reviewed, and said multiple times is approvable,” Edick you’re you’regoing goingto toget getit,” it,”and andthe theFDA FDAprovided providedguidelines, guidelines,he he TM said. said. said saidFriday. Friday.“What “Whatwe wesent sentyesterday yesterdayisisbased basedon onwhat whatour our In 2009, New York-based Pfizer Inc. – having In 2009, New York-based Pfizer Inc. – having discussion discussionwith withthe theFDA FDAhas hasalready alreadybeen.” been.” acquired dalbavancin acquired dalbavancinas aspart partof ofthe thebuyout buyoutof ofVicuron Vicuron The from TheNDA NDApackage packageincludes includesthe thefull fulldataset dataset from MC onday B I O T E C H ’ S M O S T R E S P E T E D N E W S S O U R C E F O R M O R E T H A N 2 0 Y EYAEthree R Pharmaceuticals Inc. in 2005, and having collected Pharmaceuticals Inc. in 2005, and having collected three Durata’s positive results B I O T development E C H ’ S Mprogram, O S T Rincluding E S P SEepteMber C TED N E W S S O U R C E F O R M O R E T H A N 2 0 ASR S Durata’s development program, including positive results 30, 2013 “approvable” letters from the FDA, but no approval – “approvable” letters from the FDA, but no approval – from fromtwo twoPhase PhaseIII IIItrials trials–– Discover Discover11and andDiscover Discover2, 2, TM ’ S M Oconducted SBTI ORTEES PHE’ C Tspecial EO D Sprotocol N WESS SE OC U TRECwith R SMS O Eout HEAdrug N Ointo 2into Y EA ST spun the Durata, Chicago. spun out the drug Durata, of Chicago. Regulatory C S M T ER P DE NF EOW ORUTM RTC F R0 M O RR Eof H A N Regulatory 20 YEARS under aaspecial assessment the conducted under protocol assessment with the guidelines, which had been shifting Long Time Coming guidelines, which had been shiftingin inthe theU.S., U.S.,settled settledat at Lilly’s FDA FDA––as aswell wellas asaaprevious previousPhase PhaseIII IIIstudy, study,known knownas asVERVERTM F O R M O R E last, O S T R009. E S P E C T E D N E W S S O U R C E T H A N 2 0 Y E A R S and developers of antibiotics saw the way forward. TM Bonday I O T E C H ’ S M O S T R E S P E C T E D N E W S Slast, O Uand R Cdevelopers E F O R ofMantibiotics O R E T saw H AV NoluMe 2 024forward. Y, nEo.A187 R S Inves the way M 009. Monday (See 23, 2009.) VoluMe 24 , no. 187 (SeeBioWorld BioWorldToday, Today,June June17, 17,2005, 2005,and andDec. Dec. 23, 2009.) Dalbavancin, semisynthetic SepteMber 30, 2013aasecond-generation, Dalbavancin, second-generation, semisynthetic page 1 of 10 Cans TM SepteMber 30, 2013 TM approvable “The clinical page 1 of 10 “The approvableletters lettershad hadnothing nothingto todo dowith with clinical lipoglycopeptide, which lipoglycopeptide, whichconsists consistsof oflipophilic lipophilicside-chains side-chains Monday V oluMe 24 , no. 187 V oluMe 24 , n efficacy or safety, and I think that’s a big reason why efficacy or safety, and I think that’s a big reason why o. 187By Shan attached to has attached toglycopeptides, glycopeptides, hasbeen beendesignated designatedaaqualified qualified 3 SLong epteMber 30, 2013 page 1 ofis10aArm Time Coming By Randy Osborne everybody pagebe 1 of Lilly’s VC has ‘Look, this that on everybody hassaid, said, this is adrug drug thatshould should be on10Staff Wr infectious disease product Time Coming infectious disease productby bythe theFDA, FDA,which whichmeans means VC Arm VoluMe 24 , Lilly’s n‘Look, o. 187 MLong onday SHA Staff Writer VoluMethe 24process ,process no. 187 the said. “We go Invests into themarket,’” market,’”Edick Edick said. “Wehad had toChina’s gothrough through the p age 1 of 10 S epteMber 30, 2013 Invests in China’s arm of E The antibiotic dalbavancin’s long road to approval seems likely to end near age 5 1 of ming MLong onday,Time SepteMber 30, 2013 bioWorld ™of today ppage of 10 10 doing other studies, on the Lilly’s VCthese Arm of doing these other studies,based based on thenew newguidance, guidance, Coming Cansino Biotech Lilly’s VC Arm in a sma the end of next May, now that Durata Therapeutics Inc. has submitted the new Biotech and the FDA is, that’s reasonable.” andthat’s that’s where the FDA is,and andEllis that’s reasonable.” ByCansino Shannon Invests inwhere China’s Invests in China’s compan drug application (NDA) for the drug targeting acute bacterial skin and skinawaiting By Shannon Ellis Another reason “people have been anxiously Lilly’s VC Arm Long Time Coming Anotherofreason “people have been anxiously awaiting Trials Staff Writer Lilly’s VC Arm By Randy Osborne the quality clinical trials in China. Strengthening the Cansino Biotech structure infections caused by gram-positive microorganisms, including the Cansino Biotech Staff Writer By Randy Osborne this particular ithas for the patients Continued from page 1 this particular drugis iswhat what itwill will do forventure theway way patients push for Invests inMRSA: China’s SHANGHAI –do The capital Staff Writer monitoring of drug clinical trials become increasingly Invests in China’s By Shannon Ellis third-gen