Beximco Pharma Regulatory News (BXP)

9 November 2021

BEXIMCO PHARMACEUTICALS LTD.

Beximco Pharma introduces world's first generic molnupiravir, an oral antiviral drug for COVID-19 treatment

Availability of generic molnupiravir will help broaden access and affordability of COVID-19 treatment

Beximco Pharmaceuticals Limited ("Beximco Pharma", "BPL" or "the Company"), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces the launch of the world's first generic molnupiravir, an oral antiviral drug for symptomatic COVID-19 recently developed by Merck, Sharp & Dohme (MSD) and Ridgeback Biotherapeutics, following Emergency Use Authorisation by the Directorate General of Drug Administration (DGDA), the regulatory authority in Bangladesh. Beximco Pharma's branded generic version of molnupiravir will be marketed as Emorivir.

Molnupiravir is the world's first oral product to treat symptomatic COVID-19, which was approved by the UK's Medicines and Healthcare products Regulatory Agency on 4 November 2021. Molnupiravir is currently under review by several other regulatory authorities, including the European Medicines Agency and the United States Food and Drug Administration.

As an oral treatment that can be administered at home, molnupiravir has the potential to have a significant impact on the treatment paradigm for COVID-19. For instance, it may reduce the need for infected patients to visit medical facilities, therefore also reducing the risk of infecting others. Data published by MSD suggest that it may cut the risk of hospitalisation and death by half, with 7.3% of molnupiravir patients hospitalised after 29 days compared to 14.1% of patients who were treated with placebo. Molnupiravir works by interfering with the replication of virus. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease.

With the launch of a branded generic version, Beximco Pharma is helping to broaden access and reduce cost of this potentially life-saving treatment option, which could bring significant benefit to unvaccinated or immunosuppressed patients. Emorivir will initially be launched in Bangladesh with scope for future exports depending on drug regulatory approvals from importing countries. Given the changing nature of the pandemic, it is unclear what impact the launch of Emorivir will have on sales but based on current infection rates in Bangladesh, the Company does not expect a material impact on full-year revenues.

Mr. Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented: 

"Further to our launch of the first generic remdesivir at the start of the pandemic, the launch of a generic version of molnupiravir, the world's first oral antiviral drug to treat COVID-19, is another example of Beximco Pharma's ability to rapidly respond to make affordable treatments available to patients suffering from COVID-19. This is a great achievement for the Company and one which we believe could play an important role in combating the pandemic, especially in low- and middle-income countries where access to vaccines has been limited."

For further information please visit www.beximcopharma.com or enquire to:

Beximco Pharma

Nazmul Hassan MP, Managing Director

Tel: +880 2 58611001, Ext.20080

Mohammed Ali Nawaz, Chief Financial Officer

Tel: +880 2 58611001, Ext.20030

Jamal Ahmed Choudhury, Director, Accounts & Finance

Tel: +880 2 58611001, Ext.20022

SPARK Advisory Partners Limited (Nominated Adviser)

Mark Brady / Andrew Emmott

Tel: +44 (0) 20 3368 3551 / 3555

SP Angel Corporate Finance LLP (Broker)

Vadim Alexandre / Abigail Wayne

Tel: +44 (0) 20 3470 0470

FTI Consulting

Simon Conway / Victoria Foster Mitchell

Tel: +44 (0) 20 3727 1000

Notes to Editors

About Beximco Pharmaceuticals Limited

Beximco Pharma is a leading manufacturer and exporter of medicines based in Bangladesh. Since its inception in 1976, the Company remains committed to health and wellbeing of people across all the continents by providing access to contemporary medicines. Company's broad portfolio of generics encompasses diverse delivery systems such as tablets, capsules, liquids, semi-solids, intravenous fluids, metered dose inhalers, dry powder inhalers, sterile ophthalmic drops, insulins, prefilled syringes, injectables, nebuliser solutions, oral soluble films etc. The Company also undertakes contract manufacturing for multinational and leading global generic pharmaceutical companies.

Beximco Pharma′s state-of-the-art manufacturing facilities are certified by global regulatory authorities of USA, Europe, Australia, Canada, GCC and Latin America, among others and it has a geographic footprint in more than 50 countries. More than 5500 employees are driving the company towards achieving its aspiration to be among the most admired companies in the world.