 | Webinar: Getting the most out of First-in-Human and Early Clinical Trials - Nov 15, 2pm ET / 11am PT - LAST CHANCE TO REGISTER
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.
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Today's Top Stories
1. Lundbeck makes $200M down payment in blockbuster CNS drug pact with Otsuka
2. GSK stakes $50M Canadian investment fund, betting on early-stage research
3. Cancer vax developer NewLink Genetics' IPO nets $43.4M
4. Verastem papers $20M C round amid IPO pursuit
5. Blockbuster market awaits developers of antibodies against heart attacks Editor's Corner: J&J seeds an ambitious open R&D program for neuroscience Also Noted: Novella Clinical Resourcing
Spotlight On... Resveratrol boosts metabolic function in human study
FDA denies Alimera eye drug; Napo Pharma ends Salix collaboration; and much more... More Fierce Life Sciences News:
1. Stryker to cut 5% of workforce
2. Analysts handicap Ranbaxy's Lipitor copycat
3. Teva: 'Too early' to say whether merger triggers job cuts
| This week's sponsor is Clinipace. |  | Game Plan for Therapeutic Cancer Vaccines
Free Webcast hosted by Clinipace Worldwide on December 6th at 2pm ET
Join Clinipace as we discuss the importance of having the right regulatory and clinical development strategies for success in pioneering novel therapeutics. Register today! |
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J&J seeds an ambitious open R&D program for neuroscience
 | | J&J neuroscience R&D chief Dr. Husseini Manji | Just how far can you go with an open R&D approach to drug development? Johnson & Johnson ($JNJ) is stepping up with $3 million to seed a new program that intends to find out. J&J has set up a group called Healthy Minds, which will assist the International Mental Health Research Organization in setting up a collaborative effort on neuroscience drug programs. Faced with some Herculean R&D tasks, the campaign for a collaborative research approach to brain disorders will set out to marshal forces from Big Pharma, biotech, academia and government agencies on both sides of the Atlantic, testing the limits of the new "open innovation" movement in drug development. It's a simple marriage of necessity and opportunity, explains Husseini Manji, M.D., the global head of neuroscience R&D for the pharma giant. Given the myriad advances on the genetics involved in neuroscience, there's plenty to be done. And with some big developers pulling out of the complex field after spending too much with too little to show for it, there's a big need to work together to crack some of the puzzlers that all researchers face. Three million dollars isn't much in the drug research world. But J&J's Janssen group is just priming the pump here, looking for others to jump in a project that will attempt to tackle some big tasks and test the limits of open collaboration in an industry where leaving IP unprotected by patents is considered a cardinal sin. "We're the first ones getting this going," says Manji, who's expecting other groups--in particular U.S. agencies like the Department of Defense and the NIH--to start adding cash and resources. Read the full article on FierceBiotech.com >> Read more about: Johnson & Johnson, neuroscience
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| Sponsor: PPD FierceLive! Webinars > Getting the most out of First-in-Human and Early Clinical Trials - Nov 15, 2pm ET / 11am PT
Events > Life Science in the Cloud - Nov 16, 2011 - Cambridge, MA
> Just Released: New Trends in Preventive and Therapeutic Vaccine
> CBI's 2nd CT Budgeting and PM Forum - Dec 6-7 - San Francisco, CA
> CMAC 2011 - December 6-7, 2011 - Philadelphia, PA
> New Paradigms to Fund & Move Biotech - January 11-12, 2012 - San Francisco, CA
> Pharmacovigilance and Risk Management Strategies 2012 - January 22-25, 2012 - Arlington, Virginia
> Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL
Marketplace > Fierce Special Report: Cloud Primer for Life Sciences Execs
> Biomarkers: Lab to Clinic. An eBook from FierceBiotech
> Digital Health Technology: A Guide to Medtech's Biggest New Player
Jobs > Manager, Strategic Forecasting & Analytics – NJ – Celgene Corporation
> Hematology Oncology Consultant, Hematology – Louisiana, LA – Celgene Corporation
> Director, Operations - San Francisco, CA - Fluidigm
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* General ad info: Click here | Today's Top News 1. Lundbeck makes $200M down payment in blockbuster CNS drug pact with Otsuka
