At least seven people were killed and 20 injured in a volcanic eruption in Guatemala on Sunday, according to the Associated Press. Hundreds of local residents were evacuated, and officials said an undetermined number of people were missing and feared the death toll would rise, the AP reported. The volcano erupted around noon local time, and lava flowed down the mountain into a nearby village. The AP said four people died when lava caught a house on fire, and two children were burned to death on a bridge. The volcano, Volcan de Fuego, is about 25 miles outside the capital, Guatemala City. Video posted on social media showed cars fleeing a towering cloud of volcanic ash.
It was nice start for Asian stocks on Monday, led by Japan, following end-of-week gains in the U.S. after another solid jobs report.
was up an early 1.2%, helped by declines in the yen; the greenback
was last around ¥109.70 versus ¥109.08 when Friday’s local stock trading wrapped. Big exporters Toyota
were about 3% higher. Oil names opened lower, with crude distributor JXTG
down 0.8% after jumping a combined 4.7% Thursday and Friday while and producer Inpex
shedded 2.1% to erase the gains seen during a three-day rebound through Friday. Brent oil
retreated 1% Friday and was off a further 0.3% Monday morning
Meanwhile, indexes in South Korea
started with 0.4% advances, with the latter’s benchmark having fallen for three straight weeks. New Zealand’s markets are closed for a holiday.
Singapore stocks also opened solidly higher amid broad optimism in the region after Friday’s post-jobs gains in the U.S. After three straight declines, the Straits Times Index
was up 0.7% with banks and property stocks early outperformers, rising more than 1%.
opened lower, contrasting early gains elsewhere in Asia, as the market paused following two days of roughly 1% gains.
CHICAGO, June 04, 2018 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today presented encouraging new data from a Phase 1 study evaluating ivosidenib (AG-120) or enasidenib (IDHIFA®; AG-221) in combination with azacitidine in newly diagnosed isocitrate dehydrogenase (IDH) mutant acute myeloid leukemia (AML) patients. The data were featured at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.
“Patients with newly diagnosed AML who are ineligible for intensive “7+3” chemotherapy typically have poor outcomes and few available treatment options,” said Courtney DiNardo, M.D., lead investigator and assistant professor, department of leukemia at the University of Texas MD Anderson Cancer Center. “With additional patients now treated in the ivosidenib arm of this Phase 1 study, the updated combination data demonstrate a favorable safety profile and impressive response rates vs. those expected with azacitidine alone. I look forward to further demonstrating the clinical benefit of utilizing an IDH inhibitor in combination with traditional frontline AML treatment as part of the ongoing Phase 1 and randomized trials.”
About the Ongoing Phase 1/2 Study
The ongoing Phase 1/2 study is evaluating an investigational use of enasidenib or ivosidenib in combination with azacitidine in patients with newly diagnosed IDH mutant AML unable to receive intensive chemotherapy. In the Phase 1b portion of the study, 23 patients received 500 mg of ivosidenib daily plus azacitidine and 6 patients received enasidenib (n=3 at 100 mg and n=3 at 200mg) daily plus azacitidine.
- As of the March 15, 2018 data cutoff, 19 patients remained on study (17 ivosidenib, 2 enasidenib).
- Enrollment is complete for the ivosidenib Phase 1b portion. Enasidenib and azacitidine continue to be assessed in the randomized Phase 2 portion of the study.
- The most common adverse events (AEs) regardless of causality were nausea (61%, n=14), anemia (52%, n=12) and thrombocytopenia (48%, n=11).
- The most common Grade 3-4 AEs were anemia and thrombocytopenia (44%, n=10 each), and febrile neutropenia (39%, n=9).
- IDH differentiation syndrome was reported in three patients.
- Overall, 78% of patients (18/23) had a response
- The combined CR/CRi/CRp rate was 65% (15/23).
- 44% (10 of 23 patients) had a complete response (CR)
- 22% (5 of 23 patients) had a complete response with incomplete hematologic or platelet recovery (CRi/CRp)
- All patients with a CR, CRi or CRp response remain on treatment as of the data cutoff with patients on study up to 19 months. The median duration of response has not been reached.
- The median time to first response was 1.8 months (range 0.7-3.8 months) and the median time to best response was 3.6 months (range 0.8-6.7 months).
- IDH1 mutation clearance was observed in 7 of 21 patients with available longitudinal VAF profiling
Updated data from the six patients in the enasidenib and azacitidine combination presented in December 2017 were also shown.
- The most common AEs regardless of causality were hyperbilirubinemia (n=5) and abdominal pain, nausea, vomiting and pyrexia (n=4 each).
- The most common Grade 3-4 AEs were anemia and thrombocytopenia (n=3 each) followed by hyperbilirubinemia, neutropenia, lung infection and pneumonia (n=2 each).
- Overall, four out of six patients achieved a response, including 3 CRs and one MLFS.
IDH2 mutation clearance was observed in 3 of 6 patients with available longitudinal VAF profiling
Neither enasidenib nor ivosidenib are approved in any country for the treatment of patients with newly diagnosed AML or approved in combination with azacitidine.
About Acute Myelogenous Leukemia (AML)
AML, a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia affecting adults. Undifferentiated blast cells proliferate in the bone marrow rather than mature into normal blood cells. AML incidence significantly increases with age, and the median age of diagnosis is 68. The vast majority of patients do not respond to chemotherapy and progress to relapsed/refractory AML. The five-year survival rate for AML is approximately 27 percent. IDH1 mutations are present in about 6 to 10 percent of AML cases.
Agios is focused on discovering and developing novel investigational medicines to treat cancer and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutic areas, Agios has an approved oncology precision medicine and multiple first-in-class investigational therapies in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics. For more information, please visit the company’s website at www.agios.com.
About Agios/Celgene Collaboration
IDHIFA® (enasidenib) is part of Agios’ global strategic collaboration with Celgene Corporation focused on cancer metabolism. Under the terms of the 2010 collaboration agreement, Celgene has worldwide development and commercialization rights for IDHIFA® (enasidenib). Agios continues to conduct certain clinical development activities within the IDHIFA® (enasidenib) development program and is eligible to receive reimbursement for those development activities and up to $95 million in remaining payments assuming achievement of certain milestones, and royalties on any net sales. Celgene and Agios are currently co-commercializing IDHIFA® (enasidenib) in the U.S. Celgene will reimburse Agios for costs incurred for its co-commercialization efforts.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding: the potential benefits of TIBSOVO® (ivosidenib) and IDHIFA® (enasidenib); Agios’ plans for the further clinical development of TIBSOVO® and IDHIFA®; and Agios’ strategic plans and prospects. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would,” “could,” “potential,” “possible,” “hope” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Agios’ current expectations and beliefs. For example, there can be no guarantee that any product candidate Agios is developing will successfully commence or complete necessary preclinical and clinical development phases; that positive safety and efficacy findings observed in early stage clinical trials will be replicated in later stage trials; or that development of any of Agios’ product candidates will successfully continue. There can be no guarantee that any positive developments in Agios’ business will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including: Agios’ results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Agios’ ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; Agios’ ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; Agios’ ability to maintain key collaborations, such as its agreements with Celgene; and general economic and market conditions. These and other risks are described in greater detail under the caption “Risk Factors” included in Agios’ public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Agios expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Agios Pharmaceuticals, Inc.
Posted: June 2018
PROVIDENCE, R.I.—Concert-ticketing service Ticketfly worked Sunday to get its system back online after a data breach leaked users’ personal information and disrupted services at live-music venues.
