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Today's Top Stories
1. Array adds $713M cancer drug pact with Genentech to deal roster
2. Biogen, Abbott tout promising MS data from PhIIb daclizumab trial
3. Report: FDA approval for Roche's melanoma drug vemurafenib 'imminent'
4. Investor panic could spell tougher times for biotechs
5. Corey Goodman's upstart biotech garners a $5M Series A Also Noted: Fierce Custom Publishing
Spotlight On... Intercept nails $165M diabetes pact with Servier
Lexicon reports positive data on tumor drug; Watchdogs oppose loosening FDA's conflict rules; and much more... More Fierce Life Sciences News:
1. Stanford's SPARK hosts ideas so 'crazy' they just might work
2. At the box office, bad boy pharma on top
3. Gene discovered that regulates the timing of our tickers
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> PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC
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> CBI's Pharma/Bio Forum on Preclinical Development - September 26 - 27, 2011 - Boston, MA
> AdvaMed 2011- Register Now and Save 300! - September 26-28, 2011 - Washington, DC
> 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD
> Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA
> 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" - Oct 6, 2011
> 19th Annual BioPartnering Europe - 9-11 October 2011 - London, UK
> US Conference on Rare Diseases and Orphan Products - October 11-13, 2011 - Washington, DC
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> BioNetwork West 2011 - Oct. 24-26 - The Ritz Carlton Laguna Niguel, CA
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* General ad info: Click here | Today's Top News 1. Array adds $713M cancer drug pact with Genentech to deal roster
Array BioPharma ($ARRY) has added another high-profile pact to its roster of big-name collaborations. Genentech has stepped in with an upfront payment of $28 million and a promise of up to $685 million in milestones so it can snag the rights to develop ARRY-575, a preclinical ChK-1 program that will be combined with a similar program of Genentech's and pushed into Phase I. Genentech plans to match ARRY-575 with another Phase I compound, RG7602 or GDC-0475. Genentech will be responsible for the development costs and is also committed to a double-digit royalty stream on the early-stage program. However, the companies also noted that not all the financial details are being disclosed. Genentech's clinical goal is to show that a pair of ChK-1 inhibitors will strip the body's natural defenses against DNA damage, allowing chemotherapy drugs to do their intended work without interference from the protein kinase. "Combining both companies' programs will maximize our chances for success in developing and commercializing this novel cancer therapy," says Array CEO Robert Conway. "We believe ChK-1 inhibition is a key strategy for enhancing the efficacy of chemotherapeutic and other agents in cancer patients." Boulder, CO-based Array has had considerable success attracting some of the biggest names in the industry to partner on programs. Its drugs are allied with Novartis, Amgen, Eli Lilly and AstraZeneca, to name a few. Its lead drugs are ARRY-162, a mid-stage cancer treatment partnered with Novartis, and its solely-owned ARRY-520 for multiple myeloma. Array and Genentech have been partnered for the last 7 years and one of their drugs, GDC-0068, is in Phase Ib. - see the Array release
- check out the Reuters story Related Articles:
Array BioPharma axes 70 as it cuts back on discovery work
Array shares spike on $467M Novartis cancer pact
Amgen delivers $60M upfront for Array diabetes pact Read more about: Genentech, Cancer, Cancer Drugs, Array BioPharma
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2. Biogen, Abbott tout promising MS data from PhIIb daclizumab trial
Biogen Idec and its partner Abbott Labs have taken the wraps off the top-line data from a Phase IIb study of daclizumab, touting some promising results for the once-monthly treatment of multiple sclerosis as they push ahead with an ambitious late-stage program. Researchers said that the 150-mg dose arm demonstrated a 54% reduction in the annualized relapse rate, with "highly statistically significant" data recorded on secondary endpoints. The news marks another upbeat turn of events for the new executive team running Biogen Idec, which has been buoyed by promising data on key programs. And it's a big plus for Abbott as well, which acquired Facet and the big stake in daclizumab for $450 million last year. The companies recruited 600 patients for the study. Researchers studied two doses injected once every four weeks in Phase IIb, with the 150-mg arm reporting better results on the primary