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Perosphere and Daiichi Sankyo Enter into a Clinical Trial Agreement to Evaluate the Efficacy and Safety of PER977 to Reverse the

    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 Xa Inhibitor Edoxaban

  PR Newswire

  MOUNT KISCO, New York and TOKYO, April 25, 2013

MOUNT KISCO, New York and TOKYO, April 25, 2013 /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
30minutes 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 ^® .

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 ( E ffective a N ticoa G ulation with Factor X A Next GE neration
in A trial F ibrillation), 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.

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).
 
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