07.21.14
Headquarters: Canonsburg, PA
twitter.com/MylanNews
www.mylan.com
DRUGS APPROVED
Mylan Laboratories is the world’s third largest generic drug manufacturer, with a focus on respiratory and allergy therapies. Its business is made up of generic, branded generic and specialty pharma products. The company sells more than 1,300 products in 140 countries.
Mylan Labs is vertically integrated, with over 35 manufacturing facilities globally and one of the world’s largest active pharmaceutical ingredient (API) operations.
The company grew significantly, when it bought Agila, a producer of generic injectables) from Strides Arcolab Ltd. for $1.4 billion.
Mylan had previously acquired Matrix Laboratories, Merck KgA’s generics, Bioniche, and Pfizer’s respiratory drug delivery platform. APIs are produced by Mylan Labs in India.
Mylan divides its business into specialties and generics. Mylan’s acquisition of Agila doubled Mylan’s injectables portfolio to 120 products and increased capacity from 350 million to 650 illion units (which is where it is expected to be by 2016).
The Indian company had received a Warning Letter from FDA for a number of manufacturing deficiencies and violations of current good manufacturing practices (cGMPs), including the re-use of gloves that are supposed to be sterile. The company is said to have responded and taken action. In 2012, Mylan started commercial operations in India. By December 2013, the company had submitted 324 ANDAs to the FDA.
Collaborating with Pfizer Japan
In 2013, Mylan established a long-term collaboration with Pfizer Japan to make and sell generics in Japan. Mylan handles the R&D, manufacturing and operations management, while Pfizer does the commercializing, sales and marketing. Mylan has established an agreement with Biocon of India to collaborate on generic insulin analogs.
Currently AstraZeneca is suing Mylan for patent infringement, for Type 2 diabetes drugs, while Novartis is suing the company for infringing patents on its Exelon patch, used to treat patients with Alzheimer’s disease.
Teva has filed citizens petition against Mylan and other companies to help delay the introduction of generic versions of its MS therapy, Copaxone. Recently, Roche filed a lawsuit in India, suing Mylan and Biocon over biosimilars of its herceptin.
The company currently has 303 ANDAs pending approvals, 41 of them potential first to file applications. It has developed the first generic version of Celebrex and the generic of Warner Chilcott’s Actonel tablets.
Emphasis on Compliance
As a footnote, Mylan played an interesting role in the history of generic drugs, in particular, the “generic drugs scandal” of the 1980s. Company managers hired a private investigator to spy on FDA, because of the length of time that approvals were taking. Investigations found that one inspector had been bribed. This news opened a major Congressional investigation into generic drug companies and how they are operated and regulated.
In addition, in 2000, the FTC charged that Mylan and other generic pharmaceutical companies had conspired to deny raw material supplies to their competitors, causing prices for the drug and its raw materials to increase by several thousand percent.
The company appears to be serious about compliance, and, last year, recruited Deb Autor, who had headed up FDA’s compliance office, as SVP, Strategic Global Quality & Regulatory Policy.
Mylan’s CEO, Heather Bresch, who had testified to Congress in the past on name-brand drugmaker’s tactics for delaying generic drug introduction, petitioned for passage of the FDA’s GDUFA (generic drug user fee act), but argued that more funds and oversight needed to be focused on facilities overseas.
twitter.com/MylanNews
www.mylan.com
Headcount: | 20,000 | |
Year Established: | 1970 | |
Pharma Revenues: | $6,909 | 1% |
Net Income: | $624 | -3% |
R&D Budget: | $507 | 26% |
DRUGS APPROVED
Drug | Indication |
Carboplatin | cancer |
Risedronate sodium | osteoporosis |
Celecoxib (50 mg) | anti-inflammatory |
Mylan Laboratories is the world’s third largest generic drug manufacturer, with a focus on respiratory and allergy therapies. Its business is made up of generic, branded generic and specialty pharma products. The company sells more than 1,300 products in 140 countries.
Mylan Labs is vertically integrated, with over 35 manufacturing facilities globally and one of the world’s largest active pharmaceutical ingredient (API) operations.
The company grew significantly, when it bought Agila, a producer of generic injectables) from Strides Arcolab Ltd. for $1.4 billion.
Mylan had previously acquired Matrix Laboratories, Merck KgA’s generics, Bioniche, and Pfizer’s respiratory drug delivery platform. APIs are produced by Mylan Labs in India.
Mylan divides its business into specialties and generics. Mylan’s acquisition of Agila doubled Mylan’s injectables portfolio to 120 products and increased capacity from 350 million to 650 illion units (which is where it is expected to be by 2016).
The Indian company had received a Warning Letter from FDA for a number of manufacturing deficiencies and violations of current good manufacturing practices (cGMPs), including the re-use of gloves that are supposed to be sterile. The company is said to have responded and taken action. In 2012, Mylan started commercial operations in India. By December 2013, the company had submitted 324 ANDAs to the FDA.
Collaborating with Pfizer Japan
In 2013, Mylan established a long-term collaboration with Pfizer Japan to make and sell generics in Japan. Mylan handles the R&D, manufacturing and operations management, while Pfizer does the commercializing, sales and marketing. Mylan has established an agreement with Biocon of India to collaborate on generic insulin analogs.
Currently AstraZeneca is suing Mylan for patent infringement, for Type 2 diabetes drugs, while Novartis is suing the company for infringing patents on its Exelon patch, used to treat patients with Alzheimer’s disease.
Teva has filed citizens petition against Mylan and other companies to help delay the introduction of generic versions of its MS therapy, Copaxone. Recently, Roche filed a lawsuit in India, suing Mylan and Biocon over biosimilars of its herceptin.
The company currently has 303 ANDAs pending approvals, 41 of them potential first to file applications. It has developed the first generic version of Celebrex and the generic of Warner Chilcott’s Actonel tablets.
Emphasis on Compliance
As a footnote, Mylan played an interesting role in the history of generic drugs, in particular, the “generic drugs scandal” of the 1980s. Company managers hired a private investigator to spy on FDA, because of the length of time that approvals were taking. Investigations found that one inspector had been bribed. This news opened a major Congressional investigation into generic drug companies and how they are operated and regulated.
In addition, in 2000, the FTC charged that Mylan and other generic pharmaceutical companies had conspired to deny raw material supplies to their competitors, causing prices for the drug and its raw materials to increase by several thousand percent.
The company appears to be serious about compliance, and, last year, recruited Deb Autor, who had headed up FDA’s compliance office, as SVP, Strategic Global Quality & Regulatory Policy.
Mylan’s CEO, Heather Bresch, who had testified to Congress in the past on name-brand drugmaker’s tactics for delaying generic drug introduction, petitioned for passage of the FDA’s GDUFA (generic drug user fee act), but argued that more funds and oversight needed to be focused on facilities overseas.