VIVUS Inc. (VVUS)
- Creatore Discussione chiaro
- Data di inizio
the volture
OLL LLIINNN 📢📢
- Registrato
- 15/3/05
- Messaggi
- 10.341
- Punti reazioni
- 1.428
come la vedete vvus???
the volture
OLL LLIINNN 📢📢
- Registrato
- 15/3/05
- Messaggi
- 10.341
- Punti reazioni
- 1.428
la seguo a distanza...prevedo ancora sedute rosse in usa
.Segnale definitivo long a 6.65 piccolo rin-**** e anche questa è libera di salire
Allegati
cervellofine
Volare libero
- Registrato
- 30/10/06
- Messaggi
- 6.558
- Punti reazioni
- 194
lovis
Nuovo Utente
- Registrato
- 14/4/01
- Messaggi
- 9.360
- Punti reazioni
- 376
Vivus, Inc. Announces Positive Results From Phase 3 Study Of Avanafil In Erectile Dysfunction; Data Demonstrate Robust Efficacy, Favorable Side-Effect Profile
http://www.reuters.com/finance/stocks/keyDevelopments?rpc=66&symbol=VVUS.O×tamp=20091118113000
http://www.reuters.com/finance/stocks/keyDevelopments?rpc=66&symbol=VVUS.O×tamp=20091118113000
Tommy Gun
Nuovo Utente
- Registrato
- 15/3/00
- Messaggi
- 704
- Punti reazioni
- 17
Per chi sia interessato al titolo, riporto di seguito un pò di notizie aggiornate rispetto al precedente posto dello scorso 18/11...tutte a mio giudizio positive!
Vivus, Inc. Announces Additional Results of Phase 3 avanafil Study in Erectile Dysfunction Showing Efficacy in 15 Minutes
Monday, 11 Jan 2010 07:00 am EST
Vivus, Inc. Announces Positive Results From Phase 2 Study Of Qnexa In Obstructive Sleep Apnea
Thursday, 7 Jan 2010 07:01am EST
Vivus, Inc. Submits Qnexa New Drug Application To FDA For Treatment Of Obesity
Tuesday, 29 Dec 2009 07:00am EST
http://www.reuters.com/finance/stocks/keyDevelopments?rpc=66&symbol=VVUS.O×tamp=20091118113000
Vivus, Inc. Announces Additional Results of Phase 3 avanafil Study in Erectile Dysfunction Showing Efficacy in 15 Minutes
Monday, 11 Jan 2010 07:00 am EST
Vivus, Inc. Announces Positive Results From Phase 2 Study Of Qnexa In Obstructive Sleep Apnea
Thursday, 7 Jan 2010 07:01am EST
Vivus, Inc. Submits Qnexa New Drug Application To FDA For Treatment Of Obesity
Tuesday, 29 Dec 2009 07:00am EST
http://www.reuters.com/finance/stocks/keyDevelopments?rpc=66&symbol=VVUS.O×tamp=20091118113000
Tommy Gun
Nuovo Utente
- Registrato
- 15/3/00
- Messaggi
- 704
- Punti reazioni
- 17
Jan. 21, 2010, 6:00 a.m. EST ·
Investors betting heavily on Vivus obesity drug
Analysts say Qnexa could be a blockbuster if approved, but risks remain
Qnexa, which is awaiting U.S. approval, represents a massive market opportunity for the company, with the potential to generate over a billion a year in sales in the U.S alone, according to Vivus President Peter Tam, Potentially, Qnexa could be used by two-thirds of the U.S. population," said Tam, in a recent interview with MarketWatch, referring to the fact that over 60% of American adults are considered overweight or obese.
"We're talking well above billion-dollar sales for Qnexa," Tam added.
Investors, meanwhile, have been piling on the Vivus bus. Vivus' /quotes/comstock/15*!vvus/quotes/nls/vvus (VVUS 9.54, +0.08, +0.85%) stock price has more than doubled over the last year and gained 27% over the last three months, fueled not only by hopes that Qnexa will be a cash-cow but also will make the biotech group an attractive takeover target for a pharmaceutical company looking to shore up its top-line.
