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Sunday, September 30, 2012
How Acupuncture Works According To Traditional Acupuncture And ...
Word Count: 822 Date:
Acupuncture is one of the most popular traditional Chinese medicines (TCM) that is widely used for a range of conditions. It is done by inserting a solid, metallic, thin needle into the skin at different pressure points along the meridians. Needles can be manipulated manually or through electrical stimulation.
A patient may feel varied sensations at various acupuncture points also depending on what is happening from a health perspective. Additionally there are different ways to insert the needle to induce different effects. A patient seeing a skilled acupuncturist does not need to worry about pain in general.
Two Main Schools Of Thought
There are two main schools of thought regarding the big question of: how does acupuncture work? The original school of thought agrees with the concept of TCM, which is based on the flow of energy (qi) and the school of thought which emerged from the 1970s, led by doctors such as Dr. Felix Mann which is a scientifically based system known asmedical acupuncture today. Let's examine a little these two different schools of thought.
1 - Traditional Acupuncture
In order to understand the traditional acupuncture model we need to have a basic appreciation of the traditional Chinese medicine (TCM) concept of disease.
Disease in TCM is considered to occur when there is a lack of harmony between the interactions or functioning of qi, yin, yan, xu?, z?ng-f?, meridians as well as/or possibly an imbalance between the human body and its environmental surroundings.
To cure the disease the TCM practitioner needs to identify the pattern of disharmony, which for example can also be caused by an invasion of damp, cold or wind. Proponents of this ancient healing practice believe that the body contains at least 350 acupuncture points that lie along the 12 meridians or channels of the body.
Once the pattern is identified in TCM it is commonly treated with acupuncture and/or herbs.
A traditional acupuncturist will carry out a traditional diagnosis and know which points to insert the acupuncture needles to have the best result. Expert acupuncturists can determine the root cause of a disease by inspecting the patient's tongue, breathing, smell of breath, sound of the voice and strength of the pulse. The intensity of acupuncture treatments given to patients vary depending on the results of the diagnosis.
2 - Medical Acupuncture
Medical acupuncture is best explained in the concept of neuroscience. It is believed that acupuncture plays a vital role in treating and preventing the onset of diseases by accessing and stimulating the acupuncture points in the body.
There is quite a bit of research which shows that acupuncture promotes overall health and fitness by stimulating the central nervous system to produce chemicals and hormones to the spinal cord, brain and muscles of the body.
These chemicals can either lessen the intensity of pain or trigger the production of other hormones and chemicals that can help in regulating the body's internal functions and processes. The increased production of chemicals and hormones helps in stimulating and enhancing the body's natural restorative, therapeutic and healing abilities thereby promoting a healthy emotional and physical being.
When the needles are inserted into the acupuncture points, it stimulates the nerve fibres to send nerve impulse to the spinal cord. It further stimulates the production of endorphins such as dynorphin and enkephalin that inhibit pain.
When the nerve fibres are stimulated, it also sends nerve signals to certain areas of the mid-brain that is responsible for the production of enkephalin which is a precursor to the production of monoamine transmitters like norepinephrine and serotonin. These monoamine transmitters play vital roles in suppressing the transmission of pain signals. Meanwhile, serotonin is scientifically proven to have anti-depressant effects to the brain aside from the fact that it reduces the intensity of pain.
Acupuncture is also beneficial in the production of adrenocorticotropic and beta-endorphin hormones. Endorphins provide immediate pain relief while adrenocorticotropic stimulates the adrenal gland to produce cortisol which is known for its anti-inflammatory effects.
Japanese v Chinese Acupuncture
Japanese and Chinese have different ways of conducting acupuncture. After a thorough investigation, a Japanese acupuncturist checks the pulse to determine where the needles should be inserted. Meanwhile, a Chinese acupuncturist checks the pulse once and examines the tongue to find out the activities that are taking place inside the body.
The Chinese believed that a disruption in the natural flow of energy or qi in the body can trigger the onset of different kinds of diseases. Furthermore, the lack of harmony between the mind and the body can cause an imbalance which can commence the development of diseases.
