Daily Archives: July 27, 2016

Alloy four times stronger than titanium, obtained by a researcher Romance | mobile


A metal super-hard was created in the laboratory by a team of American researchers led by Romanian woman Emilia Morosan at Rice University, Houston, by melting together titanium and gold, thus obtaining the toughest alloy known that proves compatible with living tissues.

Materialulul newly created is four times stronger than pure titanium and has medical applications, extending the life of implants, team members say the researchers. Currently, knee and hip implants conventional need to be replaced due to wear after about 10 years.

Prof. Emilia Morosan, Rice University, said his team made ​​the discovery while studying unconventional magnets made ​​of titanium and gold.

New materials must be turned into powders to verify their purity, but the new alloy obtained – beta-Ti3Au – was too strong to be crushed in a mortar covered with diamonds.

The material “showed the highest hardness of all alloys Ti-Au (titanium gold) and their compounds, and compared to many other alloys in engineering, “said Emilia Morosan.

She said the hardness of the alloy, together with its high biocompatibility, making him a “composed of next generation extending substantially lifetime of dental implants and prosthetic joints.”

It may also have applications in the drilling industry in the sports equipment and many other potential areas, added Emilia Morosan.

Titanium is one of the few metals around which human bones are able to grow strongly, this property allows it to be widely used in medicine and dentistry .

Emilia Morosan was born in 1976 in Suceava. He completed his studies at the Faculty of Physics of the University “Alexandru Ioan Cuza” and obtained his PhD in 2005 at the University of Iowa. After working a while at Princeton University, he became an assistant professor of physics, astronomy and chemistry at Rice University.

In 2010, researcher Romanian woman was honored by President Barack Obama at the gala Presidential Early Career Awards for Scientists and Engineers (PECASE).
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#Cisnadioara, Fortified Church


#Cisnadioara, Fortified Church

The fortified church is one of the oldest architectural monument built in a genuinely Romanesque style in Transylvania (1223).The general aspect of the Church has remained unchanged to the day.

Posted by Diana Talos

Locul MISTIC din România unde toate dorințele se împlinesc | Dezvaluitorul – Misterele dezvaluite


Mick Jagger implineste azi 73 de ani


Mick Jagger implineste azi 73 de ani
Sir Michael Philip “Mick” Jagger s-a nascut pe data de 26 iulie 1943 in oraselul Dartford din Anglia. Provenind dintr-o familie de profesori, Mick s-a indragostit de muzica si a decis sa-si puna in aplicare pasiunea, initial cantand in corul bisericii, ca mai apoi sa devina celebrul cantaret pe care il cunoastem azi.
Desi a fost tentat sa urmeze o cariera in politica, Jagger a ales sa-si investeasca toata energia intr-un proiect pe care l-a numit “Rollin’ Stone”, dupa numele unei piese compuse de Muddy Waters. Anii 60 au reprezentat avantul unei formatii care avea sa devina ambasadoarea genului rock din intreaga lume.
Dupa 55 de albume si compilatii, 37 de piese in top 10 si peste 200 de milioane de albume vandute in intreaga lume, formatia The Rolling Stones, proiectul de suflet al lui Mick Jagger, a fost clasata pe locul 4 in topul 100 Greatest Artists of All Time.

France 24 : Hollande joins religious leaders in calling for unity after church attack

Hollande joins religious leaders in calling for unity after church attack


President François Hollande displayed interfaith solidarity with France’s religious leaders on Wednesday after two Islamist militants killed a priest in a church, igniting fierce political criticism of the government’s security record.

