Cipher Pharmaceuticals Inc., a specialty pharmaceutical company, has strengthened its product pipeline by acquiring the worldwide rights to three products from Astion Pharma (Astion), a Denmark-based specialty pharmaceutical company. The three products are focused on inflammatory dermatological diseases: Dermadexin, Pruridexin, and ASF-1096.
Dermadexin is a patent-protected topical barrier-repair cream containing the pharmacologically active ingredient P3GCM. The product was approved in the European Union (EU) in 2014 as a Class III medical device for the treatment of seborrheic dermatitis, an inflammatory skin disorder affecting the scalp, face, and torso. Dermadexin SD Cream has been tested in two placebo-controlled, multicenter clinical trials (436 patients) where it displayed a marked and statistically significant effect on the symptoms of facial seborrhoeic dermatitis with a fast onset of action and an increasing effect over time.
Pruridexin is a patent-protected topical cream for the treatment of chronic pruritis (itching), which is a significant unmet need. Pruridexin was submitted to the European Medicines Agency in 2014 as a Class III medical device and is under active review with a response expected in the first half of 2015. Pruridexin Cream has been tested in two placebo-controlled, multicenter clinical trials (352 patients) and displayed a marked and statistically significant effect on the pruritus with a fast onset of action and an increasing effect over time.
ASF-1096 is a product candidate in phase II that is being investigated as a treatment for discoid lupus erythematosus, a severe, chronic, inflammatory and disfiguring skin disease that affects about 3 out of 10,000 in the general population. ASF-1096 has been awarded orphan drug status in the EU.
"This transaction strengthens our dermatology product pipeline and gives us two late-stage assets in Dermadexin and Pruridexin that target common, chronic conditions that are insufficiently addressed today," said Shawn O'Brien, president & chief executive officer of Cipher. "We believe there is a sizable market opportunity for these products and aim to submit both for US regulatory approval in the first half of 2015, followed by Canadian regulatory approval. We will also pursue an orphan drug indication in the US for ASF-1096, a product candidate that has promise as a treatment for a highly disfiguring rare disease with no current cure."
O'Brien added: "One of our strategic priorities is to establish US commercial infrastructure focused on dermatology. If approved, we expect to commercialize these products on our own in the US and Canada."
The transaction includes an upfront payment to Astion of CDN$6.0 million, which was funded using Cipher's current cash resources. A subsequent CDN$2.5 million milestone will be paid upon regulatory approval and commercialization of Dermadexin or Pruridexin in the US, which is where Cipher will focus its commercialization efforts. The agreement includes approximately CDN$31.5 million in additional payments contingent upon clinical milestones, regulatory approvals, commercialization and sales milestones in the both the US and other regions. Over time, Cipher expects to out-license the products to partners in certain other regions.