ViiV Healthcare and CHAI collaboration delivers second milestone with first filing with the FDA of generic dolutegravir by Aurobindo Pharma for the treatment of HIV

LONDON, United-Kingdom, May 26, 2015/African Press Organization (APO)/ — ViiV Healthcare (http://www.viivhealthcare.com), Aurobindo Pharma (http://www.aurobindo.com), and the Clinton Health Access Initiative, Inc. (CHAI) (http://www.clintonhealthaccess.org) announced today that Aurobindo Pharma has submitted an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg, for Tentative Approval, to the Food and Drug Administration (FDA), for the treatment of HIV. This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of Tivicay® (dolutegravir) for sale in the United States.

Logo ViiV Healthcare: http://www.photos.apo-opa.com/plog-content/images/apo/logos/viiv-1.jpg

Logo Clinton Health Access Initiative, Inc. (CHAI): http://www.photos.apo-opa.com/plog-content/images/apo/logos/chai.jpg

Logo Aurobindo Pharma: http://www.photos.apo-opa.com/plog-content/images/apo/logos/aurobindo-1.jpg

Logos: http://www.photos.apo-opa.com/plog-content/images/apo/logos/150526bannclint.png

Upon receiving Tentative Approval from the FDA, Aurobindo Pharma will be able to supply dolutegravir 50mg via the President’s Emergency Plan for AIDS Relief (PEPFAR) programme, following completion of required local regulatory approval process, in the licensed countries outside of the United States, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014.

This submission comes less than five years after ViiV Healthcare and CHAI signed an agreement to collaborate with the goal of bringing innovative formulations of medicines for the treatment and prevention of HIV/AIDS to people living with HIV in developing countries, on an affordable yet sustainable basis.

CHAI and ViiV Healthcare worked together to identify a generic partner after conducting feasibility research. Following this initial joint work, ViiV Healthcare submitted necessary documentation to the FDA providing a selective waiver letter for the five-year period of New Chemical Entity (NCE) exclusivity that would have otherwise prevented FDA review and Tentative Approval of Aurobindo Pharma’s ANDA at this time.

Dr. Dominique Limet, CEO, ViiV Healthcare, said: “This first ANDA for a generic dolutegravir confirms that our strong commitment to thinking and acting differently to pursue new ways to expand access to our medicines, for people living with HIV in countries where the need is most pressing, is working.”

David Ripin, PhD, Executive Vice President, and Chief Scientific Officer, CHAI, said: “UNAIDS has set global public health goals calling for 90 percent of those who are HIV-positive to know their status, 90 percent of those identified to be linked to treatment programs, and 90 percent of those in treatment to achieve undetectable viral load. To tackle these complex challenges, targeted efforts to facilitate access to HIV treatment medicines, such as dolutegravir, are needed.”

Mr. N. Govindarajan, Managing Director, Aurobindo Pharma, said: “We are pleased to be part of this innovative partnership designed to accelerate access to medicines for treating HIV. Aurobindo Pharma is committed to HIV care and aims to achieve the goals of wider access to HIV treatment, care, and support; seeking to address the spread of HIV through development of this newer class of drugs and fixed-dose combinations for low- and middle-income countries. “

The filing by Aurobindo Pharma is the second result of the agreement between CHAI and ViiV Healthcare and comes less than six months after another generic manufacturer announced that it had received Tentative Approval from the FDA for paediatric formulations of another ViiV Healthcare antiretroviral (also under PEPFAR for sale in licensed countries outside of the United States), through innovative collaboration with ViiV Healthcare and CHAI.

Distributed by APO (African Press Organization) on behalf of ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access Initiative, Inc. (CHAI).

