Friday Five – Your weekly pharma review

Alnylam's APOLLO mission complete

Success for Alnylam Pharmaceuticals' APOLLO study represents more than a positive drug trial; 20 years in the making, patisiran – developed for the treatment of hereditary amyloidosis – is now well positioned to become the first marketed RNAi therapeutic. APOLLO is the first successful Phase III RNAi trial.

The development of drugs that are designed to work by silencing specific genes has been beset with challenges, but APOLLO appears to be a resounding success. Not only was patisiran shown to be more effective at treating the symptoms of hereditary amyloidosis than expected, but its safety profile – in the past, toxicity has been shown to be particularly problematic where RNAi therapeutics are concerned – also impressed.

AnalysisViewPoints: Showtime at the APOLLO a big win for Alnylam and Spotlight On: The Medicines Co. rejoices at APOLLO's success

The biosimilar rebate trap is real

Companies marketing branded biologics in the US market are doing their level best to counter the threat from biosimilars, be it through intellectual property litigation (four of the seven biosimilars approved by the FDA to date are yet to launch as a result) or aggressive rebating with payers.

A spotlight has been shone on the latter by Pfizer's lawsuit against Johnson & Johnson, made public on Wednesday. Pfizer, which markets the biosimilar Remicade product Inflectra, has been discussing – and criticising – Johnson & Johnson's rebating activities for some time.

The rebate trap appears to be a peculiarity of the US market; in Europe, access to biosimilars is improving and oncologists will soon be able to use biosimilar Herceptin for the first time – see Physician Views: Gauging oncologist sentiment towards biosimilar Herceptin.

GlaxoSmithKline doubles up on triple-combo news

GlaxoSmithKline has secured US approval for its 'closed triple' combination product for the treatment of chronic obstructive pulmonary disorder (COPD). Trelegy Ellipta combines ICS, LABA and LAMA components into a single inhaler, which is used once-daily.

The key question now is whether US payers can be convinced of its merits and GlaxoSmithKline has new data from the IMPACT trial to support its case. Versus treatment with dual combinations – ICS/LABA (Breo Ellipta) and LABA/LAMA (Anoro Ellipta) – Trelegy Ellipta was shown to reduce moderate and severe exacerbations by 15 percent and 25 percent, respectively, over a 52-week period.

AnalysisViewPoints: GlaxoSmithKline says it's well placed to avoid further respiratory disappointment with new, first-in-class triple combo for COPD

In a year of R&D breakthroughs, cancer vaccines remain laggards

This year may have witnessed notable landmarks for both CAR-T and RNAi development (see above), but the only evidence that continues to accumulate for cancer vaccines is of the negative variety. Bavarian Nordic announced late last week that its experimental prostate cancer vaccine Prostvac had failed to better placebo in the Phase III PROSPECT trial. Shares in the company fell 50 percent.

Bavarian Nordic had previously announced in January that analysis of overall survival data would be delayed until later in 2017, suggesting that patients receiving Prostvac may be living longer. A view made in hope rather than expectation? Data from PROSPECT lay bare the facts, showing that all patients – including those receiving placebo – survived longer, as background standard of care therapy improves (and continues to do so – see ViewPoints: Pfizer may yet PROSPER from Medivation wager).

AnalysisViewPoints: Prostvac's demise marks the end of an era for cancer vaccines

Nabriva nabs funding on back of positive antibiotic readout

Nabriva Therapeutics is doing its best to challenge the lack of novel antibiotics moving from clinic to market by confirming this week positive data from the first of two Phase III studies for lefamulin for the treatment of community-acquired bacterial pneumonia (CABP). Shares in the company jumped as much as 102 percent as a result. Data from a second Phase III trial is anticipated next spring, but Nabriva moved quickly to raise funds on the back of share price movement. That extra cash will be needed, as the company says it wants to commercialise the product independently in the US.

AnalysisViewPoints: Nabriva pivots antibiotic data into a quick fundraising as it lays its commercialisation groundwork

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