– Long-term data evaluate the effectiveness of
ULTOMIRIS® (ravulizumab-cwvz) in reducing the risk of thrombosis in
PNH, the primary cause of organ damage and premature death in
untreated patients –
– Accepted abstracts include new interim Phase
3 data studying the safety and efficacy of ULTOMIRIS in pediatric
patients –
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that
five abstracts have been accepted for presentation at the 26th
annual European Hematology Association (EHA) 2021 virtual Congress,
taking place from June 9 through June 17, 2021. During the meeting,
data will be presented further supporting the long-term safety of
ULTOMIRIS® (ravulizumab-cwvz) over two years, including reduction
of thrombotic (blood clot) risk, in complement inhibitor-naïve and
complement inhibitor-experienced patients with PNH, and reaffirming
the critical role of complete C5 complement inhibition in treating
this rare disease.
Also being presented are new Phase 3 interim analysis data that
evaluate the efficacy and safety of ULTOMIRIS in pediatric patients
as well as the previously announced topline Phase 3 results for the
weekly subcutaneous formulation of ULTOMIRIS in adults with
PNH.
“Our data presentations at this year’s EHA Congress underscore
the clinical value of ULTOMIRIS – the standard of care for adults
living with PNH – and continue to build on its well-established
safety and efficacy profile,” said John Orloff, M.D., Executive
Vice President and Head of Research and Development at Alexion.
“These data also demonstrate further progress in our efforts to
continue innovating for patients – supporting the use of ULTOMIRIS
in children and adolescents and via a convenient, self-administered
subcutaneous formulation.”
The U.S. Food and Drug Administration (FDA) granted priority
review for ULTOMIRIS in children and adolescents with PNH and has
set a Prescription Drug User Fee Act (PDUFA) target action date of
June 7, 2021. The interim analysis that will be presented at EHA is
from the largest study of pediatric PNH patients to date.
The accepted abstracts are listed below and are now available on
the EHA website. All e-poster presentations will be made available
on the virtual congress platform on June 11, 2021 at 09:00 CEST
(3:00 a.m. EDT) and will be available throughout the duration of
the Congress.
Oral Presentation
Ravulizumab Reduces the Risk of Thrombosis in Adult Patients
with Paroxysmal Nocturnal Hemoglobinuria and High Disease Activity:
2-Year Data from A Phase 3, Open-Label Study. Oral presentation ID
#S301. The pre-recorded oral presentation will be published on the
virtual Congress platform on June 11, 2021 at 09:00 CEST (3:00 a.m.
EDT), with a live Q&A session on June 14, 2021. The session
begins at 11:00 CEST (5:00 a.m. EDT).
ePoster Presentations
Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of
Ravulizumab In Children and Adolescents with Paroxysmal Nocturnal
Hemoglobinuria: Interim Analysis of A Phase 3, Open-Label Study.
ePoster presentation, abstract ID #EP590.
Safety of Ravulizumab in Patients with Paroxysmal Nocturnal
Hemoglobinuria: Study 301/302 2-Year Results. ePoster presentation,
abstract ID #EP594.
Ravulizumab and Eculizumab Reduce Transfusions in Adult Patients
with Paroxysmal Nocturnal Hemoglobinuria: Evidence from Three
Real-World Databases: TriNetX US EMR, TriNetX US Claims and KOMODO
Health. ePoster presentation, abstract ID #EP1337.
Ravulizumab Administered Subcutaneously Versus Intravenously in
Adult Patients with PNH Previously Treated with Eculizumab: Results
from A Phase 3 Randomized, Open-Label Study. ePoster presentation,
abstract ID #EP586.