hospital scourge known as methicillin-resistant Staphylococcus aureus. By Ellis SHANGHAI –Co. The venture capital Staff Writer are treated,” said. “We’re about skin are treated,” he said. “We’re only talking about skin arm ofShannon Elionly Lilly and plans to invest The antibiotic dalbavancin’s long to approval seems likely to end urgent asnear thehe market grows andtalking more companies carry out vaccine. growing number of trials done in theroad country. Cansino Biotech Staff Writer orne “We wouldn’t anticipate that, within the first 60 days, [the FDA] would find Cansino Biotech Staff Writer By Randy Osborne arm of Eli Lilly and Co. plans to invest The antibiotic dalbavancin’s longTherapeutics road to approval seems likely to end near infections because the path to market. drug because that’s the path tothe the market. This inthat’s a small but rapidly growing end next May, nowfor that Durata Inc. has submitted the new trials here to getventure access to the market. The sheerbiotech quantity Mthe onday , Sof epteMber 30, 2013 io World ™SHANGHAI tinfections oday pThis age 3drug of 10 The Chinese Center Drug Evaluations (CDE), abwould By Shannon Ellis –new The capital Tian anything that cause them to not accept the filing,” said Durata CEO Paul By Shannon Ellis SHANGHAI – The venture capital Staff Writer in a small but rapidly growing biotech the end of next May, now that Durata Therapeutics Inc. has submitted the will be very effective, we believe, in osteomyelitis, and will be very effective, we believe, in osteomyelitis, and company with a strong pipeline to drug application (NDA) forFood the drug targeting acute bacterial skin and skin of trials has passed the ability of authorities to effectively department of the China and Drug Administration Staff Writer arm of Eli Lilly and Co. plans to invest tic dalbavancin’s long road to approval seems likely to end near Co. Ltd. w Edick. Staff Writer By Randy Osborne arm of Eli with Lilly and Co. plans to things.” invest The antibiotic dalbavancin’s long road tomicroorganisms, approval seemsskin likely to skin end near company adevelopment strong pipeline drug application (NDA) for the drug targeting acute bacterial and pneumonia, diabetic foot ulcers and various other pneumonia, diabetic foot ulcers and various other push forward the ato structure infections caused by gram-positive including the supervise because the number of officials has notofthings.” grown (CFDA), announced on Sept. 17has thatsubmitted all clinical trials SHANGHAI – The venture capital in a small but rapidly growing biotech May, nowDurata that Durata Therapeutics Inc. the new expedited review of six months or less, once the NDA is Lilly Asia In early July, the company met with regulators to nail down the details of – The venture capital Staff Writer in a SHANGHAI small but rapidly growing biotech the end of next May, nowasthat Therapeutics Inc. has submitted the new push forward the development of a structure infections caused byDurata gram-positive microorganisms, including But in skin infections 3drugs. patients are But inthe skindemand infections alone, 3million million patients are whooping cough hospital scourge known MRSA: methicillin-resistant Staphylococcus aureus. alongside the foralone, more conducted inapproval China now have to be registered on anarm online of Eli Lilly and Co. tothird-generation invest long road to likely to end near Continued from page 1 seems company with aplans strong pipeline to navancin’s (NDA) for the drug targeting acute bacterial skin and skin accepted. arm of Eli Lilly and Co. plans to invest The antibiotic dalbavancin’s long road to approval seems likely to end near company with a strong pipeline drug application (NDA) for the drug targeting acute bacterial skin and skin third-generation whooping cough hospital scourge known as MRSA: methicillin-resistant Staphylococcus aureus. admitted to hospitals every year. “We estimate that a third vaccine. admitted to hospitals every year. “We estimate thatPage ato third “We wouldn’t anticipate that, withinthe the first include 60 days, [the FDA] would find See Durata, 3 The industry as a whole may benefit through platform at www.chinadrugtrials.org.cn. Those in a has small but rapidly growing biotech w that Durata Therapeutics Inc. hasthat submitted new push forward the development ofalso aFDA ons caused by gram-positive microorganisms, including the “You have a drug that the already had completely in a small but rapidly growing biotech the end of next May, now Durata Therapeutics Inc. submitted the new push forward the development of a structure infections caused by gram-positive microorganisms, including the vaccine. “here’s all the stuff you’re going to get, and here’s how “We wouldn’t anticipate that, within the first 60 days, [the FDA] would find of them are only in the hospital to get the [intravenous Tianjin Cansino Biotechnology anything that would cause them to not accept the filing,” said Durata CEO Paul