– Expands and diversifies Alexion’s hematology,
neurology and critical care commercial portfolio with
transformative Factor Xa inhibitor reversal agent –
– Conference call and webcast scheduled for
today, May 5, at 8:00 a.m. ET –
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Portola
Pharmaceuticals, Inc. (NASDAQ:PTLA) announced today that they have
entered into a definitive merger agreement for Alexion to acquire
Portola, a commercial-stage biopharmaceutical company focused on
life-threatening blood-related disorders. Portola’s commercialized
medicine, Andexxa® [coagulation factor Xa (recombinant),
inactivated-zhzo], marketed as Ondexxya® in Europe, is the first
and only approved Factor Xa inhibitor reversal agent, and has
demonstrated transformative clinical value by rapidly reversing the
anticoagulant effects of Factor Xa inhibitors rivaroxaban and
apixaban in severe and uncontrolled bleeding. The acquisition will
add near-term diversification to Alexion’s commercial portfolio and
provides the opportunity to apply the company’s demonstrated global
commercial excellence to create long-term value for patients and
shareholders. The merger agreement has been unanimously approved by
the boards of Alexion and Portola.
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“The acquisition of Portola represents an important next step in
our strategy to diversify beyond C5. Andexxa is a strategic fit
with our existing portfolio of transformative medicines and is
well-aligned with our demonstrated expertise in hematology,
neurology and critical care,” said Ludwig Hantson, Ph.D., Chief
Executive Officer of Alexion. “We believe Andexxa has the potential
to become the global standard of care for patients who experience
life-threatening bleeds while taking Factor Xa inhibitors apixaban
and rivaroxaban. By leveraging Alexion’s strong operational and
sales infrastructure and deep relationships in hospital channels,
we are well positioned to expand the number of patients helped by
Andexxa, while also driving value for shareholders.”
“In developing and launching Andexxa, Portola has established a
strong foundation for changing the standard of care for patients
receiving Factor Xa inhibitors that experience a major,
life-threatening bleed. Andexxa rapidly reverses the pharmacologic
effect of rivaroxaban and apixaban within two minutes, reducing
anti-Factor Xa activity by 92 percent,” said Scott Garland,
President and Chief Executive Officer of Portola. “Given their
enhanced resources, global footprint and proven commercial
expertise, we look forward to working with Alexion to maximize the
value of Andexxa. With their commitment to commercial excellence,
together, we will be able to drive stronger utilization of Andexxa,
increase penetration and accelerate adoption in the critical care
setting.”
Transaction Details
Under the terms of the merger agreement, a subsidiary of Alexion
will commence a tender offer to acquire all of the outstanding
shares of Portola’s common stock at a price of $18 per share in
cash. The tender offer is subject to customary conditions,
including the tender of a majority of the outstanding shares of
Portola common stock, the expiration or termination of the waiting
period under the Hart-Scott Rodino Antitrust Improvements Act of
1976 and receipt of certain other regulatory approvals.
Following successful completion of the tender offer, Alexion
will acquire all remaining shares not tendered in the offer at the
same price of $18 per share through a merger. The transaction is
expected to close in the third quarter of 2020.
Alexion will fund the transaction with cash on hand. As part of
the acquisition, Alexion will also be acquiring cash currently on
Portola’s balance sheet, net of debt of approximately $215 million
that will become due upon closing. As of December 31, 2019, cash
and short-term investments were approximately $430 million. The
actual amounts will be determined as of the transaction close.
RBC Capital Markets, LLC served as Alexion’s exclusive financial
advisor. Centerview Partners served as Portola’s exclusive
financial advisor. Cooley LLP served as Portola’s legal
advisor.
Conference Call
Alexion will host a conference call and webcast today, May 5,
2020 at 8:00 a.m. ET to discuss the acquisition. To participate in
this call, dial (866) 762-3111 (USA) or (210) 874-7712
(International), passcode 5689520, shortly before 8:00 a.m. ET. A
replay of the call will be available for a limited period of time
following the call. The audio webcast can be accessed on the
Investors page of Alexion’s website at: http://ir.alexion.com.
About Andexxa
Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo]
is a recombinant modified human factor Xa (FXa) protein indicated
for patients treated with rivaroxaban or apixaban, when reversal of
anticoagulation is needed due to life-threatening or uncontrolled
bleeding.
