October 2017
SUMMARY
Statement from the Executive Director

I am pleased to present our fall newsletter with highlights from our work from February 2017-October 2017. It has been a very productive period for the Medicines Patent Pool. Last week, we signed a new licence with Gilead Sciences for investigational treatment bictegravir, and we have extended existing licences with both Gilead and Bristol-Myers Squibb to more countries.

Our manufacturing partners are making strong headway in rolling out the first low-cost versions of promising MPP-licensed antiretrovirals. In August, Mylan announced that it had received Tentative Approval from the U.S. Food and Drug Administration for its combination product tenofovir disoproxil fumarate, lamivudine and dolutegravir (TLD). We welcomed the announcement from our funder Unitaid, the Bill & Melinda Gates Foundation, UNAIDS, the Global Fund to Fight AIDS Tuberculosis and Malaria, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), governments and private sector partners of a pricing deal to accelerate the delivery of low-cost TLD made possible through the MPP and other licensing initiatives.

The MPP has also worked closely to improve access to hepatitis C and tuberculosis treatments. Over the past several months, the MPP signed agreements with Pharco Pharmaceuticals for a hepatitis C medicine ravidasvir and with TB Alliance to develop promising tuberculosis (TB) drug candidate sutezolid. This week, the MPP signed a Memorandum of Understanding with Otsuka to make tuberculosis drug delamanid more available to children infected with resistant forms of the infection. With funding from the Swiss government, last spring the MPP launched a new feasibility study to assess the role of the foundation in expanding its mandate to other patented medicines on the World Health Organization’s Essential Medicines List.

Finally, the MPP was delighted to welcome new Board Chair Marie-Paul Kieny, former World Health Organization Assistant Director-General for Health Systems and Innovation, on 1 September. Information on her appointment and other updates can be found below.

Best, 

Greg Perry
NEWS AND ANNOUNCEMENTS The MPP extends its licensing agreement with Gilead Sciences to include investigational drug bictegravir (BIC), part of a novel once-daily, single-tablet regimen. BIC/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) is currently under review in the United States and in the European Union.

Mylan is the first company to receive approval from U.S. Food and Drug Administration for generic dolutegravir combination; MPP issues congratulatory statement.

The foundation welcomes extension of MPP-Gilead Sciences HIV licences to include Belarus, Malaysia and Ukraine.

The MPP signs an extension of its licensing agreement with Bristol-Myers Squibb to further increase access to atazanavir (ATV), part of the World Health Organization-preferred second-line treatment for adults and children.

The MPP and Egyptian company Pharco Pharmaceuticals sign a licence for promising hepatitis C drug candidate ravidasvir, an investigational direct-acting antiviral (DAA) with the potential of working across all six major hepatitis C genotypes.

TB Alliance and the MPP sign a sublicensing agreement for the clinical development of sutezolid, an antibiotic drug candidate which demonstrated encouraging results in early studies. 

The MPP adds new product development partners – 1st and 2nd quarter 2017



The MPP signed sublicences with new development partners Anhui Biochem United Pharmaceuticals from China, Dr. Reddy’s Laboratories, Macleods Pharmaceuticals and Sun Pharmaceuticals from India, and TB Alliance from the United States. The MPP is now working with 20 sublicensing partners to produce World Health Organization-recommended and new HIV, hepatitis C and tuberculosis treatments.

EVENTS The MPP’s joint satellite symposium at the International AIDS Society Conference on HIV Science

The foundation co-hosted a satellite symposium on accelerating access to new antiretrovirals in low- and middle-income countries (LMICs) at this year’s International AIDS Society Conference on HIV Science in Paris, 25 July. Jointly sponsored by the World Health Organization and Unitaid, along with the governments of South Africa, France and the Global Fund, the satellite explored a range of issues key to ensuring LMIC uptake of improved HIV treatment options. ViiV Healthcare’s Helen McDowell, Unitaid’s Robert Matiru, Aurobino’s Umesh K. and AfroCAB’s Tapiwanashe Kujina were among presenters. Greg Perry and Marco Vitoria, WHO Medical Officer, chaired a post-panel roundtable discussion.Lelio Marmora, Unitaid Executive Director, provided closing remarks.



