On May 8, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Genmab, MAY 8, 2018, View Source [SID1234526185]). The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in November 2017. The U.S. FDA subsequently granted priority review to the sBLA, with a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2018. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With this label expansion, DARZALEX becomes the first antibody therapeutic to be approved for patients with newly diagnosed multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This is an important step forward as it provides an additional treatment option to patients who are newly diagnosed with multiple myeloma."

The approval was based on data from the Phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50 percent (Hazard Ratio [HR] = 0.50; 95 percent CI [0.38-0.65], p<0.0001) in patients with newly diagnosed multiple myeloma ineligible for ASCT when daratumumab is combined with VMP. The safety of DARZALEX combination therapy was consistent with the known safety profiles of DARZALEX monotherapy and of therapy with bortezomib, melphalan and prednisone, respectively. This data was presented as a Late-Breaking Abstract at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine in December, 2017.

About the ALCYONE study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter study that included 706 newly diagnosed patients with multiple myeloma who are ineligible for ASCT. Patients were randomized to receive 9 cycles of either VMP [bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid)] combined with daratumumab, or VMP alone. In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for six weeks (cycle 1; 1 cycle = 42 days), once every three weeks from cycles 2 to 9, and once every 4 weeks from cycle 9 until disease progression. The primary endpoint of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 30,770 new patients are expected to be diagnosed with multiple myeloma and approximately 12,770 people are expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 124,225 people would be diagnosed and 87,084 would die from the disease in 2015.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, myelodysplastic syndromes, B and T-ALL and selected solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On May 8, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from its early and late-stage clinical studies, on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from 1-5 June, in Chicago, IL, United States (Press release, Hoffmann-La Roche, MAY 8, 2018, View Source [SID1234526184]). More than 180 abstracts have been accepted across 13 cancer types, including two "late breakers" and 15 oral presentations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"New data to be presented from our industry-leading oncology portfolio, including our lung and haematology programmes, will demonstrate how our science-driven approach aims to improve outcomes for people living with cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "At ASCO (Free ASCO Whitepaper), we look forward to sharing our progress and commitment to build the future of personalised healthcare in oncology."

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2018 scientific programme, as well as Roche’s wider progress in cancer care, will be featured during the Roche Media Briefing from 09:00 – 10:45 CDT on Friday, 1 June at the Chicago Marriott Downtown Magnificent Mile, Chicago, IL, US. This event, independently organised by Roche, is open to journalists from outside the United States who have registered as media with the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. To register for the Roche Media Briefing, please follow this link: https://roche.cvent.com/d/6gq8k1/.

Follow Roche on Twitter via @Roche and keep up to date with ASCO (Free ASCO Whitepaper) 2018 congress news and updates by using the hashtag #ASCO18.

Key presentations in lung cancer
Key data to be presented at ASCO (Free ASCO Whitepaper) cover advances from Roche’s lung cancer programme, including a combination approach using the cancer immunotherapy, Tecentriq (atezolizumab) with targeted therapies and a range of different chemotherapies.

Updated OS data and new patient reported outcomes (PROs) data from the Phase III IMpower150 study of Tecentriq plus Avastin (bevacizumab) and chemotherapy (carboplatin and paclitaxel), in people with previously-untreated, advanced non-squamous non-small cell lung cancer (NSCLC), will be presented. The US Food and Drug Administration (FDA) recently granted Priority Review for this combination in the same patient population.

New PFS results from the Phase III IMpower131 study of Tecentriq plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with advanced squamous NSCLC will also be shared and feature as part of ASCO (Free ASCO Whitepaper)’s official press programme on Saturday, 2 June.

Additional results in lung cancer include longer follow-up results from the Phase III ALEX study of Alecensa (alectinib) versus crizotinib in people with previously untreated anaplastic lymphoma kinase (ALK)-positive NSCLC. These data build on the primary results from the ALEX study, first presented at ASCO (Free ASCO Whitepaper) 2017, which demonstrated a significant reduction in the risk of disease progression or death versus crizotinib. New data that utilise the application of a real world endpoint to identify and characterise genetic profiles of people with a poor prognosis in advanced NSCLC will also be presented at the congress.