The stolen information included customers’ names, addresses, emails and phone numbers, said the San Francisco firm’s parent company, Eventbrite.
It hasn’t disclosed other details, but a website that tracks data breaches said the hack affected more than 26 million user accounts.
Troy Hunt, who runs the “Have I Been Pwned?” website, said the hack wasn’t as damaging as other breaches because passwords weren’t stolen.
The breach left nightclubs and other venues from Seattle to Providence, R.I., scrambling for alternatives to sell tickets for upcoming shows.
Eventbrite bought rival Ticketfly for $200 million last year from music service Pandora.
—Copyright 2018 the Associated Press
Emerging-markets stocks have been pummeled lately, and the strength of the dollar gets much of the blame.
“The dollar remains the single most important consideration for EM [emerging-markets] finances,” says a report from debt-ratings company Fitch. In general, a stronger dollar tends to mean lower stock prices in emerging markets.
Following a sustained period of weakness, the U.S. currency began to rally in late January, around the time U.S. Treasury Secretary Steven Mnuchin said the U.S. didn’t want a weak dollar. From Jan. 24, the day Mr. Mnuchin spoke, through May 31, the dollar has risen 5.3%, as measured by the trade-weighted dollar index of major currencies.
Over the same period, emerging-markets stocks and funds focused on them have fallen. For instance, Vanguard FTSE Emerging Markets (VWO) exchange-traded fund, which holds a basket of emerging-markets stocks, is down more than 11%.
What is behind the negative correlation between a strong dollar and emerging-markets stocks?
For starters, when the dollar rises, everything that gets priced in other currencies becomes cheaper, including foreign stocks such as those in emerging markets. But that is only part of the story.
Many emerging-markets countries borrow in U.S. dollars despite having their own currency for domestic use. “Borrowing in foreign currency on a meaningful scale is almost entirely an EM phenomenon, spurred by the underdevelopment of local capital markets,” according to Fitch.
While borrowing that way can be a satisfactory arrangement when exchange rates don’t move, it can present problems at other times.
“If the dollar’s value increases, then the debt service will increase,” says David Ader, chief macro strategist at financial firm Informa Financial Intelligence in Westport, Conn. Put another way, Turkey’s bill to pay the interest on the dollar debt will cost more in terms of Turkish lira when the dollar strengthens. That, in turn, can worsen the country’s finances and lead to a deteriorating credit rating, further raising borrowing costs.
On a related note, when an emerging market’s currency falls in value relative to the dollar, the cost of imports into that country rise. Rising import costs frequently increase a trade deficit (or reduce a trade surplus). And depending on the country, its currency may fall even more when the trade deficit widens.
Also, many emerging-markets economies rely on markets for energy, materials or foods for export earnings, says David Marcus, co-founder and chief investment officer of asset-management firm Evermore Global Advisors. Such countries include Brazil, Russia and Nigeria, all of which export energy.
The price of all commodities is inversely correlated to the value of the dollar. So, when the dollar rises, there is a tendency for commodities prices to drop. At a minimum, a dollar surge can subdue commodity rallies.
“That creates lots of swings,” says Mr. Marcus, referring to how such economies boom or slump according to the vagaries of the commodity markets.
Finally, when the dollar rises in value, investors tend to keep their money in the U.S. or at least in U.S. dollar-denominated investments. “The strength of the dollar is a magnet and brings investors here,” Mr. Marcus says. That also means that capital tends to leave emerging markets, sending stocks tumbling as investors sell shares.
Mr. Constable is a writer in Scotland. He can be reached at email@example.com.
Tokyo, Basking Ridge, NJ, and Munich – (June 4, 2018) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the phase 3 ENLIVEN study showed a statistically significant 39 percent overall response rate (ORR) at week 25 based upon central review of MRI scans using Response Evaluation Criteria in Solid Tumors, version 1.1 (the primary endpoint) for patients treated with oral pexidartinib compared to no tumor response among patients who received placebo (P
“Current treatment options for TGCT are largely limited to surgery in order to remove as much of the tumor as possible. Despite the best surgical intervention, the recurrence rate of diffuse TGCT is high and the disease may advance to the point where surgery is no longer an option,” said William D. Tap, MD, lead investigator of the study and Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center in New York City. “Pexidartinib may offer a relevant treatment option for patients with TGCT, which is associated with severe morbidity or functional limitations, and for which surgery is not recommended.”
Pexidartinib is an investigational, oral small molecule that potently inhibits CSF1R (colony stimulating factor-1 receptor), a primary growth driver of abnormal cells in the synovium that cause TGCT.
In the ENLIVEN study, hepatic toxicities were more frequent with pexidartinib versus placebo (AST or ALT ≥3X ULN: 33 percent, total bilirubin ≥2X ULN: 5 percent, N=61). Eight patients discontinued pexidartinib due to hepatic adverse events (AEs); four were serious nonfatal AEs with increased bilirubin, one lasting ~7 months. In non-TGCT development studies using pexidartinib, two severe liver toxicity cases (one required liver transplant, one was associated with death) were observed.
Other AEs noted in ENLIVEN >10 percent and more common with pexidartinib included hair color changes, pruritus, rash, vomiting, abdominal pain, constipation, fatigue, dysgeusia, facial edema, peripheral edema, periorbital edema, decreased appetite and hypertension.
Secondary efficacy endpoints demonstrated that patients treated with pexidartinib had a 56 percent overall response rate (ORR) by Tumor Volume Score (TVS), compared to no response in patients who received placebo (P
“We are encouraged by the results from the ENLIVEN study and we look forward to submitting an NDA to the U.S. FDA and engaging European regulators for review of pexidartinib,“ said Gideon Bollag, PhD, CEO, Plexxikon, a member of the Daiichi Sankyo Group.”
About the ENLIVEN Study
ENLIVEN, a double-blind, randomized, global multi-cener, pivotal phase 3 study, evaluated pexidartinib in patients with symptomatic advanced TGCT for whom surgical removal of the tumor would be associated with potentially worsening functional limitation or severe morbidity. The first part of the study, the double-blind phase, enrolled 120 patients who were randomized (1:1) to receive either pexidartinib or placebo at 1000 mg/d for 2 weeks followed by 800 mg/d for 22 weeks in order to evaluate the efficacy and safety of pexidartinib versus placebo. The primary endpoint of the study was the percentage of patients achieving a complete or partial response after 24 weeks of treatment (Week 25), as assessed with centrally-read MRI scans using RECIST 1.1 criteria. Key secondary endpoints included range of motion, response by tumor volume score, PROMIS physical function, stiffness and measures of pain reduction.
After completing the first part of the study, patients randomized to either pexidartinib or placebo were eligible to take part in the second part of ENLIVEN, a long-term, open-label part where patients could continue to receive or start to receive pexidartinib. In October 2016, following two reported cases of serious, non-fatal liver toxicity in the ENLIVEN study, the data monitoring committee (DMC) recommended that patients receiving placebo in the first part of the study should no longer be eligible to start pexidartinib in the second part of the study. A total of 120 patients who were enrolled prior to the DMC recommendation continued with the study according to the revised protocol.