Contacts:

ViiV UK/US Media enquiries:

Sebastien Desprez (UK)

+44 (0) 7920 567 707

Isabelle Scali (UK)

+44 (0) 7557 290 420

Marc Meachem (US)

+1 919 483 8756

Clinton Health Foundation Media enquiries:

press@clintonhealthaccess.org

Aurobindo Pharma Media enquiries:

+91-40-66725000 / 66725401

Aurobindo Pharma Investor Relations:

ir@aurobindo.com

About Clinton Health Access Initiative

The Clinton Health Access Initiative, Inc. (CHAI) (http://www.clintonhealthaccess.org) was founded in 2002 with a transformational goal: help save the lives of millions of people living with HIV/AIDS in the developing world by dramatically scaling up antiretroviral treatment. When CHAI was founded, many viewed this goal as unreasonable because health systems in poor countries were too weak and prices of relevant drugs and diagnostic tests were too high. CHAI played a leadership role, working alongside governments and other partners, to lower the costs of treatment and help build the in-country systems necessary to provide lifesaving treatment to millions of people. Since then, CHAI has pursued several similarly ambitious goals, from scaling up pediatric AIDS treatment in order to achieve equity with adults in a timeframe few thought possible, to rapidly accelerating the rollout of new vaccines. CHAI has achieved many of its most important successes when seeking to fundamentally change the way the world approaches an issue and pushing the boundaries of what is considered feasible in global health. For more information, please visit: www.clintonhealthaccess.org

About ViiV Healthcare

ViiV Healthcare (http://www.viivhealthcare.com) is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

About Aurobindo Pharma

Aurobindo Pharma Ltd. (http://www.aurobindo.com) is a vertically integrated pharmaceutical company that delivers innovative solutions. Aurobindo Pharma leverages India’s globally competitive cost base and talented team of scientists to discover, develop, and commercialize a range of affordable medicines for markets across the globe. For more information, please visit www.aurobindo.com.

About President’s Emergency Plan for AIDS Relief (PEPFAR)

PEPFAR is the US government initiative to help save the lives of those suffering from HIV/AIDS around the world. This historic commitment is the largest by any nation to combat a single disease internationally. In May 2004, in support of the President’s Emergency Plan, the FDA announced a new initiative to help ensure that those being served by the President’s Plan would receive safe, effective, and quality manufactured antiretroviral drugs. This new initiative included an expedited review process. Through guidance and an active outreach program to the pharmaceutical industry, the FDA actively encouraged any sponsors worldwide to submit US marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies-even if there was still patent or exclusivity market protection for the product in the US.

Important Information about Tivicay® (dolutegravir) in the US

FDA Indication and Usage: TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.

Important Safety Information for Tivicay® (dolutegravir)

Contraindication: TIVICAY is contraindicated (1) in patients with previous hypersensitivity reaction to dolutegravir, and (2) in patients receiving dofetilide (antiarrhythmic) due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events.

Hypersensitivity Reactions: Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in 1% or fewer subjects receiving TIVICAY in Phase 3 clinical trials. Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reaction develop, (including but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing.) Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy. Delay in stopping treatment with TIVICAY or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction. TIVICAY is contraindicated in patients who have experienced a hypersensitivity reaction to dolutegravir.

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Coinfection: Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C.

Fat Redistribution: Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.

Immune Reconstitution Syndrome: During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of treatment.

Adverse Reactions: The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).

Drug Interactions: Co-administration of TIVICAY with drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations of dolutegravir and require dose adjustments of TIVICAY.

– TIVICAY should be taken2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.

– Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments.

Pregnancy: Pregnancy category B. TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Breastfeeding: Breastfeeding is NOT recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

Paediatric Patients: Safety and efficacy of TIVICAY has not been established in children younger than 12 years old, or weighing 40 kg, or in INSTI-experienced paediatric patients with documented or clinically suspected INSTI resistance.

Please visit the following link for the full US prescribing and patient information: https://www.viivhealthcare.com/media/58599/us_tivicay.pdf.

How Tivicay Works

Tivicay belongs to a class of HIV medicines called integrase inhibitors. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

Tivicay is a registered trademark of the ViiV Healthcare group of companies.

Source:: ViiV Healthcare and CHAI collaboration delivers second milestone with first filing with the FDA of generic dolutegravir by Aurobindo Pharma for the treatment of HIV

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IOM DG Highlights South Sudan Needs Amid Increasing Violence

GENEVA, Switzerland, May 26, 2015/African Press Organization (APO)/ — IOM Director General William Lacy Swing travelled to South Sudan 23–24 May to visit IOM’s largest emergency operation and call attention to the urgent humanitarian needs of conflict-affected and displaced populations across the country.

“IOM remains committed to saving lives in South Sudan as civilians continue to bear the horrific consequences of this crisis,” he said, noting the upsurge in violence in South Sudan in recent weeks.

