CAMBRIDGE, Mass., Jul 27, 2015 (BUSINESS WIRE) —
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: “Caprelsais
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

• 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 greater-than or equal to 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 greater-than or equal to 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 visitwww.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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SOURCE: Genzyme

For Genzyme

Media Relations

Laurence Bollack,
+33 (0)1 53 77 46 46
mr@sanofi.com
or
Investor
Relations
Sébastien Martel, +33 (0)1 53 77 45 45
ir@sanofi.com
or
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Ingrid Mitchell, +1 617-768-6699
Ingrid.mitchell@genzyme.com

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