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Today's Top Stories
1. Blockbuster breakup: Amylin buys out Lilly's exenatide rights in $1.6B deal
2. Key AZ/Targacept depression drug flunks first Phase III test
3. NJ wins heated competition for Allergan's new R&D facility
4. Study: Deal terms getting richer as pharmas stockpile antibody tech
5. Venture fund bows out of therapeutics as costs, timelines swell Editor's Corner: Biotech's Biggest Spenders 2011 Also Noted: Novella Clinical Resourcing
Spotlight On... China's biggest biotech plots $2B IPO
BioCryst surges on upbeat PhII gout data; IDEXX buys research/lab in $43M deal; and much more... More Fierce Life Sciences News:
1. Scripps breakthrough unlocks the potential of a promising cancer drug class
2. BMS, Lilly win new head-and-neck indication for Erbitux
3. Cancer researchers snuff out misfit T-cells in stem cell therapies
| This week's sponsor is Clinipace. |  | Game Plan for Therapeutic Cancer Vaccines
Free Webcast hosted by Clinipace Worldwide on December 6th at 2pm ET
Join Clinipace as we discuss the importance of having the right regulatory and clinical development strategies for success in pioneering novel therapeutics. Register today! |
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Biotech's Biggest Spenders 2011
 By John Carroll and Ryan McBride
If you add up the R&D budgets for the top 15 public biotechs in the world, you'll find a tab that runs right about $10 billion. That's not small change, by any means, but to put it in some perspective, it is interesting to note that Roche, which has the largest research budget for any biopharma on the planet, spent a bit more than that last year advancing new drugs and technology. Having noted that, I believe that a combination of the peak projected sales for all the experimental drugs you'll find in the biotech pipeline below would rival all that Roche is working on. This year, we've decided to sharpen the focus for our report this year on the biggest biotech R&D spenders. As we did last year, most of the numbers were drawn from the latest EU Industrial R&D Investment Scoreboard. But this year we've excluded some of the tool and tech companies that were on last year's Top 15 report so we can devote our attention to drug discovery and development. M&A activity is transforming the top 15 biotech companies on the list. These are 2010 numbers, so Genzyme is still with us--for the last time. Next year, look for it under the Sanofi banner. I dropped OSI Pharma, which was taken over by Astellas in a $4 billion deal last year. Abraxis BioScience is also gone, bought up by fast-growing Celgene, which jumps to third place in this new lineup. Genmab dropped off the list as it cut R&D costs down to $103 million. I made an executive decision to play with the list a little as well. While the EU included Switzerland's Actelion as a pharma company, I see it as more of a biotech, rushing to see if a Phase III study of a lead program can give it a replacement for the steadily fading blockbuster that has funded the company's R&D operations. Failure may not be an option, as they say at NASA, but it is a distinct possibility, and a high-stakes development program like that can't be ignored. Also, Exelixis was inexplicably listed under pharma. That's a FierceBiotech company to watch, if ever there was one. With all the M&A activity that has dominated the biopharma industry over the past year, it will be interesting to see who will be added when we come back in 2012. See the R&D budgets report >> |
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* General ad info: Click here | Today's Top News 1. Blockbuster breakup: Amylin buys out Lilly's exenatide rights in $1.6B deal
The decade-long union of Amylin ($AMLN) and Eli Lilly ($LLY) on the diabetes front ended in a blockbuster breakup today, with Amylin agreeing to pay Lilly $250 million upfront and up to $1.2 billion from the sales of exenatide products in exchange for full rights to the drug and its successors. The divorce was presented today as an amicable ending to a long and fruitful partnership, but Amylin has been acting anything but amicably over the course of the year. The biotech filed suit against Eli Lilly earlier this year after the pharma giant joined forces with Boehringer Ingelheim, a rival in the diabetes field, on Trajenta. Today's agreement also ends the litigation. Under the terms of the deal, Amylin will hand over a $1.2 billion secured note to Lilly, paying it off with the sales revenue from exenatide products. But if the FDA still hasn't approved the once-weekly injectable Bydureon--the successor to Byetta--by mid-2014, then the revenue sharing deal will terminate and Lilly's share of the sales revenue will shrink from 15% to 8%. FDA approval of a once-monthly version of the drug, now in mid-stage development, would trigger a $150 million milestone payment. Transitioning worldwide commercialization and development of new exenatide products starts in the U.S. at the end of this month then rolls