Press Releases

WASHINGTON, May 18, 2013 /PRNewswire-USNewswire/ -- "The announcement of candidacy of Ali Akbar Hashemi Rafsanjani for the June 14th presidential elections in Iran elevates the internal power struggle within the regime to unprecedented height, causes a major crisis for the regime and poses a tremendous challenge to the Supreme Leader Ali Khamenei," according to a study by the U.S. Representative office of the National Council of Resistance of Iran, released at a briefing held at NCRI-US office in Washington, DC.

"The fundamental question is what will be the outcome of this power struggle? Will Khamenei tolerate Rafsanjani and concede to some level of power sharing with him?"  the study said. 

NCRI-US emphasized that regardless of the outcome, the critical political, national security and foreign policy matters, i.e. the nuclear program, interference in Syria, and ties with the United States will be ultimately and exclusively decided by the Supreme Leader. Similarly, one should not expect any change in domestic repression and export of terrorism.

Before Rafsanjani announced his candidacy, Khamenei faction launched an onslaught against him in a bid to dissuade him from standing for the elections, threatening to expose his "seditious" activities. "However, since Khamenei has lost his aura and authority significantly, Rafsanjani chose to confront Khamenei, and thus entered the race," added NCRI-US.   

"The Guardian Council's disqualification of Rafsanjani would be quite costly, meaning that the only option for Khamenei is to rely on 'election engineering' claimed and implemented by the Islamic Revolutionary Guards Corp (IRGC) to ensure his own candidate's victory," the study said. "Nevertheless, Khamenei's primary concern is how to avoid the repeat of the 2009 uprising, which could be lethal for the system as a whole."

"In effect, Khamenei is caught between a rock and a hard place. Either way, he and the ruling clique will emerge much weaker and more vulnerable after this election," NCRI-US study concluded.

SOURCE NCRI-US

SAN FRANCISCO, May 18, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced that the companies will be presenting new data from four studies that evaluated effectiveness in treating the overall symptoms of depression in patients taking vortioxetine, an investigational agent under review with the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). These data will be presented at the 2013 American Psychiatric Association Annual Meeting (APA) in San Francisco.

The objective of these four studies was to evaluate the efficacy and safety profile of vortioxetine in doses ranging from 10-20 mg per day, complementing other studies in the New Drug Application (NDA) submission package that included dose ranges of 5-20 mg per day. Three of the four pivotal studies met the primary efficacy endpoint as measured by the change from baseline of the Montgomery-Asberg Depression Rating Scale (MADRS) total score at week 8. Statistically significant improvements in overall symptoms of depression were demonstrated, as compared to placebo. A fourth study did not meet the primary endpoint. Results of all four studies provided additional information regarding the safety profile of vortioxetine.

"It is important that we continue to seek new options in depression because, even though there are effective treatments available, many patients remain symptomatic," said Madhukar Trivedi, M.D., professor of psychiatry, UT Southwestern Medical Center. "As a clinician, I'm encouraged by these data. They represent an important addition to the broader clinical profile for vortioxetine and support its potential as a new treatment for patients living with MDD."

Dr. Trivedi, director of UT's Southwestern Depression Center, serves as scientific advisor for Lundbeck and Takeda.

About the StudiesThe studies were multicenter, randomized, double-blind, parallel-group trials of adult patients taking vortioxetine designed to assess improvement in overall symptoms of depression at week 8 with vortioxetine, compared to placebo. Two studies included an established depression therapy, duloxetine, as an active reference arm that validated the studies and confirmed "assay sensitivity." The four studies were also conducted to assess and provide further information on vortioxetine's safety profile. 

A Duloxetine-referenced Fixed Dose Study Comparing Efficacy and Safety of 2 Vortioxetine Doses in the Acute Treatment of Adult MDD Patients (Study 315 conducted in the U.S.; Poster #NR9-01):

• Vortioxetine 20 mg demonstrated significantly improved overall symptoms of MDD using the MADRS. Specifically, declines from baseline in MADRS total score +/-standard error [SE] at week 8 were -12.83(+/-0.834), -15.57(+/-0.880), ‑16.90(+/-0.884), respectively for placebo (n=161), vortioxetine 20 mg (p=0.023, n=147), and duloxetine 60 mg (p<0.001, n=152) confirming assay sensitivity. Vortioxetine 15 mg did not meet statistical significance (p=NS, n=147).
• Adverse events (AEs) reported in >/=5% of the vortioxetine group were nausea, headache, dry mouth, dizziness, diarrhea, constipation, vomiting, insomnia, fatigue, nasopharyngitis, and respiratory tract infection.