About Paroxysmal Nocturnal Hemoglobinuria (PNH)
PNH is a serious ultra-rare blood disorder with devastating
consequences. It is characterized by the destruction of red blood
cells, which is also referred to as hemolysis. PNH occurs when the
complement system—a part of the body’s immune system—over-responds,
leading the body to attack its own red blood cells. PNH often goes
unrecognized, with delays in diagnosis from one to more than five
years. Patients with PNH may experience a range of symptoms, such
as fatigue, difficulty swallowing, shortness of breath, abdominal
pain, erectile dysfunction, dark-colored urine and anemia. The most
devastating consequence of chronic hemolysis is the formation of
blood clots, which can occur in blood vessels throughout the body,
damage vital organs, and potentially lead to premature death. The
prognosis of PNH can be poor in many cases, so a timely and
accurate diagnosis—in addition to appropriate treatment—is critical
to improving patient outcomes.
About ULTOMIRIS®
ULTOMIRIS® (ravulizumab-cwvz) is the first and only long-acting
C5 complement inhibitor. The medication works by inhibiting the C5
protein in the terminal complement cascade, a part of the body’s
immune system. When activated in an uncontrolled manner, the
complement cascade over-responds, leading the body to attack its
own healthy cells. ULTOMIRIS is administered intravenously every
eight weeks or, for pediatric patients less than 20 kg, every four
weeks, following a loading dose. ULTOMIRIS is approved in the
United States (U.S.), European Union (EU) and Japan as a treatment
for adults with paroxysmal nocturnal hemoglobinuria (PNH). It is
also approved in the U.S. and Japan for atypical hemolytic uremic
syndrome (aHUS) to inhibit complement-mediated thrombotic
microangiopathy (TMA) in adult and pediatric (one month of age and
older) patients, as well as in the EU for the treatment of adults
and children with a body weight of at least 10 kg with aHUS. To
learn more about the regulatory status of ULTOMIRIS in the
countries that we serve, please visit www.alexion.com.
About SOLIRIS®
SOLIRIS® (eculizumab) is a first-in-class C5 complement
inhibitor. The medication works by inhibiting the C5 protein in the
terminal complement cascade, a part of the body’s immune system.
When activated in an uncontrolled manner, the terminal complement
cascade over-responds, leading the body to attack its own healthy
cells. SOLIRIS is administered intravenously every two weeks,
following an introductory dosing period. In many countries around
the world, SOLIRIS is approved to treat paroxysmal nocturnal
hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS),
adults with generalized myasthenia gravis (gMG) who are
acetylcholine receptor (AchR) antibody positive and/or adults with
neuromyelitis optica spectrum disorder (NMOSD) who are
anti-aquaporin-4 (AQP4) antibody positive. SOLIRIS is not indicated
for the treatment of patients with Shiga-toxin E. coli-related
hemolytic uremic syndrome (STEC-HUS). To learn more about the
regulatory status of SOLIRIS in the countries that we serve, please
visit www.alexion.com.
INDICATIONS & IMPORTANT SAFETY INFORMATION for ULTOMIRIS®
(ravulizumab-cwvz)
INDICATIONS
What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine used to treat:
- adults with a disease called Paroxysmal Nocturnal
Hemoglobinuria (PNH).
- adults and children 1 month of age and older with a disease
called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not
used in treating people with Shiga toxin E. coli related hemolytic
uremic syndrome (STEC-HUS).
It is not known if ULTOMIRIS is safe and effective in children
with PNH.
It is not known if ULTOMIRIS is safe and effective in children
younger than 1 month of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system and
can lower the ability of your immune system to fight
infections.
- ULTOMIRIS increases your chance of getting serious and
life-threatening meningococcal infections that may quickly become
life-threatening and cause death if not recognized and treated
early.
- You must receive meningococcal vaccines at least 2 weeks before
your first dose of ULTOMIRIS if you are not vaccinated.
- If your doctor decided that urgent treatment with ULTOMIRIS is
needed, you should receive meningococcal vaccination as soon as
possible.
- If you have not been vaccinated and ULTOMIRIS therapy must be
initiated immediately, you should also receive 2 weeks of
antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need
additional vaccination. Your doctor will decide if you need
additional vaccination.
