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Market Movers & Shakers
calendar of events
 
June 2015
 

Welcome to the first issue of Evaluate's Calendar of Events newsletter, your monthly digest to the key events that are happening in the industry. Each issue will highlight key clinical and regulatory events as well as provide you with detailed analysis of some the biggest moving events over the last month and opinion from EP Vantage.

This month’s features a detailed look at the PCSK9 chase between Praulent from Sanofi and Regeneron, and Repatha from Amgen, as well as a look at the upcoming presentation at Asco for Bristol-Myers Squibb/AbbVie’s multiple myeloma project Elotuzumab.

Sign up to this newsletter from EvaluatePharma Calendar of Events and EP Vantage to stay on top of upcoming industry events with analysis.

Ignatius Fogarty, Product Manager

 
 
 

EvaluatePharma Calendar of Events provides you with a single aggregated source for all the key events, stage gates and outcomes across a product's lifecycle, giving you the power to understand future value-drivers in the pharmaceutical industry.

 
 
Key Upcoming Trial Results
 
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COMMENT:
The upcoming results for Grazprevir/Elbasvir in HepC, a late entry to the market, will give an idea of where Merck will fall in relation to the current top-runners Abbvie and Gilead. However to compete with either it will need to show at least a 90% sustained viral response rate. 

The presentation of EMBODY-1 and -2 trial data by UCB seems to be highly anticipated by covering analysts. Previous evidence released indicates that epratuzumab has the potential to be more efficacious then current treatments including Glaxo’s Benlysta. 

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Upcoming Key Regulatory Dates
 
Upcoming Key Regulatory Dates

COMMENT:
Sanofi/Regeneron and Amgen’s PCSK9 inhibitors will be the subject of a two day advisory committee. The two drugs have been in a hotly contested race to market and this event will reveal how they measure up to one another before the final dash to their respective PDUFA action dates in July/August. 
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Top 5 Gains (May 2015)
 
Top 5 Gains (May 2015)
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Top 5 Losses (May 2015)
 
Top 5 Losses (May 2015)
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Feature Article
 
 
 
Event – Amgen and Sanofi face final check before start of PCSK9 chase
 

It is uncommon in pharma to see as straight-up a horse race as that facing the cholesterol-lowering agents Praluent from Sanofi and Regeneron and Repatha from Amgen – the two PCSK9 projects could be launched in the US within weeks of each other later this summer. A two-day FDA advisory committee next month will shed light on what differentiation, if any, there is between them.

Given that long-term outcomes data will not be available until 2017-18 regulators might want to limit access to those patients with genetic disease, and extend coverage more widely only when they can be shown to prevent cardiovascular events and deaths. While cost is not technically a consideration, it will be on the back of everybody’s minds when deciding who is eligible for the PCSK9s... 

 
 
 
 
Market Moving Events
 
 
Upcoming events: Survival data from Glaxo's Breo and Otonomy's move in Ménière’s
 

With US approval of Breo Ellipta in adults with asthma in the bag, GlaxoSmithKline is now gearing up for an even bigger event – data from a huge study seeking to prove that the combination therapy can extend the lives of patients with COPD.

Meanwhile San Diego-based company Otonomy is awaiting data from a phase II trial of its Ménière’s disease candidate OTO-104, expected mid-year. With a successful IPO behind it and its lead drug, AuriPro, awaiting FDA approval, Otonomy is in a fairly good position – but not so good that it can afford a miss in this trial...

 
 
 
Asco preview – The eloquence of elotuzumab
 

The slow rise of Bristol-Myers Squibb/AbbVie’s multiple myeloma project elotuzumab got another fillip with its pivotal study yielding sufficiently good data for Asco to include it as one of four highlighted abstracts in today’s presscast.

The Eloquent-2 trial suggests that elotuzumab should be added to Celgene’s blockbuster Revlimid in second and later-line uses, where it has US breakthrough designation, and its "dual" mechanism has attracted particular attention. Pricing is another thing; Revlimid is already an expensive drug, and the financial cost of adding elotuzumab, an antibody, on top of it could become as prominent an issue as the results themselves...

 
 
 
 
Dates for Your Diary
 
 
 
 
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