IMPORTANT SAFETY INFORMATION
The most frequently reported adverse reactions in clinical
trials in healthy subjects with Andexxa were mild or moderate
infusion-related reactions comprising symptoms such as flushing and
feeling hot (very common), and cough, dysgeusia, and dyspnea
(common). Amongst bleeding patients, commonly reported side effects
were ischemic stroke and pyrexia, with uncommon reported side
effects of cerebral infarction, cerebrovascular accident, transient
ischemic attack, acute myocardial infarction, cardiac arrest,
myocardial infarction, deep vein thrombosis, iliac artery
occlusion, pulmonary embolism.
Please refer to full Prescribing Information for more
information, including Boxed Warning, at www.Andexxa.com.
About Alexion
Alexion is a global biopharmaceutical company focused on serving
patients and families affected by rare and devastating diseases
through the discovery, development and commercialization of
life-changing medicines. As the global leader in complement biology
and inhibition for more than 20 years, Alexion has developed and
commercializes two approved complement inhibitors to treat patients
with paroxysmal nocturnal hemoglobinuria (PNH) and atypical
hemolytic uremic syndrome (aHUS), as well as the first and only
approved complement inhibitor to treat anti-acetylcholine receptor
(AchR) antibody-positive generalized myasthenia gravis (gMG) and
neuromyelitis optica spectrum disorder (NMOSD). Alexion also has
two highly innovative enzyme replacement therapies for patients
with life-threatening and ultra-rare metabolic disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency
(LAL-D). In addition, the company is developing several
mid-to-late-stage therapies, including a copper-binding agent for
Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for
rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D
inhibitor as well as several early-stage therapies, including one
for light chain (AL) amyloidosis, a second oral Factor D inhibitor
and a third complement inhibitor. Alexion focuses its research
efforts on novel molecules and targets in the complement cascade
and its development efforts on the core therapeutic areas of
hematology, nephrology, neurology, metabolic disorders and
cardiology. Headquartered in Boston, Massachusetts, Alexion has
offices around the globe and serves patients in more than 50
countries. This press release and further information about Alexion
can be found at: www.alexion.com.
[ALXN-G]
About Portola
Portola is a global, commercial-stage biopharmaceutical company
focused on the discovery, development and commercialization of
novel therapeutics that could significantly advance the fields of
thrombosis and other hematologic conditions. The Company's first
two commercialized products are Andexxa® [coagulation factor Xa
(recombinant), inactivated-zhzo], marketed in Europe as Ondexxya®
(andexanet alfa), and Bevyxxa® (betrixaban). Portola also is
advancing cerdulatinib, a SYK/JAK inhibitor being developed for the
treatment of hematologic cancers. Founded in 2003 in South San
Francisco, California, Portola has operations in the United States
and Europe.
Important Additional Information and Where to Find It
The tender offer for the outstanding common stock of Portola has
not been commenced. This announcement is for informational purposes
only and does not constitute a recommendation, an offer to purchase
or a solicitation of an offer to sell Portola common stock. The
solicitation and offer to buy Portola common stock will only be
made pursuant to an Offer to Purchase and related materials. At the
time the tender offer is commenced, Alexion and its acquisition
subsidiary will file a Tender Offer Statement on Schedule TO with
the United States Securities and Exchange Commission (the “SEC”)
and thereafter, Portola will file a Solicitation/Recommendation
Statement on Schedule 14D-9 with the SEC with respect to the tender
offer. Investors and security holders are urged to read these
materials (including an Offer to Purchase, a related Letter of
Transmittal and certain other tender offer documents, as each may
be amended or supplemented from time to time) carefully when they
become available since they will contain important information that
investors and security holders should consider before making any
decision regarding tendering their common stock, including the
terms and conditions of the tender offer. The Tender Offer
Statement, Offer to Purchase, Solicitation/Recommendation Statement
and related materials will be filed with the SEC, and investors and
security holders may obtain a free copy of these materials (when
available) and other documents filed by Alexion and Portola with
the SEC at the website maintained by the SEC at www.sec.gov. In
addition, the Tender Offer Statement and other documents that
Alexion and its acquisition subsidiary file with the SEC will be
made available to all investors and security holders of Portola
free of charge from the information agent for the tender offer.
Investors and security holders may also obtain free copies of the
Solicitation/Recommendation Statement and other documents filed
with the SEC by Portola at
https://investors.portola.com/sec-filings.
