Haystack 2010 Year-In-Review
Dec17

Haystack 2010 Year-In-Review

This Friday, we're looking back at 2010's big news in pharma and biotech, both the good and the bad. Check out our picks and be sure to weigh in on what you think we missed. 1. Provenge Approved In April, Dendreon's Provenge became the first approved cancer immunotherapy. Dendreon CEO Mitch Gold called it “the dawn of an entirely new era in medicine.” And while prostate cancer patients are excited for a new treatment option, the approval is perhaps most exciting for its potential to reignite interest in cancer immunotherapy research. There’s a lot of room for improving the approach—Provenge is, after all, expensive and highly individualized. Now that immunotherapy have been proven to work, there’s hope that the lessons learned in both its discovery and clinical development will aid scientists in inventing even better cancer vaccines. 2. Obesity Field Slims The obesity drug race played out in dramatic fashion in 2010, with three biotech companies-Vivus, Arena, and Orexigen, each making their case for its weight-loss medication before FDA. As of this writing, Orexigen's drug Contrave seems to be on the surest footing to approval, but longtime obesity-drug watchers know that caution seems to rule the day at FDA, so nothing is a sure bet. Orexigen's Contrave and Vivus's Qnexa are both combinations of already-approved drugs, whereas Arena's Lorqess is a completely new molecule. When C&EN covered the obesity race in 2009, it seemed that Lorqess (then going by the non-brand-name lorcaserin) had the cleanest safety profile, but Qnexa was best at helping patients lose weight. But FDA's panels didn't always play out the way folks expected. There were safety surprises- notably the worries about tumors that cropped up in rats on high doses of Lorqess, and the extensive questioning about birth defect risks from one of the ingredients in Vivus' Qnexa. The fact that FDA's panel voted favorably for Orexigen's Contrave, a drug that's thought to have some cardiovascular risks, generated discussion because FDA pulled Abbott's Meridia, a diet drug with cardiovascular risks, from the market in October. The dust still hasn't fully settled. Arena and Vivus received Complete Response Letters from FDA for Lorqess and Qnexa. Vivus has submitted additional documentation and a followup FDA meeting on Qnexa is happening in January. Also to come in January is the agency's formal decision on Contrave. And if you're interested in learning about the next wave of obesity drugs coming up in clinical trials, read this story in Nature News. 3. Sanofi & Genzyme: The Neverending Story Speaking of drama, Sanofi’s pursuit of Genzyme has been in the headlines for months now, and promises to stretch well into 2011. The...

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NY’s Newest Neighbors: Waksal & ImClone
Dec02

NY’s Newest Neighbors: Waksal & ImClone

When the Alexandria Center for Life Sciences opened along the East River in New York last month, I admit I was skeptical about its prospects given the economic challenges for a small biotech to conduct research in NY. ImClone had signed on as the anchor tenant, but it had for years worked out of older labs in Tribeca—it’s not like they were new to the city. At the opening, one of the Alexandria representatives told me a small company would be moving in shortly, but it sounded like a services firm rather than a biotech or big pharma type. But Alexandria offered up a release today with detail on the first five tenants in the building. ImClone’s first neighbor will be none other than Sam Waksal. That’s right, the former ImClone CEO is planting his first post-jail venture, Kadmon Pharmaceuticals, at Alexandria. It looks like the lunchtime chatter at Tom Coliccio’s ‘witchcraft, on the first floor of the biotech center, just got more interesting. Another intriguing mention in today’s release? News that “a top-tier big pharma scientific collaboration unit for therapeutic innovation,” will soon be a resident. Last month, Pfizer said that University of California, San Francisco, would be the first partner in a network of academic collaborators spanning the globe. Anthony Coyle, head of Pfizer’s Center for Therapeutic Innovation, told me that by the end of the year, the company would be announcing two other partnerships—one in New York, the other in Boston. Notably, Pfizer is opening labs adjacent to UCSF’s campus as part of that pact. Connecting the dots, one has to wonder if Pfizer will soon have some scientists working in Manhattan. Readers? Any guesses about what other big pharma might be eyeing New York as its next research hub. Feel free to leave them in the...

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Blood Thinner Blog Posts Worth Reading
Nov19

Blood Thinner Blog Posts Worth Reading

What you're looking at is an overview of the complex biochemical pathway behind blood clotting, and a smattering of the drugs researchers are developing to control clotting for preventing strokes and more. Over at Terra Sigillata, David Kroll has two back-to-back posts about some of these drugs that are worth reading. In the first post, Kroll discusses news out of the American Heart Association's annual meeting: Rivaroxaban (Xarelto), a blood clot preventing drug from Bayer and J&J, has been shown to be about as efficacious as the established medication warfarin (coumadin) and better with regard to spontanous bleeding complications. He also dishes on some of the fascinating historical context behind the drugs. In the second, he brings attention to Pfizer and BMS's announcement that they are halting a trial of apixaban, their investigational blood clot preventing medication. Eight other apixaban trials are ongoing. We covered some apixaban news last June, when a different apixaban clinical trial was stopped early because an independent analysis concluded that the drug candidate was more effective than aspirin at reducing strokes and blood clots in patients with a common abnormal heart rhythm. As we've written in C&EN, many factors will determine whether patients at risk of strokes or other dangerous blood clots will end up taking warfarin or will take one of the new drugs. Boehringer-Ingelheim's Pradaxa (dabigatran), which acts at a different target from apixaban and rivaroxaban, is already approved by FDA. Rivaroxaban and Pradaxa are already approved in a number of other countries for short-term use. Each drug is slightly different, from how many times a day it must be taken, to how much of it is cleared via the kidneys (a potential issue for patients on dialysis or other kidney conditions), and much more. And of course, a big question is what the difference in cost is going to be- warfarin pills are cheap but the quality of life costs- incessant testing and diet monitoring- can be steep. Image:...

