| This week's sponsor is Rules-Based Medicine. |  |
Today's Top Stories
1. J&J's success with Hep C partners might hit a snag
2. Transcept Pharma expects bad news on insomnia drug from FDA
3. FDA proposes companion Dx guidelines
4. Sanofi and Regeneron hit goals in RA drug study
5. Biotech Allozyne aims for 'backdoor' public debut Editor's Corner: Superbug antibiotics: New drugs advance amid R&D shortfall Also Noted: Novella Clinical
Spotlight On... Merck chief concerned over future U.S. biopharma innovation
Idera Pharma chief upbeat despite setback in Merck KGaA pact; InSite Vision raising $22.2M in financing; and much more... More Fierce Life Sciences News:
1. MIT's Langer discusses targeted drug delivery
2. Instant nano-delivery vehicle for brain cancer, just add water
3. Penn prof files complaint over ghostwritten Paxil study
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Superbug antibiotics: New drugs advance amid R&D shortfall
 It sounds like something out of a science fiction B-movie or a Steven King novel. Out-of-control superbugs that are resistant to anything humans can throw at them. Unfortunately, it's no fiction. It's deadly serious. The problem is so serious that the World Health Organization recently warned of an impending drug-resistance crisis if humanity does not do something quickly. WHO Director-General Margaret Chan forecasted the approach of a "post-antibiotic era, in which many common infections will no longer have a cure and, once again, kill unabated."
The WHO called on governments and researchers to step up funding and discovery of new medicines to take the place of antimicrobial drugs that have been rendered ineffective or useless through the evolution of drug-resistant diseases. At the moment, there is not much to take the place of current antibiotics that are increasingly ineffective. Today, there are only two Big Pharma companies, GlaxoSmithKline and AstraZeneca, with active antibiotic R&D programs, UPI recently reported, citing the Infectious Diseases Society of America. In 1990, there were nearly 20. Read the full superbug antibiotics report Read more about: antibiotics
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Today's Top News 1. J&J's success with Hep C partners might hit a snag
Johnson & Johnson ($JNJ) is one of the best in the business at tapping outside developers for new drugs, but the Big Pharma's success on this front in the hepatitis C arena appears have brought with it some controversy. Even though its Hep C drug is still in late-stage development, Swedish biotech Medivir isn't comfortable with the fact that its partner J&J is promoting Vertex Pharmaceuticals' ($VRTX) hot drug against the liver disease, Incivek, Medivir CEO Ron Long told Bloomberg. And Long wants J&J to resolve the potential conflicts of having one company promote two different drugs for the same disease to the same doctors. "They have to resolve that issue," Long said, as quoted by Bloomberg. "You can't use best efforts if you are prioritizing one drug over the other. I think their position is unsustainable and I've told them so." Medivir's issues with J&J might become more common with so many biotechs looking to Big Pharma to market their drugs, and large drug companies doing the smart thing and spreading their bets in key therapeutic areas. As we all know, history tells us that most of the drug programs won't reach the market as they fail at some point in the development process. On the other hand, J&J saw its partner Vertex win FDA approval of Incivek with flying colors in May, and Medivir's TMC435 showed that it might be able to provide even better cure rates than Incivek, according to a mid-stage trial. Still, Medivir, whose 435 wouldn't likely hit the market until 2013, still has to prove that its drug can have that kind of success in late-stage trials. J&J might want to see whether its Swedish partner's drug can pass the big test in the clinic before it starts to divide its kingdom. But with so much riding on the success of 435, it's no surprise to see the CEO voicing some concern over the potential conflict. - check out the Bloomberg story Related Articles:
FDA approves mega-blockbuster Vertex hep C drug Incivek
J&J lays out blockbuster R&D strategy, plans for 11 new meds
Medivir ponders layoffs
J&J is on a roll as drug deals deliver blockbuster approvals Read more about: Hepatitis C, vertex, Johnson & Johnson, Medivir
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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. Transcept Pharma expects bad news on insomnia drug from FDA
