巨大的风险和潜在的回报使得生物制药是令人兴奋的领域，网页变态传奇，被认为是未来的十五个重磅炸弹的分别是：雅培的Bardoxolone、辉瑞的Tofacitinib和Eliquis、默克的Anacetrapib、诺华的QVA149、Amarin制药的AMR 101、Elan公司的Bapineuzumab、拜耳的Xarelto、Gilead公司的Quad、 Biogen Idec公司的BG-12、礼来的Bydureon和Solanezumab、罗氏的Dalcetrapib、Trastuzumab-DM1和Pertuzumab.(生物谷 Bioon.com)
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Divining the future sales for any drug in development requires some finesse. You first must see how the experimental therapy shapes up against the current slate of marketed drugs, then add in what the competition is likely to do as they pursue their own approvals.
Looking over our slate of 15 of the biggest blockbusters now in late-stage development, it's clear the big developers are often attracted to the same megablockbuster markets. Two big cholesterol drugs are in the works, and Alzheimer's is huge. Meanwhile, looking for the newest cardiovascular disease treatment--as well as finding a better blood thinner than warfarin--has proven a tremendous magnet for Big Pharma as well as biotech.
It would be nice if all of these drugs will do exactly what the companies and analysts hope for, but a late-stage drug's prospects for success are about 50/50. Even if they win approval, there's no guarantee the treatments will live up to expectations.
But the enormous risks and potential rewards are what make drug development such an exciting field. The blockbuster is far from dead, and these 15 programs represent what biopharma can still do when it thinks big.
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The drug: Dalcetrapib
The disease: Cardiovascular
The developer: Roche
Peak projections: $5 billion-$10 billion-plus
Roche has always had a rather buttoned-down approach to drug development, careful about its science and relatively cautious on its prospects. With dalcetrapib, that caution gives way to sheer giddiness. When a Reuters reporter recently asked Roche research chief Jean-Jacques Garaud if he thought the cholesterol drug could hit $10 billion in annual sales, Garaud quickly gave the mark a thumbs up.
Roche investigators reported last summer that the patients taking the treatment saw their "good" cholesterol levels jump 31%. They were particularly happy to point out that the 476 patients in the study did not demonstrate the catastrophic cardio risks that scuttled Pfizer's torcetrapib 5 years ago. Phase III will recruit a far larger number of patients--something that will be needed to offer conclusive data for skeptical regulators.
So what's the big deal? Kaiser Permanente recently trolled through data on more than 30,000 patients with Type 2 diabetes and found that modest fluctuations in the level of HDL translated into significantly better, or worse, outcomes. Spur it up and you could reduce the risk of heart disease and stroke. Watch it drop and the risks go up.
Now translate those implications across a global epidemic of diabetes, where levels of good and bad cholesterol are playing havoc with the health bills faced by all the developed, and some of the developing, countries of the world and you get a better idea why Roche is so enthusiastic.
Analysts see the same megablockbuster potential that Roche divines, but $10 billion is a mountain of money by any calculation. Bank Vontobel analyst Andrew Weiss estimated potential sales of $5 billion a year; UBS analyst Gbola Amusa projected peak sales at $6.8 billion.
The drug: Bardoxolone
The disease: Chronic kidney disease
The developers: Reata and Abbott Pharma
Peak projections: Several billion-plus
When Richard Gonzalez took center stage a few days ago to talk up the late-stage drug prospects at the Abbott pharma spinoff he will helm, the chief zeroed in first on bardoxolone. Developed by Reata Pharmaceuticals in Irving, TX, and licensed in a deal loaded with $450 million in immediate and near-term payments, Abbott has high hopes for this late-stage treatment for chronic kidney diseases.
This treatment "has the potential to dramatically change the treatment landscape," he told analysts. "Current therapies only modestly slow the progression of the disease, while bardoxolone has the potential to markedly improve patient outcomes. We expect commercialization for bardoxolone as early as 2014." He cited the drug's blockbuster potential as cause for optimism about Abbott's newly spun off future.
Reata CEO Warren Huff might think of that as damning with faint praise. In 2009, when the biotech was angling for a partner, he estimated potential sales at $5 billion to 10 billion. But analysts have had a hard time coming up with Abbott's potential earnings from its pact. After all, clinical uncertainty has always been a trademark of the industry.
Huff felt confident enough at one point to plot an NDA on Phase IIb data. Abbott helped steer the drug into a full-fledged Phase III. Researchers are recruiting 1,600 patients with advanced kidney disease and Type 2 diabetes, hoping to prove that they can demonstrate that bardoxolone will extend the amount of time they can live without being forced onto dialy sis.