Aastrom Announces Definitive Agreement to Acquire Sanofi's Cell Therapy and Regenerative Medicine Business
April 21 2014 - 8:30AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific, expanded multicellular therapies for the
treatment of severe, chronic cardiovascular diseases, today
announced that it has entered into a definitive agreement to
acquire Sanofi's Cell Therapy and Regenerative Medicine (CTRM)
business for a purchase price of $6.5 million, with $4 million
payable in cash at closing and $2.5 million payable in the form of
a promissory note. The acquisition is subject to customary closing
conditions and is scheduled to close in approximately three weeks.
Through the CTRM acquisition, Aastrom is acquiring global
commercial rights to three marketed autologous cell therapy
products. Carticel® (autologous cultured chondrocytes) is an
autologous chondrocyte implant (ACI) currently marketed in the
United States for the treatment of articular cartilage
defects. Epicel® (cultured epidermal autografts) is a
permanent skin replacement for full thickness burns greater than or
equal to 30% of total body surface area, and is marketed in
countries around the world. MACI® (matrix-induced autologous
chondrocyte implant) is a third-generation ACI product currently
marketed in the European Union. Revenues of those three
products were $44 million in 2013. Aastrom will also acquire global
manufacturing and production centers located in the United States
and Denmark.
"The acquisition of Sanofi's CTRM business is a transformative
transaction that positions Aastrom as a fully-integrated global
regenerative medicine company," said Nick Colangelo, president and
chief executive officer of Aastrom. "The CTRM business brings
us global manufacturing, marketing and sales capabilities that are
structured to support the current portfolio of marketed products as
well as our future product development plans. This transaction
also provides us with a platform to generate operating income to
support the development of our high-potential pipeline products and
continued growth through additional strategic transactions."
"Sanofi's CTRM business, a pioneering organization with more
than 20 years of experience in cell therapy and regenerative
medicine, developed and marketed some of the first regenerative
medicine products in the world," continued Mr. Colangelo. "We
look forward to working with the talented CTRM team to build
Aastrom into the leading cell therapy company in the regenerative
medicine field."
Sanofi acquired the CTRM business in 2011 through the
acquisition of Genzyme Corporation.
Carticel® (autologous cultured chondrocytes), an autologous
chondrocyte implant (ACI) for the treatment of articular cartilage
defects, was approved by the FDA in 1997 and has had more than
22,000 implants performed since that time. MACI® (matrix-induced
autologous chondrocyte implant), is a third-generation ACI product
commercially available in the European Union since 1998, with more
than 10,000 patients treated to date. Epicel® (cultured epidermal
autografts), a permanent skin replacement for full thickness burns
greater than or equal to 30% of total body surface area, is
approved for use as a humanitarian use device in the United States
and supplied to patients outside the U.S. on a named-patient
basis.
Aastrom Biosciences
Aastrom Biosciences is the leader in developing
patient-specific, expanded multicellular therapies for use in the
treatment of patients with severe, chronic cardiovascular
diseases. The company's proprietary cell-processing technology
enables the manufacture of ixmyelocel-T, a patient-specific
multicellular therapy expanded from a patient's own bone marrow and
delivered directly to damaged tissues. Aastrom has advanced
ixmyelocel-T into late-stage clinical development, including a
Phase 2b clinical trial in patients with ischemic dilated
cardiomyopathy. For more information, please visit Aastrom's
website at www.aastrom.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
This document contains forward-looking statements, including,
without limitation, statements concerning the acquisition of
Sanofi's Cell Therapy and Regenerative Medicine business pursuant
to Aastrom's asset purchase agreement with Sanofi, including the
timing and ability to close the acquisition and the ability of the
combined business to generate operating income, among others. These
statements are often, but are not always, made through the use of
words or phrases such as "anticipates," "intends," "estimates,"
"plans," "expects," "we believe," "we intend," and similar words or
phrases, or future or conditional verbs such as "will," "would,"
"should," "potential," "could," "may," or similar expressions.
Actual results may differ significantly from the expectations
contained in the forward-looking statements. Among the factors that
may result in differences are the inherent uncertainties associated
with the closing of the acquisition described herein, regulatory
approval requirements, the ability to retain key employees from
Sanofi, the timing and cost associated with consolidating the Cell
Therapy and Regenerative Medicine business with Aastrom's existing
business, and the availability of resources and the allocation of
resources among different potential uses. We also encourage
investors to consider the risks and other significant factors
discussed in greater detail in Aastrom's Annual Report on Form 10-K
for the year ended December 31, 2013, filed with the Securities and
Exchange Commission ("SEC") on March 13, 2014 and other filings
with the SEC. These forward-looking statements reflect management's
current views and Aastrom does not undertake to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release
except as required by law.
CONTACT: Media contact:
Andrea Coan
Berry & Company
acoan@berrypr.com
(212) 253-8881
Investor contact:
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
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