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August 9, 2010

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Today's Top Stories
1. Did the odds just get worse for Arena's new weight drug?
2. What is Genzyme CEO's 'magic' number?
3. Senators advocate blockbuster remedy for rare drug woes
4. Curis shares sink as Genentech evaluates lead drug's fate
5. FDA staffers weighs risks, rewards of new epilepsy drug

Also Noted: Spotlight On... Lambda snags Biovail's Toronto CRO
DUSA shutters cancer trial on FDA orphan drug refusal; Osteotech explores alternatives; and much more...

More Fierce Life Sciences News
1. Mayo Clinic to launch center for social media
2. Healthcare reform drives biotech VCs to IT opportunities
3. FDA scolds Dendreon on Provenge marketing
More headlines...


Sponsor: Tableau

FierceLive! Webinars

> Metrics to Understand Your Brand and Help It Thrive - August 18th, 2 pm ET / 11 am PT

Events

> Pharmaceutical Strategic Alliances 2010 - Sept 21-23 - New York City
> BIO India International Partnering Conference - Sept. 21-22, 2010 - Hyderabad, India
> Life Sciences Summit 2010
> Windhover's PharmAsia Summit 2010 - Oct 25-26 - San Francisco
> Tomorrow's Project Manager: Evolving Competencies for Biopharmaceutical Professionals - October 26 - 27 - Bethesda, MD
> Windhover's Therapeutic Area Partnerships 2010 - Nov. 2-4 - Boston

Marketplace

> Products to watch in the biotech pipeline
> Drug Development Self-Study Course
> White Paper: Five Essentials for Minimizing Risk in Clinical Trials
> From H1N1 and Beyond: Growing The Flu Vaccine Pipeline
> Optimize your Media with our Animal Component Free Products and Supplements
> State of the Clinical Trials Industry
> Innovations in Life Sciences

Jobs

> Online Instructor, MCR Programme - Laureate Online Education
> Clinical Program Manager - Regeneron
> Drug Discovery/Drug Development Scientist - NeuroTherapeutics Pharma, Inc
> CMC Technical Director - GMB Executive Search & Selection Ltd.
> VP of R&D - Proven Inc., Scientific Staffing
> Supervisor, Transgenic Genotyping Service Assay Development - The Jackson Laboratory
> Senior Clinical Research Associate - Soligenix, Inc.
> Director Global Health Economics and Outcomes Research - Shire Pharmaceuticals
> Senior Director/Vice President Fibrosis - Regulus Therapeutics Inc.
> Senior Scientist Basic microRNA Mechanisms - Regulus Therapeutics Inc.
> Senior Scientist Metabolic Diseases - Regulus Therapeutics Inc.
> Senior Research Associate/Senior Scientist Immunology - Regulus Therapeutics Inc.
> Senior Director/Vice President Immunology - Regulus Therapeutics Inc.
> Senior Scientist/Associate Director Immunology - Regulus Therapeutics Inc.
> Senior Scientist/Associate Director Fibrosis - Regulus Therapeutics Inc.
> Need a job? Need to hire? Visit FierceBiotech Jobs

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Today's Top News

1. Did the odds just get worse for Arena's new weight drug?

By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn

After the FDA panel vote against Vivus's obesity drug Qnexa, analysts tracking the wave of new weight drugs headed to the agency have been hyper-sensitive about anything that could highlight concerns about the safety of the experimental treatments. So when the agency scheduled an in-depth review of Abbott's Meridia right ahead of Arena's (ARNA) lorcaserin--just as it tackled Avandia risks right ahead of the Qnexa session--it didn't take long for fresh fright to take hold.

"The Meridia discussion is likely to create an unfavorable atmosphere for the discussion of Arena's application," wrote analysts at Concept Capital's Washington Research Group. But they also offered one important proviso in a Dow Jones overview: Arena's experts will come prepared to do everything possible to make the case that their drug can clear the panel's high bar on safety.

