Update on Progress of MPP Sub-licensees July 2017
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- Tyler Briggs
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1 HOW THE MPP WORKS?
2 Update on Progress of MPP Sub-licensees July 2017
3 In-Licensing: Concluded Agreements Lopinavir Ritonavir (separate paediatrics and adults licences) Atazanavir Daclatasvir (HCV) Nevirapine (nonassert) Cobicistat Elvitegravir Emtricitabine Tenofovir Alafenamide Tenofovir Disoproxil Darunavir (paed) (nonassert) Sutezolid Raltegravir (paed) Darunavir related Valganciclovir (pricing agreement) Solid dispersion nano technology for HIV Abacavir (paed) Dolutegravir (paed) Ravidasvir (hepanns C) Dolutegravir (adults)
4 Snapshot of MPP sub-licences 61 sub-licences with 16 manufacturers; 110+ acnve projects; 4 new licensees
5 ARV A LOOK INTO THE FUTURE: IN-LICENSING PRIORITIES FOR THE MPP CharacterisMcs Bictegravir Cabotegravir LAI Doravirine Fostemsavir Rilpivirine LAI Integrase Inhibitor; submiwed for regulatory approval Integrase inhibitor; long acnng injectable being studied for treatment and PrEP (Phase 3) NNRTi with less common adverse events as compared to efavirenz (Phase 3) First in class awachment inhibitor; potennal role in salvage therapy (Phase 3) NNRTi, long acnng injectable being studied for treatment and PrEP Source: Priori+za+on of HIV and Hepa++s C medicines for in-licensing by the Medicines Patent Pool (2017)
6 ACCESS TO DOLUTEGRAVIR
7 Patent and licensing Status of Dolutegravir in LMICs Countries included in MPP licence for DTG adult Countries with no patent on DTG when the generics may be allowed to sell FUENTE: MedsPaL (
8 DTG AND
9 DTG API Till now, 13 filings by 7 licensees: 6 Filed with WHO-PQ 7 Filed with USFDA 1 filing planned in 2017, another in early st SRA3Filing DTG and CombinaMons Projects Average3 under development (1) Filed Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Average DMF filing Nmeline: Q3-16 (Seven licensees already filed)
10 DTG 50mg Till now, 7 filings by 4 licensees 3 filed with WHO-PQ 4 filed with USFDA 2 filings expected in filings expected in H st SRA3Filing DTG and CombinaMons Projects Average3 Filed under development (2) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Average dossier filing Nmeline: Q3-17 (four licensees already filed)
11 TDF/3TC/DTG Two companies filed in 2016 Local regulatory filings ininated # 6 other licensees developing this FDC; filings planned in: 3 more later in the year Q1-18: 2 filings planned 1 st SRA Filing Average Filed DTG and CombinaMons Projects Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q under development (3) Average dossier filing Nmeline: Q2-18 (two filings completed) # No update this quarter from Cipla
12 TDF/FTC/DTG 5 licensees developing this FDC (lower priority than TLD) 3 filings planned in Q more planned by st SRA3Filing Average3 DTG and CombinaMons Projects Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q under development (4) Average dossier filing Nmeline: Q2-18
13 TAF FDCs a lower priority, due to non-inclusion in WHO Guidelines TAF/FTC/DTG 1 licensee plans to file in Q others plan to develop and file in 2018 Dossier Filing Average DTG and CombinaMons Planned Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Projects Average dossier filing Nmeline: Q2-18
14 DTG generic filing analysis plans in countries
15 DTG 50mg Filing Analysis (1/3)
16 DTG 50mg Filing Analysis (1/3) Country filing plans with dates are usually finalized close to or ajer SRA/WHO PQ filing. Hence this data will become richer as further SRA/WHO PQ filings happen
17 DTG 50mg Filing Analysis (1/3)
18 TDF/3TC/DTG Filing Analysis (1/3)
19 TDF/3TC/DTG Filing Analysis (2/3) Country filing plans with dates are usually finalized close to or ajer SRA/WHO PQ filing. Hence this data will become richer as further SRA/WHO PQ filings happen
