HARBIN, China, August 15, 2014 /PRNewswire/ — China Education Alliance, Inc. (“China Education Alliance” or the “Company”, OTCQX: CEAI), a China-based education resource and services company, today announced its second quarter 2014 financia…
— Company To Pursue Next Stage of Development
REDWOOD CITY, California, Aug. 15, 2014 /PRNewswire/ — Coherus BioSciences, Inc. (“Coherus”) today announced that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a pivotal clinical pharmacokinetic (PK) similarity study that compared CHS-1420 to Humira® in healthy subjects. The parallel-group, single-dose study met the criteria for clinical PK similarity on all three required, prospectively defined, PK endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC0-t), and area under the time-concentration curve from first time point extrapolated to infinity (AUC0-inf), with all three geometric mean ratios fully within the 90% confidence interval from 80% to 125%. Both agents were well tolerated and there were no differential safety findings observed between the two agents in this study.
“An essential global regulatory requirement is the completion of a clinical study directly comparing the originator and our biosimilar candidate establishing PK similarity,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “We are pleased to have achieved robust results which we believe represents a significant reduction in development program risk.”
“Adalimumab is a very complex molecule. Achieving this clinical milestone further validates Coherus’ development platform and demonstrates our ability to advance biosimilars across our portfolio,” said Denny Lanfear, President and Chief Executive Officer of Coherus.
About Coherus BioSciences, Inc.
Coherus is a late-stage clinical biologics platform company focused on the global biosimilar market. Headquartered in the San Francisco Bay Area and composed of a team of industry veterans with decades of experience in pioneering biologics companies, our goal is to become a global leader in the biosimilar market by leveraging our team’s collective expertise in key areas such as process science, analytical characterization, protein production and clinical-regulatory development. Coherus’ commercialization partnerships include global pharmaceutical companies in Europe, Asia and Latin America.
Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. For additional information, please visit www.coherus.com.
Coherus BioSciences Contact
BANGKOK, Aug. 15, 2014 /PRNewswire/ — Global Market Advisors (GMA), a leading consulting firm to the casino gaming, hotel, and airline industries, announced today the opening of its Asia regional office. GMA’s new office is located in the central business district of Bangkok, Thailand and will support clients located in the Asian region in advisory areas such as financial feasibility reports, marketing strategies, and government relations for companies in the casino gaming, hospitality, airlines, and financial industries.
Mr. Steven Gallaway, Partner at Global Market Advisors stated, “A significant number of our new and existing clients have retained GMA to guide them in Asia. It’s time for GMA to further expand our presence by making the investment in the Asian region and we are pleased to do so. Our new office in Bangkok provides a central location in Asia to service our clients in the region effectively and with the quality GMA is known for.”
Global Market Advisors, LLC and its casino gaming industry consulting division, Gaming Market Advisors, has a significant history in advising clients in South Korea, Thailand, Singapore, Japan, Taiwan, Philippines, and eastern Russia. The firm also has a strong presence in the United States servicing a myriad of clients in the casino gaming and hospitality industries.
GMA’s new office in Bangkok will act as the firms’ regional headquarters office and will supplement existing GMA offices located in Las Vegas, Nevada and Denver, Colorado. GMA Partners Andrew Klebanow and Jonathan Galaviz will provide oversight to GMA’s new office in Asia.
About Global Market Advisors, LLC
Global Market Advisors (GMA) provides independent project feasibility reports, strategic advice, economic impact studies, and marketing strategies to companies seeking to grow in the global casino gaming, hospitality and airline industries. The firm maintains active clients in the United States, Europe and greater Asia. You can learn more about GMA by visiting www.globalmarketadvisors.us.
SECRETARY KERRY: Good afternoon, everybody. I want to thank President Thein Sein for his government’s warm welcome here during the course of this conference, for his leadership as chair of ASEAN, and for serving as the United States-ASEAN country coordinator.
Burma has made a significant amount of progress over the course of the last years, and when I was last here in 1999, I visited with Aung San Suu Kyi, who was then under house arrest. Today, she sits in parliament, and the people here are openly debating the future direction of this country. The Burmese people have made a very clear statement about their desire to build a democratic, peaceful, and economically vibrant country, and many have struggled and sacrificed in order to reach this stage.