Meridia will be Topic A for the Endocrinologic and Metabolic Drugs Advisory Committee on September 15, which will have to address the same cardio safety issues that forced the drug from European markets. Arena had actually been benefiting from the panel's clear reluctance to green-flag Qnexa, which cost Vivus more than half the value of its shares. Lorcaserin is considered the cleanest of any of the new weight drugs when it comes to safety data.

But with the experts concentrating on heart attacks and strokes related to Meridia, some Street insiders say that they'll be in a poor frame of mind to balance risks and rewards when they're forced to evaluate another weight drug that could have hidden or unappreciated side effects--as so many weight drugs have had in the past. The panel's attitude to risk right now is that it's better to be safe than sorry--and that is changing the odds for drug developers in the space.

- here's the story from Dow Jones

Related Articles:
Expert panel not convinced by Vivus' Qnexa
Orexigen weight-loss drug shows positive results in study
VCs eager to invest in obesity-focused startups
Three biotechs race for Holy Grail of drug development

Read more about: Vivus, Qnexa, obesity, lorcaserin


Tableau

Metrics to Understand Your Brand and Help It Thrive
August 18th, 2 pm ET / 11 am PT

Pfizer is the world's largest research-based pharmaceutical company. But how do they continue to thrive in an ever-changing and highly competitive environment?
This real life case study will explain how Pfizer's Animal Health division utilizes analytics and data visualization to quickly find patterns and key insights within their data to drive informed decision-making. Register Now!


2. What is Genzyme CEO's 'magic' number?

By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn

It should come as a surprise to no one that all the leaking going on last week as Genzyme and Sanofi-Aventis cautiously sidled to the deal table is seen by certain Wall Street insiders as an integral part of the complex mating ritual now underway. Leaks are a great way of checking shareholder responses. But, of course, they won't say that for the record.

"Both sides are using the press for price discovery. They are leaking numbers to see what reaction they get from shareholders," a UK hedge fund manager tells Reuters. "The consensus is that a deal will get done but Sanofi needs to avoid overpaying. There are some aggressive Genzyme shareholders talking the price up. They want to hit the magic number of around $20 billion."

As far as BNet's Jim Edwards is concerned, the magic number is $22 million. That's the golden handshake that awaits CEO Henri Termeer (photo) in the event of a buyout, regardless of the price, according to the 2009 proxy's change-of-control provision. And that will leave him more interested in completing any deal, writes Edwards, rather than the deal with the most money for shareholders.

If that were the case, though, those same Wall Street insiders wouldn't be bracing for weeks of quiet, behind-the-scenes talks with fresh leaks ahead. They certainly aren't buying the notion that Termeer will quickly fade away into retirement after shaking hands over a snap acquisition deal.

- read the story from Reuters
- here's the piece from BNet

Related Articles:
Sanofi offer a nail-biter for Genzyme employees
Should Sanofi stick to smaller deals?
Sanofi shareholders caution on Genzyme bid
Will Sanofi turn hostile to get Genzyme?



3. Senators advocate blockbuster remedy for rare drug woes

By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn

Lawmakers will soon get a chance to start pondering a bill that would dangle some blockbuster cash as an incentive to developers to take on the risk of developing new therapies for rare children's diseases.

The new law, which was proffered last week, would give pharma companies a shot at quicker approvals of blockbusters if they take on new drug programs that tackle rare pediatric diseases. Adding even a few months to a drugmaker's window of market opportunity could add hundreds of millions of dollars to a blockbuster drug's potential revenue.

As The Hill notes, the new bill essentially extends a three-year-old law that provides priority review vouchers to companies which work on treatments for rare tropical diseases. But the bill closes a loophole that gives biopharma companies access to vouchers on drugs that have already been approved. Supporters in Congress say they want to make sure that they're encouraging development of new therapies.

