The 2016 Dive Awards for the biopharma industry
From resurgent pharma to strong leaders, BioPharma Dive recognizes the top companies and trends defining the industry
It wasn't a raucous year in biopharma. There weren't a record number of IPOs, the FDA didn't approve a crazy number of new drugs, there wasn't a megamerger that sent reverberations through the industry and Martin Shkreli was uncharacteristically quiet. But amazing things were still happening in 2016.
Companies spent the year quietly but purposefully reshaping their portfolios, selling off odd drugs that no longer fit their direction and picking up little assets that padded their portfolios in key areas. While big pharma didn't make any landscape-changing deals, the look and shape of some of the industry's biggest companies is very different from when the year began.
Innovative science was a key driver. The oncology space reached a crescendo, with new areas offering exciting possibilities. Checkpoint inhibitors, CAR-T and CRISPR have become common words among industry players as the PD-1 inhibitors rack up new indications and the first CAR-T therapy nears approval.
This year was also marked by some major hits to the industry. Bristol-Myers sent stocks cascading when its announced a surprise lung cancer drug failure, and new pricing investigations have become the tune of the week.
In that spirit of disruption and innovation, we present the 2016 Dive Awards for the biopharma industry. These awards are the byproduct of months of work and research: We have been planning these awards since January, solicited suggestions for nominees from readers in August, then consulted industry insiders to help us narrow down the nominees. Ultimately, the winners were chosen by the editors of BioPharma Dive.
Here are our 10 winners for 2016:
Company of the year
Winner: Bristol-Myers Squibb
Bristol-Myers Squibb stands out for its unyielding focus on being the best in one area. While many other big pharmas have been refocusing their portfolios so that they can be the leader in multiple therapeutic spaces, Bristol has had a single-minded focus on immuno-oncology.
The company has led the race in checkpoint inhibitors, and Opdivo (nivolumab) has three times the revenues of its closest competitor. While the drug has hit some major setbacks this year, Bristol is undeterred, vowing to plow ahead with combination therapies and to keep the spotlight on the PD-1 inhibitor.
Other nominees: Johnson & Johnson, Medivation, Kite Pharma, Tesaro
Executive of the year
Winner: Joe Jimenez, CEO of Novartis
Novartis' 2016 has been characterized by big bets. Joe Jimenez, now in his sixth year as CEO, has doubled down on the new heart drug Entresto, boosting spending on marketing efforts by $200 million and launching an ambitious clinical program to expand real-world evidence for the drug.
Jimenez also appears to be preparing Novartis for a tighter pricing environment in the U.S. Under his leadership, Novartis has inked pay-for-performance deals with four major U.S. insurers to expand coverage of Entresto. At the same time, Novartis is accelerating its development efforts for biosimilars.
Jimenez has staked a lot on Entresto and other new drugs, but the CEO has forged a model for others to follow with his emphasis on new pricing models.
Other nominees: BioMarin's Jean-Jacques Bienaime, Shire's Flemming Ornskov, Editas Medicine's Katrine Bosley, Allegan's Brent Saunders, Mylan's Heather Bresch
Rivalry of the year
Winner: Opdivo vs. Keytruda
Stakeholders in Bristol-Myers Squibb and Merck & Co. watched the companies race for market dominance this year with their respective checkpoint inhibitor products, Opdivo and Keytruda (pembrolizumab). The companies have practically gone tit for tat racking up new indications.
While Opdivo took an early lead, disappointing trial results in non-small cell lung cancer (NSCLC) have given Keytruda an opportunity to make up ground.
Still, Opdivo remains ahead in terms of sales. The treatment brought in $920 million in the third quarter versus Keytruda's $356 million. Expect these two drugs to keep going head to head as they both come out with new combination data.
Other nominees: Martin Shkreli vs. Congress, the DMD community vs. the FDA, Novo Nordisk vs. Sanofi vs. Eli Lilly, the Broad Institute vs. University of California, Berkeley
Most valuable pharma deal
Winner: Bayer/CRISPR Joint Venture Casebia Therapeutics
While certainly not the most valuable deal in dollars this year, Bayer's decision to form a joint venture with CRISPR Therapeutics exemplifies the strategic thinking and emphasis big pharma is putting on outside innovation.
The CRISPR/cas-9 technology has been lauded as game-changing and Bayer's steps to get in early could pay off big in a few years' time.
Even though the other deals in the category boasted some serious cash and created real value for the acquirer, Bayer's unique deal structure gave it the win.
Other nominees: Teva/Actavis generic deal, Pfizer/Medivation, IMS Health/Quintiles merger, AbbVie/Stemcentrx
Drug launch of the year
Winner: Pfizer and Celltrion's Inflectra
Pfizer began shipping its biosimilar version of Johnson & Johnson's Remicade (infliximab) to U.S. wholesalers on Nov. 21 and already has a sales force in place. While the other drugs on the list were impressive, Inflectra represents a broader challenge to the lucrative biologics market.
