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BioPharm Executive: Top 10: 2011 in Review

12/12/2011 1:31:35 PM

Top 10: 2011 in ReviewTop 10: 2011 in Review

Here it is, our fourth annual Top 10 Year in Review--a wholly subjective look at the 10 stories or trends that shaped the year in biotech. Drum roll, please...

#10 Bad PR. FDA has made an effort to get unapproved drugs off the market by offering incentives to the companies that choose to jump through the proper hoops and get formal approvals. That's just what K-V Pharmaceuticals did for hydroxyprogesterone caproate, a drug used to prevent preterm labor. And it duly hiked the price of its officially approved Makena...from about $10 a dose to $1,500. Even FDA, which doesn't officially concern itself with pricing, was shocked enough to say it wouldn't launch enforcement actions against pharmacists who chose to continue formulating the drug on the cheap. K-V finally balked, but not before drawing a lot of unwanted attention to themselves and others pursuing similar strategies a little less...aggressively.

#9 Biosimilars get respectable. So-called follow-on biologics continue to gain steam in industry as major companies decide whether to fight the process or, increasingly, join in. Amgen and Biogen Idec have recently embraced biosimilars as a potentially profitable strategy, following on the trail of Boehringer Ingelheim, Merck, Pfizer and others.

#8 Bye-bye bellwethers. We continue to bid adieu to biotech's old guard. This year, it was Genzyme, founded in 1981, that went into the arms of Sanofi-Aventis. Specialty pharma Cephalon (founded 1987) also got bought out, by Teva Pharmaceuticals. It looked likely that we would also be waving farewell to Human Genome Sciences (founded 1992), but so far that widely predicted acquisition hasn't happened.

#7 Euro collapse? This is one of the biggest stories of the year, of course, though admittedly for many U.S. life sciences companies the impact of the crisis is indirect. Still, the likelihood of a new recession in Europe isn't good news for anyone. Moreover, difficulty accessing capital is making life difficult for European biotechs. And the distant-but-not-impossible prospect of an EU breakup could hugely complicate things for the industry. Remember the pre-1995 days of country-by-country approvals?

#6 Let the Sun Shine! Advanced melanoma, a deadly cancer with a terrible prognosis, got knocked down a few pegs this year. Zelboraf (vemurafenib), developed by Genentech/Roche and Plexxikon/Daiichi Sankyo, and Bristol-Myers Squibb's Yervoy (ipilimumab), both produced substantial benefits for patients in terms of survival and disease progression. Considering this disease had no effective treatment up to this point, the impact for patients is huge.

#5 Occupy Connecticut? The Occupy Wall Street protests, and counterpart demonstrations around the country, were big news this year, even if the focus on Wall Street bankers to the near-exclusion of far more culpable legislators was often confusing. But pharmaceutical companies also drew the movement's attention--with a vigil at Pfizer aimed at highlighting the company's decision to shutter a facility in New London that received public money. Couple mass layoffs with the fact that some pharma CEOs presided over disastrous years and still received pay raises, and the industry could receive further attention in the future.

#4 Hepatitis C. This year was certainly a big one for those who suffer from hepatitis C, or anyone who cared to invest in the area. Both Vertex Pharmaceuticals and Merck launched novel hep C protease inhibitors--Incivek and Victrelis, respectively--in May. And then came the news that Gilead Sciences, known best for its leadership in HIV, is buying Pharmasset to gain its phase 2 hep C drug...for a stunning $11 billion! The battle for this newest hot sector of the marketplace is far from over.

#3 The Dendreon Effect. Shorting drug launches often turns out to be a good (if risky) idea, but Dendreon really put that notion out front after the launch of Provenge. Widely considered to be an inevitable blockbuster, Dendreon's management withdrew guidance this year and said sales were ramping slowly due to a lack of physician education and difficulties with reimbursement mechanisms. Fear that drugs with six-figure price tags would flounder made life difficult for Seattle Genetics, too, after its launch of the cancer drug Adcetris, and led to questions about a lot of new launches. Investor caution, at least, may be a silver lining. And don't count Provenge out just yet.

#2 Lipitor goes generic. Okay, this didn't exactly come as a surprise to anyone, but the final death knell of Pfizer's exclusivity on the world's top-selling drug is the end of an era...and a boon to cash-strapped patients.

#1 Lots of Approvals! This is really where the rubber meets the road for our industry. After approving just 21 new molecular entities in 2010, FDA got a burst of speed. As of the end of November, it had already approved 34 NMEs, and is on pace for its best year since 2004. Not only did we get new treatments for melanoma and hep C, but also the first new lupus drug in over 50 years, the first new drug for medullary thyroid cancer, and a new treatment for non-small cell lung cancer. While the sudden boost in approvals is likely to be a bit of a fluke, there's reason that post-genomic discovery methods will finally start to yield a lasting uptick in productivity.

Have a great holiday and a wonderful 2012!

-Karl Thiel

Read the BioPharm Executive online newsletter December 14, 2011.

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