Kids v Cancer, which celebrated the new bill, says that in the past 20 years the FDA has approved only one drug cancer drug that was expressly developed for the pediatric market. "A priority for Kids v Cancer is to find ways to work with pharmaceutical companies to develop treatments for children with cancer and other rare diseases," said Nancy Goodman, the executive director of Kids v Cancer. "This legislation aligns government and private sector interests and will be a major step forward in addressing the unmet needs of children with devastating illnesses, including life-threatening cancer."

"We are falling woefully and inadequately short in our efforts to cure and treat rare and neglected pediatric diseases and conditions," said Senator Sherrod Brown, who introduced the bill with Sam Brownback and Al Franken.

- read The Hill's story
- here's the Kids v Cancer release

Related Articles:
Feds reviewing new R&D incentives for rare diseases
Pfizer creates a new R&D unit for rare diseases
GSK laments M&A rush, pursues rare diseases
Sarcoma Foundation calls for radical change in FDA review process

Read more about: rare diseases, legislation



4. Curis shares sink as Genentech evaluates lead drug's fate

By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn

Investigators at Roche and Genentech are preparing an in-depth analysis of a fresh crop of mid-stage data on Curis's GDC-0449, with an eye to determine whether the therapy should make the cut for ovarian cancer--less than two months after the same therapy flunked its mid-stage trial for colon cancer.

"Following these analyses," wrote Curis (CRIS) in a clinical update, "they (Roche and Genentech) expect to make a portfolio decision regarding whether, or to what extent, they will continue development of GDC-0449 in advanced ovarian cancer." That's not exactly what Curis investors wanted to hear, and the news helped drag the battered stock down by 17 percent in premarket trading.

Two months ago the closely-watched drug-which blocks the Hedgehog signaling pathway--failed a mid-stage trial for colorectal cancer. That was one of several studies mounted for Curis's lead drug. And the developer once again tried to keep its focus on the positive.

"While we await the final analysis of the data from this advanced ovarian cancer study, we remain optimistic about the continued evaluation of GDC-0449 in tumors such as basal cell carcinoma," said Curis CEO Dan Passeri. "Genentech and Roche have completed enrollment in a pivotal Phase II trial in advanced basal cell carcinoma, a use for which proof of concept has already been demonstrated in a Phase I clinical study. In addition, Roche has indicated that it expects to initiate a Phase II clinical trial in operable basal cell carcinoma patients during the second half of 2010 which we believe, assuming positive data, could expand the commercial opportunity of GDC-0449 in basal cell carcinoma."

- see the Curis release
- read the Reuters story

Related Articles:
Curis shares plunge after lead drug flunks cancer trial
Genentech witnesses dramatic tumor effect in small trial
BMS, Pfizer cancer drugs take starring roles at ASCO

Read more about: Roche, ovarian cancer, Genentech, GDC-0449



5. FDA staffers weighs risks, rewards of new epilepsy drug

By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn

Staffers at the FDA have red-flagged their concern about cases of urinary retention tracked in some patients taking Valeant Pharmaceutical's experimental new epilepsy medicine Potiga (ezogabine), which comes before an advisory panel on Wednesday. But the staff review also noted that the drug appears to be effective and most cases of an inability to urinate were reversible.

Valeant is looking for an FDA approval to use the medicine as part of a combinational approach to partial onset seizures not adequately treated by existing remedies. And the agency spelled out its interest in the panel's views on the company's plans to monitor cases of urinary retention after it's approved for use. Valeant is developing the drug with GlaxoSmithKline and stands to gain up to half of the U.S. profits ginned by the therapy.

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will gather the day after tomorrow to vote on the drug's safety and efficacy profile, offering guidance to the agency as it ponders a final decision on the drug.

