Psoriasis is one of the key growth franchisee for Novartis (NYSE:NVS), estimated by the sell-side brokers to generate at least $4B of sales in 2020 (12% of pharma sales) driven by the excellent launch of Cosentyx, which has been able to generate more than $1B of sales in 2016, after around one year from its approval.
What is plaque psoriasis?
According to the Mayo Clinic:
Psoriasis is a common skin condition that changes the life cycle of skin cells. Psoriasis causes cells to build up rapidly on the surface of the skin. The extra skin cells form thick, silvery scales and itchy, dry, red patches that are sometimes painful.
Psoriasis is a persistent, long-lasting (chronic) disease. There may be times when your psoriasis symptoms get better alternating with times your psoriasis worsens.
Psoriasis signs and symptoms can vary from person to person but may include one or more of the following:--Red patches of skin covered with silvery scales
--Small scaling spots (commonly seen in children)
--Dry, cracked skin that may bleed
--Itching, burning or soreness
--Thickened, pitted or ridged nails--Swollen and stiff joints
Treatment options for Psoriasis
While there isn't a cure, psoriasis treatments may offer relief. There are different treatment options for patients affected by plaque psoriasis:
- Topical treatments (e.g. Topical corticosteroids, Vitamin D analogues, Anthralin, Topical retinoids or Calcineurin inhibitors), which usually are creams that need to be applied on the skin and that could be helpful to treat mild to moderate plaque psoriasis.
- Light therapy (phototherapy), which implies the use of natural or artificial ultraviolet light (UVA or UVB) to treat moderate psoriasis.
- Oral therapies, as Methotrexate or cyclosporine, which can produce dramatic clearing of the psoriasis lesions but that can cause some side effects.
- Biologic drugs, these drugs are quite effective but are extremely expensive and include some old drugs as Humira, Enbrel or Stelara and some newly treatment options as Cosentyx or Taltz.
You can see here a comprehensive list of all FDA-Approved Medicines for the treatment of Psoriasis. In this article, I will focus on the “biologic drugs” category to analyze what has driven the excellent performance of NVS’s Cosentyx and what will be the key innovations in this space in the foreseeable future which could threaten the leadership of Novartis.
Why Novartis's Cosentyx had an excellent launch in this space
Novartis is one of the key players in the psoriasis space with their leading subcutaneous self-injected drug, called Cosentyx.
There are few reasons behind the successful launch of Cosentyx in this space:
- Cosentyx has shown superior efficacy against two key competitors in this space.
- In the FIXTURE study, Cosentyx demonstrated superiority over Amgen’s (NASDAQ:AMGN) Enbrel with PASI75 response of 77% in 300mg arm vs. 44% of Enbrel arm.
- In the CLEAR study, Cosentyx demonstrated superiority over JNJ’s (NYSE:JNJ) Stelara with PASI90 response of 79% in 300mg arm vs. 58% of Stelara arm.
- Cosentyx has a convenient every 4 weeks subcutaneous injection regimen and it has demonstrated a clear safety profile from the full set of Phase III trials.
- Cosentyx has a very broad label, having received approval also for psoriatic arthritis and ankylosing spondylitis.
Psoriasis will become soon a crowded market
The psoriasis market is likely to become increasingly crowded over the next couple of years. I analyze the main players that have recently entered in the psoriasis space and that will enter in 2018 and 2019:
Eli Lilly’s (NYSE:LLY) Taltz: In March 2016, Lilly has received the approval of Taltz in psoriasis by the FDA and the clinical profile of the drug looks comparable to Cosentyx. In fact, according to a press release from Eli Lilly:
The FDA approval of Taltz was based on findings from the largest Phase 3 trial program approved to date—more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries.5 This number includes patients who began the trial on Taltz or placebo, or active comparator (U.S.-approved etanercept). This clinical program included three double-blind, multicenter, Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—which demonstrated the safety and efficacy of Taltz in patients with moderate-to-severe plaque psoriasis. In all three studies, at 12 weeks, 87 to 90 percent of patients treated with Taltz saw a significant improvement of their psoriasis plaques (PASI 75). In addition, 81 to 83 percent of patients treated with Taltz achieved sPGA 0 or 1. The majority of patients treated with Taltz, 68 to 71 percent, achieved virtually clear skin (PASI 90) and 35 to 42 percent of patients saw complete resolution of their psoriasis plaques (PASI 100, sPGA 0).
