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The biogenerics are really
finally coming. After years of anticipation, the EMA and FDA have both finally
approved at least one such product. Just as encouraging to biogeneric supporters
is the $264 million deal that was recently struck between Novartis’ Sandoz
generics unit and Momenta Pharmaceuticals.
Sandoz, after all, was the
first company to get a biogeneric on both the European and U.S. markets. That drug is Omnitrope, a generic version of Genotropin (human growth
hormone), which had been netting Pfizer about $800 million per year. Sandoz
literally waited years and eventually sued the FDA to get the drug approved.
Momenta, meanwhile, has novel
technology that addresses the major problem facing biogenerics — the inherent
complexity of biotech products. Unlike traditional small molecules, “Many
biologicals are not homogenous but are heterogeneous mixtures,” explains
Momenta CEO Alan Crane.
“We believe the paradigm with
biogenerics will be based on structural analysis and characterization,” says
Crane. The three central elements to the Momenta platform are thousands of
patents, proprietary enzymes, and novel analytics.
Last year, Momenta and Sandoz
created a stir when they submitted an abbreviated new drug application (ANDA)
for M-enoxaparin — Sanofi-Aventis’ popular low-molecular-weight heparin (LMWH),
Lovenox. Worldwide sales of that drug were almost $2.5 billion in 2004.
One thing seems to have led to
another. Now the Sandoz/Momenta partnership has blossomed into: “One of the
largest deals that has been done in biogenerics and follow-on proteins,”
explains Crane. The deal covers M-enoxaparin, one late-stage compound from
Momenta’s pipeline, and two late-stage compounds from Sandoz. There is more
than $180 million in milestones riding on those projects. Sandoz has also made a
$75 million equity investment in Momenta.
The deal is undoubtedly great
news for the little startup, but it remains to be seen whether this is an
equally great start for biogenerics, or whether their complexity will keep the
flow of these products to a trickle.
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Alan Crane, CEO of Momenta
Pharmaceuticals |
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