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Despite a patent expiry in 2010, generic versions of Advair aren’t expected to appear on the market for two more years. It took FDA eight years to develop a blueprint for how generics manufacturers might establish an acceptable bioequivalence for Advair, GSK’s blockbuster fluticasone propionate/salmeterol xinafoate combo inhaler.
Will GSK be able to maintain its position in COPD and asthma, post Advair/Seretide?
Despite a patent expiry in 2010, generic versions of Advair aren’t expected to appear on the market for two more years. It took FDA eight years to develop a blueprint for how generics manufacturers might establish an acceptable bioequivalence for Advair, GSK’s blockbuster fluticasone propionate/salmeterol xinafoate combo inhaler. In the meantime, GSK is pressing forward with a next generation of combination inhalers.
Approved in May (in the US) and November (in the EU), GSK’s fluticasone furoate/vilanterol dry powder combo inhaler for Chronic Obstructive Pulmonary Disease (COPD) and asthma* – sold as Breo Ellipta in the US, and Relvar Ellipta in Europe, Mexico and Japan – is the first of four late-stage respiratory products aimed at a capturing a piece of the expanding COPD and asthma market, said Jorge Bartolome, SVP of GSK’s respiratory and med center business unit for the US.
Breo Ellipta is also the first product sporting GSK’s new Ellipta dry powder inhaler device, licensed in from Theravance along with Breo/Relvar and a dual bronchodilator for COPD called Anoro, which is expected to receive FDA approval this month. The other two products currently filed for approval are fluticasone furoate – the inhaled corticosteroid portion of Breo/Relvar – as a monotherapy, once-a-day maintenance treatment for asthma; and umeclidinium bromide, a long-acting muscarinic antagonist (LAMA) for COPD. Both products are delivered using the platform Ellipta device.
Both Breo/Relvar Ellipta and Anoro Ellipta, if the latter is approved, are expected to become blockbuster products, according to industry analysts. However, with GSK’s industry-altering CIA crouched like a monkey on its back, and competition heating up in the COPD space over the next few years, GSK will need its “Patient First” marketing approach to deliver at launch, in the primary care space and among pulmonologists.
“The heat is on GSK’s marketing group to deliver on the Breo and Anoro launches,” wrote Leerink Swann’s Seamus Fernandez, in an October note to investors. GSK’s Bartolome, described by a company spokesman as having had “a leadership role in transforming GSK’s commercial model to better align with the company’s values,” says the company’s “commercial model transformation” isn’t just about removing volume-based sales incentives for reps, it’s also about creating “integrated account management teams” to better serve health systems and physician networks, and “moving more resources into areas like medical, health outcomes, and the creation of highly-educated account managers who understand the whole GSK portfolio.”
The launch of Breo Ellipta, and the anticipated launch of Anoro later this month will give GSK an opportunity to prove that its strategic shift from “volume to value,” as Bartolome says, will work, since primary care physicians are a crucial audience for COPD and asthma drugs. How is the implementation of GSK’s new commercial model going so far? “I’m very excited about the progress that we’ve made, and I think we’re ahead of the curve…we have a great opportunity to be well-aligned with our customers as we make this journey from volume to value,” says Bartolome.
GSK will abide by PhRMA’s voluntary six-month moratorium on branded DTC ads for new products, but “there’s an extensive [unbranded] DTC effort underway right now in the asthma space” – on TV, in print, and online (asthma.com) – “to help patients understand asthma symptoms,” says Bartolome. People wondering if they have asthma can take a test to find out, for example.
GSK’s global respiratory franchise earned $12 billion last year ($8 billion came from Advair/Seretide sales alone), by far the company’s largest therapeutic area by sales, and COPD is a safe bet for the future, says Bartolome. “Twenty-seven million Americans have COPD, and about half of them are undiagnosed,” he says, adding that COPD is the third leading cause of death in the US, with related healthcare costs topping $50 billion per year. Chronic bronchitis and emphysema are the two main disease areas within COPD, and smoking patterns correlate closely with COPD incidence rates. As a result, large countries with significant smoker populations – China, India, Indonesia – represent new opportunities, as do geographies where people cook indoors and expose themselves to dangerous levels of burning gases, which can lead to respiratory illness, says Bartolome.
On the reimbursement front, GSK is “generating data sets for physicians as well as payers around the cost burden of COPD, and the impact of those cost drivers,” and with Breo, “we have, underway, the largest study carried out in COPD to date, which looks at the impact of Breo Ellipta on COPD mortality,” says Bartolome. That study will read out in 2015.
Anoro Ellipta, if that drug receives approval, will compete directly with Boehringer Ingelheim/Pfizer’s Spiriva, which earned roughly $4.5 billion in global sales last year. Spiriva will lose patent protection in 2014, but it’s unclear how much that will immediately impact sales revenues. Boehringer/Pfizer is also developing a new combination that pairs Spiriva (tiotropium) with a newly EMA-approved monotherapy Striverdi (olodaterol), using the companys’ Respimat device, which counters Ellipta’s dry powder with a “soft mist.” In the next two to three years, other new combination inhalers from Novartis, AstraZeneca and Forest/Almirall could enter the COPD global market, which is expected to grow to nearly $16 billion by 2020.
During a 3Q earnings call in October, GSK CEO Andrew Witty said the company has “the opportunity for up to ten new respiratory drugs in the next five or six years and we are very confident of our view that we can grow our respiratory franchise over the medium term as these new products start to roll in, notwithstanding the fact that there will inevitably be continued price and in some areas generic pressure to some of our existing products.”
For GSK to maintain its leadership position in the respiratory space, it will need to execute not only in the clinic, but on the commercial front as well. Breo/Relvar Ellipta and Anoro Ellipta could offer a case study on the success, or failure, of the company’s new approach to commercializing products. Investors, COPD patients and the Justice Department will be watching.
*12/12/13: Breo/Relvar Ellipta has not been approved for asthma patients in the US, or COPD patients in Japan.