of them are only in the hospital to get the [intravenous more open competition. Companies will be able to monitor bioequivalence studies, pharmacokinetic (PK) studies and company with a strong pipeline to cough the drug targeting acute bacterial skin and skin third-generation whooping efor known as MRSA: methicillin-resistant Staphylococcus aureus. reviewed, and saidCo. multiple times approvable,” Edick company with afinancial strong pipeline to drug application (NDA) for the drug targeting acute bacterial skin and skin third-generation whooping cough hospital scourge known asthe MRSA: Staphylococcus aureus. Tianjin Cansino Biotechnology you’re going towould get it,”cause and FDA provided guidelines, he anything them tomethicillin-resistant not accept the filing,” said Durata CEO Paul antibiotic] therapy,” Edick told BioWorld “Incredibly Ltd. will get ais boost from Edick. antibiotic] therapy,” Edick told BioWorld Today. “Incredibly the progress of their competition and, inToday. some cases, Phase I, within II,that III and IVfirst studies. push forward the development of a used by gram-positive microorganisms, including the vaccine. ’t anticipate that, the 60 days, [the FDA] would find said. push forward the development of ain FINANCINGS N structure infections caused by gram-positive microorganisms, including the vaccine. ASIA “We wouldn’t anticipate that, within the first 60 days, [the FDA] would find Co. Ltd. will get a financial boost from said Friday. “What we sent yesterday is based on what our Edick. flexible” dalbavancin, on the other hand, can be given in Lilly Asia Ventures, the Shanghai-based In early July, the company met with regulators to nail down the details of flexible” dalbavancin, onof the othertrials, hand,particularly can be given avoidwhooping wasteful overlaps similar in the Including information on thesaid accessible website could third-generation cough n as MRSA: methicillin-resistant Staphylococcus aureus. Tianjin Cansino Biotechnology ould cause them to not accept the filing,” Durata CEO In 2009, New York-based Pfizer Inc. – having third-generation whooping cough hospital scourge known as MRSA: Staphylococcus aureus. Tianjin Cansino Biotechnology anything that would cause them tomethicillin-resistant not accept thePaul filing,” said Durata CEO Paul Lilly Asia Ventures, the Shanghai-based discussion with the FDA has already been.” In early July, the company met with regulators to nail down the details of the emergency room, an outpatient clinic or ambulatory emergency an outpatient clinic or ambulatory generics space. allow for greater public andFollowing closer monitoring vaccine. Cansino, Page 4 Rebio Durata, Page 3room, WHO Examples pate that,Edick. within first 60 days,supervision [thethat, FDA] would find Co.See Ltd. will get aatfinancial boost from acquired dalbavancin asLtd. part ofchanging the ofburden, Vicuron Inotek Vision for vaccine. “We the wouldn’t anticipate within the first 60U.S., days, [the FDA] would find Co. will get buyout aSee financial boost from The NDA package includes the full dataset from center, and two doses ––thus the center, and at two doses thus changing the burden, But the biggest overall winners should be patients and4 of trials by regulators, including the CFDA. See Cansino, Page See Durata, Page 3 Tianjin Cansino Biotechnology use to not accept the filing,” said Durata CEO Paul Lilly Asia Ventures, the Shanghai-based the them company met with regulators to nail down the details of Pharmaceuticals Inc. in 2005, and having collected three Online Platform for Tianjin Cansino Biotechnology anything that would cause them towith not accept the filing,” Durata CEO Paul Lilly Asia Ventures, the Shanghai-basedPione In early July, the company met regulators to nail said down the details ofcost Durata’s program, including positive results location and of Glaucoma Supported location and cost oftreatment. treatment. patient groups, typically weak in China due to laws that The development website is “a good indicator that the government Co. Ltd. will “approvable” get a financial boost from letters from the FDA, but no approval –very Co. Ltd. will get a financial boost from Edick.two Phase from III trials – Discover 1 and Discover 2, What’s more, among skin infection patients, “a“avery FINANCINGS NEWCO NEWS Trials to Improve ASIA See Cansino, Page 4 See Durata, Page 3 What’s more,3By among skin infection patients, $28M in Financing hinder the Shanghai-based development of civil society. Those groups now4Resto See Cansino, Page See Durata, Page is with trying to make the clinical trial process more open to Asia Ventures, Lilly the mpany met regulators to nail down the details of spun out the drug into Durata, of Chicago. Regulatory Lilly Asia Ventures, the Shanghai-based In earlyunder July, the company met with regulators to the nail down large the details of conducted a special protocol assessment with percentage, depending on the day you look at, 65 FINANCINGS