The top Phase III R&D setbacks of 2013

Πηγή: Fierce Biotech | John Carroll

The stats on Phase III success rates aren't good. About half end in failure--and that's after developers have had a chance to do some careful testing in humans. It's no wonder, then, that late-stage failures continue to inflict some punishing damage on the world's largest R&D organizations--which in most cases are still laboring to overcome the arrival of the patent cliff.

I've singled out what I consider the most significant Phase III setbacks of the year (so far). They were selected not just because they damaged or destroyed estimates on peak sales, but because they also reflected on the companies involved, influenced their research strategies or raised questions about a disease initiative that had grabbed the attention of everyone in the field.

It doesn't always seem possible, but failure doesn't have to be solely negative. The best organizations learn from their high-profile failures and the setbacks of others. What's amazing is how often failure is still immediately shoved out of public view, and how easy it is to convince analysts it was either really a success or completely unimportant. The wake-up call on R&D came long ago, but some groups are still fast asleep.

1  Tredaptive - Merck

2  Ramucirumab - Eli Lilly

3  Fostamatinib/Onglyza - AstraZeneca

4  Aleglitazar - Roche, pRED

5  Vercirnon - ChemoCentryx, GlaxoSmithKline

Sanofi, Teva face renewed backlash as job cuts hit home countries

Πηγή: FiercePharma | Tracy Staton

Two drug company reorganizations. Two goals in mind. One common obstacle. As Teva Pharmaceutical Industries copes with the Israeli backlash from last week's layoff announcement, Sanofi continues to feel the heat from French leaders on its own R&D restructuring scheme.

The situation Teva  now faces is eerily similar to Sanofi's  experience in France last year. Immediately after learning that job cuts would hit Teva's home country, Israel, local labor leaders vowed to strike. By this morning, government officials had jumped into the game. Reportedly, Israeli Finance Minister Yair Lapid and labor leaders "see eye to eye" on the need to protect Teva's employees. And State Comptroller Joseph Shapira called Teva's layoff plans "out of place."

Seven Disruptive Drugs for the Next Decade

 

The biopharmaceutical sector is built to breed innovation from the ground up. If you think about it, drug patents are only scheduled to last for a grand total of 20 years, and that is sometimes from the point at which a company begins preclinical trials. In other words, around half of a drug's protected period can be spent running pre-clinical and clinical tests on efficacy and safety. This means the bread-and-butter period of success for even the biggest blockbusters tends to only be about one decade.

To add, the march toward creating better drugs never stops. Just because a new hepatitis-C drug hit the market two years ago doesn't mean the other four companies making hep-C drugs are suddenly going to go home with their hands in their pockets pouting about what could have been. Biopharmaceutical companies need to always be on their toes and trying to outdo their last drug if they hope to maintain success. Like technology, these drugs become bull's-eyes as soon as they're approved by the Food and Drug Administration for the next group of biopharma companies to unseat.

That's why today I'm looking at seven drugs that I feel have the power to remain a disruptive force in their treatment field throughout the next 10 years. Some are already approved by the FDA; others are not. Obviously, there could be a lot of variables here as it's difficult to see 10 years out and understand what discoveries could be made, as well as what monkey wrench clinical trials or the FDA could throw out to the handful of drugs still in clinical stages mentioned below. What I do believe, though, is that each drug below has the tools to become a dominant force over the next decade and you should, at minimum, be watching their progress. Let's begin with three recently approved drugs that have incredible potential.

Teva cuts 5,000 jobs to save $2bn a year by 2017

 

Teva is slashing the size of its workforce by 10 per cent in an acceleration of its cost-reduction plans, saying it hopes to trim $2bn off its annual expenses by 2017. The cutbacks mean that around 5,000 employees will lose their jobs - with most going before the end of next year - which will reduce 2014 costs by $1bn. By 2015 the company expects to have made 70 per cent of its savings target.

Teva first started restructuring its business at the end of last year, when it said it was looking for $1.5bn to $2bn in 2017 cost reduction.

At the time, it said that sales would decline in 2013 thanks to increased competition for multiple sclerosis (MS) blockbuster Copaxone (glatiramer acetate) and leaner opportunities in generic drugs as the infamous pharma 'patent cliff' draws to an end.

The company had already started to jettison non-core assets - including some R&D programmes - but says it will now extend that effort.

"Teva will scale down oversized parts of the company, while growing its generics business and core R&D programme," said the company in a statement. Priority areas include high-value complex generics, expanding its presence in emerging markets and broadening its portfolio, especially in speciality and over-the-counter (OTC) medicines, it added.

Forget the merger between Roche and Novartis

According to Pharma industry analysts Novartis really is considering selling off a few of its units, in deals that could be worth $15 billion to $20 billion. And no, Roche and Novartis  aren't likely to embark on any big joint projects, much less consider a merger.

This is how Bernstein Research analyst Tim Anderson sees it. He visited both Swiss drugmakers recently and talked with the companies' top brass. Both seemed intent on quashing talk of a crosstown merger, recently triggered by Novartis board member Pierre Landolt's enthusiastic comments on the prospect. Novartis chief Joe Jimenez told Anderson that Landolt's opinion was his own and might not be shared; Roche CFO Alan Hippe said mega-mergers are too disruptive, and his company just isn't interested in them.

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Merck, AstraZeneca, Pfizer top list of biggest pharma job-cutters

Since the beginning of 2008, the 11 largest prescription pharmaceutical manufacturers have shed a combined 143,536 jobs according to data collated by Bloomberg.

Merck & Co. – which announced 8500 job cuts last week as part of an initiative to "sharpen its commercial and R&D focus" – has undergone the biggest reduction in headcount over the past five years. The US pharma giant has cut 46,140 jobs since the beginning of 2008, including 15,000 job losses in early 2010 as a result of the Schering-Plough acquisition a year earlier. A further 13,000 jobs were cut in 2011, which equated to a post-merger reduction in staff numbers of around 30 percent.

Loss of US exclusivity for Merck's asthma treatment Singulair was cited as a pre-cursor to the 2011 cuts and likely also played a role in last week’s announcement.

AstraZeneca has cut its workforce by the second highest amount over the past five years, having reduced its head count by 25,733 staff. Over that period, the company has on three occasions announced cuts in excess of 5000, most recently in April. Indeed, since March of this year, the company has reduced its headcount by approximately 9000 people as CEO Pascal Soriot looks to redirect the company’s strategy and commercial outlook. 

Pfizer has shed 16,517 jobs since the beginning of 2008, but notably made the vast majority of these cuts in two announcements prior to the loss of exclusivity for Lipitor in late 2011; Pfizer cut 8180 positions in 2009 and a further 6000 jobs in 2010. Subsequently, Pfizer has cut only a further 1600 positions.

 



Loss of exclusivity for key blockbuster products has acted as the key driver for Big Pharma’s trend to cut jobs over the past five years, both due to the impact on revenue but also pharma’s ability to reduce its sales and marketing spend as a result. It is perhaps no surprise then that the number of job cuts across the Big Pharma peer set peaked in 2010 (40,146 job losses) – just ahead of the co-called 'patent cliff' in 2011/12.
 
Big Pharma’s rate of headcount reduction has subsequently declined, although Merck’s announcement last week demonstrates that there is scope for further streamlining. One analyst suggested, for example, that Eli Lilly could be a prime candidate for cost cutting should its pipeline not deliver as anticipated over the next few years.