On 23 May, Ambassador Swing and Special Representative of the UN Secretary General Ellen Margrethe Løj, with donor country and partner representatives, visited the protection of civilians (PoC) site at the UN Mission in South Sudan (UNMISS) base in Bentiu, Unity State, where IOM has biometrically has registered more than 76,400 internally displaced persons (IDPs).

IOM and camp manager Danish Refugee Council continue to receive hundreds of new arrivals each day at the site, which is undergoing a massive, IOM-led expansion to improve living conditions and prevent flooding.

During the 2014 rainy season, site residents were forced to wade through water and sewage, preventable health conditions were prevalent and hygiene standards were dismal. Despite the efforts of the UN and humanitarian agencies, the site was simply not designed to host tens of thousands of people.

Since the onset of the dry season, UNMISS, IOM and its partners have worked to improve conditions by expanding the site, developing nearly 1.5 million square meters of land, equipped with extensive drainage infrastructure, shelters, sanitation facilities and other humanitarian services.

In coordination with UNMISS, IOM is also improving the security of the site through security and drainage berms. UNMISS and relief agencies plan to begin moving IDPs to the new site in the coming weeks. IOM has provided similar improvements to the PoC sites in Malakal, Upper Nile State, and in Bor, Jonglei State.

Acknowledging the escalation of insecurity, particularly in Unity and Upper Nile in recent weeks, and the increasingly difficult and dangerous working environment in field locations across South Sudan, Ambassador Swing noted that “the safety and security of IDPs and staff working at PoC sites are paramount.”

Reports of increased violence underscore the ongoing need to provide protection and humanitarian assistance to vulnerable populations in conflict-affected areas.

During his visit, DG Swing also joined US Chargé d’Affaires David H. Kaeuper on a visit to the UN House PoC sites in the capital Juba. The UN and humanitarian partners at UN House are providing humanitarian assistance to over more than 34,500 IDPs, most of who have remained in these sites, afraid to leave, since December 2013. Through discussion with the UN House camp manager, the Agency for Technical Cooperation and Development (ACTED), the Director General noted that increased resources are required to ensure uninterrupted humanitarian services at the site.

Since December 2013, conflict and food insecurity have forced more than 2 million people from their homes, including approximately 1.5 million inside South Sudan and more than 552,100 who have fled to neighbouring countries. With the support of donors and partner agencies, IOM is providing critical multi-sector humanitarian assistance to conflict-affected populations across South Sudan.

Source:: IOM DG Highlights South Sudan Needs Amid Increasing Violence

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IOM Ethiopia Relocates 42,000 South Sudanese Refugees in Two Weeks

GENEVA, Switzerland, May 26, 2015/African Press Organization (APO)/ — IOM has transported some 41,978 South Sudanese refugees from camps in Leitchour and Nip Nip to Jewi camp in Ethiopia’s Gambella province in just two weeks.

The operation, which involved 443 buses, 86 trucks, and a helicopter, moved 39,563 refugees from Leitchour and 2,226 from Nip Nip to Jewi. Some 189 vulnerable refugees unfit to travel by road made the journey in a helicopter provided by UNHCR. The largest convoy last week consisted of 71 buses and 10 trucks carrying some 4,526 refugees.

Since the conflict broke out in neighbouring South Sudan in December 2013, the total number of South Sudanese refugees IOM has relocated from Ethiopian border crossing points in Gambella and Benishangul-Gumuz to camps on higher ground that are less prone to flooding has now reached 233,178.

The current camp-to-camp relocation which started on 8 May, followed months of planning and preparation by IOM, Ethiopia’s Administration for Refugees and Returnee Affairs (ARRA) and UNHCR.

Since the conflict broke out, the total number of South Sudanese refugees crossing into neighbouring countries has passed 551,636. Ethiopia has received the highest number of refugees with a total of over 208,177. With no sign of an end to the conflict in South Sudan, refugees continue to arrive.

Source:: IOM Ethiopia Relocates 42,000 South Sudanese Refugees in Two Weeks

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IOM Aids Over 2,000 Ethiopians Returning from Yemen

GENEVA, Switzerland, May 26, 2015/African Press Organization (APO)/ — IOM Ethiopia has provided post arrival assistance to some 2,061 vulnerable Ethiopians returning from Yemen. They have included people injured in the conflict, as well as those in need of transport and accommodation.