One of the assailants was a known would-be jihadist awaiting trial under supposedly tight surveillance, a revelation that raised pressure over the Socialist government’s response to a wave of attacks claimed by Islamic State since early in 2015.
“We cannot allow ourselves to be dragged into the politics of Daech (Islamic State), which wants to set the children of the same family against each other,” the Archbishop of Paris, Cardinal André Vingt-Trois, told journalists after the meeting at the Elysee presidential palace.
He was flanked by representatives of other Christian denominations as well as Jewish, Muslim and Buddhist leaders.
Hollande and his ministers were already under fire from conservative opponents over the policing of Bastille Day celebrations in the Riviera city of Nice in which 84 people died when a delivery man drove a heavy truck at revellers.
Former president Nicolas Sarkozy, who is expected to enter a conservative primary for next year’s presidential election, stepped up his attack on Hollande’s record since the first major attack against satirical magazine Charlie Hebdo last year.
“All this violence and barbarism has paralysed the French left since January 2015,” Sarkozy told Le Monde newspaper. “It has lost its bearings and is clinging to a mindset that is out of touch with reality.”
Sarkozy has called for the detention or electronic tagging of all suspected Islamist militants, even if they have committed no offence. France’s internal security service has confidential “S files” on some 10,500 people, although not all are suspected jihadists.
Interior Minister Bernard Cazeneuve rejected Sarkozy’s proposal, saying that to jail them would be unconstitutional and in any case could be counterproductive.
“What has enabled France to break up a large number of terrorist networks is keeping these people under ‘S file’ surveillance, which allows intelligence services to work without these individuals being aware,” he said on Europe 1 radio.
The chairman of France’s conference of religious faiths, Protestant community leader Francois Clavairoly, said after the talks with Hollande that it was impossible to protect every place of worship in the country.
“Everyone has to take responsibility, use best practice and keep an eye open,” he said.
Death at the altar
Tuesday’s attackers interrupted a church service, forced the 85-year-old priest to his knees at the altar and slit his throat. As they came out of the church hiding behind three hostages and shouting “Allahu akbar” (“God is Greatest”), they were shot and killed by police.
The knifemen arrived during morning mass in Saint-Etienne-du-Rouvray, a working-class town near Rouen, northwest of Paris, where Father Jacques Hamel had been celebrating mass. One of the hostages was badly wounded during the attack.
Islamic State said on its news agency that its “soldiers” carried out the attack. It has prioritised targeting France, which has been bombing the group’s bases in Iraq and Syria as part of a U.S.-led international coalition.
Police said they arrested a 16-year-old local youth after the incident but Cazeneuve said on Wednesday he did not appear to be linked to the church attack.
One of the attackers, 19-year-old Adel Kermiche, was a local man who was known to intelligence services after his failed bids to reach Syria to wage jihad.
Kermiche first tried to travel to Syria in March 2015 but was arrested in Germany. Upon his return to France he was placed under surveillance and barred from leaving his local area.
Less than two months later, Kermiche slipped away and was intercepted in Turkey making his way towards Syria again.
He was sent back to France and detained until late March this year when he was released on bail pending trial for alleged membership of a terrorist organisation. He had to wear an electronic tag, surrender his passport and was only allowed to leave his parents’ home for a few hours a day.
Kermiche’s tag did not send an alarm because the attack took place during the four hour period when he was allowed out.
According to the justice ministry, there are just 13 terrorism suspects and people convicted of terrorist links wearing such tags. Seven are on pre-trial bail. The other six
have been convicted but wear the electronic bracelet instead of serving a full jail term.
France was already in a state of shock less than two weeks after the Nice truck attack. In November, 130 people died in shooting and suicide bombings in and around Paris.

In March, three Islamist militants linked to the Paris attackers killed 32 people in suicide attacks on Brussels airport and a metro station in the Belgian capital.
Since the Bastille Day killings in Nice, there has been a spate of attacks in Germany too.

France 24 : French church attacker stopped twice from reaching Syria

French church attacker stopped twice from reaching Syria


The 19-year-old Normandy native who killed an elderly French priest during a church service on Tuesday was under house arrest for two failed attempts to reach Syria and was wearing an electronic bracelet at the time of the attack, investigators said.