- read the story from Reuters
- here's the Dow Jones report

Read more about: Valeant Pharmaceuticals, FDA, epilepsy



Also Noted

SPOTLIGHT ON... Lambda snags Biovail's Toronto CRO

India's Lambda Therapeutic Research has acquired Biovail's Canadian CRO and renamed it Lambda Canada. The 46,000-square-foot research center in Toronto houses 194 beds and a Phase I first-in-human operation. Lambda says it wants to burnish its reputation for developers interested in developing new therapies for the U.S. market. Report

 @FierceBiotech: GSK licenses Vectura's inhalation tech for $32M. Article | Follow @FierceBiotech

 @JohnCFierce: Another example of a weak biotech IPO. NuPathe cuts price from $14-$16 range to $10. Article | Follow @JohnCFierce

> Online tool connects patients to experimental drugs. Report

> DUSA Pharmaceuticals said Friday that it would halt a mid-stage trial for one of its cancer therapies after the FDA refused to grant it orphan drug status. Report

> With a potential proxy fight looming, Osteotech says that it has retained Deutsche Bank to explore all ‘alternatives' for boosting its value. "The board believes that the company has made tangible progress in its growth strategy focused on new, innovative biologics," but the stock hasn't "adequately reflected" the value "the management team has created," said Chairman Kenneth P. Fallon III. Story

> Australia's QRxPharma says it has gathered positive data from a mid-stage study of its pain therapy, an IV formulation of morphine/oxycodone. Story

> Helix BioPharma says it has raised $11 million in a private placement. Zbigniew Lobacz has become an "insider" of Helix as he now holds more than 10% of Helix's outstanding common shares. Release

And Finally... Postmenopausal women with diabetes taking thiazolidinediones, including rosiglitazone and pioglitazone, may be at increased risk for fractures, according to a new study. Release


 @FiercePharma: FDA slaps Novartis for Facebook widget. Report | Follow @FiercePharma

> Feds probe Merck in FCPA enforcement push. News

> AZ resolves 17,500 Seroquel claims for $198M. Report

> Merck resumes sale of all its child vaccines. Article

> FDA advisors to weigh Meridia's safety. Story


> Online tool connects patient with experimental drugs. News

> Adaptive trial modeling solution aids dose-finding. Report

> Michigan researchers to gain in IT makeover. Item

> FDA, Tox21 try IT in place of animal tests. Item


Webinars


* Post listing: Click here.
* General ad info: Click here.

> Metrics to Understand Your Brand and Help It Thrive - August 18th, 2 pm ET / 11 am PT

Pfizer is the world's largest research-based pharmaceutical company. But how do they continue to thrive in an ever-changing and highly competitive environment? This real life case study will explain how Pfizer's Animal Health division utilizes analytics and data visualization to quickly find patterns and key insights within their data to drive informed decision-making. Register Now!



Events


* Post listing: Click here.
* General ad info: Click here.

> Pharmaceutical Strategic Alliances 2010 - Sept 21-23 - New York City

PSA, the industry's most respected strategic event, focuses on the new dealmaking trend of risk-sharing between big and small companies, drug developers and payors. PSA features the most senior-level case studies for dealmaking and strategy available in the industry. Register now: www.windhover.com/psa.

> BIO India International Partnering Conference - Sept. 21-22, 2010 - Hyderabad, India

This exclusive forum will bring together premiere biotech and pharma companies from around the world who are actively seeking partnerships with India's leading biotech companies. Visit bioindia.bio.org for more details and to register.

> Life Sciences Summit 2010

Translational science partnering event featuring breakthrough discoveries, emerging companies, and new business opportunities in infectious diseases, stem cell technology & regenerative medicine, neurological disorders, and cancer therapeutics. 20% discount if registered by 8/13. Learn more

> Windhover's PharmAsia Summit 2010 - Oct 25-26 - San Francisco

Windhover Conferences, sponsor of the blockbuster Pharmaceutical Strategic Alliances, delivers the most senior experts in the Asian markets who will show you how to take the risk out of doing business in Asia, expected to be a driver for pharma growth for the next 10 years. Register now: www.windhover.com/pharmasiasummit

> Tomorrow's Project Manager: Evolving Competencies for Biopharmaceutical Professionals - October 26 - 27 - Bethesda, MD

Project management in the pharmaceutical industry is evolving to meet the ever-changing environment. Advances continue in project management skills and technology. This project management workshop will provide an opportunity to discuss the evolving role of the project manager and stimulate an interactive environment in a series of workshops that will focus on the key project management competencies. Learn more.

