Title Advice Type Anticipated publication date
Avanafil (Spedra, Menarini) Erectile dysfunction in adult men Evidence summary: new medicine August 2014
NICE's advice programmes consists of a range of products that are either based on NICE guidance or involve a critical assessment of relevant evidence. However, these products do not have the status of formal NICE guidance, and do not contain new NICE recommendations.
Copyright © 2014 National Institute for Health and Care Excellence. All rights reserved.
Shaggy, I also remain fully long, and am also interested in this issue. I have been waiting for the Annual Meeting announcement as well-- and how the current BOD will spin their re-election request
Face reality-- increasing sales reps is going to significantly further increase the cost of marketing Belviq. Eisai currently pays for 400 reps and who collectively barely out sell Qsymia, even though they have more than twice the number of boots on the ground as Vivus-- and that's with TV and print ads. Eisai is currently losing money on Belviq. Restructuring to a less expensive sales force model makes sense. Cafe Pharma must be taken with a grain of salt, but the point the poster makes is relevant to the current reality.
Eisai is doing what makes sense-- cut out unnecessary expenses and restructure sales force in more efficient way. Yes, they are increasing, but at the expense of a lower cost, less experienced sales rep force-- that likely has a reduced bonus structure. Time will tell if it pays off.
07-08-2014, 10:54 PM
Re: Belviq did a blistering $8.4 M in Q1.
It is this quarter or bust. Quintiles takes over as primary sales force and Eisai releases most reps. This place is in a major downward spiral.
07-07-2014, 09:28 PM
Re: Belviq did a blistering $8.4 M in Q1.
As an Eisai rep, my largest concern now is the bloated sales force. Not us, but the over-expansion of Quintiles. The Rent a Reps are now the majority of the sales force!
I am concerned that they will release us based on overhead costs and turn the whole thing over to Quintiles. Or, Arena says farewell and signs on with Quintiles.
Lets face it. Green Tea, Lots of water, and a little exercise can do some serious damage on obesity- " if the patient is motivated".
I can't wait to hear all of the propaganda in Dallas this week. Hooray for role play and believing.
read Eisai cafe pharma board-- dedicated reps anticipate layoffs coming as part of a cost-cutting measure-- several execs also have been fired-- poor moral
Belviq launch has underperformed/ re-launch anticipated to fail as well
Sentiment: Strong Sell
I think they are launching Spedra incrementally throughout Europe. Scotland will not be on board until after Nov., 2014 (see my other post). I imagine there are additional launches we do not yet know about. I am hoping we'll see some good royalty revenue from this quarter-- that is the wildcard.
Statement of Advice
avanafil (Spedra®) 50mg, 100mg and 200mg tablets (No: 980/14)
A Menarini Farmaceutica Internazionale SRL
9 May 2014
No part of this advice may be used without the whole of the advice being quoted in full.
This advice represents the view of the Scottish Medicines Consortium. It is provided to inform the considerations of Area Drug & Therapeutics Committees and NHS Boards in Scotland in determining medicines for local use or local formulary inclusion. This advice does not override the individual responsibility of health professionals to make decisions in the exercise of their clinical judgement in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Chairman, Scottish Medicines Consortium
CHI White Paper and Congressional Briefing Highlight Advancements in Obesity Treatment Options
CHI hosted an informative congressional briefing on May 6 to explore recent advancements in obesity treatment options, barriers to weight loss medications and disease management medical care.
Presented in cooperation with Rep. Scott Peters (D-La Jolla), who made welcoming remarks, expert panelists featured healthcare economics experts, clinicians and patient advocates including: Alex Brill, CEO, Matrix Global Advisors, and Research Fellow, American Enterprise Institute (AEI); Joe Nadglowski, President & CEO, Obesity Action Coalition; and Richard L. Atkinson, MD, Council Member, The Obesity Society (TOS). CHI President and CEO Todd Gillenwater moderated the discussion.
The briefing highlighted the importance of equipping patients and healthcare providers with meaningful tools to combat obesity by improving access to weight-loss and nutrition counseling as well as new prescription medications. Key to sustaining innovation in anti-obesity medications is appropriate Medicare and private-payer coverage and reimbursement for treatments. These tactics will foster a robust consumer market and provide real incentives to biopharmaceutical companies to continue working to combat this growing public health challenge.