Adel Kermiche, one of two assailants who attacked a church in Saint-Etienne-du-Rouvray in northern France on Tuesday, was wearing an electronic surveillance bracelet at the time of the attack, according to French Prosecutor François Molins.
Kermiche was first arrested in March 2015 by German police when he tried to use his brother’s passport to travel to Syria. He was returned to his family home but ran away again one month later.
Two months after his first attempt, he tried to go to Syria again via Turkey, but was detained and sent back to France via Switzerland.
Kermiche spent the next several months in a French prison before his release earlier this year but remained under house arrest. The teenager was fitted with an electronic surveillance device that allowed him to leave his house on weekdays between 8am and 12.30pm, Molins said.
The attack happened around 9.25am during morning Mass at a church in Saint-Etienne-du-Rouvray, a suburb of Rouen, when two assailants interrupted the service and charged up to the altar, where they slit the throat of Father Jacques Hamel, an 85-year-old Roman Catholic priest.
The two attackers were shot dead by police as they emerged from the church. The second assailant has not been formally identified.
A ‘sermon’ in Arabic, recorded by attackers
The attack, the first on a Western church claimed by the Islamic State (IS) group, shocked France and has been condemned across the world by religious leaders, including Pope Francis.
Witnesses said the assailants recorded the attack from the altar of the church.
“They forced [Father Hamel] to his knees. He wanted to defend himself, and that’s when the tragedy happened,” a Roman Catholic nun, identified as Sister Danielle, told French media. “They recorded themselves. They did a sort of sermon around the altar, in Arabic. It’s a horror.”
Sister Danielle managed to escape and call the police, who upon arrival tried to negotiate with the hostage-takers through a small door.
But police were unable to launch an assault on the church as three hostages – two nuns and one worshipper – were lined up in front of the door, Molins said.
The hostages then exited the church followed by the two attackers, one carrying a handgun. The assailants charged police, shouting “Allahu Akbar” (“God is great”) before officers opened fire.
One parishioner was severely wounded in the attack.
Charlie Hebdo attack ‘acted as a detonator’
Born in 1997 near the northern French city of Rouen, Kermiche was raised on a housing estate in Saint Etienne-du-Rouvray.
His mother, a teacher, told the Swiss French-language daily Tribune de Genève that the Charlie Hebdo attacks of January 2015 “acted as a detonator” on the teen. “He said we could not practice our religion in peace in France,” she said. “He was speaking with words that did not belong to him. He was bewitched, like he was in a cult.”
Shortly after the family confronted the boy over a secret Facebook account he used to contact other radicalised youth, Kermiche made his first attempt to go to Syria to join the IS group. He used his brother’s passport but was apprehended by German police.
For his second attempt he used his cousin’s ID, but was once again detained and sent back to France, where he was charged with conspiracy to commit a crime with a terrorist organisation and held until March 2016.
‘I knew it was him’
His involvement in the attack came as no surprise to the residents of Saint Etienne-du-Rouvray who knew him. “I saw him last Saturday, in the centre of Rouen,” a neighbour, who identified himself only by his first name of Redwan, told reporters Tuesday morning. “He was wearing a kameez (a long tunic). And this morning … I was told that an attack occurred, and I knew it was him, I was sure.”
According to Redwan, the teen talked openly about his attempts to go to Syria. “We tried to bring him to his senses. [But] every time we did, he cited a verse from the Koran – he was inventing things. He was saying that we should go there (to Syria) and fight for our brothers.”
Police on Tuesday raided the home of Kermiche’s parents, who had alerted French authorities about their son’s radicalisation after the Charlie Hebdo attacks.
A minor was taken into custody on Tuesday morning in connection with the attack.
Attack on ‘crusaders’
The two attackers were carrying a “fake explosive device covered in aluminium foil” when they entered the Catholic church, according to Molins.
Shortly after the police arrived, they used their hostages as human shields to block authorities from entering the church, he said.
Tuesday’s attack by the IS group appears to fulfill its longstanding threat against “crusaders” in what the militants paint as a centuries-old battle for power.
The incident comes as France remains under high alert after an attack in Nice that killed 84 people and a string of deadly attacks last year claimed by the IS group.

BBC News: French church attack: Faith leaders call for more security

French church attack: Faith leaders call for more security – http://www.bbc.co.uk/news/world-europe-36901897

From Wikipedia : SS Washingtonian was a cargo ship launched in 1913 by the Maryland Steel Company

SS Washingtonian was a cargo ship launched in 1913 by the Maryland Steel Company as one of eight sister ships for the American-Hawaiian Steamship Company. At the time of her launch, she was the largest cargo ship under American registry. During the United States occupation of Veracruz in April 1914, Washingtonian was chartered by the United States Department of the Navy for service as a non-commissioned refrigerated supply ship for the U.S. fleet stationed off the Mexican coast.

