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Bio World Insight 2 1 10

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Endpoint Hit, Stock Walloped:

Endpoint Hit, Stock Walloped:
Street, Media Miss the Point?

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Bio World Insight 2 1 10 Bio World Insight 2 1 10 Document Transcript

  • ® MONDAY VOL. 18, NO. 5 FEBRUARY 1, 2010 Your Weekly Source for Market and Financial Views PAGE 1 OF 20 Poniard Hardly Alone Money Raised By Biotech Endpoint Hit, Stock Walloped: In 2010 Vs. 2009 Street, Media Miss the Point? Jan. 1 – Jan. 28, 2010: $1,268.58M Jan. 1 – Jan. 29, 2009: $554.19M 600 By Randy Osborne 533 550 Editor 499 Last week, Wall Street slammed Poniard 500 450 441 Pharmaceuticals Inc. after the company disclosed apparent- ly good news: an endpoint met in the Phase II trial with 400 Millions picoplatin in metastatic colorectal cancer. It was anything 350 but the first time that the wider world reflexively failed – at 300 least from the company’s point of view – to understand 250 236 and appreciate study data. 200 What’s a drug developer to do? 150 South San Francisco-based Poniard wanted to show that the regimen containing its platinum-based 100 57 56 chemotherapy could be given without the neuropathies 50 that plague the standard of care chemo cocktail. 0 The results proved as much, but investors clipped Public Public/ Private Poniard’s shares by more than 25 percent, as skeptics Offerings Other* Biotechs picked over the data for possible clues regarding efficacy – * Includes financings of public biotech firms with the exceptions of and opined that the picoplatin regimen could be less than public offerings and certain investments from corporate partners. impressive, compared to what’s already out there. At the American Society of Clinical Oncology’s 20 1 0 an was 1 3.6 months in FOLPI, 1 5.6 months in FOLFOX Gastrointestinal Cancers Symposium, Poniard lifted the lid (p=0.53, HR 1 . 1 7). on final results from the Phase II trial, showing that the At one year, the OS rate was 80 percent vs. 83 percent. study had accomplished its main goal, proving that Six-month and one-year survival reached 80 percent and picoplatin in combination with 5-fluorouracil and leucov- 52 percent in FOLPI-treated patients respectively, compared orin (the FOLPI regimen) dropped neurotoxicity to a statis- with 83 percent and 55 percent in FOLFOX. Poniard said the tically significant degree (p <0.004) compared to outcome suggests similar efficacy between FOLPI and FOL- oxaliplatin given as a combo with 5-fluorouracil and leu- FOX, but the company didn’t go any farther than that. covorin (FOLFOX). Analysts pounced. In progression-free survival, the median was 6.8 Howard Liang at Leerink Swann conceded in a months in FOLPI patients and 7.0 months in FOLFOX research report that while the study was small and “clearly (p=0.82, hazard ratio 0.95). In overall survival, the medi- See Stock, page 4 ACORDA REBUTS THE NAYSAYERS ........................................................2 THIS WEEK IN REPROS OPTIONS RUNNING OUT AS FDA GUIDES ON ANDROXAL ........3 MONEY RAISED BY BIOTECH IN 2010 ..................................................4 BIOWORLD WEEK IN REVIEW ................................................................................6 WORD ON THE STREET, WEEK IN WASHINGTON ..................................7 INSIGHT TOP 5 UNDERWRITERS: RANKED BY GROSS PROCEEDS ..........................8 U.S. BIOTECH PUBLIC OFFERING PERFORMANCE BY UNDERWRITER ........8 To subscribe, please call BIOWORLD® Customer Service at (800) 688-242 1; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com
  • MONDAY, FEB. 1, 2010 BIOWORLD® INSIGHT PAGE 4 OF 20 Ltd., but that limits draw-downs to 2.5 percent Money Raised By Biotech in 2010: of the market cap and a share price of $3. Poniard was trading at below $2 last week. Jan. 1 - Jan. 28, 2010 (See BioWorld Today, Aug. 2 1 , 2009.) Hardly helping the partner hunt is the Phase III blowup last year of picoplatin in small 42% 39% cell lung cancer – news that sent shares reel- ($533M) ($499M) ing by 76 percent. Poniard blamed the fizzle of SPEAR (Study of Picoplatin Efficacy After Relapse) on an imbalance of third-line chemo given to patients in the best supportive care arm vs. the picoplatin arm, but the market didn’t seem to care about reasons. McMahon