NEWCO NEWS ASIA large percentage, depending on Shaffer the daythat youhas look at, 65 Catherine willChina have greater By access to information long been By Mari Transparency in the public, and have the public supervise trials in real Following U.S., WHO Examples guidelines, which had been in the U.S.,which settled at Inotek Vision for Rebiotix Seeking to FDA – as well asWu, a previous Phase study, VERpercent to percent of them have cellulitis, has See Cansino, Page 4 shifting SeeIII Durata, Page 3 asR&D, percent to70 70 percent of them have cellulitis, which has Writer outDurata, of their reach. The government’s stated intention is to 4Staff Wr By Shannon Ellis See Cansino, Page Page 3Staff time,” said Yan principal consultant at known Modular an See FINANCINGS NEWCO NEWS Following U.S., WHO Examples last, and developers of antibiotics saw the way forward. IA Online Platform for FINANCINGS NEWS Inotek Vision for Seeking todon’t 009. aa high of MRSA,” Edick said. “Hospitals Glaucoma Supported Pioneer highpercentage percentage ofRebiotix MRSA,” Edick said. “Hospitals don’t the InotekNEWCO Pharmaceuticals Corp., Rebi improve the standardization ofMicrobiota trials and better protect Staff Writer internationalASIA information and consulting firm that focuses (See BioWorld Today, June 17, 2005, and Dec. 23, 2009.) Dalbavancin, a second-generation, semisynthetic Online Platform for want to admit those patients if they don’t have to, Trials to Improve want to admit those patients if Mass., they don’t have to,abecause because Glaucoma Supported Pioneer Microbiota rights and interests of test subjects. That follows trend of Lexington, plans to apply concept Following calls to improve By $28M in Financing Restoration on drug and device development and has extensive WHO Examples FINANCINGS NEWCO NEWS Inotek Vision forInotek Rebiotix Seeking toMRSA Following U.S., WHO Examples “The approvable letters hadproblem.” nothing to do with Vision for Rebiotix Seeking toclinical FINANCINGS NEWCO NEWS ASIA lipoglycopeptide, which consists of lipophilic side-chains you’re just adding to the you’re just adding toRestoration theMRSA problem.” Trials toworking Improve that various government departments infrom Chinaa have taken than two $21 million in proceeds supervision overShaffer clinical trials, China By Catherine By Marie Powers Transparency in China experience with multinational companies on By $28M in Financing atform for oWorld™ attached tOnline oday p age 3 of 10 efficacy or safety, and I think that’s a big reason why Glaucoma Supported Pioneer Microbiota Platform for toanswers glycopeptides, has been designated a qualified Medicare data suggest that “hospitals that are treating Glaucoma Supported Pioneer Microbiota Medicare data suggest that “hospitals that are treating up of sharing supervisory tasks of various functions with venture financing and $7 million in for gastr has launched a new online registration Staff Writer Staff Writer ExamplesFollowing Fast for unobstructed By Shannon Ellis clinical trials in China. Based in Shanghai, Modular R&D has Fast answers for unobstructed By Catherine Shaffer By Marie Powers Transparency in by China Inotek Vision for Rebiotix Seeking to U.S., WHO Examples everybody hasin said, ‘Look, thiswith is a generic drug that should be on Inotek Vision for Rebiotix Seeking to mprove infectious disease product the FDA, which means these patients the hospital drugs, are By $28M in Financing Restoration Trials to Improve these patients in the hospital with generic drugs, are an increasingly vigilant and interested population. venture debt financing to advance recurring Inotek Pharmaceuticals Corp., Rebiotix Inc. has sprinted from platform that should help improve Staff Writer a number of specialized databases on drug development By $28M in Financing Restoration Staff Writer Staff Writer By Shannon Ellis m forin the market,’” Edick said. “We had toMicrobiota gobe through the process Glaucoma Supported Pioneer Microbiota Online Platform for paths to market. losing money” on people who might triaged and given Glaucoma Supported Pioneer paths to market. expedited review ofto six months or less, once the NDA isMass., By Catherine Shaffer By Marie Powers losing money” on people who might be triaged and given ency China The U.S. National Institutes of Health (NIH) set up of Lexington, plans to apply concept to clinical application in less its A1 subtype adenosine mimetic for (CDI), us Following calls improve transparency and the quality of the in China. By Catherine Shaffer By Marie Powers Transparency in China Inotek Pharmaceuticals Corp., Rebiotix Inc. has sprinted from Staff Writer of doing these other studies, based on the new guidance, ove dalbavancin without aahospital stay, he said. By $28M in Financing Restoration accepted. Trials to Improve Staff Writer Staff Writer dalbavancin without hospital stay, he said. lis $21 million in proceeds from a than two years in pursuit of treatment its