Vivus faces two upcoming events which could either tank or further stoke the stock, both involving the U.S. Food and Drug Administration. Vivus expects the agency to convene an advisory panel meeting to discuss the drug's approvability during the fourth quarter. The company hopes to get a final decision from the agency by the end of the year.
The company is seeking to have Qnexa approved to treat overweight adults with such weight-related conditions as diabetes and high blood pressure, and obese patients. Because weight-control can be a life-long battle for many people, Qnexa expects that some users would be on the product for years.
Sales could exceed a billion
If Qnexa is approved, some analysts predict it will be a blockbuster, meaning annual peak sales of over $1 billion.
Although Vivus has yet to enter into a formal commercialization agreement with a major pharmaceutical distributor, analysts speculate the royalty rate could be in the 20-25% range.
Because obesity has been linked to such conditions as cardiovascular disease, hypertension and diabetes, Vivus believes doctors might not only prescribe Qnexa to help treat those conditions in overweight patients, but also to help prevent them.
During his interview, Tam also pointed out that that some of Big Pharma's best-sellers have been drugs to treat cholesterol, diabetes, and high blood pressure.
"Qnexa can compete in those areas, because we're treating the causes of those diseases, and that's obesity," said Tam.
Also in Qnexa's favor is the fact that most of the leading diet treatments on the market are either only limitedly effective or can cause unpleasant side effects, such as gastrointestinal problems.
Jefferies & Co., in a December note, said they see Qnexa generating sales of $1.2 billion in 2015, with Vivus receiving a 25% royalty rate on sales.
Safety could be an issue
But analysts still aren't convinced that Vivus' U.S. approval is in the bag. In particular, they're concerned that an increasingly-cautious FDA might be wary of Qnexa's safety profile.
Qnexa is a combination of two compounds that have been on the market for many years -- phentermine, an appetite suppressant, and topiramate, an epilepsy medication.
Topiramate has been linked in some cases to several potentially-serious side effects, such as cognitive impairment, depression, and vision problems. The compound is also marketed as a migraine headache treatment called Topamax by Johnson & Johnson.
"We believe there still remains a very high bar for safety given the indication, and we are nervous how a FDA panel may view the safety profile of Qnexa," wrote Jefferies & Co. analyst Thomas Wei, in a recent note.
"The primary argument in favor of Qnexa is the fact that Topamax was approved for the treatment of migraines in 2004 at a dose range similar to that being used in Qnexa," Wei added.
Vivus officials are quick to point out the amounts of phentermine and topiramate in Qnexa are far lower than the maximum approved by the FDA, and that the drug is delivered through a special controlled-release formulation.
"Our view is that the side effects are very mild," Tam continued. "And there are plenty of benefits to go around."
Even Wei concedes that if approved, Qnexa could be a big hit.
"We believe that, if Vivus can convince the FDA that the safety risks with Qnexa are acceptable, Qnexa could have blockbuster sales," wrote Wei.
Rivals on the horizon
Even if it is approved, Qnexa might soon be facing competition.
Two other biotech companies, Arena Pharmaceuticals /quotes/comstock/15*!arna/quotes/nls/arna (ARNA 3.36, -0.07, -2.04%) and Orexigen Therapeutics /quotes/comstock/15*!orex/quotes/nls/orex (OREX 7.01, -0.23, -3.18%) , also have weight-loss drugs teed up for the approval process.
Arena submitted an application to the FDA for its drug, lorcaserin, in late December. Orexigen, meanwhile, has reportedly said it plans to file for its treatment Contrave during the first half of 2010.
"We view Qnexa's efficacy data as best-in-class," wrote Canaccord Adams analyst Adam Cutler, in a recent note.
"We note, however, that Qnexa does not have the edge on safety and tolerability as both Orexigen's Contrave and Arena's lorcaserin offer more benign safety/tolerability profiles," Cutler added.
Tam said that Vivus wouldn't be surprised if the other treatments also win FDA approval.