But I do want to emphasize, despite the progress, there is still obviously a lot of work yet to be done, and the leaders that I met with acknowledged that and indicated a willingness and a readiness to continue to do that in order to ensure the full promise of human rights and of justice and of democracy in this country. So yes, there’s work to done – to be done, and we certainly are prepared to work hand in hand with the government in an effort to try to make sure we move continually in the direction that people want.
The government, among other things, still needs to complete the task – the difficult task – of ending the decades-long, multiple array of civil wars involving more than a dozen groups. And they need also to expand the space for civil society, protect the media, address land rights, prevent intercommunal violence, and enshrine into their laws basic freedoms. What is interesting is that some of the freedoms that people enjoy today, because the government has made a decision to permit it, are not exactly yet enshrined in the law themselves, and it is obviously vital that that occur.
The serious crisis in Rakhine State and elsewhere, profound development challenges to raise the country’s standard of living, ethnic and religious violence that still exists, fundamental questions regarding constitutional reform, and of course the role of the military – all of these remain significant challenges of the road ahead.
Next year’s election will absolutely be a benchmark moment for the whole world to be able to assess the direction that Burma is moving in. And it is important – in fact, beyond important – that that election be inclusive, accountable, open, free, fair, accessible to all, that it wind up being a credible election that leads to the peaceful transfer of power in 2016.
I discussed each of these issues directly with the president and the members of his cabinet and the chairmen of key committees and the speaker, and we had a long and – in fact, a long discussion that made us late for everything else the rest of the day. But it was – because it was important and because it was comprehensive that that occurred. Each of the leaders that I met with – the chairmen of committees, the speaker, the president, the members of his cabinet – they indicated that they recognized the job is not complete, they understand the difficulties, and they indicated a willingness to continue to move.
I invited the speaker and his key committee chairmen to come to Washington soon and to spend time with our legislators, with the members of the House and the Senate. And hopefully doing so, which is certainly the conviction that President Obama and I share, is that that kind of exchange can assist them and encourage them as they make decisions about their constitution and the reforms for the country.
One of the things that characterized by conversations with the president and his team was that we were both able to really talk very candidly and very directly about each of these issues. And we talked, I think and I hope, as friends about the full range of possibilities and the challenges facing Myanmar.
Myanmar’s potential is limitless, and it’s blessed by a rich diversity of people and by an abundant source of natural resources. But it’s ultimately up to the leaders to make the right choices in the days, months, and years ahead. If they do and if people in Myanmar can overcome the differences that exist between them, if they can join together in common purpose, then Myanmar can complete the transition to democracy. And the United States will absolutely remain a partner in the effort to help Myanmar be able to do that.
In the last two days, I participated also in five ministerial meetings – the ASEAN-U.S. ministerial, the East Asia Summit, the ASEAN Regional Forum, the Lower Mekong Initiative, and the Friends of the Lower Mekong. All of these meetings underscored the depth and the intensity of the United States engagement with Asia, and they reinforced and strengthened the role of the institutions, which are at the heart of the problem and the heart of the efforts to solve the problems that exist in the Asia Pacific.
In the effort to solve those problems, ASEAN is really a central player. ASEAN is central to regional peace, to stability, to prosperity. And during my meetings with ASEAN foreign ministers, we affirmed our commitment to sustainable economic growth and to regional development. And American companies are already investing responsibility in order to develop jobs and help to create the economic base that could be really transformative for the people of Myanmar.
Ultimately, it is our hope that those investments will produce initiatives, companies, exciting enterprises that can become models for good corporate behavior and improve the standard of living throughout the region. I’m very proud of what our businesses are doing and I look forward to their continued partnership in the effort to help Myanmar develop.
We’re also focused on our shared interest in protecting the environment. We took practical steps to deepen our cooperation with ASEAN on climate change, on – which is a challenge, obviously, that demands elevated urgency and attention from all of us. At the end of the day, some of you may have been there when they rolled out a logo for the meeting that will take place, which China and Malaysia will host, with respect for preparedness for disasters. And as the disasters were listed – the tsunami and the typhoon and one type of disaster after another that comes from the changes of the climate – it became apparent to all that there’s literally trillions of dollars of cost being spent now with greater prospect of that expenditure in the future, where all of it could be impacted by good decisions about energy policy and good decisions to deal with climate change ahead of time.
