Category Archives: Inside BIO Industry Analysis

Recent Developments in Patentability: Prometheus and Myriad

supreme-court

By Joe Allen, President, Allen and Associates Recent Developments in Patentability: Prometheus and Myriad at the 2012 BIO International Convention was a very lively panel discussion on two cases that have set the life science industry on edge. The discussion presented an appropriate diversity of views as experts struggle with how broadly these cases should be interpreted. Briefly, the unanimous decision by the Supreme Court overtuning a decision upholding the Prometheus patents by the Court Read More >

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Only a Few Public Biotechs are Profitable, but There are More of Them Today

Of the 294 biotechs trading on public exchanges today, 248 (84%) focus on drug development. Of these 248 in the biopharmaceutical space, 81, or 33% have a drug approved. Only 32 (13%) had both a product on the market and positive net income in 2011. However, this 13% represents a significant jump from the 7.5% with positive net income we calculated for 2009. Note that this comes over a time frame in which a few profitable companies were Read More >

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

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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% Read More >

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Dealing with Rejection, the Regulatory Kind

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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 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd Read More >

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BIO Europe Spring 2012 – Opening Remarks

For Monday’s Opening Remarks at BIO Europe Spring 2012, I covered the following topics: Public market performance in the US vs other sectors Private funding environment. Drug pipeline deal volume. For a copy of the slides, they can be found here.

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