Archive for the ‘Inside BIO Industry Analysis’ Category

Apr
03

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

Posted under Blog, Business and Investments, Companies, Diagnostics, fda approvals, Funding, index, Inside BIO Industry Analysis, IPOs, Medical Devices, Medical Supply, nasdaq, NBI, Pharmaceuticals, PUBLIC BIOTECH - Stock performance, public sector research, Startups, stocks, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

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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Mar
27

Dealing with Rejection, the Regulatory Kind

Posted under Blog, Business and Investments, Companies, CRL, Diagnostics, FDA approval, Funding, Industry Analysis, Inside BIO Industry Analysis, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days?

It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1^st round. However, most companies resubmit their application, and by the 2^nd review 75% of drugs gain FDA approval. After heading for a 3^rd attempt, the cumulative percentage climbs to 83%. After that there is little data to support that subsequent submissions materially impact the probability of approval.

These percentages come from our BIO/BioMedTracker analysis of FDA reviews from 2005-2010 (n=748). The exact percentages for cumulative approval rates are shown in the chart above.

As it relates to content within the CRL, here is an interesting point: When we analyzed 83 NDA/BLA filings that never made it to approval (i.e. were finally suspended by the sponsor), only one was attributed to a manufacturing issue.