IOM is providing accommodation at its transit centre in Addis Ababa, onward transportation allowances and post-arrival health assessments, including referrals to hospitals in Addis Ababa.

“I was working as a house maid in Yemen for two and a half years. I was near a gas cylinder when an air raid took place last month. The cylinder exploded and I had to go to a hospital. I spent all of my savings on treatment there. With this money I will now be able to reach home and my two children,” said Hadra, 25, who arrived in Addis Ababa on Sunday (24/5) evening and received a transportation allowance at the IOM transit centre.

“The situation there is very dire now. There are a lot of air raids, there is no power and even a bottle of water, which was sold for Rial 1,500, now costs Rial 5,000. Life is becoming very difficult,” she added.

Since the conflict broke out, some 3,177 Ethiopians have been evacuated from Yemen. Of these, some 2,889 were evacuated through the Kingdom of Saudi Arabia. Another 250 were evacuated via Khartoum, Sudan and 38 via Djibouti.

IOM has been coordinating with the Ethiopian Government to provide post arrival assistance to Ethiopian returnees who fled the conflict in Yemen via Kingdom of Saudi Arabia since April.

It is asking donors for another USD 250,000 to continue to provide post arrival assistance for 2,500 additional Ethiopian returnees who are expected to arrive in Addis Ababa in the coming weeks.

In addition to post arrival assistance for Ethiopians, IOM has also assisted 1,215 third country nationals from over 39 countries to leave Yemen through nine flight rotations organized since 12 April: seven of those flights were organized from Sana’a to Khartoum, Sudan. One flight on 19 April flew from Sana’a to Addis Ababa. Another flight on 17 May flew from Sana’a to Mogadishu in Somalia.

In coordination with IOM Yemen, IOM Ethiopia and the relevant national authorities, IOM Djibouti is also preparing to transit 565 Ethiopian nationals currently stranded in Haradh, Yemen. The operation will include arranging travel documentation; sea transport from Hodeyda, Yemen to Obock, Djibouti; board, lodging and health screening at IOM’s Djibouti transit centre; and onward transportation to the Ethiopian border.

Source:: IOM Aids Over 2,000 Ethiopians Returning from Yemen

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IOM Evacuates Senegalese Migrants from Libya

GENEVA, Switzerland, May 26, 2015/African Press Organization (APO)/ — IOM Libya yesterday evacuated 142 Senegalese migrants from Misrata and Tripoli, Libya via Djerba airport in Tunisia. The group arrived in Dakar this morning (26/5), and was met at the airport by Secretary of State for Senegalese Abroad Souleymane Jules Diop. The fourth such evacuation in recent months, this latest group included nine minors.

This latest evacuation comes one month after IOM received a request from the Senegalese Embassy to help 187 stranded Senegalese nationals in Kararim detention centre in Misrata and another 10 in Tripoli.

IOM worked in coordination with the International Committee of the Red Cross (ICRC), which worked on the registration and photographed applicants. The information was shared with the Senegalese Embassy in Tunisia to enable them to issue travel documents in Tunis.

The Libyan Red Crescent interviewed and conducted the medical screening for all the Senegalese in Kararim centre and also provided transportation from the detention centre in Misrata to Tripoli and then to the Tunisian border at Ras Jdir. This involved a convoy of three buses, an ambulance and a two-vehicle police escort.

This latest evacuation was carried out under the IOM’s European Union-funded “START” project: “Stabilizing at risk communities and enhancing migration management to enable smooth transition in Egypt Libya and Tunisia” which has invested nearly EUR 10 million in the region since 2012.

Since the crisis in Libya began, IOM has assisted over 800 stranded migrants to leave Libya and travel back to their countries of origin. For some vulnerable groups, IOM continues to provide support after their arrival back home.

Source:: IOM Evacuates Senegalese Migrants from Libya

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New IFC and Ecobank Facility to Finance SMEs financing in Fragile and Conflict-Affected States in West and Central Africa

ABIDJAN, Côte d’Ivoire, May 26, 2015/African Press Organization (APO)/ — IFC, a member of the World Bank Group, and Ecobank Transnational Incorporated, parent company of the Ecobank Group (http://www.ecobank.com) and leading pan-African full-service banking group, today announced the launch of a $110 million risk-sharing facility that will increase access to finance for small and medium sized enterprises in fragile and conflict-affected states in West and Central Africa.

