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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:

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:

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 NVSs 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:

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 Lillys (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 datemore 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 studiesUNCOVER-1, UNCOVER-2 and UNCOVER-3which 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.

Valeants (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.

J&J's (NYSE:JNJ) Guselkumab: A further threat to Cosentyx will come from the likely approval Guselkumab in late 2017. According to a press release from Janseen:

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 Investigators 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.

Its 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 Ingelheims 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).

Conclusion

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 NVSs leadership. From my analysis, its 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

More here:
Threats And Opportunities In Psoriasis: What's Next For Novartis? - Seeking Alpha

BUFFALO, N.Y. Three studies focused on improving our understanding of the human microbiome were awarded funding through the second round of research pilots supported by the University at Buffalo Community of Excellence in Genome, Environment and Microbiome (GEM).

The projects, which total more than $110,000, will study how the relationship between the human body and the collection of microorganisms that reside on or within it affect our risk for certain diseases.

Understanding the connection these microorganisms have with our bodies may enable the development of personalized medicine and empower individuals to have greater control over their health.

The pilot grants award researchers from a variety of disciplines up to $50,000 to develop innovative projects focused on the microbiome. The funds support up to one year of research.

The awards are provided through GEM, an interdisciplinary community of UB faculty and staff dedicated to advancing research on the genome and microbiome. GEM is one of UBs three Communities of Excellence, a $9 million initiative to harness the strengths of faculty and staff from fields across the university to confront the challenges facing humankind through research, education and engagement.

In this round of pilot projects, we were able to focus on the intersection of the genome and the microbiome. This allows us to understand how microbes affect us and our health. It also starts to answer how our own genes affect the environment in which human microbes have to live and survive, says Jennifer Surtees, PhD, GEM co-director and associate professor in the Department of Biochemistry in the Jacobs School of Medicine and Biomedical Sciences at UB.

We are thrilled that all three funded projects resulted from strong interdisciplinary collaborations that were stimulated by GEM."

Along with Surtees, GEM is led by Timothy Murphy, MD, executive director and SUNY Distinguished Professor of Medicine; and Norma Nowak, PhD, co-director, professor in the Department of Biochemistry and executive director of UBs New York State Center of Excellence in Bioinformatics and Life Sciences.

The funded projects, described below, involve faculty teams from the Jacobs School of Medicine and Biomedical Sciences, the School of Public Health and Health Professions, and the College of Arts and Sciences.

Tracking the global spread of Klebsiella pneumoniae, an antibiotic-resistant superbug

A lethal form of the bacterium Klebsiella pneumoniae (hvKP) is spreading across the Asian Pacific Rim. Unlike most Klebsiella infections in Western countries, which typically cause illness in healthcare settings, hvKPcan cause serious life- and organ-threatening infections in healthy individuals living in the community. Worse, hvKP has become increasingly resistant to antibiotics.

Although all ethnic groups have suffered infections from hvKP, people of Asian descent are disproportionately affected. UB researchers will study the density of infections at various geographic locations to understand whether the higher prevalence among Asian ethnic groups is due to more frequent exposure, genetics or another factor.

The results could lend insight into the risk of hvKP infection, assist in understanding how it develops, help identify populations at risk and improve knowledge on prevention.

The study is led by Thomas Russo, MD, professor and chief of the Division of Infectious Disease; and Peter Elkin, MD, professor and chair of the Department of Biomedical Informatics, both in the Jacobs School of Medicine and Biomedical Sciences.

Decoding the genetic evolution of the skin microbiome in psoriasis and eczema patients

Immune responses to the wide range of microbial organisms colonized on and within human skin have led to a number of major genetic adaptions. Yet, researchers have not solved why autoimmune and inflammatory disorders, such as psoriasis and eczema, are common and not eliminated from the general population by natural selection.

The question has led a team of researchers to investigate the role that skin plays in our vulnerability to autoimmune and inflammatory disorders, which affect hundreds of millions of people. The study will analyze the genetic variations and microbiomes of non-affected and affected skin samples from psoriasis and eczema patients.

The principle investigators are Omer Gokcumen, PhD, assistant professor in the Department of Biological Sciences in the UB College of Arts and Sciences; and Animesh Sinha, MD, PhD, Rita M. and Ralph T. Behling Professor and chair of the Department of Dermatology in the Jacobs School of Medicine and Biomedical Sciences.

Additional collaborators include Kristina Seiffert-Sinha, MD, research assistant professor in the Department of Dermatology; Daniel Gaile, PhD, assistant professor in the Department of Biostatistics in the UB School of Public Health and Health Professions; David Tritchler, DSc, research professor in the Department of Biostatistics; and Ran Blekhman, PhD, assistant professor in the College of Biological Sciences at the University of Minnesota.

Solving how genome-shifting fungi adapt to human hosts to cause fatal infections

Over the course of an infection, pathogenic fungi continuously adjust to the human body, changing as it moves to different areas. The microbes sense and adapt to the various nutrient environments within their hosts, and respond with the necessary gene expression patterns.

One way the fungi sense nutrients is through the levels of common metabolites, such as NAD+, which is required by enzymes called sirtuins to repress gene expression. However, it remains poorly understood how NAD+ acts as a signaling molecule.

The researchers will examine three pathogenic fungi that cause serious illness among people with weakened immune systems. Their goal is to determine which genes are regulated by sirtuins and are activated when NAD+ is low, and learn how nutrient availability influences NAD+ concentrations.

The study is led by Laura Rusche, PhD, associate professor in the Department of Biological Sciences. Additional investigators include John Panepinto, PhD, associate professor in the Department of Microbiology and Immunology; and Tao Liu, PhD, assistant professor in the Department of Biochemistry, both in the Jacobs School of Medicine and Biomedical Sciences.

Go here to see the original:
UB's GEM awards funding for new studies focused on superbugs, psoriasis, eczema and deadly fungi - UB News Center