Genzyme, a Sanofi company, today announced that it has entered
into a definitive agreement with AstraZeneca to acquire Caprelsa®
(vandetanib), a rare disease therapy, indicated for the treatment
of symptomatic or progressive medullary thyroid carcinoma in
patients with unresectable locally advanced or metastatic
disease.
Caprelsa is an oral kinase inhibitor treatment and is currently
available in 28 countries. Caprelsa is in Phase III development for
differentiated thyroid carcinoma, with the study expected to finish
in the second half of 2015.
“The addition of the Caprelsa represents a strong strategic fit
for our rare Endocrinology portfolio and underscores Genzyme’s
commitment to addressing unmet needs in the thyroid community,”
said Genzyme’s President and CEO, David Meeker, M.D. “We look
forward to bringing our rare disease expertise to appropriate
patients with advanced stage thyroid carcinoma.”
The acquisition builds on Genzyme’s long-standing commitment and
scientific leadership in the field of endocrinology globally. Under
the terms of the agreement, Genzyme will pay AstraZeneca up to $300
million, including an upfront payment of $165 million to acquire
the global rights to sell and further develop Caprelsa, and further
development and sales milestone payments of up to $135 million. The
transaction does not include the transfer of any AstraZeneca
employees or facilities.
Luke Miels, Executive Vice President, Global Product &
Portfolio Strategy and Corporate Affairs, AstraZeneca, said:
“Caprelsa is a rare disease therapy and the divestment to Genzyme,
an expert leader in endocrinology, demonstrates our commitment to
ensure patients continue to have access to this medicine while we
sharpen our focus on key disease areas.”
The transaction is subject to closing conditions, including the
receipt of antitrust clearance from the US Federal Trade
Commission. The transaction is expected to complete in the second
half of 2015.
CAPRELSA (vandetanib) US Indication
CAPRELSA is indicated for the treatment of symptomatic or
progressive medullary thyroid cancer in patients with unresectable
locally advanced or metastatic disease.
Use CAPRELSA in patients with indolent, asymptomatic or slowly
progressing disease only after careful consideration of the
treatment related risks of CAPRELSA.
Important Safety Information, Including Boxed WARNING, for
CAPRELSA
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN
DEATH • CAPRELSA can prolong the QT interval. Torsades de pointes
and sudden death have occurred in patients receiving CAPRELSA • Do
not use CAPRELSA in patients with hypocalcemia, hypokalemia,
hypomagnesemia, or long QT syndrome. Correct hypocalcemia,
hypokalemia and/or hypomagnesemia prior to CAPRELSA administration
• Monitor electrolytes periodically • Avoid drugs known to prolong
the QT interval • Only prescribers and pharmacies certified with
the restricted distribution program are able to prescribe and
dispense CAPRELSA
- Do not use in patients with congenital
long QT syndrome
- CAPRELSA can prolong the QT interval in
a concentration-dependent manner. Torsades de pointes, ventricular
tachycardia and sudden deaths have occurred in patients treated
with CAPRELSA
- Do not start CAPRELSA treatment in
patients whose QTcF interval (corrected QT interval, Fridericia) is
greater than 450 ms or who have a history of Torsades de pointes,
bradyarrhythmias, or uncompensated heart failure. CAPRELSA has not
been studied in patients with ventricular arrhythmias or recent
myocardial infarction
- Stop CAPRELSA in patients who develop a
QTcF greater than 500 ms until QTcF returns to less than 450 ms.
Dosing of CAPRELSA can then be resumed at a reduced dose
- Because of the risk of QT prolongation,
obtain an ECG and serum potassium, calcium, magnesium, and
thyroid-stimulating hormone (TSH) at baseline, 2-4 weeks and 8-12
weeks after starting treatment with CAPRELSA, and every 3 months
thereafter. Following any dose reduction or interruptions greater
than 2 weeks, conduct QT assessments as described above
- Severe skin reactions (including
Stevens-Johnson syndrome), some leading to death, have occurred in
patients treated with CAPRELSA. Consider permanent discontinuation
of CAPRELSA for severe skin reactions
- Photosensitivity reactions can occur
during CAPRELSA treatment and up to 4 months after treatment
discontinuation
- Interstitial lung disease (ILD) or
pneumonitis, including fatalities, has occurred in patients treated
with CAPRELSA. Interrupt CAPRELSA for acute or worsening pulmonary
symptoms and discontinue CAPRELSA if ILD is confirmed
- Ischemic cerebrovascular events,
including fatalities, occurred in patients treated with CAPRELSA.
