| Today's Top Stories
1. Roche CEO Schwan outlines drug/diagnostic acquisition strategy
2. Vivus sinks after delivering oral cleft data on obesity drug ingredient
3. Ipsen-backed Inspiration Biopharma leaving California for Boston area
4. Will AstraZeneca get out the checkbook in search of new programs?
5. Chelsea Therapeutics reports positive efficacy results in PhII fibromyalgia study Also Noted: Spotlight On... Biotech IPOs: It's just a flesh wound
Neuraltus raises $10M for Lou Gehrig's work; Roche submits vismodegib app; PTC banks $5M grant; and much more...  In biotech, the right partnering deal can make a company, bringing in cash, expert help and a major league endorsement for the science involved. If deals go bad, the subsequent turmoil can break a company. Anyone with any doubts about the stakes involved should take a close look at the top partnering deals that soured in 2011. Top 10 deal terminations >>
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3. J&J pulls 12M Motrin bottles as recalls lawsuit gets green light
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* General ad info: Click here | Today's Top News 1. Roche CEO Schwan outlines drug/diagnostic acquisition strategy
2. Vivus sinks after delivering oral cleft data on obesity drug ingredient
Vivus' ($VVUS) data released Wednesday show how any perceived chink in an experimental drug's armor seems to give investors the jitters. The drug developer's stock sank in after-hours trading on retrospective study data linking one of the key ingredients in its experimental diet drug Qnexa with oral cleft defects in the offspring of mothers who took the pill early in their pregnancies. It appears that analysts are all over the board as to how the data might factor into the FDA's review of Vivus' application to market the weight-loss drug, which goes in front of an expert panel of FDA advisers early next year, and that was enough for traders to wipe out all of the Mountain View, CA-based developer's stock gains this year and then some. The stock, which had been up about 11% on the year, is down about 15.5% as of 12:06 pm ET today. In Vivus' retrospective study dubbed "Fortress," 5 out of 1,740 babies of mothers who took topiramate during their pregnancy to prevent migraines were born with oral cleft. The prevalence rate of 0.29% in this group was higher than the 0.16% rate among the 13,512 women whose babies were born with oral cleft and who took the drug before becoming pregnant. Qnexa is a combination of topiramate and the hunger blocker phentermine.
"We view the data disclosed as mostly in-line with investors' expectations and as ranging from neutral to incrementally positive for [Vivus]," Cowen analysts wrote in a note to investors. Cowen's analysts, however, noted that reviewers of Vivus' drug application could recommend cardio safety studies, which the FDA could require before deciding whether to approve Qnexa. MLV & Co. analyst Christopher James told Bloomberg that he believed that the data from the Fortress study was unlikely to factor into the FDA's decision on whether to approve Qnexa. An advisory committee weighs in on whether the FDA should give a green light to Qnexa in the first quarter of 2012, and Vivus' message about the Fortess data was that there weren't really any surprises. "The prevalence ratio for oral clefts in FORTRESS is within the recently reported range for topiramate from several large studies," Vivus President Peter Tam stated. - here's the release
- see Bloomberg's article
Related Articles:
FDA gives new shot to Vivus obesity drug
Vivus gets back in the race for weight-loss drug OK, resubmits Qnexa
Vivus shares buoyed as FDA allows early resubmission on Qnexa Editor's Note: This story was corrected to say that Vivus' data was released on Wednesday, not Thursday, as it was incorrectly reported in the original version of this article. Also, the stock price has been updated. Read more about: FDA, obesity, Vivus, Qnexa
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3. Ipsen-backed Inspiration Biopharma leaving California for Boston area
Score one for the Boston-area biotech scene. With a newly appointed chief executive from Genzyme, Inspiration Biopharmaceuticals is relocating from Laguna Niguel, CA, to the biotech-rich Kendall Square section of Cambridge, MA. And the move comes amid the company's planned transformation from a development-stage outfit to a commercial provider of bleeding-disorder drugs. "We're building a fully integrated company,'' Inspiration CEO John Butler, who was previously president of the rare genetic disease unit of Cambridge-based Genzyme, said in an interview with The Boston Globe. "Ultimately, we're a bricks-and-mortar company as of Jan. 1. Going forward, Cambridge is our address. We expect to have two products on the market in the second half of 2013.'' Ipsen's partnership with Inspiration, which is 40% owned by the French biotech, played a role in the relocation to Massachusetts as well, according to the Globe's article. Inspiration recently filed for approval of its experimental factor IX product for hemophilia B patients in Europe, where Ipsen has rights to market the drug. The company is also planning an FDA app for approval of the drug early next year. Ipsen has set up a bioprocessing operation in Massachusetts where the treatment will be made, and the Paris-based biotech has an option to acquire Inspiration which is tied to whether the developer'' two lead bleeding-disorder drugs pan out, the Globe reported. Inspiration's move to Massachusetts, of course, won't really improve its chances of getting market green lights for its hemophilia products. Yet there's no shortage of biotech talent walking the streets of Kendall Square, where Novartis ($NVS), Biogen Idec ($BIIB), Pfizer ($PFE) and others are building up their existing hubs and adding to their teams of scientists and business groups. And Ipsen recently revealed plans to plow $45 million into and add 100 worker s to its R&D operation in Milford, MA. Inspiration is unlikely to have problems beefing up its own work force as it readies for potential commercial releases of its products. - here's the company's release
- get more in the Globe article Related Articles:
Biotech building boom restricted to top "micro" hot spots
Inspiration nabs $35M milestone on EMA hemophilia review Read more about: Ipsen, Boston, hemophilia, Inspiration Biopharmaceuticals
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4. Will AstraZeneca get out the checkbook in search of new programs?