around the globe by the end of 2013. "Lilly remains confident that the resubmission package for Bydureon has addressed the requirements outlined by the FDA and looks forward to Amylin achieving the alliance's long-held goal of making Bydureon available to patients in the U.S.," said Enrique Conterno, president of Lilly Diabetes. "Looking forward, Lilly Diabetes remains committed to providing a comprehensive portfolio of diabetes treatment options for patients through our currently marketed products and robust clinical pipeline." Alkermes, which has a royalty stake in the success of Bydureon, will evidently stay with Amylin now that the two big partners have severed their union. - check out the press release Special Report: Bydureon - 15 top blockbuster contenders Related Articles:
Amylin waging legal war with Lilly over blockbuster Boehringer pact
Lilly, Amylin win EU recommendation for Bydureon
Amylin Pharmaceuticals - Biotech's Biggest Spenders Read more about: Eli Lilly, Diabetes, Amylin pharmaceuticals, exenatide
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2. Key AZ/Targacept depression drug flunks first Phase III test
The high-profile depression drug TC-5214 has failed the first in a string of Phase III studies, dealing AstraZeneca's struggling R&D operation another stinging setback and walloping Targacept with a meltdown in its share value this morning. Two years ago AstraZeneca ($AZN) paid Targacept $200 million upfront and promised another billion dollars in milestones to in-license the drug from the biotech, an R.J. Reynolds spinout which had used the science of nicotine to develop a product that would tamp down over-stimulated nicotine receptors in the brain, which are believed to play a role in depression. Tackling a new pathway to treating the disease was always risky, as is anything new in the depression field, but the market opportunity for an add-on treatment would be enormous. Investors were in an unforgiving mood this morning, though. Targacept ($TRGT) shares plunged 50% in pre-market trading and even AstraZeneca's shares felt the impact of the trial failure. AstraZeneca had been so impressed by the drug's potential it committed a budget for five late-stage trials. Renaissance 3 was the first to deliver data and its failure leaves the entire program under a dark cloud. In a short release, AstraZeneca simply noted that "the study did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale after eight weeks of treatment with TC-5214 as compared to placebo." AstraZeneca is committed to seeing out the next three Phase III studies, which will read out in the first half of next year. The pharma company had been expected to file for an approval in the second half of 2012. - here's the press release
- read the Reuters story Related Articles:
Key AZ/Targacept depression drug flunks first Phase III test
Add-on depression meds a bright spot in eroding market
AZ drops its option on Targacept schizophrenia program
Read more about: AstraZeneca, Targacept, TC-5214
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3. NJ wins heated competition for Allergan's new R&D facility
New Jersey officials are celebrating Allergan's ($AGN) decision to build a new 100,000-square-foot, $12 million R&D facility in the state, adding up to 400 research jobs over the next five years. The drug company--best known for selling Botox--has a 20-person subsidiary in Bedminster, but has yet to select a site for the new facility. "We conducted an extensive search process initially looking at all areas outside of California, but quickly landed on (New Jersey) due to the pool of talent in the pharma/device industry in the region, as well as the proximity to medical centers and universities," spokesperson Cathy Taylor tells The Star-Ledger. It also didn't hurt that New Jersey officials are preparing a $17 million grant to cover the company's costs, a rich prize but a necessary one for a state that has been hemorrhaging pharma jobs in recent years. Allergan's Botox bucks have helped finance a growing R&D operation. In July, the company bought Vicept and its mid-stage program for rosacea in a $275 million pact. - get the story from The Star-Ledger
- here's the report from The Wall Street Journal Related Articles:
Allergan scoops up fledgling Vicept in $275M buyout pact
Strong sales from Bayer pharma, Allergan's Botox, Novo's Victoza
Allergan snags rights to retinal disease drug in $420M pact Read more about: Allergan, Botox, Vicept, R&D
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4. Study: Deal terms getting richer as pharmas stockpile antibody tech
