 | 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. |
Today's Top Stories
1. Bristol-Myers snapping up Amira Pharma for $325M
2. Lilly's bet on R&D pipeline over mega mergers faces hurdles
3. J&J, Pfizer grab CHMP backing for key new drugs
4. Pfizer commits $100M to Mission Bay project
5. Herper: Vertex's CF saga a harbinger for targeted drug R&D Also Noted: GE Capital Healthcare Financial Services
Spotlight On... Merck, Simcere team up in China
Roche bounces back from rough 2010; Idera psoriasis treatment put on clinical hold; and much more... More Fierce Life Sciences News:
1. Lilly eyes vet assets; Pfizer says all or nothing
2. AZ: No plans for follow up on Brilinta-aspirin link
3. J&J board blames woes on middle managers, staff cuts
| This week's sponsor is INC Research. |  |
| Sponsor: 510(k) 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
> Pharmaceutical Strategic Alliances - Sept 21-23, 2011 - New York, NY
> AdvaMed 2011- Register Now and Save 300! - September 26-28, 2011 - Washington, DC
> CBI's Pharma/Bio Forum on Preclinical Development - September 26 - 27, 2011 - Boston, MA
> 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
> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative
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* General ad info: Click here | Today's Top News 1. Bristol-Myers snapping up Amira Pharma for $325M
Bristol-Myers Squibb ($BMY) has made a move to buy up potential drugs for lung disease and inflammation, agreeing to purchase venture-backed biotech Amira Pharmaceuticals. The deal gives BMS footing in a hot field involving drugs against pulmonary fibrosis, a lung disease for which there are no FDA-approved treatments. New York-based Bristol-Myers will pay $325 million upfront to scoop up Amira, a 2010 Fierce 15 company, and the drug powerhouse has committed up to $150 million in additional milestone payments to Amira's investors. This deal provides a nice payday for Amira backers such as Avalon Ventures, Novo A/S, Prospect Venture Partners and Versant Ventures, the four funds that had bet a total of $28 million on the biotech and its programs as of last September. Amira's scientists in San Diego are expected to keep advancing the firm's research after the deal closes. Some of the hot commodities the group has been working on include AM152, a small molecule LPA1 receptor antagonist that it's gearing up to move into mid-stage development for pulmonary fibrosis and scleroderma, as well as a preclinical autotaxin program. Amira CEO Bob Baltera made the tough call to trim the staff last fall at Amira--which was founded in 2005 by Merck vets Peppi Prasit, Jilly Evans and John Hutchinson--in part to focus the firm's resources on ushering its drugs through trials. Pulmonary fibrosis drugs have drawn significant interest in recent years. Gilead Sciences ($GILD) shelled out $225 million last year to scoop up Arresto BioSciences to boost its R&D in the area, Reuters reported. And InterMune's ($ITMN) stock price rallied after the European Commission approved its pulmonary fibrosis drug Esbriet (pirfenidone). Another contender in this market is Stromedix, a venture-backed upstart pursuing mid-stage data on its IPF drug STX-100.
"As part of the continued execution of our focused biopharma strategy, Bristol-Myers Squibb has identified fibrotic diseases as an area of high unmet medical need that complements our research efforts in several of our therapeutic areas," said Elliott Sigal, the company's president of R&D. - here's the release
- check out Xconomy's coverage
- read the Reuters piece Related Articles:
Amira Pharmaceuticals - 2010 Fierce 15
Bristol-Myers Squibb - The world's biggest R&D spenders
Amira slashes staff in a bid to slow burn rate Read more about: Bristol-Myers Squibb, Mergers and Acquisitions, Biotech deals, Amira
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2. Lilly's bet on R&D pipeline over mega mergers faces hurdles
Eli Lilly ($LLY) has drawn some fresh criticism for the risk in its strategy to rely on its own pipeline to bolster its future product portfolio rather than seek mega mergers like those that some of its pharma counterparts have jumped on. As Lilly grapples with one of the industry's largest attacks from generic drug competition, the company says on its website that it now has 9 drugs in late-stage development and three under review at the FDA. Some of those late-stage contenders include solanezumab for Alzheimer's disease and a long-acting diabetes drug called LY2189265. Lilly is also weighing potential acquisitions to boost its revenue, Reuters reports. Yet the firm has banked more heavily on its pipeline than an analyst who follows the firm's stock would like. "The whole dynamic of this company now is how much you buy into their pipeline, but I think it's high-risk," Atlantic Equities analyst Richard Purkiss told Reuters. While the firm's lead Alzheimer's drug could be a big seller if it passes through trials and regulatory review, he said, the compound and other late-stage drugs are no sure things. Lilly has already stumbled over the past year with some of its late stage drugs. Digestion aid liprotamase failed to garner FDA approval this spring, and semagacestat, an experimental Alzheimer's drug, went down in flames last year after early data from a Phase III trial showed a worsening of cognition among patients on the drug. The company more recently grabbed wins with partner Amylin Pharmaceuticals in the development of diabetes treatment Bydureon, which passed a key heart safety study requested by U.S. regulators and garnered an EU market green light. - see the Reuters piece Related Articles:
