Merck, Ridgeback and Emory University will not receive royalties for sales of molnupiravir as long as the WHO considers Covid-19 as a public health emergency
Merck entrance in Darmstadt, Germany. (Credit: Armin Kübelbeck/Wikipedia.)
Merck has signed a licensing agreement with the Medicines Patent Pool (MPP) to enhance global access for its investigational Covid-19 antiviral medicine molnupiravir.
MPP is a United Nations (UN)-backed public health organisation that works for the development of life-saving medicines and increasing their access.
The license agreement is expected to widen access to molnupiravir in 105 low- and middle-income countries (LMICs), after receiving regulatory approvals.
Under the terms of the agreement, the drugmaker will grant a license to MPP (MPP License), allowing manufacturers selected by MPP to make generic versions of molnupiravir.
Also, the license allows MPP to diversify the manufacturing base for the supply of the molnupiravir to countries covered by the MPP License, subject to regulatory authorisation.
MPP executive director Charles Gore said: “The interim results for molnupiravir are compelling and we see this oral treatment candidate as a potentially important tool to help address the current health crisis.
This transparent, public health-driven agreement is MPP’s first voluntary license for a Covid-19 medical technology, and we hope that Merck’s agreement with MPP will be a strong encouragement to others.”
Molnupiravir is an investigational, orally-administered potent ribonucleoside analogue that inhibits the replication of SARS-CoV-2, which causes Covid-19.
Invented at Emory University, molnupiravir was licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory (DRIVE).
Merck and Ridgeback have been jointly developing the drug for the treatment of mild-to-moderate Covid-19 in adults who are at risk of severe Covid-19.
Ridgeback and Emory University are not eligible to receive royalties for sales of molnupiravir as long as the World Health Organization considers Covid-19 as a public health emergency.
Ridgeback Biotherapeutics chief executive officer Wendy Holman said: “We are pleased to collaborate with MPP to ensure that quality-assured generic versions of molnupiravir can be developed and distributed quickly following regulatory authorization.
Merck executive vice president and human health president Frank Clyburn said: “Merck’s mission to save and improve lives is a truly global commitment.
“This agreement with MPP is another important element in our multi-faceted strategy to accelerate broad, affordable access to molnupiravir, if approved or authorised.”
In April this year, Merck entered into non-exclusive voluntary licensing agreements for molnupiravir with five generics manufacturers in India
The five Indian generic drugmakers include Cipla, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs, and Sun Pharmaceutical Industries.
Earlier this month, Merck and Ridgeback filed an application with the US Food and Drug Administration, seeking the emergency use authorisation of molnupiravir.