The top 10 FierceBiotech stories of 2014

Print 02 December 2014
John Carroll, FierceBiothech

And immuno-oncology unquestionably dominates the top stories of the year

Last year at this time, the daily reports we produce in the life sciences group were opened about 93,000 times per day, on average. Now, that opener number has swelled to 125,000 with a group of subscribers that exceeds 270,000, and web traffic is reliably more than one million visits per month. In October, we hit 1.3 million.

It's a more global audience than ever. Share of readership in Europe, after launching the EuroBiotech Report, has edged up to about 18% of the total atFierceBiotech, with the U.S. at 71% and Asia at 10%. Early next year, we'll be starting our new twice-weekly Asia pub, FiercePharmaAsia, and we expect our Asian audience will grow as well.

So what has this expanded group of readers been clicking on? Our editorial mission at FierceBiotech is to put the news in context, highlighting the implications and trends behind the headlines. Our audience has clearly responded with considerable enthusiasm. Four of these 10 stories are about the emerging immuno-oncology drug market, which promises to fundamentally change the way cancer is treated--now. Big news for readers also meant following big programs at big companies. One of our core areas of expertise is covering emerging biotech companies, but you won't find any in the top 10. While not a day goes by we don't do something about a small biotech company, those stories don't always qualify for the biggest audience.

In biotech, here are the top 10 news stories of the year so far, based on web traffic.

Amgen axing up to 2,900 staffers, shuttering R&D campus in revamp

Last year saw some continuing major realignments in research as Big Pharma continued to try and refashion its big and expensive global R&D organizations. This year, the world's biggest biotech--which sometimes looks like another Big Pharma--tackled the same task. With its late-stage efforts pumped up with a PCSK9 program,  new cancer drugs and more, Amgen ($AMGN) whipped out the budget ax. Out: Its Seattle R&D campus. And rather than stick with nearly 3,000 company-wide layoffs, Amgen later bumped the total to 4,000. As usual, analysts loved to see the cutbacks. Restructuring global R&D has been a theme now among the big players for the past 5 years. Now a number of them, including GlaxoSmithKline ($GSK), are making a fresh round of changes to try and spur more productivity. This is one story among many more to come.

Two deaths force MSK to hit the brakes on engineered T cell cancer study

This was our top immuno-oncology story on the web. FierceBiotech was tipped off early that there was trouble in this program. Cytokine release syndrome, or a cytokine storm, killed two patients in a CAR-T study, in which investigators adapt T cells to fight cancer. This particular story emerged unexpectedly at a conference and then went viral. Investigators tailored the study and changed the way they recruited patients, highlighting the big safety threat involved in these advanced therapies. It wasn't long before regulators gave them a green light to proceed after this temporary setback. And the company involved--Juno--is now prepping one of the most highly anticipated biotech IPOs of the year. Cytokine storms remain a key threat to patients, but all investigators have been adapting their trials to limit the risks involved for patients.

Anti-PD-1 cancer star nivolumab wins world's first regulatory approval

And let's stay on immuno-oncology. This world's first approval happened in Japan--not your biggest market but an important one nonetheless. Ono Pharmaceutical picked up the Japanese rights to the drug--and future bragging rights--in a collaboration deal with Medarex that dates back 9 years. Bristol-Myers owns the bulk of the global rights, though, and it wouldn't be long before the renamed Opdivo was filed with the FDA as Bristol angled for the lead on lung cancer--which promises to be a big market.

Say what? Pfizer's $101B buyout pitch to AstraZeneca sparks a megadebate

Megadeals, you'll remember, were as out of fashion in the pharma industry as bell-bottom pants for men when Pfizer sprung a stunning buyout proposal on AstraZeneca ($AZN). Pascal Soriot, though, had only recently taken the helm at the U.K. pharma giant and wasn't about to let go without a fight. Bizarrely, Pfizer pressed on--even though it had to endure taunts about its R&D acumen. Most analysts assumed that the tax benefits then available through an inversion to a low-tax haven was the real motivation in the merger. And Pfizer finally relented after AstraZeneca, with the help of the U.K.'s political class, gradually forced the U.S. company to give up--at least for a bit. U.K. biopharma investment guru Neil Woodford, a big Astra supporter, still thinks there's a very good chance Pfizer will come back and try again.