The only differences between the two products are that Taltz has PASI-100 (complete skin clearance) data on its label, while Cosentyx should benefit from fewer injection site reactions and no neutralizing antibodies. In summary, the two products look pretty similar in terms of efficacy and safety in the psoriasis space.
Valeant’s (NYSE:VRX) Siliq: In February 2017, Valeant has received the approval for Siliq by the FDA. The efficacy profile of the drug is good, but the safety profile puts the drug at disadvantage compares to Taltz or Cosentyx, given a black box for suicide risk. According to a press release from Valeant:
SILIQ has a Black Box Warning for the risks in patients with a history of suicidal thoughts or behavior. SILIQ was approved with a Risk Evaluation and Mitigation Strategy (REMS) involving a one-time enrollment for physicians and one-time informed consent for patients. The most common adverse reactions were headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea. SILIQ is contraindicated in patients with Crohn's disease. Suicidal ideation and behavior have been reported. Serious infections have occurred therefore caution should be exercised when considering the use of SILIQ in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to initiating treatment.
This issue has not been seen for the competitors, thus I think Valeant will have only a marginal role in the psoriasis space.
Data from the VOYAGE 1 trial showed significantly higher proportions of patients receiving guselkumab achieved cleared/minimal disease compared with patients receiving placebo, as defined by at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90, near complete skin clearance) and an Investigator’s Global Assessment (NYSE:IGA) score of cleared (0) or minimal disease (1) at week 16, the study co-primary endpoints. The VOYAGE 1 trial also included an active comparator arm evaluating guselkumab versus Humira® (adalimumab), and showed the superiority of guselkumab across major study endpoints and through 48 weeks of treatment.
It’s worth noting that, even if efficacy for this drug seems comparable to Cosentyx or Taltz, Guselkumab has the potential for superior patient convenience with self-administered injection every eight weeks compared to every four weeks with Cosentyx/Taltz.
Lastly, J&J could b a formidable competitor in the psoriasis space given its strong presence in the Immunology market with some old drugs as Remicade, Simponi and Stelara.
Abbvie/Boehringer Ingelheim's (NYSE:ABBV) Risankizumab: A further threat to Cosentyx will come from the potential launch of Risankizumab in late 2018/2019. According to a press release from Boehringer Ingelheim:
New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim’s investigational biologic compound BI 655066*, over ustekinumab. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30 percent of patients on ustekinumab. Patients also achieved this skin clearance significantly faster (approximately eight weeks versus approximately 16 weeks) and for more than two months longer (≥ 32 weeks versus 24 weeks) than those on ustekinumab. In addition, completely clear skin (PASI 100) was maintained after nine months in nearly triple the percentage of patients on BI 655066 compared with ustekinumab (43 percent versus 15 percent).
Thus, potentially, Risankizumab could be a transformational new therapy in psoriasis, with potential best-in-class efficacy in terms of PASI90 and PASI100 and with an attractive injection regimen (every 12 weeks).
Psoriasis is clearly one of the strongest franchises of Novartis right now, but some new treatment options will be launched over the next couple of years and could threaten NVS’s leadership. From my analysis, it’s evident that, over 3 years, there will be many products in this space with similar profile in terms of safety and efficacy, which will allow the PBMs to use formulary exclusions tools to put pressure on pricing in this space, and consensus estimates for Novartis have not reflected this risk.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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.
Additional disclosure: not investment advice