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Teva: The Path Not Taken

Written by: | josh.slatko@medadnews.com | Dated: Monday, October 12th, 2015

 

5 Basel St., P.O. Box 3190
Petach Tikva 4951033, Israel
Telephone: +972-3-926-7267
Website: tevapharm.com

 

Best-Selling Products

Product 2014 Sales 2013 Sales
Generics $9,814 $9,902
Copaxone $4,237    $4,328
OTC $996    $1,165
Treanda $767    $709
Women’s Health $504    $510
ProAir $478    $429
Azilect $428    $371
Nuvigil $388    $320

All sales are in millions of dollars.

 

Financial Performance

  2014 2013
Revenue $20,272    $20,314
Net profit $3,042    $1,253
Diluted EPS $3.56    $1.49
R&D expense $1,488    $1,427
  1H 2015 1H 2014
Revenue $9,948    $10,046
Net profit $983    $1,485
Diluted EPS $1.15    $1.75
R&D expense $718    $697

In millions of dollars, except EPS

 

 

Teva’s revenue may have been flat lately, but the company’s M&A activities have been decidedly bumpy. Looking to expand its generics and specialty portfolios, Teva made an offer to acquire competitor Mylan N.V. in April of this year that was publicly and emphatically rejected by that company’s board. After three months of waiting for Mylan to change its collective mind, Teva finally withdrew its offer in July and signed an agreement to acquire Allergan Generics instead in a $40 billion deal expected to close at the beginning of 2016 that should add about $6 billion annually to the company’s top line. Not bad — but still seemingly not Teva’s first choice.

“We continue to believe that a combination of Teva and Mylan would have made sense for our companies, our respective stockholders, and the healthcare industry as a whole,” says Teva CEO and President Erez Vigodman. “However, despite our clear commitment to consummating a transaction, and our conviction that we ultimately would have succeeded in acquiring Mylan, we believe we have an even greater opportunity to create compelling, sustainable value for Teva’s stockholders through our transaction with Allergan – and we acted quickly to seize the opportunity.”

Teva’s top-line revenue for 2014 was $20.27 billion, down 0.2 percent compared with the previous year. Net income, on the other hand, was up nearly 150 percent to $3.04 billion due primarily to the increased profitability of the company’s generics segment and a significant shift in loss contingencies due to the settlement of litigation over the drug pantoprazole. Diluted earnings per share accordingly more than doubled for the year to $3.56. Teva’s R&D expenses for the year rose 4.3 percent to $1.49 billion. In the first half of 2015, Teva’s top-line revenue dropped 1 percent to $9.95 billion. Net income was down by more than a third to $983 million and diluted EPS dropped 60 cents to $1.15. R&D expense rose 3 percent to $719 million.

Mylan acquisition attempt

Perhaps the most prominent story in the news about Teva in the past year was about something that didn’t happen — the attempted acquisition of Mylan In April, Teva announced an unsolicited proposal to acquire all of the outstanding shares of Mylan in a transaction valued at $82 per Mylan share, with the consideration to comprise about 50 percent cash and 50 percent stock. This came in the midst of Mylan’s own unsolicited effort (continuing but still incomplete as of press time) to acquire the Irish generics company Perrigo Co.

“Our proposal is compelling for both Teva and Mylan stockholders and other stakeholders,” Vigodman said on the announcement of the offer. “Our proposal would provide Teva stockholders with very attractive strategic and financial benefits and Mylan stockholders with a substantial premium and immediate value for their shares, as well as the opportunity to participate in the significant upside potential of the combined company. We have long respected Mylan’s business, and we are confident that Mylan’s board of directors and stockholders will agree that our proposal represents a significantly more attractive alternative for Mylan and its stockholders than Mylan’s proposed acquisition of Perrigo.”

As it turned out, though, Vigodman’s confidence was misplaced. Six days after Teva’s proposal was submitted, Mylan’s board rejected the offer – and tossed a couple of fastballs back at Teva for good measure.

“After thorough consideration, Mylan’s board unanimously determined that Teva’s proposal grossly undervalues Mylan, and would require Mylan’s shareholders to accept what we believe are low-quality Teva shares in exchange for their high-quality Mylan shares in a transaction that lacks industrial logic and carries significant global antitrust risk,” wrote Mylan Executive Chairman Robert Coury in response to the Teva offer. “In addition, we also believe that the proposal does not address the serious challenges of integrating two fundamentally different and conflicting cultures under a Teva board and leadership team with a poor record of delivering sustainable shareholder value.

