10th Anti-infectives Partnering and Deal-Making Conference

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10th Anti-infectives Partnering and Deal-Making Conference

  1. 1. 9thAnti-Infectives Partnering and Deal-Making – July 9-10, 2012 – San Francisco, CAAgenda is subject to change. Please visit www.gtcbio.com for the most updated agenda. Updated 6/5/128:00 Welcome & Opening Remarks9:15 A Long and Winding RoadRoger Echols, Principal Member, ID3C - InfectiousDisease Drug Development ConsultingSince 2005, the reality of “regulatory risk” has had a majorimpact on the willingness to invest in antimicrobial drugdevelopment. Understanding how this situation came aboutmay provide some answers going forward. Earlyantimicrobial development was targeted to treat specificpathogens (sulfanilamide-streptococci; streptomycin-tuberculosis; penicillin-pneumococcus). Once the principleof antimicrobial treatment was accepted, there wereadditional drug classes (mechanisms) with different spectra(tetracyclines, chloramphenicol) and modifications to thebasic structure of active moieties led to a proliferation ofantimicrobials, especially among the beta-lactams(penicillins, cephalosporins, penems). NDA regulatorypackages became routine with a high rate of approval.Randomized controlled clinical trials were the exceptionprior to the 1970s. Indication specific clinical trialsdeveloped in the 1990s with considerable input from theIDSA. Physician clinical judgment supported by objectivelaboratory and physical signs determined the outcomeestablishing treatment benefit. Standard of care activecontrol drugs were used to benchmark efficacy and safetyof new agents. Determining “non-inferiority” margins andstatistical power were managed by consensus. In the early2000s, however, the justification of NI margins becametopical and by 2005 became the new regulatory hurdle,most notably providing the withdrawal of certyainindications of Ketek (telithromycn) essentially killing theproduct. Since then few new antimicrobial drugs or evensupplemental indications have been approved, and not dueto safety concerns. Efforts by the FDA to provide newclinical trial guidelines (ABOM, CABP, ABECB, ABS, NP)have largely failed due to ethical concerns for placebocontrols or investment costs. In the face of increasingantimicrobial drug resistance, particularly among gram-negative bacteria, the development pipeline is bare.Fortunately, both the FDA and Congress recognize theurgency of stimulating the discovery and development ofnew drugs. Interestingly, the focus has returned to targeteddevelopment. The question remains how to make thesenew efforts commercially viable.9:50 Morning BreakDay 1 - Monday, July 09, 2012Session: Regulatory Guidance and OvercomingChallenges in Anti-infectives DevelopmentKEYNOTE PRESENTATION8:05 The Future of Antibiotic R&DBrad Spellberg, M.D., FIDSA, FACPAssociate Professor, MedicineLos Angeles Biomedical Research Institute atHarbor-UCLA Medical CenterEver-rising antibiotic resistance continues to plaguepublic health systems all over the world. Meanwhile, newdiscovery and development of antibiotics continues toface scientific, regulatory, and economic challenges.What does the future hold? The medical need for newantibiotics will continue to worsen. Rapid diagnostics,changes in the regulatory landscape, public privatepartnerships, improved biological technologies, andexpansion of international markets will have major impacton what antibiotics are developed and how.Benefits:1) Review the unmet medical need of antibiotics2) Discuss recent economic and legislative developments3) Discuss current and future regulatory environments4) Review the concept of public private partnershipsFEATURED PRESENTATION8:40 The Antibiotic Pipeline: Where Is It and WhatNeeds FixingBarry Eisenstein, M.D., FACP, FIDSA, FAAMSenior Vice President, Scientific AffairsCubist PharmaceuticalsThe continued increase in antibiotic resistance makes allantibiotics “wasting assets” with limited life span. Tomaintain the life-preserving armamentarium againstbacterial infections, therefore, new antibiotics must bedeveloped on a regular basis. Given the relatively lowreturn on antibiotics, compared with drugs for morechronic conditions, investment in new ATB developmenthas waned. Adding to the difficulty of new ATBdevelopment has been the inherent challenge ofdeveloping such drugs in patient populations withresistant pathogens. Thus, regulatory hurdles to approvalpresent an additional disincentive to new ATBdevelopment. My talk will explore these issues and offerseveral approaches at both the regulatory and publicpolicy level to attempt to overcome this “market failure”.Discussions that follow will, hopefully, enhance ourunderstanding of the problem and our commitment toseek change in the environment we face, resulting innew, life-saving drugs that are also reasonablebusiness investments for interested stakeholders.