Logo Ecobank: http://www.photos.apo-opa.com/plog-content/images/apo/logos/ecobank.png

The target countries face extreme and persistent poverty exceeding 50 percent of their populations, coupled with severe socio-economic challenges, such as low employment, lack of infrastructure, and high insecurity that disrupts business activity and impedes access to finance. These difficult environments have exacerbated the challenges faced by small and medium-sized enterprises (SMEs), which represent the backbone of the participating countries’ economies and provide the bulk of employment.

The facility is designed to overcome the challenges of lending to these smaller businesses, which have a higher risk profile, in what are some of the world’s poorest countries. With IFC and Ecobank sharing risk equally in the $110 million facility, SMEs in Burundi, Chad, Côte d’Ivoire, Democratic Republic of the Congo, Republic of Congo, Guinea, Mali and Togo will gain increased access to loans through Ecobank affiliates.

“IFC places a strategic priority on promoting a sustainable architecture to improve access to finance and spur job creation in fragile- and conflict-affected states,” said Saran Kebet-Koulibaly, IFC Director for West and Central Africa. “Our partnership will enable Ecobank to better support small and medium enterprises which face difficulty accessing much-needed credit in these economies.”

“Ecobank remains committed to supporting small and medium-sized enterprises, and this facility will go a long way to giving SMEs in fragile states or those emerging from conflict the kind of access to finance that they need,” said Ecobank Group CEO Albert Essien. He added: “We are pleased to be a founding member of the Global SME Finance Forum and to be able to play a part in the launching of SME Club campaigns in many African countries. This includes participating countries for this project.”

IFC and Ecobank enjoy a long-standing collaboration dating back to 1993, through which they have delivered innovative and customized initiatives to underserved markets across sub-Saharan Africa. Thanks to ETI’s unrivaled reach in SSA, IFC has been able to extend financial access in difficult environments at a scale that few other IFC-partner financial institutions can match. Most recently, IFC extended an emergency liquidity facility in response to the Ebola crisis through Ecobank’s affiliates in Guinea, Sierra Leone and Liberia, the most impacted countries. ETI continues to be a key partner of IFC in the markets where it operates.

Distributed by APO (African Press Organization) on behalf of Ecobank.

For IFC

In Dakar:

Zibu Sibanda

Phone: +221 338 59 7117

E-mail: zsibanda@ifc.org

In Washington:

John McNally

Phone: +1-202-458-0723

Email: jmcnally@ifc.org

For Ecobank

In Lome:

Mireille Bokpe

Phone: +228 22 21 0303

Email: mbokpe@ecobank.com

About IFC

IFC, a member of the World Bank Group, is the largest global development institution focused exclusively on the private sector. Working with private enterprises in about 100 countries, we use our capital, expertise, and influence to help eliminate extreme poverty and boost shared prosperity. In FY14, we provided more than $22 billion in financing to improve lives in developing countries and tackle the most urgent challenges of development. For more information, visit www.ifc.org

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About Ecobank

Incorporated in Lomé, Togo, Ecobank Transnational Incorporated (‘ETI’) is the parent company of the leading independent pan-African banking group, Ecobank (http://www.ecobank.com). It currently has a presence in 36 African countries, namely: Angola, Benin, Burkina Faso, Burundi, Cameroon,

Cape Verde, Central African Republic, Chad, Congo (Brazzaville), Congo (Democratic Republic), Côte d’Ivoire, Equatorial Guinea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea Bissau, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Sierra Leone, South Africa, South Sudan, Tanzania, Togo, Uganda, Zambia and Zimbabwe. The Group employs over 20,000 people in 40 different countries in over 1,200 branches and offices. Ecobank is a full-service bank providing wholesale, retail, investment and transaction banking services and products to governments, financial institutions, multinationals, international organizations, medium, small and micro businesses and individuals.

More information can be found on the Group’s website: ecobank.com

Source:: New IFC and Ecobank Facility to Finance SMEs financing in Fragile and Conflict-Affected States in West and Central Africa

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