Headcount: 35,000
Revenues: $11,501 (+1%)
Net Income: $17 (-95%)
R&D: $518 (-27%)

TOP SELLING DRUGS

Headcount: 35,000
Revenues: $11,434 (-4%)
Net Income: $353 (-49%)
R&D: $705 (-10%)

TOP SELLING DRUGS   

It was a challenging year for Mylan, plagued with valsartan recalls, remediation efforts, and ongoing drug shortages for EpiPen. Financially, the first quarter revealed the company’s tribulations are far from over, with revenues down 7% to $2.5 billion and a loss of $25 million, as compared to earnings of $87.1 million in 1Q18. North America sales were down 6% and sales in Europe were down 14% primarily driven by a competitive environment and the impact of the $58.8 million Morgantown plant remediation activities, partially offset by new product sales, including Wixela Inhuband Fulphila (biosimilar to Neulasta), and increased market share on Glatiramer Acetate Injection.

On November 20, Mylan initiated a voluntarily recall of certain valsartan-containing products due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA), (classified as a probable human carcinogen) contained in the API Valsartan, manufactured by Mylan Laboratories. Valsartan is used for the treatment of high blood pressure, heart failure, and to reduce cardiovascular mortality following a heart attack.

In December, the recall was expanded to include another 104 lots, including Amlodipine and Valsartan Tablets, Valsartan Tablets and Valsartan and Hydrochlorothiazide Tablets.

Additionally, Mylan’s manufacturing license for valsartan was suspended by European authorities after NDEA was found in some batches of the hypertension drug made at the company’s facility in Hyderabad, India.

Also in November, the company received a warning letter from the FDA relating to its manufacturing facility in Morgantown, West Virginia, citing problems with cleaning and quality control systems. As part of the ongoing restructuring and remediation activities, Mylan discontinued a number of products from the site while transferring some products to other sites. That being said, Mylan does not expect to have any significant new product launches from the site in 2019.

To top that off, May 10th 2019 marked one year of the EpiPen shortage, which is expected to drag on. According to a statement last August, Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, continued to experience interruptions in the production of EpiPen (epinephrine injection, USP) and EpiPen Jr. At that time, over the past few months, there was intermittent supply as the company explored several options with Pfizer to help stabilize supply. Sterile injectables require a highly complex and technical manufacturing and assembly process and despite the company’s best efforts, further supply shortages were anticipated. In June, Pfizer and Mylan announced that they are working with the FDA to extend the expiration dates by four months on all lots of EpiPen, with the exception of EpiPen Jr., in an effort to help alleviate shortages.

In more recent bad news, in May, 44 states filed a lawsuit alleging pharmaceutical companies colluded to fix the prices on their generic drugs, in which Mylan is a defendant. According to a UBS estimate, Mylan faces litigation charges of $1.1 billion.

On the bright side, Mylan and Fujifilm Kyowa Kirin Biologics Co. were granted marketing authorization from the EU for Hulio, a biosimilar to AbbVie’s Humira, for all indications. Mylan plans to launch Hulio across various markets in Europe on or after October 16. Humira is the world’s top-selling drug with nearly $20 billion in sales in 2018.

Headcount:  35,000
Revenues: $11,908 (+8%)
Net Income: $696 (+45%)
R&D: $783 (-5%)

It was prosperous 2017 for Mylan in the way of drug approvals. The FDA approved Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, a substitutable generic version of Teva’s Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both are indicated for the treatment of patients with relapsing forms of multiple sclerosis. In another approval, both the FDA and Brazil’s ANVISA green-lighted Mylan’s Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. Mylan and Biocon received another approval from their collaboration, with the FDA also approving Fulphila (pegfilgrastim-jmdb), a biosimilar to Neulasta (pegfilgrastim).  Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells, in patients treated with chemotherapy in certain types of cancer.

