| Today's Top Stories
1. R&D execs continue the global search for efficiency, open innovation
2. Biotech deal-making grows in importance as Big Pharma restructures
3. Spike in approvals can't quell industry protests about the FDA
4. Venture capital circles turn dour in the face of some tough challenges
5. Dendreon demonstrates tougher commercialization hurdles for developers Editor's Corner: A look back, and forward Also Noted: Spotlight On... Baxter, Momenta team up in potential $453M biosimilars deal
BMS disappoints in late-stage liver cancer study; Vivus gets AdComm date for Qnexa review; and much more... More Fierce Life Sciences News:
1. Drug shortages dominate 2011 headlines
2. The best of times, the worst of times for new drug launches
3. Merck leads 2011's list of job-cutting drugmakers
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A look back, and forward
This past year has held some pleasant surprises for me. I was particularly intrigued by the Plexxikon buyout for $935 million, the bulk of it upfront. In a sane world, Plexxikon--which developed the remarkable new skin cancer drug Zelboraf (vemurafenib)--would have gone public. But as far as the IPO market for biotech companies is concerned, this isn't a sane world. Plexxikon helped illustrate the potential biotechs have to distinguish themselves with great science and a sharp development focus. That kind of expertise is clearly worth a considerable sum; a maxim other companies like Pharmasset have clearly learned how to profit by. Plexxikon's experience also demonstrated the limitations developers face in a world where investors will typically turn a cold shoulder to all the risks involved in drug development. I'm wrapping this year's run of FierceBiotech reports with a look back, and forward. The key trends of 2011--with a wide array of venture capitalists complaining loudly, the R&D revolution still at the midway point, deal-making more important than ever, and regulators feeling the heat from a disgruntled industry--will all play into 2012. Fundamental changes can't occur quickly in biotech. It took years to get where we are today. Years more are required to see if new strategies can work or new biotechs can navigate the hazards of clinical development. Now that we've passed the 10th anniversary of FierceBiotech, we can say we've reached the second generation of the publication. And we're planning to take our coverage of the industry up a notch or two in 2012. Call it FierceBiotech 2.0. We'll be taking our traditional holiday break next week, returning the Tuesday after New Year's Day. It's a chance for us to retool some aspects of our coverage and come back stronger than ever. We hope you enjoy your own break and will see you in the new year. - John Carroll (twitter | email) Read more about: Biotech IPO, Plexxikon, Pharmasset
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> New Paradigms to Fund & Move Biotech - January 11-12, 2012 - San Francisco, CA
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> Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL
> Comparative Effectiveness: A Real-World User's Guide - March 14-15, 2012 - Washington, DC
> Leading the Business of BioPharma for Women - Mar 19-23 - Smith College
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> Sr. Product Manager – NJ – Celgene Corporation
> Manager, Strategic Forecasting & Analytics Job – NJ – Celgene Corporation
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* General ad info: Click here | Today's Top News 1. R&D execs continue the global search for efficiency, open innovation
Throughout 2011 we've seen a continuation of an intense reengineering of the development process at a slate of Big Pharma companies. Pfizer ($PFE), of course, grabbed the biggest headlines as it chopped up its R&D empire in pursuit of a major reduction in R&D spending. But AstraZeneca ($AZN), GlaxoSmithKline ($GSK) and others have been pushing to reboot their own R&D programs. This year the independent development teams at GSK have been forced to make a business case for their work to gain a new commitment from the company, just as a biotech might make its case to venture backers. And AstraZeneca has been pushing the same small-team approach as they bid--largely unsuccessfully--to improve the woeful return on investment that they've been seeing. In the process Sanofi ($SNY) and Eli Lilly ($LLY) and their rivals have been trying to outsource more of their development work, bringing in CROs as strategic partners in exchange for long-term deals. That push has been accelerating a shakeout in the CRO business, which is seeing bigger players emerge with global networks. And it will all continue into 2012. Another enduring R&D trend is the steady shift from west to east. With lower costs and emerging markets waiting for them, China has clearly grabbed the attention of Big Pharma companies. Merck ($MRK) helped demonstrate that with its recently announced plans to create an R&D hub in Beijing as it allocates $1.5 billion over 5 years to establish a regional research complex. Perhaps the most exciting change of all--at least for scientists in the field--has been a growing demand for open innovation networks. J&J, for example, has led the charge for investigators involved in neuroscience to pool their efforts in "precompetitive" arenas. One useful definition for a precompetitive topic would be any subject where confusion reigns. If you don't know anything, you can't really own anything. Once some solutions start emerging, of course, researchers will start nailing down IP rights. But if companies, academics and government groups can learn how to play together, everyone will benefit--especially patients. In the meantime, look for new academic partnerships in Boston, San Francisco and Cambridge in the U.K. It makes a lot of sense for developers to concentrate their R&D around the colleges and institutions doing extraordinary discovery work. Related Articles:
Big Pharma embraces "open innovation" trend to fix a broken R&D model
Will AstraZeneca get out the checkbook in search of new programs?