clinical trial registry (at clinicaltrials.gov) in 2000. supervision over clinical trials, China By $28M in Financing Restoration “The increased transparency is a measure to improve Staff Writer Staff Writer By Shannon Ellis of Lexington, Mass., plans to apply concept to clinical application in less Following calls to improve See Trials, Page 5 the See Inotek, Page 6 – the col and that’s where FDA from is, and that’s reasonable.” Ensure drug approval processes “A lot of them present at the emergency department,” Bycontrol, Catherine Shaffer By Marie Powers in China “You have ayour drugonline that the FDAthe already had completely Ensure your drug approval processes Inotek Pharmaceuticals Corp., Rebiotix Inc. has sprinted “A lot of them present at the emergency department,” venture financing and $7 million in for gastrointestinal diseases, such asthe human m has launched new registration According to Wu, the Chinese version largely follows By Catherine Shaffer By Marie Powers trial quality on par with more developed Transparency in China Inotek Pharmaceuticals Corp., Rebiotix Inc. has sprinted from Staff Writer $21 million in proceeds from a than two years in pursuit of treatment supervision over clinical trials, China Another reason “people have been anxiously awaiting Edick noted. “If you can catch them there, and give them Staff Writer Staff Writer reviewed, andcountries,” said multiple times is approvable,” Edick of Lexington, Mass., plans to apply concept to clinical application in less Edick noted. “If you can catch them there, and give them venture debt financing to advance recurring Clostridium difficile infection alls platform that should help improve U.S. one but requires more compulsory data and will in turnapprove , heto improve clinical trial Wu said. Staff Writer Staff Writer By Shannon Ellis of Lexington, Mass., plans to apply concept to clinical application in less Following calls to improve venture financing and $7 million in for gastrointestinal diseases, such as hasrun launched a new online registration smoothly and accelerate your BENCH PRESS THE BIOWORLD run smoothly and accelerate your this particular drug isthey’ve what itgot will do forBIOME the way patients their first treatment, seven days of drug on Inotek Pharmaceuticals Corp., Rebiotix Inc. has sprinted from its A1 subtype adenosine mimetic for (CDI), using the human microbiome $21 million in proceeds from a than two years in pursuit of treatment their first treatment, they’ve got seven days of drug on transparency and the quality of the r clinicalsaid. trials, China be a richer resource. For example, the principal investigator compan our The existing process trial registration will be migrated Inotek Pharmaceuticals Corp., Rebiotix Inc. has sprinted from Staff Writer $21 million in proceeds from a than two years in pursuit of treatment supervision over clinical trials, China venture debt financing to advance recurring Clostridium difficile infection platform that should help improve are treated,” he said. “We’re only talking about skin come board. Aapply lot of physicians will probably have them of Lexington, Mass., plans to apply concept to clinical application inthe less mprove In 2009, New York-based Pfizer Inc. –Cortellis™ having – collective genomes of the venture financing and $7 million in for gastrointestinal diseases, such as board. A lot of physicians will probably have them come new online registration regulatory decisions with and hospital details are mandatory on the Chinese site. applicati onto the online platform and companies will be expected of Lexington, Mass., plans to concept to clinical application in less regulatory decisions with Cortellis™ Following calls to improve venture financing and $7 million in for gastrointestinal diseases, such as • Immunity Ignores IPS has launched a new online registration Nongenetic Data Yield Risk Genes See Trials, Page 5 See Inotek, Page 6 its A1 subtype adenosine mimetic for (CDI), using the human microbiome transparency and the quality of the infections because that’s the path to the market. This drug back in or days, just to check the wound and $21over million in from a• than two years inadvance pursuit ofthree treatment alould trials, China acquired asproceeds part offinancing the buyout of million Vicuron human microbiota. In July, the FDA venture debt to$21 advance recurring Clostridium difficile infection back in two or three days, just to check the wound and help improve China’s site will undergo aClostridium one-year trial period where (microbi to take adalbavancin number of steps. in financing proceeds from atwo than two years in pursuit treatment supervision clinical trials, China venture debt to recurring difficile infection NCoR’s Encore Is Antiplatform that should help improve – the collective genomes of the Complex Diseases Can will besure very effective, we believe, inget osteomyelitis, and Regulatory Intelligence. See Trials, Page 5 collected See Inotek, Page 6such Regulatory Intelligence. make they’re doing OK. They their second dose venture financing and $7 million inA1 within forone gastrointestinal diseases, as line registration approved the Roseville, Minn.