Friday Five – Your weekly pharma review

Eli Lilly, Teva get FDA nods for novel drugs

The FDA granted approval to two novel drugs of note this week: Eli Lilly's Taltz for the treatment of psoriasis and Teva's Cinqair, a targeted therapy for the treatment of severe asthma.

Taltz becomes the second anti-IL-17 antibody to be approved for the treatment of psoriasis, following US launch of Novartis' Cosentyx last February. Experts are enthused by the efficacy of both products, which are expected to compete closely in the treatment of first- and second-line patients (Spotlight On: Eli Lilly's Taltz – a key approval, but work to be done, say experts).

Cinqair is also the second product approval in a new class of biologic drugs; the anti-IL-5 monoclonal antibodies. However, key opinion leaders expect Teva's drug to struggle to gain market share against GlaxoSmithKline's first-in-class Nucala; primarily as Cinqair is administered intravenously, while Nucala is available in a subcutaneous formulation (ViewPoints: Teva secures FDA approval for Cinqair, but faces tough competitor in GlaxoSmithKline's Nucala, say experts).

Witty's departure from GlaxoSmithKline set in motion

Following considerable speculation in recent weeks, GlaxoSmithKline announced late last week that CEO Andrew Witty will retire next year.

The First Take Podcast: Witty's departure from GlaxoSmithKline confirmed - what's his legacy?

While a number of analysts have suggested that Witty will leave GlaxoSmithKline a stronger company than the one he inherited, his stance towards drug affordability and the evolution of drug pricing – and how this has shaped the company's strategy in recent years – will likely be debated until his successor is appointed.

Witty's wager appears to have been that expensive specialty drugs will not support long-term sustainability of the pharmaceutical industry as most of GlaxoSmithKline's rivals are speculating; hence the asset-swap deal with Novartis, which boosted the company's consumer and vaccine businesses.

This outlook has at times appeared prescient during the past 8 months, as scrutiny over drug pricing has increased, but also appears to be ahead of its time. GlaxoSmithKline has underperformed each of its major European rivals during Witty's tenure. Critics argue that while the products GlaxoSmithKline has prioritised are critical to the pharmaceutical and healthcare eco-systems, the UK giant has been too ready to turn its back on innovative drugs that justify high prices.

Even Pearson's departure can't stop the clock at Valeant

Valeant Pharmaceuticals announced this week that CEO Michael Pearson will step down from his position once a replacement is found. Pearson's departure comes as scrutiny intensifies over Valeant's accounting practices, its ability to pay off debt levels worth three times its market value and whether the company can survive as a going concern.

The First Take: Pearson to be replaced as Valeant CEO but chaos reigns.

This announcement is the latest in a series of failed attempts by Valeant to push the reset button, but the company remains plagued by challenges. In addition to the fact that Pearson will continue to run the company until a successor is identified, former chief financial officer Howard Schiller – who recently stood in for Pearson as CEO – has refused to resign from Valeant's board following accusations by the company that his improper conduct contributed to the accounting practices which triggered Valeant's current woes.

Prominent shareholder Bill Ackman, who has been appointed to the board as part of this reshuffle, is reported to have told employees that Valeant's recovery will stem from the company tackling reputational rather than operational deficiencies; a view not shared by many industry commentators, who expect large-scale break-up to be Valeant's only means of survival.

Merck & Co. prevails in hepatitis C patent case versus Gilead

In the second of two recent high-profile patent cases, a US federal jury this week upheld the validity of two patents held by Merck & Co., allowing the company to seek royalties on sales of Gilead Sciences' hepatitis C drugs Harvoni and Sovaldi. Gilead will appeal against the ruling.

In the grand scheme of things, the impact of a royalty payment to Merck will represent a relatively small impact on Gilead, remarked a number of analysts, although there is some suggestion that this ruling will do the company no favours as investors grow increasingly impatient over a large-scale acquisition to bolster the company's pipeline (ViewPoints: Gilead’s (interim) loss in HCV patent case will do little to quell calls for M&A and ViewPoints: Gilead's push into oncology hits yet another roadblock).

Notably, Merck is not pursuing a ban on sales of Harvoni and Sovaldi, which differentiates this case from the ongoing patent dispute between Amgen and Sanofi/Regeneron Pharmaceuticals regarding the PCSK9 inhibitors Repatha and Praluent. A US court recently ruled in favour of Amgen's patents, with the most likely outcome being that Sanofi and Regeneron will have to pay a royalty of between 5 percent and 10 percent. Amgen is, however, seeking a permanent injunction against sales of Praluent; an unlikely – but still possible – outcome from this case – see The Q&A: Amgen triumphs in PCSK9 patent litigation – five key questions.

Bristol-Myers Squibb buys the keys to Padlock

Bristol-Myers Squibb announced it is to acquire Padlock Therapeutics in a deal potentially worth up to $600 million; the acquisition is notable on a number of fronts.

It provides evidence of Bristol-Myers Squibb's willingness to remain on the front foot in business development, while diversifying the focus of recent collaborations and acquisitions into the autoimmune disease space; an area where it has a presence via Orencia for the treatment of rheumatoid arthritis, but where biosimilar competition could steadily reduce market share over the next decade. Padlock's focus, aimed at targeting the autoantigen activity that triggers immune response in a number of disorders, could have broader application in other indications such as multiple sclerosis.

Padlock represents another success story for Atlas Venture and Padlock CEO Michael Gilman, who previously headed up Stromedix before it was acquired by Biogen. In addition, Gilman is a prominent user of Twitter, as is Atlas venture capitalist Bruce Booth; as a result, followers have been afforded an insight into how Padlock has evolved since being founded just two years ago. Read Booth's assessment of the start-up here.

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