On January 9, 2016 Kite Pharma (Nasdaq:KITE) reported that it has entered into a strategic partnership with Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) for axicabtagene ciloleucel (approved USAN for KTE-C19) in Japan (Press release, Kite Pharma, JAN 9, 2017, View Source [SID1234517325]). Axicabtagene ciloleucel, Kite’s lead product candidate, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Schedule your 30 min Free 1stOncology Demo! Under the terms of the partnership agreement, Daiichi Sankyo will be responsible for development and commercialization of axicabtagene ciloleucel in Japan. Daiichi Sankyo will make an upfront payment to Kite of $50 million and Kite will be eligible to receive future payments totaling up to $200 million for development and commercial milestones. Kite is also entitled to receive sales royalties in the low to mid double digit range.
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"We are thrilled to partner with Daiichi Sankyo, a market leader in Japan who shares our vision for engineered T-cell therapy and has strong development capabilities in oncology," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "We have a strategic roadmap to commercialize axicabtagene ciloleucel globally while focusing Kite’s development and commercialization efforts in the United States and Europe. Daiichi Sankyo’s commitment to bring autologous T-cell therapy to patients in Japan will complement our strategy and demonstrates the significant value in our pipeline, as well as the commercial potential for autologous T-cell therapy globally."
As part of the transaction, Kite will provide certain technical transfer services to Daiichi Sankyo. In addition, Daiichi Sankyo has a certain period of time to license additional Kite product candidates for Japan including KITE-718, Kite’s T cell receptor product candidate targeting MAGE-A3/A6 and certain other product candidates that proceed to a U.S. investigational new drug application filing over the next three years. Upfront and milestone payments for each additional product candidate could equal up to $200 million plus low to mid double digit sales royalties. Kite retains all development and commercialization rights outside of Japan.
"We are very enthusiastic about this partnership with Kite which has the most advanced technology platform in this area and the potential for cell-based therapy to change the way in which we treat cancer in Japan," said Koichi Akahane, Japan Head of Oncology R&D, Daiichi Sankyo. "We believe we can leverage the pioneering research conducted by Kite to potentially accelerate development and commercial availability of axicabtagene ciloleucel in Japan for those patients suffering from B-cell malignancies."
Japan, the third-largest pharmaceutical market in the world, has implemented an accelerated approval pathway for regenerative medicine and cell therapy products under the Pharmaceuticals and Medical Devices Act (PMD Act) in November 2014. There are approximately 9,300 new cases of aggressive NHL and 1,400 new cases of acute lymphoblastic leukemia (ALL) diagnosed per year in Japan, with similar treatment rates and prescribing patterns as the United States and Europe.1
Kite announced in December 2016 that it has initiated the rolling submission to the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with refractory aggressive non-Hodgkin lymphoma (NHL).
About axicabtagene ciloleucel
Kite Pharma’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
Year: 2017
Takeda to Acquire ARIAD Pharmaceuticals, Inc.
On January 9, 2017 Takeda Pharmaceutical Company Limited (TSE:4502) ("Takeda") and ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) ("ARIAD") reported that they have entered into a definitive agreement under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or an enterprise value of approximately $5.2 billion (Press release, Ariad, JAN 9, 2017, View Source;p=RssLanding&cat=news&id=2234958 [SID1234517324]). The transaction has been approved unanimously by the boards of directors of both companies, and is expected to close by the end of February 2017, subject to required regulatory approvals and other customary closing conditions. Sarissa Capital, the holder of 6.6% of ARIAD’s common shares, as well as each of the members of ARIAD’s Board of Directors have agreed to tender their shares to Takeda pursuant to the offer.
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"The acquisition of ARIAD is a unique opportunity that will enable us to positively impact the lives of more patients worldwide, advance our strategic priorities and generate attractive returns for our shareholders," said Christophe Weber, president and chief executive officer of Takeda. "This is a very exciting time for Takeda as we will broaden our hematology portfolio and transform our global solid tumor franchise through the addition of two innovative targeted therapies. Opportunities to acquire such high-quality, complementary targeted therapies do not come often, and we are very excited about the potential for this transaction to benefit patients, our shareholders and other stakeholders."
Paris Panayiotopoulos, president and chief executive officer of ARIAD, said, "We are very pleased to combine with Takeda, which will allow us to not only accelerate our mission to discover, develop and deliver precision therapies to patients with rare cancers, but also deliver immediate and meaningful value to our shareholders through a substantial cash premium. This exciting transaction is a testament to the hard work and dedication of ARIAD’s talented team of employees. We have tremendous respect for Takeda, and I believe our shared commitment to innovation and research-driven cultures will provide for a smooth transition."
