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Laquinimod- все още в тестова фаза

 
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nemezius



Регистриран на: 24 Фев 2011
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МнениеПуснато на: Чет Фев 24, 2011 12:52 pm    Заглавие: Laquinimod- все още в тестова фаза Отговорете с цитат

Здравейте.
Наскоро получих информация от мои познати, които следят провеждащите се тестове на laquinimod за федерално разрешение от FDA, които според мен за сега вървят доста добре и се очаква да е по-добър дори от най-продавания в щатите медикамент Копаксон. Самия текст и как вървят нещата ще го пусна тук:
Цитат:
10:38 AM 12/09/10

UPDATE 3-Teva multiple sclerosis pill shines in big study

* Teva hopes for U.S. regulatory green light in two years

* Teva developing laquinimod drug with Active Biotech

* Laquinimod a rival to new Novartis pill Gilenya

* Teva stock up 6.5 pct; Active Biotech gains 18 pct

* Rivals Biogen, Elan down 1 percent

(Rewrites 1st paragraph; adds background on disease, sales projections, rivals' shares)

By Steven Scheer

JERUSALEM, Dec 9 (Reuters) - Teva Pharmaceutical Industries expects its experimental multiple sclerosis pill will win U.S. approval within two years after a clinical trial met its main goal, improving the drugmaker's standing in an increasingly competitive field.

Laquinimod, being developed with Sweden's Active Biotech , is jockeying for position in the emerging area of oral treatments for multiple sclerosis (MS), where Novartis' recently approved Gilenya is the current leader.

Israel-based Teva is best known as the world's largest maker of generic drugs, but it also has a 30 percent market share globally -- and 40 percent in the United States -- for its branded injectable MS drug Copaxone. The new drug could boost that franchise.

Recently, investors have been worried about Copaxone's future, given the risk of generic competition.

Teva shares had fallen to near year lows, but they jumped 6.5 percent to $52.48 in Thursday morning Nasdaq trading on the positive results from the first of two Phase III clinical trials for laquinimod. Active Biotech jumped 18 percent.

"The big question is: Will this be enough to reverse the negative sentiment?" said Yoav Burgan, head of sell-side research at the Poalim Sahar brokerage.

"The results seem very promising, but we don't have details," he said, noting they will be presented in early 2011. "Then, we will be much smarter."

Global annual sales of laquinimod are expected to reach $1.3 billion by 2019, according to BioMedTracker.

Shares of rival MS drugmakers Biogen Idec Inc and Elan fell more than 1 percent after the release of the laquinimod data.

FAST TRACK

MS, a disabling neurological condition, can cause dizziness, fatigue, blurred or double vision and cognitive problems. It affects more than 2 million people worldwide.

Teva said the laquinimod study comparing efficacy against a placebo met the primary goal of reducing annualized relapse rates, and treatment with the drug significantly slowed progression of disability.

"The safety profile of the product is good and there were no alarming signals that worry us," Ben-Zion Weiner, Teva's chief research and development officer, told Reuters.

Deutsche Bank analysts said in a client note: "Given its putative profile as a potentially very safe but modestly effective drug, we see it as fitting a niche in patients with early-stage or less aggressive disease."

A second study that compares laquinimod against another MS drug, partly designed to see if laquinimod helps patients with more advanced forms of the disease, is expected to be completed in the third quarter of 2011.

"If all is OK, we will submit in early 2012," Weiner said of the company's planned application to the U.S. Food and Drug Administration.

The FDA has fast-tracked laquinimod, meaning the approval process should be faster than normal.

"If all goes right, approval should be in a year and a half to maybe a little more," said Chief Financial Officer Eyal Desheh. "Teva, with two multiple sclerosis treatments in the market, would have a huge advantage over competitors."

In September, Swiss drugmaker Novartis' MS drug Gilenya won U.S. approval, making it the first oral treatment for the ailment in the United States.

Further competition could come from Germany's Merck KGaA's cladribine pills, as well as from oral drugs in development at Biogen and Sanofi-Aventis .

Teva's Copaxone already competes with injectable interferon drugs from Biogen, Merck KGaA and Bayer , as well as Tysabri from Biogen and Elan .

"Laquinimod is a good answer to generic competition for Copaxone," Burgan said. "Gilenya and other oral treatments should be considered substantial competition for Copaxone and other existing MS treatments on the market."

Weiner said existing drugs, such as Copaxone, typically treat MS in earlier stages such as for relapses. Laquinimod is also aimed at the relapse stage, but Teva said it was also trying to prove the drug helps in the disability stage of the disease.

"We will file (to the FDA) with both relapse and disability," he said.

(Additional reporting by Lewis Krauskopf in New York, Abhinav Sharma in Bangalore and Ben Hirschler in London; Editing by Erica Billingham and John Wallace)

((steven.scheer@thomsonreuters.com; +972 2 632 2210; Reuters Messaging: steven.scheer.reuters.com@reuters.net))

((Multimedia versions of Reuters Top News are now available

for: * 3000 Xtra: visit http://topnews.session.rservices.com

* BridgeStation: view story .134

For more information on Top News: http://topnews.reuters.com)) Keywords: TEVAPHARMA/

-

Thomson Reuters


Е, остава да се надяваме след това и европейските фармацевтични институции да го одобрят- свещичка надежда за излизане от тунела на иглите.
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lucho



Регистриран на: 12 Юни 2005
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МнениеПуснато на: Чет Фев 24, 2011 1:30 pm    Заглавие: Re: Laquinimod- все още в тестова фаза Отговорете с цитат

Ако беше прочел, преди поста си това http://msobg.org/forums/viewtopic.php?p=10595#10595 , щеше да си на светло и дори факел нямаше да ти е нужен Wink
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nemezius



Регистриран на: 24 Фев 2011
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МнениеПуснато на: Пон Фев 28, 2011 5:24 pm    Заглавие: Отговорете с цитат

Благодаря за информацията, lucho, но точно наличните отрицателни ефекти на Gilenya са основното(да не говорим, че след определена терапия не съм имал нито ниво плаки, нито пристъп от 2004-та насам), което ме възпира от приемане на този медикамент-голяма част от тези отрицателни ефекти би трябвало да са премахнати от laquinimod, съдейки по последните данни от изследванията.
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