EXTERNAL PROGRAM PORTFOLIO GTC follows a partnership strategy in its portfolio of external programs, where both a unique intellectual property position and molecular biology expertise are used in the development of a transgenically produced version of the external partner’s protein. The advantages to external partners of using our production platform include enabling the development of proteins that are difficult to produce in traditional recombinant production systems, requiring significantly lower capital investment, assuring lower cost of goods, and providing for flexibility in capacity expansion. The most advanced program in GTC’s external portfolio is with Merrimack Pharmaceuticals. The Merrimack program is for MM-093, a recombinant form of human alpha-fetoprotein, or rhAFP. Alpha-fetoprotein is a human blood protein normally produced during pregnancy and, therefore, is not commercially available from fractionation of the human blood supply. MM-093 has been difficult to express in traditional recombinant systems. GTC has developed goats for Merrimack that express this protein in their milk. In 2002, GTC agreed to expand this relationship to include production and purification of MM-093. Merrimack completed a Phase I study of MM-093 in 2003 and began Phase II evaluations in 2004, and GTC continues to deliver purified MM-093 for use in further human clinical studies by Merrimack. Potential indications for MM-093 include autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and myasthenia gravis (a chronic autoimmune neuromuscular disease). Historically, GTC has had external partnerships with companies such as Centocor, Bristol-Myers Squibb, Abbott, Elan, Progenics and Abgenix. These programs have either been successfully concluded, have entered maintenance of founder animals or are awaiting further direction.
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