Mylan’s Advair generic, Botox rival get FDA nod; GSK bets big on oncology

By PharmaCompass

2019-02-07

Impressions: 158 Article

After rejecting several Advair knock-offs in the past, including those from Novartis, Hikma Pharmaceuticals and Mylan, FDA finally approved Mylan's generic version of GlaxoSmithKline’s blockbuster asthma treatment Advair Diskus, christened Wixela Inhub.

Mylan received approval to market its generic inhaler in three dosages for the twice-daily treatment of asthma in patients aged four years and older, the FDA said. This is the first generic drug product approval for one of the most commonly prescribed asthma and COPD inhalers in the US, where more than 26 million people are known to have asthma (including seven million children). In 2017, GSK reported revenue of about US$ 4.19 billion from Advair.

The FDA also approved Evolus Inc.’s wrinkle treatment for adult patients, which is expected to compete with Allergan’s Botox.

The treatment — called Jeuveau — received FDA approval late last week, nearly eight months after the agency first rejected the application citing deficiencies in its manufacturing and chemical composition. Evolus said it plans to price Jeuveau 20 to 25 percent lower than Allergan’s Botox, which generated US$ 3.5 billion in sales last year. “The wait is on” to see what kind of damage it does to Botox sales, Wells Fargo analyst David Maris said.

Meanwhile, Allergan is asking the International Trade Commission to investigate Evolus for allegedly stealing trade secrets to make its new version of the medicine.

The complaint alleged that a former Medytex (its Botox partner) employee stole trade secrets on the complex manufacturing process needed to turn botulism into a drug, as well as a sample of Medytex’ strain.

GSK buys Merck’s immunotherapy drug: After announcing its US$ 5.1 billion buyout of oncology-focused Tesaro in December, GSK has made another huge bet on oncology. It is licensing Merck KGaA’s next-generation immunotherapy drug (M7824) for US$ 343 million (€300m) upfront and a total possible spend of US$ 4.2 billion (€3.7 billion).

After receiving the upfront payment, Merck will become eligible for potential payments of up to US$ 569.3 (€500 million), depending on development milestones in lung cancer drug M7824 (or bintrafusp alfa). Merck could also get up to a further US$ 3.3 billion (€2.9 billion), depending on commercial milestones.

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