Additional presentations with cancer immunotherapy
Additional cancer immunotherapy data presentations of note include new Tecentriq plus Avastin PROs from the Phase III IMmotion151 study in advanced renal cell carcinoma (RCC), and Phase Ib data for the combination of Tecentriq plus Avastin in first-line hepatocellular carcinoma (HCC). These studies add to the growing body of evidence that support the use of Tecentriq plus Avastin across multiple tumour types.

New tumour mutational burden (TMB) data from two studies of Tecentriq will also be presented, including blood-based TMB data from the Phase II B-F1RST study in advanced NSCLC, and tissue-based TMB data across multiple tumour types including NSCLC, metastatic urothelial carcinoma and melanoma.

Key presentations in blood cancers
Data from pivotal studies in haematology will also be presented at ASCO (Free ASCO Whitepaper). Additional analyses on minimal residual disease (MRD) rates will be shared from the Phase III MURANO study evaluating Venclexta/Venclyxto (venetoclax) plus MabThera/Rituxan (rituximab), compared to bendamustine plus MabThera/Rituxan, in people with relapsed or refractory chronic lymphocytic leukaemia (CLL). A supplemental new drug application (sNDA) based on the MURANO data was granted Priority Review by the FDA, with an action date of 28 June 2018.

Additional data will also be presented from the Phase Ib M14-358 study of Venclexta/Venclyxto plus azacitidine or decitabine in people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Data from the randomised Phase II study evaluating polatuzumab vedotin in combination with bendamustine chemotherapy and MabThera/Rituxan in people with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) will also be presented at the meeting.

Key presentations in breast cancer
Updates from two investigational medicines in breast cancer will be presented at ASCO (Free ASCO Whitepaper). Data includes results from the Phase III SANDPIPER study of taselisib (GDC-0332) and fulvestrant, compared to fulvestrant alone, in estrogen receptor (ER)-positive, PIK3CA-mutant, locally advanced or metastatic breast cancer, and updated OS data from the LOTUS trial of ipatasertib (GDC-0068, RG7440) and paclitaxel for previously untreated, locally advanced or metastatic, triple-negative breast cancer. The SANDPIPER data will be featured as part of ASCO (Free ASCO Whitepaper)’s official press programme on Saturday, 2 June.

Overview of key presentations featuring Roche medicines at ASCO (Free ASCO Whitepaper) 2018

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies.

For more information on Roche’s approach to cancer, visit Roche.com.

On May 8, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the first quarter ended March 31, 2018 (Press release, BioCryst Pharmaceuticalsa, MAY 8, 2018, View Source [SID1234526183]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are off to a strong start in 2018 as we continue to make progress advancing all our HAE development programs and remain on track to read out top line data from APeX-2 in the first half of next year," said Jon P. Stonehouse, BioCryst’s President and Chief Executive Officer. "We remain excited about our proposed merger with Idera Pharmaceuticals, Inc., which we believe will create greater and more sustainable value for the benefit of our stockholders and our patients. We look forward to positive data readouts from Idera in early June, which would reinforce the value creation potential in combining our synergistic discovery engines and creating a more robust and diversified late-stage pipeline."

First Quarter 2018 Financial Results

For the three months ended March 31, 2018, total revenues were $4.0 million, compared to $9.4 million in the first quarter of 2017. The decrease in revenue was primarily associated with infrequent revenue events that occurred in 2017 that did not recur in 2018. Those 2017 events were the recognition of $4.1 million of royalty revenue from Japanese government stockpiling of RAPIACTA and a $2.0 million payment for the Canadian regulatory approval of RAPIVAB.

Research and Development ("R&D") expenses for the first quarter of 2018 increased to $18.4 million from $16.8 million in the first quarter of 2017, primarily due to additions in R&D personnel and increased spending on our hereditary angioedema ("HAE") and preclinical programs. These increases were partially offset by a decrease in the Company’s peramivir and galidesivir development spending in 2018.

General and administrative ("G&A") expenses for the first quarter of 2018 increased to $7.6 million, compared to $3.1 million in the first quarter of 2017. The increase was primarily due to approximately $4.7 million of merger-related costs associated with the Company’s pending merger with Idera Pharmaceuticals, Inc. ("Idera").

