Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc.
(NSYE:PFE) today announced that the companies have entered into a
collaboration agreement with Portola Pharmaceuticals Inc. (Nasdaq:
PTLA) to develop and commercialize the investigational agent
andexanet alfa in Japan. Andexanet alfa, which is in Phase 3
clinical development in the U.S. and Europe, is designed to reverse
the anticoagulant activity of Factor Xa inhibitors, including
Eliquis (apixaban).
“We are committed to reducing the risk of stroke in nonvalvular
atrial fibrillation patients and treating deep vein thrombosis and
pulmonary embolism,” said Douglas Manion, M.D., head of Specialty
Development, Bristol-Myers Squibb. “Bristol-Myers Squibb and
Pfizer’s agreement with Portola is an important step forward toward
the goal of delivering the first reversal agent for Factor Xa
inhibitors, including Eliquis, to patients in Japan. The ability to
reverse the anticoagulation effect of Eliquis and other Factor Xa
inhibitors may be helpful for some patients who experience a major
bleeding event or require emergency surgery while on Eliquis or
another Factor Xa inhibitor.”
“This agreement in Japan is another great example of the
alliance’s commitment to the patients we serve. Eliquis has proven
to be an important treatment option for patients at risk for stroke
and blood clots due to nonvalvular atrial fibrillation and for the
treatment of deep vein thrombosis and pulmonary embolism, but
currently there is no approved reversal agent,” said Rory O’Connor,
M.D., senior vice president and head of Global Medical Affairs,
Global Innovative Pharmaceuticals Business, Pfizer Inc. “With our
partner, Bristol-Myers Squibb, we look forward to working with
Portola to develop andexanet alfa as a reversal agent for Eliquis
in Japan.”
Under the terms of the agreement, Portola will receive an
upfront payment of $15 million, potential regulatory milestones of
$20 million and sales-based milestones of $70 million as well as
compensation based on andexanet alfa net sales. Bristol-Myers
Squibb and Pfizer will co-fund with Portola the development and
commercialization of andexanet alfa in Japan. Portola will retain
rights to andexanet alfa outside of Japan and remain responsible
for the manufacturing supply.
This agreement builds on the companies’ existing clinical
collaboration to develop andexanet alfa in the U.S. and Europe. In
December 2015, Portola announced it had completed the submission of
a Biologics License Application to the U.S. Food and Drug
Administration (FDA) for andexanet alfa and was awaiting acceptance
for filing. The FDA assigned a PDUFA date of August 17, 2016, under
an Accelerated Approval pathway. Portola has stated that it plans
to submit an EU application in 2017.
About Andexanet Alfa
Andexanet alfa, an investigational drug, is a modified human
Factor Xa molecule that acts as a decoy to target and sequester
with high specificity both oral and injectable Factor Xa inhibitors
in the blood. Once bound, the Factor Xa inhibitors are unable to
bind to and inhibit native Factor Xa, thus allowing for the
restoration of normal hemostatic processes. Andexanet alfa is the
only compound being studied as a reversal agent for Factor Xa
inhibitors that directly and specifically corrects anti-Factor Xa
activity – the anticoagulant mechanism of these agents.
About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By
inhibiting Factor Xa, a key blood clotting protein, Eliquis
decreases thrombin generation and thus blood clot formation.
Eliquis is a prescription medicine approved for multiple
indications in the United States, the European Union (which
includes 28 member states plus Iceland and Norway) and Japan, as
well as a number of other countries around the world based on
efficacy and safety data, including results from seven Phase 3
clinical trials. In Japan, Eliquis is approved for the prevention
of stroke and systemic embolism in patients with nonvalvular atrial
fibrillation (NVAF). Eliquis is also approved in Japan for the
treatment of venous thromboembolism (VTE), which includes deep vein
thrombosis (DVT) and pulmonary embolism (PE), and prevention of
recurrent DVT and PE following initial therapy.
ELIQUIS Important Safety Information
and Indications
ELIQUIS Important Safety Information
WARNING: (A) PREMATURE DISCONTINUATION
OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B)
SPINAL/EPIDURAL HEMATOMA
(A) Premature discontinuation of any
oral anticoagulant, including ELIQUIS, increases the risk of
thrombotic events. If anticoagulation with ELIQUIS is discontinued
for a reason other than pathological bleeding or completion of a
course of therapy, consider coverage with another
anticoagulant.
