Aastrom to acquire Sanofi's Cell Therapy and Regenerative Medicine business

ANN ARBOR, Mich.—Aastrom Biosciences, Inc., a 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 scheduled to close in approximately three weeks subject to customary closing conditions

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 percent 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 percent 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.

Governments worldwide have created provisions for granting access to drugs prior to approval for patients who have exhausted all alternative treatment options and do not match clinical trial entry criteria. Often grouped under the labels of compassionate use, expanded access, or named-patient supply, these programs are governed by rules which vary by country defining access criteria, data collection, promotion, and control of drug distribution.

In the U.S., pre-approval demand is generally met through treatment IND applications or single-patient INDs. Outside the U.S., named-patient programs provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific patients before those medicines are licensed in the patient’s home country.

Aastrom Biosciences is a 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.