Danish drugmaker Lundbeck and Japanese drug giant Otsuka have joined forces for a pact that makes the two companies major partners in the global market for drugs against diseases of the central nervous system. Both companies now have a lot riding on developmental CNS drugs in the deal as each company's best-selling drugs face generic competition in the coming years. The top drug in the new pact, which covers up to five compounds, is Otsuka's long-lasting version of the blockbuster anti-psychotic drug Abilify. The once-monthly Abilify (dubbed aripiprazole depot formulation) is in late-stage development for schizophrenia. Otsuka, Japan's second-largest drugmaker, has also made part of the pact its candidate OPC-34712, which is in Phase III development for schizophrenia and as an adjunct for treating major depression. Lundbeck is contributing three earlier-stage candidates to the collaboration. Lundbeck has agreed to pay Otsuka $200 million upfront and up to $1.4 billion in development and regulatory fees in the deal. Lundbeck is obviously footing most of the bill for the collaboration with Otsuka, and for good reason. Exclusivity on the company's lead drug, the antidepressant Lexapro (partnered with Forest Labs), expires in March, opening the gates for generics that are expected to take over part of the market for the drug with their knockoff versions. If the long-lasting Abilify comes through trials and regulatory reviews as hoped, Lundbeck stands to get half of the sales of the new treatment in Europe and Canada as well as a fifth of the sales in the U.S. Lundbeck aims to bring in total sales of up to $9.1 billion from drugs involved in the deal, Reuters reported. "We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialization agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka's CNS business," Dr. Taro Iwamoto, Otsuka Pharmaceutical's president and representative director, said in a statement. "Lundbeck's expertise in developing depression and anxiety treatments and Otsuka's expertise in developing anti-psychotics will maximize the medical and commercial value of Otsuka's portfolio in CNS." "With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with an exciting and unique potential treatment in an area of high unmet need," Lundbeck CEO Ulf Wiinberg said in statement. "This collaboration allows us to be introduced to the U.S. psychiatry community as soon as 2013." - here's the release
- see the Reuters article
- and WSJ's coverage
Related Articles:
Proximagen polishes its CNS rep with $16M Lundbeck deal
Otsuka plots $2.8B IPO Read more about: Lundbeck, Otsuka
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2. GSK stakes $50M Canadian investment fund, betting on early-stage research
GlaxoSmithKline ($GSK) wants to do its part to make sure Canada's biotech scene remains vital as drug developers struggle to find capital for early-stage research. The London-based drug giant plans to pump $50 million into the GSK Canada Life Sciences Innovation Fund, which will be supported by the company's group based in the country as well as its venture capital arm, SR One. With so many stakeholders in the biotech field in need of funding, GSK appears to be spreading its bets widely with its new fund. The fund will funnel dollars into academic groups working on important science, translational research and startups aiming to commercialize products, according to the company. In addition to writing checks for programs, the company hopes that recipients will benefit from its hefty R&D experience. GSK and many of its peers in Big Pharma have stepped up their roles in funding early-stage research in recent years as traditional sources of backing for biotech groups have come up short. The lack of funding for new ideas has been a cause of concern among pharma executives eyeing the future growth of their industry and entrepreneurs wanting to get projects off the ground. Yet GSK has been in the venture business for decades, with the formation of SR One in 1985 and the venture unit's more than $600 million in investments into biotech firms. The group appears to have more experience backing U.S. and European biotechs than companies in other countries, yet that seems reasonable as the U.S. and Europe have mature life sciences sectors. "Canada has a significant innovation gap and a big part of the issue is our ability to commercialize the research taking place in our Universities and research centres," Paul Lucas, chief executive of GSK's Canadian division, said in an interview with the Financial Post in Toronto. "One of the fundamental underlying problems is the availability of risk capital and I really believe this is going to be very important to Canada in advancing its whole life sciences strategy by providing that risk capital to move this commercialization effort along." - here's the release
- see the Financial Post article
- and the Reuters update
Related Articles:
Struggling Canadian biotechs urged to look south for cash
Survey: Canada needs to reinvest in life sciences
Glaxo R&D chief Slaoui outlines his formula for success Read more about: GlaxoSmithKline, Canada, SR One
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3. Cancer vax developer NewLink Genetics' IPO nets $43.4M