(B) Epidural or spinal hematomas may
occur in patients treated with ELIQUIS who are receiving neuraxial
anesthesia or undergoing spinal puncture. These hematomas may
result in long-term or permanent paralysis. Consider these risks
when scheduling patients for spinal procedures. Factors that can
increase the risk of developing epidural or spinal hematomas in
these patients include:
• use of indwelling epidural
catheters
• concomitant use of other drugs that
affect hemostasis, such as nonsteroidal anti-inflammatory drugs
(NSAIDs), platelet inhibitors, other anticoagulants
• a history of traumatic or repeated
epidural or spinal punctures
• a history of spinal deformity or
spinal surgery
• optimal timing between the
administration of ELIQUIS and neuraxial procedures is not
known
Monitor patients frequently for signs
and symptoms of neurological impairment. If neurological compromise
is noted, urgent treatment is necessary.
Consider the benefits and risks before
neuraxial intervention in patients anticoagulated or to be
anticoagulated.
CONTRAINDICATIONS
- Active pathological bleeding
- Severe hypersensitivity reaction to
ELIQUIS (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
- Increased Risk of Thrombotic Events
after Premature Discontinuation: Premature discontinuation of
any oral anticoagulant, including ELIQUIS, in the absence of
adequate alternative anticoagulation increases the risk of
thrombotic events. An increased rate of stroke was observed during
the transition from ELIQUIS to warfarin in clinical trials in
atrial fibrillation patients. If ELIQUIS is discontinued for a
reason other than pathological bleeding or completion of a course
of therapy, consider coverage with another anticoagulant.
- Bleeding Risk: ELIQUIS increases
the risk of bleeding and can cause serious, potentially fatal,
bleeding.
- Concomitant use of drugs affecting
hemostasis increases the risk of bleeding, including aspirin and
other antiplatelet agents, other anticoagulants, heparin,
thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
- Advise patients of signs and symptoms
of blood loss and to report them immediately or go to an emergency
room. Discontinue ELIQUIS in patients with active pathological
hemorrhage.
- There is no established way to reverse
the anticoagulant effect of apixaban, which can be expected to
persist for at least 24 hours after the last dose (i.e., about two
half-lives). A specific antidote for ELIQUIS is not available.
- Spinal/Epidural Anesthesia or
Puncture: Patients treated with ELIQUIS undergoing
spinal/epidural anesthesia or puncture may develop an epidural or
spinal hematoma which can result in long-term or permanent
paralysis.The risk of these events may be increased by the
postoperative use of indwelling epidural catheters or the
concomitant use of medicinal products affecting hemostasis.
Indwelling epidural or intrathecal catheters should not be removed
earlier than 24 hours after the last administration of ELIQUIS. The
next dose of ELIQUIS should not be administered earlier than 5
hours after the removal of the catheter. The risk may also be
increased by traumatic or repeated epidural or spinal puncture. If
traumatic puncture occurs, delay the administration of ELIQUIS for
48 hours.Monitor patients frequently and if neurological compromise
is noted, urgent diagnosis and treatment is necessary. Physicians
should consider the potential benefit versus the risk of neuraxial
intervention in ELIQUIS patients.
- Prosthetic Heart Valves: The
safety and efficacy of ELIQUIS have not been studied in patients
with prosthetic heart valves and is not recommended in these
patients.
- Acute PE in Hemodynamically Unstable
Patients or Patients who Require Thrombolysis or Pulmonary
Embolectomy: Initiation of ELIQUIS is not recommended as an
alternative to unfractionated heparin for the initial treatment of
patients with PE who present with hemodynamic instability or who
may receive thrombolysis or pulmonary embolectomy.
ADVERSE REACTIONS
- The most common and most serious
adverse reactions reported with ELIQUIS were related to
bleeding.
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER
INTERVENTIONS
- ELIQUIS should be discontinued at least
48 hours prior to elective surgery or invasive procedures with a
moderate or high risk of unacceptable or clinically significant
bleeding. ELIQUIS should be discontinued at least 24 hours prior to
elective surgery or invasive procedures with a low risk of bleeding
or where the bleeding would be noncritical in location and easily
controlled. Bridging anticoagulation during the 24 to 48 hours
after stopping ELIQUIS and prior to the intervention is not
generally required. ELIQUIS should be restarted after the surgical
or other procedures as soon as adequate hemostasis has been
established.
