Our very own version of ‘Big Pharma’

Prime Minister Sheikh Hasina at the press conference at her official residence Ganabhaban on Wednesday, November 17, 2021. Photo: PID

Attending her first parliamentary session since returning from her visit to the UK for the UN climate change conference incorporating a short bilateral to France, Prime Minister Sheikh Hasina claimed Bangladesh is capable of producing the Covid-19 vaccine and exporting the jabs to other countries provided it gets the go-ahead.

She said this while participating in a discussion on a resolution to thank Unesco for introducing “The Unesco-Bangladesh Bangabandhu Sheikh Mujibur Rahman International Prize for the Creative Economy.”

The prime minister said during her recent tour of the UK and France, she told the world leaders that Bangladesh wants to manufacture coronavirus vaccines and to allow the country to do so.

“I told them to remove all barriers to produce coronavirus vaccine in Bangladesh, this (the vaccine) is the right of the people of the whole world, and it should be declared as a global public good,” Hasina said.

She mentioned that if Bangladesh gets the chance it would produce the vaccine as it has that capability and the government has already allotted a piece of land for the purpose of an international vaccine institute.

“We can also supply vaccines to the world,” she said, adding that Bangladesh got global recognition for its success in tackling the Covid-19 pandemic.

She also said government-to-government negotiations on transferring technology were underway with countries that had developed vaccines.

Hasina said the capacity of three companies – Incepta Pharmaceuticals, Popular Pharmaceuticals, and Healthcare Pharmaceuticals – to produce Covid-19 vaccines had already been assessed while Globe Biotech was working on such vaccines too. She mentioned the vaccine developed by Globe Biotech was now at the trial stage.

The prime minister’s statement was probably buoyed by news that broke the previous week, that a slew of Bangladeshi pharmaceutical companies, led by Beximco Pharmaceuticals, will soon begin selling the world's first generic version of Merck's COVID-19 pill, molnupiravir, which has been touted as a potential game-changer in the fight against the pandemic.

Beximco Pharmaceuticals will first sell the generic version of molnupiravir in Bangladesh, before considering exports based on global regulatory approvals, it said on Tuesday, November 9. The generic version has received emergency use authorisation from Bangladesh's drug regulators.

Generic drugs like Beximco's are less expensive versions of brand-name pharmaceuticals and help expand access to treatments in poorer countries. However, none of the companies that have made vaccines for Covid-19 till now have allowed any generic versions of their product to be made, causing a fierce debate in international circles. 

Potential game-changer

Molnupiravir, developed by Merck and Ridgeback Biotherapeutics, received its first regulatory approval globally in the UK last week. It is under regulatory review in the United States and Europe.

"We believe generic molnupiravir could play an important role in combating the pandemic, especially in low- and middle-income countries where access to vaccines has been limited," Beximco Managing Director Nazmul Hassan said in a statement.

The medicine will have a maximum retail price of Tk 70 (US$0.82) per capsule, or Tk 2,800 (US$33) for a full course, a Beximco representative said, adding it was trying to lower prices.

The US government is buying 1.7 million courses of molnupiravir at US$700 per course. Many Asian countries have agreements to buy the drug at cheaper prices.

A number of companies are racing to develop drugs to combat the pandemic beyond vaccines, but only a few are developing easily ingestible oral pills. Molnupiravir has been closely watched since data last month showed it could halve the chances of dying or being hospitalised for those most at risk of developing severe COVID-19. Experts hailed the results as a potential breakthrough.

Meanwhile, Pfizer Inc. said last week its experimental pill cut by 89 percent the chance of hospitalisation or death for adults at risk of severe COVID-19. The news boosted Pfizer's share price while plummeting Merck's.

The Beximco representative said the company does not have an agreement with Merck but can sell generic molnupiravir under a World Trade Organization waiver of intellectual property rules for COVID-19 drugs in developing countries.

Beximco cannot export to most Western countries as the waiver only allows it to sell generics to less-economically developed countries that do not have a patent protection scheme, the spokesperson said.

Merck has licensing agreements with at least eight Indian drugmakers for molnupiravir, aiming to turn the South Asian nation into a manufacturing hub for the drug to supply low- and middle-income nations. It also has a licensing deal with the United Nations-backed Medicines Patent Pool to allow more companies to make generic molnupiravir.

Beximco said it does not expect sales of generic molnupiravir to significantly boost revenues, given currently low COVID-19 infections in Bangladesh.