About TGCT (PVNS/GCT-TS)
Tenosynovial giant cell tumor (TGCT), previously referred to as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is a rare, usually non-cancerous tumor that affects the synovium-lined joints, bursae, and tendon sheaths, resulting in swelling, pain, stiffness and reduced mobility in the affected joint or limb.1,2 It has been estimated that the incidence of TGCT is 11 to 50 cases per million, based on studies from three countries.3-5 Patients are commonly diagnosed in their 20s to 50s,and depending on the type of TGCT, women can be up to twice as likely to develop a tumor as men.6,7
Primary treatment of TGCT includes surgery to remove the tumor. However, in patients with a diffuse form where the tumor can wrap around bone, tendons, ligaments and other parts of the joint, it is more difficult to remove and may require multiple surgeries or joint replacement, eventually advancing to the point where surgical resection is no longer an option and amputation may be considered. It is estimated that the rate of recurrence for diffuse TGCT can be 20 to 55 percent.8
Pexidartinib is an investigational, novel, oral small molecule that potently inhibits CSF1R (colony stimulating factor-1 receptor), which is a primary growth driver of abnormal cells in the synovium that cause TGCT. Pexidartinib also inhibits c-kit and FLT3-ITD. Pexidartinib was discovered by Plexxikon Inc., the small molecule structure-guided R&D center of Daiichi Sankyo.
Pexidartinib has been granted Breakthrough Therapy Designation for the treatment of patients with pigmented villonodular synovitis (PVNS) or giant cell tumor of tendon sheath (GCT-TS), where surgical resection may result in potentially worsening functional limitation or severe morbidity and Orphan Drug Designation for PVNS/GCT-TS by the U.S. Food and Drug Administration (FDA). Pexidartinib also has received Orphan Designation from the European Commission for the treatment of TGCT. Pexidartinib is not approved by the FDA or any other regulatory agency worldwide as a treatment for any indication. Safety and efficacy have not been established.
About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com.
1. de Saint Aubain, et al. WHO. 2015;p1/par1
2. Rao AS, et al. J Bone Joint Surg AM. 1984;66(1):76-94
3. Myers BW, et al. Medicine (Baltimore). 1980;59(3):223-238.
4. Mastboom, M. J. L., et al. (2017a). Acta Orthopaedica 88(6): 688-694.
5. Ehrenstein, V., et al. (2017). J Rheumatol 44(10): 1476-1483
6. Verspoor FGM, et al. Future Oncol. 2013;10:1515-1531.
7. Ravi V, et al. Curr Opin Oncol. 2011;23:361-366.
8. Verspoor, F. G., I. C. van der Geest, et al. (2013). “Pigmented villonodular synovitis: current concepts about diagnosis and management.” Future Oncol 9(10): 1515-1531.
Source: Daiichi Sankyo
Posted: June 2018
The media company, which owns channels like the Discovery channel, TLC and Eurosport, has signed a 12-year deal with the PGA Tour for rights to air its events outside the U.S. on TV and digital platforms.
Discovery expects to spend $2 billion over the course of the alliance, which begins in 2019, including the media rights and investments to build a streaming-video platform for golf in international markets.
The deal marks a continuation of Discovery’s strategy of investing in sports rights outside of its home market of the U.S., where it has long been priced out of the top sports.
In 2015, Discovery took control of pan-European sports broadcaster Eurosport—best known for its coverage of sports like cycling and tennis—and later won rights to the Olympic Games, which it broadcast on Eurosport as well as over various free-to-air and digital platforms.
As cord cutting has pinched all media businesses in the U.S., Discovery has been among the most aggressive in diversifying into international markets where pay-TV is far less mature and still growing.
Many media companies invest in sports content because it is valuable to advertisers— it is generally watched live, and therefore viewers don’t skip over ads—and because for fans it is must-see content that they would expect to be in any major pay TV package.
In the U.S., Discovery has focused on building more scale to contend with giant distributors and cutthroat programming competition. The company recently closed its acquisition of HGTV and Food Network-parent Scripps Networks Interactive, which, provided it with increased free cash flow to do deals.
Discovery believes it can use its expertise with Eurosport’s streaming video service, Eurosport, to build out a similar offering for golf fans.
The PGA deal includes approximately 2,000 hours of content a year, including the Players Championship, the
FedExCup Playoffs, and the Presidents Cup. It doesn’t include major tournaments including the Masters and U.S. Open.
In the U.S. the PGA Tour’s media partners include CBS, NBC and the Golf Channel.
Bloomberg earlier reported on the Discovery deal with PGA Tour.
Discovery will broadcast PGA Tour content on its portfolio of pay-TV channels, free-to-air channels and digital platforms and work with the tour on how to best put forward its content library.
“This long-term partnership between the PGA Tour and Discovery will create the new global home of golf,” said David Zaslav, chief executive of Discovery, in a statement.
Jay Monahan, commissioner of PGA Tour, called the deal “a tremendous opportunity to accelerate and expand our media business outside the United States.”
June 4, 2018 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ: BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced today that elenbecestat was generally safe and well tolerated in a Phase II clinical study (Study 202) of the oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code: E2609) conducted in the United States, and the results demonstrated a statistically significant difference in amyloid beta (Aβ) levels in the brain measured by amyloid-PET (positron emission tomography). A numerical slowing of decline in functional clinical scales of a potentially clinically important difference was also observed, although this effect was not statistically significant. This study, a Phase II study of 70 patients, is the first study of a BACE inhibitor to show a statistically significant difference in amyloid beta in the brain while also suggesting a delay of clinical symptom decline in exploratory endpoints.
Study 202 (ClinicalTrials.gov identifier NCT02322021) is a multicenter, randomized, double-blind, placebo-controlled parallel-group 18-month Phase II clinical study in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease, or mild to moderate dementia due to Alzheimer’s disease with confirmed amyloid pathology by PET screening. Seventy patients were randomized to four treatment arms receiving elenbecestat (5, 15, or 50 mg) or placebo daily. During the study period, more than half the patients in the elenbecestat 5 mg and 15 mg arms were switched to the 50 mg arm for three months or more. The 50 mg treatment arm plus the group switched to the 50 mg arm are hereafter referred to as “50 mg total arm” (38 subjects) with a mean duration of approximately 11 months on 50 mg per day.
Elenbecestat demonstrated acceptable safety and tolerability profile through 18 months of study drug administration. In the elenbecestat 50 mg total arm, the six most common adverse events observed were contact dermatitis, upper respiratory infection, headache, diarrhea, fall, and dermatitis. No serious adverse reactions suggestive of hepatic toxicity were observed in this study.
In addition to the safety objectives, the study assessed Aβ in the brain at 18 months as measured by amyloid PET as well as efficacy in terms of clinical symptoms, which were exploratory objectives in this study.
The elenbecestat 50 mg total arm demonstrated a statistically significant difference in Aβ levels in the brain as measured by amyloid PET compared with placebo (35 subjects participated in this longitudinal amyloid PET assessment). This is the first time in which a significant effect in Aβ in the brain using a BACE inhibitor was confirmed in a clinical study of patients with mild cognitive impairment (MCI) through moderate Alzheimer’s dementia.
CDR-SB (Clinical Dementia Rating Sum of Boxes) was an exploratory endpoint to assess efficacy in terms of clinical symptoms. The study showed numerically less decline in CDR-SB for the elenbecestat 50 mg total arm as compared to placebo of a potentially clinically important difference (41 subjects participated in this assessment), which was not statistically significant. Further, a similar magnitude and direction of differential in decline was observed in a post-hoc analysis of ADCOMS, Eisai’s newly developed assessment scale (Alzheimer’s Disease Composite Score) in the elenbecestat 50 mg total arm as compared to placebo. The study was not powered to show statistical significance compared to placebo on clinical symptoms.
