Gilead Sciences Response to Open Letter Regarding Access to AmBisomeĀ® (liposomal amphotericin B)

June 25, 2021

Sharonann Lynch
Global Health Policy & Politics Initiative, O'Neill Institute for National and Global Health Law, Georgetown University

Dear Ms. Lynch,
I am writing in response to the open letter sent to Gilead co-signed by Médecins Sans Frontières and a number of civil society organizations and individuals, dated June 23, 2021. Thank you for raising your concerns regarding access to AmBisome® (liposomal amphotericin B).

Addressing the Public Health Crisis in India
Gilead has been working on multiple fronts to contribute to the public health efforts in India resulting from the surges in COVID-19 and mucormycosis cases across the country.

Following the rapid increase in COVID-19 cases in the country, Gilead committed to donate at least 450,000 vials of Veklury® (remdesivir) to help address the immediate needs of Indian patients. In addition, we provided technical assistance and support for new local manufacturing facilities and donated active pharmaceutical ingredient to our voluntary licensees to rapidly scale up the production of remdesivir. The significant efforts of the licensees, coupled with Gilead’s early actions, have recently led to the lifting of the export ban on remdesivir, making this medicine accessible to more patients around the world.

Gilead has responded with urgency to help address the surge in mucormycosis cases caused by the recent COVID-19 crisis in India. We have been working closely with Mylan/Viatris, the local marketing authorisation holder and official distributor for AmBisome in India, and directly with the Government of India to secure shipments of AmBisome to India as quickly as possible. Gilead has committed to providing more than 1 million vials of AmBisome, as requested by the Government of India based on their projected needs. We were able to make the first shipments during the week of May 17, 2021, within days of receiving the orders. Within 4 weeks, we were able to ship several hundreds of thousands more vials. The majority of the 1 million vials were shipped to the country by 25 June 2021, and we worked closely with Mylan/Viatris, our local partner, to ensure that the Indian Government was kept informed of our actions / progress. We suggest that any additional questions you may have on this topic are addressed to the relevant authorities in India.

Gilead is not the marketing authorization holder for AmBisome in India. Consistent with our agreement with Mylan/Viatris, the marketing authorization holder, in-country pricing and supply terms are agreed between Mylan/Viatris and the Government of India.

Visceral Leishmaniasis (VL)
Gilead has a long-standing partnership with the World Health Organization (WHO) for the management of VL.i The WHO is responsible for the VL program in India. We have remained engaged and in frequent communication with the WHO teams in India to mitigate the impact of the surge in mucormycosis cases on the VL program in India and have transparently shared information on the actions taken by Gilead. If you have any questions about the recent reallocation of AmBisome stocks for the treatment of VL in India, we recommend you address them to the WHO.

Ensuring Adequate, Uninterrupted Supply of AmBisome
Gilead does not anticipate a shortage of AmBisome supply globally, nor do we foresee a need to add additional manufacturing sites to cater to global needs.

Gilead’s La Verne facility was temporarily deployed to manufacture remdesivir in March 2020, while we were investigating other options to enhance our production capacity for Veklury, which was then still an investigational drug. Since then, Gilead has expanded its global network of both internal manufacturing sites and external organizations, including partnering with industry peers, to add manufacturing capacity for Veklury around the world. Our Veklury manufacturing network now includes more than 40 companies in North America, Europe and Asia. The temporary deployment of La Verne to manufacture Veklury did not lead to a shortage of AmBisome at any time anywhere in the world. The recent increased demand for AmBisome in India was entirely due to COVID-19 related mucormycosis as a result of the ongoing crisis.

Cryptococcal Meningitis (CM)
Gilead has made significant progress in our understanding of the public health approach and collaboration required to effectively address this devastating infection of the central nervous system, following the publication of our letter of intent to support access to AmBisome for the treatment of patients with HIV associated CM in 2018. We are also aware that the results of the AMBITION study are due to be presented at the upcoming Conference of International AIDS Society, which may bring important new insights on how to optimize treatment of CM with AmBisome.

Gilead remains committed to the non-profit pricing for the treatment of CM. It is clear that an effective public health approach to addressing this infection requires more than just the medicinal product, which is why we have been discussing frameworks to manage CM, in those countries where the burden of the disease is greatest, with a range of stakeholders, including Médecins Sans Frontières. We believe that such a framework should be sustainable, applied in the most endemic regions and should make a meaningful impact, with its outcomes transparently monitored and reported. It also goes without saying that one of the most important interventions – and our collective responsibility – should remain the prevention of infections such as CM in the first instance as these opportunistic infections are a direct consequence of advanced HIV infection. We welcome your contributions, insights and thoughts on what such a framework might look like and how we can work together to realize this ambition.

We understand the urgency and remain fully committed to supporting India and other countries during these challenging times, working in partnership with other stakeholders. No one entity can solve these problems alone, but we can make tremendous progress working in a thoughtful and collaborative manner across industry, governments, the healthcare community, with NGOs and patient advocacy groups. I would appreciate an opportunity to discuss end-to-end partnerships toward the elimination of VL, CM as well as triple preventive mother to child transmission in vulnerable populations and look forward to connecting with you in due course.

Yours sincerely,
Dr. Harald Nusser
Head of Global Patient Solutions
Gilead Sciences

In 1992, Gilead started working with the WHO to provide no-profit pricing for AmBisome for the treatment of visceral leishmaniasis (VL) in high burden countries. In 2011, we opened a new chapter in our collaboration with the donation of 445,000 vials of AmBisome over five years, across six countries. This unprecedented and proven-effective partnership has created access to one of the most effective antileishmanial drug to the most affected populations. Due to the success of the program during these five years, Gilead and the WHO embarked on another five-year collaboration effort at the end of 2016, with $14M in funding, which has already been paid in full, and an additional donation of 380K vials of AmBisome, of which more than 70% already has been provided.

We recognize the past challenges in supply and have worked to address these in order to ensure reliable supply for the success of this program, and as evidenced by the recent report kindly provided by the WHO, we are delighted that it has already led to a dramatic decrease in VL cases. In India for instance, 633 blocks (sub-districts) are endemic for VL. In 2019, 96% of the endemic blocks reached the elimination target, per preliminary data as of August 2020.