As well as different approaches and schools of thought, there are also a variety of different types of acupuncture.
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Jay-Z christens Barclays Center with Brooklyn love
NEW YORK (AP) ? The newly built Barclays Center is the home of the Brooklyn Nets, and the team's co-owner, Jay-Z, christened the venue Friday night in uniform, sporting a Nets hat and jersey as he rapped two dozen jams onstage in front of thousands.
Jay-Z performed for an excited and rowdy crowd of 18,000, wearing a jersey that featured his last name, Carter, and the number four. It was his first of eight shows at the venue.
As he emerged onstage, a video highlighting some of Brooklyn's historical moments ? like when it was named an official borough of New York City ? played in the background. There were also pictures of famous faces who were born in Brooklyn, from Michael Jordan to Al Capone to Aaliyah to Adam Yauch of Beastie Boys.
Jay-Z opened the show with the hometown anthems "Where I'm From," a song about his upbringing in Brooklyn's Marcy projects complex, and "Brooklyn Go Hard." He followed that with a tribute to one of Brooklyn's icons: the late Notorious B.I.G. He performed some of the rap vet's hit "Juicy" as the crowd joined in.
"Sing loud so he can hear you in heaven," said Jay-Z, who also held a moment of silence for the rapper, who was shot to death in 1997.
Another Brooklynite ? Big Daddy Kane ? made an appearance, performing songs like "Ain't No Half Steppin'" and "Warm It Up, Kane." He received a roaring cheer from the crowd when performing old-school dance moves with two dancers in all white.
Jay-Z said Friday's concert was incomparable to most of his other top-level performances, including the Grammys, Glastonbury or Coachella.
"Nothing feels like tonight," he told the crowd multiple times.
The audience was excited and wild, cheering on Jay-Z as blue laser lights beamed across the venue. A seven-piece band was placed a level above Jay-Z, who paced from left to right while performing jams like "Empire State of Mind," ''I Just Wanna Love U (Give It 2 Me)," ''Izzo (H.O.V.A.)," ''99 Problems" and many others. Videos played on screens behind and above Jay-Z, while screens for fans in the higher sections ? though not large enough ? showed the rapper's performance on the left and right sides of the stage.
"I want to thank you, Brooklyn, New York City, for making me the man I am today," he said. "Like I said, everybody's from Brooklyn tonight."
A fan in the front section held up Jackie Robinson's Brooklyn Dodgers jersey, immediately grabbing Jay-Z's attention. He asked the fan for it and said: "I promise I'll give it back."
"Brooklyn had their heart broken," he said as he held up the jersey and referred to the Dodgers leaving for Los Angeles after the 1957 baseball season. "We cried for so many years. ...Look how far we've come."
Jay-Z will perform at Barclays through Oct. 6 with the exception of Oct. 2.
___
Online:
http://www.barclayscenter.com/
___
Follow Mesfin Fekadu on Twitter at http://www.twitter.com/musicmesfin.
Source: http://news.yahoo.com/jay-z-christens-barclays-center-brooklyn-love-063248975.html
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Saturday, September 29, 2012
Refs cheered at first NFL game following lockout
BALTIMORE (AP) ? No one is complaining that the refs cost the Cleveland Browns the game. That mere fact is a major victory for the NFL and the seven-man crew led by referee Gene Steratore, who brought official harmony back to the nation's most popular league.
Cheered from the moment they walked onto the field, the men in stripes ran a smooth and efficient game Thursday night as the NFL's lockout of officials came to an end with the Baltimore Ravens' 23-16 win over the Browns.
"To just be applauded by 50,000 people prior to anything happening, it was something that kind of chokes you up," Steratore said. "It was a very special feeling."
Sure, there were calls that made both sides unhappy. Browns coach Pat Shurmur drew an unsportsmanlike conduct penalty for arguing an intentional grounding call, and Ravens left tackle Michael Oher could be heard raising all kinds of beef about a holding call.
