Mylan Sees Generic Advair Marathon Nearing FDA Finish Line
Executive Summary
Company management expressed confidence its application for the first generic Advair is approvable, although the US agency didn’t clear it in October as Mylan had hoped.
Mylan NV investors continue to wait for word from US FDA on the status of an application for the first generic version of GlaxoSmithKline PLC's Advair Diskus (fluticasone/salmeterol), a large commercial opportunity. An FDA approval of Mylan's ANDA for generic Advair did not come by its October action date – the third for the product – but management said during the firm's third-quarter sales and earnings call Nov. 5 that it remains confident the application is approvable.
"We are in continuous and ongoing discussions with FDA regarding the progress of the review," President Rajiv Mallik said. "Based on our latest update from the agency, they are in the final stages of labeling review. We continue to believe that FDA will be able to resolve any outstanding issues very soon."
If Mylan's product, known as Wixela Inhub, is approved shortly, it could have a strong lead in the market over any other generic versions. The company has already received two complete response letters related to the ANDA, but responded quickly to the most recent one in mid-July. It had guided investors to expect FDA action within a three-month time clock. (Also see "Mylan To Explore Strategic Options, Claiming Investors Have Failed To Appreciate The Value " - Scrip, 8 Aug, 2018.) The first complete response letter came in March 2017. (Also see "Mylan’s Generic Advair Delay Gives Leverage To Rivals" - Scrip, 29 Mar, 2017.)
Getting a generic Advair across the finish line would be an achievement given the complex nature of the inhaled product combining two active ingredients. Several generics manufacturers have had hopes to be the first to market. Novartis AG's Sandoz generic drug unit has confirmed it doesn't expect to be able to get a generic version of Advair to market until late 2019. (Also see "Eight Things To Know From Novartis' Third Quarter Call " - Scrip, 18 Oct, 2018.)
Mylan has invested heavily in complex products with high barriers to market entry, including some that have reached the market, such as a generic version of Teva Pharmaceutical Industries Ltd. Copaxone (glatiramer), and its first biosimilar, Fuphila, the first version of Amgen Inc.'s Neulasta (pegfilgrastim) to launch.
But uptake of complex drugs and biosimilars has been slower than expected in some instances and Mylan is also facing US generics pricing pressure affecting the whole sector as well as a manufacturing setback at an important facility in Morgantown, W.Va., which is in the midst of a restructuring and remediation.
In August, the company announced that its board of directors is reviewing strategic alternatives as its stock has remained under-valued. (Also see "Mylan To Explore Strategic Options, Claiming Investors Have Failed To Appreciate The Value " - Scrip, 8 Aug, 2018.) CEO Heather Bresch had no update for investors on the ongoing review, noting only that "the board is busy looking at lots of things" and that there is no timeframe for the review to be completed.
The problems at the Morgantown facility, stemming from a form 483 report FDA submitted in April, is negatively impacting Mylan's financials. North America segment net sales declined 14% in the quarter to $1.01bn, partly due to actions associated with the remediation, as well as lower volumes of products including EpiPen sales. Total revenues for the July-September period were 4% lower at $2.86bn, but in line with analyst consensus estimates, while adjusted net earnings were above analyst expectations at $648m.
The restructuring at Morgantown began in the second quarter and is focused on reducing the complexity at the facility. That means Mylan is discontinuing and transferring manufacturing of a number of products to other manufacturing sites and reducing the workforce, resulting in supply disruption. The company said it spent $98m related to the remediation program.
"Only one of our top 10 and eight of our top 50 gross margin generating products for North America are manufactured in Morgantown," Mallik assured investors. "We did not expect to have any significant new product launches from the site in 2019."
Investors are closely watching the launch of Fulphila, approved by FDA in July as the first biosimilar version of Neulasta. Fulphila has secured an 8% share of the pre-filled syringe market for pegfilgrastim, Mylan reported. Pre-filled syringes account for about half of Neulasta sales, according to Mylan. Amgen has sought to transition Neulasta patients to its Onpro on-body injector, which automatically delivers the Neulasta dose, as part of its defense of the brand.
A second Neulasta biosimilar was approved on Nov. 2 by FDA, Coherus BioSciences Inc.'s Udenyca (pegfilgrastim), which will increase the competitive dynamics.
Mylan Head of Biologics Chrys Kokino talked to Scrip in October about the launch of Fulphila and why he is optimistic the biosimilar may have better uptake than some other US biosimilar launches. (Also see "Mylan Head Of Biologics Chrys Kokino On Fulphila Launch And US Biosimilars" - Scrip, 8 Oct, 2018.)