Novartis's Positive Study For Treating Asthma Moves It One Step Closer To Market

Novartis announced positive results from two phase 2 studies using QVM149 to treat patients with asthma.

The global asthma and COPD market are expected to reach $47 billion by 2024.

Both doses of QVM149 (medium dose & high dose) obtained the primary endpoint of a statistically significant improvement in peak FEV1 (forced expiratory volume in 1 second) compared to Advair.

Besides GlaxoSmithKline with Advair, other competitors are generics like Mylan with Wixela Inhub.

Novartis (NVS) announced that it had achieved positive results in two phase 2 studies using IND/GLY/MF to treat patients with asthma. IND/GLY/MF, also known as QVM149, was superior to the standard of care in both of these studies. In addition, on the safety front, the company's drug had a comparable safety profile to placebo and Advair. QVM149 is currently in phase 3 studies, but Novartis will make additional results from the mid-stage study available in the coming months at medical conferences. It hopes to highlight the path forward for a potential regulatory filing to the FDA for the treatment of asthma.

Mid-Stage Data Highlights Importance Of New Treatment Option

QVM149 is composed of several components to help patients with asthma. It makes use of indacaterol acetate and glycopyrronium with mometasone furoate (inhaled corticosteroid) delivered with a device known as Breezhaler. Why is there a need for a new treatment option for patients with asthma? That's because, despite currently available therapies, there are still many patients who don't have their asthma under control. More than about 1/3 of patients continue to experience symptoms, despite receiving treatment with standard of care. This inhaled triple therapy provides another treatment option for these patients. I state this on the basis that QVM149 was shown to have substantial improvements in lung function compared to placebo and Advair.

In one phase 2 trial, known as CQVM149B2208, both once-daily doses of QVM149 (medium dose and high dose) obtained the primary endpoint of achieving a statistically significant improvement in peak FEV1 (forced expiratory volume in 1 second) compared to Advair. This statistical significance was achieved with a p-value of p<0.001. FEV1 is a measurement of a pulmonary function test. It measures the amount of air a person inhales and then exhales, in addition to the amount of time it takes for them to exhale completely after a deep breath. For the second trial, known as CQVM149BB2209, the study was able to meet on the primary endpoint as well. It was shown that there were lung function improvements noted over a 24-hour dosing period in both morning and evening administrations of QVM149 compared to placebo over a 14-day period. Both of these results were presented at the 2019 annual international congress of the American Thoracic Society (ATS).

Competitors

Novartis has been able to pull off highly positive phase 2 studies. The only issue now that remains is if it can pull off the same type of results in the phase 3 studies. The problem is that even if QVM149 is ultimately approved, it will have to go up against Advair. Advair is an inhaled drug to treat patients with Asthma and COPD. That means Novartis will have to go up against GlaxoSmithKline's (GSK) Advair. Considering that QVM149 did pretty well against Advair in a study, I believe it has a good shot to be successful on the market. However, Novartis just won't be fighting on one front alone. It will have to compete against generic competitors as well. That may be a problem because generic competitors tend to price drugs a lot lower. The first generic Advair Diskus to be approved was Wixela Inhub from Mylan (NASDAQ:MYL). It was launched on February 12, 2019. That means it won't be easy for Novartis if it gets its inhaled treatment to market because it will have to navigate a highly competitive environment. Still, the asthma market is a large one. I believe many competitors could succeed. For instance, the global asthma and COPD market are expected to reach $47 billion by 2024. There should be plenty of room for all these competitors. The one that will capture the majority of the market remains to be seen.

Conclusion

With the positive results from the two phase 2 studies using QVM149 to treat patients with asthma, I believe Novartis is in a good spot to eventually challenge Advair. The risk is that there is no guarantee that Novartis's treatment will be able to overcome GlaxoSmithKline's Advair. Then, Novartis also has to worry about generic competition as well like Wixela Inhub developed by Mylan. Another risk to consider would be that Novartis still needs to complete its phase 3 studies successfully before it can obtain FDA approval. There is no guarantee that it will be able to reproduce the very same results in these late-stage studies, with a much larger pool of patients. Having said that, Novartis is on the right track with QVM149. It seems that its treatment could end up being a potential competitor to Advair and possibly other generic competitors as well.

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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