A Randomized, Double-blind, Placebo-controlled, Duloxetine-referenced Study of the Efficacy and Safety of Vortioxetine in Acute Treatment of MDD (Study 13267A conducted in Europe/South Africa; Poster #NR3-055):

• Both 15 mg and 20 mg doses of vortioxetine were statistically significantly superior to placebo in mean change from baseline in MADRS total score at Week 8, with a mean treatment difference to placebo (n=158) of -5.6 (vortioxetine 15 mg, p<0.0001, n=148) and -7.1 points (vortioxetine 20 mg, p<0.0001, n=151). Duloxetine (n=146) separated from placebo, confirming assay sensitivity.
• The most commonly reported AEs (>/=5%) in the vortioxetine group were nausea, headache, diarrhea, dry mouth, dizziness and hyperhidrosis.

A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Vortioxetine 10 mg and 20 mg in Adults with Major Depressive Disorder (Study 316; Poster #NR9-06):

• Vortioxetine 20 mg significantly improved overall symptoms of MDD. Specifically, mean declines from baseline in MADRS total score at week 8 were -10.77 (+/- 0.807) (n=157) for placebo and -14.41 (+/-0.845) (p=0.002, n=150) for vortioxetine 20 mg. Vortioxetine 10 mg did not meet statistical difference (p=0.58, n=155).
• The most frequently reported AEs (>/=5%) in the vortioxetine group were nausea, headache, diarrhea, dizziness, constipation, vomiting, viral upper respiratory infection, and fatigue.

A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Two Doses of Vortioxetine in Adults with Major Depressive Disorder (Study 317; Poster #NR9-02):

• Vortioxetine 10 mg and 15 mg did not differ significantly in improvement of overall symptoms of MDD from placebo. Specifically, mean declines from baseline in MADRS total score +/-standard error [SE] at week 8 were -12.87(+/-1.043), -13.66(+/-1.064), -13.36(+/-1.087), respectively, for placebo (n=160), vortioxetine 10 mg (n=157) and vortioxetine 15 mg (n=152).
• AEs reported by >/=5% in either vortioxetine group were nausea, headache, dry mouth, vomiting, constipation, diarrhea, dizziness and flatulence.

The four pivotal studies presented during the meeting are part of a larger NDA data package that is currently under review by the U.S. FDA that includes data from seven positive studies – six short-term studies and one long-term maintenance study – conducted in regions throughout the world. The vortioxetine global clinical program evaluated the effectiveness and safety profile of vortioxetine in a broad dose range of 5-20 mg per day and included more than 7,500 total subjects.

About VortioxetineVortioxetine (currently under review with the FDA) is an investigational antidepressant with multimodal activity that is thought to work through a combination of two mechanisms of action: receptor activity modulations and reuptake inhibition.

In vitro studies indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the serotonin (5-HT) transporter (SERT). In vivo non-clinical studies have demonstrated that vortioxetine enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain.

Across the doses of 5-20mg, the most commonly observed adverse reactions in MDD patients treated with vortioxetine in placebo-controlled studies (incidence >/=5% and at least twice the rate of placebo) were: nausea, constipation and vomiting. Overall, 6.5 percent of the patients who received vortioxetine discontinued treatment due to an adverse reaction, compared with 3.8 percent of placebo-treated patients in these studies. Nausea was the most common adverse reaction reported as a reason for discontinuation and considered to be drug-related.

About Lundbeck                      Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. For this purpose, Lundbeck is engaged in the entire value chain throughout research, development, production, marketing and sales of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's pipeline consists of several mid- to late-stage development programs. Lundbeck's U.S. business is based in Deerfield, Illinois. To learn more about Lundbeck in the U.S., visit www.lundbeckus.com.

Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in Denmark. We have employees in 57 countries and our products are registered in more than 100 countries. We have research centers in Denmark, China and the United States and production facilities in Italy, France, Mexico, China and Denmark. Lundbeck generated revenue of approximately DKK 15 billion in 2012. Lundbeck's shares are listed on the stock exchange in Copenhagen under the symbol "LUN." Lundbeck has a sponsored Level 1 ADR programme listed in the US (OTC) under the symbol "HLUYY." For additional information, we encourage you to visit our corporate site www.lundbeck.com.