Mylan collaborated with numerous companies over the course of the year. A license agreement with Otsuka Pharmaceutical was initiated to commercialize delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries. Delamanid was discovered, developed, and is currently marketed by Otsuka under the brand name Deltyba. Under the terms of the agreement, Mylan has been granted an exclusive license by Otsuka to prioritize access to Deltyba in South Africa and India. In a collaboration with Theravance Biopharma a New Drug Application for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA), was approved by the FDA. It is currently pending. If approved, revefenacin would be the first once-daily, nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). Additionally, in a major partnership with Fujifilm Kyowa Kirin Biologics, the companies are working together to commercialize a biosimilar to Humira (adalimumab). Through the agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe. Humira is a TNF-inhibitor1 aimed at treating multiple chronic inflammatory conditions. The product is indicated in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

Mylan had numerous drug launches during the year, including Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis’s Gleevec Tablets, and Caspofungin Acetate for Injection, one of the first generic versions of Merck’s Cancidas. Also launched was Bivalirudin for Injection, 250 mg single-dose vial, a generic version of Angiomax from The Medicines Company. That product is a direct thrombin inhibitor indicated for use as an anticoagulant in patients.

Within acquisitions, Mylan acquired the global marking rights to GA Depot, a once monthly Glatiramer Acetate Product, through a partnership with Mapi Pharma. GA Depot is a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis, or RRMS. Recently there were reports that Mylan was in advanced talks to acquire Merck KGaA’s consumer health products business, but that report was immediately denied by Mylan.

Headcount: 35,000
Revenues: $11,077 (+18%)
Specialty Segment: $5,630 (+10%)
Net Income: $480 (-43%)
R&D: $827 (+23%)

During 2016 the generic giant Mylan made two major acquisitions. First it boosted its over-the-counter (OTC) portfolio when it paid nearly $10 billion for Swedish drug maker Meda, adding a range of branded and generic pharmaceuticals. Meda’s key products include the allergy therapy Dymista (azelastine/fluticasone) and Elidel (pimecrolimus) for dermatitis and eczema. The deal reduces Mylan’s reliance on generic drugs with the addition of specialty brands that are less prone to pricing pressure and competition.

In another deal worth $1 billion, Mylan bought the non-sterile, topicals-focused specialty and generics business of Renaissance Acquisition Holdings, which nets Mylan a complementary portfolio of approximately 25 branded and generic topical products, a pipeline of approximately 25 products, and an established U.S. sales and marketing infrastructure targeting dermatologists. The business also brings Mylan an integrated manufacturing and development platform and a topicals-focused contract development and manufacturing organization.

The dermatology/topicals space has long been an area of focus for Mylan and one that it has targeted for expansion. Renaissance had approximately $370 million in 2015 revenues and has approximately 1,200 employees. The business’s commercial segment has a diversified portfolio of specialty brands and generic products in the dermatology space, as well as a pipeline of complex topical generics and brands in active development. Also, the acquisition includes two manufacturing sites with capabilities and capacity in creams, ointments, aerosols/foams, gels, suspensions, liquids and suppositories.

Mylan was also active on the biosimilar front during the year. In a deal worth up to $250 million, it entered into an exclusive global collaboration agreement with Momenta Pharmaceuticals to develop and commercialize six of Momenta’s biosimilar candidates, including abatacept—Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia. The companies are jointly responsible for product development, and Mylan will lead worldwide commercialization. The collaboration builds on Mylan’s existing biologics and insulin analog partnership with Biocon, which includes six biosimilar programs (trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim) and three insulin analogs (glargine, lispro and aspart). Five of these biosimilar programs have successfully completed Phase I trials, and four are in Phase III development. Mylan and Biocon submitted three biosimilar applications and one insulin application in the U.S. and EU in 2016.

On the new product front, Mylan made several generic advances during the year. Following FDA approval it launched Azacitidine injection, a generic of Celgene’s (CELG) Vidaza injection. It also launched Propafenone Hydrochloride extended-release capsules, the generic of GlaxoSmithKline’s Rythmol capsules. The company then launched Hydralazine Hydrochloride injections, a generic version of Novartis’s Apresoline injection.

Mylan currently has over 250 abbreviated new drug applications (or ANDAs) pending FDA approval. A few other recent launches include: Clindamycin Palmitate Hydrochloride, a generic version of Cleocin solution; Doxycycline Hyclate delayed-release tablets, a generic version of Doxteric; Armodafinil tablets, a generic version of Nuvigil; and Frovatriptan Succinate tablets, a generic version of Frova tablets. The FDA has also accepted its ANDA for Fluticasone propionate and Salmeterol, a generic version of GlaxoSmithKline’s Advair Diskus, with a GDUFA date of March 28, 2017.