-based Pharmaceuticals Inc. in 2005, and having three its A1 subtype mimetic for (CDI), using the human microbiome make sure they’re doing OK. They get their second dose nd quality of the the CDE will make adjustments and changes tothe what isasaa PUNCH C Pre-registration ofquality trials must be uploaded ltsthe venture financing and $7 million in for gastrointestinal diseases, such has launched aand new online registration its subtype adenosine mimetic for (CDI), using the human microbiome inflammatory transparency the ofadenosine the human microbiota. In July, FDA BENCH PRESS THE BIOWORLD BIOME pneumonia, diabetic foot ulcers and various other things.” Start in Mendelian Genes week [after the first], and they’re good to go.” venture debt financing to advance recurring Clostridium difficile infection company’s investigational new drug elp improve “approvable” letters from the FDA, but no approval – – the collective genomes of the week [after the n first], they’re good to go.” posted online. Whil month of approval, and the trial will beSee given a registration debt 6financing to Inotek, advance recurring Clostridium difficile infection that help improve – and the alone, collective genomes of the A New Approach to Batten approved the Roseville, Minn.-based Seeplatform Trials, BENCH Page 5should Inotek, Page See Trials, Page 5• venture See Page 6July, But in skin infections 3lead million patients are the PRESS THE BIOWORLD BIOME By Anette Breindl Analyst Adnan Butt, RBC Capital Markets, called application for candidate RBX2660 its A1 subtype adenosine mimetic for (CDI), using the human microbiome uality of spun the out the drug into Durata, ofthe Chicago. Regulatory • Immunity Ignores IPS human microbiota. In theof FDA Analyst Adnan Butt, of RBC Capital Markets, called the Lee Jone Data Yield Risk Genes number. The CDE is adamant that no trialNongenetic subjects are toadenosine e its A1 subtype mimetic for (CDI), using the human microbiome transparency and the quality of human microbiota. In July, the FDA Disease company’s investigational new drug admitted to profile hospitals every year. “We estimate that aIIthird Science Editor (microbiota suspension). Phase Durata risk-reward of Durata “favorable, as even aaniche –Brain the collective genomes of the which had been submission shifting in the U.S., settled atDiseases • NCoR’s Encore Is Antiapproved the Roseville, Minn.-based risk-reward profile of Durata “favorable, asIts even niche device in be enlisted until the initial is completed online. R- Trials,guidelines, –application the collective genomes of the approved the Minn.-based ee Page 5 BENCH See Inotek, Page 6BIOWORLD •Complex Anorexia Pathway? Can forRoseville, lead candidate RBX2660 PRESS THE BIOWORLD BIOME • Immunity Ignores IPS Nongenetic Data Yield Risk Genes See Trials, Page 5 See Inotek, Page 6 of them are only in the hospital to get the [intravenous PRESS THE BIOME Continued from page 3 Figuring out the contribution of CD study is already under way. market share beat Street expectations and lead to human microbiota. In July,could the PUNCH FDA last,inflammatory and developers of antibiotics sawbe the wayOunce forward. company’s new drug marketinvestigational share could beat Street expectations and lead to in-reside Timely clinical trial updates must made to the human microbiota. In July, the FDA company’s investigational new drug • An of Resistance (microbiota suspension). Its Phase II • NCoR’s Encore Is AntiStart inapproved Mendelian Genes antibiotic] therapy,” Edick told BioWorld Today. and “Incredibly Complex Diseases Can While Rebiotix president CEO any gene to complex disorders isRBX2660 a the Roseville, Minn.-based • ABioWorld Newon Approach to Batten Today, June 17, 2005, and Dec. 23, 2009.) application for lead candidate RBX2660 significant upside. Minneso website a regular basis depending on the published ores IPS (See approved the Roseville, Minn.-based Nongenetic Data Yield Risk Genes application for lead candidate Prevention THE BIOWORLD BIOME See Durata, Page 5 PUNCH CD study is already under way. • inflammatory Immunity Ignores IPS Nongenetic Data Yield Risk dalbavancin, Genesnew Seedone Durata, Page By Anette Breindl PRESS THE BIOWORLD BIOME flexible” on the aother hand, can be given in 5 Lee Jones, veteran of which the medical murky fishing expedition, in drug company’s investigational drug Disease “TheBENCH approvable letters had for nothing toStart do with clinical (microbiota suspension). Its Phase II in Mendelian Genes Durata “owns dalbavancin outright, means the regulations and the “Guidelines Completing Registration approac e Is Anti- • ns company’s investigational new (microbiota suspension). Its Phase II • Alzheimer’s Antibodies While Rebiotix president and CEO NCoR’s