Novartis Makes Substantial Pipeline Progress On A Couple Of Fronts

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Summary

Novartis achieved the primary and secondary endpoints for the phase 3 QUARTZ study using QMF149 to treat patients with asthma.

Both QMF149 and QVM149 have been submitted to the EMA for potential approval in the European Union for patients with asthma.

The phase 3 study, known as FUTURE 5, met the primary endpoint, showing that a majority of patients treated with Cosentyx did not have radiographic progression at two years.

Novartis’ top-selling drug, Cosentyx, generated $791 million in sales in Q1 of 2019, and the drug is expected to launch in China in the second half of 2019, which should be a boost for sales.

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Novartis (NVS) announced that it had successfully completed a phase 3 studytreating patients with asthma using QMF149. These positive phase 3 results show that the company has a good chance at achieving European approval for this drug. Even QVM149, another asthma treatment, is up for European approval as well. Cosentyx continues to shine as the lead drug for Novartis. There was also a set of positive results released from a late-stage study known as FUTURE 5 treating patients with psoriatic arthritis.

Platinum Program Continues Its Success

In order for Novartis to make a push for the treatment of asthma, it has a solid program known as PLATINUM. One of these phase 3 studies from this program is known as QUARTZ. This study recruited patients who were inadequately controlled on low dose inhaled corticosteroids (ICS) with or without any type of additional maintenance treatment. Patients were either treated with a once-daily low dose of QMF149 or once-daily mometasone furoate (MF). QMF149 consists of indacaterol acetate and mometasone furoate and is delivered with the Breezhaler device.

Mometasone furoate alone is delivered by the Twisthaler device. It was shown that QMF149 had achieved statistical significance over MF in both the primary endpoint and the secondary endpoints. The primary endpoint was looking to see if treatment with QMF149 could end up being statistically significant over MF when it came to FEV1. FEV1 is the volume of air that can be forced out in one second after taking a deep breath. Consider FEV1 as a measure of lung function for these patients with asthma. This measurement was compared between both treatments over a 12-week period. In addition, it’s important to note that FEV1 was measured at about 24 hours after the final treatment was given.

Treatment with QMF149 was statistically significant over MF with a p-value of p<0.001. Treatment with Novartis’ drug also achieved statistical significance in a key secondary endpoint known as ACQ-7 after 12 weeks of treatment compared to MF. Basically the ACQ-7 is a questionnaire score that patients mainly report on whether or not their asthma caused severe impairment. I stated mainly because there is one question on the questionnaire that covers FEV1% which is filled out by clinic staff. The ACQ-7 in this study was assessing a responder analysis, in which patients could achieve an improvement in ACQ-7 >=0.5. The QMF149 treatment group was 74.7% versus 64.9% with those on MF.

Cosentyx Continues To Impress

Novartis also continues to make strides with Cosentyx. Especially, with its latest data from a late-stage study known as FUTURE 5. This is a phase 3 study that used Cosentyx to treat 996 patients with psoriatic arthritis. This late-stage study recruited patients with psoriatic arthritis (PsA). PsA is a type of arthritis for those who have psoriasis. One thing to note is that psoriatic arthritis can either occur before skin lesions of psoriasis appear or after. The main symptoms of the disease are: Swelling, joint pain, and stiffness. The phase 3 study tested three doses of Cosentyx in patients with psoriatic arthritis. The primary endpoint for the study was to determine the amount of radiographic progression at a two-year period. It was shown that there were a majority of patients on each dose that did not achieve radiographic progression at two years. The amount of patients that did not achieve radiographic progression is as follows:

  • 89.5% on 300 mg of Cosentyx
  • 82.3% on 150 mg of Cosentyx
  • 81.1% on 150 no loading dose of Cosentyx

 

This is very important for patients with PsA. That’s because this disease leads to structural damage. Such damage can be assessed through a radiograph. The intent is to see how much damage has taken place through the course of PsA. Therefore, the data above alludes to the notion that large percentages of patients did not deteriorate over a two-year period when treated with Cosentyx. The way that radiographic progression is assessed specifically is by a scoring system and has become a norm for assessing efficacy in large clinical trials for this patient population. If you look at many other studies today treating patients with psoriatic arthritis, you are likely to see the endpoint of radiographic progression used. You might be wondering though why is Cosentyx so important for Novartis? Well, that’s because it is the main growth driver for the company.

Consider that this drug brought in $791 million in sales in Q1 of 2019. This is a major improvement compared to the prior year. In Q1 of 2018, sales of Cosentyx were $580 million. I even believe that this drug will continue to achieve substantial growth. I make this claim for two reasons. The first reason is the strong demand in place in both the U.S. territory and ex-US territories. The second reason is because of brand new sales that will be achieved in the coming months. That’s because Novartis was able to obtain Chinese approvalfor the drug treating patients with psoriasis in April of 2019. Cosentyx is expected to launch in China in the second half of 2019. This is another opportunity to increase sales.

Conclusion

The PLATINUM program is moving along well, especially with the phase 3 QUARTZ study using QMF149 beating out once-daily mometasone furoate patients with asthma. Several weeks ago Novartis was able to show QVM149 (indacaterol acetate, glycopyrronium bromide and mometasone furoate) beat out standard of care in two phase 2 studies in patients with asthma. QVM149 is already being explored in a phase 3 study as well. Both QMF149 and QVM149 have been accepted for review by the European Medicines Agency (EMA). The risk here is that there is no guarantee that both of these asthma treatments will obtain European approval. Sales for Cosentyx are continuing to climb and that’s very good. I don’t foresee a slowdown with this drug at all. Especially, when you consider that both the U.S. territory and other territories outside of the U.S. are still seeing high demand for it. On top of that, the launch of Cosentyx in the second half of 2019 in China will only help to add to the strong growth observed thus far.

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I’m currently offering a two-week free trial period for subscribers to take advantage of. My service offers deep dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.

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.

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