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Cipher Pharmaceuticals Inc T.CPH

Alternate Symbol(s):  CPHRF

Cipher Pharmaceuticals Inc. is a specialty pharmaceutical company with a diversified portfolio of commercial and early to late-stage products, mainly in dermatology. The Company acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products in Canada, the United States, and South America. Its dermatology products include Actikerall, Epuris, and Vaniqa. Its hospital acute care products include Aggrastat and Brinavess. Its out-licensed products include Absorica, ConZip and Lipofen. Durela is its specialty medicine. Its product pipeline includes MOB-015, CF-101, and DTR-001. It delivers novel products to healthcare professionals and patients in Canada in a range of therapeutic areas, including dermatology, women’s health, urology and others. It also has the Natroba operations and global product rights to Natroba and its authorized generic Spinosad, a topical treatment for both head lice and scabies.


TSX:CPH - Post by User

Bullboard Posts
Post by kurtwalteron Sep 20, 2013 11:54am
317 Views
Post# 21754796

Canaccord on DND

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).




Bullboard Posts