Wednesday, May 30, 2007
Will Avandia's Pitfalls Affect Zimulti's Approval?
Rumblings throughout the Pharma industry and Wall Street are predicting that the recent setback of Avandia (a diabetes drug produced by GSK) will adversely affect the anticipated approval of Zimulti in the United States this summer.
The FDA has a history of allowing current events and isolated incidents to sway their decisions, especially since Zimulti and Avandia (though not the same drug classification and treatment class) can both be considered 'Metabolic Syndrome' type drugs.
Time will tell... I just hope that the historical facts presented on June 13th are the deciding factor for the anticipated late July approval date, not the 'buzz' of current events.
The FDA has a history of allowing current events and isolated incidents to sway their decisions, especially since Zimulti and Avandia (though not the same drug classification and treatment class) can both be considered 'Metabolic Syndrome' type drugs.
Time will tell... I just hope that the historical facts presented on June 13th are the deciding factor for the anticipated late July approval date, not the 'buzz' of current events.
Sunday, May 27, 2007
Sanofi Weighing All Legal Options on India Generic Zimulti/Acomplia Competition
News out of India reports that Sun Pharmaceutical Industries, has developed a generic version of rimonabant (Zimulti/Acomplia), making it the third pharmaceutical company to do so in the past 2 weeks.
"We are evaluating the situation," the Sanofi spokesman said, while confirming that Sanofi did not submit an application for patent protection for Acomplia in India until the middle of last year. Thus far, India has not granted it a patent.
In the age of the internet and global commerce, how will a generic version of a drug not yet approved by the FDA in the United States effect sales and distribution?
An FDA advisory panel will air the safety concerns about the diet drug on June 13th.
It is predicted that a final decision for approval will be made before the end of July, 2007.
"We are evaluating the situation," the Sanofi spokesman said, while confirming that Sanofi did not submit an application for patent protection for Acomplia in India until the middle of last year. Thus far, India has not granted it a patent.
In the age of the internet and global commerce, how will a generic version of a drug not yet approved by the FDA in the United States effect sales and distribution?
An FDA advisory panel will air the safety concerns about the diet drug on June 13th.
It is predicted that a final decision for approval will be made before the end of July, 2007.
Friday, May 25, 2007
Zimulti In The News - Week of 5/21
A second Indian pharmaceutical company, Torrent Pharmaceuticals Ltd., has announced that it also is selling a generic version of the new Sanofi-Aventis diet drug Acomplia (rimonabant) under the name Rimoslim. Zydus Cadila, an Indian manufacturer of generic drugs headed by one of the country's richest men, announced it had launched a generic version of rimonabant under the name Slimona last week.
Monday, May 7, 2007
Zimulti Maker Explains The Name
Sanofi's official explanation why diet drug rimonabant -- sold as Acomplia in Europe and the rest of the world -- will be marketed in the United States (if and when it is approved) as Zimulti.
"This division considered that Acomplia could be too descriptive or eventually misleading indicating that a patient taking Acomplia would acomplish his therapeutical target," Hanspeter Spek, Executive Vice President for pharmaceutical operations at Sanofi-Aventis said on a conference call.
"We proposed other trademarks and the FDA agreed finally on Zimulti," Spek added.
"This division considered that Acomplia could be too descriptive or eventually misleading indicating that a patient taking Acomplia would acomplish his therapeutical target," Hanspeter Spek, Executive Vice President for pharmaceutical operations at Sanofi-Aventis said on a conference call.
"We proposed other trademarks and the FDA agreed finally on Zimulti," Spek added.
Friday, May 4, 2007
The Name 'Zimulti' - What's So Funny?
I've been somewhat amused by the blurbs over the blogosphere the last few days about Sanofi-Aventis' decision to call the blockbuster weightloss drug (Acomplia-rimonabant) Zimulti in the United States, when and if the FDA approve it this summer. Some have called it an italian dessert or appetizer like name, other's are saying it sounds too much like 'Zoloft' or 'Zocor', so confusion will set in amongst consumers.
When I hear the name I think one thing.... a 'Blockbuster Drug' that will beat all projections for sales once it legally hits the shores of the USA.
Think about it.... All those great italian dishes we associate Zimulti with are caused by our Hypothalamus in our brain sending us hunger triggers. Not only is it the visual, smell, and taste that trigger the hunger to eat, but the actual word!
So if a Cannoli or Zeppoli makes your mouth water just from the word being viewed or heard.... why not associate a drug to COMBAT those urges?, hence the word: Zimulti !
Too bad The Sopranos has only 5 episodes in its final season left and it will never see the day that Zimulti makes it into mainstream USA.
Can you hear the dialogue: Tony: "Hey Sil... pass me the bottle of Zimulti" Silvio: "But Ton, we have a fresh box of Cannoli's from the bakery, you haven't touched one!" Tony: "I said give me the bottle, I'm down 12 pounds and I want to finish that bottle...look what it's done for Bobby Bacala, he's our best earner this quarter...down 22 pounds from the Zimulti, this stuff helps"
When I hear the name I think one thing.... a 'Blockbuster Drug' that will beat all projections for sales once it legally hits the shores of the USA.
