Dr. Reddy's Laboratories

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Dr. Reddy's Laboratories Ltd.
Type Public
Traded as NSEDRREDDY
BSE500124
NYSERDY
Industry Pharmaceuticals
Founded 1984
Headquarters Hyderabad, Telangana, India
Key people

Anji Reddy (Founder)

G. V. Prasad (CEO)
Kallam Satish Reddy (Chairman)
Revenue Increase $2.1 billion (2012)
Net income Increase $300 million (2012)
Employees 16,300 (December 2012)
Website www.drreddys.com

Dr. Reddy's Laboratories Ltd, is a pharmaceutical company based in Hyderabad, Telangana, India. The company was founded by Anji Reddy, who had previously worked in the mentor institute, Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India.[1] Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.

Dr. Reddy's began as a supplier to Indian drug manufacturers, but it soon started exporting to other less-regulated markets that had the advantage of not having to spend time and money on a manufacturing plant that would gain approval from a drug licensing body such as the U.S. Food and Drug Administration (FDA). By the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants in more-developed economies. This allowed their movement into regulated markets such as the US and Europe.

By 2007, Dr. Reddy's had six FDA plants producing active pharmaceutical ingredients in India and seven FDA-inspected and ISO 9001 (quality) and ISO 14001 (environmental management) certified plants making patient-ready medications – five of them in India and two in the UK.[2]

In 2010, the family-controlled Dr Reddy's denied[3] that it was in talks to sell its generics business in India to US pharmaceutical giant Pfizer,[4] which had been suing the company for alleged patent infringement after Dr Reddy's announced that it intended to produce a generic version of atorvastatin, marketed by Pfizer as Lipitor, an anti-cholesterol medication.[5][6] Reddy's was already linked to UK pharmaceuticals multinational Glaxo Smithkline.[7]

Company history[edit]

Dr. Reddy's originally launched in 1984 producing active pharmaceutical ingredients. In 1986, Reddy's started operations on branded formulations. Within a year Reddy's had launched Norilet, the company's first recognized brand in India. Soon, Dr. Reddy's obtained another success with Omez, its branded omeprazole – ulcer and reflux oesophagitis medication – launched at half the price of other brands on the Indian market at that time.

Within a year, Reddy's became the first Indian company to export the active ingredients for pharmaceuticals to Europe. In 1987, Reddy's started to transform itself from a supplier of pharmaceutical ingredients to other manufacturers into a manufacturer of pharmaceutical products.

International expansion[edit]

The company's first international move took it to Russia in 1992. There, Dr. Reddy's formed a joint venture with the country's biggest pharmaceuticals producer, Biomed. They pulled out in 1995 amid accusations of scandal, involving "a significant material loss due to the activities of Moscow's branch of Reddy's Labs with the help of Biomed's chief executive".[8] Reddy's sold the joint venture to the Kremlin-friendly Sistema group. In 1993, Reddy's entered into a joint venture in the Middle East and created two formulation units there and in Russia. Reddy's exported bulk drugs to these formulation units, which then converted them into finished products. In 1994, Reddy's started targeting the US generic market by building state of art manufacturing facility.[citation needed]

New drug discovery[edit]

Reddy's path into new drug discovery involved targeting speciality generics products in western markets to create a foundation for drug discovery. Development of speciality generics was an important step for the company's growing interest in the development of new chemical entities. The elements involved in creating a speciality generic, such as innovation in the laboratory, developing the compound, and sending the sales team to the market, are also stages in the development of a new specialty drug. Starting with speciality generics allowed the company to gain experience with those steps before moving on to creating brand-new drugs.

Reddy's also invested heavily in establishing R&D labs and is the only Indian company to have significant R&D being undertaken overseas. Dr. Reddy's Research Foundation was established in 1992 and in order to do research in the area of new drug discovery. At first, the foundation's drug research strategy revolved around searching for analogues. Focus has since changed to innovative R&D, hiring new scientists, especially Indian students studying abroad on doctoral and post-doctoral courses. In 2000, the Foundation set up an American laboratory in Atlanta, dedicated to discovery and design of novel therapeutics. The laboratory is called Reddy US Therapeutics Inc (RUSTI) and its main aim is the discovery of next-generation drugs using genomics and proteomics. Reddy's research thrust focused on large niche areas in western markets – anti-cancer, anti-diabetes, cardiovascular and anti-infection drugs.[citation needed]

Reddy's international marketing successes were built on a strong manufacturing base which itself was a result of inorganic growth through acquisition of international and national facilities. Reddy's merged Cheminor Drug Limited (CDL) with the primary aim of supplying active pharmaceutical ingredients to the technically demanding markets of North America and Europe. This merger also gave Reddy's an entry into the value-added generics business in the regulated markets of APIs.