"This transaction is a great outcome for shareholders of ARIAD and Takeda. Both ARIAD and Takeda are passionate about helping cancer patients, and I believe the talent and resources of Takeda coupled with ARIAD’s pipeline and people will accelerate the development of cancer treatments. I would like to extend my deepest gratitude to the management team and everyone at ARIAD for their unrelenting dedication," said Alexander J. Denner, Ph.D., Chairman of the Board of ARIAD.
Highly strategic deal which transforms global oncology portfolio and pipeline by expanding into solid tumors and reinforcing existing strength in hematology
The acquisition of ARIAD brings two innovative targeted therapies that will expand and enhance Takeda’s existing oncology portfolio. Brigatinib, an investigational drug product, has the potential to add a differentiated, global therapy in a genetically-defined subpopulation of non-small cell lung cancer (NSCLC). The addition of Iclusig will broaden Takeda’s strong hematology franchise to include chronic myeloid leukemia (CML) and a subset of acute lymphoblastic leukemia (ALL). Together, these two innovative targeted therapies will position Takeda for sustainable long-term growth in oncology.
Takeda’s track record of successful oncology product launches [ADCETRIS (Brentuximab Vedotin), NINLAROTM (ixazomib) and VELCADE (bortezomib)] means it has the experience and expertise required to deliver the successful launch of brigatinib and to ensure that it achieves global reach and share of voice thereafter.
Accretive to Takeda’s Underlying Core Earnings by FY2018 and generates immediate and long-term revenue growth
The transaction is a compelling opportunity for Takeda shareholders. It will provide immediate revenue, bring considerable long-term revenue potential and deliver synergy savings.
ARIAD provided calendar year 2016 revenue guidance for Iclusig of $170-180 million, and Takeda expects significant long-term revenue potential from the two lead assets.
Takeda projects the acquisition of ARIAD to be accretive to Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch.
Attractive value drivers include two very innovative medicines, Iclusig and brigatinib, an exciting early stage pipeline and cost synergies
Iclusig, a commercialized therapy with continued strong sales growth potential, delivers immediate value. Brigatinib, an investigational drug product with peak annual sales potential of over $1 billion, will generate significant long-term value for Takeda. U.S. approval is expected in the first half of 2017 with global filing thereafter. Beyond Iclusig and brigatinib, ARIAD’s commitment and expertise in targeted kinase inhibition linked to strong translational science generated further pipeline opportunities which provide additional long-term upside potential.
Takeda will leverage ARIAD’s R&D capabilities and platform, and largely absorb its R&D costs within Takeda’s existing R&D budget. G&A cost synergies will be fully captured by FY2018.
Takeda retains financial flexibility with no impact on dividend policy
The transaction will be funded by up to $4.0 billion of new debt and the remainder from existing cash. FY2017 Net Debt/EBITDA is estimated at approximately 2.6x, which is expected to remain investment grade. The transaction has no impact on Takeda’s dividend policy.
Transaction terms
The acquisition is structured as an all cash tender offer by a subsidiary of Takeda for all of the outstanding shares of ARIAD common stock, followed by a merger in which remaining shares of ARIAD would be converted into the right to receive the same $24.00 cash per share price paid in the tender offer and ARIAD will become an indirect wholly owned subsidiary of Takeda.
The transaction is subject to the tender of a majority of the outstanding shares of ARIAD common stock as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close by the end of February 2017.
Takeda Pharmaceuticals U.S.A, a wholly owned subsidiary of Takeda, has established Kiku Merger Co., Inc. to effect the transaction.
(1) Tender offeror Kiku Merger Co., Inc.
(2) Target company ARIAD Pharmaceuticals, Inc.
(3) Class of shares to be acquired Common stock
(4) Tender offer price $24.00 per share
(5) Acquisition amount
(Aggregate tender offer price)
Approximately $5.4 billion (estimate)
* The amount is an estimated amount calculated by multiplying the number of the target company’s shares (fully diluted basis) by the tender offer price per share. It does not include advisory fees.
(6) Payment Cash
* Funded by up to $4.0 billion of new debt and the remainder from existing cash.
(7) Period of tender offer From January, 2017 to February, 2017
** The initial period of the tender offer will commence within 10 business days following execution of the merger agreement with ARIAD [January 8, 2017 (U.S.)], and will close 20 business days after commencement. If the situation arises whereby the conditions of the tender offer are not satisfied, the period of the tender offer will be extended, but the extension period will not exceed May 2017 (or August 2017 if antitrust clearance not received).
