Indian firms lining up to obtain a license for Pfizer's Covid drug

Close on the heels of inking a deal with Merck & Co (NYSE: MRK) for its molnupiravir, Indian drugmakers are now gearing up to manufacture the generic version of Pfizer's (NYSE: PFE) COVID-19 antiviral medication, Paxlovid. Several companies are in the fray and would reach out to the Medicines Patent Pool (MPP) to seek a licence to manufacture and distribute the drug.

Sun Pharma (NSE: SUNPHARMA), Cipla (NSE: CIPLA), Dr Reddy's Laboratories (BSE: 500124) and Optimus Pharma - with the latter already working on the Pfizer drug - are among the potentials, as are smaller firms. According to an agreement Pfizer inked with the MPP, the United Nations-backed public health organization, the pharmaceutical giant will be able to sell its COVID-19 pill at a lower cost in 95 countries.

Pfizer's deal with the MPP grants sub-licenses to qualified generic medicine manufacturers for Paxlovid. Under the terms of the head licence agreement between Pfizer and the MPP, generic manufacturers that are granted sub-licenses will be able to supply Paxlovid (in combination with ritonavir) to 95 countries, covering up to approximately 53% of the world’s population.

The UN agency has signed a similar agreement with Merck for molnupiravir in 105 countries including India.

Both of the agreements that the MPP closed with Merck and Pfizer include India's neighbors - Bhutan, Nepal, Bangladesh, Myanmar, Nepal, Pakistan, and Afghanistan. The Drugs Controller General of India (DCGI) has not approved either of the two medicines.

Though Pfizer's medicine has not yet been approved by any regulatory agency, Merck's molnupiravir received UK approval earlier this month and is under consideration by other regulators, including the DCGI. Both the drugs have been found to significantly reduce the chances of serious COVID-19 disease and hospitalization in laboratory studies.

Open to exploring opportunities

Sun Pharma says it is open to all options and is keen to accelerate access to new drugs for COVID-19 treatment in India. Dr Reddy’s, too, is open to exploring opportunities, whereas scientists at Hyderabad-based Optimus Pharma have already started working on developing the drug.

Yet other smaller domestic drugmakers are eager to be the first mover to launch a generic version of the drug in India. With government and regulatory officials insisting on Phase III trials on Indians for any company that applies to make a generic version of Paxlovid in India, domestic companies are expecting "a small delay" said an official at a firm keen to make a generic version of the Pfizer drug.

However, he added the launch of innovative COVID-19 oral drugs has excited many Indian companies who are eager to grab the opportunity. The number of cases in several countries has also increased despite vaccinations, and most of them have already placed orders for innovative treatments like antibody cocktails and monoclonal antibodies. India wants to be a part of this race since these drugs will be used for years to come, added the official.

Though Merck’s has a pact for molnupiravir with many Indian generic companies, including Dr Reddy’s, Cipla and Sun Pharma, Pfizer has none in place as yet.