- Meningococcal vaccines reduce but do not prevent all
meningococcal infections. Call your doctor or get emergency medical
care right away if you get any of these signs and symptoms of a
meningococcal infection: headache with nausea or vomiting, headache
and fever, headache with a stiff neck or stiff back, fever, fever
and a rash, confusion, muscle aches with flu-like symptoms and eyes
sensitive to light.
Your doctor will give you a Patient Safety Card about the
risk of meningococcal infection. Carry it with you at all times
during treatment and for 8 months after your last ULTOMIRIS dose.
It is important to show this card to any doctor or nurse to help
them diagnose and treat you quickly.
ULTOMIRIS is only available through a program called the
ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your doctor
must: enroll in the ULTOMIRIS REMS program; counsel you about the
risk of meningococcal infection; give you information and a
Patient Safety Card about the symptoms and your risk of
meningococcal infection (as discussed above); and make sure that
you are vaccinated with a meningococcal vaccine, and if needed, get
revaccinated with the meningococcal vaccine. Ask your doctor if you
are not sure if you need to be revaccinated.
ULTOMIRIS may also increase the risk of other types of
serious infections. Make sure your child receives vaccinations
against Streptococcus pneumoniae and Haemophilis influenzae type b
(Hib) if treated with ULTOMIRIS. Call your doctor right away if you
have any new signs or symptoms of infection.
Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a meningococcal
infection or have not been vaccinated against meningococcal
infection unless your doctor decides that urgent treatment with
ULTOMIRIS is needed.
Before you receive ULTOMIRIS, tell your doctor about all of
your medical conditions, including if you: have an infection or
fever, are pregnant or plan to become pregnant, and are
breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS
will harm your unborn baby or if it passes into your breast milk.
You should not breastfeed during treatment and for 8 months after
your final dose of ULTOMIRIS.
Tell your doctor about all the vaccines you receive and
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements which could affect your
treatment.
If you have PNH and you stop receiving ULTOMIRIS, your doctor
will need to monitor you closely for at least 16 weeks after you
stop ULTOMIRIS. Stopping ULTOMIRIS may cause breakdown of your red
blood cells due to PNH. Symptoms or problems that can happen due to
red blood cell breakdown include: drop in your red blood cell
count, tiredness, blood in your urine,
stomach-area (abdomen) pain, shortness of breath,
blood clots, trouble swallowing, and erectile dysfunction
(ED) in males.
If you have aHUS, your doctor will need to monitor you
closely for at least 12 months after stopping treatment for signs
of worsening aHUS or problems related to a type of abnormal
clotting and breakdown of your red blood cells called thrombotic
microangiopathy (TMA). Symptoms or problems that can happen with
TMA may include: confusion or loss of consciousness, seizures,
chest pain (angina), difficulty breathing and blood clots or
stroke.
What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including
infusion-related reactions. Symptoms of an infusion-related
reaction with ULTOMIRIS may include lower back pain, pain with the
infusion, feeling faint or discomfort in your arms or legs. Tell
your doctor or nurse right away if you develop these symptoms, or
any other symptoms during your ULTOMIRIS infusion that may mean you
are having a serious infusion reaction, including: chest pain,
trouble breathing or shortness of breath, swelling of your face,
tongue, or throat, and feel faint or pass out.
The most common side effects of ULTOMIRIS in people treated
for PNH are upper respiratory infection and headache.
The most common side effects of ULTOMIRIS in people with aHUS
are upper respiratory infection, diarrhea, nausea, vomiting,
headache, high blood pressure and fever.
Tell your doctor about any side effect that bothers you or that
does not go away. These are not all the possible side effects of
ULTOMIRIS. For more information, ask your doctor or pharmacist.