“Furthermore, the proposal contains nothing meaningful indicating why a combination with Teva would be in the best interest of Mylan’s employees, patients, customers, communities and other stakeholders. In summary, the Board determined that Teva’s expression of interest is not in the best interests of Mylan, its shareholders or other stakeholders, and we believe that this is only a mere attempt by Teva to frustrate and distract Mylan from its business plan and strategy.”

Thus began a highly public shouting match between Vigodman and Coury. “Your letter paints a fundamentally distorted picture of Teva and ignores its rich heritage, unique culture, industry-leading achievements, and contributions that have benefited patients and healthcare systems worldwide, while for years creating substantial long-term value for our stockholders,” Vigodman wrote in response to Coury’s broadside. “I firmly believe that our respective stakeholders do not support, or benefit from, mudslinging, mischaracterization, rehashing of history or selective presentation of facts.”

But Vigodman could not help slinging a little mud himself. “Summarily rejecting our offer which provides Mylan stockholders with such a significant premium is inconsistent with the responsibilities and obligations of your board of directors to Mylan’s stakeholders,” he continued. The rest of his letter provided an overview of Teva’s recent successes and why he thought the two companies would fit well together.

Coury and his board, though, remained unimpressed, refusing to even discuss the offer while concentrating on their own unsolicited bid for Perrigo. And after several months of twisting in the wind, in July Vigodman and his board withdrew Teva’s proposal to acquire Mylan, signing an agreement to acquire Allergan Generics instead.

“In light of our strategic acquisition of Allergan Generics, which will transform the industry, our board and management team has decided that withdrawing the proposal to acquire Mylan is in the best interests of Teva stockholders,” said Vigodman upon announcement of the withdrawal. “Since announcing the proposal to acquire Mylan on April 21, 2015, we have appreciated the opportunity to talk with many of our investors about the future of the generics industry, and we are confident our proposed transaction with Allergan best positions Teva to succeed in today’s industry landscape.”

Allergan Generics acquisition

In July, Teva signed a definitive agreement with Allergan plc to acquire Allergan Generics in a transaction valued at $40.5 billion. Upon closing, Allergan will receive $33.75 billion in cash and shares of Teva valued at the time of agreement at $6.75 billion, representing an estimated under 10 percent ownership stake in Teva, with the number of Teva shares determined based on Teva’s volume weighted average trading prices during the 15 days prior to the announcement and five days following the announcement. The transaction was unanimously approved by the boards of directors of Teva and Allergan and is expected to close in first-quarter 2016.

This strategic acquisition, Teva executives say, brings together two leading generics businesses with complementary strengths, brands and cultures, providing patients with more affordable access to quality medicines, and creating significant financial benefits for Teva stockholders. The transaction is expected to create a leader in the INN and branded generics industry with an overall product portfolio that leads the industry in terms of differentiation and durability and offers promising growth opportunities.

“This transaction delivers on Teva’s strategic objectives in both generics and specialty,” Vigodman says. “Through our acquisition of Allergan Generics, we will establish a strong foundation for long-term, sustainable growth, anchored by leading generics capabilities and a world-class late-stage pipeline that will accelerate our ability to build an exceptional portfolio of products — both in generics and specialty as well as the intersection of the two. Our respective portfolios of generic medicines and applications are highly complementary, providing Teva with high quality growth and earnings visibility, and the scale and resources to expand upon our specialty capabilities.”

Teva expects Allergan Generics to contribute about $2.7 billion in EBITDA in 2016, excluding synergies. Following the completion of the acquisition, Teva is expected to have pro forma sales of about $26 billion and EBITDA of about $9.5 billion in 2016, including an estimated $11 billion in sales outside of the United States. Teva also believes the acquisition will be significantly accretive to non-GAAP EPS, including expected double-digit non-GAAP EPS accretion in 2016 and more than 20 percent accretion in year two and year three following the close of the transaction. The company expects to achieve cost synergies and tax savings of about $1.4 billion annually, largely achievable by the third anniversary of the closing of the transaction.