(8) Minimum number of shares to be purchased Consummation of the tender offer will occur once the majority of shares outstanding of the company have been tendered and other customary closing conditions have been satisfied.
(9) Financial advisor to Takeda Evercore Partners
(10) Legal counsel to Takeda Cleary Gottlieb Steen & Hamilton LLP
(11) Financial advisor to ARIAD J.P. Morgan Securities LLC, Goldman, Sachs & Co., Lazard
(12) Legal counsel to ARIAD Paul, Weiss, Rifkind, Wharton & Garrison LLP
Overview of ARIAD
(1) Company name ARIAD Pharmaceuticals, Inc.
(2) Headquarters 125 Binney Street, Cambridge, Massachusetts 02142, USA
(3) Representative Paris Panayiotopoulos, President and Chief Executive Officer
(4) Business description ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is focused on discovering, developing and commercializing precision therapies for patients with rare cancers. ARIAD is working on new medicines to advance the treatment of rare forms of chronic and acute leukemia, lung cancer and other rare cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines.
(5) Capital US$1,339 million (Additional paid-in capital as of December 31, 2015)
(6) Date of establishment April, 1991
(7) Major shareholders
and percentage of
shares held*
Wellington Management Group LLP 8.8%
FMR LLC 7.8%
Vanguard Group Inc. 6.8%
Others
(8) Relationships between Takeda Capital relationship Not applicable
Personnel relationship Not applicable
Transactional relationship Not applicable
(9) Operating result and financial conditions for the last three years (consolidated)
Accounting period Fiscal year ended December 31, 2013 Fiscal year ended December 31, 2014 Fiscal year ended December 31, 2015
Net assets
(US$ in thousands)
185,517 80,801 (103,141)
Total assets
(US$ in thousands)
370,894 603,116 546,692
Net assets per share
(US$)
1.01 0.43 (0.55)
Revenue
(US$ in thousands)
45,561 105,412 118,804
Operating profit
(US$ in thousands)
(273,566) (160,195) (217,276)
Net loss
(US$ in thousands)
(274,158) (162,602) (231,156)
Net loss per share
(US$)
(1.49) (0.87) (1.23)
* As reported in the 13F filings. Percentage of shares is calculated by dividing the number of shareholdings (as of the end of September 2016) by the number of total shares outstanding of the target company.
Change in ownership before and after acquisition
(1) Number of shares already acquired 0 shares
Percentage of voting rights: 0%
(2) Number of shares to be acquired 194,389,661 shares*
Percentage of voting rights: 100% (planned)
* Total shares outstanding
Schedule
(1) Board meeting resolution January 6, 2017
(2) Signing date January 8, 2017
(3) Commencement date and settlement date of the tender offer From January, 2017 to February, 2017
**The initial period of the tender offer will commence within 10 business days following execution of the merger agreement with ARIAD [January 8, 2017 (U.S.)], and will close 20 business days after commencement. If the conditions of the tender offer are not satisfied, the period of the tender offer will be extended, but the extension period will not exceed May 2017 (or August 2017 if antitrust clearance not received).
(4) Completion of acquisition By the end of February, 2017 (planned)*
* Fulfillment of the terms and conditions of the U.S. Antitrust Law and the satisfaction of certain other customary conditions are required to complete the acquisition.
Outlook
FY2016
At this stage we expect minimal impact on Underlying Revenue and Underlying Core Earnings. We do expect to incur transition and integration expenses, however, these expenses are not material to the current year result. We will incorporate the financial impact in our FY2016 consolidated earnings forecast and announce at the third quarter earnings conference in February 2017.
FY2017 and beyond
It is expected that the acquisition of ARIAD will be accretive to Takeda’s Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch. Takeda’s financial guidance, including EPS, for FY2017 will be announced when Takeda reports earnings for FY2016 in May 2017.
Aduro Biotech Announces Clinical Collaboration with Merck to Evaluate the Combination of Aduro’s CRS-207 with Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Gastric Cancer
On January 9, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported a clinical collaboration with Merck (known as MSD outside the United States and Canada) (Press release, Aduro Biotech, JAN 9, 2017, View Source [SID1234517322]). The companies will investigate the combination of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of gastric cancer. Schedule your 30 min Free 1stOncology Demo! "CRS-207 has demonstrated the ability to induce an anti-tumor immune response in clinical trials in other tumor types that over express the tumor antigen, mesothelin," said Dirk G. Brockstedt, Ph.D., executive vice president of Research and Development at Aduro. "Gastric cancer is an immune-sensitive mesothelin-expressing tumor where PD-1 checkpoint inhibitors have shown some activity. The combination of inducing an immune response through CRS-207, while simultaneously suppressing the cancer’s ability to evade the immune system through a PD-1 checkpoint inhibitor, has resulted in synergistic anti-tumor activity in pre-clinical studies. We aspire to reproduce this activity in the clinic in patients with gastric cancer."
