Pfizer braces itself for competition for it’s breast cancer drug, Ibrance
Pfizer’s breast cancer drug, Ibrance (palbociclib) has had the honour of being the first FDA approved CDK 4/6 inhibitor. The advantages of being a first entrant in the market are enormous and Ibrance seems to have gained from it, demonstrating a sale of $723 million in 2015 and rapid rise to $2.1 billion in 2016. Although, Ibrance initially won a FDA approval only for use alongside Letrozole in menopausal women with ER+ HER2- advanced breast cancer; eventually, it’s therapeutic areas were expanded to include combination with fulvestrant in hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic cancer patients.
Who are the competitors?
With the launch of a first competitor drug from Novartis, Kisqali (ribociclib, LEE011), early this year in the same CDK 4/6 class inhibitors, Pfizer’s monopoly is in danger in the niche breast cancer market. In addition, the recent positive results (MONARCH trials) obtained for Eli Lilly’s drug abemaciclib, speculates a new competition to be launched within next 2 years. In phase 3 trial in previously untreated patients with HR+ and HER2- breast cancer, abemaciclib demonstrated significant improvement in Progression Free Survival (PFS) in combination with an aromatase inhibitor thus achieving its primary endpoint. This comes in addition to the significant improvement in PFS already established combination with fulvestrant in women with HR+, HER2-, advanced breast cancer who have relapsed or progressed after endocrine therapy.
Lilly’s drug can come up as a strong competition with its better toxicity profile and ability to be administered daily as opposition to Ibrance which needs to be stopped for a week once every 3 weeks to avoid neutropenia. The range of positive results thus obtained forecasts an FDA approval for the drug with similar wide range as that of Pfizer’s. Apart from that Lilly has grand plans for its big launch, with the proposition to submit a new drug application (NDA) for use as a monotherapy in the second quarter of 2017, an application for MONARCH 2 trials in the third quarter and MONARCH 3 study in combination with letrozole. Predictions forecast that drug market will be around $1.3 billion by 2021 and might significantly increase in case it is able to differentiate itself from its competitors.
Does Pfizer need to worry?
Even though Kisqali and abemaciclib can be strong competitors, Ibrance still has some advantages over its competitors. Kisqali comes with safety recommendations which include frequent ECG monitoring during the treatment while abemaciclib, on the other hand, has low-grade diarrhoea as a side effect which might affect physician and patient choice. Pfizer has established a very robust drug life cycle that is the number of trials in a variety of other breast cancer settings as well as other indications such as pancreatic and head and neck cancer.
With the FDA approval for using Ibrance with any aromatase inhibitor and not solely letrozole as earlier, Pfizer has expanded its base and made it convenient for physicians to prescribe their drug. To widen its use, Pfizer has also started targeting physicians who have prescribed Ibrance for a limited period rather than only focusing on early adopter physicians. According to Fiercepharma, this will help Pfizer boost its sales, as currently, it covers only 20% of eligible physicians and among them, a large number are occasional prescribers.
How is Pfizer tackling the oncoming competition?
In February, Pfizer had faced initial setback for Ibrance with rejection from NICE (National Institute for Health and Care Excellence) in UK as not being cost effective treatment for its use in NHS (National Health Scheme). On the other hand, Novartis having gauged this early on had rolled out flex pricing model in US for its drug trying to break the Pfizer market with competitive prices. In a surprise move, and to ensure it’s access to the UK market, Pfizer has announced free drug supply to all eligible patients in UK until the final verdict from NICE is out. This scheme is supposed to last for 6 weeks after NICE announces its final verdict or on 30th September whichever is earlier.
Pfizer, with a strong dedication to tackle the competition has also launched it’s first TV advertisement in US after collecting data from patients, healthcare providers and advocacy groups. Although, Pfizer seems to be ready to face the launch of new rivals, it will be interesting to know the effect on sales and revenue as the competitors are launched.
By Sriharsha Puranik
Domain Expert, Science and Research @ Innoplexus