From: Portilla, Lili Sent: 29 Apr 20l5 11:40:36 41400 To: McConnell, Cindy (NIHJNCATS) Charles (NIHINIDDK) Subject: RE: ACTION: questions i agree with check and questinn en NIH invrilveineni on pricing needs: Id be directed to Big 1. Pricing in not in where of' in?uence. Lili M. Pur'rr'h'd. Suriname .4 Hrunrm Science-r fr?i?CL'A T31. NIH P: .ifll-2l7- ?589 H: Lilig?e nih.gev From: McConnell, Cindy (NIHINOATS) Sent: Wednesday, April 29, 2015 11:36 AM To: Glades (NIHINCATS) Portilla, Lili Subject: RE: ACTION: KEI questions 'I'lianlua. Chuck! From: Grades Sent: Wednesday, April 29, 2015 11:31 AM To: McConnell, Cindy (NIHINCATS) Portilla, Lili (NIHINCATS) Subject: RE: ACTION: KEI questions IMO. I think ll'le pricing issue is a policy question It! be addressed by Dori] or I. The issue about crimpany name is an OTT questinn. The company?s name was publicly disclosed in the lied Register Nuliee: ?Virolas LLC, a company having a place of business in California? Hmvever. guessing all additirmal info about the enlnpany might be enlisidcred lmsinesa erm?dential. but O'l'i' needs 10 epine. In general. public 01" all eumpanies are publicly available ?'mn the state where Ihey are incorporated. KFJ slmuld ask this questinn nfC'alithi-nia or Delaware. or wherever Vireras. is incorporated. From: McConnell, Cindy Sent: Wednesday, April 29, 2015 10:41 AM To: Charles Pertilla, Lili (NIHINCATS) Subject: RE: ACTION: KEI questions Ili Chuck and Lili, Please see Mary?s notes below. Do you know [he answers to her questioner? Re the lirsi one, thal?a not Nil reles?autlioriiy: lieu.- eeuld we possibly "preiecl against priee gauging"? l?m not to answer her second questian but [?111 not ennvineed it's relevant in this aim-alien Heel. Cindy me: Hams, Navy Sum Wednesday, Apnl 29, 2015 9:13 AM To McCamelI, Cindy Cc: Carma, swim: Re' KFI questions Chuck makes good pomls, also doesn't mm document and dcxribc \hc process |o Irmrke( and NIH's place process. And does N111 do anything protect gouging when we invest pubh: Funds w: aim xun the risk ul'nppealing be by ignonug Km requesl mr infunnanon about me company. Ifwe have [equesled mfo on me campany protected under AM. \Jd wrme: mm "mm . 1; MW .nul mm: I -.J A IN \th( mm mum m. mum vmludn, (mm mspunu: 'vchm, Hui max me- NIerskv, Charles Se ussflay, Am 28, 2015 8:26 PM ceanneu, Cindy aniHa, LilI subjen: RE: Amm: KEI quemnnc fiverylhing Anna says IS true. mcludxng um we need industry bring |he fruit or our \abovs to market. KEI agree loo. Bu| KEY: point will be [hm \s precucly why they lcucr '1 want make sulc me Imm- Immacliun puhmly funded mm}. mm mm mm mdum 13 m1. [hm |hcrc is my purcwfid pricc gouging, Thi mm 1ch .1 <nn Aprzx. 11m, at 7:10 PM. ('mdy m' MN nn 1 .u From: Amer, Anna Sent: Tumy, Ann! 28, 2015 Mo PM Yo: Chang, KEVIN Cc: Carma, Hank, Merv McComefi, Subjech Re ACTION: KEI (wished: 1: men>> ulhcr Ianguag: mat company would be cnlufmlahle mm (hut we could use to clad for NIH can nux bl mg Ill: fruit: of to flu; puhlu; a; an FDA product unhum pdnnumg \Ailh I'm no! \ur: KEI th ncu compnund requires a more vnvz:>Ln'4lp w. h'undm u; .n drug .md p; minimum mm my mum "umNm'm whimhmnumu \nn: Nuan Hm mu h, ~m ml'mm.' 1 mnhm'nln um". 