The treatment, which is based on a molecule first studied at Emory University as a treatment for influenza, targets an enzyme that the coronavirus uses to make copies of itself, introducing errors into its genetic code. By doing so, molnupiravir prevents the virus from replicating, so keeping the viral load low in the body and reducing the severity of the disease.

Merck said that approach should make the treatment equally effective against new variants of the virus as it evolves in the future.

Bangladeshi firms got the formulation for molnupiravir from the Medicines Patent Pool, a United Nations-backed non-profit that works to make medical treatment and technologies globally accessible.

Following concerns that poor countries could be shut out of access to the medicine, much as they have been for vaccines, in October, Merck, Ridgeback Biotherapeutics and Emory University granted a royalty-free licence for the pill to the Medicines Patent Pool.

The Medicines Patent Pool has deep experience in working with a network of global drugmakers that can meet high-quality standards, including those required for the World Health Organization prequalification. The deal allows the drug to be made and sold cheaply in around a hundred developing nations, with no fee required from the sublicensing company.

This week, Pfizer Inc. signed a deal with the Medicines Patent Pool to allow other manufacturers to make its experimental COVID-19 pill, a move that could make the treatment available to more than half of the world’s population.

In a statement, Pfizer said it would grant a license for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population. The deal excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a Brazilian drug company could get a license to make the pill for export to other countries, the medicine could not be made generically for use in Brazil.

Still, health officials said the fact that the deal was struck could help to end the pandemic quicker.

“It’s quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than 4 billion people,” Esteban Burrone, head of policy at the Medicines Patent Pool, said.

He estimated that other drugmakers would be able to start producing the pill within months, but acknowledged the agreement wouldn’t please everyone.

“We try to strike a very delicate balance between the interests of the (company), the sustainability required by generic producers and most importantly, the public health needs in lower and middle-income countries,” Burrone said.

Under the terms of the agreement, Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 remains a public health emergency.

Earlier this month, Pfizer said its pill cut the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections. Independent experts recommended halting the company’s study based on its promising results. Pfizer has asked the U.S. Food and Drug Administration to authorise the pill.

Since the pandemic erupted last year, researchers worldwide have raced to develop a pill to treat COVID-19 that can be taken at home easily to ease symptoms, speed recovery and keep people out of the hospital. At the moment, most COVID-19 treatments must be delivered intravenously or by injection.

Britain authorised Merck’s COVID-19 pill earlier this month, and it is pending approval elsewhere. In a similar deal with the Medicines Patent Pool announced in October, Merck agreed to let other drugmakers make its COVID-19 pill, molnupiravir, available in 105 poorer countries.

Doctors Without Borders said it was “disheartened” that the Pfizer deal does not make the drug available to the entire world, noting that the agreement announced Tuesday (Nov. 16) also excludes countries including China, Argentina and Thailand.

“The world knows by now that access to COVID-19 medical tools needs to be guaranteed for everyone, everywhere, if we really want to control this pandemic,” said Yuanqiong Hu, a senior legal policy adviser at Doctors Without Borders.

The decisions by Pfizer and Merck to share their COVID-19 drug patents stands in stark contrast to the refusal of Pfizer and other vaccine-makers to release their vaccine recipes for wider production. A hub set up by the World Health Organization in South Africa intended to share messenger RNA vaccine recipes and technologies has not enticed a single pharmaceutical to join. Fewer than 1% of Pfizer’s COVID-19 vaccine shots have gone to poorer countries.

Robbie Silverman of Oxfam America welcomed Pfizer’s agreement to let other makers produce its COVID antiviral, but he noted that billions would still be left without access, including to the company’s vaccine.

“This move also begs the important question: If Pfizer can share data and intellectual property on a medicine, why have they so far categorically refused to do so for their COVID vaccine?” Silverman said.

Raking in the profits

The U.S. government will pay drugmaker Pfizer $5.29 billion for 10 million treatment courses of its potential COVID-19 treatment if regulators authorize it, the nation’s largest purchase agreement yet for a coronavirus therapy.

Pfizer asked the Food and Drug Administration to authorize emergency use of the experimental pill, which has been shown to significantly cut the rate of hospitalisations and deaths among people with coronavirus infections. The FDA is already reviewing a competing pill from Merck and will hold a public meeting on it later this month.

The price for Pfizer’s potential treatment amounts to about $529 per course. The U.S. has already agreed to pay roughly $700 per course of Merck’s drug for about 3.1 million treatments.