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Today’s Holiday: Cheyenne Frontier Days

Today’s Holiday:
Cheyenne Frontier Days

What began in 1897 as an attempt to keep alive the sports and customs of the Old West has grown into a week-long festival that regularly attracts over 300,000 visitors. Cheyenne, Wyoming, was one of the wealthiest cattle-raising cities in the world in the 1880s, and now it celebrates its colorful history by staging one of the world’s largest outdoor rodeos. The festival also includes parades of covered wagons, stagecoaches and other old-time vehicles; ceremonial Native American dances; the crowning of a “Miss Frontier” queen; and pageants recreating events from Cheyenne’s past.: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Today’s Birthday: Ludovico Sforza (1452)

Today’s Birthday:
Ludovico Sforza (1452)

Sforza effectively ruled Milan from 1480, first as regent for his young nephew and later, after his nephew’s suspicious death, as duke. The patron of Leonardo da Vinci, he presided over the final and most productive period of the Milanese Renaissance but was captured and imprisoned while fighting to expel the French from Italy. Before his fall, he was one of the wealthiest and most powerful princes of Italy, spending immense sums to further the arts and sciences. What painting did he commission?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

This Day in History: Centennial Olympic Park Bombing (1996)

This Day in History:
Centennial Olympic Park Bombing (1996)

During the 1996 Summer Olympics in Atlanta, Georgia, a bombing in Centennial Olympic Park killed one person and injured 111 others. Despite the attack, officials and athletes agreed that the games should continue. Security guard Richard Jewell was initially hailed as a hero for discovering the bomb and helping clear the area before it detonated, but he soon fell under suspicion and was vilified by various media outlets before finally being exonerated. Who was actually behind the bombing?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Quote of the Day: Jonathan Swift

Quote of the Day:
Jonathan Swift

He was a bold man that first eat an oyster.: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Article of the Day: Homo Floresiensis

Article of the Day:
Homo Floresiensis

Since their discovery on the Indonesian island of Flores in 2003, small, hominid remains—labeled Homo floresiensis—have divided scientists into two camps. While some believe the remains are the bones of a modern human with a disorder that results in a smaller-than-average skull, others see them as evidence of a newly discovered species in the genus Homo that lived among modern humans and survived until as recently as 12,000 years ago. What arguments have been raised by both sides?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Word of the Day: edification

Word of the Day:

Definition: (noun) Intellectual, moral, or spiritual improvement
Synonyms: enlightenment
Usage: He knew very well that he must tell some story this evening for the edification of the company.: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

As a Romanian living in “insulin green” business in which it has invested 100 euros. “I never made the demand”



Lucian coat Oradea (34) are among the first Romanian who have chosen to deal with bitter cucumber culture. It all began in 2009 when, back in Denmark, the young engineer has invested 100 euros horticultural seeds brought from Nepal.
Several years ago, Oradea Lucian fur reading an article about bitter cucumber, so that when she decided to start an agricultural business with such a culture.
“I read about a cucumber that decrease blood glucose. As a horticultural engineer I thought it would be a good culture that would help people, and also a profitable crop, ” he confessed Eng. Lucian coat
The first seeds had bought in Nepal, 100 euros. He began to cultivate bitter cucumbers in a greenhouse than in Oradea, then expanded in culture bihorean Roit village, where he was to cultivate “insulin green” even 2.000 square meters.
“We started with some seed in Nepal. I have grown and I started wondering ecological plasticity of this cucumber. Does not have diseases, are free of viruses. Unlike ordinary cucumbers, one, what surprised me very much. Production is not so great. Only a few cucumbers per plant and seed germinates quite difficult. These were the only inconvenience, “Lucian told us. 
Oradea focused more on selling seeds and powder, but sell and bitter cucumbers, both in Oradea markets and popular websites on sales.

Prices are quite high. One kilogram is sold even 50 lei, but there were times when it was sold and more expensive. Production at the national level is quite low, it reached several hundred kilograms. For now, bitter cucumber plant is very little known in Romania.
“Do not meet demand and I never did. Seed sells for a penny apiece, the kilogram of cucumbers from 30 to 50 lei, while powder sells for 50 money gram or 1 leu. I request from all the counties, but also in Hungary, Poland, Italy or England, “said Oradea.
Fur Lucian returned to Romania after two years in Denmark where he attended a school in agriculture. He returned to the country with the thought of making more money, and do not regret a single moment choice.
“I work a lot of passion and I love everything I do,” says the young Oradea.

