J&J Could Score Priority Review Voucher with Bedaquiline NDA
Jul02

J&J Could Score Priority Review Voucher with Bedaquiline NDA

Janssen Research and Development, part of J&J, has asked the FDA to approve bedaquiline, a diarylquinoline to treat multi-drug resistant tuberculosis. If given the green light, bedaquiline would be the first drug with a new mechanism of action to be approved for tuberculosis in over four decades. Janssen points out that the pill would also be the first drug approved for multi-drug resistant TB. If approved, Johnson & Johnson will score a Priority Review Voucher, an incentive created in 2007 to prompt more R&D in neglected disease. A PRV, given to a company that wins U.S. approval for a new drug for neglected disease, is a coupon good for shaving the review time for another new drug application. The value of that coupon depends on the drug its applied to—in theory, if a drug has lofty sales potential, gaining a few extra months (as we’ve written, it could shorten the FDA’s decision time by anywhere from four to 12 months) could translate into hundreds of millions of dollars. To date, Novartis has been the only company to be granted a PRV, which it gained through the U.S. approval of the malaria drug Coartem. But that first test of the incentive had some questioning its value, as Novartis cashed in its PRV for a supplemental new drug application for Ilaris, an antibody for auto-inflammatory disorders that brought in just $48 million last year. So, readers, any thoughts on how J&J might cash in its PRV if granted?...

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Addex Dishes About J&J Deal
May11

Addex Dishes About J&J Deal

Merck wasn't the only company holding an R&D Day today- Swiss pharmaceutical firm Addex Pharmaceuticals also held a briefing for investors and journalists. (I didn't get to go to Geneva, but I did watch the webcast and downloaded the presentations here.) Addex has dedicated its entire pipeline to allosteric modulators- drug candidates that work at protein sites other than the ones where the body's chemicals typically bind. Last fall we wrote about Addex's strategy and its potential usefulness in tackling G-protein coupled receptors (GPCRs), one of the biggest (if not the biggest) classes of drug targets. Today Addex updated attendees on a few different drug candidates. But the biggest news was that it disclosed the terms of its schizophrenia drug partnership with Ortho-McNeil-Janssen Pharmaceuticals, a unit of Johnson & Johnson. According to the terms of the deal, Addex could get as much as 112 million euros subject to successful completion of development and regulatory milestones. In addition, Addex is eligible for low double-digit royalties on sales of the possible schizophrenia drug it discovered, subject to regulatory approval and successful commercial launch. Addex's stock jumped up 8.75% on the news, to 13.05 Swiss francs (about $11.75) In the deal, Ortho gets to fund and perform preclinical and clinical development for Addex's potential schizophrenia drug, known as ADX71149. The molecule dials up the activity of a GPCR that responds to glutamate, called mGluR2. The dialing-up part is what's thought to be important. It's the whole point of taking an allosteric approach. Instead of just turning a receptor on or off, you adjust its activity to acceptable levels. The philosophy at Addex is that this more subtle approach will restore more normal glutamate signaling in schizophrenia patients, with fewer of the kinds of side effects that result from an all-or-nothing, on-or-off approach. Of course all that remains to be seen for ADX71149. Phase II clinical trials (which can give an indication of therapeutic potential) for the molecule are slated to start later this year. This nuanced approach to disease was clearly attractive to J&J, but it's also one that many, including Addex, have stumbled over. Last December, Addex had a big disappointment when they had to stop development of their lead drug candidate, ADX10059, because of safety concerns. The molecule was in clinical trials for migraine and heartburn associated with gastroesophageal reflux disease. But a safety monitoring turned up signs of liver abnormalities in people receiving...

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Is Incubation a Win for Big Pharma?
Apr06

Is Incubation a Win for Big Pharma?

Johnson & Johnson appears to be the next big pharma company looking to test out the incubator model as one way to spur innovation. According to an article in the San Diego Business Journal, the big pharma company is interested in renting space to entrepreneurs that would have access to J&J’s equipment and technology at its research site in La Jolla, Calif. Diego Miralles, facility head at La Jolla, tells the SDBJ that up to 17 small biotechs could be housed at the site. The first biotechs could be moving in as early as this year. Many will recall that Pfizer established an incubator, also in La Jolla, in 2007. So far only three companies—Fabrus, Intherix, and RGo Bioscience--occupy the space there, and, as the article points out, no new firms have been signed on since Pfizer’s merger with Wyeth. Biogen Idec seems to have a similarly slow start to its incubator, also launched in 2007. So far, the big biotech’s incubator, bi3, has only invested in two companies, Escoublac and Provasculon. An incubator can offer some advantages over the traditional VC funding route. In addition to cash, companies get space in often well-appointed digs, infrastructure, scientific support, and access to bigger firms’ business acumen. On the downside, the deals also come with strings attached:  generally the big pharma firm gets a stake in the companies in which they’ve housed in their incubator. Other companies have taken a different tack. The Novartis Option Fund makes seed investments in companies with early-stage technology in exchange for a stake in the firms and the first crack at any discoveries they make. With much deeper pockets—the fund started out with $200 million—Novartis has made a substantial number of investments, including some “opt-ins” on drug candidates. The jury is out on whether incubators, internal investment funds, or some other measure will actually be a winning proposition for big pharma. But the slow start for Pfizer and Biogen’s ventures might cause J&J to keep its expectations low for filling its space with those 17...

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