Interest expense was $2.2 million in the first quarter of 2018, compared to $2.1 million in the first quarter of 2017. Also, a $1.8 million mark-to-market loss on the Company’s foreign currency hedge was recognized in the first quarter of 2018, as compared to a $1.5 million mark-to-market loss in the first quarter of 2017. These changes result from periodic changes in the U.S. dollar/Japanese yen exchange rate.

Net loss for the first quarter of 2018 was $25.8 million, or $0.26 per share, compared to a net loss of $14.2 million, or $0.19 per share, for the first quarter 2017.

Cash, cash equivalents and investments totaled $137.5 million at March 31, 2018, and reflect a decrease from $159.0 million at December 31, 2017. Net operating cash use for the first quarter 2018 was $22.9 million.

Clinical Development Update & Outlook

On February 28, 2018, BioCryst announced the dosing of the first patient in APeX-S, a long-term safety trial evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment in patients with HAE. APeX-S is an open label two-arm trial to evaluate the safety of two dose levels of BCX7353 (110 mg once daily and 150 mg once daily) over 48 weeks in patients with Type I and II HAE. The trial will enroll approximately 160 patients.

On March 15, 2018, BioCryst announced the dosing of the first patient into APeX-2, a Phase 3 clinical trial evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. APeX-2 is a randomized, double-blind, placebo-controlled, three-arm trial testing two doses of BCX7353 (110 mg and 150 mg) for prevention of angioedema attacks. The trial is expected to enroll approximately 100 patients with Type I and II HAE in the United States, Canada and Europe. The primary efficacy endpoint of APeX-2 is the rate of angioedema attacks over 24 weeks of study drug administration.

Enrollment in both the 750 mg and 500 mg cohorts of the ZENITH-1 proof-of-concept Phase 2 clinical trial liquid formulation of BCX7353 for treatment of acute angioedema attacks in HAE have been completed, and the 250 mg cohort is enrolling. We expect to report top-line results from the first cohort in the second half of 2018.

On May 1, 2018, BioCryst announced that the European Medicines Agency ("EMA") has approved peramivir with the brand name of ALPIVABTM, a single intravenous infusion for the treatment of uncomplicated influenza in adults and children from the age of 2 years. The EMA approval of ALPIVAB under the centralized licensing procedure provides marketing authorization for all 28-member states of the European Union, Norway and Iceland.

BioCryst has a license agreement with Seqirus regarding peramivir. As previously disclosed, BioCryst and Seqirus are engaged in a formal dispute resolution process involving many items under the contract including, but not limited to, the EMA approval milestone of $5 million, which BioCryst maintains is due.

In April 2018, the Therapeutic Goods Administration approved RAPIVAB (peramivir injection), an intravenous treatment for acute influenza, for commercial sale in Australia.
Financial Outlook for 2018

Based upon development plans and awarded government contracts, on a stand-alone basis, BioCryst continues to expect its 2018 net operating cash use to be in the range of $67 to $90 million, and its 2018 operating expenses to be in the range of $85 to $110 million. With merger-related costs and the aggressive advancement of programs thus far, it is expected the Company will trend to the upper-end of both ranges. The Company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst’s leadership team will host a conference call and webcast Tuesday, May 8, 2018 at 11:00 a.m. Eastern Time to discuss these financial results and recent corporate developments. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed live or in archived form in the "Investors" section of the Company’s website at www.BioCryst.com. An accompanying slide presentation may also be accessed via the BioCryst website. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

Special Meetings of Stockholders

On April 10, 2018, BioCryst and Idera jointly announced that they have each rescheduled their respective Special Meetings of Stockholders to vote on the proposed merger of BioCryst and Idera to July 10, 2018 at 10:00 a.m. Eastern Time.

The BioCryst Board of Directors unanimously recommends that BioCryst stockholders vote "FOR" the proposed merger at the BioCryst Special Meeting.

