Beximco Pharma Regulatory News (BXP)

24 February 2020

BEXIMCO PHARMACEUTICALS LTD.

Beximco Pharma announces a Commercial Agreement with Mylan

Beximco Pharmaceuticals Limited ("Beximco Pharma", "BPL" or "the Company"; AIM Symbol: BXP, LEI No.: 213800IMBBD6TIOQGB56), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces the signing of a commercial agreement for distribution of certain products of Mylan in Bangladesh. 

Under the terms of the agreement, Beximco Pharma will receive the exclusive rights to launch Mylan's portfolio of key monoclonal antibodies to treat different types of cancers, rheumatoid arthritis, Chron's disease, ulcerative colitis and other medical conditions.

The first product to be launched, in Q1 2020, will be Ogivri™, a breast cancer drug which is biosimilar to blockbuster drug Herceptin from Roche with global sales in excess of $7 billion in 2018. Ogivri is approved the U.S. Food and Drug Administration . and also has received marketing authorisation from the European Medicines Agency. Cancer is now one of the leading causes of death in Bangladesh and currently there are more than 50,000 HER2-positive breast cancer patients in the country[1].

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

"We are incredibly excited to announce this commercial agreement with Mylan, the first of its kind in Bangladesh. With one of the largest and most diverse portfolios of biosimilars approved in more than 80 countries, Mylan is the ideal partner for Beximco Pharma as we enter the key therapeutic areas covered by biosimilar products. This unique partnership, which combines world-class product development, marketing and regulatory expertise, will introduce a portfolio of biologics, in particular, target-specific high-value monoclonal antibodies, in Bangladesh. Together, we will be able to provide our patients with more affordable access to these much-needed products."

Commenting on the launch, Mr. Rakesh Bamzai, President, India and Emerging Markets, Mylan said:

"The growing incidence of breast cancer is a major public health concern among women in Developing Markets. As a global leader in the development of complex products, including biosimilar medicines, Mylan, through its commercial agreement with Beximco Pharmaceuticals, is pleased to makeTrastuzumab accessible to patients in Bangladesh. Mylan and Beximco share a commitment to bring affordable and high-quality medicines to the market, especially in areas of unmet needs and by bringing this treatment option to Bangladesh, we hope to eliminate barriers to access by providing timely and affordable treatment options to patients with HER2-positive breast cancer. Mylan remains deeply committed to serving the community through the introduction of biosimilars and other critical products to meet the unmet needs of patients in the Developing Markets."

Beximco Pharma is a leading exporter of pharmaceuticals in Bangladesh. The Company currently has a global footprint in more than 50 countries and has been accredited by the leading global regulatory authorities including U.S. FDA, Malta Medicines Authority (EU), TGA (Australia), Health Canada, GCC (Gulf) and TFDA (Taiwan).

[1] Cancer Registry Report National Institute of Cancer Reasearch and Hospital 2005-2007

Bangladesh Bureau of Statistics, Minsistry of Planning, Government of Bangladesh Statistical Yearbook of Bangladesh 2008

Mayoclinic.org/ Breast-cancer

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

Beximco Pharma

Nazmul Hassan MP, Managing Director

Tel: +880 2 58611001, ext.20080

Md. Asad Ullah, FCS, Executive Director & Company Secretary

Tel; +880 2 58611891, +880 2 58612040, Ext 10140

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 4,200 employees are driving the company towards achieving its aspiration to be among the most admired companies in the world.