  2. 2. 9thAnti-Infectives Partnering and Deal-Making – July 9-10, 2012 – San Francisco, CAAgenda is subject to change. Please visit www.gtcbio.com for the most updated agenda. Updated 6/5/1210:30 Moderator: Robert Guidos, Vice President, PublicPolicy & Govt. Relations, Infectious Diseases Society ofAmerica (IDSA)Panelist: Brad Spellberg, M.D., FIDSA, FACP, AssociateProfessor, Medicine, Los Angeles Biomedical ResearchInstitute at Harbor-UCLA Medical CenterPanelist: Barry Eisenstein, M.D., FACP, FIDSA, FAAM,Senior Vice President, Scientific Affairs, CubistPharmaceuticalsPanelist: Prabhavathi Fernandes, Ph.D., Founder,President and Chief Executive Officer , CempraPharmaceuticalsPanelist: Peter Hammann, TSU Infectious Dieseases; Headof External Opportunities and Innovation Research &Development, Sanofi Deutschland• In the face of increasing antimicrobial drug resistance,particularly among gram-negative bacteria, thedevelopment pipeline is bare. FDA has published severalclinical trial guidelines for industry that many have calledinfeasible. Both FDA and Congressional leaders have madestatements recently demonstrating a recognition of theurgency of the antibiotic R&D problem and the need forFDA to take immediate steps to resolve the clinical trialdilemma. What are the macro and micro reasons FDA’sefforts to provide feasible clinical trial guidance have failed?• Some in PhRMA are proposing a tiered approach toantibiotic approvals that allows for pathways in addition tothe traditional (2 study) approach, while others in industryhave proposed a graduated approval approach. What arethese approaches? Are they mutually exclusive? What isthe right model and why? Can FDA implement thesevarious approaches using existing authority or is newstatutory authority needed?• Regarding IDSA’s proposed Limited Use AntibacterialDrug (LPAD) approval mechanism, during lobbying aroundthe FDA Prescription Drug User Fee Act (PDUFA)reauthorization, there appeared to be a bright line drawn asfar as industry support/opposition to the concept with largecompanies appearing to line up in opposition to the conceptwhile many small companies (14 of them) lined up insupport. Was this a temporary issue related to PDUFApolitics or did a deeper policy-related divide? Might smallercompanies stand to fare better if LPAD is established thanlarge companies)? Would LPAD impact the practice ofmedicine?• Looking in your crystal ball, what do you think the futureholds? Which potential FDA-generated solutions hold thegreatest promise for the field of antibiotic R&D? Which ofthe congressional solutions likely are most helpful and why?Will additional legislation be needed? Could transferrable(sellable) R&D tax credits provide a helpful push for bothlarge and small companies?• Are there other promising solutions being discussedamong industry experts and other stakeholders?• Is there a need for new antibiotics?- What do we really need for gram positive?- What do we really need for gram negative?• Where are novel antibiotics coming from?• The role of virulence factor inhibitors in the future.• The role of neglected diseases in big pharma partneringwith universities & initiatives in this field.11:15 Molecular Methods for Rapid Detection ofAntimicrobial Resistant OrganismsFred C. Tenover, Ph.D., D(ABMM), F(AAM), F(IDSA),Executive Director, Scientific Affairs, CepheidNucleic acid amplification methods can provide data on thepresence of antimicrobial resistant microorganisms directlyfrom clinical specimens often in less than 1 hour. Bacteriacausing sepsis, respiratory tract infections (includingtuberculosis), and wound infections (such asStaphylococcus aureus) are all amenable to rapid detectionand reporting. Several studies have demonstrated thatrapid detection of resistant bacteria, especially in positiveblood cultures, can improve patient outcomes and reducethe overall cost of healthcare by optimizing therapy