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 has been generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks

On May 8, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported a strategic collaboration with Carna Biosciences, Incorporated ("Carna"). Carna will access Evotec’s INDiGO platform to accelerate the development of its programme CB-1763, which is being developed for the treatment of blood cancer, through to the submission of an Investigational New Drug Application ("IND") with the U.S. Food and Drug Administration (Press release, Evotec, MAY 8, 2018, View Source [SID1234526179]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to initiate IND-enabling studies for our next-generation non-covalent BTK inhibitor, CB-1763, in collaboration with Evotec", said Dr Masaaki Sawa, Chief Scientific Officer at Carna Biosciences. "We’ve been working with Evotec from last year and found they are a really reliable partner. We believe Evotec’s INDiGO programme and their team will help us to accelerate the development of our CB-1763 and we are confident that we will achieve our goal to reach IND-filing in the first half of 2019."

Dr Mario Polywka, Chief Operating Officer of Evotec, added: "This development of Carna’s key project directly reflects the success of our comprehensive and industry-unique INDiGO service. We are delighted to support Carna’s CB-1763 inhibitor programme, an innovative approach to blood cancer, through to the clinic. Additionally, working with Carna also highlights our increasing presence in the Japanese market."

Carna has another reversible BTK inhibitor in pre-clinical development, AS-871, a novel non-covalent BTK inhibitor targeting autoimmune diseases. AS-871 is also undergoing IND-enabling studies in collaboration with Evotec.

About Evotec’s INDiGO platform The INDiGO platform is a key value-generating component of Evotec’s broad EVT Execute business segment. INDiGO accelerates early drug candidates into the clinic by reducing time from nomination to regulatory submission in 52 weeks, and under circumstances, even less. We achieve accelerated development by tightly integrating traditional drug silos into a single project managed under one roof. The programme has been proven to reduce time and cost while achieving a quality data package for CTA/IND level regulatory filings.

Evotec’s INDiGO projects are managed by our most experienced, dedicated project managers and leading world-class drug development professionals implementing tailored development strategies designed specifically for the molecule, therapeutic area and strategic needs. The project plan is designed to integrate development areas: API Manufacture, Formulation Development, Clinical Supply, Safety Assessment, DMPK, Bioanalysis Studies and Regulatory Submission Documents Preparation.

ABOUT CARNA BIOSCIENCES, INC.

Carna Biosciences is a biopharmaceutical company focused on the discovery and development of kinase inhibitor drugs to address serious unmet medical needs. Carna has intensively focused its research efforts primarily in the areas of oncology and autoimmune/inflammation, where the company believes its extensive expertise in kinases can be most effectively leveraged. Taking advantage of Carna’s proprietary platform technologies and highly focused kinase expertise, the company continues to challenge to identify and develop innovative drugs. Carna is a publicly traded company in the JASDAQ of the Tokyo Stock Exchange with securities code 4572. For more information, please visit www.carnabio.com.

ABOUT CB-1763

CB-1763 is a highly selective, orally bioavailable, non-covalent inhibitor of Bruton’s tyrosine kinase (BTK) with a potential application in the treatment of blood cancer. Recent studies have indicated that the emergence of BTK mutations causes ibrutinib resistance. A selective and non-covalent BTK inhibitor is therefore highly demanded to overcome the emerging unmet medical need of ibrutinib resistance. CB-1763 is a next-generation non-covalent BTK inhibitor, designed to inhibit both BTK wild type and BTK C481 mutants in a highly selective and reversible manner.

MEDIA CONTACT:
CORPORATE PLANNING
CARNA BIOSCIENCES, INC.
TEL: +81-78-302-7075

On May 8, 2018 Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") and Shire plc (LON: SHP) ("Shire") reported that they have reached agreement on the terms of a recommended offer pursuant to which Takeda will acquire the entire issued and to be issued ordinary share capital of Shire (Press release, Takeda, MAY 8, 2018, View Source [SID1234526178]). Under the terms of the acquisition, each Shire shareholder will be entitled to receive $30.33 in cash for each Shire share and either 0.839 new Takeda shares or 1.678 Takeda ADSs. The transaction has been approved by both companies’ boards of directors, and is expected to close in the first half of calendar year 2019. Upon the closing of the transaction, Takeda shareholders will own approximately 50 percent of the combined group.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With leading market positions in prioritized therapeutic areas, an attractive geographic footprint, greater scale and efficiencies, and an even more productive R&D engine, the combined group will be better positioned to deliver highly-innovative medicines and transformative care providing better health and a brighter future for patients around the world.

