Perosphere and Daiichi Sankyo Enter into a Clinical Trial Agreement to Evaluate the Efficacy and Safety of PER977 to Reverse the Anticoagulant Activity of the Investigational, Oral, Once-Daily Factor

Mount Kisco, New York And Tokyo (ots/PRNewswire) -

Daiichi Sankyo to support and co-sponsor phase 1 Clinical Study

Perosphere Inc. and Daiichi Sankyo Company, Limited (hereafter,
Daiichi Sankyo) announced today that they have entered into a
clinical trial agreement under which Daiichi Sankyo will support and
co-sponsor a phase 1 clinical study testing the safety, tolerability
and effectiveness of PER977 to reverse the anticoagulant activity of
edoxaban, Daiichi Sankyo's investigational oral, once-daily, direct
factor Xa-inhibitor.[1 ],[2],[3]

PER977 is a synthetic, small new molecular entity being developed
by Perosphere that has been shown in pre-clinical studies to directly
bind to heparins as well as circulating direct factor Xa- and
IIa-inhibitors and therefore has the potential to reverse their
anticoagulant effect.[4],[5],[6],[7] PER977 does not bind to blood
coagulation factors or other blood proteins.[5] In pre-clinical
studies, PER977 has demonstrated the ability to reverse the
anticoagulant effects of direct factor Xa- and IIa-inhibitors in
vitro and ex vivo in animal and human models.[4],[6],[7] PER977
reverses anticoagulant activity within 30 minutes after intravenous
administration and has a clearance half-life of approximately 1.5
hours.[5]

"Novel oral anticoagulants were developed to help address the
limitations of older anticoagulant agents, such as the need for
frequent dose adjustments and monitoring," said Jack Ansell, M.D.,
Professor of Medicine, NYU School of Medicine, and an advisor to
Perosphere. "However, during severe bleeding or the need for
emergency intervention, there is no established therapy to reverse
the anticoagulant activity of these agents."

Edoxaban is an investigational, oral, once-daily anticoagulant
that specifically and reversibly inhibits factor Xa, which is an
important factor in the coagulation system that leads to blood
clotting.[1],[8] Edoxaban is currently approved only in Japan, since
April 2011, for the prevention of venous thromboembolism (VTE) after
major orthopaedic surgery, under the brand name Lixiana(R).

Elsewhere, including Europe and the U.S., edoxaban is currently in
phase 3 of clinical development and has not been approved. The global
edoxaban clinical trial program includes two phase 3 clinical
studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation
with Factor XA Next GEneration in Atrial Fibrillation), which are
evaluating edoxaban, administered once-daily, for treatment and
prevention of recurrence of VTE in patients with deep vein thrombosis
(DVT) and/or pulmonary embolism (PE), and for the prevention of
stroke and systemic embolic events (SEE) in patients with
non-valvular atrial fibrillation, respectively.[2],[3]

"Some potential reversal agents under evaluation for direct factor
Xa- and IIa-inhibitors are recombinant proteins or fully humanized
monoclonal antibody fragments," stated Dr. Solomon S. Steiner, CEO of
Perosphere. "PER977 is a synthetic agent that has the potential to be
an antidote for both direct factor Xa- and IIa-inhibitors as well as
heparins. In pre-clinical studies, PER977 has been shown to remain
stable for more than one year."

"The initiation of this study, in collaboration with Perosphere,
is an important next step in the development of edoxaban," said
Mahmoud Ghazzi, M.D., Ph.D., Executive Vice President of Drug
Development for the Americas and Chief Medical Advisor for Global
Drug Development, Daiichi Sankyo. "Given our focus on optimizing
patient care, the development of a reversal agent is a priority for
Daiichi Sankyo in the event one may be needed by physicians."