Momordica exotic fruit or cucumber is bitter about that, recently, researchers speak as a panacea. The fruit of the plant of Asian origin was dubbed “vegetable insulin”, but also has proven anti-tumor effects and support the functioning of important organs such as the liver or the gall. The cucumbers are bitter and vines can grow in two ways, either on trellises that can stretch up to 3-4 meters, it is left to lie on the ground.
“Cucumber bitter consuption of the meal, according to the patient’s glucose level, from half a cucumber to 3 cucumbers. Contraindications in people who have hypoglycemia and pregnant women, “explains Lucian coat.
Regarding planting seeds, it is done at a distance of one meter between plants and two meters between rows. A plant gives about 20 fruit and their size varies between 50-60 grams, but can reach up to 300 grams.
The plant adapts well soil and climate in our country. Planted in April-May, resisting temperatures up to 14 degrees. Baking needs heat up to 32 degrees. It is very drought resistant, requires no irrigation and has no natural pests.

The fruit can be kept fresh in the refrigerator up to two weeks, can mura, or dried and give the coffee grinder to yield a powder that diabetics who consume a pinch before a meal.
Bitter cucumber is the best remedy, combined with physical movement to combat diabetes. Researchers found that momordica is antitumor and remove power tumors. Also a panacea and helps the pancreas, liver and gall. Even healthy people should consume such fruits, preventive, “says Lucian.
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Bihorean a bright idea who wants to conquer Transylvania. Delivers free vegetables they cultivate with their parents’ help

Realitatea EUROPEANĂ A INVSZIEI MUSULMANE : Andrei Ilarionov, noiembrie 2014


„Țările și națiunile europene nu ar trebui să fie surprinse, dacă, să spunem, la anul, în primăvară, apare o masivă mișcare politică islamistă, o primăvară islamică în Europa, care va destabiliza țările europene și va consuma energia și atenția liderilor europeni, în timp ce Putin va încerca să-și ducă la capăt proiectele sale neo-imperiale.„ — Andrei Ilarionov, noiembrie 2014

Breathing made easy: give it a try#


Fluoride Action Network | PRESS RELEASE: Toxic Waters, Broken Laws




Severe Dental Fluorosis – Photograph by Hardy Limeback, DDS

Severe Dental Fluorosis – Photograph by Hardy Limeback, DDS

Investigation Finds Widespread Failure by Texas Regulators to Notify Residents of Toxic Fluoride Levels

LOS ANGELES, CA – Texas water systems with high levels of naturally occurring fluoride failed to warn consumers about the hazards of fluoride-contaminated water for years, in clear violation of the Safe Drinking Water Act. The violations, revealed in a five-month investigation by the Fluoride Action Network (FAN), resulted from systematic failures at the local, state, and federal levels, placing Texas children at risk for disfiguring dental fluorosis and other potential harms.

High levels of fluoride in water cause a disfiguring tooth condition called dental fluorosis, also known as “Texas Teeth” due to the high levels of fluoride that have long plagued the Lone Star state. In its advanced forms, fluorosis produces extensive brown/black staining, pitting and crumbling of the enamel.  Elevated fluoride levels have been linked to other health effects as well, including learning problems, thyroid disease, and bone fragility.

Severe Dental Fluorosis – Photograph by Hardy Limeback, DDS
To protect against disfiguring fluorosis, the Environmental Protection Agency (EPA) has established a “Secondary Maximum Contaminant Level” (SMCL) for fluoride, which requires water systems with more than 2 mg/L of the contaminant to warn consumers that children under nine should not drink the water. However, FAN’s investigation reveals that Texas water systems with  more than 2 mg/L fluoride have consistently failed to provide the federally-required warning, dating as far back as 2000.

“Every Texas water system with a fluoride SMCL violation for which we were able to obtain annual water quality reports (19 in all) failed to provide the federally required warning,” states attorney and FAN Executive Director, Michael Connett. “The real culprits, however, are not the local water operators, but the state regulators upon whom the local officials rely when drafting the water quality reports.”

Most annual water quality reports in Texas are prepared by state regulatory officials at the Texas Commission on Environmental Quality (TECQ). “There is no excuse, therefore, for TCEQ to have ever allowed fluoride SMCL violations to go unreported, let alone for so many years,” notes Connett.

In fact, TCEQ specifically told at least one local water operator (Jason Biemer from the city of Kyle) that SMCL notifications are no longer required. Based on TCEQ’s advice, Kyle ceased providing notices for fluoride violations.

The city of Kyle’s experience shows that “TCEQ not only ignored, but actively undermined, the notification requirement for fluoride SMCL violations, which is a key safeguard in the Safe Drinking Water Act for protecting against fluoride harms,” states FAN researcher Doug Cragoe.