> Windhover's Therapeutic Area Partnerships 2010 - Nov. 2-4 - Boston

TAP is the industry's most targeted, efficient, strategic-level partnering meeting for life science companies seeking partnerships in the top therapeutic areas: oncology, cardiovascular, metabolic and neuroscience. The biggest players in these areas attend to make deals. Register now: www.tapartnerships.com



Marketplace


* Post listing: Click here.
* General ad info: Click here.

> Products to watch in the biotech pipeline

Identify emerging products with a comprehensive review of pipelines for the world’s top biotech companies. Compare pipelines and financials such as R&D spend with easy-to-read charts. Get competitive insight on promising new molecular entities and products to watch: Top 50 Biotech Companies & Their Pipelines. Learn more.

> Drug Development Self-Study Course

6-Module self-study course teaches the whole process of drug development. Q&A, narrated presentation , e-Book summary (also in Chinese and Japanese) and optional web seminar. As used internationally in industry and academia. See www.alladex.com or write to j.gray@alladex.ch for further information, samples and quote.

> White Paper: Five Essentials for Minimizing Risk in Clinical Trials

Potentially valid drugs and devices are often denied regulatory approval when flawed clinical data undermines efficacy and safety findings. Discover the elements that every trial should deem mandatory to avoid such unnecessary risk. Download the free white paper: “What You Don’t Know Can Hurt You”

> From H1N1 and Beyond: Growing The Flu Vaccine Pipeline

The rise in influenza strains like H1N1 — and the demand for new vaccines — signals a new era in vaccines. Learn how flu vaccines have evolved and where they’re headed. Read the white paper from Quintiles’ vaccines experts.

> Optimize your Media with our Animal Component Free Products and Supplements

The Biotech market relies on Sheffield Bio-Science for cell culture optimization products like HyPep™ UltraPep™, Hy-Soy™ and rAlbumin. Every day we expand our capabilities to meet the changing needs of the cell nutrition market. Learn about the newest animal component-free (ACF) products we've developed at our state-of-the-art Center for Cell Culture Technology. Visit www.sheffieldbioscience.com or call 800.833.8308

> State of the Clinical Trials Industry

This annual publication a comprehensive resource that examines all aspects of the global clinical trials industry and is comprised of more than 645 charts and graphs, including 400 new and updated ones for the 2009 edition. Click here and reference coupon code 7712 to order your copy now!

> Innovations in Life Sciences

What are some of the most promising new technologies used in life sciences research today? Find out at the FierceBiotech-Enterprise Florida "Innovations in Life Sciences" microsite. Access insightful white papers, videos, news and more.



Jobs


* Post listing: Click here.
* General ad info: Click here.

> Online Instructor, MCR Programme - Laureate Online Education

Laureate Online Education, in partnership with The University of Liverpool has launched an innovative new programme, which leads to the award of the University of Liverpool's Master of Clinical Research Administration (MCR). We are looking to recruit additional Instructors and Dissertation Advisors for this ground breaking new programme. Learn more.

> Clinical Program Manager - Regeneron

Oversee and manage all activities related to the conduct of clinical research projects in order to meet deliverables and program objectives. Interact with various internal and external vendors as well as clinical study sites. Periodically travel to assure compliance with protocol and clinical research project objectives. Learn more.

> Drug Discovery/Drug Development Scientist - NeuroTherapeutics Pharma, Inc

NeuroTherapeutics Pharma, Inc. (NTP) is a biopharmaceutical company focused on developing therapies for diseases associated with central nervous system (CNS) hyper-excitability. We seek a highly motivated individual for an immediate opening for a drug development scientist position to manage scientific and clinical development project. Read more.

> CMC Technical Director - GMB Executive Search & Selection Ltd.

