Gilead Licensing Deal Expands Remdesivir Access, Capacity

Killing two birds with one stone, Gilead Sciences Inc. has granted non-exclusive licenses for remdesivir to Mylan NV, Cipla Ltd., Jubilant Life Sciences Ltd., Hetero Drugs Ltd. and Ferozsons Laboratories Ltd. for 127 developing countries, including several from Asia but excluding China, thus tilting the pricing debate in its favor while creating substantial capacity for its production.

The investigational drug is currently at the forefront of the fight against COVID-19, with the US having granted Emergency Use Authorization (EUA) and drug regulatory authorities in Japan on 7 May joining in with an exceptional expedited approval for the antiviral, branded Veklury (remdesivir).

The licensing agreement grants these five licensees a right to register, manufacture and sell Gilead’s product. The US firm will not charge a royalty on sales until the World Health Organization (WHO) declares the end of the public health emergency of international concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or vaccine is approved to treat or prevent COVID-19, whichever is earlier.

The licensees are also free to set prices for the generic product they produce.

Gilead has come under fire regarding the potential pricing of remdesivir with arguments being made about public funds having been used for its development and the need for the company to take a less commercial view, at a time when the world is suffering and developing nations need access to a potentially life-saving drug. (Also see "Gilead’s Second Chance To Re-Set The Drug Price Debate" - Pink Sheet, 6 May, 2020.) 

So far, remdesivir was available only to patients who are part of a clinical trial or for compassionate use, with Gilead supplying it free of charge for all clinical studies. In India, the medicine was only available to patients who are part of WHO’s solidarity trial.

Pricing In Developing Countries

Given that the licensees have been given the freedom to decide on pricing individually, it’s likely that competition as well as demographics and paying capacities of catered markets will lead to economically priced products.

“Many of these details are being worked out as we speak. We will be conscious of the public responsibility on the pricing [of remdesivir],” Cipla’s global chief financial officer Kedar Upadhye told Scrip.

While all the partners spoke about “ongoing efforts to support patients and public health needs during the COVID-19 pandemic,” Mylan’s statement offers another clue.

CEO Heather Bresch said "Mylan and Gilead have partnered for 15 years to fight infectious diseases like HIV and hepatitis C, reaching nearly 10 million patients in more than 100 countries with affordable medicine. We applaud Gilead's progress on remdesivir and are committed to…help expand access to this potential treatment option as it is further evaluated by regulatory authorities."

Mylan’s reference to a review by the Prequalification Program of the WHO also hints at affordable pricing or support from multilateral agencies, given that WHO programs provide access to developing countries at reasonable prices.

In 2014, Gilead’s launch of the “$1,000-a-pill” cure for hepatitis C, Sovaldi (sofosbuvir), triggered unprecedented political pressure around innovator drug pricing in the US. When the Indian patent office rejected the company’s patent application for Sovaldi on the grounds that it was not a significant improvement over an earlier compound, it became a flash point in India-US relations.

Gilead granted licenses to 11 Indian generic manufacturers at the time to sell a low-cost version of the drug in 91 developing countries.

India’s Manufacturing Prowess A Big Plus

Of the five companies in the remdesivir deal, four have production units in India and one in Pakistan, the choice being significant given that remdesivir is a complex drug to make, requiring sterile manufacturing facilities. They will receive a technology transfer of the Gilead manufacturing process for the molecule to enable them to scale up production quickly.

Gilead has been under pressure to increase capacity for its medicine rapidly so that governments don’t resort to compulsory licensing for greater access to it at the time of this public health crisis. (See sidebar)

With an ability to produce or source key starting materials and active pharmaceutical ingredients required for production of remdesivir, manufacturers Hetero Drugs, Jubilant Life Sciences, Cipla and Mylan represent an informed partnering decision. (Also see "How Gilead Intends To Deliver On Promise Of Remdesivir For COVID-19" - Pink Sheet, 8 May, 2020.)

Hetero is the world’s largest producer of antiretroviral drugs, with 36 manufacturing facilities worldwide and a presence in over 126 countries. It intends to manufacture the drug at its Hyderabad facility, which has been approved by the US Food and Drug Administration (FDA) and regulatory authorities in EU, among others.

The company said it has developed the fully vertically integrated supply chain for remdesivir in India and has already been working with the government, Indian Council of Medical Research and the Drugs Controller General of India for necessary studies and approvals to bring this product to treat COVID-19 patients in India.

Cipla, an experienced player in complex generics, also has strengths in the antiretroviral, respiratory and anti-infective segments. With 46 manufacturing sites around the world, it has a presence in over 80 markets and the company will provide the therapy under its own brand name in licensed territories under the terms of its agreement with Gilead.

Jubilant Life Sciences, an integrated firm with pharmaceuticals, life sciences ingredients and drug discovery solutions divisions, owns 11 manufacturing units, with six of US FDA approved- facilities in the US, Canada and India.

The company said it will monitor clinical trials and regulatory approvals for remdesivir very closely and would be ready to launch the drug shortly after the required regulatory approvals. It also plans to produce the active pharmaceutical ingredient (API) in-house, helping its cost effectiveness and consistent availability.

Mylan has a vast manufacturing platform in India including API, oral solid dose and injectables facilities that serve a number of markets around the world. 17 of Mylan’s facilities in India, including all of its API facilities, are approved by the US FDA. Many of these sites also are approved and regularly inspected by other regulatory authorities, including Australia's Therapeutic Goods Administration, the U.K.’s Medicines and Healthcare Products Regulatory Agency and WHO.

Clinical Trials Ongoing

With several trials ongoing to gauge the efficacy and safety of using remdesivir to treat COVID-19, most partners mentioned the investigational nature of the drug. In any case, companies will need regulatory approvals for marketing remdesivir in assigned markets.

The EUA in the US is based on available data from two global clinical trials – the US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase III study in patients with moderate to severe symptoms of COVID-19, and Gilead’s global Phase III study evaluating remdesivir in patients with severe disease. Under the EUA, both five-day and 10-day treatment durations have been suggested, based on the severity of disease.

The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process.

A new trial is also underway to combine Eli Lilly & Co.'s Olumiant (baricitinib) with Gilead’s remdesivir in the hope that together the drugs could help patients with the most severe form of disease and even save lives.

The research is the next phase of the Adaptive COVID-19 Treatment Trial (ACTT), the international adaptive trial which provided the large scale, placebo-controlled data which led to the US FDA giving remdesivir the EUA on 2 May. (Also see "Coronavirus Update: Rapid Japan Approval For Remdesivir, Combination With Lilly's Olumiant Is Next Hope" - Scrip, 11 May, 2020.) and (Also see "COVID-19 Phase III Trial Design: Big Ambitions, Little Consistency" - Pink Sheet, 11 May, 2020.)