zie de verwachting van US analyst over het nemen van de optie door Abbvie op Voba. van de seeking Alpha site:
Why AbbVie Won't Pull A Galapagos On Ablynx
Aug. 29, 2016 8:13 AM ET|
About: Ablynx NV (ABLYF), Includes: ABBV
Jon Crowley
Ablynx has reported data for two trials involving its drug Vobarilizumab.
AbbVie will decide soon if they want to continue their partnership with Ablynx.
AbbVie's pipeline and Vobarilizumab data lead me to believe AbbVie will proceed with the partnership.
Last September AbbVie (NYSE:ABBV) decided to end its partnership with Galapagos for the development of filgotinib, which was a JAK-1 inhibitor. The deal was originally inked in 2012 and involved AbbVie paying Galapagos 150 million up front and 1.2 billion tied to milestones. As a investor in Ablynx (OTC:ABLYF) this had me concerned since Ablynx and AbbVie had a very similar deal set up with Ablynx's drug vobarilizumab. However recent data and AbbVie's pipeline, lead me to believe that AbbVie will decide to continue the partnership when they make their ultimate decision later this year.
About Vobarilizumab
Vobarilizumab is an anti IL-6R antibody being studied for the treatment of Rheumatoid Arthritis and Systemic Lupus Erythematosus (SLE). AbbVie and Ablynx signed a deal a few years ago involving numerous milestones, but the biggest one will be decided in the fourth quarter of this year. If AbbVie decides to continue its collaboration with Ablynx they will take over cost of phase III trials and pay $75 million to Ablynx. Two unique attributes help differentiate vobarilizumab from the competition. Vorbarilizumab binds to albumin at a high rate which increases its half life, this leads to increased time between doses. Vorbarilizumab also selectively inhibits IL-6 trans signaling vs classic signaling. This is believed to lead to vorbarilizumab having a better side effect profile which data from a recent study seems to show. If you are interested in more information about classic vs. trans signaling of IL-6 I recommend this paper which does a good job explaining the differences and possible clinical relevancies.
Vorbarilizumab Results
Vorbarilizumab has reported data on two trials for the treatment of RA so far. The results of the first study were recently published and I think were quite favorable. This first study compared vorbarilizumab to another anti IL-6 called tocilizumab which is marketed by Roche. Tocilizumab has been fairly successful racking up about 1.5 billion in sales last year and growing 14% in the first quarter. The results of the study can be seen below.
Efficacy parameter vobarilizumab
150mg, Q4W
(N=62) vobarilizumab
150mg, Q2W
(N=62) vobarilizumab
225mg, Q2W
(N=63) tocilizumab 162mg, Q1W (N=60) or Q2W (N=4)
ACR202 73% 77% 81% 78%
ACR502 44% 37% 49% 45%
ACR702 16% 24% 21% 23%
Clinically meaningful improvement in HAQ-DI score (greater or equal than 0.25)3 65% 68% 71% 72%
DAS28CRP remission4 26% 27% 41% 27%
DAS28CRP low disease activity or remission4 42% 57% 60% 44%
*Source Ablynx
As seen above ACR 20, 50, and 70 response rates were similar when comparing vorbarilizumab 225mg every 2 weeks to tocilizumab 162mg weekly. Vorbarilizumab (225mg every 2 weeks) really stood out when comparing DAS28 scores. DAS28 is a score that uses C-reactive protein levels and swollen joints to assess disease activity. Forty one percent of vorbarilizumab (225mg every 2 weeks) patients achieved a score qualifying for remission compared to just 27% for tocilizumab. Vorbarilizumab also seemed to have a better side effect profile with only 2.1% of its patients dropping out of the study due to side effects while 6.3% of tocilizumab patients dropped out of the trial due to side effects. The last positive that sets vorbarilizumab apart is that the most effective dose was only dosed every two weeks while Tocilizumab has to be given weekly.
A second study was recently published comparing vorbarilizumab and methotrexate to placebo.
The biggest concern with the above data is the lack of differentiation between the placebo response rates and the vobarilizumab response rates, specifically ACR20 response rates at week 24 where there was no statistical difference for any dose compared to placebo. This is concerning and something AbbVie will look hard at when deciding if they want to continue with their partnership. However when looking at the data in isolation Vorbarilizumabs response rates look much more compelling. Also the data looks good when comparing Vorbarilizumabs response rates to its competitors. When comparing remission rates as determined by DAS28 scores Vorbarilizumab had a rate of remission of 49% compared to Sarilumab which had 34 percent reach remission and Tocilizumab which had a 27 percent remission rate. Both these drugs are anti IL-6R antibody as well. I want to stress that these are not head to head trials and inter trial comparisons are problematic. Why the Vobarilizumab study had such a strong placebo response is tough to say but it makes the data much more difficult to analyze.
AbbVie's pipeline
The final piece of the puzzle is that AbbVie lacks a Anti-IL-6R in its pipeline. Unlike the deal with Galapagos which involved a JAK 1 of which AbbVie had its own candidate in its pipeline. AbbVie ultimately decided to go with its candidate known as ABT-494 instead of Galapagos's filgotinib. AbbVie already sells Humira which is the best selling autoimmune medication of all time and has a well developed autoimmune pipeline. AbbVie adding Vobarilizumab to its product portfolio will give its autoimmune sales reps another drug in their arsenal as well as maintaining AbbVie as a leader in autoimmune disorders. All told considering AbbVie's lack of a Anti-IL-6R in their pipeline, the synergies with its autoimmune franchises, as well as the mostly positive clinical data I expect AbbVie to continue their relationship with Ablynx and start funding phase III studies for Vobarilizumab.
Disclosure: I am/we are long ABLYF.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.