On February 3, 2017 Tactiva Therapeutics LLC, a new biotech company spun off from Roswell Park Cancer Institute, will create jobs as it develops some of the most promising concepts in the burgeoning field of cancer immunotherapy and accelerates the timeline for getting beneficial therapies to patients (Press release, Roswell Park Cancer Institute, FEB 3, 2017, View Source [SID1234518860]). Schedule your 30 min Free 1stOncology Demo! Founded by a trio of Buffalo entrepreneurs, Tactiva will pursue and expand concepts originating from Roswell Park’s Center for Immunotherapy. Located within the New York State Center of Excellence in Bioinformatics and Life Sciences, immediately adjacent to Roswell Park laboratories and research support facilities, the company will create employment opportunities within the life sciences and develop new therapies designed to give cancer patients better, more effective treatment options.
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"The new biotech company spun off from Roswell Park Cancer Institute showcases the potential for New York innovation to impact lives around the world," said Lieutenant Governor Hochul during an announcement at Roswell Park today. "Tactiva Therapeutics is a perfect example of how government, business and academia can join forces to accomplish great things, including creating more jobs for Western New York."
Tactiva’s lead platform is a unique approach to adoptive cell transfer (ACT), a form of immunotherapy in which a patient’s own immune cells are drawn from blood, genetically engineered, multiplied and injected back into the patient in order to launch a powerful attack against cancer. Tactiva’s novel therapies use particular types of immune cells and cell reengineering processes that have never been employed before, in a way that may prove beneficial for patients with many different kinds of cancer.
There are two main types of T cells, or T lymphocytes, within the immune system — the so-called "helper" T cells, and the "killer" T cells. Through preclinical studies at Roswell Park, the Tactiva team developed a way to make "helper" CD4 T cells also act as "killer" CD8 T cells that can destroy tumor cells, significantly extending the durability of the antitumor response.
"We’re using fundamental principles of how the immune system works to enhance the body’s own ability to attack and eliminate cancer cells," says Tactiva Co-Founder and Chief Medical Officer Kunle Odunsi, MD, PhD, FRCOG, FACOG, also Deputy Director, Chair of Gynecologic Oncology and Center for Immunotherapy Executive Director at Roswell Park. "We’re making the two main types of immune cells work together in a way that has never been tried before, and which we believe will have long-lasting effects for patients with some of the most persistent, hard-to-treat cancers."
Tactiva plans to initiate a clinical trial within the next year that will make this novel platform available to patients for the first time. Preclinical studies suggest that the Tactiva platform may be an effective approach for treating several different solid and liquid tumors, including some ovarian, pancreatic, prostate, lung, esophageal, melanoma and sarcoma cancers, as well as some forms of multiple myeloma.
"We will take a patient’s own stem cells, hematopoietic stem cells that are the progenitors of all other blood cells, and engineer them to express specialized T-cell receptors that recognize and target cancer cells without damaging healthy cells," adds Richard Koya, MD, PhD, Co-Founder and Chief Scientific Officer for Tactiva as well as Associate Director of the Roswell Park Center for Immunotherapy. "The self-perpetuating nature of the stem cells gives them the ability to provide lifelong protection against cancer, standing on guard like a sentry. While much will depend on our early clinical trials, we believe this may be a highly effective way to deliver a lethal and enduring hit to the tumor cells."
"This is a potent combination of benefits, and our team’s preclinical findings convince us that this is a highly promising approach for treating cancer and keeping it at bay for many years," says Tactiva co-founder and Chief Executive Officer Matthew Colpoys Jr., who has held numerous leadership positions during his three decades working in the pharmaceutical and medical-technology industries.
This strategy is a broadly applicable model that may, if it proves to be effective, be adapted to many different antigens and employed in a variety of different cancers, notes Dr. Odunsi, who is also Professor of Gynecology & Obstetrics in the University at Buffalo’s Jacobs School of Medicine and Biomedical Sciences.
The foundational concepts that Tactiva will develop were established in large part thanks to grants to Dr. Odunsi and his team totaling $25 million from the National Cancer Institute and New York State Stem Cell Science Program (NYSTEM).
"We’ve been excited about immunotherapy for a long time because of its great potential in treating cancer and improving quality of life for cancer patients," says Roswell Park President and CEO Candace Johnson, PhD. "Tactiva has developed a unique approach that shows great promise, advancing one of our key goals: to develop our best ideas and get them quickly to the patients who can benefit most from them."
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About Roswell Park:
The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email [email protected]. Follow Roswell Park on Facebook and Twitter.