We also addressed key security issues. There was an extensive discussion on multiple occasions about the South China Sea. I expressed the concerns of many, which are shared, about the rise in tensions that have occurred. But we all underscored the importance of negotiations on a binding code of conduct. And I stressed the importance of everybody clarifying claims under international law and proceeding under the legal process through the law, through arbitration, and also through bilateral relationships in order to try to resolve these issues. And our hope is that the claimants ultimately can agree among themselves and proceed forward.
We did discuss the concept of freezing in place the actions that people choose to take on a purely voluntary basis. And these – this is a way of actually locking into place the very promises that people have already made under the Declarations of Conduct that were made in 2002. And I’m very pleased that there is positive language that came out in the communique issued by ASEAN foreign ministers yesterday as a result of that discussion that embraces this idea of resolving these issues in a thoughtful and peaceful way.
We also discussed North Korea and North Korea’s actions with respect to its nuclear program. These are actions which present a very serious threat to international peace and stability. I reaffirmed the commitment of the United States to the verifiable denuclearization of the Korean Peninsula. China joined in that, others. I think there is a unanimity within this meeting here – with one exception, needless to say, present this afternoon at the regional forum – about the need to adhere to the United Nations Security Council resolutions and to live up to the international standards with respect to nonproliferation.
So on behalf of President Obama and certainly from myself, I want to thank ASEAN for its committed partnership and very much look forward to continuing what has already been a very productive trip here to the region. I will be meeting with Aung San Suu Kyi later today. And I appreciate enormously the efforts of our hosts to have provided for a very constructive and comprehensive discussion over the course of these two days. And we certainly look forward to President Obama’s visit here in November, when the heads of state will meet to pick up where we left off today.
With that, I’d be delighted to open up to any questions.
MS. PSAKI: The first question will be from Anne Gearan of The Washington Post.
QUESTION: Thank you, Mr. Secretary. Two things quickly. On Myanmar, you’ve taken quite a lot of criticism from Congress, including from Democrats, that the Administration has moved too quickly and been too willing to take at face value the assurances from the Burmese leaders that they really were doing all of the things you’ve asked them to do and the things that I gather they’ve tried to show you today that they are doing. In your remarks a moment ago, you invited some Burmese leaders to come to Washington and I take it face its Congressional critics directly. What would you like to see come out of that kind of conversation? And what is your response to the sort of underlying criticism from Congress that you guys have been too eager to get this done quickly?
And then on the South China Sea, you said you were pleased by the language that was enshrined in the ASEAN document, but it doesn’t go quite as far as you all had hoped. China appears to still flatly disagree with the idea that binding international arbitration or the Law of the Sea ought to rule the day here. So where does this all leave you and what’s your next step? Thank you.
SECRETARY KERRY: Well, let me begin with this issue of whether we’re moving too quickly or not. We are not basing anything that we are doing in Myanmar on the basis of blind trust or some naive sense of what the challenges are. I just listed a long list of challenges, and I went through every single one of those challenges with our hosts in a very, very direct way. We talked about the need to end the civil war and the efforts that could be made to do it; we talked about the treatment of minorities; we talked about Rakhine State; we talked about the challenges of putting into law those things that people are allowed to do today but which might disappear in the future if they’re not put into law; we talked about constitutional reform.
The speaker particularly was enthusiastic about what America has done and the way America has done it and the kinds of things that our Constitution has enshrined and was very anxious to be able to come and interact with members of Congress in order to make some of the choices that they will be making as they go forward.
We talked about ethnic and religious violence, about the need to deal with these 12 or 15 or so groups that have been engaged in civil war. This is hard work, but you just don’t achieve results by the consequence of looking at somebody and ordering them to do it or telling them they either do it or else. This is country; these are the people with a history and with their own culture and with their own beliefs and aspirations and feelings and thoughts. And it is an amazing journey that has already been traveled to get to where we are today.
And there is no question about those things that have to happen to get to where we want to go. But I believe the Administration has acted very thoughtfully. Some of the sanctions have been reduced, not all. Sanctions are now very much focused on members of the junta and on key individuals who may still be representing a challenge to achieving some of these goals. But this is fundamentally a new government, in a new moment, with a possibility for an election next year.