EncoreComplex Is to AntiScience EditorDiseases Can A New Approach Batten Diseases theCD emergency room, an outpatient clinic or ambulatory Complex Can device industry, was serving as CEOwaters muddied by the interaction • Anorexia BrainTrials.” Pathway? application for lead candidate RBX2660 efficacy orClinical safety, and I Data think that’s a big• reason why PUNCH study is already under way. By Anette Breindl opportunity for partnering or selling dalbavancin directly Nongenetic Yield Risk Genes for Drug Failure to follow the guidelines who wer ySfied application for lead candidate RBX2660 PUNCH CD study is already under way. Mucus Protection • Immunity Ignores IPS Lee Jones, a veteran of the medical inflammatory Start in Mendelian Nongenetic Data Riskand Genes Figuring out the Yield contribution ofat twoof center, doses – thus changing the burden, Genes in-residence at the University of theCanada, gene in question with other • Disease An Ounce ofTo Resistance subscribe, please call Customer Service at (800) outside the U.S. and call (770) 810-3144. (microbiota suspension). Its Phase IICanada, Start in Genes everybody has said, ‘Look, this is drug that should beMendelian on To subscribe, please callaBtrial Bio ioW World orld Customer Service at (800)477-6307; 477-6307; outside the U.S. and call (770) 810-3144. While Rebiotix president and CEO tiScience Editor also exists,” Butt wrote in a research report. “At branded could result in the original clinical approval being transpla ach to Batten (microbiota suspension). Its Phase II While Rebiotix president and CEO • And Mucosal Immunity • NCoR’s Encore Is AntiComplex Diseases Can device industry, was serving as CEOA New Approach to Batten any gene to complex disorders is aVisit Anorexia BrainBy Pathway? location and cost of treatment. Complex Diseases Can Copyright 2013 Reuters. Reproduction isisstrictly prohibited. Visit our web site at Minnesota Venture Center, she was Anette Breindl Copyright 2013Thomson Thomson Reuters. Reproduction strictly prohibited. our web site atwww.bioworld.com www.bioworld.com genes and environmental influences. Prevention PUNCH CD study is already under way. By Anette Breindl the market,’” Edick said. “We©©had to go through the process Lee Jones, a veteran of the medical Figuring out the contribution of drug pricing, this could represent a $3 billion market voided. of work PUNCH CD study is already under way. Lee Jones, a veteran of the medical • Biomarker Expansion Fails inflammatory in-residence at the University of Disease murky fishing expedition, done in more, among • Ounce ofAntibodies Resistance Start instudies, Mendelian Genes What’s skin infection patients, “a very approached bygoing university researchers Science Editor • An Alzheimer’s Start in Mendelian Genes While Rebiotix president and CEO Science Editor of these other based on the new guidance, device industry, was serving as CEOBatten any gene to complex disorders is a opportunity. Even a small share to Durata could have In steps, the online database already is being n Pathway? While Rebiotix president and CEO device industry, was serving as CEOSee Attachment See Genes, Page 8 •doing A New Approach to Batten Minnesota Venture Center, she was waters muddied by the interaction Anorexia Brain Pathway? Anette Breindl large percentage, depending on the day work you look at, 65 whoimpact were on fecal Figuring out the some contribution of • Prevention Mucus Protection By Anette Breindl Lee Jones, veteran of in the medical Figuring out theacontribution ofpositive and that’s By where the FDA and that’s reasonable.” in-residence at the University of conducting murky fishing expedition, done awith significant on valuation.” populated. Asofof Sept. 27,is,there were 126 trials Resistance Lee Jones, a veteran of the researchers medical in-residence at– the University ofhas Disease of the gene in question other approached by university An Ounce Resistance • Alzheimer’s Antibodies Science Editor transplants (FT) the “first generation” percent to 70 percent of them have cellulitis, which To subscribe, please call bis ioWa orld™as Customer Service at (800) 477-6307; outside the U.S. and Canad any gene to complex disorders is aEditor • And Mucosal Immunity Science device industry, was serving CEOany gene to complex disorders Another reason “people have been anxiously awaiting Minnesota Venture Center, she was way? waters muddied by the interaction The company plans to hire about 140 customer-facing already registered online, but that’s out of 7,468 approved device industry, was serving as CEOMinnesota Venture Center, she was genes and environmental influences. • Anorexia Brain Pathway? who were conducting work on fecal Prevention Mucus Protection Copyright © 2013 Thomson Reuters. Reproduction issaid. strictly prohibited. our web site at ww Figuring out the contribution of Figuring of work in Edick the microbiome, she Visit a high percentage MRSA,” “Hospitals don’t murky fishing