Rabu, 11 Agustus 2010

If you are unable to see the message below, click here to view.


August 11, 2010

Sign up for free:
Subscribe | Website | Jobs | Mobile app
Refer FierceBiotech to a Colleague

This week's sponsor is Aptuit.


Today's Top Stories
1. Developers zero in on the new 'bio-better' strategy
2. Dicerna bags $25M Series B for next-gen RNAi work
3. Biotech M&A frenzy shows no sign of slowing
4. Merck commits up to $289M for new Alzheimer's collaboration
5. Eli Lilly taking an axe to tech ops

Also Noted: Spotlight On... Top 5 Medical Device VC Deals, H1 2010
Aegerion revives $86M IPO; MannKind prepares to raise cash; and much more...

Chutes & Ladders: Signum names Shroot as CEO

More Fierce Life Sciences News
1. Study: Device errors cost $1.1B annually
2. For kids, nose vax is better than needle
3. DNA tests aim to detect colon cancer early
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

> 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

* Post a classified ad: Click here.
* General ad info: Click here

Today's Top News

1. Developers zero in on the new 'bio-better' strategy

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

The Wall Street Journal's venture blog focuses on three upstart biotechs plotting to push programs on new "bio-betters," essentially second-gen biologics that can pull the market rug out from under some blockbuster meds. It's a simple strategy: find a new biologic that is safer and more effective than a top earner already on the market-perhaps delivered more easily for greater compliance--and you have a potential billion-dollar therapy on your hands.

At Femta Pharmaceuticals the target is Actemra, an IL-6 receptor inhibitor (an antibody) for rheumatoid arthritis. Femta thinks it can go one better by blocking IL-6 altogether with an antibody that could be self-administered rather than injected. The UK's PolyTherics is focused on pegylation technology to ramp up the duration of a new and improved interferon alpha-2a for hepatitis. And Itero Biopharmaceuticals in San Mateo, CA is switching from biosimilars to bio-betters, though it isn't saying exactly what its first program will be.

For the venture backers, one of the chief attractions of these bio-better programs is that they offer a classic de-risking for their investors. If you know the technology better and you've seen how it works in the clinic, they reason, chances are you have a better shot at goal. Bio-betters still require a long and very expensive trial program, though, which are always risky. And investors will also need to make sure that the new therapies offer a significant advantage over anything on the market, as payers are profoundly unhappy about anything that fits the profile of a me-too drug.

- here's the WSJ report

Related Articles:
Biologics will dominate in 2014
Only the biggest developers can play the biosimilar game
FDA approves Roche's Actemra for RA
Can Big Pharma effectively develop new drugs?

Read more about: PolyTherics, Itero Biopharmaceuticals, Femta, Biologics


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. Dicerna bags $25M Series B for next-gen RNAi work

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

Dicerna Pharmaceuticals has landed a $25 million Series B to fuel its work on a new and improved slate of gene-silencing therapies. Still in the preclinical stage, the Watertown, MA-based developer is focusing on solid tumors for its first clinical program.

Launched three years ago, Dicerna has been building a new platform for RNAi work that relies heavily on longer molecules than the ones used by RNAi pioneers like Alnylam and Sirna. The longer molecules improve on the potency, duration of action and the ability to deliver its therapies, explains Martin Williams, Dicerna's chief business officer. Dicerna believes that that the dicer enzyme holds the key to a better approach to quelling disease-causing genes, building in a docking section that can bind to antibodies and other molecules--peptides, for example--that enable more precise drug delivery.

That technology has attracted early interest from more established developers. And Dicerna plans to add new tech partnerships, building on the deals it has already struck with Kyowa Hakko Kirin and Ipsen. New investor Domain Associates led the round, with all existing investors--Oxford Bioscience Partners, Skyline Ventures and Abingworth - joining in. Since its launch Dicerna has raised an impressive $46.4 million.

Even on a conservative basis, CEO Dough Fambrough tells FierceBiotech, Dicerna should be able to use this round to extend its runway out two or three years, with potential new partnerships adding fuel to cover the burn rate. Currently Dicerna has a staff of 25, which Fambrough expects will push up to around 30 with a few new hires. Ultimately, he says, there's no telling whether the company will stay independent or get bought out. But as the Sirna acquisition demonstrated, he adds, there's a big appetite for companies with a promising RNAi discovery platform, so an eventual buyout offer wouldn't come as a big surprise.