AbbVie heads to the FDA with its hep C combo in a race with Gilead, Merck

Gilead ($GILD) made waves with its pioneering approval of the hep C drug Sovaldi… and the price tag it attached. And coming up in its wake are two more big players, with AbbVie ($ABBV) gaining some star quality with its antiviral cocktail. At stake are billions in revenue as new drugs radically alter the standard of care with drugs that are much more effective--and much less harsh--than the interferon-based remedies that once dominated the market. Outside of immuno-oncology and cancer, hepatitis C has faced one of the biggest revolutions in the standard of care. And we cover drug R&D revolutions like no one else.

FDA rejects Eli Lilly's SGLT2 diabetes drug empagliflozin

When it bleeds, it leads, as they say on the evening news. And there's been lots of blood at Lilly ($LLY) in recent years. This year has actually been pretty good at Eli Lilly, topped with an approval for dulaglutide. In this particular case, a manufacturing issue blocked the drug, but in early August Lilly bounced back and nabbed an OK for the therapy--now marketed as Jardiance. A late entrant into an already crowded field, analysts don't expect to see great things from this drug, which is unfortunate. Lilly, freshly knocked out of the top 10 list of Big Pharma companies by a growing Actavis ($ACT), needs all the help it can get.

Novartis' LCZ696 kindles megablockbuster projections with impressive PhIII heart data

Once upon a time, serelaxin represented Novartis' ($NVS) big hope for the cardio franchise. But the drug never lived up to the big expectations that the pharma giant created. But right as serelaxin was foundering amid considerable bluster from company execs, LCZ696 made a sudden and unexpected appearance. This story was one of many we have written about this blockbuster hopeful, which CEO Joe Jimenez bullishly believes is destined to earn $2 billion to $5 billion a year. It's by no means clear sailing yet--any drug that attempts to compete against cheap generics faces some tough challenges. But it's a heavyweight contender at a time Novartis needs a great new drug hope to come along.

Merck wins breakthrough FDA approval for blockbuster cancer contender pembrolizumab | Merck's hot immuno-oncology prospect MK-3475 grabs clear lead in blockbuster race

Here's a two-for-one immuno-oncology special. Breakthrough status was hardly needed to highlight the potential of Merck's pembrolizumab, which now represents a pipeline in itself for the pharma giant. The rapid progress, accelerating from Phase I straight into registration studies with a big complement of combination studies now underway, marks the success of Roger Perlmutter, who took over R&D at a time the company was beginning to blunder from one mistake to the next. Merck's rep is all about smart drug development, but a long stretch without major approvals left a black mark on the reputation and questions hanging over the company's future. Immuno-oncology isn't going to be enough to fix its problems by itself. But it's laid to rest nagging questions about whether Merck could get its act together. 

Party drug turned 'miracle' cure for depression spurs hype and stubborn hope

The mainstream media loves this story. And evidently it played well for us as well--despite the skepticism that should have been more than apparent. Investigators know by now that demonstrating again that the generic anesthetic ketamine--better known in some circles as Special K, a party drug with some harsh and frightening side effects--also works well as a temporary treatment for depression. Even the hardest-to-treat patients tend to respond to this drug. The problem, though, is that it's a temporary solution at best. Pharma companies, meanwhile, have been poking around for years now looking for a reformulated version that can drop the "party" and prolong the antidepressant effect. But AstraZeneca and others have found this a hard nut to crack. Never fear, though, a New Year approaches and no doubt we'll be treated to a fresh round of quickie studies on Special K and depression.

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