Expansion and acquisition[edit]

By 1997, Reddy's was ready for the next major step. From being an API and bulk drug supplier to regulated markets like the USA and the UK, and a branded formulations supplier in unregulated markets like India and Russia, Reddy's made the transition into generics by filing an Abbreviated New Drug Application (ANDA) in the USA. The same year, Reddy's out-licensed a molecule for clinical trials to Novo Nordisk, a Danish pharmaceutical company.

It strengthened its Indian manufacturing operations by acquiring American Remedies Ltd. in 1999. This acquisition made Reddy’s the third largest pharmaceutical company in India, after Ranbaxy and Glaxo (I) Ltd., with a full spectrum of pharmaceutical products, which included bulk drugs, intermediates, finished dosages, chemical synthesis, diagnostics and biotechnology.[citation needed]

Reddy’s started exploiting Para 4 filing as a strategy in bringing new drugs to the market at a faster pace. In 1999 it submitted a Para 4 application for Omeprazole, the drug that had been the cornerstone of its success in India. In December 2000, Reddy’s had undertaken its first commercial launch of a generic product in the USA., and its first product with market exclusivity was launched there in August 2001. The same year, it also became the first non-Japanese pharmaceutical company from the Asia-Pacific region to obtain a New York Stock Exchange listing, ground-breaking achievements for the Indian pharmaceutical industry.[citation needed]

In 2001 Reddy’s became the first Indian company to launch the generic drug, fluoxetine (a generic version of Eli Lilly and Company’s Prozac) with 180-day market exclusivity in the USA. Prozac had sales in excess of $1 billion per year in the late 1990s. Barr Laboratories of the U.S. obtained exclusivity for all of the approved dosage forms (10 mg, 20 mg) except one (40 mg), which was obtained by Reddy’s. Lilly had numerous other patents surrounding the drug compound and had already enjoyed a long period of patent protection. The case to allow genertic sales was heard twice by the Federal Circuit Court, and Reddy’s won both hearings. Reddy’s generated nearly $70 million in revenue during the initial six-month exclusivity period. With such high returns at stake, Reddy’s was gambling on the success of the litigation; failure to win the case could have cost them millions of dollars, depending on the length of the trial.

The fluoxetine marketing success was followed by the American launch of Reddy's house-branded ibuprofen tablets in 400, 600 and 800 mg strengths, in January 2003. Direct marketing under the Reddy’s brand name represented a significant step in the company’s efforts to build a strong and sustainable US generic business. It was the first step in building Reddy’s fully-fledged distribution network in the US market.[citation needed]

American IPO and expansion into Europe[edit]

In 2001 Reddy’s completed its US initial public offering of $132.8 million, secured by American Depositary Receipts. At that time the company also became listed on the New York Stock Exchange. Funds raised from the initial public offering helped Reddy’s move into international production and take over technology-based companies.

In 2002, Reddy’s started its European operations by acquiring two pharmaceutical firms in the United Kingdom. The acquisition of BMS Laboratories and its wholly owned subsidiary, Meridian UK, allowed Reddy’s to expand geographically into the European market. In 2003 Reddy’s also invested $5.25 million (USD) in equity capital into Bio Sciences Ltd.

Auriegene Discovery Technologies, a contract research company, was established as a fully owned subsidiary of Reddy’s in 2002. Auriegene's objective was to gain experience in drug discovery through contract research for other pharmaceutical companies. Reddy’s entered into a venture investment agreement with ICICI Bank, an established Indian banking company. Under the terms of the agreement, ICICI Venture agreed to fund the development, registration and legal costs related to the commercialization of ANDAs on a pre-determined basis. Upon commercialization of these products, Dr. Reddy's pays ICICI Venture royalty on net sales for a period of 5 years.

Global expansion[edit]

The company elected to expand globally, and acquired other entities. In March 2002, Dr. Reddy’s acquired BMS Laboratories, Beverley, and its wholly owned subsidiary Meridian Healthcare, for 14.81 million Euros. These companies deal in oral solids, liquids and packaging, with manufacturing facilities in London and Beverley in the UK. Recently, Dr. Reddy’s entered into an R&D and commercialization agreement with Argenta Discovery Ltd., a private drug development company based in the UK, for the treatment of chronic obstructive pulmonary disease (COPD).

Dr. Reddy’s entered into a 10-year agreement with Rheoscience A/S of Denmark for the joint development and commercialization of Balaglitazone (DRF-2593), a molecule for the treatment of type-2 diabetes. Rheoscience holds this product’s marketing rights for the European Union and China, while the rights for the US and the rest of the world will be held by Dr. Reddy’s. Dr. Reddy’s conducted clinical trials of its cardiovascular drug RUS 3108 in Belfast, Northern Ireland, in 2005. The trials were conducted to study the safety and the pharmacokinetic profiles of the drug, which is intended for the treatment of atherosclerosis, a major cause of cardiovascular disorders.