About Tactiva Therapeutics LLC:
Tactiva Therapeutics is an immuno-oncology company specializing in potent cancer immunotherapy using a dual T cell receptor approach. For more information, visit www.tactivatherapeutics.com
Month: February 2017
FibroGen Announces Publication of Pamrevlumab (FG-3019) Clinical Data in Pancreatic Cancer Showing Safety and Improved Survival Outcomes in Combination with Chemotherapy
On February 3, 2017 FibroGen, Inc., (NASDAQ:FGEN), a science-based biopharmaceutical company, reported that clinical results from the company’s open-label, dose-escalation Phase 1/2 study (FGCL-MC3019-028) of pamrevlumab in pancreatic cancer were published in the Journal of Cancer Clinical Trials (Picozzi et al., J Cancer Clin Trials 2017, 2:123) (Press release, FibroGen, FEB 3, 2017, View Source [SID1234517629]). The published results support a dose-related increase in survival in advanced pancreatic cancer, and that pamrevlumab can be safely combined with chemotherapy. Pamrevlumab is first-in-class fully human monoclonal therapeutic antibody that inhibits connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders. Schedule your 30 min Free 1stOncology Demo! "The data showing improved survival with pamrevlumab suggest a role for CTGF in the interactions of cancer cells and stroma responsible for tumor proliferation in PDAC," said Vincent J. Picozzi, Jr., M.D., Director of the Pancreas Center, Virginia Mason Hospital & Seattle Medical Center and lead author. "These results provide further support for the clinical evaluation of pamrevlumab in combination with chemotherapy, and evidence that pamrevlumab can be safely combined with chemotherapy without incremental toxicity in advanced pancreatic cancer patients."
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In the 028 trial, the safety and efficacy of increasing doses of pamrevlumab were evaluated in combination with two chemotherapy agents, gemcitabine and erlotinib, in 75 patients with previously untreated Stage III or Stage IV pancreatic ductal adenocarcinoma. Pamrevlumab was well tolerated with no dose-limiting toxicity observed and no dose-related trends observed in type or incidence of serious adverse events. Toxicity, tumor response by CA19-9 and CT scan-based RECIST criteria, progression-free survival (PFS) and overall survival (OS) were assessed. In a post-hoc analysis, FG-3019 trough plasma levels (a measure of exposure) on Day 15 (D15Cmin) and baseline CTGF levels were correlated with clinical outcomes. High FG-3019 exposure (D15 Cmin ≥150 μg/mL) was associated with improved median OS (9.0 vs 4.4 months, (D15 Cmin <150 μg/mL), p=0.024), and one-year OS rate (34.2% vs. 10.8%, respectively, p=0.026), respectively. Plasma CTGF showed potential as a prognostic biomarker, as low baseline CTGF levels (<10 ng/mL) were associated with improved OS (10.1 vs 4.4 months (≥10 ng/mL), p=0.028).
About Pancreatic Ductal Adenocarcinoma and Connective Tissue Growth Factor
Pancreatic ductal adenocarcinoma (PDAC), or pancreatic cancer, is the fourth leading cause of cancer deaths in the United States. According to the National Cancer Institute, in 2016, there were approximately 53,000 new cases of pancreatic cancer projected in the United States alone. Pancreatic cancer is aggressive and typically not diagnosed until it is largely incurable. Most patients are diagnosed after the age of 45, and overall five-year survival is about 7%, due to many factors, including advanced stage at diagnosis and limited response to currently available therapies (View Source). PDAC tumors often exhibit a high degree of desmoplasia, characterized by extensive connective tissue stroma and elevated levels of Connective Tissue Growth Factor (CTGF). Cancer-stroma interactions affect tumorigenesis, angiogenesis, resistance to therapy and metastatic spread of tumor cells. CTGF is overexpressed in PDAC and facilitates local desmoplasia, tumor progression and metastasis in animal models.
About Pamrevlumab
Pamrevlumab (FG-3019) is an investigational therapeutic antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. FibroGen is currently conducting clinical studies of pamrevlumab in idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy.
In desmoplastic, or fibrotic, cancers such as pancreatic cancer, CTGF in the extensive fibrous stroma associated with the tumor promotes abnormal proliferation of stromal cells and tumor cells.
FDA Accepts Two sBLAs for Merck’s KEYTRUDA® (pembrolizumab) for Locally Advanced or Metastatic Urothelial Cancer in Cisplatin-Ineligible First-Line and Second-Line Post-Platinum Failure Treatment Settings
On February 3, 2017 Merck & Co (NYSE:MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer (Press release, Merck & Co, FEB 3, 2017, View Source [SID1234517626]). Specifically, the application for first-line use was accepted and granted Priority Review for the treatment of these patients who are ineligible for cisplatin-containing therapy. The application for second-line use was also accepted and granted Priority Review for these patients with disease progression on or after platinum-containing chemotherapy. The PDUFA, or target action, date for both applications is June 14, 2017. Schedule your 30 min Free 1stOncology Demo! "Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "The data with KEYTRUDA administered to patients with advanced urothelial cancer are promising, and we look forward to working with the FDA throughout the review process with the goal of bringing KEYTRUDA to patients who may benefit as quickly as possible."