The safety of resumption of CAPRELSA therapy after resolution of an
ischemic cerebrovascular event has not been studied. Discontinue
CAPRELSA in patients who experience a severe ischemic
cerebrovascular event
- Serious hemorrhagic events, including
fatalities, occurred in patients treated with CAPRELSA. Do not
administer CAPRELSA to patients with a recent history of hemoptysis
of ≥1/2 teaspoon of red blood. Discontinue CAPRELSA in patients
with severe hemorrhage
- Heart failure, including fatalities,
occurred in patients treated with CAPRELSA. Monitor for signs and
symptoms of heart failure. Consider discontinuation of CAPRELSA in
patients with heart failure. Heart failure may not be reversible
upon stopping CAPRELSA
- Diarrhea of Grade 3 or greater severity
occurred in patients receiving CAPRELSA. If diarrhea occurs,
carefully monitor serum electrolytes and ECGs to enable early
detection of QT prolongation resulting from dehydration. Interrupt
CAPRELSA for severe diarrhea and upon improvement resume CAPRELSA
at a reduced dose
- Increased dosing of thyroid replacement
therapy was required in 49% of CAPRELSA-treated patients. Obtain
TSH at baseline, at 2-4 weeks and 8-12 weeks after starting
treatment with CAPRELSA, and every 3 months thereafter. If signs or
symptoms of hypothyroidism occur, examine thyroid hormone levels
and adjust thyroid replacement therapy accordingly
- Hypertension, including hypertensive
crisis, has occurred in patients treated with CAPRELSA. Monitor all
patients for hypertension. Dose reduction or interruption for
hypertension may be necessary. If hypertension cannot be
controlled, do not resume CAPRELSA
- Reversible posterior
leukoencephalopathy syndrome (RPLS) has occurred in patients
treated with CAPRELSA. Consider this syndrome in any patient
presenting with seizures, headache, visual disturbances, confusion
or altered mental function. In clinical studies, three of four
patients who developed RPLS while taking CAPRELSA also had
hypertension. Discontinue CAPRELSA treatment in patients with
RPLS
- Avoid administration of CAPRELSA with
anti-arrhythmic drugs and other drugs that may prolong the QT
interval
- Vandetanib exposure is increased in
patients with impaired renal function. Reduce the starting dose to
200 mg in patients with moderate to severe renal impairment and
monitor the QT interval closely. There is no information available
for patients with end-stage renal disease requiring dialysis
- CAPRELSA is not recommended for
patients with moderate and severe hepatic impairment, as safety and
efficacy have not been established
- CAPRELSA can cause fetal harm when
administered to a pregnant woman. Women of childbearing potential
should avoid pregnancy and be advised that they must use effective
contraception during CAPRELSA treatment and for at least 4 months
following the last dose of CAPRELSA
- The most commonly reported adverse drug
reactions (>20%) seen with CAPRELSA and with a between arm
difference of ≥5% are diarrhea/colitis (57%), rash (53%), acneiform
dermatitis (35%), hypertension (33%), nausea (33%), headache (26%),
upper respiratory tract infections (23%), decreased appetite (21%),
and abdominal pain (21%)
- CAPRELSA REMS Program: Because
of the risks of QT prolongation, Torsades de pointes, and sudden
death, CAPRELSA is available only through the CAPRELSA REMS
Program. Only prescribers and pharmacies certified with the
restricted distribution program are able to prescribe and dispense
CAPRELSA. To learn about the specific REMS requirements and to
enroll in the CAPRELSA REMS Program, call 1-800-236-9933 or
visit www.caprelsarems.com
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of
transformative therapies for patients affected by rare and
debilitating diseases for over 30 years. We accomplish our goals
through world-class research and with the compassion and commitment
of our employees. With a focus on rare diseases and multiple
sclerosis, we are dedicated to making a positive impact on the
lives of the patients and families we serve. That goal guides and
inspires us every day. Genzyme’s portfolio of transformative
therapies, which are marketed in countries around the world,
represents groundbreaking and life-saving advances in medicine. As
a Sanofi company, Genzyme benefits from the reach and resources of
one of the world’s largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at
www.genzyme.com.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients’ needs.
Sanofi has core strengths in diabetes solutions, human vaccines,
innovative drugs, consumer healthcare, emerging markets, animal
health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and
in New York (NYSE: SNY).
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of cardiovascular, metabolic, respiratory, inflammation,
autoimmune, oncology, infection and neuroscience diseases.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information please visit: www.astrazeneca.com
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
the Group’s ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact
of cost containment policies and subsequent changes thereto, the
average number of shares outstanding as well as those discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under “Risk Factors” and “Cautionary
Statement Regarding Forward-Looking Statements” in Sanofi’s annual
report on Form 20-F for the year ended December 31, 2014. Other
than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20150726005051/en/
For GenzymeMedia RelationsLaurence Bollack, +33
(0)1 53 77 46 46mr@sanofi.comorInvestor RelationsSébastien
Martel, +33 (0)1 53 77 45 45ir@sanofi.comorGenzyme Media
RelationsIngrid Mitchell, +1
617-768-6699Ingrid.mitchell@genzyme.com
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