Sunday, July 30, 2017

CTP-656 Cleared for Sale to Vertex Pharmaceuticals - $15.11

The FTC (Federal Trade Commission) has terminated the waiting period for the sale of CTP-656 to Vertex Pharmaceuticals. CTP-656 is the deuterated version of Kalydeco which is approved for people with Cystic Fibrosis. This is another hurdle cleared which we wrote about CNCE: Three Hurdles to Clear. The company will now hold $260 million in cash or around $11.55 per share in cash. The third and last hurdle to clear will be the patent challenge for drug CTP-543 by Incyte Corporation. This one will take longer to circumvent. Thank you for reading.

Sunday, July 23, 2017

CTP-543 Patent Challenge Response

We wrote about the challenge to the patent here CTP-543 Patent Challenge by Incyte. In the lengthy preliminary response from Concert Pharma, and on page 67 was this. "Ruxolitinib has 18 hydrogens, which can create 218 – 1 = 262,143 different deuterated ruxolitinib analogs". That statement may hold importance on the challenge of obviousness.  Thank you for reading.                                            

Monday, July 10, 2017

Phase 2 CTP-543 Clinical Hold Lifted

Today Concert Pharmaceuticals announced that the phase 2 clinical trial of CTP-543 for Alopecia Areata will resume by the end of this month after a two month suspension. We initially wrote about this being one of three hurdles to be cleared CNCE: Three Hurdles to Clear.  The small downside is that the company will start the 24 week trial with the doses of only 4mg and 8mg, but with the potential to amend the protocol to explore higher doses. Prior to the suspension of the trial by the FDA, they were planning on using 4,8,12, and 16mg twice daily from the start. The FDA wants to take a measured approach for the development of using JAK inhibitors for various indications is what the company indicated. That coupled with the phase 1 clinical trials of CTP-543 that only lasted for 7 days of testing, makes sense.
The next hurdle to clear will be the pending sale of CTP-656 to Vertex, which is being considered by the FTC, whether it would be anti-competitive. I expect that second hurdle to clear in the next couple of months. Thank you for reading.