Lilly outlines turnaround strategy as CEO calls research cuts "nuts"
Lilly, Sanofi CEOs call for a radical change in R&D thinking
Eli Lilly bonuses now tied to its troubled R&D effort Read more about: solanezumab, LY2189265, Eli Lilly, pipeline
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3. J&J, Pfizer grab CHMP backing for key new drugs
Johnson & Johnson ($JNJ) and Pfizer ($PFE) are among the developers that have received positive opinions of new drugs under review for EU approval. For Vertex Pharmaceuticals ($VRTX) and partner J&J, the recommendation is the latest development for blockbuster hopeful telaprevir, a hepatitis C treatment. The EMA's Committee for Medicinal Products for Human Use (CHMP) said today that it has recommended approval of 5 new drugs, the fate of which will ultimately be decided by the European Commission in the coming months. An odds-on favorite to gain EU approval after getting the green light from the FDA, Vertex's telaprevir (which will be marketed in Europe as Incivo) faces competition from Merck's ($MRK) rival HCV drug that has already been cleared for the EU market and will be co-promoted by Swiss drug giant Roche. The other new drugs to garner the CHMP's backing include the following: - J&J's Zytiga (abiraterone), which is under review for treating an aggressive form of prostate cancer in combination with prednisone or prednisolone. The FDA approved the potential blockbuster in April and the drug is part of string of successes J&J has had in advancing new medicines to market.
- Vyndaqel (tafamidis), a Pfizer drug for treating patients with an orphan disease called transthyretin amyloidosis, which causes of unhealthy buildup of amyloid protein in the body's tissues. Pfizer picked up the drug in its buyout of FoldRx last year.
- Dexdor (dexmedetomidine), a sedative that is intended for use in hospitals for patients who don't require "deep sedation," according to the EMA committee. Orion is seeking approval of the drug.
- Plenadren (hydrocortisone), DuoCort Pharma's version of the corticosteroid for adrenal insufficiency in adults.
- check out the rest of the CHMP's decisions here Related Articles:
Study: FDA beats EMA on new cancer drug approvals
FDA approves mega-blockbuster Vertex hep C drug Incivek
FDA approves J&J's prostate cancer drug Zytiga Read more about: EMEA Approval, telaprevir, Tafamidis, Zytiga
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4. Pfizer commits $100M to Mission Bay project
Pfizer is taking another shot at opening a research center in San Francisco's Mission Bay. The world's largest drugmaker is committing $100 million dollars over the next 5 years to partner with University of California, San Francisco, and will employ 40 staffers and researchers at the 11,000 square-foot Mission Bay Research Campus. This is Pfizer's second attempt to establish a research center in the Bay Area. The developer announced similar plans in 2008, but canceled those plans after it decided to purchase Wyeth. The deal is part of Pfizer's strategy to establish R&D centers in areas that are already known for being productive bioscience clusters. In a similar move last month, Pfizer announced that it would start a Center for Therapeutic Innovation in Boston. Another research center was also founded in New York. "There is a valley of death for many basic-science discoveries that have significant promise because they are not far enough advanced to be of interest to a biotech or pharmaceutical company," Gladstone Institutes researcher Dr. Warner Greene told the San Francisco Chronicle. "By forming closer relationships between Pfizer and biotech companies, I think more creative solutions can be had for moving research down the pipeline." - read the San Francisco Chronicle article for more Related Articles:
Pfizer ($PFE) enrolls UCSF for $85M drug discovery pact
Pfizer unveils $100M Boston effort to spark R&D innovation
Big Pharma embraces "open innovation" trend to fix a broken R&D model Read more about: Pfizer, Economic development, San Francisco
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5. Herper: Vertex's CF saga a harbinger for targeted drug R&D
Forbes' Matthew Herper brings us up close to Vertex Pharmaceuticals' ($VRTX) scientist Fred Van Goor and his part in advancing the firm's cystic fibrosis drug VX-770, which is a game-changing therapy for patients with the rare disease--or at least for the 4% of those with the illness that the treatment is supposed to benefit.