Call your doctor right away if you miss an ULTOMIRIS infusion or
for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
Please see the accompanying full Prescribing Information and
Medication Guide for ULTOMIRIS, including Boxed WARNING regarding
serious and life-threatening meningococcal
infections/sepsis.
INDICATIONS & IMPORTANT SAFETY INFORMATION FOR SOLIRIS®
(eculizumab)
INDICATIONS
What is SOLIRIS?
SOLIRIS is a prescription medicine used to treat:
- patients with a disease called Paroxysmal Nocturnal
Hemoglobinuria (PNH) .
- adults and children with a disease called atypical Hemolytic
Uremic Syndrome (aHUS). SOLIRIS is not for use in treating people
with Shiga toxin E. coli related hemolytic uremic syndrome
(STEC-HUS).
- adults with a disease called generalized myasthenia gravis
(gMG) who are anti-acetylcholine receptor (AChR) antibody
positive.
- adults with a disease called neuromyelitis optica spectrum
disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody
positive.
It is not known if SOLIRIS is safe and effective in children
with PNH, gMG, or NMOSD.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
SOLIRIS?
SOLIRIS is a medicine that affects your immune system and can
lower the ability of your immune system to fight
infections.
- SOLIRIS increases your chance of getting serious and
life-threatening meningococcal infections that may quickly become
life-threatening and cause death if not recognized and treated
early.
- You must receive meningococcal vaccines at least 2 weeks before
your first dose of SOLIRIS if you are not vaccinated.
- If your doctor decided that urgent treatment with SOLIRIS is
needed, you should receive meningococcal vaccination as soon as
possible.
- If you have not been vaccinated and SOLIRIS therapy must be
initiated immediately, you should also receive two weeks of
antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need
additional vaccination. Your doctor will decide if you need
additional vaccination.
- Meningococcal vaccines reduce but do not prevent all
meningococcal infections. Call your doctor or get emergency medical
care right away if you get any of these signs and symptoms of a
meningococcal infection: headache with nausea or vomiting, headache
and fever, headache with a stiff neck or stiff back, fever, fever
and a rash, confusion, muscle aches with flu-like symptoms, and
eyes sensitive to light.
Your doctor will give you a Patient Safety Card about the
risk of meningococcal infection. Carry it with you at all times
during treatment and for 3 months after your last SOLIRIS dose. It
is important to show this card to any doctor or nurse to help them
diagnose and treat you quickly.
SOLIRIS is only available through a program called the
SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must
enroll in the SOLIRIS REMS program; counsel you about the risk of
meningococcal infection; give you information and a Patient
Safety Card about the symptoms and your risk of meningococcal
infection (as discussed above); and make sure that you are
vaccinated with the meningococcal vaccine and, if needed, get
revaccinated with the meningococcal vaccine. Ask your doctor if you
are not sure if you need to be revaccinated.
SOLIRIS may also increase the risk of other types of serious
infections. Make sure your child receives vaccinations against
Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if
treated with SOLIRIS. Certain people may be at risk of serious
infections with gonorrhea. Certain fungal infections (Aspergillus)
may occur if you take SOLIRIS and have a weak immune system or a
low white blood cell count.
Who should not receive SOLIRIS?
Do not receive SOLIRIS if you have a meningococcal infection or
have not been vaccinated against meningitis infection unless your
doctor decides that urgent treatment with SOLIRIS is needed.
Before you receive SOLIRIS, tell your doctor about all of
your medical conditions, including if you: have an infection or
fever, are pregnant or plan to become pregnant, and are
breastfeeding or plan to breastfeed. It is not known if SOLIRIS
will harm your unborn baby or if it passes into your breast
milk.
Tell your doctor about all the vaccines you receive and
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements which could affect your
treatment. It is important that you have all recommended
vaccinations before you start SOLIRIS, receive 2 weeks of
antibiotics if you immediately start SOLIRIS, and stay up-to-date
with all recommended vaccinations during treatment with
SOLIRIS.