In Bangladesh, the Directorate General of Health Services (DGHS) has given the approval to use molnupiravir, or its generic versions, for treating Covid-19. DGHS gave the approval after Directorate General of Drug Administration (DGDA) authorised the manufacture of the oral medicine.

Bangladesh this week became the second country in the world to approve the potentially game-changing Covid-19 antiviral pill while Britain became the first last week.

The Medicines and Healthcare products Regulatory Agency of the UK recommended that the drug, which will be branded Lagevrio, be used as soon as possible following a positive Covid-19 test and within five days of the onset of symptoms. UK Health Secretary Sajid Javid said the treatment had raised hopes for the frail and immunosuppressed. Media reports said the UK had agreed to purchase 480,000 courses, with the first deliveries expected in November.

It was the first oral antiviral treatment for Covid-19 to get approved, with the green light coming ahead of potential US regulatory clearance. US advisers will meet this month to vote on whether molnupiravir should be authorised.

"An oral antiviral that can impact hospitalization risk to such a degree would be game-changing," said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, in comments to the Associated Press.

In Bangladesh, DGHS stated, "Patients who test positive for Covid-19, showing mild to moderate symptoms, will be able to use the medicine for treatment."

The notice, signed by DGHS Director (Hospital and Clinics) Dr Farid Hossain Mia, warned that the medicine cannot be used on patients who are showing severe symptoms of Covid-19.

"The medicine should not be administered to patients who are over 60, have diabetes, high blood pressure, cardiovascular disease or other comorbidity," the notice further clarified.

According to DGDA Director General Major General Mahbubur Rahman, "The drug will help to reduce hospitalisation and mortality rates by at least 50%."

The pandemic helped the Bangladesh pharmaceuticals industry achieve a staggering 18.56% growth in the 2020-21 fiscal year. The annual growth of the pharmaceutical industry may go as high as 15-16% this decade, which has been 12.1% for the last five years.

Beximco Pharmaceuticals, Square Pharmaceuticals, and Renata have raked in more than Tk500 crore profit among the dozens of companies listed on the country's stock market. During the pandemic, these companies all reported a sharp rise in profits.

Beximco Pharmaceuticals' profit grew by 46% in FY21. Its consolidated earnings per share (EPS) stood at Tk11.49, which was Tk7.88 in the previous fiscal year.

Officials at the company said profit increased from its organic growth of business and part of this is attributable to the income from vaccine distribution and increased cash incentive from exports. In November 2020, Bangladesh signed an agreement to buy 30 million doses of the Oxford-AstraZeneca vaccine from the Serum Institute of India (SII), the world's biggest vaccine-maker. According to the agreement, Beximco Pharmaceuticals would be the sole distributor of the vaccine, responsible for supplying the doses in Bangladesh. Some 7 million doses were supplied before India banned exports of the vaccine in the face of a lethal second wave of the virus earlier this year.

Square Pharmaceuticals – the industry leader – posted a 19% increase in profit in FY21 and its EPS rose to Tk17.99 from Tk15.07 in the previous year. It said in an annual declaration, the growth is in its core business. The sales of pharmaceutical products have positively affected the EPS.

Renata, the descendent of Pfizer Bangladesh, posted a 26% increase in profit. Its EPS rose to Tk51.94 from Tk41.14 in the previous year.

Orion Pharma registered a 41% increase in profit in FY21. Its consolidated EPS rose to Tk4.1 from Tk2.84 in the previous fiscal year.

A supportive policy adopted four decades ago under the leadership of Dr Zafrullah Chowdhury  together with the aspiration and talents of local entrepreneurs has created an over Tk27,000 crore pharmaceutical industry in Bangladesh, which is meeting almost the entire domestic demand alongside exporting to over 100 countries.

In a research report on the outlook for the pharmaceutical industry over the next decade, UCB Asset Management recently said the industry would reach the milestone of Tk 1 lakh crore valuation mainly riding on the growing local market demand. Alongside a local market boom, the country's pharmaceutical sector is expected to rake in over $1.5 billion or around Tk13,000 crore in export earnings per year by 2030 – almost nine times higher than $169 million earned in FY21. The outlook is certainly rosy, if you’re in the pharmaceuticals industry in Bangladesh.

  • Molnupiravir
  • Pill
  • Vaccine
  • Covid-19
  • Coronavirus

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