TOPIC: ASTM acquires former Genzyme third generation apps

Most of you will not know this- but yes there have been genuine SC apps on the market for quite some time.

Introduced there by Genzyme with some "help" from the FDA. ASTM acquired them all for an "apple and an egg"

Aastrom Biosciences, Inc. (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(R) (autologous cultured chondrocytes) is an autologous chondrocyte implant (ACI) currently marketed in the United States for the treatment of articular cartilage defects. Epicel(R) (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(R) (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(R) (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(R) (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(R) (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.

All those years and selling for peanuts....makes one wonder.

Some positive thoughts and some negative thoughts.

Fas,
An "apple and an egg" I love you my brother.

A product that has found reimbursement very difficult due to high cost and debatable efficacy. A very expensive cultured autologous treatment based on trying to grow cartilage outside the body. This is everything that CYTX and ADRC therapy is NOT.

Genzyme spent a fortune developing this product and now Sanofi is giving it away. The only reason ASTM may have bought it is for the manufacturing facilities that are cGMP compliant for cell expansion/culture given their interest in chronic heart disease using expanded bone marrow stem cells.

Tigenix has outsourced sales of Chondrocelect, a similar type product that has been on the market in europe but which does not have particularly impressive sales.

Cartilage grows very slowly as it does not have a very developed vascular system. Still, some paracrine growth factors and anti inflammation effects may make the ADRC/Celution treatment paradigm a valid treatment option .......... is there any data out there in this indication.??

All- some background on Carticell- from Centeno believe Carticell got approved 1998 or so.

there is only a handful of examples of cellular “products” that have made it to market that are regulated as are federally regulated drugs.</p>
The earliest example of this type of “product” is the autologous cultured cartilage process marketed by Genzyme as Carticel. In this process the surgeon takes a cartilage biopsy and sends this to a central Genzyme lab where it cultured for several months. The culture-expanded sample is then sent back to the surgeon for surgical re-implantation.
Despite FDA’s concerns over the risks for cultured cells, Carticel was approved in less than a year at a time when the average drug approval lag was 7.3 years. This approval was granted under an accelerated approval process for biologic products, [21 CFR 601.40-46], allowing a manufacturer to submit a surrogate endpoint rather than conduct well-controlled studies to verify clinical benefit or durable outcomes. Curiously, the approval process was dramatically accelerated by classifying a knee osteochondral lesion as a serious or life-threatening condition in need of accelerated approval.

John- data I do not know. But in my "bible" on the topic of ADRCs and osteogenic and chondrogenic stuff you can find a lot of answers-

We hypothesized that binding of growth factors to cell surface
receptors occurs within minutes, thus fitting within the
desired time frame of 15 min for induction of cell differentiation.
We tested whether the addition of 10 ng/mL BMP-2
or BMP-7, also known as osteogenic protein-1 (OP-1), for a
duration of 15 min only could stimulate the differentiation of
freshly isolated SVF cells along the osteogenic or chondrogenic
pathway (Figure 3). We found that BMP-2 induced an
osteogenic phenotype, whereas BMP-7 induced a more chondrogenic
phenotype within 4 days. In contrast, 4 days of continuous
incubation with the same dosage ofBMP-2 or BMP-7
did not affect osteogenic or chondrogenic gene expression.

Just a reminder- Olympus owns all rights to OP-1 or BMP-7

Just in case-

My Bible can be downloaded at the blog art Biomaterials etc icle on Biomaterials-

This blog post has been viewed >31000 times, so I must have hit a nerve somewhere in certain circles by writing this thing. .