Merck chief defends $8B R&D budget as vital long-term investment
Merck blueprints Asian R&D HQ in Beijing in $1.5B research blitz
GSK shakes up R&D units during high-profile review Read more about: job cuts, R&D budget, R&D spending, emerging markets
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2. Biotech deal-making grows in importance as Big Pharma restructures
The tough IPO market has clearly forced developers to build up their deal-making muscles over the past three years. Without a big cash-out for investors on a timely basis, deals have loomed ever larger in importance. We've been seeing a lot more smart biotechs doing licensing deals at an early stage this year. Preclinical pacts are not at all uncommon. And they're not all small-change pacts, contrary to what you might expect. To keep their need for venture cash in line, and hold on to equity, a smart deal-making strategy early in the process makes a lot of sense. But just as deals have become more important, they're clearly getting harder to hold on to. As we concluded in our recent study on top deal terminations of the year, pharma companies are not only restructuring pipelines and shopping out their own unneeded programs, they're also a lot quicker to pull the trigger on a termination if a trial goes wrong or development risks spike. So not only do biotechs have to get smarter about collaborations, they also need to build in an exit door so they can take all their IP with them if a partnership turns sour. The bottom line on deals is likely to keep the business development teams busy in 2012. Big Pharma still needs new technology and new products, and they're still often not very good at growing them without a lot of help. For biotechs with smart science and an inside track on a novel therapy, there are buyers willing to come to the table. They'll be back at the bargaining next year as well. Special Report: The top 10 biotech deal terminations of 2011 Related Articles:
Biotechs lug big risks with option-based pharma deals
Report: Biotech M&A activity jumps in 1H 2011
Hungry biotechs make better partners for Big Pharma Read more about: Mergers and Acquisitions, Biotech deals, deal
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3. Spike in approvals can't quell industry protests about the FDA
Throughout 2011 you could hear a growing chorus in the biopharma industry complain bitterly about the tougher regulatory challenges facing drug developers. Antibiotics got tougher. Diabetes got tougher. Obesity was always a tough nut to crack, and there were three biotechs this year that showed just how hard it can be. The FDA responded. Throughout the course of the year top regulators at the agency like Janet Woodcock periodically defended the agency, pointing to new studies showing that the FDA was faster than the Europeans when it came to drug reviews. By the middle of the year, regulators started to point to a growing number of approvals, promising a likely spike in new drugs headed to the market this year. By November the FDA had 35 approvals to boast about--with 24 coming ahead of any OKs in other countries. The agency publicly noted that 2011's approval rate will go down as one of the best years in the past decade after years of anemic approval rates. Interestingly, I don't know of anyone in the industry who thinks the spike in approvals this year represents a major change. Most industry execs I talk with just don't believe we've turned the corner on productivity. And they may well be right. Smart developers at companies like Bristol-Myers Squibb ($BMY) and Roche may have proven their R&D and regulatory teams know how to deliver the goods, but with the industry undergoing an unfinished revolution on the development front, next year could see a drop in approvals. And if that happens, the FDA will be under even more pressure to work more closely with the industry on elaboratin g just how developers can stack the odds in their favor. Related Articles:
Report: Senate staffers hammering out accelerated drug approval pathway
FDA boasts of 35 drug approvals in past year amid criticisms
FDA's Woodcock: What to expect in the next 25 years of medicine Read more about: FDA approval, Drug approvals
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4. Venture capital circles turn dour in the face of some tough challenges