Post-transaction, Teva leaders expect their company will have the most advanced R&D capabilities in the generics industry, directed at fostering innovation, with about 320 combined pending ANDAs in the United States, including exclusive offerings of about 110 U.S. FTF pending ANDAs. Together, Teva and Allergan Generics will have a commercial presence across 100 markets, including a top three leadership position in more than 40 markets.

The acquisition, company leaders say, will help eliminate inefficiencies and duplications in the global generics space and will allow Teva to better focus resources and efforts in complex generics, biosimilars, and specialty products in key therapeutic areas. This scale and breadth of operations will provide Teva with an even more efficient, flexible, and competitive global platform with industry-leading go-to-market capabilities.

Other acquisitions and partnerships

In February, Teva and Eagle Pharmaceuticals Inc. entered into an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride rapid infusion product for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. Teva will be responsible for all U.S. commercial activities for the product, including promotion and distribution. Eagle is responsible for obtaining all regulatory approvals, conducting postapproval clinical studies, if required, and initially supplying drug product to Teva.

“Since 2008, Teva’s bendamustine HCl product, Treanda, has played a valuable role in the treatment of patients with CLL or indolent B-cell NHL that has progressed,” says Paul Rittman, VP and general manager, Teva Oncology. “With a substantially shorter infusion time, Eagle’s rapid infusion bendamustine HCl represents an important and improved benefit to both patients and healthcare providers.”

In March, Teva entered into a definitive merger agreement to acquire all the outstanding shares of Auspex Pharmaceuticals Inc. for a total of about $3.5 billion in equity value. Auspex is an innovative biopharmaceutical company specializing in applying deuterium chemistry to known molecules to create novel therapies with improved safety and efficacy profiles. The deal duly closed in May. Auspex’s lead investigational product, SD-809 (deutetrabenazine), which takes advantage of Auspex’s deuterium technology platform, is being developed for the potential treatment of chorea associated with Huntington’s disease, tardive dyskinesia, and Tourette syndrome, with a pharmacokinetic profile that allows for lower doses resulting in a favorable safety profile.

In 2014, Auspex reported positive results from its Phase III clinical trial for SD-809 in Huntington’s disease, with plans to submit an NDA for this indication by mid-2015; an NDA was duly accepted by FDA in August. SD-809 has been granted orphan drug designation for the treatment of Huntington’s disease by FDA, and Auspex expects regulatory approval and commercial launch for this indication in 2016 in the United States. Topline results for Auspex’s Phase III ARM-TD study of SD-809 as a potential treatment for tardive dyskinesia, a disorder for which there are no approved therapies, were also expected in mid-2015. Other pipeline candidates include deuterated versions of pirfenidone for idiopathic pulmonary fibrosis and levodopa for Parkinson’s disease. Auspex has an additional 60 molecules in its patent portfolio.

Also in March, Teva and Ignyta Inc. announced the acquisition by Ignyta of the worldwide rights and assets relating to four targeted oncology development programs in exchange for 1.5 million shares (6 percent) of Ignyta’s common stock. The first, CEP-32496, which Ignyta has renamed RXDX-105, is a potent small molecule inhibitor of BRAF, EGFR, and RET that is currently in a Phase I/II dose escalation clinical trial. The second, CEP-40783, which Ignyta has renamed RXDX-106, is a potent, highly selective, pseudo-irreversible inhibitor of AXL and cMET that is in late preclinical development. The third, CEP-40125, which Ignyta has renamed RXDX-107, is a nanoformulation of a modified bendamustine with potential activity in solid tumors that is in late preclinical development. The fourth, TEV-44229, which Ignyta has renamed RXDX-108, is a potent, selective inhibitor of the atypical kinase PKCiota that is in preclinical studies. Ignyta has also acquired next-generation PKCiota inhibitors in addition to the lead compound.

In June, Teva and Microchips Biotech Inc. entered into a partnership under which the companies will explore ways to apply Microchips Biotech’s implantable drug-delivery device to Teva’s portfolio of products with the goal of enhancing clinical outcomes for patients on chronic drug therapies. Microchips Biotech’s electronic device is made up of microchip arrays that can store hundreds of therapeutic doses of drug for periods ranging from months to years and releases each dose at precise times. The device can be programmed to release drug on a pre-determined schedule and will have wireless control features.