Eisai plans to present detailed results of the study at a future medical meeting.
Elenbecestat, discovered by Eisai, has been jointly developed by Eisai and Biogen since March 2014. The two companies are currently conducting two global Phase III clinical studies (MISSION AD1/2) in early Alzheimer’s disease.
“It is highly encouraging that Study 202 confirmed elenbecestat’s treatment effect in reducing amyloid in the brain and suggested a slowing of clinical decline. Eisai and Biogen will continue to work together to advance the ongoing Phase III program (MISSION AD) in order to contribute a new potential treatment option to Alzheimer’s disease patients as soon as possible,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai.
“Biogen is heartened by the safety and tolerability results of this study of elenbecestat,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “We remain committed to research in Alzheimer’s, an area of significant unmet need with a devastating impact on those living with the disease, their families, friends, and society.”
Biogen Safe Harbor
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements about results from the Phase II study of elenbecestat, the potential effects of elenbecestat, Biogen’s strategy and plans, and the potential of Biogen’s commercial business and pipeline programs. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation: the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected, unexpected concerns may arise from additional data, analysis, or results obtained during our clinical trials, regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, the occurrence of adverse safety events, we may encounter other unexpected hurdles, which may be impacted by, among other things, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, or failure to protect intellectual property and other proprietary rights, or uncertainty of success in the development and potential commercialization of elenbecestat.. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this press release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Elenbecestat is an oral BACE (beta amyloid cleaving enzyme) inhibitor currently being investigated in Phase Ⅲ clinical studies for Alzheimer’s disease discovered by Eisai. By inhibiting BACE, a key enzyme in the production of Aβ peptides, elenbecestat reduces Aβ production, which is thought to lead to a reduction in amyloid plaque formations caused by the aggregation of toxic oligomers and protofibrils in the brain. Currently, two global Phase III clinical studies (MISSION AD1/2) of elenbecestat in early Alzheimer’s disease including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early stages of mild AD are underway. In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of elenbecestat, a process allowing priority reviews by the FDA for drugs deemed as having potential to treat serious conditions and tackle key unmet medical needs.
About Study 202 (ClinicalTrials.gov identifier NCT02322021)
Study 202 is a placebo-controlled, double-blind, parallel-group, randomized, dose-finding study to evaluate the safety and tolerability of elenbecestat in 70 patients with mild cognitive impairment due to Alzheimer’s disease (prodromal Alzheimer’s disease) and mild to moderate dementia due to Alzheimer’s disease. The study enrolled patients which met the core clinical research criteria of the U.S. National Institute on Aging – Alzheimer’s Association for MCI due to AD or AD dementia, with an MMSE score of 16 or higher and confirmed accumulation of Aβ by PET screening. Patients were allocated to a total of four treatment arms, three for elenbecestat (5 mg/day: 17 patients, 15 mg/day: 19 patients, 50 mg/day: 17 patients) and one for placebo (17 patients). More than half the patients in the elenbecestat 5 mg and 15 mg treatment arms had their dose increased to 50 mg/day during the 18 month treatment period. Mean duration of 50 mg total arm on 50 mg/day was 11 months. The primary objectives are safety and tolerability at 18 months. Major exploratory endpoints are the change in accumulation of Aβ as measured by amyloid PET (35 patients) and the change in dementia assessment scales including CDR-SB and ADCOMS (41 patients), at 18 months compared to baseline.
Glossary of Terms
1.) NIA-AA: A guideline (NIA-AA) for modernization of the diagnosis of Alzheimer’s disease published by The National Institute on Aging (NIA) at National Institutes of Health (NIH) and the Alzheimer’s Association.
2.) MMSE (Mini-Mental State Examination): A method for assessing cognitive function. Comprised of the categories orientation, memorization, attention, calculation, recent and distant memory, comprehension, reading and writing, as well as design. Test scores range from 30 (normal) to 0 (severely impaired).
3.) CDR-SB (Clinical Dementia Rating scale Sum of Boxes): The Clinical Dementia Rating (CDR) is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a patient’s cognitive and functional performance in six areas: memory, orientation, judgment & problem solving, community affairs, home & hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and it is an appropriate item for evaluating the effectiveness of therapeutic drugs targeting early stage AD.
4.) ADCOMS (AD Composite Score): ADCOMS, developed by Eisai, combines items from the ADAS-Cog scale for assessing cognitive functions, MMSE and the CDR scale for evaluating the severity of dementia to enable highly-sensitive detection of changes in clinical functions of early AD symptoms and changes in memory.
About the Joint Development Agreement between Eisai and Biogen for Alzheimer’s Disease
Eisai and Biogen are widely collaborating on the joint development and commercialization of Alzheimer’s disease treatments. Eisai serves as the lead in the co-development of elenbecestat, a BACE inhibitor, and BAN2401, an anti-amyloid beta (Aβ) protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen’s investigational anti-amyloid beta (Aβ) antibody for patients with Alzheimer’s disease, and the companies plan to pursue marketing authorizations for the three compounds worldwide. If approved, the companies will also co-promote the products in major markets, such as the United States, the European Union and Japan.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and marketing of Aricept®, a treatment for Alzheimer’s disease and dementia with Lewy bodies, Eisai has been working to establish a social environment that involves patients in each community in cooperation with various stakeholders including the government, healthcare professionals and care workers, and is estimated to have held over ten thousand dementia awareness events worldwide. As a pioneer in the field of dementia treatment, Eisai is striving to not only develop next generation treatments but also to develop diagnosis methods and provide solutions.
For more information about Eisai Co., Ltd., please visit www.eisai.com.
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.
We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
Source: Eisai Co., Ltd.
Posted: June 2018
MELBOURNE, Australia — Australia’s largest bank has agreed to pay an almost $530 million fine to settle a civil lawsuit that revealed numerous breaches of the country’s Anti-Money Laundering and Counter-Terrorism Act.
The proposed agreement with the federal government’s financial-intelligence agency, which remains subject to approval by a federal court, includes further admissions by the bank it contravened the law, including breaches of risk procedures, reporting and monitoring.
, Australia’s biggest bank by assets and with a market value of almost $92 billion, said Monday it would pay a penalty of 700 million Australian dollars ($529.8 million) plus the regulator’s legal costs of A$2.5 million to resolve the civil suit.
“While not deliberate, we fully appreciate the seriousness of the mistakes we made,” Chief Executive Officer Matt Comyn said.
Also popular on WSJ.com:
German Chancellor Angela Merkel outlined proposals for overhauling and strengthening the architecture of the European Union in an interview published on Sunday, including combining nations’ defense capabilities and building a common investment fund for the eurozone.
While the suggestions broadly matched known German positions about the bloc’s future, they marked Ms. Merkel’s most direct and detailed reaction to proposals for overhauling the EU that French President Emmanuel Macron laid out in September.
The proposals, including beefing up an existing backstop for cash-strapped members of the eurozone and creating a joint budget for the currency union, came after capital markets briefly sank after the formation of a populist Italian government last week, evoking memories of the 2010 eurozone crisis.
They also come against a backdrop of mounting trans-Atlantic tension after President Donald Trump slapped the EU with steep tariffs on steel and aluminum. Some analysts have predicted his aggressive stance could prompt EU members to bury their differences on a number of divisive issues.
“America is and remains the superpower, but at the moment it doesn’t recognize multilateral agreements in all areas, as shown by the decision to leave the [Paris] climate accord and now the tariffs that President Trump has levied against Europe,” Ms. Merkel told the Frankfurter Allgemeine Sonntagszeitung weekly.