But, overall, the officials kept the game in control, curtailing the chippy play and choppy pace ? not to mention the inconsistent calls ? that had marred the three weeks of games with replacement officials.
"It was great to have those guys back," Ravens running back Ray Rice said. "It looked like they knew what they were doing."
An agreement to end the lockout was reached late Wednesday after marathon negotiations, two days after a "Monday Night Football" finish brought debate over the use of the replacements to a fevered pitch nationwide.
That game ended when a 24-yard desperation pass on the last play was ruled a touchdown ? even though replays appeared to show it should have been an interception ? giving the Seattle Seahawks a disputed 14-12 victory over the Green Bay Packers.
The stage was set for something eerily similar Thursday. A fourth-down unnecessary roughness penalty on Baltimore's Paul Kruger ? a good call, given the way he shoved Cleveland's Joe Thomas after the whistle ? gave the Browns one final play from the 18-yard line.
But Brandon Weeden's 18-yard pass sailed high as time expired. No controversial ending this time.
"I thought they handled (the game) great," Cleveland coach Pat Shurmur said. "I had all the confidence in the world that this was going to be officiated in the right way."
The newfound love for the refs was evident all evening.
About an hour before kickoff, they made their first appearance on the field and heard cheers from the early arrivals. A few minutes later, Steratore was shaking hands with Shurmur near midfield and getting a hug from Ravens face-of-the-franchise Ray Lewis at the 30-yard line.
Later, when the crew returned, they received a standing ovation and doffed their caps to the crowd. One fan held up a sign that read: "Finally! We get to yell at real refs! Welcome back!"
"It was very chaotic with the replacement refs," said Karen Riley, a 44-year-old fan wearing a Rice jersey. "They couldn't control the players on either side. There were bad calls, constantly, and in some cases refs making different calls at the same time."
When Steratore then turned on his microphone to greet the captains for the pre-game coin toss, the crowd heard him say: "Good evening, men. It's good to be back."
The stadium erupted in a roar.
"You know we always pride ourselves in being a face without a name," Steratore, a 10-year league veteran, told The Associated Press about an hour before kickoff. "This will be a little different, but I don't expect it to last too long. And that's the goal ? is that we can let them get through that portion of this. It's happy to be back, it's happy to be appreciated. But then as soon as the game starts, it's happy to disappear again and let the entertainers entertain."
The deal to end the lockout is only tentative ? it must be ratified by 51 percent of the union's 121 members in a vote scheduled for Friday and Saturday in Dallas ? but both sides nevertheless went forward with the plan to have the regulars back for Thursday's game.
So Steratore hustled to Baltimore, making the 3?-hour drive Thursday morning from his home in the Pittsburgh area. He's usually in place the day before a game, but none of his regular pregame meetings had to be changed because the Browns-Ravens game was at night.
"We've had a few weeks to actually realize that this was the first September that I was home for multiple Saturdays and Sundays for almost 30 years of my life, continuously. ... It just feels completely different," Steratore said. "To be away from something that is involved with this level of professional sport, just to come back and feel that again, it doesn't take long to realize why you were missing it as much as you were missing it."
Steratore, who is a basketball official in the Big East Conference among others, also was fully aware he would be jeered the first time his crew made a questionable call ? just like always.
"Without a question," he said. "I've been yelled at by my own children many times, so this won't be any different."
Sure enough, the same fans that cheered the coin toss let out a full chorus of boos when line judge Jeff Seeman tossed his yellow flag some 20 yards to whistle Baltimore safety Bernard Pollard for a personal foul in the third quarter. Replays showed it was a good call: Pollard led with his helmet to make contact with a defenseless receiver, costing the Ravens 15 yards in a drive that led to a field goal for the Browns.
Steratore's crew nearly made a misstep in the first quarter, incorrectly spotting the ball by 2 yards after a misapplication of the rules following a holding call on the Browns. But two members of the crew caught the mistake and notified the referee before the next snap. A brief huddle ensued, and the ball was moved to its correct spot.
