Moji Christianah Adeyeye, PhD President and Chief Scienti8ic Of8icer - PowerPoint PPT Presentation

Moji ¡Christianah ¡Adeyeye, ¡PhD President ¡and ¡Chief ¡Scienti8ic ¡Of8icer Professor ¡of ¡Pharmaceutics ¡and ¡Drug ¡Product ¡Evaluation Chair, ¡Biopharmaceutical ¡Sciences, ¡College ¡of ¡Pharmacy Roosevelt ¡University, ¡Schaumburg, ¡IL, ¡USA 6/1/13 1

University-Based Development: Cheaper Means to Treat Children Living with HIV/AIDS 6/1/13 2

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Inte tellectu tual Pate tent t and Licensing } Patents: Antiretroviral Drug Formulations for Treatment of Children Exposed to HIV/AIDS PCT/US2009/031285 ◦ UK Patent Application – GB 10118925 ◦ US Patent Application – 12/863,111 ◦ South Africa Patent Application – 2010/05070 } License obtained in 2009 from Duquesne University with royalty agreement 6/1/13 5

} 2009/2010 IND Filed } January/May 2010 FDA Approval of IND } September 2010 Clinical Batch Manufactured by Emerson Resources Inc. } October 2010-April 2012 Clinical Tria l } May/June 2012 Pre-NDA Discussion Clinical Trial Data Submission } September 2012 FDA Advise to submit two New Drug Applications (NDA) 505(b)2, one for each product 6/1/13 6

GMP* Taste-masked FDC Granules (Reconstitutable Suspension Manufactured for Elim Pediatric Pharmaceuticals Inc. September 2010 by Emerson Resources, USA GMP* Batch (Taste- masked FDC Tablets for * Good Manufacturing Practice Suspension) (in FDA-certified facility) 6/1/13 7

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Dissolution Profile of Zidovudine, Lamivudine and Nevirapine in 3 in 1 tablet 100 90 80 70 % Drug Release 60 Nevirapine 50 Zidovudine Lamivudine 40 30 20 10 0 0 5 10 15 20 25 30 35 40 45 50 55 60 65 Time(min) Release of drugs met FDA’s requirements 6/1/13 9

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Lamivudine Nevirapine Zidovudine Comparison of amount t of commercially available individual drugs admixed For a ch For a child’s u ild’s use: Nev se: Nevirapin irapine plu e plus lam s lamiv ivudin dine plu e plus s Zidov Zidovudin dine (15 m (15 ml~ 1/1/2 l~ 1/1/2 tablespoons ) - Bitte ta tter ta taste te Versus Versus Elim Products El ts TES EST – – 1 ta tablet t TES EST – – 5ml (I te teaspoon) (te teste ted (te teste ted pleasant t ta taste te) pleasant t taste ta te) 6/1/13 11

} Comparison of amount t of commercially available in indiv dividu idual dru al drugs adm s admixed for a ch ixed for a child’s u ild’s use: se: ◦ Ref Referen erence: Liqu ce: Liquid id ne nevi virapine ne plu plus lam lamiv ivudin dine plu e plus zidov zidovudin dine ◦ 15 ml~ 1/1/2 ta tablespoons with th bitte tter ta taste te } El ElimPP Inc. th three drugs-in-one ta tablet t or liquid dose ◦ Granules for reconsti titu tuti tion (liquid) – 5 ml or 1 te teaspoon (te teste ted pleasant t ta taste te) ◦ Fast t dissolving ta tablet t for suspension – 1 ta tablet t (te teste ted pleasant t ta taste te) 6/1/13 12

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Bioequ Bioequiv ivalen alence: ce: El ElimPP Inc. Products ts distr tribute te similarly in th the body (bioequivalent) t) – – Met t FDA DA’s requirement t 700 Plasma concetration profile for Zidovudine 600 Cmax 900 Plasma concentration profile for Lamivudine 800 500 700 Conc ¡(ng/mL) ¡ 400 Conc ¡(ng/mL) ¡ 600 Ref Ref 500 300 Susp Susp 400 Tab 200 300 Tab 200 100 100 0 0 0 ¡ 2 ¡ 4 ¡ 6 ¡ 8 ¡ 10 ¡ 12 ¡ 14 ¡ 0 ¡ 2 ¡ 4 ¡ 6 ¡ 8 ¡ 10 ¡ 12 ¡ 14 ¡ Time ¡(h) ¡ Time ¡(h) ¡ Tmax Plasma concetration profile for Nevirapine 400 Tm Tmax ax – time to reach 350 Ref maximum concentration 300 Conc ¡(ng/mL) ¡ Test 250 (Cmax Cmax) ) Sus 200 150 100 50 0 0 20 40 60 80 100 Time ¡(h) ¡ 6/1/13 14

§ Patients will tend to continue drug use due to less number of pills to use § Less death among HIV infected children § Improved quality of life § Better formulation choice esp. in areas where there is a lack of drinkable water ( developing countries)- for the fast dissolving tablet § Granules (powder) for reconstitution can be dispensed for one month use 6/1/13 15