expedition, done in • Biomarker Expansion Fails out the contribution of in-residence at the University of murky fishing expedition, done in this particular drug is what it will do for the way patients approached by university researchers nce of the gene in questionprofessionals, with other including 100 salespeople, 10 medical trials that willofhave to be included. Antibodies• in-residence at the University of approached by university researchers An Ounce Resistance transplants (FT) – the “first generation” Alzheimer’s Antibodies And Mucosal Immunity any gene to complex disorders is a want to admit those patients if they don’t have to, because See Attachment See Genes, Page See Rebiotix, Page 7 waters muddied by theabout any gene toenvironmental complex disorders is a 8she Minnesota Venture Center, was waters muddied by the interaction are Prevention treated,” he said. “We’re only talking skin who were conducting work onwere fecal genes and influences. science liaisons, 10 regional directors and the rest The creation of the database marks ainteraction substantial tion Minnesota Venture Center, she was who work oncovering fecal of work in conducting the microbiome, she Mucus Protection • Biomarker Expansion Failsin question murky fishing expedition, done in you’re just adding to the MRSA problem.” of the gene with other murky fishing expedition, done in approached by university researchers of the gene in question with other infections because that’s the path to the market. This drug transplants (FT) – the “first generation” ies reimbursement and hospital discharges. Butt expects a improvement to the past system, Wu said, adding that To subscribe, please call b io W orld ™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (770) 810-3144. Immunity• approached by university researchers transplants (FT) – the “first generation” Alzheimer’s Antibodies And Mucosal Immunity See© Attachment See Genes, Page 8 suggest Seethat Rebiotix, Page 7 waters muddied by theThomson interaction Medicare data that “hospitals are treating genes environmental influences. Copyright 2013 Reuters. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com waters muddied bywork the interaction who were conducting work on fecal genes and environmental influences. Fast answers for unobstructed be very effective, weand believe, in osteomyelitis, and of in the microbiome, she partnering deal outside the U.S. regulators will be among the biggest beneficiaries. pansion will Fails who were conducting work on fecal of work in the microbiome, she • Mucus Protection Biomarker Expansion Fails of diabetic the genefoot in question with other these patients in the hospital with generic drugs, are of the gene in8atquestion with other transplants (FT) –Durata’s the “firststock generation” Toitsubscribe, please call bioW orld ™ Customer Service (800) 477-6307; outside the U.S. and Canada, call(FT) (770) 810-3144. pneumonia, ulcers and various other things.” (NASDAQ:DRTX) closed Friday at $9. 10, 7 ity In the past, has been difficult for authorities to See See Genes, Page See Rebiotix, Page 7 transplants – the “first generation” • Attachment And Mucosal Immunity See Attachment See Genes, Page 8 See Rebiotix, Page paths to market. genes and environmental influences. losing money” on people who might be triaged and given Copyright © 20133Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com genes and environmental influences. of work in the microbiome, she But in skin infections alone, million patients are up 21 cents. n n Fails • monitor the progress of Fails clinical trials after they were of work in the microbiome, she Biomarker Expansion subscribe, please call bioWorld ™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call outside (770)without 810-3144. dalbavancin a hospital stay, he810-3144. said. To subscribe, please call bio World ™ Customer Service at (800) 477-6307; the U.S. and Canada, (770) admitted toin hospitals every year. “We estimate that a third See Attachment See Genes, Page 8 See Rebiotix, Page 7 call approved, large part due to the infrequent contact See Attachment See Genes, Page 8 See Rebiotix, Page 7 Copyright © Ensure 2013 Thomsonyour Reuters. Reproduction is strictly prohibited. Visit our web site at www.bioworld.com drug processes Copyright ©approval 2013 Thomson Reuters. Reproduction is strictly prohibited. Visit our web site at at www.bioworld.com “A lot of them present the emergency department,” ofbetween them are only in theand hospital to get the [intravenous authorities sponsors during the progress of a e, please call bioWorld™ Customer Service atplease (800) call 477-6307; the U.S. and Canada, (770)noted. 810-3144. Edick “Ifthe you catchisthem there, and give them To subscribe, bioWorldoutside ™ Customer Service at (800)call 477-6307; outside U.S.can and Canada, call (770) 810-3144. antibiotic] therapy,” Edick told BioWorld Today. “Incredibly BioWorld on Twitter! 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