About Takeda Pharmaceutical Company LimitedLocated in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc.  Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology and cardiovascular disease treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.takeda.us.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

SOURCE Takeda Pharmaceutical Company Limited; Lundbeck

LOS ANGELES, May 18, 2013 /PRNewswire/ -- Today, Ronald McDonald House Charities® (RMHC) of Southern California awarded $328,000 in scholarship funds to 104 exceptional high school seniors from Los Angeles, Orange, Riverside, San Bernardino and Ventura counties. The scholarships were presented during a recognition luncheon at the legendary Millennium Biltmore Hotel in Downtown Los Angeles, where recipients were recognized and applauded by their parents, school counselors and Southern California McDonald's Owner/Operators.

Mekahlo Medina, KNBC Channel 4 social media, technology and neighborhood reporter opened the celebration with an enthusiastic congratulatory message to the 2013 RMHC of Southern California scholarship class. Award-winning rocket scientist and featured keynote speaker, Olympia LePoint, delivered an inspiring message focused on overcoming obstacles on the way to achieving ones dreams, while stressing the importance of completing a college education and giving back to the community. Additionally, attendees had the unique experience to hear straight from LePoint about her experiences with NASA and her contributions to launching the Endeavor, Discovery, Columbia and Atlantis space shuttles.

RMHC of Southern California awarded the scholarships through its four programs including: (RMHC)/African American Future Achievers, RMHC/Asian Pacific American Students Increasing Achievement (ASIA), RMHC/Hispanic American Commitment to Educational Resources (HACER) and RMHC/Scholars. The selected 104 recipients may apply their scholarship funds towards tuition, fees and other appropriate educational expenses.

"For over 20 years, our organization has helped alleviate some of the financial strain that comes with funding a higher education, so that Southland students can focus on pursuing their dreams of going to college," said Vince Bryson, CEO, RMHC of Southern California. "Today it is our privilege to congratulate the 2013 scholarship class for their outstanding academic achievements thus far, and wish them well as they set out towards a bright future of many more accomplishments."

Since 1990, RMHC of Southern California has awarded more than $4.5 million in scholarship funds to local students to help make their dreams of a college education a reality. Funding for these scholarships is made possible through the global and Southern California chapters of RMHC and the fundraising efforts of local McDonald's owner/operators and corporate staff. The McDonald's Operators' Association of Southern California (MOASC) pays for administrative costs of the scholarship programs, including the production and distribution of applications and the recipient recognition event.

For more than 30 years, RMHC of Southern California has been committed to providing comfort, care and support to children and families across the Southland.  The organization is dedicated to creating a community where children and their families embrace life and healing with a sense of hope, enthusiasm, courage and joy by operating six Ronald McDonald Houses, Camp Ronald McDonald for Good Times, two Ronald McDonald Family Rooms, a Community Grants program and scholarships.

MOASC is comprised of more than 600 franchised and company-owned McDonald's restaurants in Los Angeles, Orange, Riverside, San Bernardino and Ventura counties. Follow us on Twitter: @McDonalds_SoCal.

SOURCE Ronald McDonald House Charities of Southern California

MEMPHIS, Tenn., May 18, 2013 /PRNewswire-USNewswire/ -- Jane Fraser, president, the Stuttering Foundation (www.StutteringHelp.org) issued the following remarks concerning the passing of Ken Venturi, the first spokesman for the Foundation

"The stuttering community lost a real champion in Ken Venturi.

"Nearly 30 years ago, Ken became our first "Famous Person Who Stutters" – an ever-growing list of more than 100 well-known people which provide hope and courage to the 68 million people who stutter worldwide. He was one of the first to offer his help to the stuttering community, and remained faithful to the cause for decades.

"Ken faced no bigger obstacle than stuttering. Ken Venturi is a hero to those who stutter, going out of his way to share his personal experience when consulted by a colleague, friend, or child who stutters.

"Ken was the first national spokesman for the Stuttering Foundation nearly three decades ago. As was his way, he offered to fill that role for us because his concern for those who stutter was unparalleled. In a letter dated July 1986, Ken wrote my father, our founder Malcolm Fraser, saying he wished to do whatever he could to help those who stutter."

About the Foundation



Malcolm Fraser, a successful businessman and stutterer, went on to establish and endow the nonprofit Stuttering Foundation in 1947. The Stuttering Foundation provides a toll-free helpline, 800-992-9392, and free online resources on its Website, www.StutteringHelp.org, including services, referrals and support to people who stutter and their families, as well as support for research into the causes of stuttering. Please visit us at www.StutteringHelp.org.

SOURCE Stuttering Foundation