If you have PNH, your doctor will need to monitor you closely
for at least 8 weeks after stopping SOLIRIS. Stopping treatment
with SOLIRIS may cause breakdown of your red blood cells due to
PNH. Symptoms or problems that can happen due to red blood cell
breakdown include: drop in the number of your red blood cell count,
drop in your platelet count, confusion, kidney problems, blood
clots, difficulty breathing, and chest pain.
If you have aHUS, your doctor will need to monitor you
closely during and for at least 12 weeks after stopping treatment
for signs of worsening aHUS symptoms or problems related to
abnormal clotting (thrombotic microangiopathy). Symptoms or
problems that can happen with abnormal clotting may include:
stroke, confusion, seizure, chest pain (angina), difficulty
breathing, kidney problems, swelling in arms or legs, and a drop in
your platelet count.
What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including serious
infusion-related reactions. Tell your doctor or nurse right
away if you get any of these symptoms during your SOLIRIS infusion:
chest pain, trouble breathing or shortness of breath, swelling of
your face, tongue, or throat, and feel faint or pass out. If you
have an infusion-related reaction to SOLIRIS, your doctor may need
to infuse SOLIRIS more slowly, or stop SOLIRIS.
The most common side effects in people with PNH treated with
SOLIRIS include: headache, pain or swelling of your nose or
throat (nasopharyngitis), back pain, and nausea.
The most common side effects in people with aHUS treated with
SOLIRIS include: headache, diarrhea, high blood pressure
(hypertension), common cold (upper respiratory infection),
stomach-area (abdominal) pain, vomiting, pain or swelling of your
nose or throat (nasopharyngitis), low red blood cell count
(anemia), cough, swelling of legs or feet (peripheral edema),
nausea, urinary tract infections, and fever.
The most common side effects in people with gMG treated with
SOLIRIS include: muscle and joint (musculoskeletal) pain.
The most common side effects in people with NMOSD treated
with SOLIRIS include: common cold (upper respiratory
infection), pain or swelling of your nose or throat
(nasopharyngitis), diarrhea, back pain, dizziness, flu like
symptoms (influenza) including fever, headache, tiredness, cough,
sore throat, and body aches, joint pain (arthralgia), throat
irritation (pharyngitis), and bruising (contusion).
Tell your doctor about any side effect that bothers you or that
does not go away. These are not all the possible side effects of
SOLIRIS. For more information, ask your doctor or pharmacist. Call
your doctor for medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to
the FDA. Visit MedWatch, or call 1-800-FDA-1088.
Please see the accompanying full Prescribing Information and
Medication Guide for SOLIRIS, including Boxed WARNING regarding
serious and life-threatening meningococcal infections.
About Alexion
Alexion is a global biopharmaceutical company focused on serving
patients and families affected by rare diseases and devastating
conditions through the discovery, development and commercialization
of life-changing medicines. As a leader in rare diseases for more
than 25 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)
as well as the first and only approved Factor Xa inhibitor reversal
agent. 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 hematology, nephrology, neurology,
metabolic disorders, cardiology, ophthalmology and acute care.
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-P]
Forward-Looking Statement
This press release contains forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Alexion and its products, including
statements related to: the anticipated benefits of the ULTOMIRIS
and SOLIRIS; the robust clinical value of ULTOMIRIS; the Company
continues to build on ULTOMIRIS’ well established safety and
efficacy profile; the Company continues to progress efforts to
innovate for patients; the Company’s commitment to advancing the
understanding of PNH (and other indications) with ongoing studies
and emerging clinical data; and the anticipated timing of the
review and decision of regulatory agencies with respect to the
potential approval of certain of our product candidates.
