A total of 27 contract manufacturing organisations (CMOs) in emerging pharma markets have signed licensing deals to produce generic versions of Merck & Co’s (Kenilworth, New Jersey) Covid-19 antiviral pill molnupiravir. The companies will manufacture the drug under sublicensing deals with the Switzerland-based Medicines Patent Pool (MPP), which has a licensing deal with Merck.
Working together, the 27 manufacturers will produce molnupiravir for 105 countries in Africa, Asia and the Middle East. The deals cover both active pharmaceutical ingredient (API) and dose manufacturing (Table 1). The group of manufacturers includes excess capacity pharma companies such as Celltrion Inc (Incheon, South Korea) and Lupin (Mumbai, India). Paul Schaper, Executive Director, Global Public Policy, Merck, commented that the company is pleased with the ‘strong geographic diversity in MPP’s selected generic manufacturing sublicensees’.
|Remington Pharmaceutical Industries||Pakistan||X|
|Aspen Pharmacare Holdings||South Africa||X|
|Chemical Process Technologies Pharma||South Africa||X|
|BDR Pharmaceuticals Internationals||India||X||X|
|Biophore India Pharmaceuticals||India||X||X|
|Strides Pharma Science||India||X||X|
|PT Kimia Farma||Indonesia||X||X|
|Dongbang Future Tech & Life||South Korea||X|
|Hanmi Pharmaceuticals||South Korea||X||X|
|BrightGene Bio-Medical Technology||China||X||X|
|Shanghai Fosun Pharmaceutical (Group)||China||X||X|
|Zhejiang Langhua Pharmaceutical||China||X|
Source: GlobalData; Medicines Patent Pool ©GlobalData
Aside from the sublicensing deals with the MPP, several other CMOs are contracted directly with Merck to manufacture molnupiravir, including ThermoFisher Scientific (Waltham, Massachusetts) and Divi’s Laboratories (Hyderabad, India), according to the GlobalData Pharmaceutical Intelligence Centre.
Molnupiravir is a potent ribonucleoside analogue that acts as an antiviral. It is formulated into capsules for oral use. The drug is approved or has emergency use authorisation in the UK, US, India, Australia, Japan and many other countries. The European Medicines Agency (EMA) is currently reviewing the drug, but is unlikely to grant conditional marketing authorisation this month and, according to a Financial Times report on 16 February, may never grant approval because of concerns about molnupiravir’s efficacy.
Pfizer, Lilly and Regeneron offer rival Covid-19 drugs
Simultaneously with molnupiravir, Pfizer has received approval or emergency use authorisation in many countries for its oral antiviral drug, Paxlovid (nirmatrelvir tablets, ritonavir tablets), for post-exposure prophylaxis. The MPP signed a similar licensing deal to molnupiravir’s with Pfizer in November last year, but has not announced whether it has granted sub-licenses to manufacturers for Paxlovid.
Data posted to the bioRxiv preprint server on 19 January suggest that the oral small molecule drug is effective against the Omicron variant of Covid-19. It is approved in the UK, US, EU and other countries. Paxlovid is indicated for the treatment of mild-to-moderate Covid-19 in adults and patients older than 12 years of age, giving it an advantage over molnupiravir, which the US Food and Drug Administration (FDA) has only approved for use in adults.
Paxlovid is a combination of nirmatrelvir tablets co-packaged with ritonavir tablets. The US Government has pre-ordered ten million doses of the drug, while Pfizer recently announced that it is increasing its production projections for this year from 50 million courses to 120 million (‘Contract Manufacturing: Opportunities and Threats’, B/POR, November 2021). This is, however, still far less than the company’s estimate of the global addressable patient population, which it places at 250 million people.
Also in the armamentarium is GlaxoSmithKline (Brentford, UK) and Vir Biotechnology’s (San Francisco, California) sotrovimab, the only authorised monoclonal antibody that works against the Omicron variant. But demand for these drugs, especially Paxlovid, is outstripping supply even in wealthy nations such as the US (GlobalData Insights, Covid-19 antiviral access: uneven supply patterns hinder US rollout, February 2022). The FDA recently advised against using antibodies from Eli Lilly (Indianapolis, Indiana) or Regeneron Pharmaceuticals (Tarrytown, New York) against the Omicron variant