"Since its inception, Takeda has transformed into an agile, R&D-driven global pharmaceutical company that is well-positioned to deliver innovative and transformative care to patients around the world," said Christophe Weber, president and chief executive officer of Takeda. "Shire’s highly complementary product portfolio and pipeline, as well as experienced employees, will accelerate our transformation for a stronger Takeda. Together, we will be a leader in providing targeted treatments in gastroenterology, neuroscience, oncology, rare diseases and plasma-derived therapies. We are looking forward to the benefits this combination will bring to patients worldwide, the opportunities it will bring for our employees and the returns it will deliver for our shareholders."

Susan Kilsby, chairman of Shire, said, "Over the last 30 years, Shire has become the global leader in treating rare diseases, delivering innovative products that transform patients’ lives. With this combination, Shire helps create an even stronger biopharmaceutical company, with a robust R&D pipeline and expanded global footprint. We are proud of what Shire has become and are grateful to all Shire employees for their contributions. We firmly believe that this combination recognizes the strong growth potential of our leading products and innovative pipeline and is in the best interests of our shareholders, our patients and the communities we serve."

Flemming Ornskov, chief executive officer of Shire, said, "I would like to thank the entire Shire team for all that we have accomplished over the last five years to transform Shire into a leading rare disease biotech company and a tenacious champion for patients in need. I am confident that this relentless focus will enable us to continue delivering against our priorities throughout this process. With a truly innovative portfolio and pipeline, I believe that the combination of the two companies is in the best interests of shareholders and offers an opportunity to improve the lives of even more patients globally with rare and highly specialized conditions."

Highly Compelling Strategic and Financial Rationale

Brings together complementary positions in GI and neuroscience; provides leading positions in rare diseases and plasma-derived therapies to complement strength in oncology and focused efforts in vaccines

The acquisition of Shire will accelerate Takeda’s transformation by bringing together Takeda and Shire’s complementary positions in GI and neuroscience. It will also provide the combined group with leading positions in rare diseases and plasma-derived therapies to complement strength in oncology and focused efforts in vaccines. Takeda will continue to focus on the acceleration of its oncology business, following its recent acquisition of ARIAD Pharmaceuticals. In addition, Takeda’s vaccine business will continue to address the world’s most pressing public health needs.

Creates a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, with an attractive geographic footprint and provides the scale to drive future development

The acquisition will build on Takeda’s long Japanese heritage and values-based culture to create a global biopharmaceutical leader, driven by innovative and world-class R&D. The combined group will have an attractive geographic footprint, with significantly increased exposure in the United States (U.S.), an important and growing market. In addition, Shire’s portfolio will benefit from Takeda’s strong international presence in emerging markets and Japan. The integrated company will continue to be headquartered in Japan, expand its R&D presence in the Boston area and have major regional locations in Japan, Singapore, Switzerland and the U.S. Together, the combined group will have leading positions in two of the largest drug markets globally: the U.S. and Japan. The acquisition is expected to result in Takeda being the only pharmaceutical company listed on both the Tokyo Stock Exchange in Japan, where it will continue to have its primary listing, and the NYSE in the U.S., enabling it to access two of the world’s largest capital markets.

Creates a highly complementary, robust, modality-diverse pipeline and a strengthened R&D engine focused on breakthrough innovation

Takeda and Shire have highly complementary pipelines. Shire has strong expertise in rare diseases, an attractive modality-diverse mid- and late-stage pipeline, enriched with large-molecule programs, as well as cutting-edge technologies in gene therapy and recombinant proteins. Combining this with Takeda’s early development and research-oriented R&D program will result in a highly complementary, robust, modality-diverse pipeline and a strengthened R&D engine focused on breakthrough innovation. The combined group will build on existing partnerships, including Takeda’s more than 180 active partnerships with academia, biotechnology companies and startups, to further enrich the pipeline.

Enhances Takeda’s cash flow profile, with management committed to delivering substantial annual cost synergies and generating attractive returns for shareholders

The acquisition of Shire will provide compelling financial benefits for the combined group. It will be significantly accretive to underlying earnings per share from the first full fiscal year following completion, and will produce strong combined cash flows. The transaction is also expected to result in attractive returns for shareholders, with the return on invested capital (ROIC) expected to exceed Takeda’s cost of capital within the first full fiscal year following completion. The substantial cash flow generation expected to result from the acquisition will enable the combined group to de-lever quickly following completion. Takeda intends to maintain its investment grade credit rating, with a target net debt to EBITDA ratio of 2.0x or less in the medium term.

