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February 11, 2016 6:39 PM ET

Pharmaceuticals

Company Overview of Mylan Laboratories Limited

Company Overview

Mylan Laboratories Limited engages in the manufacture and supply of active pharmaceutical ingredients (APIs) in India and internationally. It offers its products in various therapeutic categories, including anti-bacterials, central nervous system (CNS) agents, antihistamine/anti-asthmatics, cardiovascular, anti-virals, anti-diabetics, anti-fungals, proton pump inhibitors, and pain management drugs. The company also maintains a portfolio of finished dosage forms of generic antiretroviral products used for the treatment of HIV/AIDS, including pediatric therapies. In addition, Mylan Laboratories offers contract research and development services during early stages of development and contract ma...

Plot No. 564/A/22

Road No. 92

Jubilee Hills

Hyderabad,  500034

India

Founded in 2001

3,005 Employees

Phone:

91 40 3086 6666

Fax:

91 40 3086 6699

Key Executives for Mylan Laboratories Limited

Chief Executive Officer, Managing Director, Executive Director and Member of Audit Committee
Age: 51
Head of Finance and Senior Vice President
Age: 47
President of Mylan N.V.
Age: 54
Senior Vice President
Age: 50
Senior Vice President
Age: 52
Compensation as of Fiscal Year 2015.

Mylan Laboratories Limited Key Developments

Phosphagenics Limited Commences Legal Action against Mylan Laboratories Limited

Phosphagenics Limited announced that it has commenced legal action against Mylan Laboratories Limited by filing notices of arbitration at the Singapore International Arbitration Centre. Phosphagenics and Agila Specialties Private Limited (Agila) entered into a Master Research Agreement (in 2011) and a Licensing Agreement (in 2012) to develop and ultimately commercialise a formulation combining Phosphagenics’ proprietary TPM® technology with the injectable antibiotic daptomycin, which is indicated for the treatment of complicated skin and skin structure infections, and staphylococcus aureus bloodstream infections. In 2013 Mylan acquired Agila. A lead TPM®/Daptomycin formulation is in the final stages of development by Mylan and, based on a patent filed by Agila, is expected to have commercial advantages over the existing formulation of daptomycin. Daptomycin is currently marketed by Merck under the brand name Cubicin, and is expected to have generic competition in the United States in June 2016. The arbitration notices assert that Mylan is liable for breaches of several provisions under the two relevant agreements, fraudulent or negligent misrepresentations, breaches of confidence and/or unjust enrichment in relation to intellectual property and commercial licensing terms, amongst others. The dispute has been referred to arbitration in Singapore, in accordance with the relevant agreements. The substantive hearing is expected to take place in late 2016. Meanwhile, the Licensing Agreement continues in full force and effect pending the Arbitrator's decision. Phosphagenics has already planned for the legal costs associated with the arbitration proceedings in its 2016 budget. There is no assurance in respect of the outcome of the arbitration proceedings and Phosphagenics will, in accordance with its continuous disclosure obligations, notify the market of any material events as and when they occur.

Mylan Laboratories Limited Expands Hepatitis C Licensing Agreement with Gilead Sciences Inc. to Include Investigational Pan-Genotypic Agent

Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences Inc. to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir(Sovaldi®)/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that the company entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. The company also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.

Mylan to Supply ARV Medications to South African National Department of Health

Mylan Inc. revealed that its subsidiary in India, Mylan Laboratories Ltd. has been selected as a supplier of ARV medications to the South African National Department of Health. The supply agreement was made through Mylan's South African-based subsidiary Mylan (Proprietary) Limited and covers the tender period 1 April 2015 to 31 March 2018. Mylan will supply the South African Government with triple therapy fixed dose combination (FDC) treatments.

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