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.

Takeda Agree Sale of Respiratory Portfolio to AstraZeneca

Takeda Pharmaceutical Company Limited announced that it has entered into a definitive agreement to sell its respiratory portfolio to AstraZeneca. In 2014 Takeda defined four therapeutic areas of focus: Gastroenterology, Oncology, Central Nervous System, and Cardiovascular and Metabolic. This divestiture will allow Takeda to work on becoming best-in-class in these therapeutic areas, while maintaining continuity of care for patients.

Under the terms of the agreement, AstraZeneca will acquire the respiratory business including products Daxas (roflumilast), Alvesco and Omnaris (ciclesonide). The acquisition will also include regional and local products, as well as several pre-clinical assets. A number of Takeda employees will transfer to AstraZeneca upon completion of the divestiture.

The financial impact from this divestiture on Takeda’s 2015 consolidated financial statements is expected to be minimal. Sales of respiratory products, Daxas, Alvesco and Omnaris, totaled approximately 24 billion yen in fiscal year 2014. The transaction is expected to close during the first calendar quarter of 2016, subject to customary closing conditions.

Leuplin PRO now Available in Japan

Takeda Pharmaceutical Company Limited announced that “Leuplin^® PRO for Injection Kit 22.5 mg” (hereafter 24-week depot formulation), the 24-week depot formulation of “Leuplin^®” (generic name: leuprorelin acetate), is now available in Japan for the treatment of prostate cancer and premenopausal breast cancer.

Leuplin is an LH-RH agonist that consistently stimulates the pituitary gland, resulting in suppressed production of male/female hormone. Leuplin is used as a treatment for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, and it is currently available in the United States, Europe, and Asia. The 24-week depot formulation becomes available for the first time in the world for the treatment of premenopausal breast cancer.

The 24-week depot formulation can maintain stable blood concentration by sustained release using Takeda's unique microcapsule formulation technology through 24 weeks with a single injection. The new formulation providing sustained efficacy over a 24-week period will be a valuable addition to the available dosing options and provides the added benefit of less frequent dosing thus helping reduce the burden of treatment for patients with prostate cancer and premenopausal breast cancer.

Takeda and Cour Partner in Collaboration

Takeda Pharmaceutical Company Limited and Cour Pharmaceutical Development Company, Inc. announced a partnership to research and develop novel immune modulating therapies for the potential treatment of celiac disease. The partnership will focus on using nanotechnologies based on Cour’s Tolerizing Immune Modifying nanoParticle (TIMP) platform, which can be extended to certain autoimmune and allergic conditions by inhibiting the abnormal immune responses that cause disease, without affecting the beneficial parts of the immune system.

The collaboration will explore the potential of TIMP therapy to allow celiac patients to tolerate gluten in their diet. The TIMPs, developed in cooperation with Northwestern University researchers, consist of a proprietary polymer and antigenic proteins, which are fully encapsulated for safety and administered intravenously. The TIMP compounds target the underlying cause of celiac disease by systemically targeting and controlling, gluten-reactive T-cells in patients, as opposed to broad immunosuppression.
Cour will receive upfront and success based milestone payments from Takeda leading to an exclusive option to acquire a global license to the TIMP-GLIA program after the completion of the Phase 2a clinical trial. Cour will also receive royalties on sales of any successful commercialized products resulting from the partnership. Takeda will also have the option to collaborate on up to three additional TIMP compounds each with development, regulatory, and sales milestones and royalties on sales. Further details of the agreement were not disclosed.