early inthe course of disease. Commercial molecular diagnosticassays to detect resistant organisms are already in use inmicrobiology laboratories around the world. These includeassays that detect rifampin-resistant strains ofMycobacterium tuberculosis directly in sputum samples inless than 2 hours. Implementation of the new assays oftenrequires education programs for physicians to assist themin understanding how to use the molecular data to optimizeantibiotic treatment regimens. It is likely that molecularassays will have a substantial impact on addressing thecritical issue of antimicrobial resistance.After listening to this presentation on rapid diagnostics,attendees will be able to:- identify at least three molecular assays for resistantbacterial infections that will decrease the time to optimizingtherapy for bacterial infections by at least 48 hours.- Describe three molecular technologies that can be used toidentify resistant bacteria present in positive blood culturevials to decrease time to identification in at least 80% ofcases- Describe at least 2 molecular methods for identifyingmutations in Mycobacterium tuberculosis that result inrifampin resistance in >95% of strains.Panel Discussion: Current Trends and Future inAnti-infectives DevelopmentNovel Diagnostics Against Drug Resistance
  3. 3. 9thAnti-Infectives Partnering and Deal-Making – July 9-10, 2012 – San Francisco, CAAgenda is subject to change. Please visit www.gtcbio.com for the most updated agenda. Updated 6/5/1211:40 Lunch on Your Own2:00 Moderator: Joyce Sutcliffe, Senior Vice President,Biology, Tetraphase PharmaceuticalsPanelist: Richard J. Hatchett, M.D., Chief Medical Officerand Deputy Director, Biomedical Advanced Researchand Development Authority (HHS/ASPR/BARDA)Panelist: Ed Moran, Vice President R&D Projects,TheravancePanelist: TBA, Novartis (NIBR)Panelist: John Doyle, Chief Operating Officer, Achaogen2:45 Afternoon BreakGovernment Collaborations and Non-dilutive Funding1:00 FEATURED PRESENTATIONJoseph Larsen, Ph.D.Chief, Broad Spectrum Antimicrobials (BSA) Program;Division of CBRN CountermeasuresDHHS/ASPR/BARDAThe Biomedical Advanced Research DevelopmentAuthority (BARDA) is responsible for developing andacquiring medical countermeasures directed againstmicrobes of biodefense interest. BARDA is a componentof the Department of Health and Human Services, underthe Assistant Secretary for Preparedness and Response(ASPR). BARDA initiated its program for the developmentof novel antibacterial and antiviral drugs in January 2010.The goals of BARDA’s Broad Spectrum Antimicrobialsprogram are to enable the U.S. Government to acquiremedical countermeasures to protect the American publicagainst bioterrorist threats and to develop additionalantimicrobial treatment options needed to counter thegrowing threat of antimicrobial resistance in commonbacterial pathogens.Given these goals, BARDA funds antimicrobialdevelopment programs that concurrently focus on bacterialbiodefense threats while supporting the commercializationand regulatory approval of drug candidates directedtoward more common microbes. This strategy includessupporting pre-clinical and clinical studies, manufacturingactivities, etc, that would expedite antibiotic developmentfor clinically relevant/prevalent infectious diseases. It isBARDA’s intent to increase the robustness of theantimicrobial developmental pipeline for both biodefensepathogens and clinically relevant infectious diseases. Tothis end, we are seeking to develop public privatepartnerships for the development of antimicrobials forbacterial threat agents.Benefits of this talk include: 1. Learn about BARDA 2.Understand how to do business with BARDA 3. Gainappreciation for the technologies BARDA’s antimicrobialprogram is interested in.in.FEATURED PRESENTATION1:30 Gov’t Collaborations and Non-dilutive FundingRosemarie Aurigemma, Ph.D.Chief, Drug Development Section; Office