Headcount: 35,000
Revenues: $9,363 (+22%)
Specialty Segment: $1,205 (+2%)
Net Income: $848 (-9%)
R&D: $672 (+15%)

Dey, Mylan’s specialty business, focuses on respiratory, allergy and psychiatric therapies. Its flagship product is EpiPen Auto-Injector, which treats anaphylaxis; the product is the No. 1 prescribed auto-injector with over 90% market share in the U.S. and worldwide.

DRUGS PENDING

After a failed bid for Perrigo, Mylan moved forward with a $9.9 billion deal to merge with Swedish pharma company Meda, boosting its range of branded and generic pharmaceuticals. The deal also gives Mylan a better position in the market for over-the-counter (OTC) medicines. After the deal goes through, the Mylan/Meda OTC business will have sales of around $1 billion per year.

OTC medicines have become an attractive area of the pharma industry as their growth has outstripped the prescription drug sector, mainly driven by emerging markets. Meda’s key products including allergy therapy Dymista (azelastine/fluticasone) and Elidel (pimecrolimus) for dermatitis and eczema are set to benefit from Mylan’s greater international scale. The deal reduces Mylan’s reliance on generic drugs with the addition of specialty brands that are less prone to pricing pressure and competition.

During the year, the company, through its Indian subsidiary Mylan Laboratories, acquired certain female health care businesses, including Jai Pharma, from Famy Care, a specialty women’s health care company with global leadership in generic oral contraceptive products (OCPs) for $800 million.

The acquisition builds on Mylan’s existing partnerships with Famy Care in North America, Europe and Australia, and provides Mylan with an enhanced and now vertically integrated platform that will accelerate the company’s growth in the global women’s health care space. This transaction especially complements Mylan’s acquisition of Abbott’s non-U.S. developed markets specialty and branded generics business, which also includes women’s health care portfolio and sales and marketing capabilities. Additionally, the acquisition of the Famy Care businesses will make Mylan a hormonal contraceptives leader in high-growth emerging markets around the world.

In another deal announced in 2015, Renaissance Acquisition Holdings, a portfolio company of private equity firm RoundTable Healthcare Partners, sold its topical pharmaceutical business to Mylan for $1 billion. The topical division is a specialty pharmaceutical business focused on the manufacture, development, sales and marketing of branded and generic topical pharmaceutical products. RoundTable started Renaissance in 2010 when it acquired two contract manufacturing and development organizations, Confab Laboratories and DPT Laboratories. Renaissance, through significant investments in senior leadership, product acquisitions, R&D, capital expenditures, and the development of a pipeline of more than two dozen topical ANDAs and NDAs, has developed into one of the largest, privately-held, specialty pharmaceutical companies in the topicals/dermatology market in North America.

At the beginning of 2016, Mylan entered into an exclusive global collaboration agreement with Momenta Pharmaceuticals to develop, manufacture and commercialize six of Momenta’s biosimilar candidates, including abatacept (Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia), which had $1.9 billion in sales in 2015.

Momenta received $45 million up front and as much as $200 million in milestone-related payments, with each company sharing the costs and profits for the products. The companies will be jointly responsible for product development, and Mylan will lead worldwide commercialization.

This collaboration builds upon Mylan’s existing biologics and insulin analog partnership with Biocon, which includes six biosimilar programs (trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim) and three insulin analogs (glargine, lispro and aspart). Five of these biosimilar programs have successfully completed Phase I trials, and four are in Phase III development. Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016.

Also on the biosimilar front, during the year Mylan launched the first biosimilar to GlaxoSmithKline’s Seretide Evohaler (salmeterol xinafoate/fluticasone propionate) under the name Sirdupla in the UK. Sirdupla is a pressurized metered-dose inhaler (pMDI) indicated to treat symptoms of asthma. 3M Drug Delivery Systems will manufacture the product, which is available in 125/25 mcg and 250/25 mcg with 120 doses.

In another development and commercialization deal, Mylan and Theravance Biopharma partnered on TD-4208, a novel investigational once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases. TD-4208 has shown positive results in COPD in multiple Phase II studies, and the design of the Phase III registrational program for 2016.