said the SPEAR results are still being discussed with the FDA, and noted that Phase II data in prostate cancer are coming in March. (See BioWorld Today, Nov. 1 7, 2009.) Whether any of this will be enough to save Poniard remains in question, though, and Oppenheimer analyst Bret Holley predicted 19% the terms of any partnership the firm might ($236M) Public Offerings 39% ($499M) draw “would likely be fairly modest.” Public/Other 1 9% ($236M) McMahon is keeping faith that a partner will know the difference between Wall Street Private Biotechs 42% ($533M) perceptions and reality, but the stock thump- ing taken by Poniard stands as a blot that could make suitors nervous. Among those who probably feel Poniard’s pain are officials Stock at Arena Pharmaceuticals Inc. Continued from page 1 Less than a year ago, after San Diego-based Arena’s not conclusive, we believe [the readout] does increase the first Phase III trial with its obesity drug lorcaserin met all risk of a non-inferiority Phase III trial, as the HR is already out- three co-primary endpoints, the company watched its side of the normal non-inferiority margin of 10–15 percent, shares plummet by 28 percent. (See BioWorld Today, March and the upper bound of the 95 percent confidence interval 3 1 , 2009.) would be even worse.” Poniard, with a cash clock that’s Top-line data from the intent-to-treat population of the ticking, “may not be able to survive” if the firm doesn’t find 3, 1 82-patient BLOOM trial showed that lorcaserin patients a partner soon, Liang wrote. lost an average of 1 2.7 pounds, or 5.8 percent of their body No fair, said Jerry McMahon, Poniard’s chairman and weight, while placebo patients lost an average of 4.7 CEO. The Phase II study was not powered for efficacy, he pounds, or 2.2 percent. pointed out; that’s the work of a larger Phase III effort, to The difference between the two groups, 3.6 percent, be funded (Poniard hopes) by the big-pharma player who wasn’t quite up to the 5 percent goal in the FDA guidelines, inks a deal based on picoplatin’s promise in CRC as well but lorcaserin fulfilled the other half of the agency’s edict, as other cancers. Anyway, “the efficacy measures, all which wants the proportion of patients who lose 5 percent three of them, indicated comparable efficacy” so far, of their weight on drug to be roughly double that on place- though they need to be affirmed by more work, he told bo. In BLOOM, 47.5 percent of lorcaserin patients lost more BioWorld Insight. than 5 percent of their weight, compared to 20.3 percent Poniard, McMahon said, represents “a very compelling of placebo patients. The news in that department got even story to partners,” even if “some of the analysts may have better: 22.6 percent of lorcaserin patients lost more than felt the data in [CRC] were the only data that would allow 1 0 percent of their weight, compared to 7.7 percent of this drug to be useful.” placebo patients. The main problem for Poniard – as for so many Wall Street only sniffed, and punished Arena accordingly. biotechs now – is money. Net cash totaled about $20 mil- By the time lorcaserin’s second Phase III trial, called lion as of the end of the third quarter of last year, enough BLOSSOM, came around, the company was educating to last into the first quarter of this year. There’s a commit- observers ahead of data disclosure regarding endpoints ted equity financing facility with Azimuth Opportunity See Stock, page 5 To subscribe, please call BIOWORLD® Customer Service at (800) 888-39 1 2; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
  • MONDAY, FEB. 1 2 01 , 0 BIOWORLD ® INSIGHT PAGE 5 OF 20 Stock adverse events. But Anadys also disclosed that three out of Continued from page 4 24 patients treated in a 1 4-day healthy volunteer study and their meaning. This worked out better, though the developed a Grade 2 rash and discontinued treatment. value of the results took a while to soak in. (See BioWorld That’s what sparked the crash, although in this case, Today , Sept. 2 1 , 2009.) some analysts tried to hold the boat steady. Phil Nadeau BLOSSOM hit – albeit just barely – the FDA’s 5-per- of Cowen & Co. wrote in a research note that a “1 2.5 per- cent-weight-loss efficacy benchmark. cent rate of rash in two weeks of dosing is Just as important, lorcaserin proved sat- “People are making determi- worrisome,” but called the