At the briefing, CHI unveiled a new white paper – “Combating Obesity: Advancements in Treatment Options and Access to Care” – describing the underlying science of obesity, highlighting innovative new medical therapies for obesity and identifying barriers to patient access to anti-obesity treatments. Copies of the report were distributed to the Washington, D.C. offices of all members of California’s congressional delegation, officials in the U.S. Department of Health and Human Services (HHS) and relevant patient advocacy and research organizations.
CHI would like to recognize and thank Arena Pharmaceuticals, Eisai, Inc., Orexigen Therapeutics, Takeda and Vivus
the drug (the media). It was provided on March 27 at Studio Harcourt (Paris) in the presence of Dr. Philippe Brenot (psychiatrist, sexologist and anthropologist, director of the International Observatory Couple) and Prof. François Giuliano (uro-andrology neurologist and professor Therapeutics at the University of Paris West). Figaro article (dated March 28)
It recalled that erectile dysfunction is a "sexual disorder that affects nearly one-third of men over 40 years and that profoundly affects the lives of couples." Recalled that "the advent of gender-active drugs has profoundly altered the experience of this disorder by making men with erectile dysfunction (formerly known as" powerless "), the possibility of finding a necessary for successful sexual intercourse erection." Emphasized that with the provision of Spedra ® 7 April 2014, these men receive "first therapeutic innovation for over 10 years."
It stressed that it is his "fast action" that characterizes Spedra ®. Efficacy "is manifest from 10 to 12 minutes" after taking either "barely time preliminary whose average duration is 15 minutes for the majority of French. " Added to this is the "long-acting drug that gives couples time to live peacefully their love."
How? Spedra ® will be marketed at a "very reasonable price of about EUR 6 per tablet, or about two times less expensive than other treatments available brand." Drug available only in pharmacies upon presentation of a medical prescription. Practical experience shows that we can find the specialty less than 5 euros each (note: all pharmacies in France are still far from being properly stocked - which is never the case with Viagra ® Levitra ® and Cialis ®).
Experiment: "The avanafil was evaluated in three randomized, double-blind, controlled versus placebo, conducted in parallel groups over a period of up to 3 months in the general population of patients with erectile dysfunction (ED) in patients with type 1 or type 2 and DE, and diabetes than patients with ED after radical prostatectomy with bilateral nerve-sparing. In total, 1168 patients received avanafil, which was taken as needed at doses of 50 mg, 100 mg and 200 mg. He was asked patients to take a dose of study medication about 30 minutes before sexual activity. "
Results (manufacturer dixit): "In all studies, there was a statistically significant improvement for all primary endpoints for assessing the efficiency for the three doses of avanafil compared with placebo. These differences were maintained for the long term treatment. For all the "pivotal" conducted with avanafil, the percentage of successful intercourse attempts was significantly "higher" for all avanafil doses compared with placebo, for attempts at all intervals time studied after taking the product. "
In practice. The recommended dose is 100 mg taken as needed approximately 30 minutes before sexual activity. Sexual stimulation is required for response to treatment. The maximum frequency of 1 is taken once daily. Depending on the effectiveness and tolerance of the individual, the dose may be increased to 200 mg up to 50 mg or reduced.
Precautions. If Spedra ® is taken with food (high fat meal), the onset of activity may be delayed compared to a fasted state. Coadministration of avanafil with potent CYP3A4 inhibitors is cons-indicated because they may increase exposure to avanafil (contact the prescriber). It is also believed that grapefruit juice, probably increases exposure to avanafil. If you do not want to take the risk it is advisable to avoid grapefruit juice during the 24 hours preceding the decision.
Close monitoring: this is a drug whose National Security Agency of Medicines (MSNA) provides "enhanced surveillance" . Without knowing exactly how this monitoring is performed.