The crew made it clear it wouldn't tolerate the extra shoving and yelling after the whistle that had been frequently permitted by the replacements. Offsetting personal fouls were called on Cleveland's Johnson Bademosi and Baltimore's James Ihedigbo for extracurricular roughness on a punt return in the first quarter.
Then there was Shurmur's unsportsmanlike conduct penalty. Replays appeared to validate the grounding call he was trying to contest, and the coach took responsibility for his loss of temper.
"I can't do that," Shurmur said. "It's an emotional game, and I got to make sure I keep my emotions in check."
There were 18 penalties called in the game, mostly the familiar calls for holding and false start. There were two rare ? and indisputable ? whistles for fair catch interference on punt returns, and a hands-to-the-face call on Baltimore's Kelechi Osemele was so obvious that it drew three flags.
The league's new agreement with the officials runs for eight years. Commissioner Roger Goodell acknowledged the ending of the Seahawks-Packers game "may have pushed the parties further along" in the talks.
"Obviously when you go through something like this it is painful for everybody," Goodell said. "Most importantly, it is painful for our fans. We are sorry to have to put our fans through that, but it is something that in the short term you sometimes have to do to make sure you get the right kind of deal for the long term and make sure you continue to grow the game."
The dispute even made its way to the campaign trail, with President Barack Obama's spokesman, Jay Carney, calling Thursday "a great day for America."
"The president's very pleased that the two sides have come together," Carney said.
___
AP Sports Writer Rachel Cohen and AP Pro Football Writer Barry Wilner in New York, AP Pro Football Writer Howard Fendrich in Washington, and AP Sports Writer David Ginsburg in Baltimore contributed to this report.
___
Follow Joseph White on Twitter: http://twitter.com/JGWhiteAP
___
Online: http://bigstory.ap.org/NFL-Pro32 and http://twitter.com/AP_NFL
Source: http://news.yahoo.com/refs-cheered-first-nfl-game-following-lockout-081746847--nfl.html
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Man fatally shoots self on TV after Arizona chase
In this video grab provided by Fox 10 News, a vehicle involved in a police car chase is followed on an interstate highway by a television station helicopter west of Phoenix, Friday, Sept. 28, 2012. Police say a man fatally shot himself in the head on live national television at the end of the high-speed chase that began in Phoenix when the driver stopped, ran into the desert and placed a handgun to his head and fired. (AP Photo/Fox 10 News)
In this video grab provided by Fox 10 News, a vehicle involved in a police car chase is followed on an interstate highway by a television station helicopter west of Phoenix, Friday, Sept. 28, 2012. Police say a man fatally shot himself in the head on live national television at the end of the high-speed chase that began in Phoenix when the driver stopped, ran into the desert and placed a handgun to his head and fired. (AP Photo/Fox 10 News)
Map shows Tonopah Arizona, where a suspected car-jacker appears to shoot himself on live television.
PHOENIX (AP) ? Authorities still haven't released the identity of a man who fatally shot himself in the head on live national television at the end of a high-speed carjacking chase that began in Phoenix and ended close to the California border.
Fox News was covering the chase that began about midday Friday using a live helicopter shot from Phoenix affiliate KSAZ-TV. The man driving a copper-colored four-door sedan stopped, ran into the desert and placed a handgun to his head and fired.
The man was declared dead at the scene, according to Sgt. Tommy Thompson, a Phoenix police spokesman.
Fox News anchor Shepard Smith told viewers that the video was supposed to be on a 10-second delay so it could be cut off from airing if something went awry.
"We really messed up, and we're all very sorry," Smith said.
Fox apologized for showing the violence on air.
"We took every precaution to avoid any such live incident by putting the helicopter pictures on a five second delay," said Michael Clemente, executive vice president of news editorial. "Unfortunately, this mistake was the result of a severe human error and we apologize for what viewers ultimately saw on the screen."
More frequently than its rivals, Fox News Channel picks up car chases from its local affiliates and airs them live. It's gripping television, a live mystery with no clear resolution, and often provides a short-term ratings boost as viewers tune in to see how it ends. Critics say the chases themselves rarely rise to the level of national news. The Phoenix station was not airing the chase live when it ended.