FAN’s investigation also revealed a surprising degree of misinformation at the federal level about the requirements for fluoride SMCL violations, with one EPA webpage falsely implying that the fluoride SMCL regulation is completely voluntary, and Outreach Specialists at EPA’s Safe Drinking Water Act hotline repeatedly assuring FAN that notifications are not required for SMCL violations.

Fortunately, FAN’s investigation into Texas’s Safe Drinking Water Act violations has already sparked change, with both local and state officials scrambling to correct the glaring and longstanding violations.  In April 2016, the TCEQ posted an “update” to its website to remind local officials of the need to include SMCL notifications for fluoride, and in June, TCEQ followed up by calling water systems with high levels of fluoride to directly inform them of the SMCL requirement.

“While we are happy our investigation has sparked vital and necessary changes, these changes will be too little, too late for the children who have already been harmed by the widespread negligence of Texas officials,” concludes Connett.

For FAN’s full report, see: http://www.fluoridealert.org

Commentary by Erin Brockovich:
You gotta love the Texas Commission on Environmental Quality… they are notorious for picking and choosing the regulations that they enforce.

” If your system exceeded the fluoride secondary constituent level (SCL) of 2.0 mg/L but has not exceeded the maximum contaminant level of 4.0 mg/L, you are required to notify your customers in the CCR per 30 Texas Administrative Code §290.118(g) and §290.122(d)(3)(B). “

Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM) | Business Wire

Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM)
First-in-class CD38-directed active immunotherapy provides new treatment option for MM patients who have exhausted other approved treatment options

May 23, 2016 06:57 AM Eastern Daylight Time

“However, there is still a lot of work to be done to ensure that daratumumab is available for patients in health systems across Europe.”
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Janssen-Cilag International NV (“Janssen”) today announced that the European Commission (EC) has granted conditional approval to DARZALEX® (daratumumab) for monotherapy of adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Daratumumab was approved under an accelerated assessment, a process reserved for medicinal products expected to be of major public health interest, particularly from the point of view of therapeutic innovation.1

Daratumumab is the first CD38-directed monoclonal antibody (mAb) approved in Europe. It works by binding to CD38, a signalling molecule highly expressed on the surface of multiple myeloma cells regardless of stage of disease.2-4 In doing so, daratumumab triggers the patient’s own immune system to attack the cancer cells, resulting in rapid tumour cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumour cell death via apoptosis (programmed cell death).5-9

“Despite recent advances, multiple myeloma remains a complex, incurable disease, with relapse being inevitable in almost all patients. With each relapse, the disease typically becomes more aggressive and more challenging to treat,” said Professor Jesús San Miguel, Director of Clinical & Translational Medicine, Universidad de Navarra, Spain. “Daratumumab has shown promising efficacy results and a manageable safety profile as a single agent for heavily pre-treated and refractory myeloma patients. Overall survival improved significantly in these patients, whose prognosis is typically very poor, and who therefore have the greatest need for new treatments.”

The approval of daratumumab was based on data from the Phase 2 MMY2002 (SIRIUS) study, published in The Lancet; the Phase 1/2 GEN501 study, published in The New England Journal of Medicine;10,11 and data from three additional supportive studies. Findings from a combined efficacy analysis of the GEN501 and MMY2002 (SIRIUS) trials demonstrated that after a mean follow-up of 14.8 months, the estimated median OS for single-agent daratumumab (16 mg/kg) in these heavily pre-treated patients was 20 months (95 percent CI, 15-not estimable). The overall response rate (ORR) for the combined analysis was 31 percent, and 83 percent of patients achieved stable disease or better.12 Daratumumab demonstrated a tolerable and clinically manageable safety profile as a monotherapy in heavily pre-treated patients. 10,11 The most common adverse events (AEs) in the Phase 2 MMY2002 (SIRIUS) trial, which occurred in more than 20 percent of patients, were fatigue, anaemia, nausea, thrombocytopenia, back pain, neutropenia and cough.10 The most common adverse events (AEs) in the Phase 1/2 GEN501 trial were fatigue, allergic rhinitis, and pyrexia (fever).11

“Today’s decision on daratumumab is fantastic news for patients as it will help to address a major area of unmet need in people with relapsed or refractory myeloma,” said Sarper Diler, MD, PhD, President of Myeloma Patients Europe. “However, there is still a lot of work to be done to ensure that daratumumab is available for patients in health systems across Europe.”