Mis Missin ing P Puzzle zzle } Funding of Registr trati tion Batc tches: ◦ Clinical batch manufacturing by contract research organization – pharmaceutical company ◦ Stability testing (up to six months) ◦ Testing for drug release (dissolution) – [Items 2 and 3 can be done in house (within the university )] – a cost-saving approach ◦ Labeling and Packaging ◦ Filing of application } Marketing (PEPFAR, WHO, Clinton Foundation, etc.) 6/1/13 16

Proposed Transaction Details 6/1/13 17

} Elim Pediatric Pharmaceuticals Inc. signs contract manufacturing agreement with a company for the clinical batch, submission of NDA and registration } Elim Pediatric Pharmaceuticals Inc. performs analytical assay development, testing and stability studies at Roosevelt University under good laboratory practice and signed cooperative research agreement with the university } All data are complied by EPP Inc. } A consultant (form Investor) aids ElimPP Inc. in submission } Marketing outlets facilitated by a consultant and aided by investor } Distribution – consultant/investor aided 6/1/13 18

} 1 in 4 children currently receive treatment } Promising market potential in Africa ◦ 75% of HIV infections are in sub-Saharan Africa 6/1/13 19

Children (<15 years) estimated to be living with HIV | 2009 Ea Easte tern Eu Europe 
 Weste tern & & Centr tral Asia Centr tral Eu Europe 18 000 18 000 1400 1400 North th America [8600 – 29 000] [<1000 – 1800] 4500 4500 Ea East t Asia 8000 8000 [4000 – 5800] [3600 – 13 000] Middle Ea East t & North th Africa 21 000 21 000 Caribbean Carib ean 17 000 17 000 [13 000 – 28 000] South th & South th-Ea East t Asia [8500 – 26 000] 150 000 150 000 [97 000 – 200 000] Sub Sub-Sa -Saha haran n Afr Africa Centr tral & 2.3 m 2.3 million illion South th America Oceania Oceania [1.4 million – 3.1 million] 36 000 36 000 3100 3100 [25 000 – 50 000] [1500 – 4800] Tota tal: 2.5 million [1.6 million – 3.4 million]

Estimated number of children (<15 years) newly infected with HIV | 2009 Easte Ea tern Eu Europe 
 Weste tern & & Centr tral Asia Centr tral Eu Europe 3400 3400 <100 <100 North th America [1500 – 6000] [<200] <100 100 East Ea t Asia 1900 1900 [<200] [<1000 – 3600] Middle Ea East t & North th Africa 6400 6400 Caribbean Carib ean 1900 1900 [4000 – 8900] South th & South th-Ea East t Asia [<1000 – 3100] 20 000 20 000 [12 000 – 29 000] Sub Sub-Sa -Saha haran n Afr Africa Centr tral & 330 000 330 000 South th America Oceania Oceania [190 000 – 460 000] 4300 4300 <1000 <1000 [2600 – 6500] [<500 – 1200] Tota tal: 370 000 [230 000 – 510 000]

Estimated deaths in children (<15 years) from AIDS | 2009 Ea Easte tern Eu Europe 
 Weste tern & & Centr tral Asia Centr tral Eu Europe 1800 1800 <100 <100 North th America [<1000 – 3300] [<200] <100 <100 East Ea t Asia 1000 1000 [<200] [<500 – 1900] Middle Ea East t & North th Africa 3300 3300 Carib Caribbean ean 1600 1600 [2100 – 4500] South th & South th-Ea East t Asia [<1000 – 2600] 14 000 [8300 – 20 000] Sub Sub-Sa -Saha haran n Afr Africa Centr tral & 230 000 230 000 South th America Oceania Oceania [130 000 – 330 000] 2700 2700 <500 <500 [1400 – 4200] [<200 – <1000] Tota tal: 260 000 [150 000 – 360 000]

} Nearly 700,000 children need treatment } Estimated cost for a year treatment/ child ◦ $192-352 } 20% of market = 140,000 children ◦ Es Esti timate ted $272 x 140,000 ◦ $38,080,000 $38,080,000 6/1/13 23

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} Faster (tentative) approval by FDA for HIV/AIDS drugs } Excerpts (from personal FDA’s e-mail subscription) } Examples: – The Food and Drug Administration, on March 18, 2009, granted tentative approval for stavudine and lamivudine fixed dose combination tablets, 30mg/150mg & 40mg/ 150mg, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection as a component of combination therapy. Fixed dose combination products such as this can ease pill burden and simplify dosing, and can help increase drug adherence. 6/1/13 25

} Excerpts – On On March March 30, 30, 2009, 2009, FDA granted tentative approval for abacavir sulfate and lamivudine tablets, 600 mg / 300 mg, manufactured by Matrix Laboratories Limited of Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection. The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (<http:// www.pepfar.gov/>PEPFAR). 6/1/13 26