Cancer Genetics has nixed plans to launch an initial public offering this week, having planned to raise million to advance a pipeline of molecular diagnostics for cancer, Renaissance Capital reported Thursday. Last week Rib-X Pharmaceuticals delayed its own IPO, following a history of biotechs struggling to trade their shares on the public market. Seeking Alpha reasoned this week that Cancer Genetics' IPO might be small enough to slip through even though Wall Street has been bracing for the blockbuster maiden offering of Facebook. Guess not. Item
Over the last few years, the whole drug R&D ecosystem has been undergoing a sea change. Productivity in R&D on the Big Pharma side of the equation has been abysmal. And on the biotech side the emphasis has been on capital efficiency and cutting-edge innovation–which don't necessarily go hand in hand.
As a result of these forces, we're seeing pharma breaking down many of the old barriers that had been established to guard the research castle. Pharma scientists are being reorganized into smaller groups and redeployed to get closer to the top development hubs, while companies restructure internal research divisions from soup to nuts. And biotechs have been springing up in the richest fields aiming to advance disruptive ideas, increasingly looking to partner up with pharma at a very early stage of development.
Getting to mid-stage proof of concept data on a careful budget is now one of the most demanding mandates in the industry. And I'll be moderating a breakfast panel on June 19 with a group of experts who will explore just how this trend is reshaping the way drugs are discovered and developed.
Joining us at the Westin Waterfront in Boston will be Jason Gardner, head of the Center of Excellence in External Drug Discovery for GlaxoSmithKline; "Mene" Pangalos, executive vice president, innovative medicine, at AstraZeneca; Jim Burns, head of the Sanofi Boston R&D hub; biotech veteran Jill Milne, who helped found the virtual biotech company Catabasis Pharmaceuticals; and Bernard Munos, the founder of the InnoThink Center for Research in Biomedical Innovation, one of the most influential industry voices calling for change in R&D.
We're hosting this discussion as an affiliated event to the big BIO annual confab. So if you're already in Boston, or planning to attend BIO, I hope to see you there. It's one of the most important discussions now under way in biopharma. You won't want to miss it. And if there's something you'd like to tell me about, be sure to come by after the breakfast. I'm staying until the last guest leaves. Register for the breakfast here. — John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.
With plans to kick-start a bumper crop of biotech activity in Fall River, MA, Massachusetts officials are touting plans for a million biotech facility in the southeastern part of the Bay State. Plans call for the Massachusetts Accelerator for Biomanufacturing to attract a host of startups and companies that will hopefully put the small city on the biotech map.
Yet the site is far from even approaching the biotech largesse of Boston/Cambridge. This week Gov. Deval Patrick and officials from the University of Massachusetts, which will run the new facility, stood on the muddy construction site and talked up the future prospects of the project, The Herald News reported. With grand projections to employ 8,000 people at a life sciences park planned for the area, the biotech facility is expected to house a modest 10 UMass employees when it opens next year.
Patrick championed the growth of the life sciences industry in the Bay State with a billion plan to stimulate biotech activity that was passed early in his first term, yet lawmakers from around the state demanded that the money flow to areas outside of the state's industry core in the Boston area. The state's Life Sciences Center, which administers the stimulus money, granted about half of the funding for the project with UMass and other sources cobbled together the rest, according to the Herald.
Fall River has a history as a hub of manufacturing in the Bay State, and officials hope that the production of life sciences products in the city will bring new jobs. The new facility will serve as a test site for producing biotech products and house startups involved in life sciences.
- here's the Herald article
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Next Mother’s Day, say it with an evolved model of logistical efficiency — a flower. A new discovery about how nature’s icons of romance manage the distribution of sperm among female gametes with industrial precision helps explain why the delicate beauties have reproduced prolifically enough to dominate the earth.
This image shows the differences in chemical structure of the
5-methylcytosine (5mC) base (left) from the 5-hydroxymethylcytosine
(5hmC) base in DNA against a background of DNA sequencing imagery. Imagine reading an entire book, but then realizing that your glasses did not allow you to distinguish “g” from “q.” What details did you miss?
This is a reconstruction of Carbonemys preying upon a small crocodylomorph. Picture a turtle the size of a Smart car, with a shell large enough to double as a kiddie pool. Paleontologists from North Carolina State University have found just such a specimen – the fossilized remains of a 60-million-year-old South American giant that lived in what is now Colombia.
One-letter switches in the DNA code occur much more frequently in human genomes than anticipated, but are often only found in one or a few individuals.
Fresh doubts have cropped up for raising "good cholesterol" to combat heart attack risk, after a new study showed that patients genetically programmed to have higher levels of HDL cholesterol didn't appear to be more protected from heart disease than those with low levels. The news comes as Merck ($MRK) and Eli Lilly ($LLY) are spending millions of dollars to develop HDL-raising treatments, aiming to deliver on the blockbuster potential of the CETP drug class.