Institutional changes to the EU would ensure that “its voice is taken seriously in the world,” she said.
French officials welcomed Ms. Merkel’s proposals, even if her ideas for the eurozone fell short of Mr. Macron’s ambitions. The 40-year-old French leader has called for a deeper overhaul that would see eurozone countries share more resources and liabilities in a budget as large as several percentage points of eurozone economic output. That would potentially place the largest burdens on Germany and France, respectively the two largest eurozone economies.
Without steps toward such burden sharing, he said, the next economic shock could pull apart the 19-nation currency bloc.
“France and Germany still need to work on these subjects in the coming weeks for a more ambitious accord on banking union and the fiscal capacity for the eurozone,” an official at Mr. Macron’s office said on Sunday.
An official at the European Commission, the EU’s executive arm, welcomed the chancellor’s comments, saying the interview showed “that Merkel is determined to shape Europe in an ambitious and responsible manner in the coming months.”
The comments suggest a new willingness by Ms. Merkel to engage with Mr. Macron’s proposals, despite signs this year that the chancellor would cede to domestic pressure to keep any eurozone overhauls to a minimum.
Ms. Merkel is under pressure from the conservative wing of her own center-right party and the euroskeptic Alternative for Germany, which swept into Parliament in September, to shun fiscal handouts to southern Europe.
Germany isn’t alone: Eight northern European finance ministers, led by the Netherlands, warned in a letter in March against any far-reaching eurozone overhauls.
Sunday’s interview marked more significant rapprochement with Mr. Macron on topics including migration and public investment in innovation and technology. “It’s a positive move that shows the European commitment of the chancellor and her government,” the official said.
The chancellor also backed Mr. Macron’s plans for a common European defense force, which have previously won little support in Berlin. Deeper military cooperation could help reduce complexity and overlapping systems, and could be extended to the U.K. after it leaves the bloc next March, Ms. Merkel said.
As they try to set a road map for eurozone overhauls by the end of the month, Mr. Macron and Ms. Merkel plan to meet at the meeting of the Group of Seven leading nations in Canada on Friday and Saturday.
“The chancellor is revitalizing the European overhaul process that has been started to strengthen Europe’s ability to act in an uncertain and unstable world,” one EU official said.
Ms. Merkel’s comments followed a week of tumultuous politics in Italy, the eurozone’s No. 3 economy, and precede an EU summit this month where leaders hope to agree on plans to strengthen the currency union.
German officials have increasingly voiced their frustration with the U.S. government’s decisions to abandon key international accords, including the Iran nuclear deal, and impose restrictions on international trade that threaten Germany’s large export sector.
Ms. Merkel’s proposals included a common investment fund for the eurozone, with an annual budget in the low-two-digit-billion-euro range, that could help boost the bloc’s technological capabilities. That falls well short of Mr. Macron’s proposal that envisaged an instrument with budgetary firepower of around €200 billion ($233.2 billion).
Ms. Merkel also called for the eurozone’s €500 billion rescue fund, the centerpiece of its crisis-fighting strategy, to be converted into a European version of the International Monetary Fund that could offer long-term loans under conditions to stressed governments as well as short-term credit lines.
The fund should be equipped with tools to monitor government budget policies and address concerns about fiscal sustainability, she said. The idea partly stems from a desire to reduce Europe’s dependency on the IMF, but it is also driven by German concern that the European Commission is becoming more politicized and that enforcement of fiscal rules should be trusted to a new, independent body.
Mr. Macron articulated his vision for the EU’s future in a September speech at Paris’s La Sorbonne university. Ms. Merkel hadn’t publicly respond directly to Mr. Macron’s ideas, in part because Germany was plunged into months of political uncertainty following September’s inconclusive general election.
Ms. Merkel also warned in the interview that the EU’s border-security and asylum policy should be strengthened because they had become an “existential question” for the bloc. She suggested the turbulence in Italian politics resulted in part from weaknesses in the EU’s current asylum processes, and called for a common system for processing asylum seekers and a more powerful border police force.
“Part of the insecurity in Italy is because Italians felt they were left alone after Libya’s collapse to deal with the task of taking in the many refugees and migrants from Africa,” she said.
—Bojan Pancevski in Berlin and Emre Peker in Brussels
contributed to this article.
Appeared in the June 4, 2018, print edition as ‘Merkel Outlines Proposals For Overhauling the EU.’
DEFINITION of ‘College Of Insurance’
College Of Insurance is one of several institutions of higher learning that teach courses related to specific aspects of insurance. The College of Insurance is a specialized institution that provides undergraduate and graduate degrees in insurance, actuarial science and financial services. The college is located in the financial district of lower Manhattan.
BREAKING DOWN ‘College Of Insurance’
The College of Insurance was founded in New York in 1901. Its entire curriculum was taken over by St. John’s University 100 years later and now comprises its school of Risk Management, Insurance and Actuarial Science under the The Peter J. Tobin College of Business. It consists of high-tech classrooms, computer labs and the Kathryn and Shelby Cullom Davis library.
Programs offered by the college include:
- Actuarial Science, Bachelor of Science
- Actuarial Science, Master of Science
- Enterprise Risk Management, Master in Business Administration
- Enterprise Risk Management, Master of Science
- Risk and Insurance, Certificate
- Risk Management, Master in Business Administration
- Risk Management and Insurance, Bachelor of Science
- Risk Management and Insurance, Master of Science
Its undergraduate programs include:
- Accounting, BS
- Actuarial Science, BS
- Business, BS
- Economics, BS
- Finance, BS
- International Management, BS
- Marketing, BS
- Risk and Insurance, Certificate
- Risk Management and Insurance, BS
“The School of Risk Management, Insurance and Actuarial Science (SRM) has a rich history and tradition. It was formed initially as the Insurance Society of New York in 1901, and became the School of Insurance in 1947 and the College of Insurance (TCI) in 1962. SRM evolved from the merger of TCI and St. John’s University in 2001. The academic programs of SRM are located at 101 Astor Place,” according to its website.
“SRM is a global leader in risk and insurance education and training and draws candidates from all regions of the world. All of the degree programs offered by The Peter J. Tobin College of Business, and thus by SRM, are fully accredited by the Association to Advance Collegiate Schools of Business.”
All applicants to the graduate degree programs are required to submit a competitive GMAT or GRE score report. All applicants must possess a baccalaureate degree from an accredited institution or the international equivalent prior to enrollment at the graduate level. Applicants to the M.S. in Accounting program must have been an undergraduate business major.
The college’s Center for Executive Education offers Actuarial Science Associates and Fellows Exam Preparation Courses, agents, brokers and adjusters continuing education, CPCU/IIA Designation exam prep and specialized workshops.
Italian bank UniCredit
is considering a merger with France’s Societe Generale
according to a report Sunday night by the Financial Times. While no formal offer has yet been made, officials from both banks are in the early stages of talks, the FT said. UniCredit CEO Jean-Pierre Mustier, who is French and a former SocGen executive, has been developing the plan for months, the FT said. Italy’s volatile political situation has reportedly pushed back the timeline for a potential merger. UniCredit and SocGen are among Europe’s biggest banks, each with a market cap of around 32 billion euros.
WEDNESDAY: The U.S. Commerce Department releases international trade data for April. In March, the trade gap narrowed, as exports rose and imports fell. Economists will monitor this report to see whether the trade deficit with China is widening. Economists surveyed by The Wall Street Journal forecast the April trade gap was $48.6 billion.
