| This week's sponsor is Rules-Based Medicine. |  |
Today's Top Stories
1. Seattle Genetics drug gets FDA panel nod for Hodgkin patients
2. Dendreon, cancer drug developers top slate of buyout candidates
3. Verastem snags $32M for drugs against cancer stem cells
4. Bristol-Myers grabs EU approval of key melanoma drug
5. DVS Sciences lands $14.6M round with Big Pharma support Also Noted: Novella Clinical
Spotlight On... FDA makes management changes
EMD Serono has new president; Endocyte boosted by prospects of ovarian cancer therapy; and much more... More Fierce Life Sciences News:
1. Expect more pharma M&A, less pharma hiring
2. The CIA, bin Laden and the future of vaccine programs
3. Shingles vaccination levels fall short of expectations
Today's Top News 1. Seattle Genetics drug gets FDA panel nod for Hodgkin patients
Seattle Genetics ($SGEN) had a good morning. An FDA panel of experts voted 10-0 for accelerated approval of the developer's drug brentuximab vedotin (Adcetris) for patients with a rare form of blood cancer called Hodgkin lymphoma, The Street's Adam Feuerstein reports. This afternoon the panel is expected to discuss the question of whether the treatment should be approved for another type of blood cancer called anaplastic large cell lymphoma. (As always, check back here at FierceBiotech for updates.) The FDA advisory committee's vote this morning followed what many industry watchers viewed as a mixed agency staff review of Seattle Genetics' application for approval of the drug for the two forms of blood cancer, in which questions were raised about whether the relatively small, single-arm trials that the company has completed to date show enough data of the drug's benefits. With the panel experts backing Adcetris, at least in Hodgkin patients, a lingering question is whether Seattle Genetics will gain full approval of the drug from the FDA or a form of approval that would require studies to confirm that the drug works and is safe in patients. Still, the company seems well on its way to grabbing its first approval. Its drug could also become the first marketed antibody-drug conjugate, which combines the selective binding capabilities of an antibody with the cancer-killing effects of a chemotherapy agent. The FDA, of course, will take the recommendations from the advisory committee into account in its decision on approval expected later this summer. We'll update this story later today with more developments at the FDA panel. - check out Feuerstein's coverage
- see the report from Reuters Related Articles:
Seattle Genetics takes step closer with FDA review of lymphoma drug
SGN-35 - 10 promising late-stage cancer drugs
Seattle Genetics ($SGEN) plots FDA app on promising PhIII cancer data Read more about: FDA, Seattle Genetics, Hodgkin's lymphoma, brentuximab vedotin
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 | An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist - Tuesday, July 26th, 1 pm ET / 10 am PT
Join us as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process.
Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more Register today. |
2. Dendreon, cancer drug developers top slate of buyout candidates
This summer's been somewhat tame on the biotech mergers front. It's lacked a blockbuster deal on par with Sanofi's buyout of Genzyme, reports of which began last summer and kept biotech reporters chasing to tidbits of news for months. Now industry watchers tell Reuters that cancer drug firms like Dendreon ($DNDN), Seattle Genetics ($SGEN) and Exelixis ($EXEL) are top candidates for buyouts. Dendreon is perhaps the most obvious biotech in the crop developers that could get scooped up in the near future, given that it's already got a drug on the market in Provenge, a immunotherapy against prostate cancer that costs a whopping $93,000 a year. Morningstar analyst Damien Conover told the news service that Dendreon could have an immediate impact on the bottom line of an acquirer, making it that much more attractive compared with companies without drugs on the market. To be clear, none of these companies is at all likely to fetch $20 billion like Genzyme or anything close to that sizable sum. But there are some interesting dynamics occurring in the cancer drug game and pharmaceutical business worth highlighting. For instance, the growth of the oncology drug market is expected to be double that of the rest of the pharmaceutical business, according to IMS Health data cited by Reuters. And companies like Bristol-Myers Squibb ($BMY) and others are seeing their buyout bets on cancer drug developers paying off as drugs like melanoma treatment Yervoy gain approvals this year. We have seen some very successful oncology drugs," Fariba Ghodsian, chief investment officer at hedge fund DAFNA Capital, told Reuters. "Novel drugs with novel targets are in demand." Analysts also talked up the prospects of a buyout of biotech giant Biogen Idec ($BIIB), which offers an acquirer a lot because of its large pipeline and top-selling multiple sclerosis therapies. If a Big Pharma were to make an offer for Biogen soon, what has been a quiet summer for major buyouts could become a lot more interesting. - read the Reuters article Related Articles:
Successful biotechs try to fend off Big Pharma
Fresh signs of a biotech buyout blast in 2011
Pioneering Dendreon CSO ponders biotech's innovation challenge Read more about: Dendreon, Provenge, Prostate Cancer, Exelixis
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3. Verastem snags $32M for drugs against cancer stem cells
