ALLEGAN – Perrigo Company has entered into a
collaborative agreement with Cobrek Pharmaceuticals, a newly formed entity
of Pentech Pharmaceuticals Inc., a privately owned company that specializes
in the research and development of niche generic dosage forms.
Pentech will contribute its ANDA filing for a generic equivalent to Luxiq(R) foam, a $34 million branded pharmaceutical product, to the agreement. Perrigo will
contribute two of its early stage generic topical pipeline products. The
parties will share the development costs and profits generated by these
products, with Perrigo being the exclusive distributor.
Pentech filed its ANDA for Luxiq foam containing a Paragraph IV
Certification with the U.S. Food & Drug Administration and notified
Connetics, the New Drug Application holder for the brand product. On
November 6, 2007, Connetics filed suit alleging patent infringement in the
United States District Court for the Northern District of Illinois to
prevent Pentech from proceeding with the commercialization of its product.
The lawsuit formally initiated the patent process under the Hatch-Waxman
Act. Pentech believes that it is the first to file an ANDA with a Paragraph
IV certification against Luxiq and Perrigo believes that it will be the
first company to market this product.
Perrigo will also invest $12.5 million in cash in Cobrek in exchange
for a minority ownership position. Pentech will contribute to Cobrek all of
its interests in current and future ANDA filings including a potential
first-to-file on a generic version of Hectorol (Doxercalciferol).
For more information, click on Perrigo.Com
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