THE MEDICINES PATENT POOL - EXPANDING ACCESS TO PUBLIC HEALTH
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THE MEDICINES PATENT POOL EXPANDING ACCESS TO PUBLIC HEALTH
IMPLEMENTATION OF
DOLUTEGRAVIR LICENCES
Development Report
2017-March 2021
CURRENT SUBLICENSEES
FOR VIIV-MPP DOLUTEGRAVIR LICENCE
17 dolutegravir sublicensee agreements
DOLUTEGRAVIR
*Aurobindo is a direct licensee of ViiV. A tripartite agreement Aurobindo-ViiV-MPP has been signed. For the purposes of this presentation only, Aurobindo will be referred to as an MPP licensee.
Note: the following presentation contains updates as of March 2021, however approvals through June 2021 are included.
DTG 50mg:
FORMULATION DEVELOPMENT TIMELINES
Dossiers
approved/
filed
WHO-PQ Filing 8/8
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
USFDA Filing 7/9
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
< 2018
Total 2018 2019 2020 2021 2022
10
Companies approved Companies filed Companies planning to file
Note: Each triangle represents a manufacturer and timelines represent date of filing
10 MPP LICENSEES HAVE DEVELOPED DTG 50MG AND
ARE READY TO COMMERCIALIZE THE PRODUCT
Licensees Approved*: Aurobindo, Cipla, Desano, Emcure, Hetero, Laurus, Macleods, Micro Labs, Mylan, Sun Pharma
2 licensees awaiting USFDA approvals
2 additional licensees developing | One plans to file with WHO and USFDA in Q3-21 | Another plans to file with USFDA in Q4-21 and WHO in Q1-22
*USFDA and/or WHO-PQ
Recent approvals: Macleods (USFDA-Mar 2021) Data as of March 2021
DTG 50mg:
COUNTRY-WISE FILING STATUS
Generic DTG 50mg has been filed in 63 countries, of which approval has been received in 45 countries
Filings have occurred where 90.9% of PLHIV^ reside in the licensed territory#
APPROVED (45) FILED (18)
86.3% PLHIV 4.6% PLHIV
Iran (Islamic
Anguilla Costa Rica Niger Tajikistan Benin Honduras
Republic of)
Antigua and
Côte d'Ivoire Kenya Nigeria Tanzania Bolivia Jamaica
Barbuda*
Bahamas* Dominica Malawi Pakistan Thailand Burkina Faso Kyrgyzstan
Turks and
Barbados* Ethiopia Mauritius Peru Burundi Mali
Caicos Islands*
Botswana Ghana Montserrat Philippines Uganda Cameroon Morocco
Cambodia Grenada Mozambique Rwanda Ukraine Dominican Republic Panama*
Chile* Guatemala Myanmar Saint Lucia Uzbekistan El Salvador Senegal
Saint Vincent and
Congo, Dem. Rep India Namibia Zambia Gabon Sri Lanka
the Grenadines
Congo, Rep Indonesia Nicaragua South Africa Zimbabwe Guyana Viet Nam
§ New filings and approvals in green vis-à-vis last update (Q4-20)
§ Countries where DTG has been sold indicated in bold type
* Countries not included in DTG Adult licence but supply by MPP licensees permitted if no patent is being infringed in that country
^ People living with HIV
Note: Sales may occur in countries in the absence of registration via procurement channels, registration waivers and/or exemptions
# MPP-ViiV DTG licence agreement
Data as of March 2021
MPP IMPACT MAP:
DTG 50mg
DTG 50mg sales have occurred in 112 countries in which 98.5% of PLHIV^ reside in the licensed territory#
Note: Sales may occur in countries in the absence of registration via procurement channels, registration waivers and/or exemptions
^ People living with HIV
# MPP-ViiV DTG licence agreementTDF/3TC/DTG (TLD):
FORMULATION DEVELOPMENT TIMELINES
Dossiers
approved/
filed
WHO-PQ Filing 8/12
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
USFDA Filing 7/11
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
< 2018
Total 2018 2019 2020 2021 2022
11
Companies approved Companies filed Companies planning to file
Note: Each triangle represents a manufacturer and timelines represent date of filing
13 MPP LICENSEES HAVE DEVELOPED TDF/3TC/DTG, OF WHICH:
11 COMPANIES ARE READY TO COMMERCIALIZE THE PRODUCT
Licensees Approved*: Aurobindo, Celltrion, Cipla, Desano, Emcure, Hetero, Laurus, Macleods, Mylan, Strides, Sun Pharma
4 licensees awaiting WHO-PQ approvals | 4 licensees awaiting USFDA approvals
2 additional licensee developing | One plans to file with WHO in Q3-21 | Another plans to file with USFDA and WHO in H2-22
*USFDA and/or WHO-PQ Data as of March 2021TDF/3TC/DTG (TLD):
COUNTRY-WISE FILING STATUS
Generic TDF/3TC/DTG has been filed in 66 countries, of which approval is received in 48 countries
Filings have occurred where 92.1% of PLHIV^ reside in the licensed territory#
APPROVED (48) FILED (18)
88.3% PLHIV 3.7% PLHIV
Anguilla Chile* Indonesia Namibia Turkmenistan Bolivia Lebanon