of BiodefenseResearch AffairsDMID, NIAID, NIHThe Division of Microbiology and Infectious Diseases(DMID) within the National Institute of Allergy andInfectious Diseases (NIAID) supports development ofcountermeasures for diseases of global healthsignificance, including malaria, drug resistant tuberculosis,and influenza by developing new drugs, vaccines andpoint-of-care diagnostics. DMID also promotes basic andclinical research aimed at the development ofantimicrobials and vaccines for emerging and re-emerginginfectious diseases, including antibiotic-resistant bacteriaand supports the development of medicalcountermeasures for biodefense and emerging infectiousdiseases in support of the Public Health EmergencyMedical Countermeasure Enterprise (PHEMCE) mission.To achieve the goals of bringing new products through thetranslational pipeline, DMID offers a range of support, fromgrants to contracts as well as providing access todevelopment services that can fill gaps in the productdevelopment pipeline.Panel Discussion: Finding the Middle Ground inPartnerships with Big Pharma and Govt.Session: Recent Advances in Anti-Infectives -Part 1: Short PresentationsFEATURED PRESENTATION1:30 Gov’t Collaborations and Non-dilutive FundingRosemarie Aurigemma, Ph.D.Chief, Drug Development Section; Office of BiodefenseResearch AffairsDMID, NIAID, NIHThe Division of Microbiology and Infectious Diseases(DMID) within the National Institute of Allergy andInfectious Diseases (NIAID) supports development ofcountermeasures for diseases of global healthsignificance, including malaria, drug resistant tuberculosis,and influenza by developing new drugs, vaccines andpoint-of-care diagnostics. DMID also promotes basic andclinical research aimed at the development ofantimicrobials and vaccines for emerging and re-emerginginfectious diseases, including antibiotic-resistant bacteriaand supports the development of medicalcountermeasures for biodefense and emerging infectiousdiseases in support of the Public Health EmergencyMedical Countermeasure Enterprise (PHEMCE) mission.To achieve the goals of bringing new products through thetranslational pipeline, DMID offers a range of support, fromgrants to contracts as well as providing access todevelopment services that can fill gaps in the productdevelopment pipeline.
  4. 4. 9thAnti-Infectives Partnering and Deal-Making – July 9-10, 2012 – San Francisco, CAAgenda is subject to change. Please visit www.gtcbio.com for the most updated agenda. Updated 6/5/123:15 NZ2114, a Novel Plectasin Analogue, Aiming atResistant Gram Positive BacteriaItzchak Angel, Ph.D., President and Chief Executive Officer,Pharmaceutical Consulting and technologies /NovozymesNZ2114 is an improved ‘engineered’ variant of Plectasin, afungal antimicrobial peptide developed by Novozymes. It isa next generation antibiotic drug, for treatment of grampositive infections with a novel mode of action: it inhibits cellwall biosynthesis through sequestering of Lipid-II.The objective of the development project was to develop anAPI for an iv antibiotic which target severe gram positivehospital infections caused by especially resistantstaphylococcus and streptococci strains such aspneumonia, bacterimia, and skin infections.After a comprehensive screening of more than 500.000Plectasin variants the 3 most promising candidates havebeen investigated further with regard to safety/tox profile (invitro and in vivo), efficacy (in vitro and in vivo infectionmodels), manufacturing potential (fermentation yields, up-scaling potential, stability, formulation potential, andpurification potential with process and product relatedimpurities).The Plectasin variant NZ2114 has been selected for pre-clinical and clinical development. NZ2114 is especiallyeffective against Staphyloccoci and Streptococci and hasshow equivalent or superior effect in in vivo infectionmodels compared to current benchmark