Within 24 hours of the news that AstraZeneca ($AZN) had experienced back-to-back pipeline setbacks, the pharma giant had countered the news with new deals aimed at adding early- and mid-stage therapies to its roster of R&D programs. But it's going to take more than that to satisfy the analysts who follow AstraZeneca and who clearly don't like the pattern of failures that has long plagued the company's development efforts. "AstraZeneca seems to have had more than its fair share of misfortune when it comes to the development pipeline," noted analysts at Barclays Capital following the news. "Additional development failures increase the probability that management will reassess the likely return on investment from additional R&D investment and cut costs further." For now, says Barclay, fostamatinib--slated for a potential 2013 approval in the U.S. and Europe--looks like the only big commercial contender, Barclays' analysts said. Another analyst says that AstraZeneca's dealmakers are going to need to get busy finding promising experimental drugs to partner on. "It's a setback in a pipeline that's already relatively thin, at a company that does need pipeline products because of the patent expiries on the horizon," Berenberg Bank's Alistair Campbell told Bloomberg. "There are still some pipeline options, though I have to say my hopes aren't high for many of those." - here's the article from Bloomberg Related Articles:
AZ commits $140M to cancer pact as it inks back-to-back deals
AstraZeneca pumping $100M more into VC unit
AZ R&D unit has orders to hunt down new targets of opportunity
AstraZeneca's newly tailored R&D operation beefs up presence in Boston area Read more about: AstraZeneca, R&D spending, R&D, fostamatinib
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5. Chelsea Therapeutics reports positive efficacy results in PhII fibromyalgia study
Chelsea Therapeutics ($CHTP) has racked up some more positive efficacy data for its lead drug droxidopa, which is now up for review at the FDA. Investigators reported the drug spurred a statistically significant response on some key measures of fibromyalgia in the Phase II study, which was designed to test a range of doses as well as a combo approach with carbidopa. The biotech recruited 120 patients for the study, ultimately zeroing in on 7 separate arms. Charlotte, NC-based Chelsea designed the trial with the understanding that droxidopa, a synthetic amino acid, is converted by the body into norepinephrine. By boosting levels of norepinephrine, Chelsea believes it can directly address some of the disease's severe side effects. Shares of Chelsea were up slightly this morning. "Since norepinephrine is a key neurotransmitter involved with the modulation of chronic pain, we were not surprised to see evidence of droxidopa's therapeutic benefit in treating patients with fibromyalgia," stated Dr. Art Hewitt, Chelsea's chief scientific officer. "As we continue to evaluate potential indications for droxidopa such as fibromyalgia and adult attention deficit disorder, trials like this provide insight into how to optimize dosing for more robust future clinical evaluations. Given the broad biologic activity of norepinephrine, we continue to believe there are wide-ranging therapeutic applications for a first-in-class oral prodrug of norepinephrine. We also continue to be encouraged by the remarkable safety profile of droxidopa which, even at its highest dose, again proved not to be associated with any serious or significant adverse events." A few weeks ago the FDA accepted Chelsea's application for droxidopa as a new treatment for hypotension. The drug, in-licensed from Japan's Dainippon Sumitomo 5 years ago, flunked its first Phase III, but Chelsea regrouped and announced positive data in 2010. Regulators are expected to make its final decision on the program by March 28 under a priority review. - here's the press release
- read the Reuters story Related Article:
Chelsea shares rocket up after lead drug clears PhIII Read more about: Chelsea Therapeutics, Droxidopa, Fibromyalgia, Dainippon Sumitomo
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Also Noted SPOTLIGHT ON... Biotech IPOs: It's just a flesh wound VC blogger Bruce Booth turns to Monty Python's Holy Grail to help illustrate his thoughts on the ever-elusive biotech IPO. The IPO is not dead, but it has been bloodily hacked up. Looking back on 23 biotech IPOs, Booth finds that the group stock price dropped a collective 17%, with 61% trading below their initial price. Among the poorest performers: Tengion, Alimera, Pacific Biosciences and NuPathe, which all plunged more than 80%. Bright spots include AVEO and Aegerion. Column  @FierceBiotech: More than 1/3 of clinical trials conducted by pharma cos. are now being outsourced, says a Kalorama report. Story | Follow @FierceBiotech
