Takeda in New Business Venture With Teva

Takeda Pharmaceutical Company Limited and Teva Pharmaceutical Industries Ltd. made the below follow-up announcement regarding the overview of their new business venture in Japan, which was initially disclosed on November 30, 2015 in the press release titled, "Teva and Takeda establish unique partnership to meet the wide-ranging needs of patients and growing importance of generic medicines use in Japan".

• The new business venture, to be established in or after April 2016, will deliver Teva's high-quality generic medicines and some of Takeda's long listed products to patients and healthcare professionals in Japan, leveraging Takeda's corporate brand and unique distribution network in Japan and Teva's wide product portfolio and cutting-edge business efficiency.
• The major long listed products of Takeda to be transferred to the new business venture in FY2016 are BLOPRESS, TAKEPRON and BASEN. Total sales of the products to be transferred in FY2016 were 125 billion yen in FY2014, which was 7% of Takeda's global revenue. As a result of the transaction, Takeda’s FY2016 revenue is estimated to decrease by approximately 50 billion yen, based upon current assumptions. LEUPLIN remains at Takeda, as a product of Takeda Oncology.
• The new business venture, to be owned 51% by Teva and 49% by Takeda, will consist of Teva Takeda Pharma and Teva Takeda Yakuhin. The details of establishing these companies by an absorption-type company split are outlined in a separate release issued by Takeda to file to the Tokyo Stock Exchange: "Takeda Announces Details of New Business Venture with Teva in Japan - Splitting off (absorption-type split) of Takeda's Long Listed Products Business and its Subsequent Succession by Teva" (herein called "Takeda's TSE Filing").
• Takeda anticipates that the transaction will be both EPS and cash flow accretive in FY2016 and over the long-term, due to growth of the generic business and the addition of products from Takeda and Teva to the new business venture. The new business venture will be instantly accretive to Teva's non GAAP EPS in 2016 and beyond. Some additional details about the financial impact of the transaction are outlined in Takeda's TSE Filing, and all will be incorporated into Takeda's FY2016 forecast which will be communicated in May 2016.

Teva’s Statement on its Internal Specialty Pharmacy

All of Teva’s products are processed through payer networks. Over 99.5% of Teva’s sales go through unaffiliated specialty or retail pharmacies and less than 1% (approximately .05%) of Teva’s sales flow through the Company’s pharmacy and 100% of claims are processed through payer networks.

Our internal pharmacy works in collaboration with payers and PBMs to align services to optimize the patient experience. Our internal pharmacy is reviewed by payers and PBMs on an annual basis. We are fully transparent with payers and are focused on patient outcome.

Teva’s pharmacy enables us meet the special shipping requirements (i.e. cold and warm chain management) as specified in regulatory labeling for specialty pharmacy distributed products. This special handling and shipping is not typically required of retail products. The focal point of our pharmacy is to assist in patient onboarding and service including benefits investigation and patient assistance. Additionally, it helps patients with chronic conditions that require ongoing support with their therapy. The support provided has been shown to improve patient adherence and compliance.

Teva’s internal pharmacy is fully licensed and adheres to all applicable local, state, and federal laws and regulations, including HIPPA. We remain committed to assisting patients through our pharmacy operation.

COPAXONE Approved in Japan

Teva Pharmaceutical Industries Ltd. announced the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) of once-daily COPAXONE^® (glatiramer acetate injection) 20mg injection for the prevention of relapse of multiple sclerosis . The product will be commercialized in Japan by Takeda Pharmaceutical Company Limited (Takeda). 

In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of the MHLW. In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize COPAXONE^® in Japan.  

The Japanese approval for COPAXONE^® is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis in Japan as well as the pivotal trial data sets used for approvals in other countries. 

COPAXONE^® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE^® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. 

Teva Pharmaceuticals and IBM Partner to Build Global e-Health Solutions

IBM Watson Health and Teva Pharmaceuticals Industries Inc announced that Teva has been selected as its first Foundational Life Sciences Partner for the Watson Health Cloud. As part of this new strategic partnership, Teva becomes the first global pharmaceutical company to tap the power of 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.

Watson is a groundbreaking cognitive computing platform that represents a new era of computing based on its ability to interact in natural language, process vast amounts of Big Data to uncover patterns and insights, and learn from each interaction. The Watson Health Cloud provides an open development platform for physicians, researchers, insurers and companies focused on creating health and wellness 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, which has one of the world’s largest portfolios of medicines, 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.

FDA Accepted Supplemental New Drug Application for ProAir

Teva Pharmaceutical Industries announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for ProAir^® RespiClick (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in patients 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB). 

ProAir^® RespiClick was approved by the FDA in March 2015 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 EIB. ProAir^® RespiClick is the only multi-dose, breath-activated short-acting beta-agonist (SABA) inhaler available to patients in the U.S. It differs from other currently available rescue inhalers as it utilizes breath-activated technology that enables patients to breathe in to receive a measured dose of the medicine, eliminating the need for hand-breath coordination during inhalation.

The sNDA for ProAir^® RespiClick includes data from Teva’s pediatric clinical trial program that evaluated the safety and efficacy of the treatment in children 4 – 11 years of age. The sNDA for ProAir^® RespiClick has been accepted by the FDA for standard review, with FDA Regulatory Action expected in April 2016. 

First Transdermal Patch system for Migrain Available in US

Teva Pharmaceutical Industries Ltd. announced that ZECUITY^®, the first and only patch system designed to provide relief from migraine, is now available by prescription through specialty pharmacies. 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

Approximately 36 million people in the United States suffer from migraine and its various characteristics. According to the American Migraine Study II, 85 percent of respondents experience throbbing pain, 80 percent experience sensitivity to light, 76 percent experience sensitivity to sound and 73 percent experience nausea.

ZECUITY^® is a prescription medicine used for the acute treatment of migraine headaches with or without aura in adults. ZECUITY^® is used for people who have been told by a healthcare provider that they have migraine headaches. ZECUITY^® is not used to prevent or decrease the number of migraine headaches you have.