin appears to have unique properties that could produce improved patient outcomes, and these are currently being evaluated in the clinic."

About Plasmin (Human), TAL-05-00018

Plasmin (Human), TAL-05-00018, is a plasma-derived thrombolytic protein currently under development by Talecris Biotherapeutics for treating acute peripheral arterial occlusion. Plasmin is a catheter-delivered, direct and locally acting, fibrin-specific thrombolytic with additional potential applications in other acute bleeding disorders including deep vein thrombosis and ischemic stroke. The plasmin molecule contains fibrin-binding domains not present in other direct thrombolytics. Plasmin is rapidly inactivated by alpha-2 antiplasmin when not bound to fibrin therefore minimizing risk of systemic bleeding.

(delta) plasmin, TAL-6003

Talecris scientists are utilizing biotechnology applications to produce modified Plasmin molecules that may exhibit improved fibrinolytic properties. (delta) plasmin ((delta)Pm), TAL-6003, is a simplified form of human plasmin where Kringle 1, which carries the fibrin and alpha-2 antiplasmin-binding site, is directly attached to the serine protease domain. Early research on this modified form of the plasmin molecule reinforces the importance of fibrin binding for its fibrinolytic potency. This attribute is critical for direct thrombolytics to maintain efficacy under dynamic flow conditions, i.e., not get washed away from the clot as blood flow begins to be restored.

About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.

Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.

Talecris, which earned revenues exceeding $1.1 billion in 2006, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 3,000 talented people worldwide.

To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.

Contact

Talecris Biotherapeutics
Lacy McMahon, 919-316-6316
Fax: 919-316-6673
lacy.mcmahon@talecris.com

Posted: July 2007

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