Business and Science for BD & others
#65, November 2011
Avastin fails on appeal to keep breast cancer approval in US; Roche will do a trial with VEGF-A as biomarker
Genentech failed to get the FDA to change its mind after an aggressive appeal. The FDA did not want to change the definition of accelerated approval as approval on a surrogate marker with clinical benefit to be confirmed by later trials; this should make it easier for them to grant accelerated approval in the future. Roche has said that it will study blood VEGF-A levels in patients with Avastin and paclitaxel to identify super-responders. The European Medicines Agency has approved Avastin for breast cancer. In the US, the National Comprehensive Cancer Network, a highly respected consortium of U.S. oncology programs, has four times reaffirmed its recommendation that Avastin is "an appropriate therapeutic option," and this should keep it on the list for Medicare reimbursement. Roche is now offering a pay-for-performance scheme to both hospitals and public insurers in Germany, returning the costs of the drug to payers if the drug does not work. http://www.inpharm.com/news/170007/fda-pulls-roche-s-avastin-breast-cancer http://online.wsj.com/article/SB10001424052970203611404577046133283707236.html http://mobile.reuters.com/article/idUSL5E7LO2W820111024?irpc=932
New support for startups in House bills?
The US House passed the Entrepreneur Access to Capital Act, which makes it easier for businesses to raise capital through “crowdfunding,” using the Internet to solicit small equity investments from large numbers of people. The legislation allows businesses to use crowdfunding to sell unregistered securities as long as the total amount raised is $2 million or less. The bill also limits individual investments in crowdfunded securities to $10,000 or 10 percent of the investor’s annual income.
The House also voted to reform the Securities and Exchange Commission’s Regulation A that currently allows small companies to offer up to $5 million in stock to the public without registering it with the SEC. The Small Company Capital Formation Act raises that threshold to $50 million, which would allow more companies to raise capital without going through the lengthy and costly SEC registration process. http://www.portfolio.com/business-news/2011/11/03/house-passes-two-bills-to-help-startups-raise-capital#ixzz1eNE8mEYz http://www.newscientist.com/article/mg21128321.500-quantum-life-the-weirdness-inside-us.html?full=true
Stanford incubator pays its entrepreneurs; U Michigan invests in startups.
Stanford’s incubator StartX offers start-ups free office space, mentoring and coaching, access to venture capitalists and other investors, and pays entrepreneurs a $4,000 to $5,000 stipend to cover housing and food over several months as they develop their companies. The only requirement: one of the start-up's founders needs to currently be or recently have been a student at Stanford University. So far, 32 companies have graduated from StartX, with many receiving funding from venture-capital firms. Other universities may mimic this more intensive incubation model. http://online.wsj.com/article/SB10001424052970203633104576621571511894728.html?KEYWORDS=stanford+accelerator
University of Michigan will invest directly in startups that licensed technology from faculty labs. Once a startup has secured an initial round of funding from a qualifying independent venture capital firm, it will be eligible under MINTS for up to $500,000 of university financing. The University of Michigan Tech Transfer has helped to launch close to 100 startups during the past decade. In the last few years, five startups have had lucrative exits, including medical device firm HandyLab, which was acquired by New Jersey-based firm BD for $275 million in 2009. Under MINTS, the university would reap the benefits of its initial investment when a company is either acquired, as HandyLab was, or goes public. http://ns.umich.edu/new/releases/8594
Personalized Medicine TV
Personalized Medicine TV is building a collection of interviews. The most recent is on drug pricing. I discussed personalized medicine and partnering in October. The links are:
See you at the next meeting?
4400 Paseo Santa Rosa, Newbury Park, CA 91320
This newsletter is a free service of Pullan Consulting. About 3600 readers, representing VCs, BD and CEOs of biotech and pharma companies, are on the list. Back issues are on the website www.PullanConsulting.com . Please add the email to your safe sender list to avoid it being treated as junk. To subscribe or unsubscribe, just send me an email.