This is both a technical and a commercial oversight role managing a portfolio of products from early development through transition into full development and into commercial manufacturing. This individual will have a leadership role as a member of an interdisciplinary Chemistry Manufacturing and Controls (CMC) team and will be the key process knowledge expert for the company. Learn more.

> VP of R&D - Proven Inc., Scientific Staffing

This person will head up the R&D function for a pharmaceutical company poised for growth. Will have up to 20 direct reports so must have proven ability to lead and coach a team but must also have strong technical experience in the area of oncology drug discovery. Infectious disease experience is also a plus. Learn more.

> Supervisor, Transgenic Genotyping Service Assay Development - The Jackson Laboratory

The Transgenic Genotyping Service (TGS) has a position available as Supervisor, Transgenic Genotyping Assay Development. The position will work to improve genotyping efficiency, oversee the assay validation effort, and be responsible for importing and developing assays for ~800 strains annually. Learn more.

> Senior Clinical Research Associate - Soligenix, Inc.

Travel to and monitor Sponsor studies at sites within the U.S. Responsible for the management of assigned clinical study sites. Ensures the regulatory and scientific integrity of studies. Evaluates, monitors, and documents all study information. Maintains excellent relationships, and contact with site personnel and uses good judgement based on GCPs, ICH Guidelines. Learn more.

> Director Global Health Economics and Outcomes Research - Shire Pharmaceuticals

Primary Role: To provide strategic planning & design input and implementation of health outcomes programs to support the go/no go decision of product candidates, pricing and reimbursement for Shire products across global markets. Learn more.

> Senior Director/Vice President Fibrosis - Regulus Therapeutics Inc.

Reporting to the Chief Scientific Officer, the Senior Director/Vice President, Fibrosis will be an integral member of the Regulus team and will contribute significantly to the advancement of numerous discovery and preclinical compounds into the clinic. Read more

> Senior Scientist Basic microRNA Mechanisms - Regulus Therapeutics Inc.

We are seeking a Senior Scientist to investigate how microRNA-modulating drugs interact with RNAi machinery. The successful candidate will be experienced in analyzing the biochemistry of RNAi pathways. He/she will also have broad knowledge of microRNAs and expertise in fundamental aspects of the RISC complex. Read more.

> Senior Scientist Metabolic Diseases - Regulus Therapeutics Inc.

The successful candidate will have considerable expertise in metabolism and/or adipose tissue biology and will be expected to spend the majority of his/her time working in the lab. He/she should have experience working with in vivo models of metabolic disease. Read more.

> Senior Research Associate/Senior Scientist Immunology - Regulus Therapeutics Inc.

The successful candidate will have considerable expertise in modern and classical experimental models in immunology and will be expected to spend the majority of his/her time working in the lab. He/she will also have broad knowledge and expertise in fundamental immune mechanisms as well as experience with animal models in immunology. Read more.

> Senior Director/Vice President Immunology - Regulus Therapeutics Inc.

Reporting to the Chief Scientific Officer, the Senior Director/Vice President, Immunology will be an integral member of the Regulus team and will contribute significantly to the advancement of numerous discovery and preclinical compounds into the clinic. Read more.

> Senior Scientist/Associate Director Immunology - Regulus Therapeutics Inc.

The successful candidate will have considerable industrial experience and expertise in modern and classical experimental models in immunology. He/she will also have broad knowledge and expertise in fundamental immune mechanisms as well as experience with animal models in immunology. He/she will be working closely with a small team of scientists involved in cutting-edge research to develop microRNA therapeutics. Read more.

> Senior Scientist/Associate Director Fibrosis - Regulus Therapeutics Inc.

The successful candidate will be an expert in fibrosis/wound healing, with considerable industrial experience in experimental fibrosis research. He/she will also have broad knowledge and published expertise in molecular/cellular biology. He/she will be working closely with a small team of scientists involved in cutting-edge research to develop microRNA therapeutics. Read more.

> Need a job? Need to hire? Visit FierceBiotech Jobs

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