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The multicenter Phase 1 study, planned to begin in the first half of the year, will enroll patients with metastatic gastric cancer who have failed at least two prior therapies to receive the combination of CRS-207 and pembrolizumab.
About LADD and CRS-207
LADD is Aduro’s proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to generate a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity.
CRS-207 is one of a family of product candidates based on Aduro’s LADD immunotherapy platform that has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.
Adaptimmune Announces FDA Acceptance of IND Application for Affinity Enhanced T-Cell Therapy Targeting MAGE-A4 in Multiple Solid Tumors
On January 9, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that the US Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for autologous genetically modified T-cells expressing an affinity optimized T-cell receptor (TCR) specific for MAGE-A4 in patients with multiple malignant solid tumors (Press release, Adaptimmune, JAN 9, 2017, View Source [SID1234517320]). This will be Adaptimmune’s third wholly-owned therapeutic candidate to enter clinical trials. The IND is now active. Schedule your 30 min Free 1stOncology Demo! Under this IND, Adaptimmune will initiate a Phase I, open-label, modified 3+3 dose escalation study of autologous T-cells genetically engineered with an affinity optimized MAGE-A4 TCR in HLA*02 positive patients with inoperable locally advanced or metastatic melanoma, and urothelial, head and neck, ovarian, non-small cell lung, esophageal, and gastric cancers expressing MAGE-A4. Patients will receive preconditioning with modified fludarabine and cyclophosphamide as used in the Company’s ongoing synovial sarcoma study. This multi-tumor study will enroll up to 32 patients.
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Sierra Oncology Successfully Transfers Sponsorship of SRA737 Clinical Trials
On January 9, 2017 Sierra Oncology, Inc. (NASDAQ: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported that it has successfully transferred sponsorship of the two ongoing Phase 1 clinical trials evaluating its Checkpoint kinase 1 (Chk1) inhibitor, SRA737, from the Cancer Research UK Centre for Drug Development to the company (Press release, ProNAi Therapeutics, JAN 9, 2017, View Source [SID1234517317]). In accordance with the license agreement for SRA737, a $2.0 million fee is due to CRT Pioneer Fund LP for the achievement of this milestone. Schedule your 30 min Free 1stOncology Demo! "SRA737 targets Chk1, a key cell cycle checkpoint and central regulator of the DDR network, an exciting emerging target in oncology that has broad clinical and commercial potential," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We are pleased to announce that the formal transfer of sponsorship to Sierra Oncology of these two actively recruiting clinical trials was completed as planned and ahead of schedule. Our goal is to provide an update from these studies within twelve months that will further inform our development strategy."
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Professor Paul Workman, Chief Executive and President of The Institute of Cancer Research, London, added, "Working with Sierra Oncology, we have made very promising progress with these studies. I’m confident that SRA737 – which was discovered here at the ICR – is in excellent hands for the future. Sierra is developing a sophisticated strategy for advancing SRA737 and we look forward to continuing to collaborate in taking this agent forward together for the benefit of cancer patients."
In September 2016, Sierra Oncology licensed the exclusive worldwide rights to SRA737, a highly selective, orally available, small molecule inhibitor of Chk1. SRA737 was discovered and initially developed by scientists in the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research (ICR) in collaboration with Sareum Holdings plc (LSE AIM: SAR), with funding provided by Cancer Research UK, the ICR and Sareum. SRA737 is being investigated in two recently initiated Phase 1 clinical trials in patients with advanced solid tumors: a monotherapy trial and a trial of SRA737 in combination with chemotherapy. (ClinicalTrials.gov identifiers: NCT02797964 and NCT02797977).
"Working with the ICR and The Royal Marsden NHS Foundation Trust, we are charting an expanded and optimized development plan for SRA737. In particular, we are keen to evaluate SRA737’s potential to induce synthetic lethality as monotherapy in certain genetically-defined patient cohorts, while also exploring its potentiating effects in combination with chemotherapy," added Dr. Barbara Klencke, Chief Development Officer of Sierra Oncology. "Concurrently we are also conducting preclinical research evaluating SRA737 in combination with other DDR agents including PARP inhibitors and our proprietary Cdc7 inhibitor, SRA141, as well as with immuno-oncology therapeutics. Results of this research, expected in late 2017, will guide a potential next wave of clinical development for our asset, possibly further broadening its therapeutic utility."