Protalix BioTherapeutics, Inc.
) recently signed a supply and technology transfer agreement with
Fundação Oswaldo Cruz (Fiocruz), a Brazilian Health Ministry Arm,
for Uplyso (alfataliglicerase). Uplyso is the company's
proprietary enzyme replacement therapy for treating Gaucher
disease, which is a rare lysosomal storage disorder that affects
very few people worldwide.
According to the agreement, the transfer of technology is
expected to complete in seven years. The transfer is intended to
provide Fiocruz with the capability and skills needed for the
Brazilian government to build its own production facilities, at
its own expense, to provide efficient supply of Uplyso, taking
sustainability, quality and cost-effectiveness into
As per the agreement, Fiocruz will be purchasing Uplyso for at
least $40 million in the first two years, and at least $40
million per year in the following years. Fiocruz is required to
purchase a minimum of $280 million worth of Uplyso, failing which
Protalix is not bound to close the final stage of the transfer.
If needed, the agreement can be extended for another five years
to complete the transfer. The additional years will carry the
same terms of the arrangement, including the minimum annual
The technology transfer agreement is expected to become
effective in one month, once approval is received from the
Brazilian National Institute of Industrial Property.
Protalix has a commercialization partnership with
), for alfataliglicerase. In order to facilitate the technology
transfer agreement, Protalix amended its agreement with Pfizer.
As per the amended agreement, Pfizer returned its
commercialization rights in Brazil to Protalix for a maximum
payment of $12.5 million from the company's net profit each year
of the agreement.
We note that Uplyso received regulatory approval in Brazil in
Mar 2013. Uplyso, which is marketed as Elelyso outside Latin
America, was approved by the FDA and Israel's Ministry of Health
in May 2012 and Sep 2013, respectively.
Currently, other approved therapies for type I Gaucher disease
include Cerezyme and Vpriv. Additionally, Zavesca is another
approved therapy and is the only oral medication approved for
patients suffering from mild to moderate type I Gaucher disease,
and on whom enzyme replacement therapy cannot be carried out.
Protalix currently carries a Zacks Rank #1 (Strong Buy). At
present, companies like
Jazz Pharmaceuticals Public Limited Company
) also carry a comparable rank.
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