[Ip-health] WSJ: FTC Urged to Probe Shire, Sanofi & Icahn Med School Over Fabry Drugs

Thiru Balasubramaniam thiru at keionline.org
Tue Jul 15 06:13:17 PDT 2014


http://blogs.wsj.com/pharmalot/2014/07/15/ftc-urged-to-probe-shire-sanofi-icahn-med-school-over-fabry-drugs/


8:54 am ET
Jul 15, 2014FTC Urged to Probe Shire, Sanofi & Icahn Med School Over Fabry
Drugs

   -



   - By
   - ED SILVERMAN

Two years ago, Shire issued two announcements about its medicine for
treating Fabry disease, a rare affliction that causes a buildup of fatty
material in the autonomic nervous system, eyes, kidneys and cardiovascular
system. On the surface, the announcements – one was about plans to market
the drug in the U.S. and the other was about patent litigation – appeared
unrelated.

But a consumer advocacy group alleges the developments were actually
closely related and may have been the result of a possible conspiracy among
two drug makers – Sanofi
<http://online.wsj.com/public/quotes/main.html?type=djn&symbol=SAN.FR> and
Shire – and the Icahn School of Medicine at Mount Sinai, one of the most
prestigious medical schools, to stifle competition. And now, the U.S.
Federal Trade Commission is being asked to investigate in a letter
<http://freepdfhosting.com/6c7d37f2af.pdf> by the advocacy group.

At the heart of the story are two different Fabry medications – Replagal,
which is sold by Shire, and Fabrazyme, which is sold by the Genzyme unit of
Sanofi. The medical school plays a role because it was awarded a patent 20
years ago on the Genzyme drug, which was developed with support from the
U.S. National Institutes of Health. Shortly afterward, the medical school
licensed exclusive rights to Genzyme.

Here is a brief outline of events <http://freepdfhosting.com/2a4556ef84.pdf>:
In 2005, Shire obtained Replagal after acquiring another company that had
won regulatory approval to sell the drug in Europe, although not the U.S.
At the time, Genzyme was selling the only Fabry treatment approved by the
FDA. But in 2008, Genzyme had to ration supplies due to serious
manufacturing problems that later forced the drug maker into a consent
decree with the FDA.

The following year, the FDA asked Shire to apply for US approval for
Replagal, since Genzyme continued to experience quality-control gaffes and
Fabrazyme remained in short supply. These difficulties battered Genzyme
finances and activist investor Carl Icahn
<http://topics.wsj.com/person/I/carl,-icahn/65> – who was also a trustee at
the medical school – began a proxy battle to force Genzyme management to
alter its game plan.

During 2010 and 2011, the back story grew more complicated. Genzyme
continued to struggle and Sanofi bought the drug maker. The medical school,
meanwhile, alleged Shire violated its patents in several European
countries. And U.S. Fabrazyme patients petitioned the NIH to issue a
license to allow another company to make the drug. The NIH could have done
so, but declined.

Behind the machinations was a serious issue for Fabry patients – they
lacked medicine. Shire was allowed to supply some U.S. patients, but could
not meet demand. The patients lambasted the NIH, since U.S. taxpayer
dollars helped the medical school and Genzyme to profit. And they
complained Genzyme supplied patients in Europe with full doses, which
Genzyme denied.

In short, a public health fiasco was alleged. In response, the medical
school repeatedly promised the NIH that it would not seek to block Shire
from selling Replagal in Europe, although the patent litigation was still
ongoing. By early 2012, however, things began to change rapidly. Genzyme
won FDA permission to produce Fabrazyme at a new plant, which boosted
production.

Then, Shire withdrew an application on file with the FDA to market
Replagal, citing a need for further studies that were unlikely to be
completed soon enough to help alleviate the Fabrazyme shortage. By May
2012, Shire and the medical school settled all patent litigation over
Replagal.

The upshot is that the advocacy group believes Shire agreed to halt its
effort to compete in the U.S. if the medical school granted permission to
Shire to sell its drug in Europe. “It is ironic and deeply disturbing that
NIH-funded research on Fabry disease has been used in a perverse way to
limit competition in the U.S.,” says Jamie Love of Knowledge Ecology
International.

An FTC spokesman declined to comment, as did a spokeswoman for the medical
school and a spokeswoman for Shire. Sanofi did not respond, but we will
update you accordingly.



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