It's worth letting out a "hooray" when a biotech does an initial public offering. NewLink Genetics, a cancer vaccine developer, made its public debut today, raising about $43.4 million through the sale of 6.2 million shares for $7 a pop, according to an Associated Press report. The company is now trading under the symbol "NLNK." Like a lot of biotechs that go public, Ames, IA-based NewLink had to lower its offering price to get the deal done. The company, which announced initial plans for the offering in December, said last month that it was looking to sell 5.5 million shares with a price range of $10 to $12. With the money it raised in the IPO, the biotech plans to advance its late-stage candidate called HyperAcute Pancreas, which is a therapeutic vaccine intended to spur immune system attacks against pancreatic cancer. While therapeutic vaccines offer relatively new ways to combat cancer by harnessing immune responses to fight tumors, the first commercial mover in this field, Dendreon ($DNDN) has faced an uphill battle getting doctors to prescribe its $93,000 prostate cancer vaccine Provenge. The high expense of making the drug has also played a role in the profitability of the business. NewLink might face similar challenges as its pancreatic cancer vaccine advances, yet the drug first must be proven in the ongoing Phase III trial. NewLink previously announced plans to recruit 700 patients with stage I and stage II pancreatic cancer into its Phase III study, targeting full enrollment in the trial in 2013. The FDA has granted fast-track and orphan status for the therapy, which is being tested for use to wipe out cancer cells after surgeries to remove tumors. - see the Wall Street Journal's coverage
- check out the AP story
- and the update from RTTNews
- here's the firm's latest SEC filing Special Report: HyperAcute Pancreas - Biotech's 5 key attacks on pancreatic cancer
Related Articles:
NewLink looks to IPO for $66M to back cancer vaccine
NewLink nails $7.5M round Read more about: pancreatic cancer, cancer vaccine, Biotech IPO, NewLink Genetics
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4. Verastem papers $20M C round amid IPO pursuit
Verastem won't go hungry during its unlikely hunt for an initial public offering. The Cambridge, MA-based biotech, which is researching drugs that target cancer stem cells, has filed paperwork for a $20.1 million Series C round of financing this week, according to an SEC document. Without a single drug in the clinic, Verastem surprised biotech industry watchers last week with a seemingly bold plan to raise $50 million in an IPO. It's still unclear how public investors will react to the IPO plans, but one thing is clear: The upstart has raised about $68 million in three rounds of financing in less than two years. The Series C round was first disclosed in the company's filing for the IPO last week, but the deal is generating buzz today after pubs caught wind of it through a separate filing that appeared on the SEC website Nov. 10. But to be clear, this round was raised before the firm revealed the IPO plans. Christoph Westphal, the chairman and CEO of Verastem, has a track record for raising lots of cash for biotechs and taking them public. For example, he did the same at Sirtris, a developer of drugs against diseases of aging, before GlaxoSmithKline ($GSK) scooped up the developer for $720 million in 2008. Sirtris' science has been heavily criticized after some research groups failed to replicate some of the early findings about the benefits of resveratrol on which the company was founded. With researchers continuing to scrutinize the benefits of the natural chemical, Westphal and his new team at Verastem have been building a case for the new company Verastem. The company is pursuing drugs that target cancer stem cells, which are suspected culprits in enabling cancer to survive after treatments and spread to other organs, according to a report in Xconomy. Even biotechs with drugs in late-stage trials have struggled to become publicly traded. Many people are watching to see whether Verastem, which is still doing preclinical work, can buck the trend and pull off an IPO. - check out Xconomy's report
- and one from Mass High Tech
- see the SEC filing Related Articles:
Upstart Verastem challenges Wall Street with puzzling $50M IPO
Verastem snags $32M for drugs against cancer stem cells
Westphal VC group backs a cancer stem cell startup Read more about: GlaxoSmithKline, Biotech IPO, Christoph Westphal, Verastem
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5. Blockbuster market awaits developers of antibodies against heart attacks
Sanofi ($SNY) and Regeneron ($REGN) made headlines yesterday for compelling results of their antibody drug for lowering bad cholesterol, potentially reducing the risk of heart attacks. And Bloomberg's Robert Langreth today gets the pulse of a host of major drug developers' programs focused on experimental antibodies that target a gene that, when mutated, is linked with dramatic drops in heart-attack risk. Amgen ($AMGN) is very much in the race with its candidate AMG 145, another antibody targeting PCSK9. The Thousand Oaks, CA-based biotech giant is slated to present data from early human studies of the drug next week at the American Heart Association meeting, Bloomberg reports. Amgen R&D chief Roger Perlmutter told the news service that at least 4 million people could benefit from the drugs. Some patients can't tolerate traditional cholesterol pills such as Pfizer's Lipitor, for instance, and shots of the antibody treatments could help lower the LDL or "bad" cholesterol that endangers such people. The treatments are based on findings that a mutation to the PCSK9 gene lowers output of proteins that reduce the ability of the liver to filter bad cholesterol from the blood, Langreth wrote. So lowering the protein levels has been linked to steep drops in cholesterol levels. Exploiting this research with drugs could make fortunes for companies developing PCSK9-targeted drugs. "It is the biggest opportunity for lowering cardiovascular risk for the entire pharmaceutical industry," Perlmutter told Bloomberg. "Millions of people could benefit from this." - get more in the article Special Report: Regeneron Pharmaceuticals - Biotech's Biggest Spenders 2011 Related Article:
