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March 26, 2003 Oxford GlycoSciences (NASDAQ: OGSI) submitted an amendment to its Zavesca (miglustat) NDA. The amendment addresses FDA concerns that the original August 2001 NDA required supplemental data derived from both further and completed investigation. When requesting the additional data, the FDA indicated that benefit/risk ratio management could be achieved through restricted use of Zavesca, and we remain optimistic that the drug will be approved. However, U.S. label restrictions are likely to be similar to or even more extensive than those on the European Zavesca label.
In March, Actelion (Swiss: ATLN) launched Zavesca in the United Kingdom, indicated for the treatment of patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable. Actelion expects to launch Zavesca throughout the European Union in the near future. OGS seeks marketing approval for the same indication in the U.S. The companies also plan to develop the drug for use in other inborn genetic errors of metabolism such as type 3 Gaucher disease, Niemann-Pick type-C, and late onset Tay-Sachs disease.
Zavesca is both more convenient and less expensive than Genzyme’s (NASDAQ: GENZ) Cerezyme. Zavesca’s overall risk/benefit ratio and its cost-effectiveness profile remain unclear.
OGS is in the midst of a bidding war to be acquired by either Cambridge Antibody Technologies (CAT, NASDAQ: CATG) or Celltech (NYSE: CLL). While CAT and OGS developed the original merger agreement in January 2003, Celltech is attempting to outbid CAT with a superior cash offer. Both CAT and Celltech are lobbying OGS shareholders.
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