About Perosphere

Perosphere is a specialty pharmaceutical company with
internationally recognized drug delivery expertise. The company
identifies market opportunities where application of drug delivery
technology to a drug already on the market can create a new medical
use for that drug or enhance its safety, efficacy or ease of use.
Perosphere also selectively identifies and develops new chemical
entities and other therapeutics that can be used as "rescue" drugs.
PER977, a clinical-stage anticoagulant reversal agent for direct
factor Xa- and IIa-inhibitors, is Perosphere's lead drug candidate.
For more information, please visit http://www.perosphere.com.

About Daiichi Sankyo

The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging markets.
While maintaining its portfolio of marketed pharmaceuticals for
hypertension, hyperlipidemia, and bacterial infections, the Group is
engaged in the development of treatments for thrombotic disorders and
focused on the discovery of novel oncology and
cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo
Group has created a "Hybrid Business Model," which will respond to
market and customer diversity and optimize growth opportunities
across the value chain. For more information, please visit
http://www.daiichisankyo.com.

Forward-looking statements

This press release contains forward-looking statements and
information about future developments in the sector, and the legal
and business conditions of DAIICHI SANKYO, Co. Ltd and DAIICHI
SANKYO, Inc. Such forward-looking statements are uncertain and are
subject at all times to the risks of change, particularly to the
usual risks faced by a global pharmaceutical company, including the
impact of the prices for products and raw materials, medication
safety, changes in exchange rates, government regulations, employee
relations, taxes, political instability and terrorism as well as the
results of independent demands and governmental inquiries that affect
the affairs of the company. All forward-looking statements contained
in this release hold true as of the date of publication. They do not
represent any guarantee of future performance. Actual events and
developments could differ materially from the forward-looking
statements that are explicitly expressed or implied in these
statements. DAIICHI SANKYO, Co. Ltd and DAIICHI SANKYO, Inc. assume
no responsibility for the updating of such forward-looking statements
about future developments of the sector, legal and business
conditions and the company.

References

1) Ogata, K et al. Clinical Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy Volunteers. J
Clin Pharmacol. 2010;50:743-753.
2) Clinicaltrials.gov: NCT00986154. Comparative Investigation of Low Molecular
Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the
Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots (The Edoxaban
Hokusai-VTE Study). Available at: http://clinicaltrials.gov/show/NCT00986154.
[Last accessed: April 2013].
3) Clinicaltrials.gov: NCT00781391. Global Study to Assess the Safety and
Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in
Patients With Atrial Fibrillation (ENGAGEAFTIMI48). Available at:
http://clinicaltrials.gov/show/NCT00781391. [Last accessed: April 2013].
4) Laulicht, B et al. Small Molecule Antidote for Anticoagulants. Circulation.
2012:126;A11395.
5) Perosphere Inc. Data on File.
6) Bakhru, S et al. Small Molecule Antidote for Anticoagulants. Presentation at
the Thrombosis and Hemostasis Summit of North America, Chicago, Illinois, May 4, 2012.
Available at http://www.perosphere.com/pdf/PER977-THSNA-Presentation_Slides.pdf.
[Last accessed: April 2013].
7) Laulicht, B et al. Small Molecule Antidote for Anticoagulants. Presentation
at the American Heart Association Meeting, Los Angeles, California, November 5, 2012.
Available at: http://www.perosphere.com/pdf/PER977_AHA-presentation.pdf. [Last
accessed: April 2013].
8) Comp, P. Selective Factor Xa Inhibition Improves Efficacy of Venous
Thromboembolism Prophylaxis in Orthopedic Surgery. Pharmacotherapy. 2003;23(6
):772-787.

ots Originaltext: Daiichi Sankyo Company (TSE: 4568) and Perosphere Inc
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Solomon S. Steiner, Ph.D., CEO, Perosphere Inc.,
+1-914-241-0191, s.steiner@perosphere.com. Philip N. Sussman, CFO,
Perosphere Inc., +1-212-769-0916, p.sussman@perosphere.com. Michaela
Paudler-Debus, PhD, Daiichi Sankyo Europe GmbH, +49-89-780-8685
(office).
Daria Munsel, Daiichi Sankyo Europe, GmbH, +49-89-780-8728 (office).