Patent Expiration Dates

A drug's patent is of extreme importance to the company that has developed the drug, and competitors looking for acquisition.  This is a running patent list, as new drugs become of interest.  The typical drug patent extends for 20 years from the priority date, once the patent is approved.  After 20 years, and any additional patent extensions, generic companies are able to replicate, and sell the drug at a very high discount to the expired patented drug.

AVP-923 US 2026                                                          

AVP-923 EU 2023

AVP-786 US 2030
AVP-786 EU 2028
AXS-05  US 2040
AXS-07 US 2036
D-Baricitinib US (August 2032)
D-Baricitinib EU xxxx
Baricitinib US 2028
CTP-543 US 2037
CTP-543 EU xxxx
Ruxolitinib US (Dec 2027)
CTP- 656 US (May 2031)
CTP- 656 EU xxxx
Kalydeco US 2027
Kalydeco EU 2025
CTP-692 2038
CTP- 730 US 2030
CTP- 730 EU 2030
Otezla US 2024 (pending through 2028)
Otezla EU 2028
GLPG0634  US (June 2029)
GLPG 1837  US 2034
ITI- 007 US 2028
JZP-386 US, EU, JP (2030-2032)
Xyrem  2019-2024
MIN-101 GR US 2035
D-Momelotinib US (Jan 2033)
D-Momelotinib EU  xxxx
Momelotinib US (March 2027)
Nuplazid US 2028
Nuplazid EU 2025
Rexulti US (February 2027)

Rexulti EU (December 2026)
SAGE-217 US  April 2034
SAGE-217 EU April 2034
SAGE-547 US  to 2033 - 2037
SAGE-718 US  Sep 2032 or Oct 2037
                                  
 

CTP-730: Potential Milestone and Royalty Winner

We originally wrote about CTP-730 here, What is CTP-730.  Today Celgene held it's second quarter conference call this morning.  This is what Scott Smith head of Global Inflammation and Immunology had to say regarding the launch of Otezla, and the future pipeline of indications that Otezla could potentially get approved for.  
Scott Smith President, Global Inflammation and Immunology
"Thank you, Jackie.  Q2 was a great quarter for Celgene I and I.  During the quarter, we saw significant acceleration of prescriptions and revenues for OTEZLA in the U.S. and strong initial uptake in the early launch countries internationally. We also made progress on indication expansion for OTEZLA advancing a global Phase III program in Behcet's Disease and Phase II studies in atopic dermatitis and ulcerative colitis.
Now turning to OTEZLA, were seeing a substantive uptick in revenues and demand in the U.S. Total prescriptions far outpace the recent launch analogs in the I & I space and currently measure over 4,500 TRx' per week based on the latest data. Revenues for the quarter grew to $90 million worldwide and we're tracking well in line with internal plans. We're very encouraged at the progress we're seeing outside of the U.S., both in Canada and in early launch countries in the EU.  After only five months, we're outpacing all recent launches in Germany.  Still very early in the launch, but this initial success helps reinforce the global value proposition of OTEZLA and the need for novel approaches to the treatment of I & I disease.
The trends in the U.S. are supported by positive launch metrics.  While the PSA launch continues to make strong and steady progress, the launch of psoriasis indication has fueled much of the recent acceleration.
Access to new therapies is a critical component of success in the market.  And it's important to note that over 70% of OTEZLA prescriptions in pre-biologic patients are being approved on first pass. Total U.S. patient share for OTEZLA in psoriasis surpassed ALLERA some months ago and passed ENBREL's overall patient share in June.  The source of business in psoriasis continues to be heavily weghted towards the pre-biologic sector with 75% of patients coming to OTEZLA from topical therapy or no therapy at all over the past 12 months".

Bottom Line:  CTP-730 is Concert Pharmaceutical's deutered enhanced Otezla, that just finished a phase 1 clinical trial.  CTP-730 has been licensed to Celgene, with future milestone, and royalty payment potential for Concert.  Otezla has had a very strong launch, and could expand into Behcet's Disease, atopic dermatitis, and ulcerative colitis. Thank you for reading.
 

What is CTP-730

CTP-730 is the deutered enhanced version of Otezla (Apremilast), that is manufactured by Celgene.  The drug was approved in March of 2014 for psoriatic arthiritis, and again in September of 2014 for moderate to severe plaque psoriasis. The patent for Otezla runs until 2024 US and EU.  The drug is forecasted to bring in around $2 billion in revenue by 2020. The typical dose is 30 mg twice daily, and the drug is known to exhibit side effects such as diarrhea, nausea, and headache. A deuterated version could potentially reduce the dosage to once daily, improve the efficacy, and side effect profile.
Concert is currently in phase 1 testing to explore the safety and pharmacokinetics profile compared to placebo with a full readout around September 2015.  Once the trial is complete a one time $8 million milestone will be awarded to Concert from Celgene. More importantly, will be the trial results....the first in human trials for CTP-730.  The relevance for increased efficacy, or safety with a once a day tablet, would be valuable to Celgene, not to mention the increased patent life that the D-Apremilast version would have, to 2030. Thank you for reading.  
                                                                                       

Concert Pharmaceuticals - ($14.73)

Concert Pharmaceuticals (CNCE), is an interesting company, with a well established and cohesive management team.  The company description below is directly from the most recent 10-K. "We are a clinical stage biopharmaceutical company applying our extensive knowledge of deuterium chemistry to discover and develop novel small molecule drugs. Our approach starts with approved drugs, advanced clinical candidates or previously studied compounds that we believe can be improved with deuterium substitution to provide better pharmacokinetic or metabolic properties, thereby enhancing clinical safety, tolerability or efficacy. We believe our approach may enable drug discovery and clinical development that is more efficient and less expensive than conventional small molecule drug research and development".

The company is taking existing drugs, and potentially improving them with selective deuterium.  They plan on developing drugs in-house and through partnership with other companies.  Some quick facts below.

Quick Facts:
22 million shares outstanding
330 million market cap
75 million in cash

Intellectual Property:
AVP-786 (Otsuka) (2030 US), (2028 EU) 
AVP-923 (Otsuka) (2026 US), (2023 EU)
Rexulti (Otsuka) (2027 US), (2025 EU)
CTP-499 (2029 - 2030) U.S. EU, Japan
CTP-730 (2029 - 2034) U.S. EU, Japan
JZP-386 (2030 - 2032) U.S. EU, Japan
CTP-656 (2032) U.S.
Kalydeco (Vertex) (2027 US), (2025 EU)

As you can see above, the company has done a fine job of protecting their intellectual property with extended patent dates, which gives them enough time to get through clinical trials to commercialization, either in house or through partnership. A $280 million market cap puts CNCE in microcap territory (less than $300 million). Hard to find a microcap stock with this much future potential, with an established and cohesive management team in place. We'll have more to say about Concert Pharmaceuticals. Thank you for reading.