compounds(Vancomycin, Linezolid).It is at present time ready for phase-I clinical trials.3:35 To be considered for an oral presentation,please submit an abstract here by June 9, 2012.Selected presentations will be based on quality ofabstract and availability. Presentation slots fill up fastso please submit your abstract ASAP.3:55 Moderator: Malcolm Kendall, President and CEO,Indel TherapeuticsPanelist: Chau Q. Khuong, Private Equity Principal,OrbiMed AdvisorsPanelist: Kush M. Parmar, M.D., Ph.D., Principal,5AM VenturesPanelist: Patrick Heron, General Partner, FrazierHealthcarePanelist: Dov Goldstein, Partner, Aisling Capital- Current state of VC investment in antibiotics? Are theremany new companies?- Deal climate with large pharma?- Exit environment and IPO window for antibioticdevelopment companies?- Building an investment syndicate – more or less partiesat the table?- Attractiveness of anti-infectives from a VC perspective:- The relatively strong translation of preclinical data toclinical POC w/ anti-infectives- Relatively short time-frames to demonstrate efficacy,although regulatory bar is different depending onindications.- Pharma has substantially move out of ID, thereforemaking this the best time to invest for when appetitestrengthens and pipelines are thin.- Challenges from a VC perspective:- Regulatory challenges remain significant, despitelanguage towards a more personalized therapyapproach.- Technology—inability to know up front whether a patientrequires a truly novel drug presents a challenge for drugdevelopment.- Pricing—the culture of commodity pricing for antibioticsis entrenched, although we are seeing strong examplesrecently that is moving towards “value-based” pricing.This will be critical.- Areas we are watching as VCs:- MDR gram(-) infections- HBV- RSV- Orphan diseases (e.g., BK virus)- Companion diagnostics that offer truly rapid susceptibilitytesting without first requiring positive cultures4:45 3 minute speed meetings. Delegates can RSVPonce they register.Seated Delegates that do not change seats: delegatesfrom Big Pharma, Government Officials, VentureCapitalistsDelegates that change seats every 3 minutes: all otherdelegates5:30 Networking Reception and Poster SessionOral Presentations from Submitted AbstractsPanel Discussion: Investment Opportunities withVenture CapitalistsActivity: Speed Meeting
  5. 5. 9thAnti-Infectives Partnering and Deal-Making – July 9-10, 2012 – San Francisco, CAAgenda is subject to change. Please visit www.gtcbio.com for the most updated agenda. Updated 6/5/12Day 2 - Tuesday, July 10, 2012Panel Discussion: Licensing vs. Co-developmentPartnershipsPanelist: Brad Prosek, Senior Director, CorporateDevelopment, Cubist PharmaceuticalsPanelist: Yuan-Hua Ding, Senior Director, External R&DInnovation, PfizerPanelist: Neil Abdollahian, MS, MBA, Vice President,Corporate Development, Trius TherapeuticsPanelist: Bhooshitha de Silva, Vice President, BusinessDevelopment & Strategy, Optimer Pharmaceuticals1) What’s the conceptual difference in value & riskbetween a co-development and out-licensing deal2) trade-offs between licensing and co-development andwhen to consider3) Alliance management and governance challenges withco-development deals4) Recent deals commentary5) Search strategies6) Valuation strategies7) Developing market perspectives / opportunitiesOld Drugs, New Drugs8:45 Market Opportunities for Antibacterials Insideand Outside of the HospitalDanielle Drayton, Ph.D., Chief Operating Officer, ArlingtonMedical ResourcesThe hospital antibacterial market represents a high-value,high-unmet-need segment of the overall antibacterialmarket. Characterized by an expanding population of at-riskpatients and growing prevalence and diversity of antibiotic-resistant pathogens, the hospital is ripe with opportunity fornovel therapies to treat not only MRSA but also Clostridiumdifficile infection (CDI) and gram-negative infections (GNIs).Additionally, the market for outpatient parenteral antibiotictherapy (OPAT) is also an area of increasing opportunity forantibacterial agents. As market competition increases, agranular understanding of the patients, indications,products, pathogens, and key prescribers will be paramountto the positioning and commercial success of current andemerging therapies.Benefits of this Presentation:- This presentation will explore the current marketlandscape for MRSA (including ABSSSIs), CDI, andGNIs in the context of the larger hospital antibioticsmarket- Review promising near-term and long-term candidates inthe pipeline and how key agents fit into the market.- Review of key unmet needs and drug developmentopportunities in the hospital and for OPAT9:20 IV/Oral Step-down Therapies for SeriousHospital Infections: Synthetically Novel TetracyclinesJoyce Sutcliffe, Senior Vice President, Biology, TetraphasePharmaceuticalsThe ability to deliver clinical candidates from anyantibacterial program is challenging, especially in the faceof multidrug-resistant pathogens where combinationtherapies are rapidly becoming the norm. Tetracyclinerepresented an early, broad-spectrum antibiotic and avaluable addition to the medical armamentarium. Newmolecules with advantageous IV/oral pharmacokinetics thatretain activity against all mechanisms of tetracyclineresistance, and are potent against contemporary multi-drug-resistant pathogens can be designed using a platform thatallows for totally novel modifications to the scaffold. Whilemany companies seek a novel compound that has anunexploited mechanism of action, this presentation providesan alternative approach for novelty. For example, wecontend that the design of a novel tetracycline with adesirable pharmacokinetic and safety profile is innovative,faster-to-development, and provides a less risky than theidentification and development of novel matter that hits anunexploited target. An update on TP-434, presently inphase 2 trials for complicated intra-abdominal infections,and data on discovery compounds that protect inPseudomonas aeruginosa lung and thigh models will bepresented.9:45 Development of An Entirely New Class ofAntibiotic: PMX-30063 Small Molecule Mimetic of Host-defense ProteinsNicholas Landekic, President and Chief Executive Officer,PolyMedix10:10 Morning BreakNeglected Infectious Diseases10:45 EthR Inhibitors that Boost Ethionamide ActivityMarcel Tigges, Ph.D., Chief Scientific Officer, BioVersysAG
  6. 6. 9thAnti-Infectives Partnering and Deal-Making – July 9-10, 2012 – San Francisco, CAAgenda is subject to change. Please visit www.gtcbio.com for the most updated agenda. Updated 6/5/12Up to 9 million people contract tuberculosis every year and50 million people are presently infected with Mycobacteriumtuberculosis resistant to both first-line drugs isoniazid andrifampicin (WHO, Fact sheet No. 104, March 2007).Ethionamide (2-ethylthioiso¬nicotinamide, 2-ethylpyrimidine-4-carbothioamide), a structural analogue ofisoniazid, is currently the last line of defense in thetreatment of multi-drug-resistant tuberculosis (MDR-TB).During 35 years of its clinical use, ethionamide hasfortunately elicited little cross-resistance with isoniazid asboth prodrugs have to be activated by differentmycobacterial enzymes to develop their antimicrobialactivity. Yet, ethionamide continues to be prescribed athepatotoxic doses as a consequence of EthR repressingethA, the monooxigenase that catalyses activation of theprodrug ethionamide into an anti¬mycobacterialnicotinamide adenine dinucleotide derivative. Up to a 1g/day are required for an acceptable concentration in blood(Holdiness, M. R., Clin Pharmacokinet 1984, 9, 511-44),which is associated with severe side-effects includingneurotoxicity and fatal hepatotoxicity.The research groups of Prof. Alain Baulard, Prof. BenoitDeprez, Prof. Nicolas Willand and Prof. Fussenegger haveidentified