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Tuesday, February 26, 2008
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 Biogenerics in '08?
Burnt out on the 2008 race for the White House before the contestants are even selected? I hear ya. But with the two nominees soon to be determined--perhaps as early as the March 4 primaries in Ohio and Texas--we get to move to the next phase of the game: What will a Clinton, McCain, or Obama Presidency mean for our industry?
Needless to say, the wonks and lobbyists responsible for helping to shape legislation are way ahead of the game. And one issue that has already raised its head again is, excuse the expression, biogenerics.
Okay, some people don't like that term, arguing that there can't be generic biologics in the same way there can't be generic wine. There's just too much going on to make one product a true copycat of another. Some prefer "follow-on protein product" (except they're not all proteins--just ask Momenta about its stalled heparin product), and...well, you can see where it gets a little messy. So messy, in fact, that despite considerable momentum in the last legislative session, no bill to expedite approval of "subsequent entry biologics" (the Canadians' preferred term) reached a full vote.
President Bush, however, recently resurrected the issue in his 2009 budget request for FDA, saying he "will seek new statutory authority to allow FDA to approve abbreviated applications for certain biologic products...." Already, one new bill from Rep. Anna Eshoo (D-Calif.) (thank you for spotting this, FDA Law Blog) is ready to enter the fray, offering a new wrinkle on various bills introduced last year by Reps. Henry Waxman (D-Calif.), Jay Inslee (D-Wash.), and a Senate compromise from Ted Kennedy (D-Mass.), Mike Enzi (R-Wy.), Hilary Clinton (D-NY), and Orrin Hatch (R-Utah). John Dingell (D-Mich.), chair of the House Energy and Commerce Committee, has also said he is seeking to craft a proposal.
The main points of contention with an abbreviated approval pathway for biologics is a) what kind of clinical evidence will be required to show similarity and/or interchangeability with the reference drug, and who will have discretion on when those studies are required; and b) what kind of exclusivity period the innovator company will get.
The Biotechnology Industry Organization (BIO) would in its heart of hearts love it if biogenerics never saw the light of day. But it has taken a practical tack to dealing with the issue. The trade group was vehemently opposed to Waxman's bill last year, and didn't much like the Kennedy/Enzi/Clinton/Hatch compromise measure, but offered tepid support for Inslee's proposal. We'll have to see what they think of Eshoo's bill, which should please them in that it offers a way to extend exclusivity up to 14.5 years. However, BIO would like to force clinical trials of products, and Eshoo would leave the FDA with broad discretion on waiving trials.
Of course, President Bush's declared wishes for a biogeneric pathway may not hold much sway in his final year. And while all three viable presidential candidates have spoken in support of creating some sort of expedited approval process, they couldn't spearhead much activity until 2009. So is it another year of waiting?
Probably. But BIO has reportedly decided it would actually prefer the devil it knows to what could be a Congress further stacked in favor of Democrats seen as more friendly to the generic drug industry. According to Pharmalot, the trade group doesn't want to "start all over again" with a new crop of lawmakers. And all of a sudden, the Generic Pharmaceutical Association isn't in such a hurry.
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Cancer vaccines continue to be a fascinating area of biotech research. Bedeviled by equivocal clinical results, several products seem to benefit patients, but in ways that have proven difficult to prove in conventional clinical studies...at least, without a lot of expensive trial and error to find the right patients, the right setting, the right combinations. The plot concerning Dendreon's Provenge thickened earlier this month when a request from four Congressmen to hold hearings on FDA's handling of the Provenge application was turned down by the House Energy & Commerce Committee. Almost simultaneously, the company released another analysis supporting the efficacy of the product. -KT
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I know, I know, more job cuts, what's new? Bit it's a little surprising to see Zymogenetics on the list. After all, this company just got FDA approval for its recombinant thrombin (cleverly named Recothrom), which has reportedly been reasonably well received thus far--perhaps more so than Omrix Biopharmaceuticals' rival human-plasma derived thrombin, which was approved a few months earlier. Zymogenetics is looking to lower costs by cutting out some early-stage R&D, even as a $40 million milestone payment from partner Bayer rolls in. It's a tough reminder that it's a slow, expensive path to building a commercial drug company. -KT
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The hands-down winner for deal of the month went to Amgen and its massive product-sharing agreement with Takeda. Amgen has had its share of troubles recently, and the deal offers a way for it to cuts its costs. It is selling its Japanese subsidiary and offering Takeda 12 pipeline products. These are for the Japanese market, but Amgen is also licensing worldwide rights to one of its lesser products in exchange for offloading the lion's share of development costs and a profit share. The really interesting thing is how much traditionally go-it-alone Amgen has embraced risk-sharing in light of hard times. -KT
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Time was when pharmaceutical companies--and, by extension, profitable biotech companies--were considered safe havens in times of economic uncertainty. After all, even during a recession, you keep buying your medicine, right? It was an eye-opener, then, to see that Bristol-Myers Squibb's fourth quarter financial results included a $275 million writedown from its investments in subprime mortgages. Subprime mortgages?! That's right. Cash-rich pharmaceutical companies, of course, moonlight as venture capitalists and as banks. In this case, BMS cut the value of some debt-backed securities. While the writedown could ultimately increase, it's won't have a material impact on BMS' business. What a sign of the times, though. -KT
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The U.S. Supreme Court's decision in Riegel v. Medtronic, which favored the device manufacturer, has broad-reaching implications for tort law. In essence, the Supremes agreed, 8-1, that the fact that FDA declares a device (or, by extension, drug) safe and effective means that individuals cannot make claims in state court concerning that product's safety. In other words, a federal determination that the product is safe preempts the rights of states to find them otherwise. That's a big boon for life sciences companies that have wrangled with differing federal and state standards (not to mention unpredictable juries). The good news might even overshadow a number of federal and foreign investigations into some rather high-profile alleged wrongdoing. -KT
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FDA catches a lot of flack for its low rate of new drug approval, but this month we are again reminded of why, for better or worse, the agency so conservative. That's right, there are more safety concerns about approved products. It's enough to make man-on-a-mission Rep. Barty Stupak (D-Mich.), chair of the House subcommittee on Oversight & Investigations call on FDA Commissioner Andy von Eschenbach to step down. Meanwhile, Teva and Sanofi-Aventis give economists an interesting case study in advanced game theory with their seemingly unfathomable back-and-forth over the acid reflux drug Protonix. Theories abound as to what is really going on here. -KT
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Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.
You may contact Karl Thiel at Karl.thiel@biospace.com.
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