Friday Five – Your weekly pharma review

Another week – another suitor for Medivation?

Following reports that Sanofi is considering a hostile approach for Medivation, it was the turn of AstraZeneca to be linked to the oncology-focused biotech company this week. In response to the chatter, Medivation has seen its share price increase by 43 percent over the past month.

Having fended off Pfizer's advances two years ago, AstraZeneca may be in need of its own deal to shore up mid-term operating performance, argue some analysts; the UK company faces a sustained period of high-profile patent expiries over the next few years. Medivation's focus on cancer drug development would fit with AstraZeneca's legacy and pipeline efforts in this therapy area, while lead franchise Xtandi – for the treatment of prostate cancer – remains an attractive growth asset. That said, Medivation's most advanced pipeline compound, the PARP inhibitor talazoparib, is vying to compete with AstraZeneca's olaparib, which is already approved for ovarian cancer.

What stood out at AACR?

With Medivation's rumoured takeout illustrative of the investment being made in oncology assets, this week's annual meeting of the American Association for Cancer Research (AACR) has been watched with much interest, with a sharp focus on immuno-oncology development.

In terms of late-stage data, Bristol-Myers Squibb confirmed an impressive overall survival (OS) benefit for its PD-1 inhibitor Opdivo in advanced head and neck cancer, when it presented results from the Checkmate-141 study. The notable results, while widely expected given that the '141 study was halted early in January, should ensure that both Opdivo and Merck & Co.'s Keytruda secure US approval for head and neck cancer in the second half of 2016 - see Spotlight On: New data heats up the race to market for immunotherapies in head and neck cancer

One of the more intriguing early-stage presentations at AACR concerned a pair of agents – being developed by Ignyta and Loxo Oncology – which are targeting neuropathic tyrosine receptor kinase (NTRK) mutations - see ViewPoints: AACR offers an early look at how the NTRK battle is shaping up. These mutations are thought to occur in a small subset of patients – just 1 percent of the non-small-cell lung cancer population, for example – although the presence of NTRK has been identified across multiple tumour types. Both products appear to be racing down an abbreviated path to market with patients enrolled into Phase II studies, which could potentially support regulatory applications.

Boehringer Ingelheim confirms CV studies for Jardiance

Following confirmation last year that Jardiance had become the first diabetes treatment to demonstrate a cardiovascular outcomes benefit, Boehringer Ingelheim announced this week plans to study the SGLT-2 inhibitor for the treatment of chronic heart failure with partner Eli Lilly.

Two studies, which will last between three and four years, are expected to commence within the next year and will assess the efficacy of Jardiance and standard of care in diabetic and non-diabetic patients versus placebo and standard of care. The studies will be designed to study the effect of Jardiance on two different types of heart failure; patients with reduced ejection fraction (HFrEF) and patients with heart failure with preserved ejection fraction (HFpEF).

A Boehringer Ingelheim spokesperson noted to FirstWord that the decision had primarily been driven by Jardiance's demonstrated effect in reducing the risk of hospitalisation for heart failure in patients with type 2 diabetes by 35 percent in the EMPA-REG study. Jardiance also demonstrated a 38 percent reduction in cardiovascular death.

Announcement of these studies coincides with Novartis' first-quarter financial results and confirmation that the chronic heart failure treatment Entresto generated sales of $17 million for the first three months of the year. This was below consensus expectations of around $30 million, while Novartis' full-year sales guidance of $200 million is below a consensus of $300 million.


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Novartis, Roche, Johnson & Johnson and Biogen report Q1 results

Loss of share to Gleevec generics, following US patent expiration in February, weighed on Novartis' first-quarter pharmaceuticals performance, while the Alcon unit continued to struggle. Analysts described overall results as "reasonable." 

Cross-town rival Roche kick-started Big Pharma earnings seasons earlier in the week by reporting 5 percent year-on-year growth for its pharmaceuticals division and clarifying when a series of oncology data readouts will occur over the remainder of 2016. The company also hopes to gain approval for its PD-L1 inhibitor atezolizumab in bladder cancer and second-line non-small-cell lung cancer during this period - see ViewPoints: Roche's pipeline keeps it busy

Johnson & Johnson saw its pharmaceutical sales grow by 5.9 percent during the first quarter, versus declines of 5.8 percent and 2.4 percent for its consumer healthcare and medical device units, respectively. Sitting on a cash pile of $17 billion, Johnson & Johnson looks an acquirer in waiting – will it seek to grow the prominence of its pharma division or try to balance its revenue base by deals in consumer and medtech, having hinted once again that a breakup is not on the cards - see ViewPoints: Do Q1 results show pharma is the way for J&J? 

Biogen's Q1 revenues were up 7 percent year-on-year, driven by a 15 percent increase in sales of the multiple sclerosis treatment Tecfidera; while sales were down sequentially, they were in line with consensus, noted ISI Evercore analyst Mark Schoenebaum. There was a substantial miss for global interferon sales, which continues a trend from the Q4 2015. Sequential quarterly sales of the haemophilia therapies Eloctate and Alprolix – which Biogen is rumoured to be exploring divestment of – increased by 6 percent and 5 percent, respectively.


Gene therapy wave continues to swell

Replacing a faulty gene with one that functions properly is about as elegant a therapeutic strategy as there is, but technical hurdles of putting the plan into practice have proven sufficiently challenging that just a single product has been approved in the Western world – and even it was recently deemed a commercial failure.

Despite the lack of historical success, and cognizant of the false dawns the gene therapy field has experienced in the past, it is hard not to get the sense there is growing optimism that a number of products currently in development – or on the doorstep of an approval, as is the case with GlaxoSmithKline’s Strimvelis – could have the type of significant impact on the lives of patients that proponents have been promising for years.

Haemophilia B is one condition in which a lot of progress has been made, with at least five companies having now begun human testing with gene therapies designed to replace deficient Factor XI. Haemophilia A, however, has proven more complicated in part because the gene that needs replacing, which codes for Factor VIII, is too large for use with normal delivery vectors.

BioMarin thus announced a breakthrough this week when the company provided the Street with a first look at human data for its BMN 270, a therapy that uses a truncated section of the gene and, at first blush anyway, appears to generate an encouraging amount of Factor VIII expression. (See ViewPoints: BioMarin suggests gene therapy is on the way to point A from point B in haemophilia.)

While BioMarin appears to have a bit of a head start, several competitors hope to move products of their own into human testing by the end of the year, reflecting the growing amount of competition in the gene therapy space.


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