A strong jobs report for the month of May propelled stocks higher Friday, with the Dow Jones Industrial Average , S&P 500 Index and Nasdaq Composite all rallying about 1% or more. As such, here are our top stock trades for the first week of June:
Top Stock Trades for Tomorrow #1: IQiyi (IQ)
I feel really lucky to have stumbled upon this stock after someone on Twitter Inc (NYSE: TWTR ) flagged it down a few weeks ago. After I dug through the key numbers in its prospectus (it’s a recent IPO), the growth was too strong and the market cap was too low to ignore.
In fact, we pointed it out on InvestorPlace when it was at $20.50 just a few weeks ago!
Lately it’s been off to the races, up almost 25% this week alone! Where do investors go from here?
Unfortunately, I don’t think we can blindly chase it. In its brief history, it has shown that it tends to consolidate after a move higher. Although as more momentum traders stumble upon it, those rallies and pullbacks will likely become more extreme.
I would look to buy pullbacks in IQ as opposed to selling rallies because of how much growth its underlying story has (with some of that highlighted in the link above). I like this story here and would start to nibble on a pullback into the $25-ish range.
Top Stock Trades for Tomorrow #2: Lululemon (LULU)
While the move is promising for existing bulls and long-term shareholders, traders should take a pass on this one. The relative strength index (RSI) measures how overbought or oversold a stock is, with north of 70 being considered overbought (on the chart above, it’s in yellow circles). The higher the number goes, the more overbought it is.
I don’t base my thesis around an RSI reading, but I do take it into consideration. Now near 90, LULU is pretty well overbought as it’s up more than 50% so far in 2018. But as shown by the last two times the RSI was elevated, it doesn’t mean an impending collapse is coming for LULU.
If I were long LULU I’d book some gains at this point and I wouldn’t bother trying to short. I certainly wouldn’t take a new long position today.
Top Stock Trades for Tomorrow #3: Twitter (TWTR)
I guess I’m just Johnny Raincloud today, but like Lulu, I don’t think traders should be loading up on Twitter right now.
We made it clear bulls could buy a breakout over $32 less than one month ago. Now near $37, Twitter is up more than 15% and is coming into some potential resistance.
With an elevated RSI, Twitter could easily fail to push through $37 and opt to consolidate – possibly just over $34. I wouldn’t call that a bearish development necessarily, but I wouldn’t chase TWTR right here, right now on the hope it will get through on the first time.
If Twitter does breakout, bulls can buy on a close over $37. Other than that, wait for a better price.
Top Stock Trades for Tomorrow #4: Amazon (AMZN)
As long as Amazon can stay over this $1,600 level, I like it on the long side. Should it falter, I also like AMZN on a pullback to trend-line support, a rough estimate of which puts it between $1,500 and $1,550.
Amazon stock is in a solid up-trend while Amazon’s businesses operate in long-term secular trends . You can short it on valuation – something that’s never bound its price before – but only if you’d like to get run over.
Keep it simple: Buy Amazon on dips or get out of its way.
Top Stock Trades for Tomorrow #5: Apple (AAPL)
If the second-largest U.S. company is making new highs and we’re talking about it, how can we avoid talking about Apple Inc. (NASDAQ: AAPL )? Okay, okay, shares didn’t notch a new all-time high Friday. But they came pretty darn close.
It’s hard to see a stock go from ~$160 to the upper-$180s in a few days, consolidate for nearly a month and not be excited. Bulls should look for an eventual break out of the rectangle drawn above. Essentially, a powerful close above $190.
Wall Street analysts keep taking their price targets higher and its because Apple is simply a darn good company without a premium valuation . Plus, it’s buying back $100 billion of its own stock and has the world’s most popular investor in Warren Buffett backing the name with big bucks.
A breakdown rather than breakout likely sends AAPL down to $177.50 to $180 area.
More From InvestorPlace
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
SAN FRANCISCO, June 03, 2018 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ:FGEN), a biopharmaceutical company, today announced Phase 1/2 clinical trial results of pamrevlumab in combination with standard-of-care chemotherapy in patients with locally advanced unresectable pancreatic cancer (LAPC). Principal investigator Vincent J. Picozzi, Jr., M.D., Director, Pancreas Center of Excellence, Virginia Mason Cancer & Digestive Diseases Institutes, presented the results in a discussion poster session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Pamrevlumab is a proprietary first-in-class antibody targeting connective tissue growth factor (CTGF) under development for the treatment of fibrosis and fibroproliferative disorders.
“These are some of the most exciting clinical trial results in locally advanced pancreatic cancer I have seen since I began treating pancreatic cancer patients,” said Dr. Picozzi. “The data suggest that pamrevlumab in combination with chemotherapy has the potential to become a neoadjuvant treatment regimen for locally advanced unresectable pancreatic cancer patients that has not existed before.”
Patients with locally advanced pancreatic cancer (without metastasis) tend to have a poor prognosis with a median survival of 9–18 months. In patients who have undergone resection of their tumor, median survival and five-year survival rates have been reported to be higher than those without resection. Therefore, treatment to achieve a surgical resection in this patient population is a meaningful treatment goal to potentially achieve a favorable overall survival outcome.
In this open-label, randomized Phase 1/2 study, pamrevlumab was administered in combination with standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) and compared to treatment with chemotherapy alone in patients with locally advanced pancreatic ductal adenocarcinoma, who were not eligible for surgical resection based on histology, computerized tomography (CT) scans, and laparoscopy criteria, prior to randomization. Upon completion of the six months of study drug treatment, patients underwent surgical eligibility assessment based on pre-specified objective criteria. The study enrolled 37 patients: 24 received pamrevlumab + chemotherapy: 13 received chemotherapy alone.
At ASCO 2018, FibroGen reported that a higher proportion of patients whose tumor was previously considered unresectable became eligible for resection (based on protocol pre-specified post-treatment surgical eligibility criteria) after receiving pamrevlumab and chemotherapy than after receiving chemotherapy alone (at the end of 6 months of treatment), 70.8% vs. 15.4%. For those patients who met these surgical resection eligibility criteria at post-treatment assessment, individual patient condition and circumstance contributed to whether resection subsequently occurred. A higher proportion of pamrevlumab-treated patients achieved surgical resection than those received chemotherapy alone, 33.3% vs. 7.7%.
In the study, patients were followed for survival after evaluation for eligibility for resection and, when applicable, after resection. Patients who had successful resections in this study had a statistically significant longer median survival benefit as compared to patients who did not undergo resection, 40 months vs.18.6 months (p=0.0141), as of May, 2018. FibroGen is continuing to monitor study patients for survival.
“Patients with unresectable locally advanced pancreatic cancer are in need of an innovative and effective treatment with the potential to transform non-operable cancer into resectable disease,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development and Drug Safety. “The updated clinical results we are reporting at ASCO suggest that pamrevlumab may improve the treatment outcomes for patients who are currently deemed unresectable.”
About Locally Advanced Pancreatic Cancer
In locally advanced pancreatic cancer (LAPC), tumors typically encase structures, particularly blood vessels that are closely associated with the pancreas such as the superior mesenteric artery and superior mesenteric vein. Involvement of the cancer around these blood vessels precludes surgical removal of the tumor. Approximately 80% of newly diagnosed LAPC patients are classified as having unresectable disease, and patients with unresectable LAPC have a median survival only slightly better than that of patients with metastatic pancreatic cancer. Patients with resectable cancer whose tumors are surgically removed have a much better prognosis, with median survival of approximately 23 months, and some patients being cured.