“The approval of daratumumab within an accelerated timeframe is a result of working with patient-focused urgency, delivering against unmet needs with transformational science and through strong collaborations,” said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa. “We are delighted that daratumumab has been approved in Europe and will continue to study its potential across the treatment continuum in multiple myeloma and other tumour types.”

The marketing authorisation approval follows a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued on 01 April 2016.13 This approval allows for the marketing of daratumumab in all 28 member states and the three European Economic Area countries of the European Union.

Janssen has exclusive worldwide rights to the development, manufacturing and commercialisation of daratumumab. Janssen licensed daratumumab from Genmab A/S in August 2012.


About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.14 MM is the second most common form of blood cancer, with around 39,000 new cases worldwide in 2012.15 MM most commonly affects people over the age of 65 and is more common in men than in women.16 The most recent five-year survival data for 2000-2007 show that across Europe, up to half of newly diagnosed patients do not reach five-year survival.17 Almost 29 percent of patients with MM will die within one year of diagnosis.18 Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure. While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.14 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.19

About Daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.2-4 Daratumumab induces rapid tumour cell death through apoptosis (programmed cell death)6,7 and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).5,6,8 Daratumumab has also demonstrated immunomodulatory effects that contribute to tumour cell death via a decrease in immune suppressive cells including T-regs, B-regs and myeloid-derived suppressor cells.9 Five Phase 3 clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed. For more information, please see http://www.clinicaltrials.gov.

About MMY2002 (SIRIUS) and GEN501

These studies included heavily pre-treated patients with relapsed and refractory multiple myeloma who had exhausted other approved treatment options and whose disease was progressive at enrolment. Safety data from the MMY2002 (SIRIUS) and GEN501 trials suggested that daratumumab (16 mg/kg) has a tolerable and clinically manageable safety profile as a monotherapy.10,11

The most common adverse events (AEs) in the Phase 2 MMY2002 (SIRIUS) trial, which occurred in more than 20 percent of patients, were fatigue (40 percent), anaemia (33 percent), nausea (29 percent), thrombocytopenia (25 percent), back pain (22 percent), neutropenia (23 percent) and cough (21 percent).10 The most common adverse events (AEs) in part 2 of the Phase 1/2 GEN501 trial were fatigue, allergic rhinitis, and pyrexia (fever).11 The most frequent haematologic AE was neutropenia (abnormally low levels of neutrophils, a type of white blood cell), which occurred in 12 percent of patients (n=5) in the 16 mg/kg cohort.11

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/janssenEMEA.

Janssen in Oncology

Our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on haematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualised use of our therapies; as well as safe and effective identification and treatment of early changes in the tumour microenvironment.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the anticipated benefits and potential of a newly approved product. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including further investigation of the clinical benefits of the product; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.



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  3. Lin P, Owens R, Tricot G, et al. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004;121:482-8.

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  5. de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol. 2011;186:1840-8.

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  7. Jansen JH, Bross P, Overdijk MB, et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012;120(21):abstract 2974.

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  9. Krejcik J, Casneuf T, Nijhof I, et al. Immunomodulatory effects and adaptive immune response to daratumumab in multiple myeloma. Blood 2015:126(23):abstract 3037.

  10. Lonial S, Weiss BM, Usmani SZ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016;387:1551-60.

  11. Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med. 2015;373:1207-19.

  12. Usmani S, Ahmadi T, Ng Y, et al. Analyses of real world data on overall survival in multiple myeloma patients with at least 3 prior lines of therapy including a PI and an IMiD, or double refractory to a PI and an IMiD. Blood. 2015:126(23):abstract 4498.

  13. European Medicines Agency. Committee for Medicinal Products for Human Use: Summary of opinion. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004077/WC500203957.pdf. Last accessed May 2016.

  14. American Society of Clinical Oncology. Multiple myeloma: overview. Available at: http://www.cancer.net/cancer-types/multiple-myeloma/overview. Last accessed May 2016.

  15. GLOBOCAN 2012. Multiple myeloma. Available at: http://globocan.iarc.fr/old/burden.asp?selection_pop=62968&Textp=Europe&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=13&type=0&window=1&submit=%C2%A0Execute. Last accessed May 2016.

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  19. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

May 2016


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