"The market certainly is big enough for multiple players," said Tam. "Obesity is a devastating disease and doctors need multiple options."
Finding the right partner
Also fanning the fires of investor speculation is the fact that Vivus still has not secured a commercial partner for Qnexa. Because the drug is in late-stage development, Vivus should be in a position to strike a much more lucrative deal than if the product was in earlier stages of development.
"We're having partnering discussions as we speak," said Tam.
Qnexa's free-agent status has also fed speculation that Vivus is a good candidate for a takeover by a major pharmaceutical player. When asked if Vivus could be a takeover target, Tam was not dismissive.
"We all know that Big Pharma is looking for big products, and this product is one of them," Tam answered.
Val Brickates Kennedy is a reporter for MarketWatch in Boston
Investors betting heavily on Vivus obesity drug
Analysts say Qnexa could be a blockbuster if approved, but risks remain
Qnexa, which is awaiting U.S. approval, represents a massive market opportunity for the company, with the potential to generate over a billion a year in sales in the U.S alone, according to Vivus President Peter Tam, Potentially, Qnexa could be used by two-thirds of the U.S. population," said Tam, in a recent interview with MarketWatch, referring to the fact that over 60% of American adults are considered overweight or obese.
"We're talking well above billion-dollar sales for Qnexa," Tam added.
Investors, meanwhile, have been piling on the Vivus bus. Vivus' /quotes/comstock/15*!vvus/quotes/nls/vvus (VVUS 9.54, +0.08, +0.85%) stock price has more than doubled over the last year and gained 27% over the last three months, fueled not only by hopes that Qnexa will be a cash-cow but also will make the biotech group an attractive takeover target for a pharmaceutical company looking to shore up its top-line.
Vivus faces two upcoming events which could either tank or further stoke the stock, both involving the U.S. Food and Drug Administration. Vivus expects the agency to convene an advisory panel meeting to discuss the drug's approvability during the fourth quarter. The company hopes to get a final decision from the agency by the end of the year.
The company is seeking to have Qnexa approved to treat overweight adults with such weight-related conditions as diabetes and high blood pressure, and obese patients. Because weight-control can be a life-long battle for many people, Qnexa expects that some users would be on the product for years.
Sales could exceed a billion
If Qnexa is approved, some analysts predict it will be a blockbuster, meaning annual peak sales of over $1 billion.
Although Vivus has yet to enter into a formal commercialization agreement with a major pharmaceutical distributor, analysts speculate the royalty rate could be in the 20-25% range.
Because obesity has been linked to such conditions as cardiovascular disease, hypertension and diabetes, Vivus believes doctors might not only prescribe Qnexa to help treat those conditions in overweight patients, but also to help prevent them.
During his interview, Tam also pointed out that that some of Big Pharma's best-sellers have been drugs to treat cholesterol, diabetes, and high blood pressure.
"Qnexa can compete in those areas, because we're treating the causes of those diseases, and that's obesity," said Tam.
Also in Qnexa's favor is the fact that most of the leading diet treatments on the market are either only limitedly effective or can cause unpleasant side effects, such as gastrointestinal problems.
Jefferies & Co., in a December note, said they see Qnexa generating sales of $1.2 billion in 2015, with Vivus receiving a 25% royalty rate on sales.
Safety could be an issue
But analysts still aren't convinced that Vivus' U.S. approval is in the bag. In particular, they're concerned that an increasingly-cautious FDA might be wary of Qnexa's safety profile.
Qnexa is a combination of two compounds that have been on the market for many years -- phentermine, an appetite suppressant, and topiramate, an epilepsy medication.
Topiramate has been linked in some cases to several potentially-serious side effects, such as cognitive impairment, depression, and vision problems. The compound is also marketed as a migraine headache treatment called Topamax by Johnson & Johnson.
"We believe there still remains a very high bar for safety given the indication, and we are nervous how a FDA panel may view the safety profile of Qnexa," wrote Jefferies & Co. analyst Thomas Wei, in a recent note.