Forward-Looking Statements
Certain statements made in this press release, including any
statements as to future results of operations and financial
projections, may constitute “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements include, among other things,
statements related to the proposed acquisition of Portola by
Alexion, including: that the acquisition would add near-term
diversification to Alexion’s commercial portfolio; that the
acquisition provides the opportunity to apply Alexion’s
demonstrated global commercial excellence to create long-term value
for patients and shareholders; Alexion’s belief that Andexxa has
the potential to become the global standard of care for patients
who experience life-threatening bleeds while taking Factor Xa
inhibitors apixaban and rivaroxaban; that Alexion is well
positioned to expand the number of patients helped by Andexxa,
while also driving value for shareholders; that Alexion can drive
stronger utilization of Andexxa, increase penetration and
accelerate adoption in the critical care setting; and the
expectation that the transaction will close in the third quarter of
2020. Forward-looking statements are based on management’s current
expectations, beliefs, estimates, projections and assumptions. As
such, forward-looking statements are not guarantees of future
performance and involve inherent risks and uncertainties that are
difficult to predict. As a result, a number of important factors
could cause actual results to differ materially from those
indicated by such forward-looking statements, including: the risk
that the proposed acquisition of Portola by Alexion may not be
completed; the possibility that competing offers or acquisition
proposals for Portola will be made; the delay or failure of the
tender offer conditions to be satisfied (or waived), including
insufficient shares of Portola common stock being tendered in the
tender offer; the failure (or delay) to receive the required
regulatory approvals of the proposed acquisition; the possibility
that prior to the completion of the transactions contemplated by
the acquisition agreement, Alexion’s or Portola’s business may
experience significant disruptions due to transaction-related
uncertainty; the occurrence of any event, change or other
circumstance that could give rise to the termination of the
acquisition agreement; the risk that stockholder litigation in
connection with the proposed transaction may result in significant
costs of defense, indemnification and liability; the failure of the
closing conditions set forth in the acquisition agreement to be
satisfied (or waived); the anticipated benefits Andexxa and other
Portola therapies not being realized, including the result of
delays or failure to obtain regulatory approval and failure to
attain sales targets; the Phase 4 study regarding Andexxa does not
meet its designated endpoints and/or is not deemed safe and
effective by the FDA or other regulatory agencies (and commercial
sales are prohibited or limited); future clinical trials of Portola
products not proving that the therapies are safe and effective to
the level required by regulators; anticipated Andexxa sales targets
are not satisfied; Andexxa does not gain acceptance among
physicians, payers and patients; potential future competition by
other Factor Xa inhibitor reversal agents; decisions of regulatory
authorities regarding the adequacy of the research and clinical
tests, marketing approval or material limitations on the marketing
of Portola products; delays or failure of product candidates or
label extension of existing products to obtain regulatory approval;
delays or the inability to launch product candidates (including
products with label extensions) due to regulatory restrictions;
unanticipated expenses; interruptions or failures in the
manufacture and supply of products and product candidates; failure
to satisfactorily address matters raised by the FDA and other
regulatory agencies; the possibility that results of clinical
trials are not predictive of safety and efficacy results of
products in broader patient populations; the possibility that
clinical trials of product candidates could be delayed or
terminated prior to completion for a number of reasons; the
adequacy of pharmacovigilance and drug safety reporting processes;
the impact of the COVID-19 pandemic on Alexion’s and Portola’s
business operations, including sales, clinical trials, operations
and supply chain; and a variety of other risks set forth from time
to time in Alexion's or Portola’s filings with the SEC, including
but not limited to the risks discussed in Alexion's Annual Report
on Form 10-K for the year ended December 31, 2019 and in its other
filings with the SEC and the risks discussed in Portola’s Annual
Report on Form 10-K for the year ended December 31, 2019 and in its
other filings with the SEC. Alexion and Portola disclaim any
obligation to update any of these forward-looking statements to
reflect events or circumstances after the date hereof, except when
a duty arises under law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200505005333/en/
Alexion: Media Megan Goulart, 857-338-8634 Senior
Director, Corporate Communications
Investors Chris Stevo, 857-338-9309 Head of Investor
Relations
Portola: Media Emily Faucette,
Media@portola.com
Investors Jennifer Zibuda, IR@portola.com
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