"I'd say the HDL hypothesis is on the ropes right now," said outside observer Dr. James A. de Lemos, a professor at the University of Texas Southwestern Medical Center, as quoted by The New York Times.
The HDL mechanism took a recent blow last week when Swiss drug giant Roche ($RHHBY) announced that it was nixing development of its contender designed to raise good cholesterol to thwart heart disease because of absent efficacy, following previous failures at Pfizer ($PFE) and Abbott ($ABT). Informed of the new genetic study revealed this week in The Lancet, Merck and Lilly representatives told the Times that the companies were both undeterred and continuing with their massive CETP programs. Yet the findings have dampened expectations for the drugs.
"This will have a sobering effect, it would have to," said John LaMattina, a senior partner at PureTech Ventures and former Pfizer R&D chief, as quoted by Bloomberg. "HDL has always been a controversial area. You have a question that you have to be willing to commit over a billion dollars in order to get the answer, and that is a very daunting commitment."
With billions of dollars in development costs and potential revenues on the line, expect scientists inside and outside of biopharma companies to take heed of the findings and dig deeper into the role of HDL in heart disease. As the Times notes, mouse studies showed that HDL carried cholesterol out of the arteries. But scientists will now look into whether HDL is an indicator or driver of reduced heart-attack risk.
- read the NYT's article
- and Bloomberg's report
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Beth Seidenberg, Investment Partner–Source: KPCB |
Kleiner Perkins Caulfield & Byers has closed the books on a new 5 million fund. And a chunk of that treasure is earmarked for early-stage life science companies promising to satisfy Kleiner Perkins' trademark appetite for disruptive new technologies.
"Portfolio companies in KPCB 15 will benefit from the firm's holistic approach to company building that we pioneered more than a decade ago," said Ted Schlein, partner at KPCB, in a statement. "We will identify promising early-stage companies in our areas of focus and bring value-added resources in key areas to help early-stage companies grow and succeed. This includes applying our considerable industry, operational and financial expertise and network of relationships to help entrepreneurs build lasting enterprises."
Among the group of partners with a key to the cash box is Beth Seidenberg, the former chief medical officer at Amgen ($AMGN) who has been handling the fund's investments in Tesaro, Epizyme, iPierian and Auxogyn, among others. KPCB has also invested in Foundation Medicine and Celladon.
Seidenberg's interest in biotech goes well beyond the board room. She's been one of the leading forces at the Medical Innovation and Competitiveness Coalition, which joined up with the National Venture Capital Association to apply pressure on the FDA to change. The lobbying effort has helped inspire new legislation aimed at speeding drug approvals while putting the FDA on the defensive about its regulatory track record.
"The major problem is the lack of predictability, which leads to delayed timelines," Seidenberg told The Wall Street Journal last fall. "Entrepreneurs are smart people, and they want to get their products to patients. And because of the lack of transparency, and the lack of consistency (at FDA), they are moving to Europe, setting up their organizations and creating jobs overseas."
- here's the press release
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Osiris Therapeutics ($OSIR) has made history. The Columbia, MD-based biotech has won the first approval of an off-the-shelf therapy made with stem cells, a major milestone for the field but one with unremarkable business implications for the developer.
Canadian authorities have stamped an approval on Osiris' Prochymal, a drug made with mesenchymal stem cells from adult donors, to treat certain children with potentially lethal graph versus host disease (GvHD), the company announced Thursday. The stem-cell drug has approval only for children whose disease can't be controlled with steroids, which doctors typically use to ward off the immune attacks from the ailment. Osiris will have to conduct post-approval clinical studies as a condition of the market nod for the treatment in Canada.
"This is the first regulatory approval of a stem-cell drug–where the active ingredient of the drug is a stem cell–in the world," Osiris CEO Randal Mills said, as quoted by Bloomberg. "It's a huge deal for us and a huge deal for the entire field of stem-cell therapy."
The approval provides a welcome turnaround for Osiris, which has been riddled by a string of recent setbacks. In February French drug giant Sanofi ($SNY) ditched work on Prochymal, for which the company had rights the sell outside of North America, The New York Times reported. The FDA last year rejected Osiris' bid for approval of the therapy as a treatment for GvHD, requesting more data from the developer. And the stem-cell field as a whole suffered a blow when Geron ($GERN) revealed last year that the biotech was shutting down its stem-cell programs.
Yet Osiris hasn't hit the jackpot. After spending years developing Prochymal, the company is expected to make only modest revenues from the drug for children in Canada with GvHD. Piper Jaffray analyst Edward Tenthoff projected sales of the drug to hit .7 million next year, Bloomberg reported. In the meantime, Osiris aims to build on this approval with another regulatory submission in the U.S. this year and has been developing the drug for other uses such as Type 1 diabetes, Crohn's disease and for patients who have suffered heart attacks.
- here's the release
- get more from the NYT article
- check out Bloomberg's report
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