| This week's sponsor is Rules-Based Medicine. |  |
Today's Top Stories
1. Roche gearing up to seek approvals of breast cancer treatment
2. FDA staffers: AZ, BMS diabetes drug dapagliflozin has risks
3. Transcept Pharma faces more hurdles to gain approval of sleep drug
4. Valeant Pharma's $345M buyout signals opportunity for biotechs
5. Biotech Zyngenia sees growth with MedImmune vets at helm
6. Vical, Astellas ink $130M vaccine licensing deal Also Noted: Novella Clinical
Spotlight On... Seattle Genetics' stock falls despite panel recommendation
CoLucid Pharma has new chief; Biotech center in Wisconsin faces construction woes; and much more... More Fierce Life Sciences News:
1. Medicis shares drop on death at CEO's house
2. Transcend Medical boosts Series B to $51M
3. Should pharma refocus on customers, not shareholders?
| Sponsor: An Expert Briefing: Biotechnology 101 FierceLive! Webinars > An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist
Events > Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR
> Rutgers Mini MBA: BioPharma Innovation Program
> Skill-building and Summer Fun in Boston!
> Online Pharmaceutical & Healthcare Marketing MBA for Executives
> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA
> PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC
> PDA 2011 Combination Products Workshop - Sept. 21-22, 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
> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA
> BIO China 2011 - October 12-13 - Shanghai, China
> PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD
Marketplace > Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years
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* General ad info: Click here | Today's Top News 1. Roche gearing up to seek approvals of breast cancer treatment
Roche has its eyes on another cancer drug approval after the Swiss drug giant met the primary goal of a pivotal trial for a combination therapy against a form of breast cancer. Yet at least one analyst questions whether the data are enough for a U.S. market green light. The trial found that the experimental antibody pertuzumab, when given with Herceptin and the chemo drug docetaxel, helped patients with HER2-positive breast cancer live longer without their cancer getting worse than those who got only Herceptin and chemo. With no new safety issues found in the study, Roche aims to seek regulatory approvals for the treatment this year. "These results with pertuzumab combined with Herceptin and docetaxel are very encouraging and represent our commitment to developing potential new personalized options for people with this aggressive disease," Hal Barron, Roche's chief medical officer and global head of product development, said. While the trial hit its primary endpoint of progression-free survival, Sanford C. Bernstein analyst Jack Scannell said Roche might need to come to regulators in the U.S. with data on overall patient survival to gain approval. "The Food and Drug Administration wonders if a therapy is worth approving if all it can claim is that it slows the rate at which CT and MRI scans get worse," Scannell wrote today in a note to clients, as cited by Bloomberg. "The size of pertuzumab's incremental benefit may also come under scrutiny given the likely cost." Any way you look at the data, breast cancer remains a disease without a cure. With pertuzumab, Roche at least has a new way to home in on HER2, which is a driver of growth in about a quarter of all breast cancers. It's also the receptor that Roche's blockbuster drug Herceptin targets. Yet the experimental antibody hits a different region of the receptor, providing a multi-pronged attack on the breast tumors. - here's Roche's release
- see the coverage from Bloomberg
- have a look at Reuters' report Related Articles:
Genentech breathes new life into failed breast cancer drug
Dying breast cancer patient calls for personalized medicine
Globe highlights targeted cancer drugs from Pfizer, Roche ahead of ASCO Read more about: breast cancer, Roche, pertuzumab
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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. FDA staffers: AZ, BMS diabetes drug dapagliflozin has risks
AstraZeneca and Bristol-Myers Squibb's experimental diabetes drug dapagliflozin comes with some risks attached, according to FDA staffers. The drug appears to be linked with breast and bladder cancer, and to some serious liver risk. Dapagliflozin is part of a new class of drugs called SGLT2-inhibitors that prevents sugar from being absorbed, forcing it to be excreted through the urine. "Several unexpected safety issues identified in this clinical development program were of sufficient concern to FDA to merit discussion of their impact on the overall benefit-risk consideration of dapagliflozin," said agency reviewers, according to Bloomberg. Nine cases of bladder cancer and nine cases of breast cancer were found in trial subjects taking the diabetes drug; just one of each type of cancer was found in the control group. Additionally, staffers found that the diabetes treatment may have led to two instances of serious liver injury. "At the least, we expect a strong warning in the label for the possibility of liver injury, and we also think there could be a requirement for liver function monitoring," ISI Group analyst Mark Schoenebaum told Reuters. "This could reduce the competitiveness of (the drug) in the real world." While some analysts think an outside panel of experts will still recommend the drug's approval, the agency would likely call for a strong warning about the drug's risks. That may cause physicians to use caution until long-term safety data are available--and could cut into AZ and BMS's bottom line. The FDA's dapagliflozin decision will be closely watched by Johnson & Johnson, Eli Lilly, Boehringer Ingelheim and Astellas Pharma--all of whom are developing their own SGLT2-inhibitors. - read the Bloomberg report
