Beximco Pharma Regulatory News (BXP)

19 December 2016

BEXIMCO PHARMACEUTICALS LIMITED

US FDA approves extended-release Metformin for diabetes control

Third product approval for the US market

Beximco Pharmaceuticals Limited ("Beximco Pharma" or "the Company"; AIM Symbol: BXP),  the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, and Bangladesh's leading exporter of pharmaceutical products, today announces that it has received approval for its Metformin Hydrochloride extended-release tablets (500 mg and 750 mg) from the US Food and Drug Administration (US FDA). This product is the generic equivalent to Bristol-Myers Squibb's (BMS) Glucophage XR tablets (500 mg and 750 mg).

Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Annual sales for Glucophage XR in the US were $918 million for the twelve months ending 31 October 2016, according to IMS data. This is Beximco's third Abbreviated New Drug Application (ANDA) approval since the Company's oral solid dosage facility was approved by the US FDA in June 2015.

Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals Limited, commented:

"This marks our third US FDA product approval since November last year and clearly demonstrates our competitive in-house expertise, in particular, our strength in extended-release formulation. We expect to launch this product through our US distribution partner during the middle of 2017."

Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015 and also the first in the country to export medicine to US. 

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

Beximco Pharma

Nazmul Hassan MP, Managing Director

Tel: +880 2 58611001, ext.20080

SPARK Advisory Partners Limited (Nominated Adviser)

Mark Brady / Sean Wyndham-Quin

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

Daniel Stewart & Company plc (Broker)

David Lawman / Daphne Zhang

Tel: 020 7776 6550

FTI Consulting

Simon Conway / Victoria Foster Mitchell 

Tel: +44 (0)20 3727 1000

Notes to Editors

About Beximco Pharmaceuticals Limited

Founded in 1976 and based in Dhaka, Bangladesh, Beximco Pharma manufactures and sells generic pharmaceutical formulation products and active pharmaceutical ingredients. The Company also undertakes contract manufacturing for multinational and leading global generic pharmaceutical companies. The Company operates from a 23 acre site in Dhaka and has manufacturing facilities for producing various drugs in different delivery systems such as tablets, capsules, liquids, semi-solids, intravenous fluids, metered dose inhalers, dry powder inhalers, sterile ophthalmic drops, prefilled syringes, injectables, nebuliser solutions, oral soluble films etc. Ensuring access to quality medicines is the powerful aspiration that motivates 3,500 employees of the Company.

Beximco Pharma′s state-of-the-art manufacturing facilities are certified by global regulatory authorities of the US, Europe, Australia, Canada, GCC and Latin America, among others. The Company's products are sold to retail outlets, medical institutions and other pharmaceutical manufacturers in Bangladesh, in regional markets such as Sri Lanka, Nepal, Bhutan, Vietnam, Cambodia and Myanmar and in other markets overseas, principally in South East Asia, including Singapore, Taiwan, Malaysia, Indonesia, Philippines and Hong Kong; Africa, including South Africa, Mauritius, Kenya, Ghana, Ethiopia, Uganda and Nigeria; Central Asia, including Azerbaijan; Middle East, including Kuwait and Jordan; Pacific Island countries; Latin and Central American countries; Europe, including Austria, Germany and Romania; Australia and the US.