Condoms: Sometimes you have to trust Liberation newspaper Serge July and Jean-Paul Sartre. Delivery on April 30. Sex & Gender section under "the Avafanil"
"There are texts and there is reality. While since 2006 each school has a duty to establish "a comprehensive plan of prevention" sexually transmitted infections, which involves the installation of condom vending machines near a high school in two (46%) still do not. Or, the property is equipped with a valve, but it does not work. This observation is the Fidl the union of students, who shall, after conducting its investigation. And his concern is legitimate.
According to the National Institute for Prevention and Health Education, the young abandon condoms. One third of students do not use condoms. For those who are on the edge of their sexuality, Fidl reiterates its demand for free distribution, wherever youth activities (sports clubs, driving schools ...). "
Libération may, at its option, complete the ellipsis.
Spedra ®, a new erectile. Acts immediately and longer. Less expensive (6 euros). Beware of grapefruit juice.
May 1, 2014 jeanyvesnau Uncategorized Le Figaro , Liberation
Sometimes wary of Liberation newspaper Jean-Paul Sartre and Serge July. In the delivery of 30 April, heading Sex & Gender. It boasts, in big bold body, the virtues of the Avafanil.
"This is the name of the last molecule designed to treat erectile dysfunction, says Liberation. Compared to Viagra (and Levitra and Cialis, his little brothers), this new antipanne pill, marketed under the name Spedra acts faster. Fifteen minutes may suffice between the plug and sex resulted, trumpets the Menarini laboratory. Entered the market in 1998, Viagra and his followers today have 600,000 loyal customers. This has sold 2.5 million boxes last year in France. "
But the Avafanil does not exist! But the avanafil, yes. Attention to inversions.
Avanafil or Spedra ®. Here is what the evergreen Vidal ® . For more details regarding the efficacy and clinical safety data, consult what the Ministry of Health on Spedra ®.
Spedra Stendra ® or ® in the United States ( see the commercial incentive to consumption - under the banner "This time he WAS ready" for adults only)
Spedra ® "new drug indicated for the treatment of erectile dysfunction in adult men. "
Efficiency: conditioned to sexual stimulation which must itself be effective.
Availability: in 3 dosages: 50 mg, 100 mg and 200 mg.
Active ingredient: avanafil is nothing other than a reversible inhibitor, highly potent and selective phosphodiesterase type 5 (PDE5), specific cyclic guanosine monophosphate (cGMP).
Worki t: sexual stimulation causes local release of nitric oxide, but the inhibition of PDE5 by avanafil causes increased levels of cGMP in penile corpus cavernosum. Results: a smooth muscle relaxation and inflow of blood into the penile tissues. Conclusion: an erection. Reminder: no success without being sexually stimulated.
CHESTERBROOK, Pa., May 12, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (AUXL), a fully integrated specialty biopharmaceutical company, today announced that certain members of the executive management team will participate in the UBS Healthcare Conference to be held May 19-21, 2014 at the Sheraton Times Square in New York. Adrian Adams, Chief Executive Officer and President, is scheduled to present an overview of the Company and its product portfolio at 11:00 a.m. ET on Monday, May 19, 2014.
The presentation will also be webcast on the "Investors" section of the Auxilium website under the "Events" tab on May 19, 2014. To access the live webcast, please log on to Auxilium's site approximately 15 minutes prior to the presentation to register and download any necessary audio software. The presentation replay will be available for 90 days after the event.
we don't really know that, but the presumption must be that it's up-- because I don't think insurers are necessarily discriminating between the two new obesity meds, and because the earnings per Qsymia script is rising...
Insurance coverage has not fallen from 47% to 30%-- it's probably grown.
The confusion is because Fischer said in the recent conference call that "30% of Q1 scripts filled were covered by insurance"-- i.e., paid by insurance-- which is different than talking about the percentage of "covered lives" (which is the percent of people with insurance whose plan has coverage for Qsymia. Similarly, Eisai announcing today that they have 60% coverage relates to covered lives-- this does not mean that 60% of Belviq scripts filled were paid for by insurance.
I completely agree-- this is a big source of future revenue. In addition, the Stendra royalty is a tiered agreement, and will increase as Stendra sales increase. Furthermore, avanafil marketing partners are also paying the Vivus royalty obligation directly to MTPC-- so Vivus's royalties are theirs to keep.