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The FDA previously granted Breakthrough Therapy Designation to KEYTRUDA for the second-line treatment of patients with locally advanced or metastatic urothelial cancer with disease progression on or after platinum-containing chemotherapy.
The applications, which are seeking approval for KEYTRUDA (pembrolizumab) monotherapy at a dose of 200 mg administered intravenously every three weeks, are based on data from the phase 2 KEYNOTE-052 trial and the phase 3 KEYNOTE-045 trial, respectively. KEYNOTE-052 is an open-label study investigating KEYTRUDA as a first-line treatment in patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing therapy. KEYNOTE-045 is a randomized study investigating KEYTRUDA as a second-line therapy compared to investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with locally advanced or metastatic urothelial cancer that has recurred or progressed on or after platinum-containing chemotherapy. In October 2016, the company announced that, although it did not show significant improvement in progression-free survival, the trial met its co-primary endpoint of overall survival (OS) and was stopped early at the recommendation of an independent Data Monitoring Committee (DMC).
KEYTRUDA is being evaluated in over 30 tumor types in more than 400 clinical trials, at least half of which combine KEYTRUDA with other cancer treatments.
QB3@953 Facilitates Strategic Alliance between Innovative Start-Up Member and a Sponsor Company
On February 2, 2017 QB3@953, the Bay Area’s premier life science incubator, reported the collaboration between one of its member companies, Telo Therapeutics, and one of its sponsor companies, GlaxoSmithKline (GSK) (Press release, Telo Therapeutics, FEB 2, 2017, View Source [SID1234574485]). Telo Therapeutics is a start-up biotechnology company co-founded by Joe Costello, PhD, UCSF Professor of Neurological Surgery, and Robert Bell, PhD, a former post doc in Dr. Costello’s lab. GSK’s Discovery Partnerships with Academia (DPAc) group recently extended its 2015 collaboration agreement with QB3@953, and has now formed a collaboration with Telo Therapeutics to develop a novel precision medicine with the aim to reverse cancer cell immortality.
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"We’re delighted to collaborate with GSK because of their extensive chemistry resources and drug development expertise," said Dr. Costello.
"This collaboration is a tremendous step forward for Telo, and it will accelerate our development timeline towards patient trials faster than would be possible alone," added Dr. Bell, now CEO of Telo Therapeutics.
"Telo is exactly the type of innovative target concept that we were hoping to see through our collaboration with QB3@953," said Carolyn Buser-Doepner, Head of the GSK DPAc team. "The principal scientists and their innovative, early target concept are an excellent fit for the DPAc model."
Telo first became a member of QB3@953 and then a collaborator with GSK’s DPAc team as well as the recipient of GSK’s "golden ticket" lab bench at QB3@953. The "golden ticket" is provided by QB3@953 to allow sponsor companies to select a promising Bay Area biotech company of their choice to allocate use of state-of-the-art research equipment and lab space granted to partners of QB3@953. As a "golden ticket" company, Telo Therapeutics will have access to GSK’s allocated space and equipment for one year while the two companies work together to perform a series of small molecule screens. If promising drug candidates are identified through this collaboration, a longer multi-year partnership between the parties could be established to advance the drug to the clinic.
"The formation of the collaboration between Telo Therapeutics and GSK is a great example of how QB3@953 serves as a launch pad to pair local researchers possessing great science and entrepreneurial aspirations with partner resources necessary to advance innovative programs within new companies," said Doug Crawford, QB3@953 Managing Director.
Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited)
Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 February 2, 2017 Ono Pharmaceutical Co., Ltd. ("The Company") has announced its consolidated financial results for nine months ended December 31, 2016. The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRSs"). This Third Quarter Flash Report 2017 (unaudited) is summary information extracted from the financial statements announced, and the financial statements and the figures contained herein are prepared for reference only for the convenience of readers outside Japan with certain modifications and reclassifications made from the original financial statements presented in Japanese language. The translations of Japanese yen amounts into U.S. dollar amounts are included solely for the convenience of readers outside Japan using the rate of 116 to $1, the approximate rate of exchange at December 30, 2016. Amounts of less than one million yen and one thousand U.S. dollars have been rounded to the nearest million yen and one thousand U.S. dollars in the presentation of the accompanying consolidated financial statements. Financial Highlights Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Revenue ¥ 112,419 ¥ 160,284 ¥ 188,845 $ 1,627,977 Profit (Owners of the parent company) Total equity 483,313 476,255 509,342 4,390,881 Total assets 531,365 540,450 583,405 5,029,353 Basic earnings per share ¥ 36.19 ¥ 47.13 ¥ 80.13 $ 0.69 Diluted earnings per share ¥ 36.19 ¥ 47.13 ¥ 80.13 $ 0.69 (Note) The company conducted a stock split of common stocks at a ratio of 1:5 with an effective date of April 1, 2016. As for "Basic earnings per share" and "Diluted earnings per share", it is calculated assuming that the stock split was conducted at April 1, 2015. 366,140 24,979 19,181 US$ YenYen US$ 42,472 ONO PHARMACEUTICAL CO., LTD. Thousands of US$ Millions of yen 3rd Quarter 3rd Quarter ended Dec. 31, 2015 9 months Annual 12 months ended Mar. 31, 2016 9 months ended Dec. 31, 2016 3rd Quarter 9 months ended Dec. 31, 2016 1 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Revisions of Consolidated Financial Forecasts Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries (1) Revisions to the full-year Consolidated Financial Forecasts Ending March 2017 (April 1, 2016 ~ March 31, 2017) (Unit: Millions of yen, except basic earnings per share) Revenue Operating Profit Profit before Tax Profit Profit (Owners of the Parent Company) Basic earnings per share (Owners of the Parent Company) Previous Forecast (A) * 240,000 54,000 56,000 42,000 41,800 78.86 Revised Forecast (B) 240,000 68,500 70,500 52,500 52,300 98.68 Change (B – A) ― 14,500 14,500 10,500 10,500 ― Change (%) ― 26.9% 25.9% 25.0% 25.1% ― (Reference) Results of the p revious p eriod 160,284 30,507 33,272 25,192 24,979 47.13 (Note) The company conducted a stock split of common stocks at a ratio of 1:5 with an effective date of April 1, 2016. As for "Basic earnings per share", it is calculated assuming that the stock split was conducted at the beginning of the previous period. * The previous forecast was announced on December 21, 2016 (2) Reasons for the revisions Although there was a dispute by filing a patent infringement litigation against sale of the anti-PD-1 antibody product by Merck (USA) and its subsidiaries, it was settled in January 2017. Ono will receive an initial payment and estimates the amount of the initial payment after deducting litigation costs and others as "Other income". Consequently, operating profit is forecasted to be ¥68.5 billion (an increase by ¥14.5 billion from the previous forecast), profit before tax to be ¥70.5 billion (an increase by ¥14.5 billion from the previous forecast), profit for the year attributable to owners of the parent company to be ¥52.3 billion (an increase by ¥10.5 billion from the previous forecast). (Note) The financial forecasts and statements contained in this announcement are made based on information that are available as of the date the announcement is made. Actual results may differ materially from those set forth in the announcements due to various uncertain factors. 