There's nothing new about antibody technology. The field has been growing for years now. But a new study from Deloitte Recap crunched the numbers and found that a group of key players are still actively stockpiling all the most promising antibody work they can find on the planet. And there's no sign that the antibody race is even close to the finish line. "The antibody technology field is not saturated yet," says Jennifer Doyle, the Deloitte Recap senior analyst who authored the new report. "Companies are stockpiling antibody technology as quickly as they can." Looking over the deals done in the last decade, Deloitte Recap found that cancer is the dominant disease in the antibody arena, accounting for slightly more than half of the mAb deals they could track. Autoimmune and inflammatory diseases followed at 16% with infectious diseases (14%) and CNS (5%) accounting for another chunk. But the numbers took an odd twist after that stage. Deloitte Recap concluded that the median upfront cash and equity available for autoimmune and CNS programs was several times higher than cancer deals commanded. Upfront cash and equity totaled about $15 million per autoimmune/CNS deal versus a median of $5 million for cancer deals. "Autoimmune and inflammatory and CNS have the richest deals; that was a little surprising," says Doyle. Maybe, she adds, that's because these other disease arenas have a broader market potential, with numerous label expansions possible. And there's no doubt that overall market potential is driving richer deal terms. "Because of the price point of antibodies," says Doyle, "once approved they can be very successful in treating diseases with a significant unmet need." And as Deloitte spelled out in its first analysis of the antibody market, "after you get to market the sales are huge." Read the full report at FierceBiotech.com Related Articles:
Tiny antibodies could beat out blockbusters
Blockbuster antibodies face a unique set of challenges
Report: Monoclonal antibodies set to drive drug-delivery growth Read more about: antibodies, infectious diseases, inflammatory diseases, Cancer
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5. Venture fund bows out of therapeutics as costs, timelines swell
Scale Venture Partners' portfolio of life sciences companies can claim five regulatory approvals in the past three years, with two more pending a final decision. But that's not good enough to warrant future bets on the industry. Fortune reports this morning that Scale is bowing out of healthcare, with two senior partners sticking around only to support the existing lineup. The retreat from the therapeutics field is simple, say principals with the fund. It takes too much time and money to win an FDA approval, and the numbers just no longer work. So now Lou Brock and Mark Brooks will remain focused on their existing investments, with added money available for follow-on rounds. "Our portfolio has had seven NDA submissions since 2008, with five approved and two still pending," Scale's Kate Mitchell tells Fortune. "That should be a success, except it has taken twice as long to get there as it used to five or six years ago. The math with the FDA just doesn't work anymore for us in terms of a venture fund lifecycle ... It's incredibly frustrating to watch this happen, particularly to people like Mark and Lou who have really good investing acumen." That sentiment is likely to resonate with the rest of the venture crowd involved in biotech. As third quarter investment numbers softened, several pinned the blame on the FDA. Scale's current portfolio is rather small, including Alimera ($ALIM), Ascenta and Sonexa. - here's the story from Fortune Related Articles:
PwC: Life Science VC funding dips in Q3 2011
Fresh signs that VC deal, dollar flow is shrinking for biotech
Venture rounds shrivel as "bipolar" investors turn cautious Read more about: Biotech Venture Capital, Venture Capital fund
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Also Noted | This week's sponsor is Novella Clinical Resourcing. |  | Your goal is to enable people to enjoy life's special moments, and we're proud to join you in your pursuit. Our promise is to match your clinical trial specifics with resourcing insight and strategy that moves your program's potential forward. See how at novelladreamteam.com |
SPOTLIGHT ON... China's biggest biotech plots $2B IPO Citing sources, Bloomberg is reporting that China National Biotec is planning a $2 billion IPO. The company is ranked as the largest biotech in China and the fourth largest vaccine-maker in the world. If all goes according to plan, the company's shares will start trading next year. Report  @FierceBiotech: Blockbuster breakup: Amylin buys out Lilly's exenatide rights in $1.6B deal. News | Follow @FierceBiotech
@JohnCFierce: Key AZ/Targacept depression drug flunks first Phase III test. Item | Follow @JohnCFierce
@RyanMFierce: Medidata (SaaS clinical trials software) reports profits up in 3Q, 33 new customers, $MDSO up 2.04%. Release | Follow @RyanMFierce
