Mistral starts clinical studies for generic
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BY OUR PHARMA CORRESPONDENT
13th August, 2005:Montreal-based Mistral
Pharma is expecting the results of the preliminary
trials of its first unnamed generic product during
autumn 2005. If the trials are successful, the
product will enter Pivotal Clinical trials, the
last important step before submitting the product
to the FDA for approval, the company announced in
a press release.
The news came with an announcement that ratiopharm
has informed Mistral it is ending the two
development agreements the two firms have signed.
ratiopharm and Mistral entered into the product
development, collaboration and licensing
agreements in March and November 2004. The
agreements were for two undisclosed generic
controlled delivery products, including the one
now entering clinical trials, along with a
manufacturing agreement with ratiopharm and Confab
Laboratories.
Under the terms of the agreements, ratiopharm was
to finance the development work for two products
for the US and Canadian markets, using Mistral
Pharma's proprietary technology, and was to pay
Mistral a series of milestone payments upon
completion of successful developmental stages as
well as royalties.
Mistral said with the termination of the
agreement, it will pursue its collaboration with
Confab for commercial manufacturing of the
products.
Mistral added that according to ratiopharm, the
decision to end the agreement had come following a
review of ratiopharm's development programme, and
was not related to Mistral's technologies or
product development status. Mistral will continue
to pursue the development work of its generic and
branded products.
Mistral Pharma Inc. is a pharmaceutical company
specializing in the development of
controlled-delivery generic and branded drug
products. The company formulates, develops and
commercializes controlled-release, oral
pharmaceuticals. Mistral Pharma licensed worldwide
rights to Procise, an oral, controlled-release,
drug delivery technology developed and patented by
GlaxoSmithKline (GSK), based on a constant surface
area concept. In addition, Mistral Pharma licensed
from Savit Consulting Inc. the exclusive worldwide
rights to Savit and Chronop, two next-generation
surface area controlling oral drug delivery
technologies.
Ratiopharm is a privately-held company based in
Ulm, Germany. Founded in 1974, it now claims to be
the leading generic company in Germany, and the
third largest pharmaceutical company overall, in
terms of prescriptions.Sales in 2004 amounted to
just under 1.2 billion euros, of which just over
half was generated in Germany. The company also
has a major presence in other European countries,
such as the UK and the Netherlands. ratiopharm has
only a very limited presence in North America,
although it has recently been expanding its
Canadian operations.
ratiopharm's latest major acquisition was
Magnafarma, a Dutch generic company. This was
purchased in February 2004 and has now been
renamed ratiopharm BV. ratiopharm has a generic
biologic subsidiary named BioGeneriX. BioGeneriX
has a number of alliances with potential
biogeneric companies around the world.
BY OUR PHARMA CORRESPONDENT |
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