"The primary argument in favor of Qnexa is the fact that Topamax was approved for the treatment of migraines in 2004 at a dose range similar to that being used in Qnexa," Wei added.
Vivus officials are quick to point out the amounts of phentermine and topiramate in Qnexa are far lower than the maximum approved by the FDA, and that the drug is delivered through a special controlled-release formulation.
"Our view is that the side effects are very mild," Tam continued. "And there are plenty of benefits to go around."
Even Wei concedes that if approved, Qnexa could be a big hit.
"We believe that, if Vivus can convince the FDA that the safety risks with Qnexa are acceptable, Qnexa could have blockbuster sales," wrote Wei.
Rivals on the horizon
Even if it is approved, Qnexa might soon be facing competition.
Two other biotech companies, Arena Pharmaceuticals /quotes/comstock/15*!arna/quotes/nls/arna (ARNA 3.36, -0.07, -2.04%) and Orexigen Therapeutics /quotes/comstock/15*!orex/quotes/nls/orex (OREX 7.01, -0.23, -3.18%) , also have weight-loss drugs teed up for the approval process.
Arena submitted an application to the FDA for its drug, lorcaserin, in late December. Orexigen, meanwhile, has reportedly said it plans to file for its treatment Contrave during the first half of 2010.
"We view Qnexa's efficacy data as best-in-class," wrote Canaccord Adams analyst Adam Cutler, in a recent note.
"We note, however, that Qnexa does not have the edge on safety and tolerability as both Orexigen's Contrave and Arena's lorcaserin offer more benign safety/tolerability profiles," Cutler added.
Tam said that Vivus wouldn't be surprised if the other treatments also win FDA approval.
"The market certainly is big enough for multiple players," said Tam. "Obesity is a devastating disease and doctors need multiple options."
Finding the right partner
Also fanning the fires of investor speculation is the fact that Vivus still has not secured a commercial partner for Qnexa. Because the drug is in late-stage development, Vivus should be in a position to strike a much more lucrative deal than if the product was in earlier stages of development.
"We're having partnering discussions as we speak," said Tam.
Qnexa's free-agent status has also fed speculation that Vivus is a good candidate for a takeover by a major pharmaceutical player. When asked if Vivus could be a takeover target, Tam was not dismissive.
"We all know that Big Pharma is looking for big products, and this product is one of them," Tam answered.
Val Brickates Kennedy is a reporter for MarketWatch in Boston
cervellofine
Volare libero
- Registrato
- 30/10/06
- Messaggi
- 6.558
- Punti reazioni
- 194
in accumulazione credo, stretta in un canalicolo..potrebbe uscirne fuori
accoppiata vincente
Credo che il grande punto di forza sia l'accoppiata diminuzione peso senza aumento della pressione arteriosa, anzi con tendenza a diminuirla... cioe' senza appesantire il lavoro cardiaco.
E' un fatto nuovo tra i farmaci antiobesita'.
Si parla di aumento forte della volatilita' nei prossimi mesi anche per l'avvicinarsi del 15 di luglio quando si riunira' il comitato endocrinologico americano per giudicare il farmaco prima della FDA.
Credo che il grande punto di forza sia l'accoppiata diminuzione peso senza aumento della pressione arteriosa, anzi con tendenza a diminuirla... cioe' senza appesantire il lavoro cardiaco.
E' un fatto nuovo tra i farmaci antiobesita'.
Si parla di aumento forte della volatilita' nei prossimi mesi anche per l'avvicinarsi del 15 di luglio quando si riunira' il comitato endocrinologico americano per giudicare il farmaco prima della FDA.
Tommy Gun
Nuovo Utente
- Registrato
- 15/3/00
- Messaggi
- 704
- Punti reazioni
- 17
La strada è lunga ma l'accumulo è appena iniziato.
non trascurerei neanche ARNA che è in diretta concorrenza con il farmaco Lorcaserin, meno efficace sotto il profilo della perdita di peso ma con minori effetti collaterali pertanto più sicuro per i pazienti obesi che presentano ulteriori patologie (pressione arteriosa, diabete...)