With its second shot at trying to gain FDA approval of its insomnia drug expected to fall short, Transcept Pharma ($TSPT) has some choices to make about how to proceed with development of its lead candidate. The company's application for approval of Intermezzo--a treatment intended for people who wake up in the middle of the night and struggle to fall back asleep--appears to be dogged again with safety concerns. Yet company officials, who spoke with FDA staff earlier this week, say they won't have details on the nature of the agency's safety concerns until after they receive an expected complete response letter on or before a PDUFA data of July 14. Transcept, which is going to provide plans for future development of the treatment later this week, will likely have to show the FDA more safety data. Two years ago, the agency declined to approve the treatment amid concerns about whether the drug would cause people who took the treatment to be impaired while driving after they wake up. The company's latest application included data from a study that showed no impairment four hours after people took the drug got behind the wheel. Indeed, the FDA has a history of making insomnia med developers jump through additional hoops, often because of the agency's safety concerns. Neurocrine Biosciences ($NBIX) and Somaxon ($SOMX) are just two biotechs that we've seen go back and forth with the agency in pursuit of gaining approval of insomnia drugs. At least Transcept can take some comfort in the story of Somaxon's quest to get FDA approval of sleep med Silenor, which failed to gain the green light from regulators twice before they allowed it onto the U.S. market. - here's Transcept's release
- check out the news from TheStreet
- see Bloomberg's coverage Related Articles:
Transcept readies second attempt at sleep drug approval
Transcept shares battered after FDA denies Intermezzo OK Read more about: insomnia, Transcept Pharmaceuticals, Intermezzo
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3. FDA proposes companion Dx guidelines
The FDA has proposed new rules for the review of companion diagnostics--tests designed to identify patients most likely to respond to a drug, or predict unfavorable side effects. Companion diagnostics are increasingly attractive to drug developers because the pairings can help healthcare providers improve outcomes for certain patients while saving time, money and potentially serious side effects by withholding treatment from those who are unlikely to respond to the therapy. The FDA's proposal recommends early engagement between the FDA and developers; it explains the agency's plan to simultaneously review therapies and companion diagnostics. The proposal also outlines instances in which the regulator may approve a medicine without a companion test. Therapies for serious illnesses that have no other available treatment may receive priority review, with the companion diagnostic approved later. The FDA is soliciting comments on the draft guidance for 60 days. "These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability," said CDRH director Jeffrey Shuren in a statement. "It is the agency's goal to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients." - here's the FDA release
- read the Reuters article Related Articles:
Algorithms assist in personalized diagnostics
In new healthcare world, are diagnostics king?
Experts discuss challenges, promises of personalized medicine Read more about: FDA regulation, companion diagnostics
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4. Sanofi and Regeneron hit goals in RA drug study
Regeneron appears to be on a roll. Just weeks after an FDA panel backed its eye drug for approval, the company ($REGN) and French drug giant Sanofi ($SNY) have shown that an experimental antibody drug has significantly improved symptoms of rheumatoid arthritis. The companies' Phase IIb "MOBILITY" trial showed that the drug, sarilumab, in combination with a standard RA treatment, methotrexate, made a "significant and clinically meaningful improvement" in RA patients' symptoms compared with those who in the study treated with methotrexate alone. And RA symptom improvements were the greatest in patients treated with the highest dose of sarilumab in the 306-patient study. Yet the drug fell short in a Phase IIb study for a separate inflammatory disease, ankylosing spondylitis. "Following these encouraging Phase IIb results in rheumatoid arthritis, the companies are currently discussing the dose(s) of sarilumab to advance into the Phase III portion of the MOBILITY trial," Elias Zerhouni, Sanofi's global head of R&D, said. Still, Regeneron investors are likely most enthusiastic about the Tarrytown, NY-based company because of its solid chances of gaining FDA approval later this summer for its eye drug called VEGF Trap-Eye. The FDA action date on the company's application for approval of the experimental treatment is Aug. 20. - here's Regeneron's release
- see the report in RTTNews Related Articles:
Regeneron eye drug gets green flag at AdComm
Sanofi, Regeneron buoyed by Ph3 colon cancer success for aflibercept Read more about: Regeneron Pharmaceuticals, VEGF Trap-Eye, Sanofi, sarilumab
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5. Biotech Allozyne aims for 'backdoor' public debut
Intrepid biotechs tend to get creative about financing strategies when traditional funding routes appear too rocky to traverse. After considering a traditional IPO, little-known biotech Allozyne is now advancing plans to go public by acquiring a shell company that is listed on the Nasdaq. Allozyne CEO Meenu Chhabra talked to Xconomy's Luke Timmerman about the company's plans. The Seattle-based firm aims to buy the public shell of Poniard Pharmaceuticals ($PARD), which fizzled after its small-cell lung cancer drug failed in clinical development. The deal would give Poniard shareholders a 35% stake in the new company and provide Allozyne the ability to tap the public markets for future financing. The start-up has been around for about 6 years and has raised $43 million from venture backers such as MPM Capital. Its gambit appears to be another sign of the tricky financing environment