The young field of cancer stem cells has some new financial firepower behind it. Start-up Verastem has closed a $32 million Series B round of financing with plans to advance its first drug against cancer stem cells into the clinic next year. The deal comes about a month after former Genzyme chief Henri Termeer joined the start-up's board and less than a year after its founders from MIT and the Boston-area biotech scene unveiled the firm with a $16 million first round. Now the Cambridge, MA-based firm has brought on new investors Advanced Technology Ventures and Astellas Venture Management--the venture arm of the Japan-based drug maker Astellas Pharma--to lead its second-round financing, which also includes previous backers Longwood Founders Fund, Bessemer Venture Partners, Cardinal Partners and MPM Capital. Cancer stem cells, which are believed to cause tumors to surge back after treatment and spread to other organs in the body, have been discussed as targets for new drugs for years. Verastem has a system for screening compounds with the potential to home in on and destroy cancer stem cells, and it has the backing of biotech veterans and co-founders such as Christoph Westphal, Michelle Dipp and Rich Aldrich-who sold their last company, Sirtris, to GlaxoSmithKline ($GSK) for $720 million in 2008. They are now partners at one of Verastem's venture backers, Longwood. "Targeting cancer stem cells via the epithelial-to-mesenchymal transition, or EMT, has the potential to transform the treatment paradigm for certain serious cancers, such as triple negative breast cancer," MIT biology Prof. Robert Weinberg, a Verastem co-founder and top scientific advisor, said. - here's the company's release Related Article:
Westphal VC group backs a cancer stem cell startup Read more about: Biotech Venture Capital, Verastem, cancer stem cells, Henri Termeer
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4. Bristol-Myers grabs EU approval of key melanoma drug
As expected, the European Commission has approved Bristol-Myers Squibb's ($BMY) immunotherapy called Yervoy (ipilimumab) for melanoma that spreads to internal organs. And the company's European chief says that more collaborations like the one that brought the firm Yervoy are in the offing. The commission approved Yervoy, which was previously available to some 3,000 patients in Europe under a compassionate use program, for patients who have been previously treated for the deadly skin cancer. The drug was approved in the U.S. back in March and has been celebrated for being the first treatment to extend the lives of patients with advanced melanoma. Bristol-Myers gained control of the therapy through its acquisition of its collaborator Medarex, the developer of Yervoy. The pharma has since partnered with cancer drug powerhouse Roche on the melanoma drug, and its executives aim to keep the collaborations coming as part of its strategy to provide new treatments against tumors. Indeed, companies are banding together on the business side as cancer treatment on the clinical end of the spectrum moves toward use of more combination therapies. "We will continue this strategy to seek and establish collaborations with other leading innovators across the globe," Ron Cooper, president of Bristol-Myers Squibb Europe, said. "Through these and other initiatives we work towards our single mission: to discover, develop and deliver innovative medicines that help patients prevail over serious diseases." - here's the BMS release
- check out Reuters' coverage
- see the report in the Wall Street Journal (sub. req.) Related Articles:
BMS, Roche join forces and drugs on combo melanoma program
Roche, GSK melanoma drugs in ASCO's "hottest" spotlight
FDA hands Bristol a blockbuster approval for breakthrough cancer drug Read more about: Roche, Bristol-Myers Squibb, EMEA Approval, Melanoma
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5. DVS Sciences lands $14.6M round with Big Pharma support
Big names in life sciences are backing DVS Sciences in a $14.6 million Series A round. With biomarker analysis technology for personalized medicine, the start-up has garnered investments from the investment vehicles of drug giants Pfizer ($PFE) and Roche as well as the venture firms 5AM Ventures and Mohr Davidow Ventures. 5AM led the round. DVS plans to use its cash infusion to commercialize its system that is similar in concept to a flow cytometer and can identify up to 100 biomarkers at a time. The system, which was developed with seed money from the Ontario Institute for Cancer Research, will be used for scientific research as well as clinical trials in which researchers aim to match patients with appropriate drugs based on biomarker analyses. Cancer drug development is expected to be a key area for the system. The company has its corporate headquarters in Sunnyvale, CA, and its manufacturing and research operations in Canada. "This financing is the first step in our transformation from a research-based entity to a commercial company," Scott Tanner, DVS Sciences' president, said. "We are now in a position to commercialize our innovative instrumentation and reagents that will foster the acceleration of medical research, enable personalized therapeutic diagnosis and prognosis, and transform drug discovery." Life sciences investors have had some success investing in flow cytometer technology as of late, with scientific tools giant Becton Dickinson's ($BDX) buyout of venture-backed Accuri Cytometers in Ann Arbor, MI, earlier this year. Given the potential applications of DVS Systems' technology in personalized medicine, perhaps it's no surprise to see Pfizer and Roche--two Big Pharma players with huge stakes in this field--making bets on the company through their respective investment arms. - here's DVS Sciences' release Read more about: biomarkers, Biotech Venture Capital, DVS Sciences
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Also Noted | This week's sponsor is Novella Clinical. |  | Your goal is to give people more opportunities to enjoy life's little moments. We’re proud to be a part of your mission, and promise to give you the individual attention you deserve, with therapeutic and in-country expertise to help reach your goal.