Antigua and Turks and
Congo, Dem. Rep Kenya Niger Burundi Myanmar
Barbuda* Caicos Islands
Bahamas* Congo, Rep. Kyrgyzstan Nigeria Uganda Dominican Republic Nicaragua
Barbados* Côte d'Ivoire Madagascar Philippines Ukraine Ecuador Pakistan
Benin Dominica Malawi Rwanda Uzbekistan
El Salvador Peru
Viet Nam
Botswana Ethiopia Mali Saint Lucia
Gambia Senegal
Saint Vincent and
Burkina Faso Gabon Mauritania Zambia
the Grenadines
Guatemala Sierra Leone
Cambodia Ghana Mauritius South Africa Zimbabwe
Jamaica Sudan
Cameroon Grenada Montserrat Tanzania
Kazakhstan Togo
Chad India Mozambique Thailand
§ New filings and approvals in green vis-à-vis last update (Q4-20)
§ Countries where DTG has been sold indicated in bold type
* Countries not included in DTG Adult licence but supply by MPP licensees permitted if no patent is being infringed in that country
^ People living with HIV
Note: Sales may occur in countries in the absence of registration via procurement channels, registration waivers and/or exemptions
# MPP-ViiV DTG licence agreement
Data as of March 2021MPP IMPACT MAP:
TDF/3TC/DTG (TLD)
TLD sales have occurred in 94 countries in which 98.7% of PLHIV^ reside in the licensed territory#
Note: Sales may occur in countries in the absence of registration via procurement channels, registration waivers and/or exemptions
^ People living with HIV
Note:
# Sales may
MPP-ViiV DTGoccur in countries
licence agreementin the absence of registration via procurement channels, registration waivers and/or exemptionsDTG & TLD:
COUNTRIES OF SALE- (2017- March 2021)
Countries of Sale (117), where 99.3% of PLHIV^ covered by the license reside#
Afghanistan Burkina Faso Ecuador Haiti Mauritania Paraguay Tanzania
Albania Burundi Egypt Honduras Mauritius Peru Thailand
Angola Cabo Verde El Salvador India Moldova, Republic of Philippines Timor-Leste
Anguilla Cambodia Equatorial Guinea Indonesia Mongolia Rwanda Togo
Antigua and Barbuda Cameroon Eritrea Iran (Islamic Republic of) Montserrat Saint Kitts and Nevis Turkmenistan
Argentina Central African Republic Eswatini Jamaica Morocco Saint Lucia Turks and Caicos
Saint Vincent and the
Armenia Chad Ethiopia Kenya Mozambique Uganda
Grenadines
Azerbaijan* Chile Fiji Kosovo Myanmar Sao Tome and Principe Ukraine
Bahamas Comoros Gabon Kyrgyzstan Namibia Senegal Uzbekistan
Lao People's Democratic
Bangladesh Congo Gambia Nepal Sierra Leone Venezuela
Republic (the)
Congo, democratic
Barbados Georgia Lebanon Nicaragua South Africa Viet Nam
Republic of the
Belize Costa Rica Ghana Lesotho Niger South Sudan Virgin Islands (British)
Benin Côte d'Ivoire Grenada Liberia Nigeria Sri Lanka Yemen
Bermuda Cuba Guatemala Libya Oman Sudan Zambia
Bhutan Djibouti Guinea Madagascar Pakistan Suriname Zimbabwe
Bolivia Dominica Guinea-Bissau Malawi Panama Syrian Arab Republic
Botswana Dominican Republic Guyana Mali Papua New Guinea Tajikistan
Analysis include sales of DTG 50mg and TDF/3TC/DTG:
** Sales of DTG 50mg only (n=23) Sales of TLD only (n=5)
* Sale of paedaitric DTG 50mg only
^ People living with HIV Data as of March 2021
# MPP-ViiV DTG licence agreementCUMULATIVE PACKS SOLD: TLD & DTG 50mg
(2017-March 2021)
373.7 million packs of TLD and 23.5 million packs of DTG 50mg sold till March 2021
Cumulative Number of Packs (30's) Sold by Quarter
450M
397.1M 60.9M
400M
350M 71.5M
2.4M
300M
51.1M
Packs (30's)
250M 2.6M
40.1M
200M 2.6M
33.7M
150M 3.7M
36.3M
3.1M
100M 16.7M
17.8M 1.6M
12.2M 2.0M
50M 10.9M
10.8M 1.3M
10.1M 553K
733K 1.5M 731K
0 278K 485K 401K
292K 636K
Q2-17 Q3-17 Q4-17 Q1-18 Q2-18 Q3-18 Q4-18 Q1-19 Q2-19 Q3-19 Q4-19 Q1-20 Q2-20 Q3-20 Q4-20 Q1-21
Source: confidential sales data by MPP licensees
DTG 50mg TLD Total Packs
Note: Packs of 90’s converted to 30’s for this analysis Data as of March 2021PATIENT EQUIVALENTS RECEIVING TDF/3TC/DTG (TLD)
THROUGH MPP LICENSEES
Today, at least 18.63 million people living with HIV (PLHIV) are on MPP-enabled generic TLD1
(79.3% of PLHIV on ART in LMICs)3
Patient Equivalents2 Receiving TDF/3TC/DTG Supplied Through MPP Licensees per Quarter
26 M
23.8 M
24 M
22 M
20.3 M
20 M
18 M 17.0 M
Patient Equivalents2
16 M
14 M 13.4 M
12.1 M
12 M 11.2 M
10 M
8M 5.6 M
5.9 M
6M
3.6 M 3.6 M 4.1 M
4M 3.4 M
2M 0.5 M
0M
Q1-18 Q2-18 Q3-18 Q4-18 Q1-19 Q2-19 Q3-19 Q4-19 Q1-20 Q2-20 Q3-20 Q4-20 Q1-21
TLD
Source: confidential sales data by MPP licensees
Note:. Packs of 90 converted to 30’s for this analysis. Analysis excludes sales of DTG 50mg singles.