- get more from Reuters Related Articles:
Bristol-Myers' pioneering diabetes drug bests rivals in 2-year study
BMS, AZ diabetes drug will face scrutiny
AZ, BMS drug dapagliflozin supports weight loss
AZ, BMS tout new batch of PhIII diabetes data for dapagliflozin Read more about: AstraZeneca, Type 2 Diabetes, Bristol-Myers Squibb, dapagliflozin
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3. Transcept Pharma faces more hurdles to gain approval of sleep drug
Will three times be a charm for Transcept Pharmaceuticals? The developer of neuroscience drugs ($TSPT) revealed late last night details of an expected complete response letter from the FDA for the firm's second attempt at approval of a middle-of-the-night insomnia drug called Intermezzo. The FDA has again declined to approve the drug--which is supposed to be taken by those who wake up in the middle of the night and have trouble falling back asleep--amid concerns over potential impairment of people who get behind the wheel after taking the treatment. The agency, which has previously raised the driver impairment concern, apparently wasn't satisfied with the data from a driver study the company conducted after the first denial. Transcept said it plans to meet with regulators to discuss next steps, which might include another driving study. Yet even a delayed approval of the drug (zolpidem tartrate sublingual tablet)--which uses the same ingredient as Sanofi's Ambien--could be costly to the developer due the terms of its partnership with Purdue Pharma. Purdue no longer has to pay Transcept a $30 million fee for approval of the treatment if the marketing green light comes after Sept. 23, according to the two firms' deal. Yet Transcept said it had about $59.6 million in cash as of June 30, and that should be enough to fuel its operation for a while based on its $1.2 million monthly burn rate. - here's Transcept's release
- see the coverage from RTTNews Related Articles:
Transcept Pharma expects bad news on insomnia drug from FDA
Transcept readies second attempt at sleep drug approval
Purdue, Transcept ink $145M commercialization deal Read more about: Purdue Pharma, Transcept Pharmaceuticals, Intermezzo
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4. Valeant Pharma's $345M buyout signals opportunity for biotechs
Valeant Pharmaceuticals' ($VRX) planned $345 million acquisition of Johnson & Johnson's ($JNJ) Ortho Dermatologics could be another positive sign for biotech companies, as Big Pharma outfits shed their auxiliary businesses to enhance focus on novel drugs. Janssen Pharmaceuticals, a J&J unit, and French drug giant Sanofi ($SNY) have both opted to sell dermatology product businesses to specialty Canadian pharma Valeant this week. And at least in Sanofi's case, the Big Pharma wants to pump the proceeds of its $425 million sale of its Dermik skincare group into its core pharmaceutical business. For biotech firms, that could be good news as Sanofi, J&J and other huge drugmakers form partnerships with outside developers with novel science.
As we've noted before, J&J is one of the perennial standouts on the biotech deal front. The company is realizing the payoff of its investments in deals such as its partnership with Vertex Pharmaceuticals ($VRTX), which gave the company European rights to newly approved hepatitis C drug telaprevir (Incivek), and its $1 billion buyout of Cougar Biotechnology, which brought J&J its recently approved prostate cancer drug abiraterone (Zytiga). And further external deals are in the offing, J&J executives have said. In the meantime, small developers could also benefit from opportunities to gain rights to drug programs that Big Pharma outfits decide to discontinue internally. One of the great historic examples of this would be how Cubist Pharmaceuticals ($CBST) grabbed rights on the cheap to the antibiotic Cubicin from Ely Lilly ($LLY) back in the 1990s and developed the asset into the top-selling product it is today. - here's Valeant's release
- check out Reuters' report Related Articles:
Valeant CEO scanning biopharma horizon for fresh targets
Biovail, Valeant Pharma strike merger deal
J&J lays out blockbuster R&D strategy, plans for 11 new meds Read more about: Sanofi-Aventis, Johnson & Johnson, Mergers and Acquisitions, Valeant Pharmaceuticals
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5. Biotech Zyngenia sees growth with MedImmune vets at helm
Zyngenia has graduated from a virtual biotech to a very real R&D operation under the leadership of former MedImmune R&D chief Peter Kiener, who is CEO of the early-stage researcher of antibody-derived treatments. The firm's drugs are supposed to be able to address multiple targets of disease with a single molecule. Keiner joined the company, whose technology comes from Scripps Institute in La Jolla, CA, back in 2009 when there were only three employees. With some financial backing from venture firm New Enterprise Associates--where former MedImmune CEO and current Zyngenia Chairman David Mott is a partner--the upstart biotech has now grown to 30 employees and resides in a 14,000-square-foot headquarters in Gaithersburg, MD, The Gazette reports today. The newspaper says that much of the employee growth has come through the start-up's recruitment of folks from Maryland's major biotech shops Human Genome Sciences ($HGSI) and MedImmune, which AstraZeneca bought in 2007 for more than $15 billion. Last year, Zyngenia pulled in a $15 million addition to its Series A, which brought in an initial $10 million back in 2009 from NEA. "When I joined MedImmune, there were about 50 people in research and development and it grew to more than 1,000 by the time I left," Kiener told The Gazette. "It was a great place to work. Seeing how MedImmune grew made it easy for me to think about starting over again with the kind of people I work with at Zyngenia." -see the newspaper's profile on Kiener and his start-up Related Article:
MedImmune vets launch biotech with $10M Series A Read more about: Zyngenia, Peter Kiener
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6. Vical, Astellas ink $130M vaccine licensing deal
Japan's Astellas will pay up to $130 million to license a vaccine to prevent cytomegalovirus (CMV) reactivation in transplant recipients. The disease is typically dormant in those who are healthy but can cause illness in immunocompromised people, such as those who've received an organ transplant. A Phase III trial of TransVax in hematopoietic stem cell transplant recipients and a Phase II study in solid organ transplant patients are slated to begin in 2012. Astellas will develop and commercialize TransVax in the U.S. and for all territories in the rest of world, with Vical retaining the right to co-promote the vaccine in the U.S. The Japanese drug developer will take on all developing and commercialization costs. Vical will continue to assist Astellas with some manufacturing and development work related to the vaccine. "Our first-in-class CMV vaccine would complement the existing Astellas franchise in the transplant market, a strategic focus area for Astellas," explained Vical CEO Vijay Samant in a statement. "This program will bring together Astellas' substantial resources and strong commercial presence in key world markets, and Vical's development, regulatory and manufacturing expertise with DNA-based product candidates." - here's Vical's release Related Articles:
Vical raises $20M for vaccine programs
LifeCycle shares soar after low-dose organ rejection drug edges Prograf in Ph3 Read more about: Vical, Astellas Pharma, Licensing deals, TransVax
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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... Seattle Genetics' stock falls despite panel recommendation Seattle Genetics' stock price fell to $19.17 in pre-market trading despite yesterday's expert panel recommendation accelerated approval of the company's drug, brentuximab vedotin (Adcetris). Investors are apparently concerned that the FDA may ask for more data about the drug's benefits given the fact that the developer only conducted two small trials for the blood cancer drug. The developer's stock dropped to $18.81 after the market opened. Story  @FierceBiotech: Dendreon, cancer drug developers top slate of buyout candidates. Article | Follow @FierceBiotech
> Aslan Pharmaceuticals has secured a license of Array BioPharma's gastric cancer drug, ARRY-543, a Her2/EGFR inhibitor. Array will financially back the treatment through proof-of-concept, and Aslan will search for partners for commercialization after Phase II testing. The deal could include work on a second compound. Story > While placebos didn't improve patients' lung function in a recent study, they did make patients feel better. All 39 asthma patients received placebo treatment, an albuterol inhaler and fake acupuncture three times each, and reported greater symptom relief than was documented medically. Item > There's trouble brewing for a new Madison, WI, biotech center. According to Madison.com, the Madison Development Corp. has to cover a $1.5 million to $2.5 million gap in construction costs, or it could lose a $4.5 million federal grant. And that would jeopardize the entire operation. More > Fraunhofer USA has established a new six-year partnership to the University of Delaware. The collaboration will provide additional technology and expertise to both the University and Fraunhofer, according to Fraunhofer president Georg Rosenfeld. Report > CoLucid Pharmaceuticals has appointed Thomas P. Mathers as its new CEO. Release > Piramal Life Sciences has entered the second stage of its drug discovery partnership with India's Department of Biotechnology. The company hopes to find 14,000 bioactive cultures as it works with nine different national institutes in India. The treatments could be used on a variety of diseases ranging from cancer to inflammation to diabetes. News Pharma News @FiercePharma: Expect more pharma M&A, less pharma hiring. Report | Follow @FiercePharma > How will the generics biz cure its blockbuster hangover? Piece > Medicis shares drop on death at CEO's house. Item And Finally... A team at the Harvard Medical School has cracked the genetic code of E. Coli, showing that they can take control of a genome rather than simply copying it, team leaders Farren Isaacs and George Church tell New York Times' Nicholas Wade. 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 > 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. > 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. > 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. > 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.
| > Developing Enterprise M2M Apps in Days or Weeks - Not Months or Years With a surge in remote monitoring devices, mHealth developers are clamoring to build M2M applications that can transmit patient data in real time. Download this whitepaper today to learn more about developing apps for pharma-manufacturing and beyond. Download this white paper today!
| > 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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