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Thank you good post.
Yes sir no problem.
2010- Flibanserin Failure: Female Viagra Drug Disappoints
Commentary on low sex drive and a pharmaceutical-sponsored Discovery Channel documentary
By Deborah Kotz
June 16, 2010 RSS Feed Print
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Video: Women's Health Tips
Video: Women's Health Tips
A new drug designed to boost sexual desire in women is controversial for some and eagerly awaited by others, but it's hit a potentially serious snag. The drug didn't boost women's desire any more than a placebo in two clinical trials. The Food and Drug Administration posted the clinical trial results on its website today in advance of a committee meeting on Friday, when a panel of experts will vote whether or not to recommend approval of the drug called flibanserin. (The FDA usually follows the recommendations of its expert panels.) Although there was a slight increase in the number of sexually satisfying events flibanserin users had each month, the FDA staff who reviewed the results said the so-called response rate isn't "particularly compelling."
In a statement posted on the FDA website, manufacturer Boehringer Ingelheim maintains that flibanserin really works, while acknowledging it's better at increasing a woman's "global desire" than "the intensity of [her] acute episodes of desire." That phrasing suggests the drug's effects are, well, rather subtle.
Trouble is, flibanserin has side effects that may outweigh its tepid benefits. About 15 percent of flibanserin users in the experimental trial stopped taking the drug because of bad reactions like dizziness, nausea, anxiety and insomnia, compared to 7 percent of the placebo users. Side effects were heightened in those who used the drug at the same time they were taking other medications, such as anti-fungal treatments, hormonal contraceptives, and antidepressants. Flibanserin itself was originally designed to be an antidepressant, but past clinical trials found that it didn't alleviate depression.
While flibanserin's fate rests in the hands of the FDA, Boehringer Ingelheim has kicked off a widespread education campaign to make us aware that having a low sex drive is a real medical condition that affects "approximately 1 in 10 women"—a statistic disputed as overinflated by some sexual health experts. The company has hired actress Lisa Rinna to be the poster girl for low libido and funded the "Sex, Brain, Body" website that has an "educational toolkit" that urges women to please talk to their doctors if they think they have a problem.
[Not in the Mood? You Could Have Hypoactive Sexual Desire Disorder]
Interestingly, the Discovery Channel has also hopped on the bandwagon to educate their viewers about low sexual desire disorder. This documentary aired on its stations last month and was funded by, yes, Boehringer Ingelheim. John Whyte, a physician who oversees Discovery's continuing medical education (CME) and patient education programs, told U.S. News that Discovery maintained full editorial control of the film, which has the feel of an infomerical but doesn't mention flibanserin. Whyte said that the drug manufacturer was allowed to review the film before it aired "as a courtesy" and that "they could suggest experts for us to interview." One of the experts featured prominently is Sheryl Kingsberg, a clinical psychologist at Case Western Reserve University School of Medicine who is a paid consultant for Boehringer Ingelheim and is participating in their clinical trials of flibanserin. Another person interviewed is Phyllis Greenberger, head of the Society for Women's Health Research, which received funding from the drug manufacturer to produce the "Sex, Brain, Body" website.
If the Discovery program had mentioned flibanserin by name, Boehringer Ingelheim could have ended up in hot water with the FDA, which restricts marketing of drugs it hasn't approved. While the Discovery program doesn't identify the unapproved drug, it does show women who were somehow helped by their doctors—it doesn't say specifically how. One woman proclaimed, "I felt vital again. I felt energetic again. I had that drive." When asked if any of the women featured in the film were participants in the flibanserin clinical trials, Elizabeth Hillman, senior vice president of communications at Discovery responded, "we really don't know." She did admit, though, that this film made by Discovery's CME department isn't "a traditional Discovery Channel documentary" in terms of its journalistic rigor.
Eicoman INFORMATIVE FEMPROX REPOST-
We Await Further Vitaros/Femprox Visibility; Reiterate HOLD Rating And $2.00 PT
Earnings Review
· 3Q:13 revenue miss offset by somewhat encouraging updates: Apricus reported 3Q:13 revenues of $0.03M and a loss of ($0.09) versus FactSet consensus of $0.8M and ($0.11). Operating expenses came in below our expectations, and we updated our model accordingly. Management plans to continue investing in R&D while conserving cash on G&A and believes it has sufficient cash through 2014. The company's EU partners are expected to start selling Vitaros in 2014, and management reported commercial orders for the product. Additionally, Apricus licensed Vitaros to privately held Laboratoires Majorelle (a company specializing in lifestyle products) in France, Monaco, and select African territories. Apricus will receive a portion of the $4M upfront payment in 4Q:13 and also expects to generate additional revenue from another EU partnership before year-end. We remain on the sidelines until we can gain more confidence in the Vitaros EU launch trajectory as well as the future prospects for Femprox discussed in more detail below.