The MPP at the 70th World Health Assembly

Antimicrobial resistance, the global shortage and access to medicines and vaccines, and the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) were top themes debated during the 70th World Health Assembly this May. The MPP briefed delegates on its feasibility study to examine the potential role of the MPP in addressing access issues for patented medicines on the WHO Essential Medicines List and welcomed efforts to ensure proper stewardship of new antibiotics. The foundation also highlighted its commitment to patent status transparency, a key GSPOA recommendation.

Read MPP’s interventions on antimicrobial resistance, on the evaluation and review of the global strategy and plan of action on public health, innovation and intellectual property, and on addressing the global shortage of, and access to, medicines and vaccines



Forecast vs. Reality: MPP’s Third Annual Industry Event

In collaboration with the World Health Organization, the MPP held its third industry event to brief private sector partners on progress in medicine development and rollout on 27 March in Geneva. This year’s discussion, Forecasts vs. Reality: Are we on Course? focused on MPP-WHO developed joint forecasts for HIV medicines as well as hepatitis C treatment uptake. MPP’s Sandeep Juneja and Aastha Gupta and WHO’s Daniel Low-Beer, Boniface Dongmo, Vincent Habiyambere and Marc Bulterys were among presenters. Shailesh Pednekar, Hetero; Helen McDowell, ViiV Healthcare; Prashant Sisodia, Mylan and Martin Auton from the Global Fund spoke at the event as well.




MPP IN THE MEDIA


Fierce Pharma writes about MPP’s new licence with Gilead Sciences for bictegravir in their article: Gilead offers itsnewest HIV drug candidate to patent pool for low-cost production. (October 2017)  

The Lancet covers the MPP in two stories, one on hepatitis C access (September 2017) and the other on tuberculosis medicine development (March 2017).

An IP Watch editorial reviews the territorial scope and advantages of the ViiV-MPP voluntary licence for dolutegravir. (May 2017)

Several publications, IP Watch, Forbes, Pharm Exec, and Pharma Biz, run stories on the MPP-TB Alliance agreement for the clinical development of sutezolid. (March 2017)

Multiple outlets such as Pharmaceutical Processing and Interfax Ukraine cover the announcement of the extension of the Bristol-Myers Squibb-MPP licensing agreement. (July 2017)

The Middle East North Africa Financial Review reviews an open approach to patentmanagement and potential for a sustainable future. Voluntary licensing through the MPP is mentioned as one vehicle in improving access to healthcare commodities in developing countries. (May 2017)

The Pharma Letter, Genetic Engineering & Biotechnology News, IP Strategy News and others cover licence and technology transfer agreement between Pharco Pharmaceuticals and the MPP for hepatitis C drug candidate ravidasvir. (April 2017)

The European Pharmaceutical Review profiles Gilead’s new research and treatments on HIV and its licensing agreements with the MPP which allow generic supply in developing countries. (March 2017)





HIGHLIGHTS The MPP Governance Board appoints Dr. Marie-Paule Kieny as its new chair


In July, the MPP Governance Board announced the appointment of Dr. Marie-Paule Kieny as its new chair effective 1 September 2017.  

“In its short six-years, the MPP has played a valuable role in supporting international public health efforts to increase treatment options for people living with HIV, and is now engaged in tuberculosis and hepatitis C,” said Dr. Kieny. “I am pleased to lend a hand to the organisation during this crucial period in its history, a time when new public health mechanisms such as the MPP are desperately needed to address pressing access to medicines challenges.”

Access the press release

PROGRESS TO DATE 9  patent holders have licensed to the MPP 
17 medicines licensed to the MPP
20 generic manufacturers have signed sublicensing agreements with the MPP
87 - 91% of people living with HIV in developing countries covered by MPP adult licences
130+ ongoing pharmaceutical development projects
312  million dollars in savings to the international community through MPP’s licences*
4.7  billion doses of treatment distributed in low- and middle-income countries*
Up to 131 countries covered by MPP licences

*Through December 2016


MPP LAUNCHES NEW WEBSITE


We are happy to present the new https://medicinespatentpool.org launched on 2 October. The redesign includes detailed pages on each of the products licensed to the MPP as well as an overview of all our licences, licensors and licensees. We have also created new pages on the MPP model, strategy and our forecasting work.

