07.14.15
Headquarters: Petach Tivka, Israel
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www.tevapharm.com
TOP SELLING DRUGS
Teva Pharmaceutical Industries operates two business segments: generic and specialty medicines. It is the world’s largest generics producer, with a portfolio of more than 1,000 molecules producing a wide range of products in nearly every therapeutic area. These include chemical and therapeutic equivalents of originator medicines in a variety of dosage forms, including tablets, capsules, injectables, inhalants, liquids, ointments and creams.
In specialty medicines, Teva has a portfolio of treatments for disorders of the central nervous system (CNS), including pain, as well as a strong portfolio of respiratory products. These include several franchises, most significantly its core therapeutic areas of CNS medicines such as Copaxone, Azilect and Nuvigil and of respiratory medicines such as ProAir HFA and QVAR. The specialty medicines segment also includes other therapeutic areas, such as oncology, women’s health and several other areas.
Teva’s revenues in 2014 amounted to $20.3 billion, which fell flat against last year’s results due to the decline in sales of OTC as well as generic medicines, and offset by higher revenues of specialty medicines. Forty-eight percent of Teva’s revenue was generated from its generics business, including API’s sold to third parties, and amounted to $9.8 billion, a decline of $88 million, or 1%. During the year Teva received 22 final generic drug approvals.
Forty-two percent of revenues came from specialty medicines and amounted to $8.6 billion, an increase of 2%. Copaxone, the leading multiple sclerosis therapy in the U.S. and worldwide, led the charge with $4.2 billion in sales. Teva enhanced its MS franchise through the introduction of a three-times-a-week Copaxone 40 mg/mL product in the U.S., and will launch Copaxone 40 mg/mL in Europe and other countries in 2015.
Geographically, the U.S. market was responsible for 45% of generic sales, Europe 32% while the remaining 23% came from ROW markets, primarily Japan, Canada and Russia.
At the beginning of the year, Erez Vigodman was appointed president and chief executive officer of Teva. Mr. Vigodman, formerly chief executive of Makhteshim Agan Industries (MAI), a global generic agrochemical company, took over for Eyal Desheh, who returned to his position as group executive vice president and chief financial officer. During his tenure with MAI, Mr. Vigodman returned the company to profitability through operations improvements and investing in organic growth, and led the expansion of MAI into emerging markets across Asia and Latin America, and China.
Teva expanded its CNS portfolio with the acquisition of NuPathe Inc. for approximately $144 million. NuPathe shareholders may also receive additional payments if sales milestones are met for NuPathe’s migraine treatment, ZECUITY, the first prescription migraine patch approved by the FDA for the acute treatment of migraine in adults. ZECUITY is a disposable, single-use, iontophoretic transdermal patch that actively delivers sumatriptan, a widely prescribed migraine medication. Teva also gains access to NuPathe’s technology, including its transdermal delivery system.
Also during the year, Teva and Active Biotech decided to continue development of Nerventra (laquinimod) despite the opinion of the Committee for Medicinal Products for Human Use (CHMP), which recommended against approval for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the EU.
Both companies remain committed to the clinical development program for MS and will evaluate the CHMP feedback to determine potential next steps. To confirm the benefits of the drug on disability progression, Teva is conducting the Phase III CONCERTO trial, the largest MS trial with disability progression as the primary endpoint. Teva is also investigating the potential of Nerventra in progressive forms of MS.
Teva expanded its biotech assets in pain care franchise when it acquired Labrys Biologics, Inc., a privately-held biotechnology company focused on treatments for chronic and episodic migraine, for $200 million and as much as $625 million in potential milestones.
Labrys has a range of investigational, approved and marketed treatments for migraine, cancer pain and chronic pain. Labrys is developing LBR-101, a fully humanized monoclonal antibody in Phase IIb trials for prevention of chronic and episodic migraine.
During the year the company also sold its rights to Andromeda Biotech Ltd. for Andromeda’s drug DiaPep277 for the treatment of type 1 diabetes for $72 million.
Teva made several organizational changes in the middle of the year, aligning all operations under two commercial business units, Global Specialty Medicines (GSM) and the newly-formed Global Generic Medicines group (GGM). GGM will have full global responsibility for all existing generic markets, including portfolio management and selection, product launch, and commercial execution. GGM will also be responsible for Teva’s OTC business, led by its joint venture with The Procter and Gamble Co. Sigurdur Olafsson has been appointed president and chief executive officer of GGM and will be based in the U.S. The GSM group, led by Dr. Rob Koremans, is responsible for Teva’s global specialty medicines business.
twitter.com/tevapharm
www.tevapharm.com
Headcount: | 43,000 | |
Year Established: | 1901 | |
Revenues: | $20,272 | (flat) |
Specialty Pharma Revenues: | $8,560 | (+2%) |
Net Income: | $3,042 | (+143%) |
R&D: | $1,488 | (+4%) |
TOP SELLING DRUGS
Drug | Indication | 2014 Sales | (+/-%) |
Copaxone | multiple sclerosis | $1,121 | -2% |
Treanda | cancer | $226 | 28% |
ProAir | asthma | $120 | 5% |
Azilect | Parkinson’s disease | $108 | 10% |
Nuvigil | insomnia | $105 | 38% |
Qvar | asthma | $77 | -13% |
Teva Pharmaceutical Industries operates two business segments: generic and specialty medicines. It is the world’s largest generics producer, with a portfolio of more than 1,000 molecules producing a wide range of products in nearly every therapeutic area. These include chemical and therapeutic equivalents of originator medicines in a variety of dosage forms, including tablets, capsules, injectables, inhalants, liquids, ointments and creams.