· We feel more optimistic about the Femprox regulatory pathway: Following its end of Phase II meeting with FDA, Apricus received positive FDA buy-in on its dosing, and clinical endpoints (importantly, focusing on arousal domains of the FSFI questionnaire rather than on desire, which was a prior concern for us). FDA also did not ask for any additional data on the drug's permeation enhancing agent (another positive, in our view, since this same issue stalled the development of Vitaros for Warner Chilcott). The downside to the discussions is that the agency wants the company to study safety and efficacy in populations of both pre- and post-menopausal women, which may result in a large and expensive development program. For this reason, Apricus has opted to seek a U.S. partner while simultaneously discussing an expedited program to enter the E.U. market. Apricus awaits the outcome of the Flibanserin complete response letter prior to initiating U.S. partnering discussions. We have increased our probability of Femprox approval from 30% to 40% due to lower clinical risk, but lowered our expected royalty rate on the product from 22% to 15% given a partner's required investment in the Phase III program.
· We also desire more clarity on U.S. pathway for Vitaros: Actavis now holds U.S. rights to Vitaros and we would add risk-adjusted revenues for Vitaros transfer pricing if Actavis opted to develop it further.
This is to easy .Can you then post those emails from 2011? or any emails? He Adam F. had an article on apri in 01/02/2012 Also on 07/05/2013 .
I posted this during the same time period.She answered quit frankly what she could.Will you post those emails for us since you have them?
kingme123 Wednesday, 07/10/13 10:49:16 AM
Re: None
Post # of 11664
I just spoke to lourdes at Argo Partners at 212-600-1902.I asked why do they not respond to the negative storys ect,ect,ect.She told me the new management is not responding to Adam F. storys because they think he is a person with no credentials ect,ect,ect.She told me there is nothing negative going on to make the price drop.Femprox news could be any day now possibly.They are waiting for launch do not know who will launch first. They do not comment on Abbt.Mentioned earning coming up in I believe Aug.She refered to earnings coming up a couple of times.Says this management is very good and will not comment on every hack job that comes out.That the new Ceo is very focused and they read all the stuff news and blogs ect,ect,ect.I told her I was thinking of selling and that us the shareholders need more backing from management. By the end I decided to give it more time before selling.(She said their is no reason for the stock to be going down today.)No problems no negative news at all.News on Femprox seemed to be possibly coming soon from what I got out oft this conversation, although she did not come straight out and say it.She was very nice and tried to answered any Question that I had.Of course she could not answer all f them.
Lostcoastkid I owe you an apology for getting you mixed up with casinokid A.K.A court, who knows how many ids. Anyway I was wrong.
By the way folks I did try and get a hold of Steve Martin he is the svp, cfo, and secretary. Investor Contact
For further information, please contact:
Steve Martin, SVP, CFO & Secretary My earlier post.Hopfully I will hear from him.
kingme123 Friday, 12/06/13 02:28:10 PM
Re: kingme123 post# 11653
Post # of 11661
I just called Apricus and asked if the C.F.O had a phone for messages or contact.She the operator gave me her email to send my question to him. I also told her I have been trying to get an answer for three days now. Sending email now.
Copy of email sent.
To: DHARRANGPON@APRICUS.COM
Have been trying to get this question from Lordes at customer relations concerning the bio company that you received 2.5 million from. Can please tell me who the mystery bio tech company is? I am a share holder, I am not comfortable in investing more in the company and/or possibly staying a share holder without this question being answered. It has been three days now. Your immediate response would be greatly appreciated.
I just called Apricus and asked if the C.F.O had a phone for messages or contact.She the operator gave me her email to send my question to him. I also told her I have been trying to get an answer for three days now. Sending email now.
Still no call back from Lourdes at public relations.Disapointing trying to get an answer one way or the other on 8-k mystery biotech.She said yesterday he still had not answered her email. HOW ABOUT A PHONE CALL! Frustrating. Why don't you all call and ask why they will not answer the question. 1-212-600-1902 ask for Lourdes.
........................
Preceded the first 2 posts.http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1376026057682.pdf
2mg = informative repost- http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1376026066712.pdf
Very informative he stuttered? Not trying to start anything but why even post, if you are not going to say what he said?What name did you use?What is his phone number.Its great if he is finally concerned by screw up or not for us the shareholders.Still no callback for me from Lourdes either.I do not understand why we cannot get any answers.
This is the post I was refering to. It was articles and hack jobs lol! News and blogs.
kingme123 Wednesday, 07/10/13 10:49:16 AM
Re: None
Post # of 11628
I just spoke to lourdes at Argo Partners at 212-600-1902.I asked why do they not respond to the negative storys ect,ect,ect.She told me the new management is not responding to Adam F. storys because they think he is a person with no credentials ect,ect,ect.She told me there is nothing negative going on to make the price drop.Femprox news could be any day now possibly.They are waiting for launch do not know who will launch first. They do not comment on Abbt.Mentioned earning coming up in I believe Aug.She refered to earnings coming up a couple of times.Says this management is very good and will not comment on every hack job that comes out.That the new Ceo is very focused and they read all the stuff news and blogs ect,ect,ect.I told her I was thinking of selling and that us the shareholders need more backing from management. By the end I decided to give it more time before selling.(She said their is no reason for the stock to be going down today.)No problems no negative news at all.News on Femprox seemed to be possibly coming soon from what I got out oft this conversation, although she did not come straight out and say it.She was very nice and tried to answered any Question that I had.Of course she could not answer all f them.