Thompson said the man allegedly stole a car from a couple at gunpoint outside a Phoenix restaurant just before 11 a.m. MST.
Police officers located the vehicle and began a pursuit and the man fired several shots, Thompson said. He said at least one shot hit the police vehicle but the officers escaped injury.
The suspect headed west on Interstate 10, then pulled onto a dirt road near the town of Tonopah that Thompson said was "70 to 80 miles east of the California line."
TV footage showed the man exiting the vehicle and running erratically in a field before putting the gun to his head and firing. He then fell to the ground.
"Efforts to revive him were not successful and he was dead at the scene," Thompson said. "We don't have an ID yet."
Fox returned repeatedly to shots showing the car passing big-rig trucks that typically travel at about 70 mph as if they were standing still.
Police cars did not appear to be immediately behind the car during most of the chase.
Smith was narrating the video and clearly had his doubts about what was being shown from the moment the man stopped the car. "This scares me," he said.
"You wait for the end of these things and you worry about how they may end up," he said. "This makes me a little nervous, I got to tell you. A little nervous."
After the man shot himself, Fox's picture quickly cut to Smith, who was shouting "get off, get off, get off, get off."
Smith apologized repeatedly following the commercial break.
"That didn't belong on TV. We took every precaution we knew how to take to keep that from being on TV and I personally apologize to you that that happened," he said.
___
AP television writer David Bauder reported from New York. Associated Press writer Walter Berry in Phoenix also contributed to this report.
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Lake Forest horse racing, restaurant plan still in the gate | horse ...
LAKE FOREST ? Six guys from South County who bought a former Black Angus site just off the I-5 hope it will be the place to be during next year's Kentucky Derby.
They envision a room filled with ladies in hats, an upscale restaurant and a betting scene where patrons can gamble on the ponies while watching the races on big screens.
Developers Bruce T. Lehman, left, and Brad McKinzie are two of six partners planning to transform the former Black Angus restaurant in Lake Forest into a high-end restaurant and sports bar with satellite horse race betting. The site is near the I-5 Freeway and Lake Forest Drive.
EUGENE GARCIA, THE ORANGE COUNTY REGISTER
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"We want to build a fun, vibrant, classy place where horse racing becomes a social activity," said Brad McKinzie, one of the six partners hopeful that the city's Planning Commission lets them open Sammy's, a fine-dining restaurant with mini-satellite horse wagering. "Having it open for the Kentucky Derby ? now, that would be fun!"
City officials aren't so sure they'll bet on the idea just yet, however.
McKinzie, a 25-year executive at the Los Alamitos Race Course, and his longtime friend Bruce Lehmen, a real estate developer, say the Lake Forest location is the perfect spot for a vision they've been crafting with their golfing buddies for three years.
But while the six call it perfect, city planners haven't given the OK to spring open the race gates. The Planning Commission reviewed the project two weeks ago and had some concerns. They questioned how well an adult-use business fits into the family-minded Lake Forest vibe. They also wanted to know more about plans for the exterior and changes to the parking lot. McKinzie and Lehman, who with their partners bought the 10,000-square-foot building in 2009, want it to operate as a trendy restaurant with a mini-satellite horse-wagering lounge as an extra.
Planning Commissioners are interested to hear more about the proposed $1 million remodel of a building near the city's gateway. The developer proposal calls for a renovation inside and out, including new landscaping and an upgrade to the weed-overgrown parking lot.
Jerry Verplancke, commission chair, said that while the applicants had hoped for an immediate decision, commissioners are still considering many factors related to the gaming lounge?? among them, a proposal to require that guests be 21 or older. Since Sammy's is being billed as a high-end American cuisine restaurant, commissioners asked the applicant to rethink how it might become a family-oriented place in addition to being a wagering lounge.
Commissioners will also consider how the zoning code affects combining gaming and dining. Security concerns will also be taken seriously, Verplancke said. The commissioners will also balance the city's family-oriented theme with a request for an adult-oriented business.
