Indices, IPOs, and New Drug Approvals – Update April 3rd 2012

Indices, IPOs, and New Drug Approvals – Update April 3rd 2012

1. Stock Performance. The Nasdaq Biotech Index (NBI) continued to outperform in March, maintaining its Year-to-Date (YTD) lead of 18% vs. 12% for the S&P 500. Concentrated portfolios holding Amlyin, Regeneron, and Illumina came out even higher. For example, the Amex Biotech Index (BTK) is up 29% this year mainly because it held concentrated positions in these names.

Amylin (ALMN) has doubled on the FDA approval for Bydureon and post-approval buy-out rumors. Illumina (ILMN) is up 72% this year due to acquisition bids from Roche. The outcome remains uncertain as Ilumina has rejected the latest $6.7B bid from last week. Regeneron’s (REGN) stock doubled after a strong launch of its biologic, Eylea, for wet AMD. Regeneron is also getting a boost from its pipeline, with the LDL lowering PCSK9 antibody (partnered with Sanofi) receiving a lot of press last month.

2.  IPOs: Merrimack Pharmaceuticals (MACK) was March’s sole U.S. IPO.  The company works on targeted cancer therapeutics; its lead product is in Phase 2 of clinical development. That brings us to five IPOs for 2012:

3. FDA approvals:Two more approvals came in March, bringing the 2012 total to nine. Affymax’s (AFFY) pegylated peptide, Omontys, will compete with Amgen’s hyperglycosylated Epo (Aranesp) in the CKD dialysis setting. Discovery Labs (DSCO) is now approved to market the first non animal-derived peptide to be added to a lipid surfactant used in treating infants with respiratory distress.

Green = peptide, Blue = enzyme biologic, (no color = small molecule)

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