Friday Five – Your weekly pharma review

Does Sanofi have Medivation in its sights?

Following the collapse last week of Pfizer's proposed merger with Allergan, M&A chatter has picked up – but the rumour catching most attention is Sanofi's reported pursuit of Medivation.

Long touted as a likely acquisition target, Medivation has spurned Sanofi's advances, reported Bloomberg. The French company – whose relatively new CEO Oliver Brandicourt is looking to make his mark – may come back with a hostile bid, they add.

The vast majority of Medivation's value is tied to Xtandi, the prostate cancer treatment it co-markets with Astellas. Approved in 2012, Medivation's share of Xtandi revenue is expected to more than double from $1.2 billion last year to around $2.6 billion by 2020, with key opinion leaders interviewed by FirstWord confident of increased usage in earlier-stage patients over the next few years. The company also has a number of promising cancer drugs in its pipeline.

Sanofi has been looking to expand its long-term presence in the oncology market via a series of licensing deals signed since Brandicourt's appointment, predominantly over the past two quarters. Acquiring a player like Medivation would provide more immediate diversification away from the competitive pressures faced by its core diabetes franchise.


Venclexta hits the finish line…

At least one analyst likened Medivation to Pharmacyclics, the US-based oncology specialist acquired by AbbVie for $21 billion last year. AbbVie's oncology portfolio is steadily forming around Pharmacyclics' lead asset Imbruvica, but was enhanced this week by the approval of a second leukaemia treatment – Venclexta – which has been co-developed with Roche.

Venclexta has been approved for a subset of the chronic lymphocytic leukaemia population; those patients with the 17p deletion gene mutation. Analysts and key opinion leaders are confident, however, that Venclexta holds much broader potential, with some experts lauding it as the biggest advance in haematological therapy for 15 years - see Spotlight On: AbbVie and Roche's newest cancer drug could be a game-changer


…while Clovis' rociletinib stumbles

While breakthrough therapy status for Venclexta has helped to usher AbbVie and Roche's drug painlessly through the US regulatory process, things have not been so straightforward for Clovis Oncology's rociletinib.

Another targeted cancer therapy, which in this case is designed to treat non-small-cell lung cancer patients with a particular genetic mutation, rociletinib was shot down by an FDA advisory committee panel this week, which voted 17-1 in favour of delaying any approval decision until further Phase III clinical data is reported.

This likely delays any market entrance for rociletinib until 2019, with analysts left to question whether Clovis should continue to fund development of the asset. If rociletinib does reach the market, only niche usage beckons, argue analysts; AstraZeneca's Tagrisso, which was approved by the FDA last November following a rapid development programme, has been a thorn in Clovis' side. Will it be the cause of rociletinib's demise? - see Spotlight On: How AstraZeneca upturned Clovis' applecart


Intercept nears first FDA approval

Another FDA AdCom held this past week – in this case assessing Intercept Pharmaceuticals' obeticholic acid (OCA) for the treatment of primary biliary cholangitis (PBC) – ended on a more positive note, with panel members voting 17-0 in favour of approving the drug. Why then did Intercept's share price trade down 10 percent as news of the vote was digested?

Some analysts have questioned whether side-effect concerns raised during the meeting will have a negative read across, if and when OCA is submitted for the much larger indication of non-alcoholic steatohepatitis (NASH) towards the end of the decade. It's too early to say for sure, argues Brent Neuschwander-Tetri, director for the Division of Gastroenterology and Hepatology and professor of Internal Medicine at the Saint Louis University School of Medicine.

Furthermore, in speaking to FirstWord earlier this week, Neuschwander-Tetri noted that identifying any specific NASH candidate for particular success is challenging at this point, given both a lack of non-invasive biomarker diagnosis tools and ongoing assessment of surrogate endpoints. He does, however, expect progress to be made over the next three to five years and the market for NASH to be substantial - see 


Merck drops once-weekly diabetes drug

An announcement which largely slipped under the radar was Merck & Co.'s disclosure late last week that it no longer plans to submit its once-weekly DPP-4 inhibitor omarigliptin – for the treatment of type 2 diabetes – to US and European regulators. The drug had once been viewed as a successor of sorts to Merck's blockbuster Januvia franchise, which remains the best-selling DPP-4 available.

This class of therapies has come under pressure in recent years, however, in a variety of forms. Pricing pressure in the US has played some role, as competitors seek to gain market share, while side-effect concerns and stronger-than-expected uptake of the SGLT-2 class have also played a role in limiting growth for the DPP-4 inhibitors. This pressure looks poised to continue with lead assets in both the SGLT-2 and GLP-1 agonist classes having now demonstrated a cardiovascular outcomes benefit; which has evaded the DPP-4 class.

With Merck also confirming this week that its immuno-oncology treatment Keytruda has been awarded priority review status from the FDA for the treatment of head and neck cancer, the decision not to seek approval of omarigliptin appears symbolic of a therapeutic 'changing of the guard' at the company. It is not a decision that has been taken lightly; Merck has enrolled more than 7000 patients in clinical studies for omarigliptin, but a rapidly evolving diabetes market does not appear supportive of further investment in the asset.    

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