Headcount: 30,000
Revenues: $7,720 (+12%)
Specialty Segment: $1,187 (+21%)
Net Income: $933 (+49%)
R&D: $582 (+15%)

A few months ago Teva made an offer to acquire Mylan for $40 billion. The combination would create an industry giant in the global generics space, but Mylan’s board shot down the offer pretty quickly. However, Teva is still in hot pursuit, looking possibly for a hostile takeover. Just a month ago the Israeli drugmaker upped its Mylan stake to 4.61% and said it legally had the right to initiate proceedings before the Dutch Enterprise Chamber. At the same time Mylan is trying to takeover Perrigo. If that deal goes through, it could put a halt to Teva’s advances. Aside from the M&A talk, Mylan has been actively expanding. For one, it partnered with Theravance Biopharma for the development and commercialization of TD-4208, a novel investigational once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases. TD-4208 has shown positive results in COPD in multiple Phase II studies, and the design of the Phase III registrational program is underway and anticipated to begin this year. Theravance will lead the U.S. development program and Mylan will be responsible for costs up until approval of the first new drug application, after which costs will be shared. Mylan will be responsible for commercial manufacturing and will lead commercialization in the U.S. Theravance will retain the right to co-promote the product under a profit-sharing arrangement. Outside the U.S. (excluding China), Mylan will be responsible for development and commercialization and will pay royalties.

Mylan’s India-based subsidiary, Mylan Pharmaceuticals Ltd., has been named an exclusive business partner for Gilead’s branded medicines in India. Mylan will market and distribute Gilead’s HIV therapies Viread, including its indication for chronic hepatitis B virus (HBV) infection, Truvada, and Stribild, as well as AmBisome, a treatment for life-threatening, systemic fungal infections, and visceral leishmaniasis, a parasitic disease. Mylan will also manage regulatory and pharmacovigilance activity.

In 2006 Gilead granted Mylan rights to manufacture and sell generic versions of its HIV therapies in India and as many as 111 developing countries where HIV is endemic. Mylan will continue to maintain these rights, in addition to those in the new agreement.

Most recently, Mylan launched the first biosimilar to GlaxoSmithKline’s Seretide Evohaler (salmeterol xinafoate/fluticasone propionate) under the name Sirdupla in the UK to treat asthma symptoms. 3M Drug Delivery Systems will manufacture the product, which is available in 125/25 mcg and 250/25 mcg with 120 doses.

Headcount:20,000
Pharma Revenues:$6,909
Net Income: $624 (-3%)
R&D Budget: $507 (26%)

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.

Headcount: 20,000
Pharma Revenues: $6,750 (11%)
Total Revenues: $6,796 (11%)
Net Income: $641 (19%)
R&D Budget: $401 (36%)

Top Selling Drugs

Account for 88% of total pharma sales, up from 85% in 2011

Headcount: 13,000

Pharma Revenues: $5,404  (8%)

Total Revenues: $5,451 (7%)

Net Income: $224 (138%)

R&D Budget: $282 (3%)

Top-Selling Drugs in 2010

Account for 81% of total pharma sales, same as in 2009.

Previous Profile: Gilead Sciences

Headcount: 11,415
Pharma Revenues: $8,441 (+11%/+3%)
Total Revenues: $8,658 (+11%/+3%)
Net Income: $435 (-9%/-15%)
R&D Budget: $1,931+ (24%/+15%)

Revenues converted at average exchange rate / based on reported currency (JPY)

Account for 60% of total pharma sales, down from 61% in 2008.

#18 – Otsuka Pharmaceutical

2-9 Kanda-Tsukasamachi, Chiyoda-ku
Tokyo 101-0048 Japan
Tel: (81) (0)3-6717-1410
www.otsuka.com

Revenues converted at average exchange rate / based on reported currency (JPY)

Otsuka did not provide sales breakdowns for its pharmaceutical products for FY2009.

#19 – Gilead Sciences

333 Lakeside Dr.
Foster City, CA 94404
Tel: (650) 574-3000
Fax: (650) 578-9264
www.gilead.com

Account for 94% of total pharma sales, down from 97% in 2008.

#20 – Mylan Inc.

1500 Corporate Dr., Ste. 400
Canonsburg, PA 15317
Tel: (724) 514-1800
www.mylan.com

Account for 76% of total pharma sales, up from 74% in 2008.

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