Inflectra is only the second biosimilar launched in the U.S., threatening a franchise that earned almost $4.5 billion in U.S. sales for J&J last year.
The biosimilar's scheduled launch underscores the hastening arrival of long-anticipated copycat biologics. Pfizer, along with several other drugmakers, is now in the position to set the tone for how biosimilars are going to be handled by payers and received by patients.
Other nominees: Roche's Tecentriq, Merck's Zepatier, Gilead's Epclusa, AbbVie's continued label expansion for Humira
Most disruptive innovation of the year
Next year could see the approval of the first CAR-T therapy in the U.S. if Kite Pharma's KTE-C19 clears the FDA’s review for aggressive non-Hodgkin lymphoma (nHL).
An approval of Kite's therapy would serve as an early validation for the drug class, despite the setbacks that have hit other early adopter Juno Therapeutics and the decision from Novartis to disband its dedicated CAR-T unit, which has tempered some of the unbridled optimism for the science.
CAR-T remains promising and the broader development of pipelines speaks to the potential for greater disruption of existing treatment options, particularly in hematologic cancers.
And other companies, such as Bellicum and Cellectis, are hard at work developing the next generation of CAR-T technology, which could address some of the early growing pains.
Editor's Note: After the award winners were chosen, Juno reported two deaths in a study of its lead CAR-T candidate, leading the company to halt its trial and consider other options. The implications of this development on the space as a whole are not yet discernible.
Other nominees: CRISPR/Cas-9, liquid biopsies, Intarcia Therapeutics' GLP-1 injectable pump, wearable tech for clinical trials/post-marketing studies
Turnaround of the year
Big changes have been happening at one of pharma's largest companies. Pfizer spent about a year scrambling from one failed megamerger to the next — remember its attempts to scuttle taxes — first through unwanted advances toward AstraZeneca and then its ill thought out tie-up with Allergan.
But the behemoth drugmaker is getting its act together, making deals for more traditional reasons. It finally closed some strategic acquisitions that made a lot more sense from a pipeline perspective than either of the aforementioned megamergers, picking up Anacor to bolster its inflammation and immunology biz and then Medivation to build out its oncology presence.
It also has been shedding non-core assets at a rapid clip as it reshapes into a company with true focus.
Other nominees: Teva Pharmaceutical Industries, Relypsa, Inc., Vertex Pharmaceuticals, Eli Lilly & Co.
Obsession of the year
Winner: Drug Pricing
Democratic presidential nominee Hillary Clinton kicked off a firestorm around an already tense discussion when she tweeted about pharma drug pricing before the election cycle even began.
Events around the subject have followed at a rapid clip, with senators and lawmakers targeting a slew of companies. Some, like Mylan, stoked public outrage with steep increases for older products. And the cast of characters, from Heather Bresch to Bernie Sanders to Mike Pearson to Martin Shkreli, have only made the discussions more over the top.
Amid the resulting outrage, pharmaceutical companies initiated plans to tighten prices and quell demands for reform while also bracing for hits to their bottom lines. Industry groups have mounted high-profile campaigns to showcase the cost of innovation. Throw a Donald Trump presidential victory into the mix, with his promises to reduce business regulation, and this obsession will drag well into 2017 and beyond.
Other nominees: Gene therapies, oncology combination trials, biosimilars, opioid regulations
Most 'epic fail'
Winner: Valeant's business strategy
The serial acquirer typically only went after already-marketed or close-to-market assets that it could then market itself for a higher price tag. This allowed the company to keep R&D costs to under 5% of revenues — well off the average 17% to 22% of revenues spent by other pharma companies.
For a couple of years, this strategy appeared to work. Valeant's stock price climbed above $250 and the company was lauded by Wall Street for its high rates of return and low cost of operations.
Its fall was just as steep as its climb, however, after an accounting scandal, federal investigations and accusations of price-gouging battered its image. The company now trades near $15 a share and has the lofty task of filling an empty R&D engine.
Other nominees: Opdivo in NSCLC, MannKind's Afrezza, Clovis Oncology's rociletinib, AstraZeneca's acquisition of ZS Pharma and the subsequent rejection of ZS-9, Biogen's DTC marketing campaign for Tecfidera
Most uncomfortable DTC campaign
Winner: Mylan's unbranded allergy ad
Yikes. This lightly branded ad from Mylan depicted the harrowing experience of a severe allergic attack through the eyes of a teenager, implicitly underscoring the importance of having an EpiPen ready.
While uncomfortable and goose-bump inducing, the ad is dramatically effective in conveying the need for a quick-acting epinephrine injector for those who are highly sensitive to a particular allergen (in this case, peanuts).
All of the ads mentioned below had that cringe-worthy effect, by either being sexually uncomfortable or by promoting a drug that arguably should never have a consumer campaign, but something about a suffering child went a little far for us.
Reporting contributed by Lisa LaMotta, Ned Pagliarulo and Jacob Bell