endpoint than the 300-mg group. Investigators also noted the "cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 (69% (for 150 mg); 78% (300 mg); in the number of new or newly enlarging T2 hyperintense lesions at one year (70%; 79%); and in the reduction in the proportion of patients who relapsed (55%; 51%). DAC HYP also showed a trend toward improvement in quality of life measures at one year." Doug Williams, Biogen Idec's EVP of R&D, expressed enthusiasm about the results. "The exciting results for DAC HYP, along with previous clinical data, support our continued investigation of this candidate as a promising new approach to treating multiple sclerosis," he said in a statement. "DAC HYP's convenient once-monthly, subcutaneous administration, combined with a strong efficacy profile, suggest that it may provide an attractive option for MS patients. We hope to confirm the results of SELECT in our second registrational trial, DECIDE." Daclizumab is an antibody which binds to CD25, a receptor found on T cells that are believed to be abnormally activated in autoimmune conditions, such as MS. - here's the release Related Articles:
Biogen hands over $30M milestone on daclizumab progress
Facet seeks new bids after Biogen offer flops
Biogen turns hostile in $356M bid to acquire Facet Read more about: Abbott Labs, Biogen Idec, daclizumab
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3. Report: FDA approval for Roche's melanoma drug vemurafenib 'imminent'
Quoting sources, Reuters reports that Roche's remarkable experimental melanoma drug vemurafenib appears headed for an early approval by the FDA. Roche filed for an approval in May, putting it in line for a final decision by November 11. But encouraged by some dramatic evidence that the drug significantly cut the risk of death versus chemotherapy, the news service's source says that an approval may be just around the corner. "We are getting the sense that approval is imminent," the source told Reuters. Vemurafenib, which will be named Zelboraf on the market, is likely to join a roster of new cancer drugs to gain FDA approval. The agency approved Bristol-Myers Squibb's melanoma drug Yervoy last March with an approval for J&J's prostate cancer therapy Zytiga arriving just weeks later. Peak sales of vemurafenib have been estimated at more than $700 million a year. Roche's vemurafenib was advanced by Plexxikon, a biotech that was bought out last March by Daiichi Sankyo in a $935 million deal. The drug took center stage at ASCO last June as a poster child of sorts for drugs developed to target the molecular drivers of cancer growth. - here's the report from Reuters Related Articles:
Roche's vemurafenib plays a starring role at ASCO
Globe highlights targeted cancer drugs from Pfizer, Roche ahead of ASCO
Roche cancer programs angle for a starring role at ASCO Read more about: Roche, Melanoma, vemurafenib
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4. Investor panic could spell tougher times for biotechs
The big message delivered from yesterday's stock market rout was simple: shun risk. Flee to safety. And that kind of investment recipe does not benefit an industry like biotechnology. For biotechs, for whom red ink and high risk are staples of any business plan, it likely meant even less of an appetite for IPOs, which can only make raising fresh funds harder. Biotech IPOs haven't exactly been met with great enthusiasm this year, but going public has at least been an option for some. For biotech companies that are already public, the pain triggered by investor panic was spread far and wide. The Nasdaq Biotech Index has plunged by almost a quarter in the past few weeks. That was in line with the 22% drop in the Massachusetts biotech index tracked by the Boston Globe. The Amex ^BTK has melted from 1340 to 1068--yesterday's close--in just 7 short days. So where the Dow was badly mauled, biotechs were being bludgeoned. Big Pharma companies, which like many multinationals have long been cautious in the wake of the 2008 financial crisis, have been hoarding huge reserves of cash. According to the Star-Ledger, Johnson & Johnson is sitting on $3 billion in cash. Merck has $1 billion in cash on the books. There is a silver lining to the black cloud over Wall Street. A turnaround could push Big Pharmas to spend more of their reserves on new drug deals. And investors looking for bargains could well turn to the biotech sector once the angst has died down a bit. Things were also starting to look up this morning as the Dow jumped more than 200 points and the battered ^BTK surged 3%. - read the story from the Boston Globe
- here's the report from the Star-Ledger Related Articles:
Forbes columnist: Vegas rules apply to biotech investing
Are biotech's tough times over?