2 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Financial Position Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Current assets Cash and cash equivalents ¥ 110,485 ¥ 108,503 $ 935,368 Trade and other receivables 62,043 88,007 758,680 Marketable securities 21,583 19,584 168,829 Other financial assets 800 800 6,897 Inventories 23,232 24,562 211,738 Other current assets 5,430 4,409 38,005 Total current assets 223,573 245,864 2,119,517 Non-current assets Property, plant, and equipment 80,094 82,151 708,198 Intangible assets 38,324 43,211 372,512 Investment securities 182,396 179,335 1,545,990 Investments in associates 982 1,008 8,693 Other financial assets 6,753 26,747 230,579 Deferred tax assets 5,179 1,802 15,538 Other non-current assets 3,149 3,286 28,327 Total non-current assets 316,877 337,541 2,909,836 Total assets ¥ 540,450 ¥ 583,405 $ 5,029,353 As of December 31, 2016 Millions of yen Thousands of US$ ASSETS As o f March 31, 2016 As of December 31, 2016 3 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Income Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Revenue ¥ 112,419 ¥ 188,845 $ 1,627,977 Cost of sales (29,981) (50,268) (433,345) Gross profit 82,438 138,577 1,194,632 Selling, general, and administrative expenses (30,391) (45,159) (389,306) Research and development costs (29,400) (38,980) (336,035) Other income 341 261 2,252 Other expenses (664) (1,396) (12,032) Operating profit 22,324 53,303 459,511 Finance income 3,081 2,937 25,320 Finance costs (257) (75) (645) Share of profit (loss) from investments in associates (37) 27 232 Profit before tax 25,112 56,193 484,419 Income tax expense (5,829) (13,611) (117,340) Profit for the p eriod 19,283 42,581 367,079 Profit for the period attributable to: Owners of the parent company 19,181 42,472 366,140 Non-controlling interests 101 109 940 Profit for the p eriod 19,283 42,581 367,079 Earnings per share: Basic earnings per share 36.19 80.13 0.69 Diluted earnings per share 36.19 80.13 0.69 Yen US$ Millions of yen Thousands of US$ 3rd Quarter 9 months ended Dec. 31, 2015 3rd Quarter 9 months ended Dec. 31, 2016 3rd Quarter 9 months ended Dec. 31, 2016 5 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Comprehensive Income Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Profit for the period ¥ 19,283 ¥ 42,581 $ 367,079 Other comprehensive income: 9,662 10,246 88,326 (1,704) 373 3,218 (1) 111 7,957 10,620 91,555 (32) 23 199 (32) 23 199 Total other comprehensive income (loss) 7,925 10,643 91,754 Total comprehensive income for the period 27,208 53,225 458,834 Comprehensive income for the period attributable to: Owners of the parent company 27,080 53,112 457,861 Non-controlling interests 128 113 972 Total comprehensive income for the period 27,208 53,225 458,834 2016 Millions of yen 9 months 3rd Quarter 2015 ended Dec. 31, 2016 ended Dec. 31, Thousands of US$ 3rd Quarter ended Dec. 31, 9 months 3rd Quarter 9 months Items that will not be reclassified to profit or loss: Net gain (loss) on financial assets measured at fair value through other comprehensive income Remeasurement of defined benefit plans Share of net gain (loss) on financial assets measured at fair value through other comprehensive income of investments in associates Exchange differences on translation of foreign operations Items that may be reclassified subsequently to profit or loss: 6 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Changes in Equity Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Share capital Capital reserves Treasury shares Other components of equity Retained earnings Equity attributable to owners of the parent company Non-controlling interests Total equity Balance at April 1, 2015 ¥17,358 ¥17,080 (¥59,308) ¥45,756 ¥449,690 ¥470,575 ¥4,638 ¥475,213 Profit for the period 19,181 19,181 101 19,283 Other comprehensive income 7,899 7,899 26 7,925 Total comprehensive income for the period – – – 7,899 19,181 27,080 128 27,208 Purchase of treasury shares (40) (40) (40) Cash dividends (19,081) (19,081) (3) (19,084) Share-based payments 16 16 16 Transfer from other components of equity to retained earnings 999 (999) – – Total transactions with the owners – 16 (40) 999 (20,080) (19,105) (3) (19,108) Balance at December 31, 2015 ¥17,358 ¥17,095 (¥59,348) ¥54,654 ¥448,791 ¥478,550 ¥4,763 ¥483,313 Share capital Capital reserves Treasury shares Other components of equity Retained earnings Equity attributable to owners of the parent company Non-controlling interests Total equity Balance at April 1, 2016 ¥17,358 ¥17,103 (¥59,358) ¥43,307 ¥452,983 ¥471,393 ¥4,862 ¥476,255 Profit for the period 42,472 42,472 109 42,581 Other comprehensive income 10,640 10,640 4 10,643 Total comprehensive income for the period – – – 10,640 42,472 53,112 113 53,225 Purchase of treasury shares (23) (23) (23) Cash dividends (20,142) (20,142) (3) (20,145) Share-based payments 30 30 30 Transfer from other components of equity to retained earnings (2,809) 2,809 – – Total transactions with the owners – 30 (23) (2,809) (17,333) (20,135) (3) (20,138) Balance at December 31, 2016 ¥17,358 ¥17,133 (¥59,381) ¥51,138 ¥478,122 ¥504,370 ¥4,972 ¥509,342 Share capital Capital reserves Treasury shares Other components of equity Retained earnings Equity attributable to owners of the parent company Non-controlling interests Total equity Balance at April 1, 2016 $149,640 $147,442 ($511,711) $373,336 $3,905,024 $4,063,732 $41,917 $4,105,649 Profit for the period 366,140 366,140 940 367,079 Other comprehensive income 91,722 91,722 33 91,754 Total comprehensive income for the period ––– 