It's been a big first quarter for biotech, full of big wins (Acorda Therapeutics' (ACOR) FDA approval of multiple sclerosis drug Ampyra), big losses (FDA rejection of XenoPort's (XNPT) restless legs drug Horizant), big deals (Astellas' $3.5 billion hostile offer for OSI Pharmaceutcials (OSIP)) and big debuts (Ironwood's (IRWD) $216 million initial public offering).
What could possibly happen next? Here's a peek at what's in store during the second quarter.
- Cell Therapeutics' (CTIC) Pixuvri (pixantrone): an approval decision on this lymphoma drug wasn't expected until April 23, but after a unanimous panel rejection, the agency didn't waste any time in turning it down two weeks early
- Dendreon's (DNDN) Provenge (sipuleucel-T): this prostate cancer vaccine comes up for a much anticipated review on May 1. With good Phase III data in hand, it could be the first-ever therapeutic cancer vaccine approved and is expected to be a blockbuster.
- Intermune's (ITMN) Esbriet (pirfenidone): this drug for idiopathic pulmonary fibrosis will be reviewed by May 4. Despite shortcomings in the data, an FDA advisory panel voted to approve it to give desperate IPF patients hope.
- Pozen's (POZN) Vimovo: this naproxen/esomeprazole combo for pain relief is up for review on April 30. It is partnered with AstraZeneca and met its Phase III endpoints, but there's some concern as to whether or not the FDA will agree with the endpoints chosen.
- Astellas' tender offer for OSI expires April 23 -- will OSI's shareholders take the $3.5 billion bait?
- April 14-18 brings a big liver disease conference known as EASL. Wedbush analyst Katherine Xu predicts it could kick off some partnering activity for HCV players like Idenix (IDIX), Achillion (ACHN), Anadys IANDS), Pharmasset (VRUS), Inhibitex (INHX) and Presidio.
- Affymax (AFFY) has promised top-line data from its four-trial Phase III program of synthetic EPO drug Hematide in the second quarter, which could pick up some slack from Amgen's (AMGN) EPO products
- Meanwhile Amgen's FDA decision on Prolia (denosumab) for osteoporosis may not be coming until July, but some analysts have said Phase III data in preventing prostate cancer from spreading to the bone could be right around the corner, although Amgen is targeting the second half.
- Seattle Genetics (SGEN) should have data soon from a potentially pivotal trial of SGN33 in elderly acute myeloid leukemia, an indication that has proven challenging.
- April 17-21 brings the American Association for Cancer Research (AACR) annual meeting, followed by the American Society of Clinical Oncology (ASCO) meeting June 4-8. Expect lots of biomarkers and personalized medicine buzz at the former and late-stage clinical data at the latter.