sell-off an isfyingly safe, a factor in potential pre- nations of how do I flip this “overinterpretation.” scriptions that some investors may stock quickly, in order not to Gil Bashe, with the public relations previously have given short shrift. The take any risk? . . . it’s not a firm Makovsky + Co. in New York, said the obesity market is crowded, but Arena reaction to the data. It’s a problems that beset Poniard, Arena and has reasonable cause to stay optimistic reaction to many factors in Anadys are far from uncommon. about lorcaserin, a 5-HT2c serotonin the market at that moment, “We’re dealing in an area where the receptor agonist, replacing the approved and a lack of understanding ‘tweet’ is more powerful than the read,” phentermine, beset by side effects. (See of what the data mean .” he said, blaming opinion-based report- BioWorld Today , Sept. 1 0, 2009.) ing on the blog style of writing, coupled Another notable historic casualty in –Gil Bashe, Makovsky + Co. with the haste to get news published on the battle for comprehension: Anadys the Internet. Pharmaceuticals Inc.’s non-nucleoside polymerase In Wall Street sell-offs prompted by quick, shallow inhibitor ANA598, for which the company unveiled fateful news reports, “we’re really dealing with managing risk data in the spring of last year. Shares in San Diego-based more than understanding science,” Bashe told BioWorld Anadys plunged 40 percent that day, as investors appar- Insight . “People are making determinations of how do I ently mixed up results from one trial with another – and flip this stock quickly, in order not to take any risk?” In the ran away fast. (See BioWorld Today , April 24, 2009.) case of Poniard and others, “it’s not a reaction to the data,” The nosedive happened just a few months after inter- he said. “It’s a reaction to many factors in the market at im data from a Phase Ib study of ANA598 for treatment- that moment, and a lack of understanding of what the naïve hepatitis C virus patients sent Anadys’ stock soaring data mean.” 1 1 5 percent and prompted analysts to call the drug a Analysts become part of the problem, Bashe said, potential “best-in-class.” (See BioWorld Today , Jan. 9, 2009.) because they, too, are under pressure to issue reports Full, carefully detailed data from the randomized, double- quickly. “The analysts become part of the story” immedi- blind, placebo-controlled, multiple ascending dose trial ately, since they – rather than, for example, trial investiga- offered at EASL continued to show strong efficacy, and the tors – are quoted by reporters in stories that are put drug was well tolerated in the Phase Ib trial with no serious together to meet ever-tightening deadlines. Acorda patent filing that could extend coverage to 20 1 8. Continued from page 2 What happens then? Acorda has three programs in pre- One issue Acorda does not deny, however, is the exis- clinical, but the company is actively seeking assets to fill tence of an Ampyra patent cliff. The drug’s patents expire its pipeline gap. Macdonald said small molecules or large in 20 1 3, but orphan drug exclusivity will cover the com- molecules in Phase II or Phase III for neurology indications pound until 20 1 7. Additionally, Acorda is working on a are the top in-licensing priority. ‘All My Clones’: BioWorld’s Biotech-Themed Soap Opera Prada-wearing investment banker Odessa shook things up at a luncheon for the New York Biotechnology Association. She devised the Rational Research Bundle, a new way for big biopharma to invest – even when the num- bers don’t add up. But will the new M&A idea get her a big enough bonus to buy that marine blue Bottega Veneta coat? Meanwhile, in California, Cappuccino Pharmaceuticals’ Rupert Madasheck meets the mysterious Vivian. Will her VarpaWare technology still be able to help his fledgling firm after he learns she’s his long-lost daughter? To make sure you get “All My Clones” every month, opt-in for free to our weekly e-zine, BioWorld Perspectives. Just go to BioWorld.com and click on “BioWorld Perspectives.” Don’t miss out! Our newest publication is frequently funny, thoroughly thought-provoking, exceptionally entertaining and always FREE. To subscribe, please call B IOWORLD ® Customer Service at (800) 888-391 2 ; outside the U.S. and Canada, call (404) 262-5476 . Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.