Think about it.... All those great italian dishes we associate Zimulti with are caused by our Hypothalamus in our brain sending us hunger triggers. Not only is it the visual, smell, and taste that trigger the hunger to eat, but the actual word!
So if a Cannoli or Zeppoli makes your mouth water just from the word being viewed or heard.... why not associate a drug to COMBAT those urges?, hence the word: Zimulti !
Too bad The Sopranos has only 5 episodes in its final season left and it will never see the day that Zimulti makes it into mainstream USA.
Can you hear the dialogue: Tony: "Hey Sil... pass me the bottle of Zimulti" Silvio: "But Ton, we have a fresh box of Cannoli's from the bakery, you haven't touched one!" Tony: "I said give me the bottle, I'm down 12 pounds and I want to finish that bottle...look what it's done for Bobby Bacala, he's our best earner this quarter...down 22 pounds from the Zimulti, this stuff helps"
Labels: Acomplia, Weight Loss, Zimulti
Thursday, May 3, 2007
Sanofi-Aventis Says Profits Fell in 1Q - Acomplia Sales
Acomplia, a breakthrough anti-obesity drug, had first-quarter sales of euro15 million ($20 million), the company said, noting that it has been used by more than 130,000 patients since its European launch in June last year. Acomplia is also available in Mexico, Argentina and Chile.
The drug is still awaiting final regulatory approval in the United States, where it is expected to be launched under the name of Zimulti. The Food and Drug Administration decision is expected by the end of July, after an advisory panel scrutinizes the pros and cons of the highly anticipated drug at a meeting on June 13.
The drug is still awaiting final regulatory approval in the United States, where it is expected to be launched under the name of Zimulti. The Food and Drug Administration decision is expected by the end of July, after an advisory panel scrutinizes the pros and cons of the highly anticipated drug at a meeting on June 13.
Tuesday, May 1, 2007
Zimulti (Acomplia) - Get the Facts
Obesity is now the most common nutritional disorder in western industrialised countries and arises from the accumulation of excess fat in the body from over consumption of fatty foods.
Zimulti works by blocking endogenous cannabinoid binding to neuronal CB1 receptors. Activation of these receptors by endoegenous cannabinoids, such as anadamide, increases appetite. It is the most advanced endocannabinoid receptor antagonist in clinical development and offers a novel therapeutic approach to appetite control and weight reduction.
The central cannabinoid (CB1) receptors are believed to play a role in controlling food consumption and the phenomena of dependence / habituation. To develop suitable drugs against this target, the human cannabinoid receptor was first cloned and then expressed in cells.
Rimonabant (Zimulti/Acomplia) has been developed from the knowledge that cannabis smokers often experience extreme hunger pangs, which cannabis smokers refer to as 'the munchies'.
The promising preclinical findings with Zimulti (rimonabant) have been confirmed in a series of clinical studies, including pivotal phase III trials involving over 6,000 obese subjects that were carried out in both the US and Europe.
Two-year data from the phase III multicentre Rimonabant In Obesity (RIO) trials, which compared rimonabant at doses of 5mg and 20mg with placebo with respect to weight reduction and prevention of weight gain, showed that the positive results seen after a year's treatment were sustained over the full two-year trial period.
Filed for approval with the FDA in April 2005, it has encountered significant delays over the past two years. In February 2007, the company learnt that the FDA had extended their decision on whether or not to approve Acomplia by a further 3 months. Despite the repeated setbacks, analysts remain optimistic that it will eventually be approved in the US as an aid to weight loss.
Zimulti works by blocking endogenous cannabinoid binding to neuronal CB1 receptors. Activation of these receptors by endoegenous cannabinoids, such as anadamide, increases appetite. It is the most advanced endocannabinoid receptor antagonist in clinical development and offers a novel therapeutic approach to appetite control and weight reduction.
The central cannabinoid (CB1) receptors are believed to play a role in controlling food consumption and the phenomena of dependence / habituation. To develop suitable drugs against this target, the human cannabinoid receptor was first cloned and then expressed in cells.
Rimonabant (Zimulti/Acomplia) has been developed from the knowledge that cannabis smokers often experience extreme hunger pangs, which cannabis smokers refer to as 'the munchies'.
The promising preclinical findings with Zimulti (rimonabant) have been confirmed in a series of clinical studies, including pivotal phase III trials involving over 6,000 obese subjects that were carried out in both the US and Europe.
Two-year data from the phase III multicentre Rimonabant In Obesity (RIO) trials, which compared rimonabant at doses of 5mg and 20mg with placebo with respect to weight reduction and prevention of weight gain, showed that the positive results seen after a year's treatment were sustained over the full two-year trial period.
Filed for approval with the FDA in April 2005, it has encountered significant delays over the past two years. In February 2007, the company learnt that the FDA had extended their decision on whether or not to approve Acomplia by a further 3 months. Despite the repeated setbacks, analysts remain optimistic that it will eventually be approved in the US as an aid to weight loss.
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