"We are favorably impressed by Dicerna's management team and the progress it has made in developing differentiated RNAi technology, and in forming strategic alliances," said Domain Associates' partner Brian K. Halak, who is joining the board. "We believe Dicerna's broad Dicer Substrate Technology platform favorably positions the company to overcome the challenges of first generation approaches, and offers significant advantages over other technologies in the field in terms of potency, specificity and deliverability."

- here's the Dicerna release
- read the story from Xconomy

Related Article:
Dicerna lands $124M RNAi development pact

Read more about: Dicerna Pharmaceuticals



3. Biotech M&A frenzy shows no sign of slowing

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

With Genzyme in the news, we've all been hearing plenty about the wave of M&A deals that's been rolling through the world's life sciences industry. Last year, Thomson Reuters tracked more than 1,400 such deals worth $206 billion worldwide, giving the Boston Globe the hard numbers it needs to assert that this is one trend that has yet to crest.

The reasons are more than obvious at this stage of the consolidation game. Pharma companies are desperate for new products to replace those big earners losing patent protection. And a big tie-up with another company provides new technology, new markets and new hope for expansion--case that Wall Street analysts demand from any market player. It also doesn't hurt that the old blockbusters on the market now have ginned billions in revenue, giving Big Pharma the kind of big bucks needed to strike new deals.

Last year, Boston recorded about $5 billion in buyout deals, says the Globe, including the Sepracor acquisition. Of course, that would just be a fraction of a potential merger between Sanofi and Genzyme, which is likely to fetch around $20 billion if both parties could ever agree on a price. So far this week, though, there's been little new from that front, as insiders have grown uncharacteristically mum about any back-and-forth.

- here's the Globe story

Related Articles:
Biotech inspired $295B in M&A deals over the last decade
Biopharma execs predict a big spike in M&A deals
Dealmaking reaches fever pitch at year's end
Roche CEO offers his vision for new R&D era

Read more about: Mergers and Acquisitions, Biotech deals



4. Merck commits up to $289M for new Alzheimer's collaboration

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

Undaunted by its mixed results trying to come up with a new therapy for Alzheimer's, Merck has struck a $289 million deal with Canada's Alectos Therapeutics to collaborate on new molecules for the memory-wasting ailment and other disorders. The pact includes an upfront payment and milestones, but there was no breakout on the payments.

The collaboration will target that modulate O-linked N-acetylglucosaminidase, an enzyme that is believed to be involved in the development of Alzheimer's disease. "We are delighted to establish a collaboration with the exceptional team at Merck to advance this potentially new, disease-modifying therapeutic approach for patients affected by Alzheimer's disease," said Ernest McEachern, the CEO of Alectos. "This is an important validation of our scientific leadership in this area and we look forward to working with Merck to realize the full value of this novel mechanism for a range of neuroscience disorders."

Like other developers, Merck has experienced plenty of frustration trying to develop new therapies for the disease, an incredibly elusive target that afflicts a steadily growing number of seniors.

- check out the Merck release

Related Articles:
Merck buys vax unit from bankrupt Hawaii Biotech
Elan, Transition push ahead with troubled Alzheimer's drug
Biomarkers promise to revolutionize Alzheimer's research
Big Pharma coalition will pool data on failed Alzheimer's drugs

Read more about: Alectos, Merck, Alzheimer's



5. Eli Lilly taking an axe to tech ops

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

Eli Lilly's plans for a new round of job cuts in Indianapolis apparently includes taking an axe to its technology operations. According to a report in the Indianapolis Star, the Big Pharma company told state officials that it plans new layoffs at its HQ, with more cuts at the north and south campuses of its technology center as well as its Intech Park campus.

Lilly spelled out some of its plans in a letter to the Indiana Department of Workforce Development, making it clear that these are permanent cuts. As FiercePharma reports, Lilly has been shifting its workforce, laying off workers in the U.S. as it adds new staffers overseas. China, in particular, has been one of the emerging markets gaining plenty of attention from Lilly.

