BOSTON ( TheStreet) -- @Eli75NY tweets, "Adam, are you still big on $YMI? In the past you named it top 10 Bio under $300 million cap? Thanks."YM Biosciences ( YMI) faces a big test Monday night when new data on its myelofibrosis drug CYT387 is presented at the American Society of Hematology (ASH) annual meeting. These new CYT387 results will encompass data from 166 myelofibrosis patients enrolled at six centers, giving YM Bio an opportunity to counter the skepticism raised by non-believers when initial study results culled from about 60 patients at the Mayo Clinic were presented last spring. Or, the new CYT387 data will prove the YM Bio bears correct. The key watch points for Monday's 6 p.m. New York time presentation: 1. Will the anemia response hold up? CYT387's ticket to stardom is its potential to reverse the anemia associated with myelofibrosis. This is important because myelofibrosis patients who are anemic or require red blood cell transfusions have more aggressive disease and shorter life spans. If CYT387 can demonstrate a positive and clinically meaningful impact on anemia in myelofibrosis patients, it could claim superiority over Incyte's ( INCY) recently approved drug Jakafi, which has no effect on anemia. From the last data presentation in June (42 evaluable CYT387 patients), 50% achieved an anemia response. All anemia responses persisted for a minimum of 12 weeks. Of the 33 patients transfusion dependent at baseline, 19, or 58%, became transfusion independent, with a median duration of transfusion independence of 7.5 months. These data came from patients all treated at the Mayo Clinic, which led to questions about selectivity bias. The data to be presented Monday will come from multiple centers and will incorporate many more patients. An equal or better anemia response rate Monday will be very positive. More likely the anemia response decreases. How much lower is acceptable to investors is hard to gauge. Monness Crespi Hardt analyst Avik Roy says he's keying on the patient's hemoglobin curves, which should go up over time on CYT387 treatment if the drug's anemia response is real. "Those same curves go down for Jakafi," he says. "Even if the anemia response is lower this time around, it still puts CYT387 far ahead of Incyte's drug." Whatever the anemia data show, expect Incyte bulls to stubbornly question the impact. Front and center will likely be Bank of America analyst Rachel McMinn, a big Incyte bull and a vocal YM Bio bear.
@oncobull tweets, "@adamfeuerstein, hey adam, what's up with YMI? acting like a dog ... but its mkt cap is soooo low. ... what's your bet for Monday ASH?" The only bet I'd make with confidence is that Monday night's data presentation will be controversial. Any flaw in the data will be magnified; positive data will be marginalized. I realize that's a pessimistic view for a drug and a stock for which I have some hope and optimism, but it's a prudent mindset given the way YM Bio traded after last spring's ASCO presentation. I do believe that forced hedge fund selling remains the most logical explanation for the more recent weakness in the stock, but we're not exactly seeing many buyers step in either. YM Bio has a dodgy reputation, mostly deserved, for developing bad drugs in the past so I'm not surprised that investors, generally speaking, mistrust the CYT387 data to date. I'm hoping this time around is different.
Dapo A. writes, "Adam, what does the Exact Sciences (EXAS) announcement of Dec. 5, selling more shares, mean?" Exact sold 3.125 million shares at $8, netting around $24 million. This is cushion money -- the company didn't really need it -- but it should give them enough cash to get through 2013 when, if all works well, the Cologuard colon-cancer screening test should be approved.
@tiltorama tweets, "@adamfeuerstein, Any thoughts on PPHM news this morning?" On Tuesday, Peregrine Pharmaceuticals ( PPHM) released preliminary results from a phase II study of bavituximab ("bavi" for short) in front-line non-small cell lung cancer patients. Eighty-six lung cancer patients treated with bavi plus carboplatin and paclitaxel (chemo) demonstrated an overall response rate of 39% compared to an overall response rate of 26% for patients treated with carboplatin and paclitaxel alone. Let's dissect: Kudos to Peregrine for running a randomized phase II study. The response rate in the bavi arm is numerically higher than the control arm but obviously not statistically significant. How do I know? Because Peregrine would have been shouting from the rooftop if the result was statistically significant. In the headline of its press release, Peregrine characterizes the difference between the 39% and 26% response rates as a "50% improvement." That's suspect, especially since the result is not statistically significant. The relative difference between the two response rates is irrelevant. The 26% response rate in the control arm -- those patients who received chemo only -- might be unusually high. In its benchmark phase III "E4599" study of Genentech's Avastin in non-small cell lung cancer, researchers reported a 15% response rate in patients treated with carboplatin and paclitaxel.
Patrick A emails, "Please blast Spectrum Pharmaceuticals' (SPPI) CEO, Raj Shrotriya. Please. I am a shareholder but I am absolutely sickened by the amount of compensation this guy receives. Yes, the stock has had a nice run, but assuming Shrotriya gets his 520,000-share award this month, the total amount of shares awarded to Shrotriya in 2011 will be 2.87 million shares. Yes, 2.87 million shares in either awards or options in a single calendar year! This in addition to a $1.9 million cash bonus! Am I wrong in considering this absolutely ridiculous? I am pissed off as a shareholder. The dude pays himself like he's running a multibillion-dollar large pharma with thousands of employees bringing in billions of revenue. Spectrum is a $800 million
John Paul writes, "I really don't know who the worst biotech CEO should be, but I pronounce you the winner in the homer