Now is everything hunky-dory? No, not yet, absolutely not. And I think Aung San Suu Kyi, who I will visit with shortly, will be the first to say that, and I’ll be the second right behind her, saying that there are still things that need to be done. But the key is to have an effective manner of trying to achieve those things and to recognize where there may be a legitimate effort if, in fact, it is being exhibited.
And we will continue to work very, very carefully, without jumping ahead of anybody’s rights and without turning a blind eye to anything that violates our notion of fairness and accountability and human rights and the standards by which America always stands. And those will be forefront in all of our discussions, as they were throughout the last two days.
The other piece was on the —
QUESTION: South China Sea and whether this language goes far enough.
SECRETARY KERRY: No, I think the language does go far enough. I think we made the points that we came to make. We weren’t seeking to pass something, per se. We were trying to put something on the table that people could embrace. A number of countries have decided that’s what they’re going to do. It’s a voluntary process. We absolutely laid it out as a voluntary series of potential steps. And I think it has helped to be able to achieve the language that we do have. But by the same token, I think there’s a way to achieve some progress, and I think we’ll see some progress with respect to the South China Sea, based on the conversations that we’ve had here.
MS. PSAKI: The next question is from Aye Thu San of 7Day Daily.
QUESTION: Good evening, sir. So I would like to ask —
SECRETARY KERRY: Can you pull it very close so I can hear you? Thank you.
QUESTION: Yes. Good evening, sir. I would like to ask about the relation in United States foreign policy between Myanmar and United States. So in yesterday meeting with the President Thein Sein said to you United States will be – United States will (inaudible) the democratization process in Myanmar rather than talking about the criticisms. So Myanmar have many —
SECRETARY KERRY: I couldn’t hear that. I’m sorry. Rather than talking about what?
QUESTION: Rather than talking about the criticisms.
SECRETARY KERRY: Criticisms.
QUESTION: Yes, yes. Myanmar have many support from United States in the last three year. But Myanmar have to face conflict, human rights (inaudible) issue according to the Congress letter to you. So I will like to ask, how do you see on the democratization process in Myanmar in the last three year? And what is your comments and views on the United States foreign policy about Myanmar? Thank you.
SECRETARY KERRY: Well, let me make it clear to everybody – again, I will reiterate, I think I said this in my opening comments – we had a very frank discussion with the president and with his team. And we raised every single issue that exists with respect to this relationship. It was very comprehensive. We talked about human rights; we talked about the law; we talked about democracy and how you move to it; we talked about the election and the need for it to be open and free and fair; we talked about people’s full participation without penalty; we talked about journalists who recently have been arrested. We talked about all of these things and made it very clear that these are important changes that need to take place in the course of the evolution of Myanmar into a full democracy.
Now it doesn’t happen overnight anywhere. It didn’t happen overnight in the United States of America. We started out with a constitution that had slavery written into it before 100 years later it was finally written out of it. It sometimes takes time to manage change. Now that doesn’t allow you to turn a blind eye to things that are critical, and we’re not. You have to call them to account. And I believe we’ve been very clear about that.
Burma is undertaking very important changes right now, and it clearly faces significant challenges that take time to address. There are some people in the public life of Burma who don’t want to see those changes, and there are some people who are very passionate about them and do want to see them. And so that’s why there’s an election. But this relationship right now is not a relationship about Burma meeting U.S. demands every day. It’s about Burma meeting the potential of the country. And that’s what has to happen over the course of these next months, and particularly this next year leading into the election.
So during this visit, I made it very clear that the country needs to do more. Myanmar needs to do more, and we made that very, very clear. And it will not be able to reach its full potential, whether that’s foreign investment coming in or whether it’s the full participation of people in a democracy here in the country – it just won’t do it unless they address the issues that exist right here at home. And I think we made that very, very clear.
So we want to work with the government. We want to work with the people. And we will be very clear, as I have been here today and was in my conversations, about those things where greater progress needs to be made. But we also need to be realistic about what’s achievable at what pace and at what particular moment. We will never stop fighting for the human rights and basic rights of the people of Myanmar, Burma, whatever somebody chooses to call. That’s what we’re fighting for.
MS. PSAKI: Thank you, everyone.
SECRETARY KERRY: That’s it?
MS. PSAKI: Yes.
SECRETARY KERRY: Thank you all very much. Appreciate it.
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