- here's the Indianapolis Star report

Related Articles:
Lilly chief vows to create lean, mean drug-making machine
Lilly to open San Diego biotech center
Lilly CEO: Pipeline to soften patent losses

Read more about: layoffs, Eli Lilly



Also Noted

SPOTLIGHT ON... Top 5 Medical Device VC Deals, H1 2010

A simplified diabetes device, two eye treatments, a surgical back device, and diagnostic biomarkers--these five technologies attracted the most venture capital funding in the first half of 2010. At the halfway point, Intuity Medical and its all-in-one glucose monitoring system gained the most funding. Overall in the first half, medical device makers drew in $1.272 billion in 156 device deals. Report >>

 @FierceBiotech: Report: China readies $1.5B plan to bolster biotech. Article | Follow @FierceBiotech

 @JohnCFierce: SciClone says the feds are probing China activities; shares plunge 32 percent. News | Follow @JohnCFierce

> Aegerion Pharmaceuticals has dusted off its old IPO plans. The developer has re-registered its $86.3 million offering, which it pulled after the 2008 market collapse. Aegerion is developing a new therapy, now in a late-stage trial, for a rare genetic disorder. Report

> MannKind plans to sell 36.4 million shares to help pay down debt. The developer is waiting for the FDA's decision on its inhaled insulin therapy Afrezza. Story

> With revenue from its China ops surging at a fast pace, Qiagen--which markets sample and assay technologies for biomarker development--says it's on track to see its Asian market cash flow double this year, according to a report from Seeking Alpha. And a recently formed partnership on molecular biomarkers with WuXi PharmaTech should help feed its swelling revenue stream. Report

> Trigemina says that a small Phase IIa trial of TI-001 produced positive results as a treatment for chronic daily headache. Trigemina release

> Researchers in Belgium have found another potential biomarker for detecting Alzheimer's. Using a spinal tap test, a team at Ghent University took samples of cerebrospinal fluid from 400 elderly individuals in varying states of dementia, and of the 102 participants considered to have Alzheimer's, 90 had an identical biomarker. Article

And Finally... UK health officials say they're alarmed to see evidence of a new superbug that is resistant to almost all existing antibiotics. News


@FiercePharma: Top 10 Generic Drug Companies 2010. Report | Follow @FiercePharma

> Lilly calls latest Indiana job cuts 'permanent.' Article

> Amgen drug flunks head-and-neck cancer trial. News

> Novo Nordisk wins appeal in retaliation suit. Story

> Genzyme extends timeline for plant overhaul. Article


> FAA fines Boston Scientific $91K for transport issues. Report

> Boston Sci gets document request from grand jury. Article


> Researchers crack blood-brain barrier to treat tumors. Story

> Metal-packing nanoparticles treat cancer, useful for MRI. Item

> Elan's drug delivery unit takes on innovation. News


Signum Biosciences has appointed Braham Shroot, formerly CSO of Barrier Therapeutics, as CEO. Shroot replaces Gregory Stock, who will continue to remain active with the company as a member of the board. Signum release

Renhuang Pharmaceuticals has announced that company CFO Yan Yi Chen has resigned for personal reasons effective immediately. Renhuang release

Orexo has appointed Robin Wright as EVP head of finance, replacing Claes Wenthzel who, after five years in the group, has decided to leave the company for other assignments. Orexo release

Invida Group has added three new members to the senior management team. Invida has appointed Sumeet Sud has been named chief marketing officer, a newly created position. In addition, Girdhar Balwani and Thomas Birsinger have been named country managers for India and Vietnam, respectively. Invida release

The International AIDS Vaccine Initiative has tapped Michael Caulfield as executive director of the IAVI AIDS Vaccine Design and Development Laboratory. IAVI release

CorMedix has appointed Robert Hopkins as head of clinical operations and project management and Dilip Wadgaonkar as head of product development and manufacturing. CoreMedix release

Robert Baldini has been elected to K-V Pharmaceutical's board by a unanimous vote. K-V release

Hana Biosciences has announced the appointment of Robert (Bob) Spiegel to the company's board. Spiegel was employed at Schering Plough for 26 years where he was deeply involved in clinical research culminating with his position as CMO. Hana release

Novavax has announced the appointment of Richard Douglas to its board of directors. Douglas is currently senior VP, corporate development at Genzyme. Novavax release

Generex Biotechnology has named Craig Eagle to its scientific advisory board. Generex release

Bionovo has appointed James Pickar to its medical advisory board. Bionovo release

Quantum Immunologics has announced that Wilhelmina Tribble is joining the board as the sixth independent board member. Quantum release


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.

> 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

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at http://www.fiercebiotech.com/jobs.