91,722 366,140 457,861 972 458,834 Purchase of treasury shares (194) (194) (194) Cash dividends (173,638) (173,638) (27) (173,665) Share-based payments 258 258 258 Transfer from other components of equity to retained earnings (24,214) 24,214 –– Total transactions with the owners – 258 (194) (24,214) (149,425) (173,574) (27) (173,601) Balance at December 31, 2016 $149,640 $147,700 ($511,905) $440,844 $4,121,739 $4,348,019 $42,862 $4,390,881 Millions of yen Equity attributable to owners of the parent company Millions of yen Equity attributable to owners of the parent company Thousands of US $ Equity attributable to owners of the parent company 7 Third Quarter (April 1 – December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Consolidated Statement of Cash Flows Ono Pharmaceutical Co., Ltd. and Consolidated Subsidiaries Cash flows from operating activities Profit before tax ¥ 25,112 ¥ 56,193 $ 484,419 Depreciation and amortization 4,857 5,651 48,716 Impairment losses 1,182 736 6,349 Interest and dividend income (2,668) (2,836) (24,446) Interest expense 9 10 89 (Increase) Decrease in inventories 2,959 (1,278) (11,017) (Increase) Decrease in trade and other receivables (11,553) (25,959) (223,784) Increase (Decrease) in trade and other payables 1,940 6,432 55,451 Increase (Decrease) in retirement benefit liabilities (6,013) 304 2,624 (Increase) Decrease in retirement benefit assets (87) – – Increase (Decrease) in long-term advances received (526) (319) (2,754) Other (2,722) 6,788 58,521 Subtotal 12,491 45,723 394,167 Interest received 242 114 985 Dividends received 2,456 2,732 23,553 Interest paid (9) (10) (89) Income taxes paid (9,922) (11,401) (98,283) Net cash provided by (used in) operating activities 5,258 37,159 320,333 Cash flows from investin g activitie s Purchases of property, plant, and equipment (5,700) (12,608) (108,686) Purchases of intangible assets (5,811) (6,719) (57,923) Purchases of investments (250) (2,437) (21,009) Proceeds from sales and redemption of investments 22,079 22,341 192,595 Payments into time deposits (600) (20,600) (177,586) Other 392 596 5,134 Net cash provided by (used in) investing activities 10,110 (19,427) (167,476) Cash flows from financin g activitie s Dividends paid to owners of the parent company (18,223) (19,347) (166,789) Dividends paid to non-controlling interests (3) (3) (30) Repayments of long-term borrowings (274) (290) (2,499) Net increase (decrease) in short-term borrowings 92 (37) (319) Purchases of treasury shares (39) (22) (187) Net cash provided by (used in) financing activities (18,446) (19,699) (169,823) Net increase (decrease) in cash and cash equivalents (3,078) (1,968) (16,966) Cash and cash equivalents at the beginning of the period 104,222 110,485 952,455 Effects of exchange rate changes on cash and cash equivalents (40) (14) (121) Cash and cash equivalents at the end of the period ¥ 101,105 ¥ 108,503 $ 935,368 Millions of yen Thousands of US$ 3rd Q uarter 9 months ended Dec. 31, 3rd Q uarter 9 months ended Dec. 31, 2016 3rd Q uarter 9 months ended Dec. 31, 2016 2015 8 Ongoing clinical studies Product Name / Development Code Development Indications Clinical Stage Area In-house / In-license Opdivo Intravenous Infusion (ONO-4538) / BMS-936558 Gastric cancer Phase III USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Malignant pleural mesothelioma Phase III USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Diffuse large B cell lymphoma Phase II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Follicular lymphoma Phase II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Primary central nervous system lymphoma / Testicular malignant lymphoma Phase II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Colon cancer Phase I/II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Solid tumors (triple negative breast cancer, gastric cancer, pancreatic cancer, small cell lung cancer, urothelial cancer, ovarian cancer) Phase I/II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Virus-positive/negative solid tumor Phase I/II USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Hematologic cancer (T-cell lymphoma, multiple myeloma, chronic leukemia, etc.) Phase I USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Chronic myeloid leukemia Phase I USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Hepatitis C Phase I USA Europe In-house (Co-development with Bristol-Myers Squibb Company) Sepsis *7 Phase I USA In-house (Co-development with Bristol-Myers Squibb Company) Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *7: Phase I of Opdivo Intravenous Infusion was initiated for the treatment of Sepsis. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. 