compounds that overcome EthR-mediatedresistance to ethionamide. Based on experimentsperformed in various assay modules, the in vitro efficacyand specificity of LEAD compounds could be validated invivo. Together with the BioVersys AG these compoundshave been further developed towards preclinical studiesand restoring ethionamide as important therapeutic optionin treatment of M.tuberculosis infections.Benefits of talk:- Novel approach to overcome antibiotic resistance- Restoring activity of existing drugs- Close interaction of Start-Up with academic partners- Drug-development in a small Start-Up company, hurdlesand opportunitiesFEATURED PRESENTATION11:10 Building a Portfolio of Anti-infectives AgainstNeglected Diseases Through Industry-PDP PartnershipShing Chang, Ph.D.Director, Research and DevelopmentDrugs for Neglected Diseases initiative [DNDi]Product development partnerships (PDPs) are not-for-profitR&D organizations dedicated to address the health needsfor developing countries. DNDi (Drugs for NeglectedDiseases initiative) is one of the PDPs. Established in 2003with the goal of delivering improved treatments forneglected patients suffering from diseases such as sleepingsickness, leishmaniasis, Chagas Disease, malaria,filariasis, and pediatric HIV infection.To date, DNDi has delivered 6 new treatments, and hasbuilt a pipeline with many NCEs. The success is largelybuilt on long-term partnerships with academia, the publicsector, international agencies, and particularly, withpharmaceutical and biotech industry.On 30 January 2012, leading pharmaceutical companies,the Bill & Melinda Gates Foundation, donor organizations,NTD-endemic country representatives and non-governmental organizations gathered in London toannounce a series of coordinated commitments to helpreach WHO goals to control or eliminate ten NeglectedTropical Diseases (NTDs) by 2020.I will highlight the collaborative model of building the anti-infective portfolio to combat the neglected infectiousdiseases, which afflict 1.4 billion of the world’s poorest,demonstrating power of PDP-Industry collaboration inaddress global health challenges.Session: Recent Advances in Anti-Infectives - Part 211:35 Malcolm Kendall, President and CEO, IndelTherapeutics12:00 The First Fluoroketolide, Solithromycin, inDevelopment to Meet the Need for A New MacrolidePrabhavathi Fernandes, Ph.D., Founder, President andChief Executive Officer , Cempra PharmaceuticalsThe spectrum of activity, safety, anti-inflammatoryproperties, intracellular activity and tissue distribution havemade macrolides the go-to antibiotic for treating respiratorytract infections. They are also widely used in many otherinfections, including bacterial urethritis. Widespread use ofmacrolides, primarily azithromycin, has led to greater than30% resistance in the US and greater than 96% resistancein China for pneumococci, the primary pathogen in bacterialpneumonia. Solithromycin has multiple binding sites on thebacterial ribosome, overcoming pneumococcal resistanceto older macrolides like azithromycin. It has been welltolerated in Phase 1 clinical trials and has completed aPhase 2 trial where it has demonstrated comparableefficacy to levofloxacin, even at the 72 hour early responseend point, and has shown a favorable safety profile. It hasbeen chemically, metabolically and mechanisticallydifferentiated from telithromycin (Ketek). Phase 3 studieswith oral tablets are planned. Macrolides are traditionallyused orally because of tolerability issues. Solithromycin’sintravenous formulation is also under development and hasbeen well tolerated in a Phase 1 study. Phase 3 studieswith intravenous to oral step-down therapy are planned andthis dosing regimen is expected to provide apharmacoeconomic advantage by providing broadcoverage against respiratory bacterial pathogens andallowing the patient to be dosed intravenously and orallywith the same product.