This year ended on a series of sour notes from venture groups that the biotech industry found impossible to ignore. The National Venture Capital Association helped get the party started with a survey showing a significant chunk of the VC community looking outside the U.S. to place its bets. Only one in three VC execs later said they expect investment levels to rise in the U.S. next year; slightly more expect a drop. And there's widespread anger and dissatisfaction about the regulatory hurdles facing drug developers, with some disease fields being particularly affected by tougher FDA standards. Another moribund year for biotech IPOs hasn't helped the venture community one little bit. Without a timely exit for companies that can take years to get through mid-stage testing, investors will have a hard time generating a lot of enthusiasm for drug development. By the time the principals at Scale Venture Partners announced they were throwing in the life sciences towel back in November, the angst in investment circles had grown palpable. Despite all the stormy headlines, it's not all darkness and despair. Third Rock Ventures has been barreling ahead, handing out large rounds to early-stage startups with some intriguing science. Steven Burrill may not have rounded up all the cash he had promised for his fourth fund, but at better than $300 million, he will continue to play a key role in the investment scene. And new investors at RusNano have popped up to back nanobio plays with some major cash. Even Europe, which has been struggling, saw some big rounds for emerging companies. It's unlikely 2012 will see any dramatic changes at the FDA that will make life any easier for developers. And IPOs remain a dark spot. The simple fact is it's hard for the vast majority of biotechs to get investors excited about the potential of an experimental drug. What they see is huge clinical trial risk, followed by big hurdles at the regulatory agencies and even bigger challenges on the commercialization stage. But there are enough visionaries--and, let's face it, opportunists--to keep the money tap open in the year ahead. Plexxikon, BioVex and Pharmasset have all helped demonstrate how developers can provide hefty returns for investors. They all were bought out this year, of course. But as long as those kinds of payoffs remain possible, there's hope for better times ahead for the venture side of the business. Related Articles:
Biotech IPOs: It's just a flesh wound
VC drought for biotech hits hard in Europe with 44% drop in 3Q investment
Venture survey forecasts tough life sciences investment scene for 2012
Venture fund bows out of therapeutics as costs, timelines swell
Fresh signs that VC deal, dollar flow is shrinking for biotech Read more about: Biotech IPO, Venture Capital
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5. Dendreon demonstrates tougher commercialization hurdles for developers
It takes years in biotechnology to forge an enduring success. But failure is always just one false step away. Look at Dendreon ($DNDN). A little more than a year ago, the biotech pioneer was celebrated for its groundbreaking science and steadfast perseverance in the face of FDA obstacles as it won an approval for the prostate cancer vaccine Provenge. Now the biotech is subjected to harsh criticism--if not outright scorn--every time it comes out with a quarterly report with weak sales figures and uncertain projections. If you just listened to CEO Mitch Gold, who went from hero to goat in less time than it takes to design a Phase III study, you might believe that the only major problem the company faces is physician reluctance to order its expensive treatment without some reassurances payers will reimburse for it on a timely basis. But in survey after survey--from Decision Resources to R.W. Baird--the issues fracture into a complex set of factors that aren't easy to control and that need to be clearly understood by everyone in the development industry. Physicians aren't just feeling threatened about getting left on the hook for a $93,000 bill--although that is a factor. They're also deeply conflicted about providing a drug to patients who may face a 25% to 30% or 35% coinsurance charge on the treatment. Many doctors clearly don't believe that a drug that delivers a median benefit of four months of life warrants the overall cost. Meanwhile, new rivals are appearing in the market that cost less and aren't as difficult to administer. One of the new priorities in any development group these days is to get a clear and early read on payers' willingness to cover a drug once it gains approval. Maybe they should take some extra time and try to figure out how providers are assessing costs and benefits in the U.S. The bar keeps getting raised in biotech. That trend will not end anytime soon. Related Articles:
Dendreon's sudden fall from grace offers biotechs a tough lesson
Dendreon cuts deep into work force to conserve cash
Dendreon banks on restructuring after stock craters
Xconomy: Dendreon has only itself to blame for Provenge fiasco Read more about: Dendreon, Provenge, REIMBURSEMENT
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Also Noted SPOTLIGHT ON... Baxter, Momenta team up in potential $453M biosimilars deal Drugmakers and biotech groups continue to partner up in the biosimilars game. With plans to develop up to 6 knockoffs of biologic drugs, Baxter International ($BAX) has agreed to pay Momenta Pharmaceuticals ($MNTA) $33 million in cash and potentially more than $419 million in milestone payments and other fees, according to a representative for Momenta. Read the full story  @FierceBiotech: Here's the full list of the 40+ reports we published this year: List. 15 blockbuster contenders was most viewed of 2011. | Follow @FierceBiotech
@RyanMFierce: BMS missed the mark in its late-stage study of brivanib for liver cancer, but $BMY not giving up. Report | Follow @RyanMFierce @FierceMedDev: Smiths Medical starts nationwide vlntry recall of certain Bivona neonatal, pediatric and FlexTend tracheotomy tubes. Release | Follow @FierceMedDev > Bristol-Myers Squibb ($BMY) struck out in a late-stage trial for the liver cancer drug brivanib, failing to show that the drug could improve overall survival compared with placebo, but the drug powerhouse plans to forge ahead with the program, with a trio of trials testing the drug in other groups of liver cancer patients in the works. Article > SkyePharma faces more delays on the European approval decision for its inhaled asthma treatment Flutiform because member states couldn't reach a consensus on the approval process. The U.K.-based drug delivery company now expects a 6- to 9-month delay on the approval. Report > Merck ($MRK) has ended an Alzheimer's partnership with Acumen Pharmaceuticals, giving back rights to the developer for anti-ADDL antibodies and diagnostics. Item > Albany, NY-based AMRI ($AMRI) announced that it has cut workers as it winds down internal R&D and focuses on its manufacturing business and providing contract services. The number of workers being let go was not disclosed in the company's announcement Thursday. Release > Vivus ($VVUS) said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee is slated to meet Feb. 22 to review the Mountain View, CA-based developer's application for approval of the diet drug Qnexa. The FDA action date on the application is April 17. Release > South San Francisco, CA-based Poniard Pharmaceuticals' ($PARD) shares took a hit after its merger pact with Seattle-based biotech Allozyme fell through. Bloomberg reported that the deal couldn't get done because the combined company's shares wouldn't qualify for listing. Report > ViroPharma ($VPHM) has paid $7.5 million upfront a deal that gives the Exton, PA-based company an option to buy Meritage Pharma, a San Diego developer of a drug against chronic inflammatory disorder of the esophagus. Announcement Pharma News @FiercePharma: Merck leads 2011's list of job-cutting drugmakers. Story | Follow @FiercePharma > EMA blesses ovarian cancer use for Roche's Avastin. Report > Big Pharma buybacks, spinoffs cater to investors. Piece > Drug shortages dominate 2011 headlines. Story > Merck leads 2011's list of job-cutting drugmakers. Article > European crisis crimps pharma's finances. Report And Finally... Happy holidays and a big thank you to our subscribers for reading FierceBiotech! > 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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This position exists to evaluate, analyze, design, coordinate, direct, and implement complex engineering solutions using existing and new technologies to meet infrastructure and monitoring application requirements...Read More. > Telecommunications Engineer - 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 Telecom Engineer provides level 2/3 support for all VoIP related activities, including the design, implementation, support and maintenance of MedImmune's VoIP and network infrastructure, performing other duties as required...Read More. > Manager, Telecomm/Facilities - 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. 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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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