@MaureenFierce: Nabi will explore strategic options after its anti-smoking vaccine NicVAX failed in a second Phase III trial. Article | Follow @MaureenFierce > Shares of BioCryst Pharmaceuticals surged on positive mid-stage results for its experimental gout therapy. The results set the stage for a Phase III program. Report > IDEXX Laboratories has struck a deal to buy a research and diagnostic lab business from the University of Missouri for $43 million. Report > NeurogesX announced positive top-line results from its Phase II clinical study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia. Release > Insmed reported that the clinical hold on its late-stage lung drug spurred a bigger-than-expected loss for the last quarter. Story Pharma News @FiercePharma: Integrating Cephalon, Teva eyes up to 1,500 job cuts. News | Follow @FiercePharma > Key antidepressant from AZ/Targacept fails trial. Report > AZ launches Crestor co-pay card to battle. Story > Lipitor copies Amid FCPA probe, AZ indicted in Serbia for bribery. Article Biotech Research News > Eliminating 'senescent' cells in mice delayed age-related ailments. News > Stem cell therapy for Parkinson's works wells in two animal models. Story > Scripps breakthrough unlocks the potential of a promising cancer drug class. More Manufacturing News > Plant check reveals Genentech report flaw repeat. Article > Pharma recalls up 54% in Q3. Item > MedImmune cell-culture plant named facility of the year. Story And Finally... Investigators at three sites in the U.S. are studying an experimental retroviral gene therapy from Tocagen for glioblastomas. Story > Getting the most out of First-in-Human and Early Clinical Trials - Nov 15, 2pm ET / 11am PT In a follow-up to our webinar last month on first-in-human drug studies, FierceBiotech editor, John Carroll is hosting a second discussion on the increasing complexity of first-in-human/early clinical pharmacology studies. Three trial experts will present real-life case studies of trials that went well beyond the standard safety and PK assessments in typical FIH studies is recommended. Register now.
| > BioImmersion Course - Nov 9-11 - Chicago, IL Understand the key science, applications and terminology in your industry. This three-day course delivers an in-depth understanding of both fundamental and advanced biotechnology concepts used in both biotech and pharma companies. View Agenda. Register today! > Life Science in the Cloud - Nov 16, 2011 - Cambridge, MA Join Accelerys, Appistry, BiogenIdec, Linguamatics, Novartis and Pubget to network and explore cloud computing from those that have been there. http://lifesciencecloud.eventbrite.com/ #lifescicloud11 > Just Released: New Trends in Preventive and Therapeutic Vaccine This new Insight Pharma Report analyzes current R&D activities and commercial prospects for vaccines. Sectors covered include bacterial infections; viral infections including hepatitis, HIV, influenza, and others; autoimmune diseases, cancer, and many more. For more info, www.insightpharmareports.com > 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 > Pharmacovigilance and Risk Management Strategies 2012 - January 22-25, 2012 - Arlington, Virginia Get New Insights into the Current Issues and Associated Challenges Impacting Drug Safety. Join top pharmaceutical, biotech, and regulatory representatives to discuss the new and updated legislation in various ICH regions, important new harmonization initiatives, life cycle management, the impact of social media, biosimilars, and the use of other data sources and observational research, and much more! Register today and SAVE $200! > 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.
| > Fierce Special Report: Cloud Primer for Life Sciences Execs Our newest report highlights the growth of cloud service IT applications while providing examples of cost savings and efficiency gains that suggest the cloud is gaining traction in the life sciences industry. Download for free today! > Biomarkers: Lab to Clinic. An eBook from FierceBiotech Don't miss this in-depth look at biomarkers. What role do they play in clinical trials? How do they factor into the diagnosis of diseases such as Alzheimer's? What role does the FDA play in creating guidelines for biomarkers? Get the answers to these questions and more when you download this free eBook.
| > Manager, Strategic Forecasting & Analytics – 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 a BS/BA and 5 to 7 years financial and/or forecasting experience (pharmaceutical/biotechnology industry experience required). This position will provide ongoing forecasting and long-range analytical support for the Americas Hematology/Oncology business and will participate on cross-functional teams....Learn more. > Hematology Oncology Consultant, Hematology – Louisiana, LA – 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 a Bachelor's degree in Business or Science; minimum of 5 years' sales experience in the pharmaceutical/biotechnology industry with two years Oncology experience preferred. This position will be responsible for achieving all territory sales goals through the promotion, sale, and support of company products or services in his/her geographic territory. The territory includes Baton Rouge, Louisiana to Shreveport and Monroe, Louisiana (must live in territory)...Learn more. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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