In past years two adult clubs at the city's entrances?? Captain Cream (also known as Captain's Cabaret) at Lake Forest Drive and Rockfield Boulevard and the Library Gentleman's Club at El Toro Boulevard and Rockfield?? shut down. A Hooters restaurant that opened three years ago in the former Library building also recently closed.
In turn, city officials have focused their efforts on reinvigorating old shopping centers, spending more than $800,000 renovating 10 city parks and building a state-of-art $39 million sports park The city is also continuing to focus on the community recreation center and completing a final gap closure on Rancho Parkway. In the next few years, developers are expected to have built more than 4,000 homes in the city.
"Our job is to look at the code and decide, is it prudent to have this here?" he said.
The commission plans to revisit the Sammy's concept at its last meeting in October. In April, the panel approved an ordinance that allows mini-satellite wagering.
In 2007, the California Legislature passed a law allowing mini-satellite wagering facilities at restaurants and bars. All wagering would be operated by Southern California Off Track Wagering Inc., an association of race track and race horse owners created to oversee and administer statewide satellite facilities. According to law, the facilities must be 20 miles from a horse track and 10 miles from another satellite wagering facility. The closest wagering spot is in San Clemente.
McKinzie, a Huntington Beach resident, said he and others in the industry were delighted when San Clemente's OC Tavern, already popular for sports-watching, decided to go for the mini-satellite horse racing.
"We all made pilgrimages down there when they opened," he said.
Planning Commissioner David Carter also reported to his colleagues that he went to visit the site. It's different from the one McKinzie and Lehman have planned in Lake Forest, he told them. The tavern was already a sports bar when satellite wagering was added.
Phillip Ramminger, a manager at the tavern, said business is booming even more with the horse racing. A lot of locals were really excited for it to start up but the bar draws people from all over. He also said it's brought in a new type of clientele.
"It's a lot higher-class?? there are a lot more Bentleys parked out front," he said. "Everyone is like a family. Everyone helps each other out. If one has a good pick on a horse, they have no problem telling other people about it. They're real gentlemen."
That demographic, McKinzie said, one he perceives as underserved in the Saddleback Valley, is what he envisions at Sammy's in Lake Forest, too. He and his partners want to take it up a notch by also offering fine dining and dancing. They like the Lake Forest area's demographics and view their clientele as a high-end, higher-educated and older group.
"We won't have children throwing cheese pizzas or offer booster seats here," Lehman said.
Designs call for one-third of the restaurant's space to be a horse-race wagering room. The room would be decked out with leather-upholstered chairs, two- and four-person tables, and soffits housing high-definition, flat-screen TVs showing horse races from local tracks.
Horse race fans would be able to bet on live races from Thursday through Sunday. All the money bet would go to the same pool as those betting at Santa Anita Park, Los Alamitos Race Course and Del Mar Thoroughbred Club. The advantage, Lehman said, is horse race fans could experience the thrill of live racing without having to drive to the track.
By state law, only those 21 and older would be allowed in the horse room during betting days, which generally are Wednesday through Sunday. Operating hours would be 10 a.m. to 2 a.m. Monday through Friday. On Saturday and Sunday they would be from 9 a.m. to midnight. Security guards would be present during wagering and an armored transport would remove the money.
Before the 2007 law, off-track bets could be placed at other racetracks, some tribal casinos and fairgrounds, and by phone and on the Internet. Yet horse racing still faced falling revenue. McKinzie said establishing mini-satellites would attract new bettors and generate more money for the industry. And just maybe those new bettors would go to the tracks and become horse-racing fans, he said.
In Lake Forest, Lehman and McKinzie said they expect to hire at least 40 people. The city would also get one-third of 1 percent of what would be wagered at Sammy's, McKinzie said.
Lawmakers wanted to boost the industry to save thousands of jobs and revenue generated for the state by the horse-racing industry, said Rod Blonien, a lobbyist for Los Alamitos Race Course in Cypress.