Forward-looking statements are subject to factors that may cause
Alexion's results and plans to differ materially from those
expected by these forward looking statements, including for
example: ULTOMIRIS and SOLIRIS may not generate the expected
benefits to patients or the healthcare system that are anticipated;
anticipated regulatory approvals may be delayed or refused; results
of clinical trials may not be sufficient to satisfy regulatory
authorities to approve ULTOMIRIS or SOLIRIS as a treatment for PNH
and/or aHUS or other indication (or they may request additional
trials or additional information); results in clinical trials may
not be indicative of results from later stage or larger clinical
trials (or in broader patient populations once the product is
approved for use by regulatory agencies); the possibility that
results of clinical trials are not predictive of safety and
efficacy and potency of our products (or we fail to adequately
operate or manage our clinical trials) which could cause us to
discontinue sales of the product (or halt trials, delay or prevent
us from making regulatory approval filings or result in denial of
approval of our product candidates); the severity of the impact of
the COVID-19 pandemic on Alexion’s business, including on
commercial and clinical trial and clinical development programs;
unexpected delays in clinical trials; unexpected concerns regarding
products and product candidates that may arise from additional data
or analysis obtained during clinical trials or obtained once used
by patients following product approval; future product improvements
may not be realized due to expense or feasibility or other factors;
delays (expected or unexpected) in the time it takes regulatory
agencies to review and make determinations on applications for the
marketing approval of our products; inability to timely submit (or
failure to submit) future applications for regulatory approval for
our products and product candidates; inability to timely initiate
(or failure to initiate) and complete future clinical trials due to
safety issues, IRB decisions, CMC-related issues, expense or
unfavorable results from earlier trials (among other reasons); our
dependence on sales from our complement inhibitors; future
competition from biosimilars and novel products; decisions of
regulatory authorities regarding the adequacy of our research,
marketing approval or material limitations on the marketing of our
products; delays or the inability to launch product candidates due
to regulatory restrictions, anticipated expense or other matters;
interruptions or failures in the manufacture and supply of our
products and our product candidates; failure to satisfactorily
address matters raised by regulatory agencies regarding products
and product candidates; uncertainty of long-term success in
developing, licensing or acquiring other product candidates or
additional indications for existing products; the possibility that
current rates of adoption of our products are not sustained; the
adequacy of our pharmacovigilance and drug safety reporting
processes; failure to protect and enforce our data, intellectual
property and proprietary rights and the risks and uncertainties
relating to intellectual property claims, lawsuits and challenges
against us (including intellectual property lawsuits relating to
ULTOMIRIS brought by third parties); the risk that third party
payors (including governmental agencies) will not reimburse or
continue to reimburse for the use of our products at acceptable
rates or at all; failure to realize the benefits and potential of
investments, collaborations, licenses and acquisitions; the
possibility that expected tax benefits will not be realized;
potential declines in sovereign credit ratings or sovereign
defaults in countries where we sell our products; delay of
collection or reduction in reimbursement due to adverse economic
conditions or changes in government and private insurer regulations
and approaches to reimbursement; adverse impacts on our supply
chain, clinical trials, manufacturing operations, financial
results, liquidity, hospitals, pharmacies and health care systems
from natural disasters and global pandemics, including the
coronavirus; uncertainties surrounding legal proceedings, company
investigations and government investigations; the risk that
estimates regarding the number of patients with PNH, aHUS, gMG,
NMOSD, HPP and LAL-D and other indications we are pursuing are
inaccurate; the risks of changing foreign exchange rates; risks
relating to the potential effects of the Company's restructurings;
and a variety of other risks set forth from time to time in
Alexion's filings with the SEC, including but not limited to the
risks discussed in Alexion's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2021 and in our other filings with the SEC.
Alexion disclaims 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.
Forward-Looking Statement Regarding Acquisition of Alexion by
AstraZeneca
This communication contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. You can generally identify forward-looking statements by
the use of forward-looking terminology such as “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “explore,”
“evaluate,” “intend,” “may,” “might,” “plan,” “potential,”
“predict,” “project,” “seek,” “should,” or “will,” or the negative
thereof or other variations thereon or comparable terminology.
