Alchemia Ltd Ordinary Shares (Australia)

[BioSpecialist]

Heparin Trail: Pig Intestines From China Via Wisconsin
Posted by Jacob Goldstein February 15, 2008, 8:27 am
http://blogs.wsj.com/health/2008/02/15/heparin-trail-pigs-intestines-from-china-via-wisconsin/

This is what global drug outsourcing looks like.

Baxter International, of Deerfield, Ill., buys the active ingredient for the anti-clotting drug heparin (possibly tied to a few deaths and several hundred cases of nasty side effects) from Scientific Protein Laboratories of Waunakee, Wis., the WSJ reports.

chinadrugsScientific Protein gets most of the stuff — which comes from pig intestines — from a joint venture called Changzhou SPL in Changzhou, China. Scientific Protein, by the way, is owned mostly by a buyout and financing firm called American Capital Strategies based in Bethesda, Md.

Got all that?

The heparin story is adding to worries over FDA oversight of imported drugs and drug ingredients and heightening specific concerns about Chinese health products. China, though a minor supplier of finished drugs, already is a major source of active ingredients for drugs. FDA says it hasn’t inspected the Changzhou plant. The agency is required to inspect domestic drug manufacturers every two years, but that requirement doesn’t apply to the growing number of overseas plants.

Scientific Protein said it has been making the heparin active ingredient at the Chinese plant since 2004, and that the company “engages in the same testing and quality-control procedures as U.S. facilities that produce bulk heparin” and meet FDA standards.

David G. Strunce, president of Scientific Protein, told the WSJ that most of its active ingredient for heparin is made in China, but some comes from a Wisconsin factory. “There’s nothing that would explain these reactions, and we are very concerned about this,” he said. “We have no idea if these reactions have anything to do with our product.”

________________________________________________________________


All natural heparins are now sourced from pig intestines. That includes the full length heparin Baxter was selling and the low molecular weight heparins like enoxaparin. They used to be sourced from Cattle as well but since mad cow disease that supply source has stopped.

The issue with the Baxter material seems to one of quality control. That's a very difficult issue when the product is extracted from animal sources because the heparin comes out as a complex mixture (like crude oil). It is not yet certain whether that is at source or in the US (though I bet there will be a lot of finger pointing going on).

Fortunately for Alchemia, fondaparinux is a synthetic heparin and can't suffer from animal contamination issues. It will be interesting to see how much of the market moves to the safer fondaparinux option in light of the recent problems with pig heparin. Fondaparinux certainly seems to have a market advantage here.