Under the terms of the agreement Teva made a $35 million upfront payment to Microchips Biotech in the form of an equity investment and technology access fee. The partnership has an initial focus on one selected disease area, but will provide Teva with the option to later expand the program into several additional therapeutic areas and sensing applications that are proprietary to Teva. As programs advance, Microchips Biotech will receive development and commercial milestone payments and royalties on future product sales. Microchips Biotech will also receive funding to develop products for any future additional indications Teva may develop, and Teva will be responsible for Phase II and Phase III clinical development and regulatory filings.

In August, Teva and Immuneering Corp. entered into an agreement in which Teva would purchase a 51 percent equity share of the genomic analysis company. Immuneering uses advanced proprietary techniques to identify hidden signals and biological insights across an array of genetic, genomic, and proteomic data that can direct research for enhanced discovery, development, and clinical success.

Teva and Immuneering have worked together over the past several years to unlock significant findings into genetic biomarkers, therapy-specific gene expression signatures, and breakthrough work in characterizing non-biological complex drugs. Teva’s majority holding in Immuneering provides right of first refusal in projects relating to the company’s stated objective of developing, personalizing, and improving treatment of disorders of the central nervous system.

In September, Watson Health announced that Teva had been selected as its first Foundational Life Sciences Partner for the Watson Health Cloud. As part of this strategic partnership, Teva is becoming the first global pharmaceutical company to use the Watson Health Cloud to benefit patients and healthcare providers across geographies. Teva has chosen the IBM Watson Health Cloud as a preferred global technology platform and aims to build solutions designed to help millions of individuals worldwide with complex and chronic conditions such as asthma, pain, migraine, and neurodegenerative diseases. In addition, a joint Teva-IBM Research team will deploy big data and machine learning technology to create disease models and advanced therapeutic solutions.

Teva will work with IBM on long-range platform and solutions development, with experts collaborating to enhance IBM Watson Health Cloud capabilities and explore synergies with existing Watson Health ecosystem partners. The company expects to develop solutions designed to collect and analyze real world evidence, draw powerful insights, and inform a variety of initiatives such as reducing drug misuse or increasing prescribed medication adherence.

Product performance

As usual, Teva’s generics portfolio was the leading revenue producer for the company in 2014, though generics sales dropped by 0.9 percent to $9.81 billion for the year. While U.S. generics sales were up 6 percent in 2014, generics sales in Europe dropped 6 percent and sales in the rest of the world were down by 5 percent. However, profit for the generics segment rose 29 percent to $2.1 billion due primarily to lower sales and marketing expenses. In the first half of 2015, generics sales rose 3.5 percent to $5.09 billion.

During the course of 2014, Teva launched 19 new generic products in the United States, 209 in Europe, and 87 in the rest of the world. The most significant U.S. launches included generics for Xeloda (launched in March 2014), Evista (March), Lovaza (April), Lunesta (April), Lovenox (November), and Celebrex (December). In the first half of 2015, important new launches included Diovan (January), Nexium (February), Abilify (April), and Intuniv (June). As of July 16, Teva had 106 generic product registrations awaiting FDA approval, including 23 tentative approvals. The company was first to file for 36 of these products. In Europe, the company had 1738 marketing authorization applications pending approval in 31 countries, relating to 153 compounds in 312 formulations.

On the branded side of the ledger, the multiple sclerosis drug Copaxone remained atop Teva’s charts in 2014 with sales of $4.24 billion, down 2.1 percent compared with the previous year. According to company leaders, this was due mostly to the appearance of oral competition in the United States. Even so, Copaxone still accounted for 25.9 percent of new MS prescriptions and 31.5 percent of total prescriptions in the United States, retaining its place as the country’s top MS therapy. Sales of Copaxone in the first half of 2015 totaled $1.98 billion, a decrease of 1.5 percent.

In April, Teva announced new 36-month data from the placebo-controlled and open-label extension phases of the GALA study evaluating the efficacy and safety of three-times-a-week Copaxone in patients with relapsing forms of multiple sclerosis. The study compared early-start patients who received three-times-a-week Copaxone for 36 months versus delayed-start patients, who started Copaxone after the 12-month placebo-controlled phase of the trial. The data show the adjusted mean annualized relapse rate was significantly lower for ES over 36 months (0.23 versus 0.30). In addition, early treatment with three-times-a-week Copaxone resulted in a sustained reduction in lesion activity and the evolution of active lesions to chronic black holes.