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and has been granted Orphan Drug Designation (ODD) in each of these indications, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab recently received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with locally advanced unresectable pancreatic cancer. Pamrevlumab has demonstrated a good safety and tolerability profile in multiple Phase 2 trials conducted to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
FibroGen, Inc., headquartered in San Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF), connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity in worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), with a New Drug Application currently under review in China by the State Drug Administration or SDA (formerly the China Food and Drug Administration). Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes (MDS). Pamrevlumab, an anti-CTGF human monoclonal antibody, is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development of the company’s product candidates pamrevlumab and roxadustat, the potential safety and efficacy profile of our product candidates, and our clinical, regulatory, and commercial plans, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, and our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2018 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
Event-ticketing company Ticketfly was still working to get back online Sunday, four days after a hacker reportedly hijacked the site and stole data from more than 26 million customers.
The breach apparently occurred Wednesday night, when a hacker took control of the site and demanded to be paid in bitcoin to release it. Last week, Vice’s Motherboard reported it communicated with someone claiming to be the hacker, who said they had asked Ticketfly for one bitcoin
(around $7,500 at the time) in exchange for sharing details about the site’s vulnerability. The ransom was not paid, and the hacker posted user data online. Ticketfly said it took the site offline as a security measure.
Ticketfly, which is owned by Eventbrite, confirmed on its website that it had been breached, and that some customers’ names, addresses, email addresses and phone numbers had been exposed. Passwords and credit-card numbers were apparently not affected.
“Due to a recent cyber incident, Ticketfly.com is offline,” a message on the site read. “We’ve engaged leading third-party forensic and cybersecurity experts to investigate and help us address the issue, and have done this with your security top of mind.”
While Ticketfly did not say how many customer accounts were breached, the data-breach-tracking website haveibeenpwned.com said more than 26 million accounts were affected.
Last year, San Francisco-based Eventbrite bought Ticketfly from Pandora Media Inc.
for about $200 million.
The site’s takedown left a number of promoters and music and comedy clubs in the lurch for upcoming shows.
This Ticketfly hack is insane. Being a promoter with literally thousands of dollars on the line daily and not knowing how many tickets we have sold or when we can get back up online is a nightmare. Nothing has bummed me out this much since I began promoting shows.
— M¡KE Z¡EMER (@MikeZiemer) June 1, 2018
To our fans in Buffalo TONIGHT:
ATT: Due to a cyber attack on Ticketfly, all online sales are currently down. However – TICKETS will still be available AT THE DOOR – cash only.
— Strange Music Inc (@StrangeMusicInc) June 2, 2018
??? FREE SHOW ALERT ???
All ticket purchasers will be refunded as soon as Ticketfly is back up and running. pic.twitter.com/Su0L3SQPHW
— Club Glow (@ClubGlow) May 31, 2018
FREE SHOW! The website was down and people couldn’t purchase tickets to tomorrow night’s @LargoLosAngeles benefit. Ticketfly/Largo are covering the $ for the unsold tickets so tomorrow’s show is FREE! First come first serve, paid ticket holders are guaranteed to get in + perks! pic.twitter.com/salFArup9o
— Rachel Bloom (@Racheldoesstuff) June 1, 2018
The U.S. and China moved closer to imposing tariffs on one another as negotiators made little progress in talks and Beijing threatened that it won’t abide by a deal on farm and other products if the U.S. goes ahead with sanctions.
U.S. Commerce Secretary Wilbur Ross and Liu He, China’s economic czar, led the weekend negotiations in Beijing, after several days of talks by lower level officials. Discussions centered on getting China to carry out recent promises to buy more American farm and energy products.
TAIPEI, Taiwan, June 03, 2018 (GLOBE NEWSWIRE) — Computex—NVIDIA and Taiwan’s Ministry of Science and Technology today announced an extensive collaboration that will advance Taiwan’s artificial intelligence capabilities.
Announced at the start of Computex 2018, the partnership will extend over the next decade to build up local deep learning and associated AI technologies.
“Taiwan was at the center of the PC revolution and now it is investing to play an important role in the next era of computing,” said Jensen Huang, founder and chief executive officer of NVIDIA. “With the essential infrastructure and tools, the rich talent in Taiwan’s schools and industry will create world-changing breakthroughs in science and society.”
Taiwan Premier Lai Ching-te expressed enthusiasm for the collaboration, which he called essential to sharpening national competitiveness.
“Taiwan is committed to be an important global player in the AI ecosystem,” Premier Lai said. “NVIDIA is the leader of AI computing in the world. By collaborating with NVIDIA, we will gain the expertise and technical platforms to train AI talents, build the strongest AI ecosystem of both software and hardware, and further reshape the world with our own technologies and services of AI.”
The collaboration is focused in five key areas:
- Supercomputing infrastructure. NVIDIA and Taiwan government agencies will co-invest to bring NVIDIA’s most advanced technology to Taiwan, including the new NVIDIA® HGX-2™, which fuses AI and high performance computing into a single platform.
- Research. NVIDIA Research, a global organization that includes some of the world’s best computer scientists, will collaborate with Taiwan researchers and startups to exchange best practices.
- Training. NVIDIA will expand its Deep Learning Institute — which has provided developers worldwide with hands-on training for beginning and advanced AI techniques — to train thousands of Taiwanese developers on the latest AI capabilities.
- Startups. Taiwan agencies and NVIDIA will work together to help Taiwan AI startups through NVIDIA’s Inception startup accelerator program, which is helping more than 2,800 young companies globally.
- Innovation. Joint investment in developing AI solutions for key vertical markets for Taiwan, including manufacturing, healthcare, safe cities and transportation.
Building on Grand Plan
The announcement extends the Taiwan Ministry of Science and Technology’s “AI Grand Plan,” which was unveiled last year. Last month, MOST unveiled its Taiwania HPC supercomputer powered by NVIDIA technology. And last week, it selected NVIDIA for an AI supercomputer powered by 2,000 NVIDIA Tesla® V100 32GB Tensor Core GPUs with access to the NVIDIA GPU Cloud™ (NGC) container registry of AI-optimized software.
Speaking last Wednesday to more than 2,200 technologists, developers, researchers and business executives at NVIDIA’s GPU Technology Conference Taiwan, Huang described a series of AI initiatives underway in Taiwan. These address a range of pressing domestic issues in such fields as manufacturing, healthcare and transportation, which align with the government’s focus on furthering AI.
Among the five examples he cited:
- Foxconn drives superhuman inspection accuracy in manufacturing. Using GPU-powered deep learning with NVIDIA HGX-1 and Tesla P4 GPUs, Foxconn is slashing its manufacturing defect detecting “escape rate.” It has cut the rate to 0.015 percent from the 4.3 percent rate expert human inspectors can achieve — a 287x performance improvement.
- China Medical University Hospital attacks Asia’s highest cancer fatality rate. Using the NVIDIA DGX-1™ supercomputer, CMUH and Eddie Huang — a post-doc student from MOST — developed an AI to detect liver cancer. The AI diagnostic “super assistant” is especially important on Taiwan, which has Asia’s highest cancer fatality rate.
- National Taiwan University addresses locally acute cancer type. Working with Dr. Winston Hsu, NTU has made breakthroughs in detecting nasopharyngeal carcinoma, a rare head and neck cancer that’s locally prevalent due to diet and environmental factors. NVIDIA DGX-1 enabled Dr. Hsu to combine CT scans with AI-generated MRI images into one algorithm — improving detection rates by as much as 36 percent.