Dendreon releases death-eaters into biotech sector stocks Read more about: business development, Biotech Stock, investment
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5. Corey Goodman's upstart biotech garners a $5M Series A
Corey Goodman's fledgling microbiome biotech, Second Genome, has raised $5 million in a small but tidy A round that brought in two new investors. Advanced Technology Ventures and Morgenthaler Ventures have jumped on board a bandwagon of venture groups that includes Wavepoint Ventures, Seraph Group and some individual seed investors. Their money will back an ambitious plan to pursue microbiome-based personalized medicines for a slate of gastrointestinal diseases, including irritable bowel syndrome, inflammatory bowel disease, antibiotic-associated diarrhea and necrotizing enterocolitis. As Ron Leuty at the San Francisco Business Times notes, Second Genome's big idea is to compare the microbiome in healthy guts with diseases ones--analyzing 59,000 bacteria to see which are spurring disease--so they can identify a personalized treatment. And Goodman, a noted academic turned Bay Area biotech entrepreneur, has been gaining support for the upstart. "Over the past decade we have witnessed the enormous impact that personalized medicine can have on patient care," said Goodman, who co-founded the company--formerly known as PhyloTech--and acts as chairman of the board. "Our ability to analyze the entire microbiome and to identify signatures gives us a key set of tools to unlock the potential of microbiome?based personalized medicine in major disease areas." - read the Second Genome release
- here's the story from the San Francisco Business Times Related Articles:
A drug development revolutionary advocates radical change in R&D
New biotech venture firm targets private/public deals
Promising stem cell start-ups merge, add $11.5M
Pfizer's biotech leader makes an unexplained exit Read more about: Biotech Venture Capital, personalized medicine, Corey Goodman, Second Genome
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Also Noted
SPOTLIGHT ON... Intercept nails $165M diabetes pact with Servier Intercept Pharmaceuticals has struck a $165 million deal with Les Laboratoires Servier to collaborate on new TGR5 agonists for diabetes and other metabolic ailments. "We are very happy to enter into this collaboration with Intercept which will allow us to further expand our diabetes and metabolic disease franchise," stated Dr. Emmanuel Canet, head of Servier R&D. "TGR5 is a target of great interest with its effects on GLP-1 that complement those of other classes of marketed diabetes drugs." Release  @FierceBiotech: Is the FDA writing a recipe for the failure of biosimilars in the U.S.? Report | Follow @FierceBiotech
@JohnCFierce: ATV and Morgenthaler line up behind Second Genome, a Corey Goodman biotech, with a small but tidy $5M Series A. | Follow @JohnCFierce @MaureenFierce: Several Russian companies have establish a $113M joint venture designed to develop innovative treatments in the country. News | Follow @MaureenFierce > Lexicon Pharmaceuticals announced this morning that LX1032 or telotristat etiprate posted positive mid-stage data demonstrating its potential for reducing symptoms associated with tumors. Story > A group of healthcare watchdogs led by Gary Schwitzer says they're vehemently opposed to any relaxation of the FDA's conflict of interest rules for advisory committee members. The group offered a list of experts who could fill empty AdComm spots. Story > Human Genome Sciences has hired Craig Parker as senior vice president of strategy and corporate development. Parker had been CEO and co-founder of Vega Therapeutics. Release > NeurogesX has entered into a $20 million loan agreement with Hercules Technology Growth Capital. Release > Apricus Biosciences say it is filing for an approval of its ED drug Vitaros in Latin America. Release Pharma News @FiercePharma: Study finds Revlimid's interaction w/Pgp affects blood levels, so dosing might need tweaks. Article | Follow @FiercePharma > Pharma feels threatened by new US austerity push. Article > Merck, Pfizer among cash stashers as markets gyrate. Story Biotech Research News > Gene discovered that regulates the timing of our tickers. News > DoD gives NeoStem $1.7M to develop adult stem cells for osteoperosis. More > Scientists discover possible genetic route to killing pain. Details > Standford's SPARK hosts ideas so "crazy" they just might work. Story > Researcher find faulty gene responsible for some ovarian cancers. Report > Texas Gov. Perry support adult stem cells after undergoing procedure. Article Manufacturing News > At the box office, bad boy pharma on top. Details > UPS sees new tech, distribution models for supply chain. Story > Roche deals API plants in SC, CO. Article > Merck pushes pharma to top jobs-cutter. More > NSF expands into chemical reference standards. Report And Finally... Contrary to widespread belief chimps have an altruistic side, researchers say. Some had speculated that altruism had to be a