'Mumx mum Am wwu'l" "mm tn luwlwun' mm .wm; mm" link uh mm" ,Mm mm>> mm. mm mm m, Iwmum. Im- ,xJ numb 'lm mm . my." mm um I m; From Camera, (Ns'en Huh/monk) San! Monday, Ann 27, 2015 07 AM 13m; Mfily MCEOWHDH, Lindy Anw, Amm [a 5mm; :5 Arm. x51 qm's mh um Hm: "Hum," m-lh Md mm m. Nu |uv "Lu-Aw mm HI "1 MA Mn Mum-u '4qu mu m-vc van mm. mm my ml\ mus} From: Canera' Sent: April 2'1, 201; 2? AM Yo: Chang, Kevin Cc: Harvls, McCunnel, Cindy Amer, Anna 5mm: ACTION: KEI questions in kcw, Pic-N ihuqncsumhf'n "(Fl mm" m: nwimlc lung." vmuhln aim 'iw ii". \:Iluc "mnmmu mim- 3m mm The \iqucqmn mm OTT Iczm you th' Minimum; .'uhncn ,uxm" 3Uilihitlln) mun" Thanh>> Carrera Mom Relalions and Pub Ic Liaisan Taarr Naumai cl mamas and Digestive and Kidney D>seases Nanuuai Insnuies ul Hea in um Turning Dlszovery Into Huhh'TS' mm From (mam aerial oftlizabdn Rajaslng Se 13, 2015 3:68 PM rrera, Kwsien Subject Re: quesuons in: our researchers Hi Yes, I have tried to speak with the authors of ihal article about their research. I have a few questions regarding their work. i) 1; compound referenced in article, "Repurpuaing of the antihistamine chlurc lizinc and relaleil compounds [or of hcpumls virus infecliun." the same compound ihml is referenced in the Federal Register, "Prospemive Gram ni Exclusive Lil'mse: Small Against Hepatitis Virus Infection?' 2) Can you describe the nexisteps you will be taking to further this research? Does the compound appear to be a cure/game changer? Does it have the potential in be a low-cost form of treatment for Hep patients? a) Is the NIH srill funding research, specifically clinical trials, on this compuund? it so, can you provide details on the cost of the clinical trials that the NIH is funding? 4) Can you pmvide any information about the pharmaceuiicul company ihai is seek the exclusive license in the previously mentioned federal regisicr notice, such as names, addleSSES or titles in Ihe Company (board of direciurs or shareholders)? Thank you for your help, Elizabeih Rajasingh Elizabeth Rajasingh Pei-Is Research and Policy Fellow, Knowledge Ecology International 1621 Connecticut Ave. NW, Suite 500 Washington, DC 20009 On Thu, Apr23, 2015 nt 9.1 I AM, Carma, -- Dear Ms. Rajasingh. We understand you have been reaching out to the audlun of the recent publicailon. "Repurposing mime antihistamine ind rclalcd compounds for irenimcnl of hcpalilis tints infection" Whai specific qucslions do ynu have regarding the science? We would he harm it) send wrilien responses on hehnit'ot the authors to help them manage nnie focus on (hair research, Thanh. Canera Media Relzitons and Pub tc Liam. Team Nahuna' dDusbeles am: meal we and Kmey Dwseascs Na< lh (c Dismvery Into Healkh 1R: ummgum mg>> qlnugCOm ,mz' unugcmu nun munmmwumxr (10-le0 mm mm came ac: mammal, may (NM/Nuts) Dang, New- mnuoo) Ma, Arm (mummx) :1 qt: HIDWImexmne/m. wfl/mzazmin'. mrww" sum-m re. muvrzw. um um om: ans/mm 19.2715 Mum: mm WK: Made )1 luv 01mm mm qumlvm} '2 On Aar 2m 5. 5:09 PM. Cavrcm, (MN VIDDK) < May (mu/mom) [n Fro-t: Carrera, Sent: Ma ZOIS 6:43:37 -0400 Subject: .: ques ions orour researc ers Hi Elizabeth. Thanks for year patience. Here are our answers to your questions. Best. Current 1) Is the compound referenced in the article. "Repurposing of the antihistamine and related compounds for treatment of hepatitis virus infection.? the same compound that is referenced in the Federal Register. "Prospective Grant of Exclusive License: Small Molecule Therapeutics Against Hepatitis Virus Infection?? The patent applications referenced in the Federal Register cover several new classes of compounds that have the potential ofheing it new treatment against the hepatitis virus. One class is related to the antihistamine compound described in the paper. This molecule is an over-thccounter drug that already is in the public domain. 