SPOTLIGHT - MPP'S NEW INDIA OFFICE  The MPP’s new liaison office in Gurgaon, India is now up and running. Approved by the Indian authorities in late 2016, the office now houses several Business Development team members who work closely with generic manufacturing partners in India and elsewhere to speed the development of MPP-licensed medicines.

SPECIAL FEATURE The MPP publishes analysis of projected savings of its licensing agreements in peer-reviewed journal

The MPP published a study in peer-reviewed journal PLOS ONE estimating that savings of its licensing agreements for antiretrovirals (ARVs) to treat HIV in low- and middle-income countries could reach US$ 2.3 billion by 2028. The MPP has negotiated licences for 16 medicines and a technology platform for HIV, hepatitis C and tuberculosis, including nine formulations on the World Health Organization Essential Medicines List. Only its HIV portfolio, however, was the subject of the PLOS ONE analysis. The PLOS ONE study estimated the financial impact of MPP’s licensing work by comparing the originator’s baseline price for MPP-licensed ARVs versus lower-priced medicines in countries where generics could not sell before MPP licensing agreements, through each ARV’s patent expiry. The total savings of US$ 2.3 billion from 2010-2028 is equivalent to more than 24 million people receiving first-line antiretroviral therapy for one year. This represents an estimated cost-benefit ratio of 1:43, which means for every US dollar invested in MPP’s programmes, the global public health community saves US$ 43.

Access the PLOS One article

WHAT PEOPLE ARE SAYING ABOUT THE MPP
“Successful cooperation of the Ministry of Health of Belarus with the Medicines Patent Pool is crucial in light of our current work to achieve the “90-90-90” goals and put an end to the epidemic in the country which is only possible when access to affordable and quality assured medicines is increased. Generic Bictegravir as well as other medicines for treating HIV, which Belarus will be able to procure due to the MPP’s agreement, are very much needed for the country.” — Valery Malashko, Minister of Health of Belarus

“We are grateful for MPP efforts to ensure the availability and quality of guaranteed HIV treatment for Ukrainian patients and we hope to further expand access to innovative medicines for the treatment of HIV infections, viral hepatitis C and tuberculosis.”— Dr. Ulana Suprun, Minister of Health, Ukraine

“This (expansion of the BMS atazanavir licence) is great news for Malaysia as it provides a very interesting option for affordable second-line treatment.” — Edward Low, Director of the Positive Malaysian Treatment Access & Advocacy Group (MTAAG+) 

“The availability of generic atazanavir will bring more treatment options for PLHIV in Indonesia. Considering that atazanavir has lower pill counts and more favourable effects on lipid levels than existing protease inhibitors used in-country, its availability is beneficial.” — Edo Agustian, National Coordinator of the Indonesia Drug User Network

“Chronic hepatitis C affects approximately 71 million people globally, with Egypt suffering from one of the highest burdens. Ravidasvir, in combination with other hepatitis C treatments, could support new national as well as global goals to eliminate the virus.” — Dr. Sherine Helmy, CEO of Pharco Pharmaceuticals

“Unitaid strongly supports the TB Alliance-Medicines Patent Pool collaboration to jump-start the clinical development of the new tuberculosis treatment sutezolid. This World Tuberculosis Day, we must re-double efforts to find better, faster-acting treatment solutions, especially for resistant forms of the disease.” — Lelio Marmora, Executive Director of Unitaid

... And more

PUBLICATIONS The MPP launched its 2016 Annual Report, Expanding For Better Treatment Options, during the week of the World Health Assembly. (May 2017)





The MPP and the WHO developed a joint presentation on the occasion of the MPP-WHO industry event in March 2017: Forecasted demand for Current and New ARV medicines in low- and middle-income countries, 2016-2026. (March 2017)


The MPP 2017 Prioritization Report selects five HIV and two hepatitis C compounds that, if successfully developed, could improve standard of care for people living in developing countries. (February 2017)
ABOUT THE MEDICINES PATENT POOL The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for thirteen HIV antiretrovirals, one HIV technology platform, two hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP is funded by Unitaid.

The Medicines Patent Pool was founded and is funded by 

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