Canaccord on DND Up 13% at 11:55. Read the last sentence in this brief report.
Cipher Pharmaceuticals* (DND : TSX : $6.41), Net Change: -2.89, % Change: -31.08%, Volume: 1,090,107
Uh oh, Spaghettios. Shares of Cipher Pharmaceuticals were hammered after the company announced that its sales and
distribution partner, Ranbaxy Laboratories has received a Paragraph IV Certification Notice of filing from Watson Laboratories
of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) for a generic version of Absorica.
Ranbaxy and Cipher intend to vigorously defend Absorica's intellectual property rights and pursue all available legal and
regulatory pathways in defense of the product. Absorica is currently protected by two issued patents listed in the FDA's
Approved Drug Products List, which expire in September 2021. Ranbaxy shall take appropriate actions in response to the
Paragraph IV notice letter, and FDA approval of the ANDA shall then be governed by the Hatch-Waxman Act. Absorica was
approved by the FDA in May 2012, and granted a three-year market exclusivity period, which expires in May 2015. The
Paragraph IV is notification that the generic competitor does not believe that it infringes Cipher's patents. Assuming that Cipher
sues Actavis, this would trigger a 30-month stay of an FDA approval for Actavis' drug (it would not be eligible for approval
until March 2016).