@JohnCFierce: Proposed "model" plan would restrict portions of sensitive studies to "legitimate scientists." Via WSJ: News | Follow@JohnCFierce @RyanMFierce: Seattle's biotech scene lacked startup activity in '11 but didn't want for M&A action. via @ldtimmerman. Article | Follow@RyanMFierce > Palo Alto, CA-based Neuraltus has reportedly raised close to $10 million in a new round. The biotech is developing a treatment for Lou Gehrig's disease. Story > Roche has submitted its European application for vismodegib, a new treatment for advanced basal cell carcinoma. Roche release > PTC Therapeutics has banked a $5 million discovery grant from the Wellcome Trust to support its work on a new antibiotic. Release > Transcept Pharmaceuticals has received a $10 million milestone payment from Purdue Pharma in connection with the listing of Intermezzo formulation patents in the FDA Orange Book. Release Pharma News @FiercePharma: Actavis CEO says generics biz "as we know it" is doomed as company launches branded pain drug in U.S. Release | Follow@FiercePharma > U.S. officials seek execution drugs in India. Report > Eyeing diagnostics growth, Roche up for $3B deal. Story > Actavis CEO: Today's generics business is doomed. Item > SC judge upholds $327M fine in Risperdal 'doctor letter' case. News > J&J pulls 12M Motrin bottles as recalls lawsuit gets green light. Report Vaccines News > Pfizer, GSK to provide more discount vaccines for GAVI. Story > Oxford researchers find malaria vaccine target. Article > Canadian researcher gets FDA ok for HIV vaccine trial. Report > Sanofi to relaunch Shan5 in 2013. Story Manufacturing News > FDA cites Akzo for contamination, leaky equipment. News > Counterfeiter with Chinese connections is busted. Story > Daiichi grimaces at Ranbaxy, FDA consent decree. Report > Trout forges ahead on Novartis-MIT continuous processing effort. Article And Finally... Editors at two prominent science publications are considering a "model" arrangement under which they may print part of the new research on a more lethal variety of bird flu and hold sensitive sections in a special repository that could only be accessed by "legitimate" scientists. An advisory panel has voiced concerns that terrorists could use the information to make a lethal virus capable of triggering a worldwide pandemic. Story > BIOCOM Global Life Science Partnering Conference - Jan 31- Feb 2,2012 - La Jolla, CA Exclusive global partnering and networking forum that brings together senior executives and business development professionals from leading pharmaceutical and biotech companies. Speakers include Roger Pomerantz, SVP and Head Worldwide Licensing, Merck/ Jeremy Levin, Senior Vice President, Strategy, Alliances and Transactions, Bristol-Meyers Squibb/ Brian McVeigh, Vice President, WWBD Transactions and Investment Management, GlaxoSmithKline Pharmaceuticals and many more. Register today. > BioConference Live – Laboratory Animal Sciences – Virtual Online-only Event - February 15-16, 2012 The Veterinary Bioscience Institute and LabRoots, Inc. announce this inaugural event. The theme is Animal Well being and Welfare Science. It is free to participants, with no out-of-pocket expenses for travel. Register and learn more at www.bioconferencelive.com. > Webinar: JHU's Master's in Biotechnology Enterprise & Entrepreneurship Learn more about Johns Hopkins University's 10-course graduate program that is designed for those seeking to pursue a biotechnology entrepreneurial career beyond the laboratory. The entire degree can be completed online. Available On-Demand | REGISTER NOW > Online GMP Courses Priced as Low as $75 for Individual Learners Our web-based GMP courses can be purchased online and taken at your own pace. Once completed with adequate proficiency, you'll receive a certificate of completion. Developed by GMP experts and taken by thousands, these courses provide quality GMP training for far less than other alternatives. Click Here > New Paradigms to Fund & Move Biotech - January 11-12, 2012 - San Francisco, CA New Paradigms is guided by key individuals from biotech, pharma and the investment community to advance R&D through alternative sources of funding, non-traditional partnering strategies and innovative approaches to drug approval for the successful commercialization of new therapies. The conference is backed by an exceptionally distinguished speaking faculty with diverse experience and expertise. Co-located at the same time as the JP Morgan Healthcare event, on-site networking partnering services available to registered attendees. Register today! 