  7. 7. 9thAnti-Infectives Partnering and Deal-Making – July 9-10, 2012 – San Francisco, CAAgenda is subject to change. Please visit www.gtcbio.com for the most updated agenda. Updated 6/5/1212:25 Lunch Provided by GTC1:40 Michael N. Dudley, Pharm.D., FCCP, FIDSA ,Senior VP, Research & Development and Chief ScientificOfficer, Rempex Pharmaceuticals2:05 Ceftobiprole – A Broad-spectrumCephalosporin with Proven Clinical Efficacy inPneumoniaLaurenz Kellenberger, CSO, Basilea Pharmaceutica2:30 Heterodimer Antibiotics for Resistant GramPositive Infections – Multi-Pharmacology Approachesto Treating Difficult InfectionsEd Moran, Vice President R&D Projects, Theravance2:55 Closing Remarks3:00 Conference Concludes
  8. 8. REGISTRATION FORMFax to: 626-466-4433Mail to: GTC, 635 W. Foothill Blvd, Monrovia, CA 91016Use this form to register up to 3 attendees – Please TYPE or PRINT your responses clearlyAttendee #1 Attendee #2 Attendee #3_________________________________________ _________________________________________ ________________________________________Name Name Name_________________________________________ _________________________________________ ________________________________________Job Title Job Title Job Title_________________________________________ _________________________________________ ________________________________________Department Department Department_________________________________________ _________ SAME AS ATTENDEE #1 __________ _________ SAME AS ATTENDEE #1 _________Organization Organization Organization_________________________________________ _________________________________________ ________________________________________Mailing Address Mailing Address Mailing Address_________________________________________ _________________________________________ ________________________________________City, State & Zip Code City, State & Zip Code City, State & Zip Code___________________ ____________________ ___________________ ____________________ ___________________ ___________________Phone Fax Phone Fax Phone Fax_________________________________________ _________________________________________ ________________________________________Email Address: Email Address: Email Address:NAME OF CONFERENCE ATTENDING: ______9thANTI-INFECTIVES PARTNERING & DEAL-MAKING____________PRICING OPTIONS:Standard Pricing per AttendeeCommercial ______$1,795.00_______Acad./Gov. ______ $ 845.00_______Student ______$ 695.00_______Discounted Rate before 6/9/2012Commercial ______$1,650.50_______Acad./Gov. ______ $ 760.50_______Student ______$ 625.50_______Fax to: 626-466-4433Pricing for 3 for 2 discountCommercial ______$3,590.00_______Acad./Gov. ______ $1,690.00_______Student ______$1,390.00_______PAYMENT METHOD (CHECK ONE)  Check*  Bank Transfer**  Money Order  Visa  MasterCard  American Express  DiscoverCard #: __________________________________________________________ Exp: Date: ______________________ CSV #: ______________________Cardholder Name: _________________________________________________ Signature: ___________________________________________________Billing AddressStreet: ______________________________________________________ City, State, Zip : ________________________________________________HOW DID YOU HEAR ABOUT THIS CONFERENCE: ___________________2012 Brochure_____________________________________________CANCELLATIONSAll cancellations will be subject to a $195 cancellation fee. In order to receive a refund, you must submit a written notice of cancellation (by letter or fax) no later than 6 weeks prior to the conference. We regret thatrefunds will not be issued after this date. A conference voucher will be issued for use at any future GTC conferences within 12 months of cancellation. If you plan on sending a substitution in your place, thesubstitution must be from the same organization. Please notify GTC of any substitutions as soon as possible so the proper preparations can be arranged. In the event of a conference cancellation, GTC is not liablefor transportation, hotel, or other costs incurred by registrants.*Checks must be drawn on a US bank and made payable to Global Technology Community, or GTC. International money orders are also acceptable.**Bank Transfer Information: Bank of America, 230 S. Myrtle Ave., Monrovia, CA 91016 **BANK TRANSFER REQUIREMENTS: WhenABA Routing #: 121-000-358, Account #: 0230604059 submitting a bank transfer, please add the name of theSwift Code: Bofaus6s attendee on the transfer.

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