- Taoyuan City makes its streets safer. Taiwan’s third-largest city is pushing development of autonomous vehicles to cut back on accidents and carbon emissions, while improving the productivity of trucks, taxis and buses. It is using the NVIDIA DGX Station™ deskside supercomputer for AI model training and the NVIDIA DRIVE™ PX2 autonomous driving computer as it works to have 30 percent of its fixed-route buses equipped with autonomous capabilities by the start of the new decade.
- Tainan City girds against typhoons. The municipal government of Taiwan’s fourth-largest city is deploying drones, with AI software developed using NVIDIA DGX-1 systems, to monitor the structural integrity of the city’s 1,650 bridges. By evaluating their risk to potential damage from flooding, earthquakes and mudslides, it can fix bridges before the next typhoon hits.
NVIDIA’s (NASDAQ:NVDA) invention of the GPU in 1999 sparked the growth of the PC gaming market, redefined modern computer graphics and revolutionized parallel computing. More recently, GPU deep learning ignited modern AI — the next era of computing — with the GPU acting as the brain of computers, robots and self-driving cars that can perceive and understand the world. More information at http://nvidianews.nvidia.com/.
Certain statements in this press release including, but not limited to, statements as to: the goals, impact and benefits of the collaboration between NVIDIA and Taiwan, including the collaboration advancing efforts to transform Taiwan’s artificial intelligence technologies, its ability over the next decade to build up deep learning and associated AI technologies, fueling world-changing breakthroughs in science and society, Taiwan gaining the expertise to train AI talents, building the strongest AI ecosystem, reshaping the world with its own technologies and services of AI, co-investing to bring NVIDIA’s most advanced technology to Taiwan, exchanging best practices, training developers on the latest AI capabilities, working together to help Taiwan AI startups, and developing AI solutions for key vertical markets; Taiwan bringing the AI revolution home; NVIDIA partners slashing the manufacturing defect detecting escape rate; detecting cancers; developing autonomous vehicles to cut back on accidents and carbon emissions, and improving productivity and the goals and timing for the development; and the benefits of deploying drones to monitor the structural integrity of bridges are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: global economic conditions; our reliance on third parties to manufacture, assemble, package and test our products; the impact of technological development and competition; development of new products and technologies or enhancements to our existing product and technologies; market acceptance of our products or our partners’ products; design, manufacturing or software defects; changes in consumer preferences or demands; changes in industry standards and interfaces; unexpected loss of performance of our products or technologies when integrated into systems; as well as other factors detailed from time to time in the reports NVIDIA files with the Securities and Exchange Commission, or SEC, including its Form 10-Q for the fiscal period ended April 29, 2018. Copies of reports filed with the SEC are posted on the company’s website and are available from NVIDIA without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, NVIDIA disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
© 2018 NVIDIA Corporation. All rights reserved. NVIDIA, the NVIDIA logo, DGX, DGX Station, NVIDIA DRIVE, NVIDIA GPU Cloud, NVIDIA HGX and Tesla are trademarks and/or registered trademarks of NVIDIA Corporation in the U.S. and other countries. Other company and product names may be trademarks of the respective companies with which they are associated. Features, pricing, availability and specifications are subject to change without notice.
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DEFINITION of ‘Wool Growers Floater’
Wool Growers Floater is a type of insurance policy that provides coverage for sheep owners and to warehouse owners who store and transport wool. This is a type of inland marine insurance which provides coverage for property damage and liability exposure during transportation – specifically for sheep in this case. Most inland marine insurance policies cover properties that are on land, as opposed to on the ocean as the name suggests.
BREAKING DOWN ‘Wool Growers Floater’
The word “floater” stems from the original policies that covered property loss before, during and after the completion of an oceanic voyage (the insured property was therefore floating). Today, these inland marine insurance policies, including the wool growers policy, applies to property that involves some type of transportation.
Wool has been in use since at least the Stone Age, 10,000 years ago, notes the American Sheep Industry Association. “Between 3000 and 1000 BC the Persians, Greeks and Romans distributed sheep and wool throughout Europe as they continued to improve breeds. The Romans took sheep everywhere as they built their Empire in what is now Spain, North Africa, and on the British Isles. They established a wool plant in what is
now Winchester, England as early as 50 AD.”
According to the International Wool Textile Organization, the wool industry produces around 1160 million kilograms (2557 million pounds) of clean wool per year. Wool is produced on several million small-hold and commercial farms worldwide, and the industry employs millions of people in producing, harvesting, and processing the valuable raw material. “A single sheep provides, in general, about 4.5 kg of wool per year, or the equivalent of 10+ meters of fabric. That’s enough for six sweaters or to cover one large sofa. The wool industry, globally, cares for about 1.160 billion sheep,” the organization stated.
“Sheep are usually shorn once a year in the spring/summer months, although in some countries shearing may take place as many as three times a year. Where production systems are advanced, the wool is rigorously tested to determine properties and different grades are packed separately.”
There’s much to go wrong with wool during its production, storage and shipment. Among the perils are damage from temperature, odor, humidity and moisture, contamination, ventilation, mechanical influences, biotic activity, toxicity and hazards to human health, gases, shrinkage and shortage, self-heating and spontaneous combustion, insect infestation and diseases, according to Transport Information Service. “The high content of wool grease makes greasy wool even more highly flammable than combed top and it may be easily set alight by sparks, cigarette ends etc.. Its high keratin content also makes it liable to self-heating/spontaneous combustion, particularly through the action of moisture and fats/oils.”
DEFINITION of ‘Coincidental Excess Coverage’
Coincidental Excess Coverage provides excess coverage for a specified event or circumstance. Coincidental excess coverage will only apply under certain circumstances, and is a type of excess liability insurance.
BREAKING DOWN ‘Coincidental Excess Coverage’
In some cases, the insurance coverage provided by a primary insurance policy is deemed insufficient by the policyholder. In these circumstances, the policyholder may seek to have additional coverage provided under a conditional excess coverage provision.
How Coincidental Excess Coverage Works
In order to be considered a true conditional excess coverage policy, the language of the policy must be written in such a way as to clearly indicate so. This primarily involves the policy providing primary coverage in all circumstances stated under the policy, and only in certain circumstances would it provide any excess coverage. The policy is still an insurance policy at the most basic level.
An example of coincidental excess coverage would be a company’s auto policy that provides coverage for the cars that are owned by the company. The company may purchase additional coverage that only applies in situations in which company personnel are using a car that is not owned by the company.
In some cases an insured party may have multiple insurance policies that cover the same event. The language of each of the policies will seek to limit the insurer’s liability for these insured events. If it is unclear as to which policy applies in a particular situation – especially if the policies are provided by different insurance companies – the insurers may rely on the courts to determine who is ultimately responsible for coverage. If two policies provide the same coverage, but one policy provides pro-rata coverage and the other policy provides coincidental excess coverage, then the pro-rata policy will be treated as the primary policy. It will be required to provide all of the coverage up to the policy limit, after which the excess coverage policy will provide coverage.
Perhaps not surprisingly, this is an area of insurance contarcts that has frequently landed in the courts. True excess policies typically provide that coverage is not available until the limits of the underlying primary policy have been exhausted. What happens then if the primary insurer settles a claim for less than its policy limits but less than the total amount of the loss claimed? Does that mean the primary policy limits been exhausted or does the excess insurer have to pay the rest of the claimed loss?