FDA approves Cosentyx for the treatment of ankylosing spondylitis and psoriatic arthritis

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• We reported in November that the EMA had approved Cosentyx for the treatment of psoriatic arthritis and ankylosing spondylitis.  This coincided with impressive data reported at ACR
• In particular, for ankylosing spondylitis Cosentyx efficacy in MEASURE 2 (dosing with the approved sc induction regimen) was maintained for 52wks and was associated with long term prevention of radiographic progression in MEASURE 1.  An observation that the presenters differentiated from a lack of TNFi effect
  
• For psoriatic arthritis notable data included long term benefit including 104wk data from FUTURE 1 (iv induction) and 52wk data for FUTURE 2 (approved sc induction).  Cosentyx demonstrated efficacy in FUTURE 2 irrespective of TNF treatment history or MTX background, although 300mg produced an improved effect (vs 150mg) in TNF-IRs or those patients with skin involvement.  The involvement of IL-17 in enthesitis, and the importance of enthesitis in psoriatic arthritis were stand out messages at ACR and Cosentyx produced a considerable improvement in this measure
• The Cosentyx SPC was since updated.  Importantly Cosentyx is specifically approved with or without MTX for psoriatic arthritis in DMARD-IRs without specifying conventional or biologic DMARD.  This opens the way for possible first line biologic use.  300mg Cosentyx is indicated in TNF-IRs and those with moderate to severe plaque psoriasis, but 150mg is indicated in others.  This reflects FUTURE 2 and importantly could offer a  cost benefit for pre-TNFi use.  Of note the label included a considerable amount of data on enthesitis.  For ankylosing spondylitis, the indicated dose is 150mg for all with no guidance offered on line of treatment or MTX background.  Radiographic data were not included, possibly because 104wk data reporting progression were not available at the time of filing
• The FDA has now reportedly approved Cosentyx for the treatment of both ankylosing spondylitis and psoriatic arthritis.  Further detail are yet to be disclosed

US Patent office rejects Amgen's petition against Humira formulation patents potentially delaying market entry of ABP 501

• One strategy through which companies have been attempting to gain biosimilar market entry utilizes IPR (Inter Partes Review) Petitions
  
• IPRs offers a legal strategy whereby a biosimilar developer can test the validity of innovator patents prior to filing
  
• This strategy is increasingly being adopted.  Amgen filed IPR petitions in Jun 2015 against Humira US formulation patents: 8,916,157 and 8,916,158
• Coherus subsequently filed IPR Petitions against AbbVie patents claiming 40mg q2w dosing for rheumatoid arthritis (8,889,135, 9,017,680, 9,073,987).  Boehringer Ingelheim also attacked this dosing strategy, petitioning 8,889,135 in Dec 2015
• A legal decision on the Coherus petition is expected mid-2016, however in the meantime Amgen’s initial petitions have now been rejected by the patent office

Comments:  Amgen filed ABP 501, its biosimilar adalimumab, in the US on Nov 25th.  This is believed to be the first adalimumab biosimilar filed in the US.  Abbvie has previously commented that one of its biosimilar defense strategies will include patent defense, including a broad estate of relatively recent, method of use, dosing and formulation patents.  The patents that Amgen petitioned were two of these formulation patents and by rejecting the company's IPRs the Patent Office has maintained one barrier to Amgen finding a way through Abbvie's IP estate.  Claims in the two patents are of interest.  In particular, we understand that these patents claim formulations which support a longer shelf life, stability if frozen, an absence of citric acid and the possibility of neutral pH.  These properties are distinct from the Humira formulation currently available in the US and if the Patent Office had decided the claims were indeed unpatentable, Amgen would not only have been offered a route to early market entry, they may also been offered a competitive advantage over Humira.  In this respect Abbvie has developed a new formulation Humira.  This has recently been approved in the US and EU and is characterized by low volume/high concentration and also reduced injection site pain (due to the lack of citric acid).  This new formulation appears to have different characteristics to those claimed in the patents petitioned by Amgen and may represent a next level of Abbvie's defense if Amgen (or others) launch a biosimilar adalimumab.  For the moment however Amgen will have to develop new strategies, one of which is contesting the patents through the court system.  This however will take a number of years