I was recently in San Francisco so thought I would continue my theme of writing about biotechnology regions that I visit around the United States.
Growing up in England, I remember listening to the radio broadcasts of the late Alistair Cooke, who from 1946 to 2004 shared his “Letter from America“; the longest running radio programme ever produced. In the pre-internet era his mixture of anecdotes, insights and reflections reminds me of modern day blogs.
In a case of national significance to the pharmaceutical and biotechnology industry, the United States Supreme Court on January 7 decided to hear the case of Sorrell (Attorney General of Vermont) v. IMS Health Inc & Pharmaceutical Research and Manufacturers of America (PhRMA).
This case is about whether States have the right to regulate how physician prescriber data is sold and used, and whether physicians have a right to privacy in the use of their personal information. In Vermont, the legislature enacted a law that allowed prescribers on their annual licensing renewal to opt-out of allowing the use of information that would identify them in any data used for marketing or promotion of prescription drugs.
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
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.”
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.
Intellectual 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).
Inspire Pharmaceuticals (NASDAQ:ISPH), a North Carolina based biopharmaceutical company that focuses on products for ophthalmic and pulmonary diseases, recently announced positive results from their phase 3 trial (TIGER-1) of denufosol tetrasodium in patients with Cystic Fibrosis (CF).
Cystic Fibrosis is a genetic disorder that can lead to death as a result of pulmonary complications from airway obstruction, bronchial thickening and accumulation of mucous. Lung function tests are widely used in the diagnosis, treatment and management of patients with CF. Measurement of FEV1 (Forced Expiratory Volume in 1 second) is regarded as the best predicator of mortality. As the disease progresses and the lungs become more obstructed, FEV1 decreases.
Welcome to the biotech strategy blog which provides commentary and insight on current news and emerging trends in biotechnology.
As a strategy and marketing consultant with a background in clinical development I am interested in how biotechnology companies grow, manage alliances, partner with CROs and bring new products to market. I hope that you will find posts on this blog to be informative and interesting.