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Today's Top Stories
1. Vertex's telaprevir cuts hep C treatment time in half
2. Endo buying partner in pain Penwest for $168M
3. Elan, Transition push ahead with troubled Alzheimer's drug
4. Report: China readies $1.5B plan to bolster biotech
5. TetraLogic nabs $32M round for lead cancer therapy Also Noted: Spotlight On... Top 10 Generic Drug Companies 2010
Medicago investing $32M in new production facility; SciClone shares plunge on China probe; Zurex opens shop in Madison; and much more... More Fierce Life Sciences News
1. Abbott CEO: Diversification delivers
2. Scientists look to newt to regenerate tissue in mice
3. Activis revs up for Tylenol shortage
More headlines...
Today's Top News 1. Vertex's telaprevir cuts hep C treatment time in half Vertex Pharmaceuticals (VRTX) has added a fresh haul of solid Phase III data to support its rolling application for telaprevir, a potential blockbuster that some analysts believe is a likely game changer in the market. An overwhelming majority of hepatitis C patients who registered a quick response to a telaprevir-based cocktail were effectively cleared of the virus after 24 weeks, according to researchers, making further treatments unnecessary. And that indicates the new hep C drug could cut the current standard treatment time in half for a large group of patients. Investigators set out to determine if patients who achieved undetectable levels of the virus after four and 12 weeks of treatment would benefit by going past the 24-week mark and push on to 48 weeks of therapy. But they found that subjects with an extended rapid viral response, or eRVR, had a cure rate of 92 percent at 24 weeks and 88 percent at 48 weeks. "The viral cure rates seen in (the Phase III Illuminate trial) showed that there was no benefit to extending telaprevir-based therapy to 48 weeks for the majority of people," said Kenneth Sherman, the principal investigator of the trial. "Patients who had a rapid response to telaprevir-based regimens at weeks four and 12 had a high likelihood of achieving a cure with 24 weeks of total treatment, which may provide important information to motivate people to continue therapy." Vertex plans to release more late-stage data next month in the lead-up to completing their rolling FDA application by the end of this year. Seeking Alpha says it expects an approval of the drug in early 2011 with a huge market to tap. The market, though, has evidently seen enough positive data to discount any new releases like this. Vertex shares were up a little more than one percent this morning. - here's the Vertex release
- read The Street's story
- see more from Seeking Alpha Related Articles:
With losses rising, Vertex rolls out its telaprevir app
Vertex delivers blockbuster payload of PhIII telaprevir data
Telaprevir study emphasizes need for hep C cocktails Read more about: vertex, telaprevir, Hepatitis C
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2. Endo buying partner in pain Penwest for $168M Looking to burnish its reputation in the field of pain therapy, Chadds Ford, PA-based Endo Pharmaceuticals (ENDP) struck a deal to buy out its development partner Penwest Pharmaceuticals for about $168 million on the same day it filed an NDA for a new abuse-resistant drug. The buyout deal--struck at a price of $5 per share, a 19 percent premium--gives the developer Penwest's interests in Opana ER, a therapy that the two biotech companies have been working on for the past 13 years, along with a pipeline of experimental therapies and new delivery tech. Both boards have signed off and shareholders controlling close to 40 percent of Penwest's shares are already on board. "Our acquisition of Penwest sets the stage for maximizing the value of the Opana franchise and for leveraging Penwest's drug delivery technologies and pipeline across our branded and specialty generics businesses for the benefit of patients," said Julie McHugh, Endo's chief operating officer. "This transaction highlights the growth potential of Endo's core pain management franchise." Endo also announced its NDA for a new extended-release formulation of oxymorphone, a new abuse- and misuse-resistant opioid treatment developed in partnership with Grunenthal GmbH. - read the Endo release
- check out the Reuters story Related Articles:
Endo Pharma to buy HealthTronics in $223M deal
Endo Pharma CEO plots new round of deals
Endo inks $210M deal for testosterone therapy
Endo will pay up to $637M for Indevus Read more about: Penwest Pharmaceuticals, Mergers and Acquisitions, Endo Pharmaceuticals
3. Elan, Transition push ahead with troubled Alzheimer's drug Elan and Transition Therapeutics have reported fresh trouble with their partnered Alzheimer's drug, noting that it failed to hit its mid-stage primary endpoints. Late last year, the deaths of nine patients in the study prompted investigators to drop the highest dose being used in the trial. But the two developers say they're committed to pushing ahead into Phase III, despite a considerable amount of flak coming from analysts following their progress. Elan reported that the ELND005 study's cognitive and functional co-primary endpoints "did not achieve statistical significance." Data was being held in reserve, though, for a future scientific meeting. "Based on the preponderance of evidence from both biomarker and clinical data, and after extensive discussions with experts in the field, Elan and Transition Therapeutics intend to advance ELND005 into Phase III development." That strategy didn't win over any skeptical analysts. "Even though this compound was shown to be safe and well tolerated, its efficacy reported for the Phase II study seems to be rather borderline. Hence we remain skeptical whether this agent will show therapeutic benefits in the planned Phase III trials," Helvea equity researcher Olav Zilian noted. In other news, Elan also announced that poor market conditions persuaded the pharma company to put the sale of its drug delivery unit, Elan Drug Technologies, on hold. Elan first tried to sell EDT two years ago, but was forced to shelve those plans after the market swooned. - check out the Elan release
- read the Dow Jones report
- and here's more from the Irish Times on EDT Related Articles:
Deaths force researchers to drop Alzheimer's drug doses
Elan drops top Alzheimer's drug dosage in trial
