FirstWord Lists – Key pharma and biotech events to year-end

This year may be approaching its conclusion, but there is a catalogue of key events set to occur among the large cap pharmaceutical and biotech players over the next two and half months.

Monday (October 20) could see Novo Nordisk gain approval for Saxenda in obesity, a potential catalyst for the company to step up its development in this disease area (Spotlight On: Exit from inflammatory development a case of time management, explains Novo Nordisk's chief science officer to FirstWord and Physician Views Poll Results: A post-AdCom assessment of Novo Nordisk's liraglutide for obesity).

Q3 earnings season also gains momentum this week, with GlaxoSmithKline's results – which will be announced Wednesday (October 22) – among the more keenly anticipated, given the status of the UK drugmaker as Big Pharma's weakest performing player for the year-to-date (Spotlight On: Big Pharma's leaders and laggards in 2014). Pfizer's Q3 investor call (October 28) – particularly any management disclosures around future strategy – will no doubt be eagerly digested given recent dramatic changes to the tax-inversion M&A landscape (ViewPoints: AbbVie gets cold feet as tax inversion jitters increase).

In the area of immuno-oncology, a dominant pharma theme in 2014, it is data from Bristol-Myers Squibb that is due to be published by year-end which holds the greatest potential to move share price. Data from the CHECKMATE '017 and CHECKMATE '063 studies will provide a much clearer picture as to how the company's PD-1 inhibitor Opdivo (nivolumab) can compete in the non-small-cell lung cancer (NSCLC) market, and help to reinforce the perception of Bristol-Myers Squibb as the leader in this development space.

Immuno-oncology is also certain to play a key role in AstraZeneca's investor day (November 18), when CEO Pascal Soriot will look to further enhance the company's pipeline recovery story, which has been another notable Big Pharma narrative of 2014 and one which analysts expect to accelerate next year when clinical promise will hopefully be transferred into clinical milestones.

Sanofi is also holding an R&D open day (November 20), which could prove important given the company's lack of new product launches in recent years relative to peers. On that front, a PDUFA date of November 28 for the multiple sclerosis treatment Lemtrada – which was rejected by the FDA in late 2013 – will also be important for sentiment. Amgen is the third large cap player due to hold an R&D investor event in Q4 (October 28), where the company's second phase of restructuring, longer-term margin performance and biosimilars are likely to be key topics of debate (ViewPoints: Amgen becomes first Big Pharma to unveil Phase III biosimilar antibody data.

Another important data disclosure anticipated in Q4 are results from Roche's MARIANNE study, which is assessing the combination of Perjeta and Kadcyla in first-line HER2-positive breast cancer. The trial is designed to help relegate Roche's older therapy Herceptin to the second-line setting, thus protecting future revenues from potential biosimilar competition. Recently published, highly impressive, data for the combination of Perjeta and Herceptin looks, however, to have raised the bar significantly for the MARIANNE study (ViewPoints: Why the next quarter is an important one for Roche). Roche's Japanese partner Chugai is also expected to showcase highly anticipated clinical data in Q4, for its haemophilia treatment ACE910 (ViewPoints: Roche tinkers with Chugai agreement as hopes for a full buy-out fade). Positive results will no doubt heighten existing blockbuster expectations.

Tomorrow (October 21) will see Celgene discuss Phase II data for its experimental Crohn's disease treatment GED-0301, which was in-licensed in April from Nogra Pharmaceuticals with a hefty upfront cost of $710 million.

From an approvals perspective, an FDA green-light for AbbVie's triple-combination hepatitis C therapy is highly anticipated and has a PDUFA date of December 28. In reality, focus is not on the approval of AbbVie's drug, but how it is marketed, priced and rebated, and how this dictates market share gain in relation to Gilead's Harvoni; a trend that will only become apparent in 2015 (Spotlight On: Four important talking points to watch now that Gilead's Harvoni is approved).

Next month's meeting of the American Association for the Study of Liver Diseases (AASLD) (November 7-11) should also provide incremental insight into how the hepatitis C market will develop in the longer term, with Merck & Co.'s proposed shorter-duration therapies a notable area of interest (ViewPoints: Early winners and losers from upcoming AASLD meeting begin to emerge).

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