In second place among Teva’s branded product sales in 2014 was the oncology drug Treanda. Indicated for treating chronic lymphocytic leukemia and indolent B-cell non-Hodgkin’s lymphoma, Treanda generated sales of $767 million for the year, an improvement of 8.2 percent, which company leaders credit to price increases. In November, Teva launched a liquid formulation of Treanda that removed the step of reconstituting lyophilized powder with sterile water prior to adding the required dose of medicine to the infusion bag and administering to a patient. In the first half of 2015, sales of Treanda fell 6.9 percent to $336 million.

The bronchospasm inhaler ProAir was Teva’s third-best selling branded product in 2014, with sales rising 11.4 percent to $478 million. ProAir maintained its leadership in the short-acting beta agonist market, with a market share of 57 percent in total number of prescriptions during the fourth quarter of 2014, an increase of 3.1 points compared to the fourth quarter of 2013. In the first half of 2015, sales of ProAir were $252 million, an improvement of 2 percent.

In April, FDA approved ProAir RespiClick inhalation powder, a breath-actuated, multidose, dry-powder, short-acting beta-agonist (SABA) inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older.ProAir RespiClick is the first breath-actuated, dry-powder rescue inhaler to be approved by FDA for the treatment of acute asthma symptoms. Teva subsequently filed an SNDA in September for patients 4 to 11 years of age.

Azilect, Teva’s branded product for Parkinson’s disease, brought in $428 million in sales during 2014, an improvement of 15.4 percent, due to price increases in the United States and volume growth in both the United States and Europe. In the first half of 2015, sales of Azilect were down 2.3 percent to $212 million.

The wakefulness drug Nuvigil showed the most impressive growth of any of Teva’s branded products in 2014, with sales up 21.3 percent to $388 million. Nuvigil’s market share by total prescriptions in the U.S. wake category was 42.5 percent as of the end of the year. In the first half of 2015, sales of Nuvigil dropped 6.9 percent to $176 million.

Recent product approvals and pipeline updates

In November, Teva and partner developer Active Biotech announced the expansion of the laquinimod clinical development program with the initiation of the ARPEGGIO trial, which will evaluate the potential of laquinimod to treat primary progressive multiple sclerosis. Additionally, Teva has screened the first patient in the LEGATO-HD trial, which will evaluate laquinimod in Huntington’s disease. Currently, there are no approved therapies available for the treatment of PPMS or the treatment of Huntington’s disease, beyond symptom management.

The ARPEGGIO study will evaluate the efficacy, safety, and tolerability of laquinimod in patients with PPMS with a primary endpoint of percent brain volume change (PBVC) through MRI analysis. PPMS is characterized by the worsening of neurologic function without distinct relapses (also called attacks or exacerbations). About 15 percent of MS patients fall into the PPMS category.

The LEGATO-HD study will evaluate the efficacy, safety, and tolerability of once-daily oral laquinimod as a potential treatment for adult patients with Huntington’s disease. The primary endpoint for LEGATO-HD is change from baseline in the Unified Huntington’s Disease Rating Scale-Total Motor Scale (UHDRS-TMS) as defined by the sum of the scores of all UHDRS-TMS sub-items after 12 months of treatment.

In December, FDA approved Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. Granix, a leukocyte growth factor, is indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Granix has been commercially available in the United States since November 2013. The currently marketed Granix syringe is indicated only for administration by a healthcare professional. Teva planned to launch a new Granix syringe for self-administration by patients and caregivers, in early 2015.

In February, FDA accepted for review the new drug application for Teva’s hydrocodone bitartrate extended-release tablets formulated with the company’s proprietary abuse deterrence technology (CEP-33237). CEP-33237 is an investigational, 12-hour, acetaminophen-free formulation of extended-release hydrocodone for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The NDA filing is supported by a clinical program that evaluated the safety and efficacy of CEP-33237, as well as the abuse potential of CEP-33237 via the oral and intranasal routes of abuse in Human Abuse Liability (HAL) studies. Results from the Phase III clinical program for CEP-33237 showed significant improvement in the treatment of patients’ chronic low back pain as measured by both weekly average Worst Pain Intensity (WPI) and weekly Average Pain Intensity (API) scores.