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Pfizer Adds UCSF as First Partner in Academic Network
Nov16

Pfizer Adds UCSF as First Partner in Academic Network

Pfizer has committed up to $85 million over five years to an expansive research agreement with the University of California, San Francisco, intended to speed the development of new biologic-based medications. More critically, the relationship with UCSF will be the first spoke in a network of academic collaborators, with Pfizer at the hub. Called the Center for Therapeutic Innovation, the goal is to bridge the gap between basic science and early clinical studies of potential drug candidates. Anthony Coyle, former head of respiratory, inflammation, and autoimmune disease research at MedImmune, will lead the network. Coyle says CTI will eventually be comprised of seven or eight partners: three or four in the U.S., one or two in Europe, and the remainder in Asia or Australia. Expect to see two more U.S.-based partners, one in NY and the other in Boston, added to the network by the end of the year, he adds. The creation of the CTI is Pfizer’s latest shake-up of the model for industry-academic collaborations. If you’ll recall, last spring, Pfizer caused a stir when it said it would give scientists from Washington University's School of Medicine access to data on 500 compounds that have gone through or are in some stage of clinical development. The hope is that fresh eyes with deep insights into the biology of disease and drug targets might lead to new uses for the compounds. See our recent cover story on the deal for much more detail on how that arrangement works. Ultimately, Pfizer hopes that by breaking down some of the barriers that have hindered an open exchange between industry and academia—the right to publish, ownership of intellectual property, shared profits on products, to name a few—it will be able to get new drugs to market faster. Coyle says the CTI will be solely focused on biologic-based drugs, mainly because he wants each center to be fairly autonomous and able to make decisions quickly. With the infrastructure required to develop small molecules, they would have had to rely on medicinal chemists “in distant locations,” and would run the risk of creating an “overburdened” project. The first step in the UCSF collaboration will be a trip by Coyle and other Pfizer executives to the campus in December to explain the program. Because Pfizer believes the projects will only work if scientists are working side-by-side, the company will set up new labs that can accommodate up to 40 scientists close to the UCSF campus. University scientists will have access not just to Pfizer’s drug development knowledge, but to its research tools—of particular note is that Pfizer is making its phage display libraries accessible to those...

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Is Pfizer After Biocon’s Insulin Portfolio?
Oct07

Is Pfizer After Biocon’s Insulin Portfolio?

The Economic Times is reporting that Pfizer is interested in buying the U.S. and European rights to Bangalore-based Biocon’s insulin franchise in a deal that would include a $200 million upfront payment. Rumors that Pfizer would buy Biocon's oral insulin product emerged in August, but the specifics on a possible pricetag have caused shares of the Indian company to rise over 8%. Biocon’s diabetes pill is in Phase III trials in India and Phase I studies in the U.S. The potential for an oral insulin product is vast, but so is the risk—getting the right balance in insulin administration is a tricky business. (Click here for my colleague Ann Thayer’s take on efforts to make inhaled or oral insulin products.) One has to wonder how much money Pfizer would be willing to pay for another alternative insulin after the colossal failure of the inhaled insulin Exubera. Low demand for the treatment prompted Pfizer to pull it from the market a year after its approval, costing the company some $5 billion after licensing fees, R&D costs, and write-offs. To be fair, an insulin pill has been the holy grail for diabetes researchers for some time. It would be less onerous than daily injections and more discrete than the unwieldy to downright ridiculous inhaled insulin instruments. Some background on Biocon’s technology: Biocon’s oral insulin program came from its 2006 acquisition of Nobex, a N.C.-based biotech that developed a way to make a pill form of biologics, which normally need to be given as an injection or IV infusion. Nobex used what it called “PegAlkylation” technology, which links a polyethylene glycol chain (those same PEGs used to improve the delivery of interferons and other large molecules) and an alkyl to a biologic like a protein or peptide. The design creates a molecule with a water-soluble and fat-soluble end that can travel through the myriad environments inside our bodies. Nobex claimed its oral insulin drug effectively reproduces the “first-phase spike,” or the large hit of insulin the pancreas puts out after a meal, a challenge for injectable and inhaled forms of insulin. Pfizer wouldn’t be the first big pharma to invest in an insulin pill. GlaxoSmithKline licensed an earlier version of Nobex’s oral insulin drug, but gave back the rights in late 2003. Nobex abandoned worked on that molecule in favor of a newer and better one, which Biocon licensed in 2004, prior to its acquisition of Nobex. Oral insulin aside, its worth noting that today’s ET story says the $200 million is for Biocon’s insulin portfolio, whereas earlier stories focused on Pfizer’s interest in the oral insulin program. European regulatory authorities recently gave the...

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