Sanofi drug packs anti-cholesterol punch in Ph2 trials Read more about: Amgen, cholesterol drug, Regeneron Pharmaceuticals, AMG 145
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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... Resveratrol boosts metabolic function in human study There's fresh batch of data on the anti-aging chemical resveratrol for scientists to puzzle over. In an 11-person, double-blind study, researchers in the Netherlands and Switzerland found that some metabolic benefits were seen in the obese subjects who took the chemical, which is found in red wine grapes and other natural sources. Blogger Derek Lowe reviewed the results, which follow controversy over wowing data from tests of the chemical in early lab studies that couldn't be replicated in subsequent experiments. Post  @FierceBiotech: We have another new Fierce addition! Please say hello to @MarkHfierce, who will be covering drug delivery, biotech research and more. News | Follow @FierceBiotech
@JohnCFierce: So Verastem has now raised $68M in VC cash; spent $8.5M and wants a $50M IPO. Sure. Article | Follow @JohnCFierce @RyanMFierce: After what's happened at $DNDN, folks will look very carefully at next crop of cancer vax developers like NewLink. | Follow @RyanMFierce @MaureenFierce: Reading: Resveratrol in humans: Results of a controlled trial. Blog entry | Follow @MaureenFierce > The FDA has opted to not approve Alimera's ($ALIM) application for its eye drug Iluvien for treating diabetic macular edema. News of the agency's Complete Response Letter prompted a selloff of Alimera stock and that of pSivida ($PSDV), which provides the drug delivery tech for the experimental eye drug. Alimera release > Napo Pharmaceuticals said that it has nixed its collaboration agreement with Salix Pharmaceuticals related to Napo's developmental diarrhea candidate crofelemer. Item > Venture capitalist Bruce Booth gives his take on the facts and fictions associated with "virtual biotechs," which has been favored as a limber model for advancing drugs. Blog post > New York Blood Center has garnered the first FDA approval for its hematopoietic progenitor cells-cord cell therapy used in the treatment of cancer patients. Update > Affymax has received $13 million in its settlement with Janssen Biotech related to a patent on peginesatide. Report > Florida's Vaccine and Gene Therapy Institute (VGTI) has spun off a new upstart called TomegaVax to advance vaccines technology that could be useful in providing new attacks against HIV, tuberculosis and hepatitis C. Interview Pharma News @FiercePharma: Are the best times for Big Pharma in China already over? Or will volume make up for new price cuts? Bloomberg: Article | Follow @FiercePharma > Analysts handicap Ranbaxy's Lipitor copycat. Report > Less cash, more promises in pay-to-delay deals. Story > Teva: 'Too early' to say whether merger triggers job cuts. Report > IntelGenx antidepressant gets FDA nod, but no launch yet. Item > Aggressive pricing tarnishes China's promise to pharma. News > Doxil shortage drags on, with J&J exec citing 'limited options.' Story And Finally... We salute our nation's military veterans today. Thank you for your sacrifices. > 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.
| > 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 > CBI's 2nd CT Budgeting and PM Forum - Dec 6-7 - San Francisco, CA Clinical Finance & PM Professionals: Find the balance between timeline, budget & quality management. Network, earn CPEs and hear from Arno Therapeutics, AVI BioPharma, Fibrogen, Genentech, Halozyme, Medtronic and more. Register by 11/18 to save $400 with code CTBPMW - www.cbinet.com/budgeting > CMAC 2011 - December 6-7, 2011 - Philadelphia, PA Wanted: A commercially successful product. Found: CBI's Commercialization and Market Access Congress. CMAC delivers pre and post-launch strategies, customized programming and extensive coverage of market access trends. Register at www.cbinet.com/cmac2011 by 11/18 and save $400 with code CMACFM > 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. > Digital Health Technology: A Guide to Medtech's Biggest New Player Are you up to date on the latest in digital health technology? Let Elsevier Business Intelligence guide you in navigating this growing field. This report covers new technology and policies that could affect your bottom line. Learn more at http://pages.elsevierbi.net/digitalhealth/
| > 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. > Director, Operations - San Francisco, CA - Fluidigm Directly reporting to the VP of Manufacturing, the Operations 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 Operations 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. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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