In the oral HAL study in nondependent, recreational opioid users, abuse potential was significantly lower for finely crushed CEP-33237 than for immediate-release hydrocodone powder based on peak at-the-moment drug liking. Overall drug liking was also significantly lower for finely crushed CEP-33237 compared to IR hydrocodone. The intranasal HAL study found that in nondependent, recreational opioid users, abuse potential for finely milled intranasal CEP-33237 was significantly lower based on peak at-the-moment drug liking than for intranasal IR hydrocodone powder and finely milled intranasal Zohydro ER (hydrocodone bitartrate) extended-release capsules as commercially available at the time the study was conducted. Overall drug liking was also significantly lower for finely crushed CEP-33237 compared to IR hydrocodone and Zohydro ER.

Also in February, Teva announced positive results from a Phase IIb study evaluating the efficacy, safety, and tolerability of two doses of subcutaneous TEV-48125, an investigational anti-calcitonin gene-related peptide monoclonal antibody for the prevention of chronic migraine (migraine with headaches on at least 15 days per month).

The study compared two active arms of different doses of TEV-48125, administered as a subcutaneous injection, once a month for three months, against placebo. Results demonstrated that both tested doses of TEV-48125 achieved the primary and secondary efficacy endpoints of the study at one and three months. The data revealed a significant and clinically relevant reduction in the number of monthly cumulative headache hours and the number of headache days of at least moderate severity, relative to baseline.

In April, FDA accepted Teva and partner developer Eagle Pharmaceuticals’ new drug application for a liquid bendamustine hydrochloride rapid infusion product. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

This product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in 10 minutes in a low-volume, 50 mL admixture.

In April, Teva and Xenon Pharmaceuticals Inc. announced that the first patient had been enrolled into the Phase IIb study designed to evaluate the safety and efficacy of the novel topically applied TV-45070 (4 percent and 8 percent w/w ointment) in patients with postherpetic neuralgia. TV-45070 is a small molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system. The drug candidate is being developed for the treatment of patients with various pain indications, including neuropathic and osteoarthritis pain.

In June, Teva and Active Biotech announced that the patient enrollment for the pivotal Phase III CONCERTO trial had been finalized, as well as a planned sample size reassessment analysis of the study. CONCERTO, the third Phase III trial of laquinimod in patients with relapsing-remitting multiple sclerosis, is designed to evaluate the safety and efficacy of laquinimod with a primary endpoint of time to Confirmed Disability Progression (CDP), as measured by the Expanded Disability Status Scale (EDSS). CONCERTO study results are expected to be available toward mid-2017. Regulatory submission will follow study completion.

Also in June, FDA accepted for review the biologics license application for reslizumab, Teva’s investigational humanized monoclonal antibody which targets interleukin-5, for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid-based regimen. A marketing authorization application for reslizumab was filed with European regulators the following month.

The BLA for reslizumab includes data from Teva’s Phase III BREATH clinical trial program. The program consisted of four separate placebo-controlled trials involving more than 1,700 adult and adolescent asthma patients with elevated blood eosinophils whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies. Results demonstrated that reslizumab, in comparison to placebo, reduced asthma exacerbation rates by at least half and provided significant improvement in lung function and other secondary measures of asthma control when added to an existing ICS-based therapy.

In July, Teva and Xenon reported top line results from the double-blind, placebo-controlled Phase IIb study designed to evaluate the safety and efficacy of topically applied TV-45070 (4% and 8% w/w ointment) in patients with chronic pain due to osteoarthritis of the knee. Results from this trial showed that TV-45070 4% and 8% did not demonstrate statistically significant difference from placebo in efficacy endpoints of reductions in pain due to OA.

In September, Teva announced the launch of Zecuity, the first patch system designed to provide relief from migraine. Zecuity is a single-use, disposable patch system that delivers sumatriptan through the skin. The device is designed to be worn for a four-hour period either on the upper arm or thigh.

In a clinical study, at two hours following application, significantly more patients using Zecuity versus a non-medicated patch system reported, as the study’s primary endpoint, no headache pain (18 percent versus 9 percent). The secondary endpoints of the study showed that, at two hours following application, significantly more patients reported no nausea (84 percent versus 63 percent), no sensitivity to sound (55 percent versus 39 percent), no sensitivity to light (51 percent versus 36 percent), or headache pain relief (53 percent versus 29 percent).

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