Consolidation Trends Within the Blossoming RegenMed Service Sector

The WuXi acquisition of Apptec (posted last week) is continuing the trend of consolidation in the cell manufacturing sector. It is similar to Lonza’s (a Swiss company) purchase of Cambrex’s biologics division in 2006, and GE’s purchase of Wave Biotech in mid-2007. Lonza is currently the largest manufacturer of cells for therapy, and has process development and manufacturing relationships with many of today’s clinical-stage regenerative medicine companies. GE is making a big splash with Continue reading

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Posted in Apptec, BD, Bioprocessing, Invitrogen, JNJ, Lonza, Manufacturing, Progenitor Cell Therapy, Regenerative Medicine, Stem Cells Inc, WuXi Pharmatech | 1 Comment

Biomimetics Therapeutics Expands into New Markets with Innovative GEM OS Combination Device

by Susan Hsiong, PhD

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Biomimetics Therapeutics, Inc. (Franklin, TN), a company which develops drug-device combination products for orthopedic applications, recently announced positive results from its Canadian clinical study evaluating its GEM OS®1 Bone Graft for the open surgical treatment of foot and ankle fusions. The GEM OS®1 is a combination product comprised of a β-tricalcium phosphate matrix and recombinant-human platelet-derived growth factor (rhPDGF-BB) and is based on the same platform technology as their first product, GEM 21S®, only the second FDA recombinant protein approved product for orthopedic applications.

This product is similar to the market leading INFUSE® Bone Graft by Medtronic Sofamor Danek (the first FDA recombinant protein approved product (2002)) in that they are biomaterials releasing molecular therapeutics to drive local bone regeneration. The differences between the two products are the molecules (growth factor in this case) used to drive bone regeneration and the material used to guide where the bone regenerates: Continue reading

Posted in Biomaterials, biomimetics therapeutics, bone regeneration, combination products, Company Profiles, controlled release, Medtronic, Regenerative Medicine | Tagged , , , , , , , , | 3 Comments

Chinese CRO WuXi Pharmatech Acquires Apptec Laboratory Services

wuxi.pngWuXi (pronounced Woo-See) Pharmatech, a contract research organization (CRO) based in China, announced the acquisition of MN-based Apptec Laboratory Services. WuXi acquired Apptec to gain an immediate US footprint, better access to the US market, and important biologics expertise to expand outside the world of small molecules. This biologics expertise includes Apptec’s cell therapy bioproduction business which they were aggressively moving in to.

These two fast growing companies may be a match made in heaven Continue reading

Posted in Apptec, BD, Bioprocessing, business models, Company Profiles, Invitrogen, JNJ, Lonza, Manufacturing, Regenerative Medicine, WuXi Pharmatech | 1 Comment

Celgene Strengthens Adult Stem Cell Patent Estate

celgene-logo.pngI have recently signed up for the StemCellPatents.com weekly newsletter, and it is great to keep updated on all the patents that get issued in regenerative medicine. In the most recent newletter, they reported on two patents that issued last week that strengthen Celgene’s patent estate in adult stem cells. Celgene got into the stem cell business in late 2002 when they aquired Anthrogenesis (also see Celgene’s History graffic from their website below). Anthrogenesis had technology for harvesting placenta-derived stem cells from post-birth placentas, as well as Continue reading

Posted in adult stem cell, Biomaterials, Celgene, Intellectual Property, placenta stem cells, Regenerative Medicine, stem cells | Tagged , , , , | 1 Comment

New Year’s Resolutions for the Regenerative Medicine Industry

With the New Year upon us, I thought it would be good to make a set of New Year’s Resolutions for the regenerative medicine industry. This set of resolutions is not company specific, but things that will be required to build long term value for this nascent industry.

  1. Get those marketing people working: Any way you look at it, cell-based therapies and combination products are going to be expensive to manufacture. It is therefore important to address unmet medical needs that have devastating consequences in order to justify reimbursement for Continue reading
Posted in business models, Innovation, Regenerative Medicine | Tagged , , , | 2 Comments

FDA Proactively Addresses Embryonic Stem Cell Safety Testing

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The FDA has scheduled an April 10, 2008 meeting to “discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells.” This meeting will be followed by another meeting on April 11 that will “discuss updates on 1) research management related to the September 29, 2005 review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; 2) FDA’s Somatic Cell Therapy Letter; and 3) recently released FDA Guidance documents.” Both meetings will be open to the public, and they are allowing for 30 minutes each day for limited public presentations for those that would like to contribute and provide public input to the discussion.

This meeting has been called “unusual” in the press since Continue reading

Posted in Advanced Cell Technology, cell delivery, Clinical Trials, Embyonic Stem Cells, FDA, Geron, Novocell, Regenerative Medicine, regulatory, stem cells | 1 Comment

Top Ten Events in the Regenerative Medicine Industry in 2007

Top Ten Events in the Regenerative Medicine Industry in 2007 (according to Jon Rowley, and in no particular order):

Posted in Regenerative Medicine | 1 Comment