20 TDF/3TC/DTG Filing Analysis (3/3)
21 LONG ACTING INJECTABLES??
22 Both CAB-LAI and RPV-LAI are nanoformulated They are intramuscular injecnons into buwocks, at least 2-3 ml each CAB-LAI does not need cold chain, but looks like RPV-LAI does (at least per its current formulanon) Use of long acnng injectables in PrEP: CAB-LAI (ViiV) is ahead of RPV-LAI (Janssen) in terms of PrEP invesnganon, 2 major global phase 3 (sponsored by NIH and run by HPTN) For PrEP, the two are being studied on their own, not in combinanon. The injecnon frequency for CAB-LAI is every 2 months in Phase 3 trials Use of long-acnng injectables for Treatment: Being studied for long-term maintenance strategy for people when the virus is already undetectable/suppressed). CAB-LAI and RPV-LAI are being studied in combinanon, as monthly INFORMATION injecnon (there s a bigger loading ON injecnon LONG-ACTING at the beginning) Before any long acnng injectable is given, people are given oral CAB (or RPV, or both depending on the use) for some 4-5 weeks, to make sure there are no side effects, allergies, etc. INJECTABLES
23 TAG pipeline report that has just come out: hwp://cts.vresp.com/c/?treatmentacnongroup/e ea/ dd82f08562/35e00307e5 On treatment: hwp:// There s a secnon on Long-AcNng Cabotegravir and Rilpivirine On PrEP: hwp:// ADDITIONAL INFORMATION ON There s a secnon on IMPLANTS AND INJECTABLE LONG-ACTING FORMULATIONS that talks about CAB LAI and RPV LAI LONG-ACTING INJECTABLES TAF /FTC in case TAF eventually replaces TDF/FTC for PrEP.
24 Is there any expectanon/interest in the community about them? Do you think CAB-LAI and RPV-LAI should be used both for PrEP and treatment or only for one of the two? Why? How do you see the role of civil society, communines in making the medicines available, affordable and accessible for all those in need in your country/ region? What needs to be done by civil society and other stakeholders? QUESTIONS TO COMMUNITIES ON Do you think your country/ other countries of your region might need support from MPP in making the LAIs more affordable? LONG-ACTING INJECTABLES
25 Treatment Do you think PLWHIV in your region might prefer LAI once a month to oral pills on a daily basis? Which groups/populanons might be able to benefit from LAI? What could be the potennal challenges? (including programmanc challenges e.g. treatment models, availability of treatment sites, accessibility of hospitals, HIV clinics etc) Do you think there might be problems with adherence? PaNents coming to a treatment site for injecnon once/month? QUESTIONS TO COMMUNITIES ON Do you think they can be used in your country/region? On what condinons? (affordability, state procurements, adapted treatment models, EML, treatment guidelines etc) LONG-ACTING INJECTABLES Could it be a problem given the storage condinons in some countries of the region? (CAB - in room temperature but RPV - refrigerated)
26 PrEP Do you think community groups in your country are aware of the likely future possibility to use the LAI (either CAB or RPV) instead of orals for PrEP? Which groups could benefit from the LAI for PrEP most? (Injectable drug users? Sex workers? Adolescent women? MSM? Others?) Do you see potennal challenges for any of those groups? Any programmanc challenges? (e.g. criminalizanon, sngmanzanon, lack of PrEP programs, no or lack of harm reducnon programs, prevennon acnvines, lack of OST sites, low awareness, no access to public hospitals etc) Do you have any other concerns regarding the use of LAI for PrEP? Do you think community groups in your country would prefer the LAI (either CAB or RPV) instead of orals? QUESTIONS TO COMMUNITIES ON Do you think the LAIs might potennally be used for PrEP in your country? On what condinons (affordability, PrEP guidelines, state procurements, EML etc) LONG-ACTING INJECTABLES
27 @MedsPatentPool.org
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