human trait that developed as humans evolved. Release > 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. > PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC This Conference offers a unique opportunity to join FDA representatives and industry experts in face-to-face dialogues. FDA speakers provide updates on the current state of efforts impacting global regulatory strategies. Industry professionals will present case studies on how they employ global strategies in their daily processes. Click here. > PDA 2011 Combination Products Workshop - Sept. 21-22, 2011 - Washington, DC This workshop focuses on the device design validation requirements of FDA's Quality System Regulation and the international harmonized quality standard ISO 13485:2003 which may be applied during the life-cycle of a combination product. Click here. > Pharmaceutical Strategic Alliances - Sept 21-23, 2011 - New York, NY IS THIS BIG PHARMA'S LAST DECADE? Hear from leading executives such as Biogen's CEO George Scangos, BMS's CEO Lamberto Andreotti and J & J's Tom Heyman at PSA, the only conference to deliver detailed strategic analysis on the biopharma subjects you need to understand now. www.windhover.com/psa > CBI's Pharma/Bio Forum on Preclinical Development - September 26 - 27, 2011 - Boston, MA Enhance your capabilities of utilizing biomarkers, translational research and toxicity detections within global regulations. The forum provides a unique platform for industry professionals to manage successful partnerships throughout the preclinical R&D process. Register now: www.cbinet.com/preclinical. > AdvaMed 2011- Register Now and Save 300! - September 26-28, 2011 - Washington, DC Whether you focus on compliance or business development, marketing, finance or regulatory affairs, AdvaMed 2011 is where medical device and diagnostic industry stakeholders come to do business, share best practices, and influence policy. Don't miss out. Early registration ends Aug. 5th. www.AdvaMed2011.com > 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD This interactive forum will closely examine the latest developments, preparation and use of inspection standards and practical aspects of manual and automated methods along with the regulatory and compendial requirements that govern them. Click here. > Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA PDA, ISPE, the FDA and EMA have created a joint conference dedicated to teaching the principles of ICH Q10. This will be a unique opportunity to learn principles from companies that implemented a Pharmaceutical Quality System across the product lifecycle according to the ICH Q10 model. Click here. > 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" - Oct 6, 2011 "Cancer Immunotherapy: A Long Awaited Reality" is a unique, single-day conference event that unites founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy. For information, please email info@mdbpartners.com or contact Michael Becker or Janet Dally of MD Becker Partners at phone (267) 756-7094. To register or for more information, visit www.regonline.com/mdbpartners > 19th Annual BioPartnering Europe - 9-11 October 2011 - London, UK Take your place at the table with global leaders, put your company in the spotlight and help define the future of medicine. Join us for BioPartnering Europe in London this October. Visit: http://www.techvision.com/bpe > US Conference on Rare Diseases and Orphan Products - October 11-13, 2011 - Washington, DC The Rare Diseases and Orphan Drugs Summit 2011 is the first annual program representing a collaboration among academic researchers, clinical researchers, pharmaceutical and biotechnology companies, regulatory and health agencies, patient organizations, payors and venture capital/private equity concerns to address the need for effective therapies for rare diseases. Learn more. > PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD This conference will gather industry professionals to network and benefit from a program that demystifies the underlying science of microbiology and seeks to solve the problems that our industry faces. The agenda will include presentations from regulatory and industry representatives globally. Click here. > BioNetwork West 2011 - Oct. 24-26 - The Ritz Carlton Laguna Niguel, CA BioNetwork is the key industry biopharma partnering event that provide the essential meeting place for pharma and biotech companies to develop relationships and move programs forward. Get 25% off with code 10386XZ88EN. For more info and to register now, visit www.bionetworkus.com, call 888-482-6012.
| > New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative This FierceMedicalDevices eBook examines the background situation, current position and the future of the CDRH’s revision of the 510(k) premarket notification process. Click here to download today. > Capitalizing on the Outsourcing Option - New Fierce eBook Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.
| > 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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