20% off registration fee for Fierce Readers with code FBNP > PCC 2012 - CBI's 9th Pharma Compliance Congress - Jan 24-25 - Washington, DC 17 CCOs anchor the faculty of 70+ from the DOJ, NIH, DDMAC, AZ, Celgene, Eisai, Endo, GSK, J&J, Lilly, Medicis, Novartis, Noven, Otsuka, Pfizer, Purdue, Sunovion, UCB and more! Hundreds attending - Don't miss the compliance event of the year! Visit www.cbinet.com/pcc and save $400 with PCCFRC. > Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL Partnerships is the largest clinical trial operations, development and outsourcing meeting in the world with over 1500+ attendees and 200 exhibitors. This leading event is a unique senior leadership meeting focused on overcoming challenges clinical trial executives face. Visit www.cliicaltrialpartnerships.com. > Comparative Effectiveness: A Real-World User's Guide - March 14-15, 2012 - Washington, DC Moving from Policy to Practice in Research and Delivery! Push beyond basic questions to evaluate the importance of comparative effectiveness research (CER) and provide participants with actionable understandings of how CER evidence can be better managed and developed within their own organizations. This event will provide participants with a "what does it mean for me" perspective on CER and HTA, providing take-aways to apply within day-today drug development and marketing positions. Register Today! > Leading the Business of BioPharma for Women - Mar 19-23 - Smith College Leading the Business of BioPharma is the top talent development opportunity for women in the life sciences. The curriculum covers topics on the impact of FDA regulation, industry trends in biotech, pharma and medical devices, strategic alliance management and much more. 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| > Director, Reagent Manufacturing & Operations - San Francisco, CA - Fluidigm Directly reporting to the VP of Manufacturing, the Director will be responsible for managing and directing Fluidigm's Reagents and Assays Manufacturing operations. This includes formulating manufacturing operations strategies in support of business goals and objectives, developing and mentoring manufacturing employees and driving continuous improvements to achieve optimal operational efficiency. He or she will set up the systems and tools to deliver quality products and services that will meet customers' expectations in the most cost-effective manner. The Director will also lead and manage the supply chain operations in South San Francisco which includes but is not limited to: purchasing, inventory management, supplier management... Learn more. > Sr. Product Manager – NJ – Celgene Corporation Celgene Corporation is a global biopharmaceutical company that is helping to turn incurable cancers into chronic, manageable conditions. An ideal candidate for this position will have BS/BA degree and a minimum of 7 years' pharma/biotech industry and 3 years product management/marketing research. Sales experience in the pharmaceutical industry required. The Sr. Product Manager assists in the development and implementation of marketing and educational programs, leading segments of the projects as appropriate. Also participates in the development of business plans, product strategies, and tactical implementation.....Learn more. > Manager, Strategic Forecasting & Analytics Job – NJ – Celgene Corporation Celgene Corporation is a global biopharmaceutical company that is helping to turn incurable cancers into chronic, manageable conditions. An ideal candidate for this position will have BS/BA degree. 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The successful candidate manages the IT organization's relationship with the Telecom providers, including the planning and provisioning of all carrier circuits, reconciliation of carrier invoices and other carrier-related duties as required...Read More. > IT Account Administrator - Gaithersburg, MD - MedImmune MedImmune is a company that shares your passion for helping to improve human health around the world. Explore a MedImmune career as we strive to better more lives, more often, around the world. The Account Administration team primary function is to safeguard and manage access to MedImmune IT resources while adhering to MedImmune IT Controls guidelines. As a team member, the IT Account Administrator is responsible for the day-to-day administration of systems accounts such as Microsoft Active Directory, Microsoft Exchange, Blackberry Enterprise Server as well as other critical business applications...Read More. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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