www.novellaclinical.com/bd |
SPOTLIGHT ON... FDA makes management changes Former Dartmouth Medical School dean Stephen Spielberg has been named the deputy commissioner for medical products and tobacco, a newly-created position at the FDA. In a letter, Commissioner Margaret Hamburg said the reorganization "more accurately reflect the agency's responsibilities, subject matter expertise and mandates in an ever more complex world, where products and services do not fit into a single category." Spielberg will oversee for drugs, medical devices, biological products and tobacco. Additionally, current CDER Office of Compliance director Deborah Autor will become Deputy Commissioner for Global Regulatory Operations and Policy. She'll be tasked with addressing global regulatory issues. Article | Report  @FierceBiotech: J&J's success with Hep C partners might hit a snag. Story | Follow @FierceBiotech
> Impax Pharmaceuticals, division of Impax Laboratories ($IPXL), says that it has received $400,000 from The Michael J. Fox Foundation to continue developing IPX066, an extended release carbidopa-levodopa for patients with Parkinson's disease. Release > Seeking Alpha has a story about how cancer drug developer Endocyte ($ECYT) has made strides with its stock price since its IPO in February, boosted by the prospects of its experimental treatment for advanced ovarian cancer. Report > Inovio Pharmaceuticals ($INO) said today that it has seen "significant" immune responses in an initial clinical trial of its DNA vaccine called VGX-3400X for avian H5N1 influenza. Item > James Hoyes has been named president of EMD Serono, the U.S. affiliate of German pharmaceutical maker Merck KGaA. He will also be a member of the executive management board of Merck Serono. Announcement > Regeneron ($REGN) financial chief Murray Goldberg told Xconomy's Arlene Weintraub that collaborations with companies like French drug giant Sanofi ($SNY) have put the company in the "top tier" in drug R&D. Article @FiercePharma: Note to Pfizer: Bayer shopping for vet buys. Article | Follow @FiercePharma > Merck job cuts set to accelerate. Item > Expect more pharma M&A, less pharma hiring. Report > Yervoy may help BMS survive European squeeze. More > FDA taps Dartmouth ex-dean for new post. Story > French minister overhauls pharma regs. Article Manufacturing News > Indian pharmas seek to protect their edge Report > Corpedia, Second City bring comedy to compliance training. Item > Hamburg appoints FDA deputies; Spielberg oversees drugs. Report > GSK's Witty: West can compete in manufacturing. Story > Pew track/trace call highlights congressional dallying. News > Expert: Boost audit programs to keep up with outsourcing More Vaccines News > With Gates Foundation backing, Liquidia advances novel flu vaccine. Item > Shingles vaccination levels fall short of expectations. Report > Crucell and Scripps find antibody for universal flu vax. News > The CIA, bin Laden and the future of vaccine programs. Story > GSK gets Boostrix approval for adults over 65. Article > Microneedles may be better for H1N1 delivery. More > An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist Join us Tuesday, July 26th, 1 pm ET / 10 am PT as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process. Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more. Register Today
| > Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR The world's leading clinical drug development and outsourcing event returns to Latin America for its 2nd Annual Partnerships in Clinical Trials Latin America meeting- bringing its unique formats, high-level strategic discussions, and unparalleled networking to Sao Paulo, Brazil. Visit www.PCTLA.com. > Rutgers Mini MBA: BioPharma Innovation Program > Skill-building and Summer Fun in Boston! Boston offers exciting summer options for visitors of all ages. You could see a movie in the local park, listen to a concert on City Hall Plaza, or learn to paint on the waterfront. So why not explore Boston in August and build your professional skills at the same time? > Online Pharmaceutical & Healthcare Marketing MBA for Executives Saint Joseph's University offers an expanded portfolio of globally accessible AACSB-accredited programs ideal for working professionals in the pharma, biotech, medical device, diagnostics and healthcare sectors. Apply now; our September Cohort begins 9/8. Visit sju.edu/epharma or call 800-SJU-EMBA. > Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA Led by Pfizer and Novartis, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA Keynoted by Dr Robert Langer of MIT, this is a strategic level event for pharma and biotech BD&L executives to meet a wide range of drug delivery companies with the latest technologies. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > BIO China 2011 - October 12-13 - Shanghai, China Organized by the Biotechnology Industry Organization (BIO) and Shanghai Zhangjiang Hi-Tech Park (Z-Park), BIO China will bring together executives from biotechnology, pharmaceutical companies and investment firms from North America, Europe and Asia to meet and explore business opportunities with China's emerging biotech sector. Registration Now Open.
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| > Regional BD Director We are considering candidates for a Regional Business Development (BD) Director to join our BD team! The ideal candidate should have specific experience calling on and selling into the R&D and clinical development/operations and study start up side of the industry, including but not limited to Phase I-IIIB as well as Phase IV post marketing surveillance, outcomes research and patient registry programs. Learn more. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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