A Scottish company that focuses on producing recombinanthuman proteins in the milk of transgenic livestock hasachieved a toehold in the U.S. through its merger withTransPharm Inc. of Blacksburg, Va., announced Tuesday.

TransPharm, which has expertise in creating transgenic pigs toproduce the blood coagulation factor Protein C, will continue tooperate as a wholly owned subsidiary of the newly formedPharmaceutical Proteins Holdings plc. Meanwhile,Pharmaceutical Proteins Ltd. (PPL) of Edinburgh will alsocontinue to function as a wholly owned subsidiary. Bothcompanies will continue trading under their own names.

"This merger creates the first multinational corporation withtransgenic expertise using more than one species of farmanimal, allowing us to choose the best species for each product,"said Tracy Wilkins, who founded TransPharm. A professor anddirector of the Center for Biotechnology at Virginia PolytechnicInstitute and State University, he will join the board of theholding company.

PPL may use the Virginia base to manufacture pharmaceuticalproteins for the U.S. market, said PPL's managing director, RonJames, whose company uses transgenic sheep.

PPL announced major collaborations in 1992 with the Wyeth-Ayerst division of American Home Products to developimproved special-use products, and with Bayer AG to developalpha-1-antitrypsin (AAT) in milk of transgenic animals.

Congenital deficiency of AAT is a common genetic disorder thataffects about 100,000 people in Europe and North America,leading to excess elastase activity and permanent lung damage,including chronic emphysema. Bayer's U.S. pharmaceuticalaffiliate, Miles Inc., already has a plasma-derived product onthe market to address this deficiency, but a more plentifulsource is needed to supply the large doses used.

PPL uses transgenic mice to establish initial feasibility ofprotein production, then switches to sheep for bulk production.The recombinant proteins are exclusively secreted in milk, andthe animals develop normally. In Europe, sheep are routinelymilked by machine, allowing automated protein recovery.Purification costs are equivalent to or better than those forconventional protein sources, depending on levels ofexpression.

PPL has established transgenic mice containing genes for sixdifferent human proteins and is carrying out contract researchfor three companies. Development from mice to livestock takesabout five years, and can be used to produce pharmaceuticalsthat normally have high costs or require large volumes, or tomake reference standards or other reagents.

-- Nancy Garcia Associate Editor

(c) 1997 American Health Consultants. All rights reserved.