1 Total PLHIV on TLD-based treatment calculated by dividing total packs sold in the last 4 quarters by 12 (months);
2 “Patient Equivalents” per quarter calculated by dividing the total packs of TLD sold in a quarter by 3 (months)
3
Epi data sourced from ‘Consolidated Forecast of Global ARV Demand’: 23,500,000 Adult PLHIV on 1st Line ART (2020)
Data as of March 2021TOP COUNTRY RECIPIENTS OF DTG & TLD
(2017-March 2021)
Top 10 countries comprise 80% of the TLD Market in LMICs (by volume)
DTG 50mg is largely being used for TB-coinfection and/or 2L ART
Sale of DTG-Based HIV Treatment Through MPP Licensees By Country (TLD & DTG)
90 M
81.3M
80 M
70 M
Total Packs (30's)
60 M
50 M 46.0M
40 M 38.4M
27.8M 26.5M
30 M
25.6M 23.4M
23.3M
20 M
16.0M
11.6M
10 M 8.0M 7.8M 6.3M 6.1M 5.8M 5.8M
3.3M 2.7M 2.5M 2.5M
0
Ukraine
Zimbabwe
Tanzania
Malawi
Ethiopia
South Africa
Congo, DR
Mozambique
Eswatini
SSA
Lesotho
Botswana
Côte d'Ivoire
Uganda
Kenya
Zambia
Nigeria
India
Namibia
Cameroon
Source: confidential sales data by MPP licensees
DTG 50mg TLD # DTG + TLD
*Sub-Saharan Africa (SSA): non-identified countries by which sales were made through procurement agents Data as of March 2021
Note: Packs of 90’s & 180’s converted to 30’s for this analysis;RAPID SCALE-UP OF TLD
(2018-March 2021)
As of March 2021, TLD was supplied in 94 countries by 11 of MPP Partners
TLD sales were reported for the first time in Bangladesh, Belize, Djibouti, Lebanon in Q1 2021
Cumulative Packs of TDF/3TC/DTG Supplied Through MPP Licensees By Country
90M
81.2M
80M
70M
60M
Total Packs (30’s)
50M
44.0M
40M 37.0M
26.8M
30M 25.6M
22.6M22.4M
22.3M
20M
14.6M
10.1M
10M 7.4M 6.5M
5.6M 5.5M 5.2M 5.1M
3.2M 2.6M 2.4M 2.3M 2.2M 1.8M
1.1M 1.1M 1.0M 971K 959K 902K 884K 729K
0
Eswatini
Zambia
Haiti
SSA
Ethiopia
South Sudan
Zimbabwe
Ukraine
Malawi
India
South Africa
Nigeria
Venezuela
Mozambique
Ghana
Kenya
Togo
Viet Nam
Tanzania
Lesotho
CAR
Botswana
Côte d'Ivoire
Namibia
Rwanda
Cameroon
Uganda
Congo
Congo, DR
Burundi
Source: confidential sales data by MPP licensees
2018 2019 2020 Q1-21 # Total Packs Sold
*Sub-Saharan Africa (SSA): non-identified countries by which sales were made through procurement agents
Note: Packs of 90’s & 180’s converted to 30’s for this analysis
Data as of March 2021TAF/FTC/DTG (TAF-ED):
FORMULATION DEVELOPMENT TIMELINES
Dossiers
approved/
filed
USFDA Filing 2/6
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
< 2018
Total 2018 2019 2020 2021 2022
2
Companies approved Companies filed Companies planning to file
Note: Each triangle represents a manufacturer and timelines represent date of filing
6 MPP LICENSEES HAVE DEVELOPED TAF/FTC/DTG, OF WHICH:
2 COMPANIES ARE READY TO COMMERCIALIZE THE PRODUCT
Licensees Approved: Laurus, Mylan
4 licensees awaiting USFDA approval | 3 additional licensees developing this product | Two plan to file in 2021 | Another plans to file in 2022
q We anticipate development by additional licensees to accelerate, once there is an update on WHO’s position about use of TAF-containing formulations Data as of March 2021THANK YOU
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