DRUG INTERACTIONS
- Strong Dual Inhibitors of CYP3A4 and
P-gp: Inhibitors of cytochrome P450 3A4 (CYP3A4) and
P-glycoprotein (P-gp) increase exposure to apixaban and increase
the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg
or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when
ELIQUIS is coadministered with drugs that are strong dual
inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole,
ritonavir, or clarithromycin). In patients already taking 2.5 mg
twice daily, avoid coadministration of ELIQUIS with strong dual
inhibitors of CYP3A4 and P-gp.
- Strong Dual Inducers of CYP3A4 and
P-gp: Avoid concomitant use of ELIQUIS with strong dual
inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine,
phenytoin, St. John’s wort) because such drugs will decrease
exposure to apixaban and increase the risk of stroke and other
thromboembolic events.
- Anticoagulants and Antiplatelet
Agents: Coadministration of antiplatelet agents, fibrinolytics,
heparin, aspirin, and chronic NSAID use increases the risk of
bleeding. APPRAISE-2, a placebo-controlled clinical trial of
apixaban in high-risk post-acute coronary syndrome patients treated
with aspirin or the combination of aspirin and clopidogrel, was
terminated early due to a higher rate of bleeding with apixaban
compared to placebo.
PREGNANCY CATEGORY B
- There are no adequate and
well-controlled studies of ELIQUIS in pregnant women. Treatment is
likely to increase the risk of hemorrhage during pregnancy and
delivery. ELIQUIS should be used during pregnancy only if the
potential benefit outweighs the potential risk to the mother and
fetus.
Please see full Prescribing Information, including BOXED
WARNINGS and Medication Guide, available at
www.bms.com.
Indications in the United States
ELIQUIS is indicated to reduce the risk of stroke and systemic
embolism in patients with nonvalvular atrial fibrillation.
ELIQUIS is indicated for the prophylaxis of deep vein thrombosis
(DVT), which may lead to pulmonary embolism (PE), in patients who
have undergone hip or knee replacement surgery.
ELIQUIS is indicated for the treatment of DVT and PE, and to
reduce the risk of recurrent DVT and PE following initial
therapy.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a
worldwide collaboration to develop and commercialize apixaban, an
oral anticoagulant discovered by Bristol-Myers Squibb. This global
alliance combines Bristol-Myers Squibb's long-standing strengths in
cardiovascular drug development and commercialization with Pfizer’s
global scale and expertise in this field.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit www.bms.com or follow us on
Twitter at http://twitter.com/bmsnews.
About Pfizer Inc.: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us at
www.pfizer.com.
Bristol-Myers Squibb Forward Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, the compound described in
this release is subject to all the risks inherent in the drug
development process, and there can be no assurance that the
development of this compound will be successful. Forward-looking
statements in the press release should be evaluated together with
the many uncertainties that affect Bristol-Myers Squibb's business,
particularly those identified in the cautionary factors discussion
in Bristol-Myers Squibb's Annual Report on Form 10-K for the year
ended December 31, 2014, its Quarterly Reports on Form 10-Q, and
Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Pfizer Disclosure Notice
The information contained in this release is as of February 1,
2016. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about Eliquis
(apixaban) and andexanet alfa, including their potential benefits,
that involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including, without limitation, the ability to meet anticipated
clinical trial commencement and completion dates as well as the
possibility of unfavorable clinical data and additional analyses of
existing clinical data; whether and when any Biologics License
Application (BLA) may be filed for andexanet alfa; whether and when
regulatory authorities will approve any such BLA; decisions by
regulatory authorities regarding label and andexanet alfa; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2014 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160201005542/en/
Bristol-Myers SquibbMedia:Sarah Koenig,
609-252-4145sarah.koenig@bms.comorKirby Hosea,
609-419-5071kirby.hosea@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.comorPfizer
Inc.Media:Steven Danehy,
212-733-1538steven.danehy@pfizer.comorInvestors:Ryan Crowe,
212-733-8160ryan.crowe@pfizer.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Feb 2024 to Mar 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Mar 2023 to Mar 2024