2) Can you describe the next steps you will be taking to further this research? Does the compound appear to be a cure/game changer? Does it have the potential to be a low-cost form of treatment [or Hep patients? in an FDA-approved clinical trial at the NIH Clinical Center, researchers are one of the over-the-counter antihistamines described in the paper. The small study is evaluating the compound?s safety and identifying any side effects in people who have hepatitis C. and is also designed to assess whether this compound has any antiviral effect with a short-term dosing. This study Will not determine whether this compound can he used to treat the hepatitis vints. Currently we do not know if the drug has any effect in people infected with the virus. Even if the initial trial raises no serious safety concerns, FDA would require additional. larger clinical trials to further study safety and to determine cfl'rcaCy of the drug to treat the hepatitis Virus. FDA would consider the results of the clinical trials before deciding if the drug should be approved for use in hepatitis C. The. NIH values partnerships with industry and academia to deliver groundbreaking technology and medical advances to the public as quickly as These collaborations help innovative ideas become reality. leveraging resources and expertise from a variety of disciplines. The NIH contributes scientific knowledge and discoveries from the research it supports and does not control approval or pricing of drugs. 3) Is the NIH still funding research, speci?cally clinical trials, on this compound? If so. can you provide details on the cost of the clinical trials that the NIH is funding? The clinical trial is a small phase lb study supported by the NIH intramural Research Program. The cost is part of the program?s operating budget and does not require additional funding. 4) Can you provide any information about the pharmaceutical company that is seek the exclusive license in the previously mentioned federal register notice, such as nines, addresses or titles in the company (board of directors or shareholders)? Virotas Biopharmaccuticals, LLC is a privately held start-up company with founders experienced in drug development and commercialization. le: 35115140 marmma Ratasinn sent: l'l'vursday, Aprll 23, mi: 3:05 1'0: Owen, Subject: Re: questions fol cur researmers Hi \'cs.1liavelried lo speak VIIllh lhe authors of lliat article about their I have il few questions regarding Illeir work. ii is [lit [Morena-d tic amnlr, "Rspurpnsing oflho antihistamine and tvlalvrl (ifl'lvpalitis P. \1'rus infection." [by came L'On'pollnd that is referenced In the Federal chisier. "Prospectne Grant or 9 License: Small Molt-cult>> Tlierapeulu-s Agalnsl Hepalilis Virus Infection?" 2) Can you dist-titre the next slaps you will in tailing in further this research? Does the compound appear to bc ll cure/game changer? Does it have (he potential to lie a low- cusl form of treatment for Hep palirnts? 3) Is >lill funding rl'sl'ailli. specifically niral trials, {in mi: so, can you provide details on lhe nfflie ('l'mr'all all: thal th NIH is funding? 4) Can you provide any ahout the pharmaceutical company that IS seek the exclusive license in the previous], mentionedieclei-tl register notice, such as names, nr lillnr in the ('nmpany (board at Cirocmrs or shareholders)? Thank you f0 kaiasingh Paris Resaarrh and pnlicy Fellow, Knowledge Ecology International 162: Avr. NW, Sullr 5m) \V'asllinglun, DC 20009 Un Ihll at '47 ll Carrel". We Dear WC undemand you been mm :0 WC numon of (he pubhcamm, "Repumusmg Mme L'hluruycluine and relaxed compounds for uealmenl uf hepmilis vas infeclion What spemfic quesuons do you have regarding scuencc" We would be happy Io send wrillcn responses on behalr'oftluc aumors help them 1mm: go than [me and focus an {heir research, Thankt. Carrera Mama Reladoru and Fublu: balm Team Mammal Insmme ov and Digestive and Kmney D'seases Nalmnal Inemums n' Heallh (t (c kavery mm Health(R) I40 mat Linea, men GWUUP "idem Km (WHOM 'rhms, Maw [a 'A'vtav, Am