Contact the writer: 949-454-7307 or eritchie@ocregister.com or twitter.com/lagunaini
Source: http://www.ocregister.com/news/horse-373003-race-city.html
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Friday, September 28, 2012
Stivarga: Advanced Colon Cancer Drug Approved By FDA
* Bayer drug intended for cancer that has progressed or spread
* Wholesale cost set at $9,350 for 28-day treatment course
* Label has liver toxicity warning
* Onyx entitled to 20 percent royalty
* Bayer shares up 1.3 pct, Onyx shares up 2.8 pct (Adds Bayer comment, analyst forecast, potential other use for drug)
By Bill Berkrot
Sept 27 (Reuters) - The U.S. Food and Drug Administration on Thursday approved a new drug for advanced colon cancer developed by Bayer AG, a month ahead of the agency's expected action date for a decision.
The drug, to be sold under the brand name Stivarga, was approved to treat colon cancer that has progressed after prior treatment or that has spread to other parts of the body, the agency said.
"Someone has clearly lit a fire under the FDA," Sanford Bernstein analyst Geoffrey Porges said of the speedy approval. "We're seeing a fairly consistent pattern of drugs for high unmet needs diseases being approved on an expedited basis."
Bayer said Stivarga will be ready for distribution as soon as Friday and set a wholesale price for the drug of $9,350 for a 28-day cycle of treatment.
In pivotal clinical trials, Stivarga - known chemically as regorafenib - helped severely ill patients live on average 1.4 months longer than those who received standard treatment without the Bayer drug. Stivarga plus standard care also delayed tumor growth for an average of two months compared with 1.7 months for standard care alone.
Bayer is currently awaiting a colon cancer approval decision for the drug in Europe and is also seeking U.S. approval of regorafenib as a treatment for gastrointestinal stromal tumors.
"Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients' lives and is the second drug approved for patients with colorectal cancer in the past two months," Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said in a statement.
In August, the FDA approved Zaltrap, an advanced colon cancer treatment from Sanofi SA and Regeneron Pharmaceuticals.
Onyx Pharmaceuticals Inc is entitled to a 20 percent royalty payment on global net sales of Stivarga under a settlement agreement with Bayer following a dispute over how closely related the medicine is to Nexavar, the kidney and liver cancer drug that the companies co-developed and share.
Bayer and Onyx will jointly promote Stivarga in the United States.
Porges, Bernstein's biotechnology analyst, called the Onyx royalty agreement, "a fairly attractive deal."
But he said initial sales expectations for Stivarga are relatively modest "because this is really a relatively small indication late in the disease."
However, Morningstar analyst Damien Conover forecast sales of the drug reaching $1 billion by 2020. Bayer declined to provide its own sales forecast for the medicine.
"Bayer has very high expectations for Stivarga," Shannon Campbell, head of oncology for Bayer Healthcare, said in a telephone interview. "We certainly expect that Stivarga is going to play an important role once (patients) have gone through some of the more standard infusion based chemotherapies that are out there."
Stivarga is a pill that works by blocking several enzymes that promote cancer growth.
The drug was reviewed under the FDA's priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists. A decision had been expected by Oct. 27.
The Stivarga label will include a warning that severe and fatal liver toxicity occurred in some patients treated with the medicine during clinical studies, the FDA said.
In addition to Zaltrap, Stivarga will likely also compete with Roche Holding AG's multibillion-dollar cancer drug Avastin and Erbitux from Bristol-Myers Squibb Co and Eli Lilly and Co.
An estimated 143,460 Americans will be diagnosed with colorectal cancer, and 51,690 will die from the disease in 2012, according to the National Institutes of Health.
Bayer shares rose 1.3 percent to 68.40 euros in Germany. Onyx shares were up 2.8 percent at $84.85 on Nasdaq. (Reporting by Bill Berkrot in New York; editing by Gerald E. McCormick, Matthew Lewis and Carol Bishopric)
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Source: http://www.huffingtonpost.com/2012/09/27/stivarga-advanced-colon-cancer-drug-fda_n_1919525.html
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