Dr. Reddy’s entered into a marketing agreement with Eurodrug Laboratories, a pharmaceutical company based in Netherlands, for improving its product portfolio for respiratory diseases. It introduced a second-generation xanthine bronchodilator, Doxofylline, which is used for the treatment of asthma and COPD patients.

In 2004, Reddy’s acquired Trigenesis Therapeutics Inc; a US-based private dermatology company. This acquisition gave Reddy’s access to proprietary products and technologies in the dermatology sector.

Dr. Reddy’s Para 4 application strategy for generic business received a severe setback when Reddy’s lost the patent challenge in the case of Pfizer’s drug Norvasc (amlodipine maleate), a drug indicated for the treatment of hypertension and angina. The cost involved in patent litigation as well as the unexpected loss of the patent challenge affected Reddy’s plans to start speciality business in the US generic markets.

In March 2006, Dr. Reddy’s acquired Betapharm Arzneimittel GmbH from 3i for 480 million Euros. This is one of the largest-ever foreign acquisitions by an Indian pharmaceutical company. Betapharm is Germany’s fourth-largest generics pharmaceutical company, with a 3.5% market share, including 150 active pharmaceutical ingredients.

Reddy’s has promoted India’s first integrated drug development company Perlecan Pharma Pvt Ltd together with ICICI ventures capital fund management company Ltd and Citigroup Venture Capital International growth partnership Mauritius Ltd. The combined entity will undertake clinical development and out-licensing of new chemical entity assets.

Dr. Reddy's is presently licensed by Merck & Co. to sell an authorized generic version of the popular drug simvastatin (Zocor) in the USA. Since Dr. Reddy's has a license from Merck, it was not subject to the exclusivity period on generic simvastatin.[9]

As of 2006, Dr. Reddy’s Laboratories exceeded $500 million USD in revenues, flowing from their APIs, branded formulations and generics segments; the former two segments account for almost 75% of revenues. Dr. Reddy's deals in and manages all the processes, from the development of the API to the submission of finished dosage dossiers to the regulatory agencies.

Issues and recalls[edit]

Drug discovery problems[edit]

In September 2005, Dr. Reddy's spun off its drug discovery and research wing into a separate company called Perlecan Pharma Private Limited. At the time, this was hailed as an innovative move, but in 2008, the company it had to be wound down due to funding constraints.[10] Dr. Reddy's was the first Indian pharma company to attempt such an effort to de-couple risk of drug discovery from the parent company by creating a separate company with external source of funding. Perlecan Pharma was partially funded by ICICI Venture Capital and Citigroup Venture International, both of which held a 43% stake in Perlecan for an estimated $22.5 million. However, the company was forced to buy back the Perlecan shares from ICICI and Citigroup due to doubts regarding the commercial viability of the drug candidates that were in Perlecan's pipeline. At that point, Perlecan became a wholly owned subsidiary. In the board meeting of 23 October 2008, the company chose to amalgamate/absorb Perlecan, thereby making it an in-house research facility, as it was before 2005.[10]

In 2009, the company did a U-turn and has handed over discovery research and related intellectual property to its Bangalore-based subsidiary, with the possibility of spinning it off as a different entity altogether. "The company may be hoping to find a strategic partner in the future to share the risks and research funding."[11]

2011 recall[edit]

In June 2011, certain lots of Dr. Reddy's generic simvastatin tablets were recalled due to tablets having a "musty" or "moldy" smell.[12]

On June 24, 2014, the New York Times published an article "Warning Unheeded, Heart Drugs Are Recalled" in which it said another large Indian manufacturer and "Dr. Reddy's Laboratories, have announced recalls over the past two months totaling more than 100,000 bottles" of "a widely used heart drug, Toprol XL" "because their products were not dissolving properly".

Key people[edit]

As of 31 March 2014 board members and senior executives included.

  • Mr. Satish Reddy - Chairman
  • Mr. GV Prasad - Co-Chairman & CEO
  • Mr. Ravi Bhoothalingam - Independent Director
  • Mr. Anupam Puri - Independent Director
  • Dr. Omkar Goswami - Independent Director
  • Dr. J.P. Moreau - Independent Director
  • Ms. Kalpana Morparia - Independent Director
  • Dr. Bruce LA Carter - Independent Director
  • Dr. Ashok Ganguly - Independent Director
  • Mr. Sridar Iyengar - Independent Director

Key products[edit]

Top active pharmaceutical ingredients[edit]

Top ten brands in India[edit]

  • Omez
  • Nise
  • Stamlo
  • Stamlo Beta
  • Enam
  • Atocor
  • Razo
  • Reclimet
  • Clamp
  • Mintop

See also[edit]

References[edit]

External links[edit]