Indeed, the story drills down to some of the unique dynamics of developing targeted drugs--treatments that are intended for specific patients based on the molecular drivers of their disease. Developers have shown that the treatments can do wonders for those with the right genetics in diseases like cancer and relatively rare conditions such as CF. With some cancers, for example, there's a big push toward developing combinations of the targeted treatments, yet the cost of treating patients with multiple expensive drugs will likely be steep.
Developing niche drugs for small pools of patients is nothing new, as Sanofi's ($SNY) Genzyme made providing ultra-expensive treatments for people with rare diseases into a multibillion-dollar business. The Genzyme story has motivated other companies, including Big Pharma outfits, to get in on the act. "Pharmaceutical firms have shown new willingness to develop drugs for very rare diseases," Herper wrote, "partly because they have found they can charge a small fortune for the ones that work." - read Herper's article Related Articles:
Vertex shares slide as CF drug combo raises questions in Ph2
Vertex posts more promising data on Ph3 CF program
Biotech CEO campaigns to speed drugs for rare diseases
Feds ramp up new efforts to spawn rare disease R&D Read more about: VX-770, rare diseases, cystic fibrosis, vertex
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Also Noted | This week's sponsor is GE Capital Healthcare Financial Services. |  |
SPOTLIGHT ON... Merck, Simcere team up in China Merck has inked a joint venture partnership with China's Simcere Pharmaceutical Group. In addition to vaccines, which the two companies already market together, Simcere and Merck will market and manufacture cardiovascular and metabolic drugs. The joint venture also covers some development work, though Merck's release didn't provide any details about that aspect of the deal. Report  @FierceBiotech: Roche could get groove back with potential early approvals of cancer drugs. Article | Follow @FierceBiotech
@JohnCFierce: The semagacestat Alzheimer's drug story demos again how little we know about consequences of messing with believed triggers. Item | Follow @JohnCFierce @RyanMFierce: Translational research is very difficult. Forbes lists the ways. Article | Follow @RyanMFierce @MaureenFierce: Experiments that insert human genes, cells into animals need rules to ensure they don't create 'monsters.' Article | Follow @MaureenFierce > The Wall Street Journal's Goran Mijuk praises Roche CEO Severin Schwan's "more bullish outlook and his confident pipeline prognosis," as the company continues to strengthen after a difficult 2010. Piece > The European Medicines Agency has accepted Santhera Pharmaceuticals' marketing authorization application for its Leber's Hereditary Optic Neuropathy treatment, idebenone. The disease, which causes blindness, currently has no approved therapies to reverse vision loss. Santhera release > Idera Pharmaceuticals reports that its investigational new drug application for IMO-3100 will be placed on clinical hold by the FDA, according to verbal communication with the agency. The psoriasis treatment has completed two Phase I trials, and had proposed a Phase II trial. Idera release > As Icon takes on Pfizer's Sandwich, U.K. work as part of an outsourcing deal, the company has agreed to accept Pfizer's staff, but not its facilities. Parexel, which has a similar deal with Pfizer, has not disclosed whether it will absorb the existing facilities as part of its agreement. News > Approximately 245 jobs will be created in East Cork, Ireland as Sangart builds its new European headquarters in the area. Of those jobs, 125 will come from construction and another 120 from manufacturing positions. Article > Santa Rosa, CA-based Sapheon has enrolled 30 patients in a single-arm study of the Sapheon Closure System, which is designed to treat saphenous vein reflux disease. According to the company, no adverse effects were seen, and patients experienced relief from their symptoms within 24 hours. Sapheon release Pharma News @FiercePharma: Now that Brilinta's approved, AZ has to sell it. Story | Follow @FiercePharma > Lilly eyes vet assetts; Pfizer says all or nothing. More > AZ: No plans for followup on Brilinta-aspirin link. News > J&J board blames woes on middle managers, staff cuts. Article > Merck amps up in China with Simcere JV. Report And Finally... A biotech company, code named "Project Big," is considering a move to Sarasota County, FL, which would establish 356 jobs within three years in the area. Report > 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. > 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 > 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 > 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. > 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! > 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.
| > 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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