In specialty medicines, Teva has a portfolio of treatments for disorders of the central nervous system (CNS), including pain, as well as a strong portfolio of respiratory products. These include several franchises, most significantly its core therapeutic areas of CNS medicines such as Copaxone, Azilect and Nuvigil and of respiratory medicines such as ProAir HFA and QVAR. The specialty medicines segment also includes other therapeutic areas, such as oncology, women’s health and several other areas.
Teva’s revenues in 2014 amounted to $20.3 billion, which fell flat against last year’s results due to the decline in sales of OTC as well as generic medicines, and offset by higher revenues of specialty medicines. Forty-eight percent of Teva’s revenue was generated from its generics business, including API’s sold to third parties, and amounted to $9.8 billion, a decline of $88 million, or 1%. During the year Teva received 22 final generic drug approvals.
Forty-two percent of revenues came from specialty medicines and amounted to $8.6 billion, an increase of 2%. Copaxone, the leading multiple sclerosis therapy in the U.S. and worldwide, led the charge with $4.2 billion in sales. Teva enhanced its MS franchise through the introduction of a three-times-a-week Copaxone 40 mg/mL product in the U.S., and will launch Copaxone 40 mg/mL in Europe and other countries in 2015.
Geographically, the U.S. market was responsible for 45% of generic sales, Europe 32% while the remaining 23% came from ROW markets, primarily Japan, Canada and Russia.
At the beginning of the year, Erez Vigodman was appointed president and chief executive officer of Teva. Mr. Vigodman, formerly chief executive of Makhteshim Agan Industries (MAI), a global generic agrochemical company, took over for Eyal Desheh, who returned to his position as group executive vice president and chief financial officer. During his tenure with MAI, Mr. Vigodman returned the company to profitability through operations improvements and investing in organic growth, and led the expansion of MAI into emerging markets across Asia and Latin America, and China.
Teva expanded its CNS portfolio with the acquisition of NuPathe Inc. for approximately $144 million. NuPathe shareholders may also receive additional payments if sales milestones are met for NuPathe’s migraine treatment, ZECUITY, the first prescription migraine patch approved by the FDA for the acute treatment of migraine in adults. ZECUITY is a disposable, single-use, iontophoretic transdermal patch that actively delivers sumatriptan, a widely prescribed migraine medication. Teva also gains access to NuPathe’s technology, including its transdermal delivery system.
Also during the year, Teva and Active Biotech decided to continue development of Nerventra (laquinimod) despite the opinion of the Committee for Medicinal Products for Human Use (CHMP), which recommended against approval for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the EU.
Both companies remain committed to the clinical development program for MS and will evaluate the CHMP feedback to determine potential next steps. To confirm the benefits of the drug on disability progression, Teva is conducting the Phase III CONCERTO trial, the largest MS trial with disability progression as the primary endpoint. Teva is also investigating the potential of Nerventra in progressive forms of MS.
Teva expanded its biotech assets in pain care franchise when it acquired Labrys Biologics, Inc., a privately-held biotechnology company focused on treatments for chronic and episodic migraine, for $200 million and as much as $625 million in potential milestones.
Labrys has a range of investigational, approved and marketed treatments for migraine, cancer pain and chronic pain. Labrys is developing LBR-101, a fully humanized monoclonal antibody in Phase IIb trials for prevention of chronic and episodic migraine.
During the year the company also sold its rights to Andromeda Biotech Ltd. for Andromeda’s drug DiaPep277 for the treatment of type 1 diabetes for $72 million.
Teva made several organizational changes in the middle of the year, aligning all operations under two commercial business units, Global Specialty Medicines (GSM) and the newly-formed Global Generic Medicines group (GGM). GGM will have full global responsibility for all existing generic markets, including portfolio management and selection, product launch, and commercial execution. GGM will also be responsible for Teva’s OTC business, led by its joint venture with The Procter and Gamble Co. Sigurdur Olafsson has been appointed president and chief executive officer of GGM and will be based in the U.S. The GSM group, led by Dr. Rob Koremans, is responsible for Teva’s global specialty medicines business.
The Israeli generics giant began the year in turbulent waters, desperately trying to protect its blockbuster branded multiple sclerosis (MS) treatment Copaxone from generic competition. Ironic as it sounds from a company that has made its billions doing exactly what it’s trying to stop, Teva tried very hard to preserve its patent. At the start of April the company began banging on the door of the FDA, begging them not to approve a generic version of the drug, using various angles of attack including arguing lack of equivalence and presenting gene-expression studies. Unfortunately for Teva, its efforts have fallen on stony ground as the FDA approved Sandoz’s daily injection at the end of that month and Synthon already has one approval in Brazil… and it would certainly be a surprise if these companies stop there. Taking into consideration the substantial impact that generic competition will have on its top selling drug and the fact that the approval has hit earlier than it hoped, this can’t be good news. Teva does have a long-acting preparation on the market, but patient switches won’t necessarily save its bacon. At the same time efforts to buy Dutch generic competitor Mylan have been overtly dismissed, and although it did complete the acquisition of U.S.-based Auspex Pharmaceutical earlier this year, Teva seems to be suffering from a severe innovation drought. —Adele Graham-King |