Biotech Strategy Blog

Commentary on Science, Innovation & New Products

Posts tagged ‘Biotech’

I’m off to WordCamp Phoenix 2011 #wcphx

By on January 28, 2011

I will be at WordCamp Phoenix tomorrow, along with 650 other attendees, for what is set to be an exciting meeting. Not only is it a great opportunity to escape the lousy New Jersey weather, but the meeting program is awesome.

I’m looking forward to learning from WordPress experts and enthusiasts about how I can improve this blog, its design, marketing and functionality. Saturday’s session schedule can be found here.  I have to say the volunteers who set up this meeting have done a great job!!

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Innovation in Healthcare Symposium

By on January 12, 2011

A conference on Innovation in Healthcare is being held in Cambridge, MA on Tuesday, February 1, 2011.

The speaker list is impressive and includes Michael Porter (Porter’s 5 forces model is well known to all MBA students), John Mendelsohn (President of MD Anderson), Janet Woodcock (Director of Center for Drug Evaluation and Research at FDA) and Peter Senge (author of the Fifth Discipline: The art and practice of the learning organization).

The symposium, whose lead sponsor is Merrimack Pharmaceuticals, will discuss how to to improve the system for delivering healthcare services, and how to increase the productivity of translating biomedical research into medical innovation.  The conference certainly has ambitious goals in the topics it plans to cover!

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U.S. Supreme Court to decide if only statistically significant adverse events need to be disclosed to investors

By on January 11, 2011

In a case that is set to have major impact on the biotechnology industry, the United States Supreme Court heard oral argument yesterday in the case of Matrixx Initiatives Inc. v. Siracusano. The question presented to the court is:

“Whether a plaintiff can state a claim under § 10(b) of the Securities Exchange Act and SEC Rule 10b-5 based on a pharmaceutical company’s nondisclosure of “adverse event” reports even though the reports are not alleged to be statistically significant.”

You can find all the briefs and documents related to the case on the excellent Scotusblog. website.  A transcript of yesterday’s oral argument has been published on the U.S. Supreme Court website.

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Vertex plans NDA for VX-770 in Cystic Fibrosis for Second Half of 2011

By on January 10, 2011

As an update to this morning’s blog post that mentioned Vertex’s VX-770, the company have just announced their key business objectives for 2011.  Further information will be included in the presentation by Vertex at the JP Morgan Healthcare conference scheduled for later today.

The news in Cystic Fibrosis is that if the phase 3 clinical trial data is positive the NDA for VX-770 is expected in the second half of 2011.  The following are the relevant sections from the press release:

Cystic Fibrosis: Phase 3 Registration Program for VX-770 Nears Completion

VX-770 NDA Submission Planned for Second Half of 2011

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New research points to role of Cystic Fibrosis Transmembrane Conductance Regulator Signaling in Emphysema

By on January 10, 2011

One of the exciting things about the biotechnology industry is its ability to innovate and translate developments in basic science into potential new drugs.

I previously wrote about denufosol in cystic fibrosis (CF), a disease that affects about 30,000 people in the United States and 70,000 worldwide.  The disease is characterized by the accumulation of mucus that leads to bacterial overgrowth and chronic lung infections. Mucus cannot be removed from the lung in CF due to abnormal mucociliary transport resulting from impaired epithelial chloride secretion and sodium hyperabsorption.  This is now known to be due to defective cystic fibrosis transmembrane regulator (CFTR) protein. A good overview of this can be found in the 2006 New England Journal of Medicine Editorial by Felix Ratjen, “Restoring Airway Surface Liquid in Cystic Fibrosis.”

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$XOMA signs partnership for Xoma 052 with Servier

By on January 4, 2011

Screen shot 2011 01 04 at 8.57.40 AM $XOMA signs partnership for Xoma 052 with ServierFollowing on from the recent rise in Xoma shares, that i discussed in yesterday’s blog post, the company announced this morning that they have signed a commercialization deal with Les Laboratoires Servier, France’s largest privately held pharmaceutical company (2010 revenue 3.7 billion euros).

According to the press release, the key elements of the deal are:

  • XOMA will receive approximately $35 million upfront, up to approximately $470 million in milestone payments and tiered royalties up to a mid-teens percentage rate.
  • XOMA retains development and commercialization rights for Behcet’s uveitis and other inflammatory and oncology indications in U.S. and Japan. Servier receives similar rights in the rest of the world.
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Inspire Pharmaceuticals Shares Plunge on Negative Data

By on January 3, 2011

Thanks to Adam Feuerstein of TheStreet for breaking the news this morning, that shares in Inspire Pharmaceuticals (NASDAQ: ISPH) have plunged following the announcement of negative data from the phase 3, TIGER-2 clinical trial for denufosol in cystic fibrosis.

According to the Chief Medical Officer at Inspire Pharma: ”The analysis of the primary endpoint, key secondary endpoints and select subgroup populations in TIGER-2 indicates an absence of meaningful treatment benefit in this patient population.”

I wrote a blog post last week about denufosol and the hope that this drug offered to cystic fibrosis patients despite the uncertainty about its clinical effectiveness.

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WIPO Intellectual Property Courses

By on December 31, 2010

logo 2010 WIPO Intellectual Property CoursesIntellectual property (IP) rights are important in the biotechnology industry; one only has to look at a licensing, consulting or service agreement to appreciate this.

If you are a non-lawyer new to the area, and wish to gain a basic understanding of the different types of intellectual property protection such as copyright, trademarks, industrial design, patents and unfair competition, then the World Intellectual Property Organization (WIPO) Academy offers a free general course (DL-101).

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Lilly completes acquisition of Avid Radiopharmaceuticals

By on December 27, 2010

Screen shot 2010 12 23 at 11.55.31 AM Lilly completes acquisition of Avid RadiopharmaceuticalsA company I have been watching for a while is Philadelphia based Avid Radiopharmaceuticals, now a wholly owned subsidiary of Lilly. They have a novel imaging biomarker, florebetapir (18F-AV-45) in development for the detection of Alzheimer’s disease.

In a press release last week, Lilly announced that the FDA had assigned a priority review to the marketing application of florebetapir. The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA meet on January 20, 2011.

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Amphastar sues FDA

By on October 27, 2010

The race to bring a biosimilar version of Sanofi-Aventis’ low molecular weight heparin, Lovenox® (enoxaparin sodium), to market had three players, Momenta Pharmaceuticals in partnership with Sandoz, Amphastar Pharmaceuticals and Teva.

The winner was Momenta/Sandoz who (as mentioned in a previous post) recorded $292 million of sales in 69 days post launch.   As reported by the Wall Street Journal, Amphastar are now suing the FDA alleging the agency acted arbitrarily in delaying its imports of raw heparin.  There certainly seems to be no love lost between Amphastar and the FDA, who earlier this year alleged a conflict of interest between Janet Woodcock, the Director for the Center for Drug Evaluation and Research (CDER) and Momenta as a result of the collaboration that identified the contaminant in chinese heparin that killed patients in 2008.  Following an FDA investigation, Woodcook was cleared of any conflict of interest but announced she would not participate in the biosimilar approval decision.

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