Takeda is confident that the acquisition will create an opportunity to recognize significant recurring cost synergies, with potential for additional revenue synergies from the combination of Shire and Takeda’s combined infrastructure, market presence and development capabilities. Takeda expects recurring pre-tax cost synergies for the combined group to reach a run-rate of at least $1.4 billion per annum by the end of the third fiscal year following completion of the acquisition.

The acquisition will accelerate Takeda’s strategic transformation toward Vision 2025, and strong combined cash flows will enable continued investment in R&D. Takeda’s well-established dividend policy will remain a key component of future shareholder returns.

Execution

Takeda’s experienced management team has a proven track record of executing complex business integrations and large-scale transformations, and is well-positioned to successfully integrate Shire and maximize the value of the combination. The integration will be supported by the companies’ highly complementary organizational structures in geographic areas, including hubs in the Boston area, Switzerland and Singapore, as well as similar therapeutic area focus and complementary approaches to R&D. Takeda is dedicated to carrying out integration efforts in a manner consistent with the company’s core values of integrity, fairness, honesty and perseverance, building on the expertise of employees of both companies.

Transaction Terms

Under the terms of the acquisition, Shire shareholders will be entitled to receive, for each Shire share, $30.33 in cash and either 0.839 new Takeda shares or 1.678 Takeda ADSs.

The acquisition terms imply an equivalent value of:

£48.17 per Shire share based on the closing price of ¥4,535 per Takeda share on May 2, 2018, and the exchange rates of £:¥ of 1:147.61 and £:$ of 1:1.3546 on May 4, 2018 (being the latest practicable date prior to this announcement); and
£49.01 per Shire share based on the closing price of ¥4,923 per Takeda Share and the exchange rates of £:¥ of 1:151.51 and £:$ of 1:1.3945 on April 23, 2018 (being the day prior to the announcement that the Shire board would, in principle, be willing to recommend the consideration).

The equivalent value of £49.01 per Shire share values the entire issued and to be issued ordinary share capital of Shire at approximately £46 billion.

Immediately following completion of the transaction, Takeda shareholders will hold approximately 50 percent of the combined group.

The transaction has been approved by the boards of both companies, and is subject to the approval of Shire and Takeda shareholders and certain customary closing conditions, including regulatory approvals.

The acquisition is expected to close in the first half of calendar year 2019. Upon completion, the new Takeda shares will be listed on the Tokyo Stock Exchange, and local Japanese stock exchanges. In addition, Takeda will apply for its ADSs (each representing 0.5 Takeda shares) to be listed on the NYSE effective on or shortly after the effective date.

Financing

Takeda has entered into a bridge facility agreement of $30.85 billion with, among others, J.P. Morgan Chase Bank N.A., Sumitomo Mitsui Banking Corporation and MUFG Bank, Ltd., part of the proceeds of which will be used to fund the cash consideration payable to Shire shareholders in connection with the acquisition. It is currently contemplated that, prior to completion, the commitments under the bridge facility agreement will be reduced or refinanced with a combination of long-term debt, hybrid capital and available cash resources.

Conference Call Webcast Information

Takeda will host a transaction conference call at 4.15pm – 5pm JST / 8.15am – 9am BST / 3.15am – 4am EST on May 8, 2018 to discuss the transaction.

Investors and analysts can dial in to the conference call using the numbers below:

Standard International Access: +44 (0) 20 3003 2666; Japan Toll Free: 006633132499; UK Toll Free: 0808 109 0700; USA Toll Free: 1 866 966 5335; Tokyo Toll Free: +81 (0) 3 5050 5366; and Passcode: 161017

A presentation for the call will be available at:

View Source

Takeda will host an additional audio webcast at 10.00 p.m. JST / 2.00 p.m. BST / 9.00 a.m. ET on May 8, 2018 with Japanese translation, to discuss the transaction. The webcast can be accessed at the following link:

View Source

Replays of the conference calls will be available within 24 hours.

For more information, the full Rule 2.7 announcement setting out full details of the offer to Shire shareholders is available at: View Source