These forward-looking statements are only predictions and involve
known and unknown risks and uncertainties, many of which are beyond
Alexion’s and AstraZeneca plc’s “AstraZeneca”) control. Statements
in this communication regarding Alexion, AstraZeneca and the
combined company that are forward-looking, including anticipated
benefits of the proposed transaction, the impact of the proposed
transaction on Alexion’s and AstraZeneca’s businesses and future
financial and operating results, the amount and timing of synergies
from the proposed transaction, the terms and scope of the expected
financing for the proposed transaction, the aggregate amount of
indebtedness of the combined company following the closing of the
proposed transaction, are based on management’s estimates,
assumptions and projections, and are subject to significant
uncertainties and other factors, many of which are beyond Alexion’s
and AstraZeneca’s control. These factors include, among other
things, market factors, competitive product development and
approvals, pricing controls and pressures (including changes in
rules and practices of managed care groups and institutional and
governmental purchasers), economic conditions such as interest rate
and currency exchange rate fluctuations, judicial decisions, claims
and concerns that may arise regarding the safety and efficacy of
in-line products and product candidates, changes to wholesaler
inventory levels, variability in data provided by third parties,
changes in, and interpretation of, governmental regulations and
legislation affecting domestic or foreign operations, including tax
obligations, changes to business or tax planning strategies,
difficulties and delays in product development, manufacturing or
sales including any potential future recalls, patent positions and
the ultimate outcome of any litigation matter. Additional
information concerning these risks, uncertainties and assumptions
can be found in Alexion’s and AstraZeneca’s respective filings with
the SEC, including the risk factors discussed in Alexion’s most
recent Annual Report on Form 10-K, as updated by its Quarterly
Reports on Form 10-Q, in AstraZeneca’s most recent Annual Report on
Form 20-F and in each company’s future filings with the SEC.
Important risk factors could cause actual future results and other
future events to differ materially from those currently estimated
by management, including, but not limited to, the risks that: a
condition to the closing the proposed acquisition may not be
satisfied; a regulatory approval that may be required for the
proposed acquisition is delayed, is not obtained or is obtained
subject to conditions that are not anticipated; AstraZeneca is
unable to achieve the synergies and value creation contemplated by
the proposed acquisition; AstraZeneca is unable to promptly and
effectively integrate Alexion’s businesses; management’s time and
attention is diverted on transaction related issues; disruption
from the transaction makes it more difficult to maintain business,
contractual and operational relationships; the credit ratings of
the combined company declines following the proposed acquisition;
legal proceedings are instituted against Alexion, AstraZeneca or
the combined company; Alexion, AstraZeneca or the combined company
is unable to retain key personnel; and the announcement or the
consummation of the proposed acquisition has a negative effect on
the market price of the capital stock of Alexion or AstraZeneca or
on Alexion’s or AstraZeneca’s operating results. No assurances can
be given that any of the events anticipated by the forward-looking
statements will transpire or occur, or if any of them do occur,
what impact they will have on the results of operations, financial
condition or cash flows of Alexion or AstraZeneca. Should any risks
and uncertainties develop into actual events, these developments
could have a material adverse effect on the proposed transaction
and/or Alexion or AstraZeneca, AstraZeneca’s ability to
successfully complete the proposed transaction and/or realize the
expected benefits from the proposed transaction. You are cautioned
not to rely on Alexion’s and AstraZeneca’s forward-looking
statements. These forward-looking statements are and will be based
upon management’s then-current views and assumptions regarding
future events and operating performance, and are applicable only as
of the dates of such statements. Neither Alexion nor AstraZeneca
assumes any duty to update or revise forward-looking statements,
whether as a result of new information, future events or otherwise,
as of any future date.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210512005957/en/
Media Megan Goulart, +1 (857) 338-8634 Executive
Director, Corporate Communications
Investors Chris Stevo, +1 (857) 338-9309 Head of Investor
Relations
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