for biotechs. Wall Street doesn't seem interested in IPO stories involving young firms like Allozyne, which is in Phase I with an experimental multiple sclerosis therapy (even some venture firms are staying away from such early-stage developers). And the scant IPO successes of recent years in biotech have involved companies--including Pacira Pharmaceuticals ($PCRX), Aveo Pharmaceuticals ($AVEO) and Ironwood Pharmaceuticals ($IRWD)--with late-stage drug candidates. Indeed, public investors seem most comfortable in backing IPOs for companies with strong pipelines with near-term chances to get a product onto the market. Strong support from large pharma partners helps too. Allozyne's plan to go public faces some challenges of its own, including winning enough votes from Poniard shareholders to consummate the deal and gaining favor among public investors to support the company in the future. Yet the firm is going down a road that appears to have worked out for other biotechs such as neuroscience drug developer Transcept Pharmaceuticals ($TSPT), which went public in 2009 through its buyout of shell company Novacea. Novacea, like Ponaird, went south due to the failure of a cancer drug. - check out Xconomy's piece Related Article:
Allozyne goes public via merger with Poniard
Seattle start-up gains $30M in second venture round Read more about: Biotech IPO, Poniard, Allozyne
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Also Noted | This week's sponsor is Novella Clinical. |  | Your goal is to give people more opportunities to enjoy life's little moments. We’re proud to be a part of your mission, and promise to give you the individual attention you deserve, with therapeutic and in-country expertise to help reach your goal.
www.novellaclinical.com/bd |
SPOTLIGHT ON... Merck chief concerned over future U.S. biopharma innovation Merck ($MRK) CEO Kenneth Frazier has weighed in on some of the U.S. biopharmaceutical industry's most pressing issues in an opinion piece in the Wall Street Journal. He warns that weak protections on drug patents, drug pricing policies and the high cost of drug development threaten the global leadership of the U.S. biopharma industry. The op-ed calls on policymakers to take actions that would support further innovation in biopharma. Item  @FierceBiotech: Superbug antibiotics: New drugs advance amid R&D investment shortfall. Special Report | Follow @FierceBiotech
> Xconomy caught up with Idera Pharmaceuticals ($IDRA) after the developer of drugs that target Toll-like receptors suffered a setback last week in its collaboration with German drug maker Merck KGaA. Idera, as the story notes, is still working with the other Merck ($MRK) and has money in the bank to continue its research. Article > InSite Vision ($INSV), a developer of eye treatments, says that expects to receive gross proceeds of $22.2 million through a private placement of the firm's common stock and warrants. Release > Array BioPharma ($ARRY) said has licensed a cancer drug called ARRY-543, which is entering Phase II trials, to Singapore-based ASLAN Pharmaceuticals. Item > PharmaGap, an Ontario-based developer of peptide drugs, said it has competed the first close of a private financing for a total of $500,000. Announcement > Montreal-based Thallion Pharmaceuticals ($TLN) said it has temporarily stopped the screening and enrollment of a high-dose cohort in a Phase II study of an antibody treatment in patients with STEC infections, as a precautionary measure after observing an "out-of-specification" finding in stability testing. Release Pharma News @FiercePharma: Novartis mulls IPO on China's planned int'l board. News | Follow @FiercePharma > Studies: Gilead HIV drugs prevent transmission. Report > Justice hits J&J with misdemeanor in Natrecor probe. Article > Note to Pfizer: Bayer shopping for vet buys. Item > Penn prof files complaint over ghostwritten Paxil study. News > Hospitals want action on 'unprecedented' drug shortages. Report Drug Delivery News > Alnylam applies for trial of RNAi delivery tech for high cholesterol. Item > MIT's Langer discusses targeted drug delivery. Report > EnGeneIC, scientists search for antibodies to grab hold of tumors. Item > Multitasking gel, polymer chain could deliver many drugs at once. Article > Instant nano-delivery vehicle for brain cancer, just add water. Story Medical Device News > Kinetic Concepts to be bought for $4.98B. News > Medtronic asks for $2.5M to expand Jacksonville ops. Article > Shuren talks CDRH performance, staffing in Boston. News > Representatives discuss Scottish device, diagnostic biz. Story And Finally... As rumors swirl, Shire eyes Vyvanse for binge eating. Article > 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
| > BioImmersion: Biotech for the Non-Scientist - July 13-15, 2011 - Chicago, IL Three-day class delivering an in-depth understanding of both fundamental and advanced science and technology concepts. Focusing on the healthcare industry, participants learn about biologics- what they are, how they are discovered, how they are developed and how they are used as therapies. Learn More. > 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 > 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.
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| > 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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