Top 10: 2010 In Review
As traditions go, this one is still in short pants. Nevertheless, the arrival of December means it is time for our third annual Top 10 Year in Review--Biopharm Executive’s entirely subjective look back at 10 stories or trends that shaped the year we just lived through...and perhaps the one ahead. Let the countdown begin.#10: Wikileaks. This is, of course, about a lot more than the biotech and pharma industry, but there seems to be no limit to the revelations coming from these leaked documents. We learned about overseas pharma facilities that the U.S. government deems vital to U.S. security--mainly those making vaccines of various kinds, but also other products that could “critically impact the public health, economic security, and/or national and homeland security of the United States.” And we saw some documents talking about Pfizer’s seamy dealings in Nigeria. What will come out next?! #9: The IPO window. It remained stubbornly open all year, even though few companies managed to raise what they were initially hoping for, and fewer still performed well in the aftermarket. The aftermath of the financial crisis has been about financial institutions healing their balance sheets...by not lending money. That’s made for a tough environment, but biotech has shown just how tough it is.#8: Continuing job losses. This is an unfortunate holdover from last year. Despite improvements to many aspects of the economy, jobs have not come back in any meaningful way. In fact, they’re still being lost in the life sciences industry. Industry layoffs for the year top 50,000, according to FiercePharma, led by AstraZeneca, Pfizer, and GlaxoSmithKline.#7: (Some) Biotech Stocks Soar! As of this writing, the Nasdaq Biotech index is up 10.4% year-to-date, trailing slightly behind the 11.1% gain for the S&P 500. But the AMEX Biotech Index, more weighted toward large bellwethers, is up 24.3%. Yes, you read that right. Many pundits were calling for 2010 to be the year of the small biotech company, but it didn’t work out that way. What’s interesting, though, is that among the top 5 biotechs, the two best performers--Genzyme and Biogen Idec--had performance driven by takeover speculation to a lesser or greater extent. The other three, Amgen, Gilead Sciences, and Celgene, trailed the averages. Genzyme had an objectively bad year while Amgen had a good one--but never mind that. It is buyout rumors that are driving returns.#6: Keep it Clean. Manufacturing issues grabbed a lot of headlines in 2010. The main focus, of course, was the massive recall of products made by Johnson & Johnson’s consumer products division. But FDA was serious about tackling lax manufacturing, and Genzyme felt the sting in a serious way. So did Baxter, Perrigo, and some others. No surprise that when Pfizer got reports of a “musty smell” on some Lipitor, a recall was quick to follow. #5: FDA’s Amazing Discretion. FDA is an agency that has long been given a lot of leeway by lawmakers in the courts in going about its business, even if it means stretching the First Amendment (e.g., rules against off-label promotion) or exceeding its strict statutory authority. It seems the agency’s new REMS (Risk Evaluation and Management) authority, which went into effect in 2007 but really picked up momentum this year, is pushing it further in that direction. As it showed this year, it can decide a drug is effective and safe in its intended audience, but refuse approval because it is worried about who will gain access to it. And that authority comes from where, exactly?#4: The Ten Year Anniversary of the Complete Human Genome. Ten years already? There were a lot of headlines this summer about how disappointing the decade following the first complete human genomic sequence has been in terms of new cures. That’s unfortunate, because it has been a fantastic advance for science and a necessary first step to more important discoveries. The real lesson is that scientists anxious for funding or notoriety made too many ill-advised promises, and may have lowered public interest in new important projects.#3: Cancer Vaccines! Well...make that cancer vaccine, namely Dendreon’s Provenge. It’s not often that an entirely new therapeutic modality reaches the market. Think of the explosion of value created in the biotech industry after monoclonal antibodies finally reached commercial success...and now think of all the cancer vaccines in development. This story is just beginning.#2: The Biosimilar Law that Wasn’t. Along with a landmark healthcare reform bill came a new regulatory pathway for biosimilars, follow-on proteins, biogenerics, or whatever you choose to call them. So...been hearing a lot about all those new 351(k) filings? No? That’s probably because the new bill disadvantages companies using the pathway in so many fundamental ways that most companies appear to be choosing to simply conduct clinical trials and file regular old BLAs. Chock up a victory for the biotech lobbyists.#1: Healthcare reform. It actually happened, yet most Americans still don’t know what to make of it. Even industry pundits were surprised by the hits to earnings some companies reported would result from reform. But the real impact is yet to be felt...assuming Republicans don’t get their way and manage to repeal it. (That’s a pretty safe bet). Best wishes for a happy holiday and a great 2011!-Karl ThielRead the BioPharm Executive online newsletter December 2010.
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