17 Third Quarter (April 1– December 31, 2016) Flash Report (unaudited) Nine months ended December 31, 2016 Supplemental Information Status of Development Pipeline as of January 31, 2017 I. Main Pipelines Other than ONO-4538 i. Developments Status in Japan Approved PARSABIV Intravenous Injection for Dialysis (ONO-5163) / AMG-416 / Etelcalcetide Hydrochloride *1 ・ New chemical entities ・ Secondary hyperparathyroidism [Calcium sensing receptor agonist] ・ Injection ・ In-license (Amgen Inc.) Ongoing clinical studies ● Onoact Intravenous Infusion 50 mg / 150 mg (ONO-1101) ・ Additional indication for pediatric use ・ Tachyarrhythmia in low cardiac function [Short acting beta 1 blocker] / Phase II/III ・ Injection ・ In-house Filed KYPROLIS Intravenous Injection (ONO-7057) / Carfilzomib ・ Additional Dosage and Administration ・ Multiple Myeloma [Proteasome inhibitor] ・ Injection ・ In-license (Onyx Pharmaceuticals, Inc.) ● Onoact Intravenous Infusion 50 mg / 150 mg (ONO-1101) ・ Additional indication ・ Ventricular arrhythmia [S hort acting beta 1 blocker] / Phase II/III ・ Injection ・ In-house Ongoing clinical studies Orencia IV (ONO-4164) / BMS-188667 ・ Additional indication ・ Juvenile Rheumatoid Arthritis [T-cell activation inhibitor] / Phase III ・ Injection ・ In-licens e (Bristo l-M y ers S q uibb Com p an y) ONO-2370 / Opicapone ・ New chemical entities ・ Parkinson’s disease [Long acting COMT inhibitor] / Phase II ・ Tablet ・ In-license (Bial) Orencia IV (ONO-4164) / BMS-188667 ・ Additional indication ・ Lupus nephritis[T-cell act ivation inhibitor] / Phase III ・ Injection ・ In-license (Bristol-Myers Squibb Company) ONO-5371 / Metyrosine ・ New chemical entities ・ Pheochromocytoma [Tyrosine hydroxylase inhibitor] / Phase I/II ・ Capsule ・ In-license (Valeant Pharmaceuticals North America LLC.) Orencia SC (ONO-4164) / BMS-188667 ・ Additional indication ・ Rheumatoid Arthritis [T-cell activation inhibitor] / Phase III ・ Injection ・ In-licens e (Bristol-Myers Squibb Company) ONO-7268 MX1 ・ New chemical entities ・ Hepatocellular carcinoma [Therapeutic cancer peptide vaccines] / Phase I ・ Injection ・ In-license (OncoTherapy Science, Inc.) Orencia SC (ONO-4164) / BMS-188667 *2 ・ Additional indication ・ Primary sjögren syndrom e [T-cell activation inhibitor] / Phase III ・ Injection ・ In-licens e (Bristol-Myers Squibb Company) ONO-7268 MX2 ・ New chemical entities ・ Hepatocellular carcinoma [Therapeutic cancer peptide vaccines] / Phase I ・ Injection ・ In-license (OncoTherapy Science, Inc.) KYPROLIS Intravenous In j ection (ONO-7057) / Carfilzomib ・ Additional Dosage and Administration ・ Multiple Myeloma [Proteasome inhibitor] / Phase III ・ Injection ・ In-license (Onyx Pharmaceuticals, Inc.) ONO-2160 / CD ・ New chemical entities ・ Parkinson’s disease [le vodopa pro-drug] / Phase I ・ Tablet ・ In-house ONO-1162 / Ivabradine ・ New chemical entities ・ Chronic heart failure [If channel inhibitor] / Phase III ・ Tablet ・ In-license (Les Laboratoi res Servier) ONO-4059 ・ New chemical entities ・ B cell lymphoma [Bruton’s tyrosine kinase (Btk) inhibitor] / Phase I ・ Capsule ・ In-house ONO-7643 / Anamorelin ・ New chemical entities ・ Cancer anorexia/cachexia [Ghrelin mimetic] / Phase III ・ Tablet ・ In-license (Helsinn Healthcare, S.A.) ONO-8577 ・ New chemical entities ・ Overactive bladder [bladder smooth muscle relaxant] / Phase I ・ Tablet ・ In-house 12 Ongoing clinical studies ONO-4578 *3 ・ New chemical entities ・ Solid tumor [PG receptor (EP4) antagonist] / Phase I ・ Tablet ・ In-house Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *1: A manufacturing and mark eting approval for PARSABIV intravenous injection for dialysis (calcium sensing receptor agonist) was obtained in Japan for the treatment of sec ondary hyperparathyroidism in patients on hemodialysis *2: Phase III of Orencia SC (ONO-4164) / BMS-188667 (T-cell activation in hibitor) was initiated for primary sjögren syndrome. *3: Phase I of ONO-4578 (PG receptor (EP4) antagonist) was initiated for solid tumor. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. ii. Developments Status outside Japan Ongoing clinical studies ONO-4474 ・ New chemical entities ・ Osteoarthritis [Tropomyosi n receptor kinase (Trk) inhibitor] / Phase II ・ Capsule ・ Europe ・ In-house ONO-7475 *5 ・ New chemical entities ・ Acute leukemia [Axl / Mer inhibitor] / Phase I ・ Tablet ・ USA ・ In-house ONO-4059 *4 ・ New chemical entities ・ B cell lymphoma [Bruton’s tyrosine kinase (Btk) inhibitor] / Phase II ・ Capsule ・ USA & Europe ・ Ou t-license (Gilead Sciences, Inc.) ONO-7579 *6 ・ New chemical entities ・ Solid tumor [Tropomyosin receptor kinase (Trk) inhibitor] / Phase I ・ Tablet ・ USA & Europe II. Main Pipelines ONO-4538 etc i. Developments Status in Jap an, South Korea, and Taiwan Approved Product Name / Development Code Development Indications Area In-house / In-license Opdivo Intravenous Infusion (ONO-4538) / BMS-936558 Hodgkin’s lymphoma *1 Japan In-house (Co-development with Bristol-Myers Squibb Company) Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *1: Approval for the partial change in approved items of the manufacturing and marketing approval for Opdivo Intravenous Infusion was obtained in Japan for the treatment of relapsed or refractory classical Hodgkin lymphoma. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. Filed Product Name / Development Code Development Indications Area In-house / In-license Opdivo Intravenous Infusion (ONO-4538) /BMS-936558 Non-small cell lung cancer (Non-Squamous) Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Renal cell carcinoma Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Head and neck cancer Japan Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Gastric cancer *2 Japan In-house (Co-development with Bristol-Myers Squibb Company) Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *2: A supplemental application for Opdivo Intravenous Infusion was filed in Japan fo r the treatment of unr esectable advanced or recurrent gastric cancer for a partial change in the a pproved items of the manufacturing and marketing approval. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. Ongoing clinical studies Product Name / Development Code Development Indications Clinical Stage Area In-house / In-license Opdivo Intravenous Infusion (ONO-4538) /BMS-936558 Head and neck cancer Phase III South Korea In-house (Co-development with Bristol-Myers Squibb Company) Gastric cancer Phase III South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Esophageal cancer Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Esophagogastric junction cancer and Esophageal cancer Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Small cell lung cancer Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) 14 Ongoing clinical studies Product Name / Development Code Development Indications Clinical Stage Area In-house / In-license Opdivo Intravenous Infusion (ONO-4538) /BMS-936558 Hepatocellular carcinoma Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Glioblastoma Phase III Japan In-house (Co-development with Bristol-Myers Squibb Company) Urothelial carcinoma Phase III Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Malignant pleural mesothelioma Phase III Japan In-house (Co-development with Bristol-Myers Squibb Company) Ovarian cancer *3 Phase III Japan In-house (Co-development with Bristol-Myers Squibb Company) Solid tumor (Cervical cancer, Endometrial cancer, Soft tissue sarcoma) Phase II Japan In-house (Co-development with Bristol-Myers Squibb Company) Primary central nervous system lymphoma / Testicular malignant lymphoma Phase II Japan In-house (Co-development with Bristol-Myers Squibb Company) Virus-positive/negative solid tumor Phase I/II Japan South Korea Taiwan In-house (Co-development with Bristol-Myers Squibb Company) Biliary tract cancer Phase I Japan In-house (Co-development with Bristol-Myers Squibb Company) Anti-TIGIT Antibody (ONO-4686 / BMS-986207) Solid tumor *4 Phase I/II Japan In-license (Co-development with Bristol-Myers Squibb Company) Urelumab (ONO-4481 / BMS-663513) Solid tumor Phase I Japan In-license (Co-development with Bristol-Myers Squibb Company) Anti-LAG3 Antibody (ONO-4482 / BMS-986016) Solid tumor Phase I Japan In-license (Co-development with Bristol-Myers Squibb Company) Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *3: Phase III of Opdivo Intravenous Infusion was initiated for the treatment of ovarian cancer. *4: Phase I/II of Anti-TIGIT Antibody (ONO-4686 / BMS-986207) was initiated for the treatment of solid tumor. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. ・ In-house ONO-8055 ・ New chemical entities ・ Underactive bladder [PG receptor (EP2 / EP3) agonist] / Phase I ・ Tablet ・ Europe ・ In-house Changes from Second Quarter Flash Repor t for the Fiscal Year ending March 2017 announced on November 7, 2016 *4: Phase II of ONO-4059 (Bruton’s tyrosine kinase (Btk) inhibitor) was initiated for B cell lymphoma. *5: Phase I of ONO-7475 (Axl / Mer inhib itor) was initiated for acute leukemia. *6: Phase I of ONO-7579 (Tropomyosin receptor kinase (Trk) inhibitor) was initiated for solid tumor. * Development of ONO-2952 (TSPO antagonist) for the treatment of irritable bowel syndrome was discontinued due to the strategic reason considering differentia tion among existing product and competing product under development and others comprehensively. * Development of ONO-4232 (PG receptor (EP4) agonist) for the trea tment of acute heart failure was discontinued due to the strategic reason considering future development peri od, development cost, and others comprehensively. Note : "In-house" compounds include a compound ge nerated from collaborative research. In the case of clinical development of the anticancer co mpound in the same indication, the most advanced clinical phase is described. 13
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