Elan cuts 230 jobs as it waits for trial results Read more about: Transition Therapeutics, Elan, Alzheimer's
4. Report: China readies $1.5B plan to bolster biotech In a bid to break out of its dependence on manufacturing and cheap labor, the Chinese government is planning to invest $1.5 billion into new drug development between 2011 and 2016. And biotechnology is one of seven emerging industries that the Asian powerhouse will use to spearhead the next big step in its economic development, according to a report in China's 21st Century Business Herald. The National Development and Reform Commission is leading the effort on biotech, according to the business publication, citing sources close to the development planning. And the details will be unveiled at a major political conference next year, when China will herald its next big five-year plan for the economy. Late last year, the NDRC established 20 venture funds to funnel hundreds of millions of dollars into new enterprises, ranging from drug development to energy companies. China has quickly become a central player in the world of drug development, attracting Big Pharma and CROs alike as they take advantage of low-cost scientific help and hope to capitalize on one of the world's fastest-growing economies. - check out the story from Bloomberg
- read 21st Century Business Herald's piece Related Articles:
China's growing appeal to the global CRO industry
China gets serious about biotech
China's vax industry poised for rapid growth Read more about: Economic development, China
5. TetraLogic nabs $32M round for lead cancer therapy Malvern, PA-based TetraLogic Pharmaceuticals has rounded up $32 million in Series C cash to back the development of its lead cancer drug, the early-stage TL32711. Clarus Ventures led the round with new investor Hatteras Venture Partners joining Amgen Ventures, HealthCare Ventures, Latterell Venture Partners, Novitas Capital, Quaker BioVentures and the Vertical Group in the venture round. TL32711 is a SMAC mimetic designed to neutralize the activity of an inhibitor of apoptosis proteins, which block tumor cell death. The drug is in a Phase I study as a single agent in patients with hard-to-treat solid tumors and lymphoma. "SMAC mimetics are a novel class of cancer therapeutics with the potential to enable treatment of solid and hematological cancers that would otherwise be resistant to therapy," said Michael Steinmetz, the managing director of Clarus Ventures. "We are encouraged by TL32711's preclinical and early clinical data that it may fulfill the broad potential of an effective targeted pro-apoptotic therapy." - check out the TetraLogic release Related Articles:
Clarus raises $660M for new life sciences fund
Veteran entrepreneur gets backing for start-up
Top 5 Biotech Venture Capital Deals, H1 2010 Read more about: TetraLogic, Quaker Bioventures, Healthcare Ventures, Clarus Ventures
Also Noted SPOTLIGHT ON... Top 10 Generic Drug Companies 2010  In recent years, Big Pharma has begun to look beyond brand-name drugs to the generics market. With the rising costs of healthcare, governments and payers alike are pushing for increased generics usage. And Big Pharma companies like Novartis and Pfizer are paying attention, striking deals with generics companies and even building units of their own. FiercePharma's 2010 generic drugmakers report includes profiles of the top generics companies. Report >>
 @FierceBiotech: Mayo Clinic to launch center for social media. Report | Follow @FierceBiotech
@JohnCFierce: It's rare to see a Phase III drug with the kind of compelling, clean profile that telaprevir has. | Follow @JohnCFierce > The vaccine developer Medicago, which is making vaccines from tobacco plants, is investing $32 million in a new production facility in Research Triangle Park. The project will lead to the creation of 85 new jobs. Report > Shares of SciClone Pharmaceuticals plunged after the company said that the feds are investigating its business activities in China. Article > The UK's Tissue Regenix has received its first approval, gaining the European CE mark for a new patch designed to promote tissue repair. The dCELL vascular patch uses human and animal cells to create a scaffold for tissue regeneration. And the company says it is now pursuing an FDA approval as well. Tissue Regenix went public through a reverse merger in June. It makes the patch, which is designed to avert the use of anti-rejection therapies, in York. Story > The startup Zurex Pharma, which is developing antimicrobial products, set up shop in Madison, WI. Item > Nabi has earned an $8 million milestone from its sale of PentaStaph (Pentavalent S. aureus Vaccine) and related assets to GSK. Nabi release > Syndax Pharmaceuticals has raised $6 million from 12 investors. Story > AVI BioPharma revealed that it paid $2.6 million to its ex-CEO, Leslie Hudson, huirting its second quarter results. Hudson left the company in April and the CFO is serving as interim CEO. News And Finally... Fresh research shows that a big waist is a big risk. Report 
@FiercePharma: Sanofi deal could bring $22M bonus for Termeer. Article | Follow @FiercePharma
> No more NICE as we know it. Report > Elan puts off unit sale, plans to cut debt. Article > Genzyme jettisons more subpar inventory. News > Merck to reacquire sold-off plant. Item
> Gene recipe regenerates damaged heart tissue. Story > Debate over chimps pits lawmakers against researchers. News > Investigators create cancer-fighting T cell receptors. Item > Lab accident opens door to new fertility treatment. Article > Leptin fades as a prime obesity target. News 
> Indian packager Bilcare looks west for expansion. Report > Gilead SEC filing anticipates FDA warning letter. Item > FDA to skip legal review of warning letters. News > Distribution change affects supply chain balance of power. Article > Sun enjoys fleeting profit boost from oxaliplatin. Story > 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!
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| > 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 > From H1N1 and Beyond: Growing The Flu Vaccine Pipeline > 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.
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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. 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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 | | 