I did not say anything either.I was focused on finding out the bio company in 8-k. Why does no one consider that they check the message boards? A way for them to get a feel on shareholders.In an old post I said Lourdes and management looked at the boards.I will try and find it.
LOL! Invester relations, she should be scared. lol! She did tell me in the past that they actually do follow the APRI message boards.Weather its true or not I do not know.
Called Lourdes again and she said she still had not heard back from the CFO I said it makes me nervous as an invester that I cannot get an answer one way or the other on the mystery Biotech company in 8-k.She said well it's is positive news the 2.5 millon .I said yes it is but the concern is why they are not naming the co.She said it is most likely a regulatory thin with FCC. Said once again when she gets an answer she will call me.I said I will wait for your call until tomorrow, to decide my position on APRI.
Is it not time to get rid of these board manipulators. Zman to jsb early today.
zmanindc Thursday, 12/05/13 06:37:20 AM
Re: jsbeach23 post# 11588
Post # of 11614
JS, make sure you download a screen copy of her profile as I in case it is suddenly updated to remove PIII.
Vitaros alprostadil cream & gel
Vitaros is a topical formulation of alprostadil. Alprostadil is a vasodilator when absorbed through the skin as a gel or cream, directly boosting blood flow causing an erection. Vitaros includes the active ingredient alprostadil, a common FDA-approved vasodilator that is currently sold as an injectable medication, or as an intra-urethral insert product, to treat erectile dysfunction.
One drop of Vitaros rubbed on the glans will generate good results within six minutes. A single application will cost in the area of $10 to $12, similar to the cost of the popular ED pills. It seems the major side effect is that about 6 – 8% of the study group reported penile burning, which,technically, could be as little as a warming feeling.
On the positive side, it is reported that Vitaros does not cause the side effects attributed to the pills (palpitations, vision issues, dizziness, headaches, congestion, etc,)) and hopefully those unable to use the pills due to cardiac concerns, Patients on Nitrates and beta blockers will have success with Vitaros.
Vitaros: The Drug
Many male patients will find Vitaros cream to be more convenient and safer than the current oral medications. Instead of being a pill, Vitaros is applied directly as a cream. When absorbed through the skin Vitaros directly boosts blood flow, thereby causing an erection within minutes — much faster than results from oral medications. The topical application helps to reduce side effects and offers patients a substitute to the current drugs. Vitaros (topical alprostadil and DDAIP for the treatment of Erectile Dysfunction) offers rapid onset with efficacy, tolerability and a favorable safety profile. It has been studied in over 3,300 patients, including difficult to treat populations, those with (diabetes, cardiac issues, sildenafil failures, prostatectomies, patients on nitrates and alpha blockers).
Vitaros Sales in Canada
Vitaros was approved by Health Canada in late 2010. For many months everyone was waiting for a deal to market the drug. Finally, on January 9, 2012 Abbott (ABT) signed an agreement to market Vitaros in Canada and sales are expected to start in 2012. The agreement included $16 million in up-front, and sales milestone payments, as well as royalty payments based on Abbott’s sales in Canada. According to IMS Health data, the annual ED market in Canada in 2010 was about $180 million. In addition, there will probably be some cross-border sales as people from the United States search for a safer and more convenient alternative than the current oral drugs.
Vitaros Approval in Europe
On June 28, 2011 Apricus announced that its marketing application for Vitaros had been accepted for review through the European Decentralized Procedure (EDP). The EDP takes approximately 240 days from the time of acceptance to final approval. Approval would give Apricus the right to sell Vitaros in multiple countries within the European Union. The period of 240 days has passed, which means we should have a decision soon. But Apricus Biosciences stated in their annual report that they expect approval in the first half of 2013 and also expect royalty revenues beginning in late 2013. Apricus’ Vitaros is already partnered in Germany and Italy so sales should start at once.
The deal with Sandoz, a division of Novartis for marketing in Germany, includes $28 million in regulatory and commercial milestones as well as royalty payments. Once Vitaros is approved, other European countries will make deals similar to the Sandoz deal to market Vitaros in countries such as France, Austria, and Spain.
Over the past several years, Apricus completed several clinical trials assessing the efficacy and safety of Vitaros. These trials, which administered Vitaros in over 3,300 patients, led to the approval of Vitaros in Canada and, according to the company, positive guidance of its filed marketing authorization application (MAA) in Europe.
Vitaros® differs from oral medications in two ways. First, it is applied locally, directly to the penis as a cream, instead of administered orally as a tablet or injected. This topical application helps to reduce side effects and provides a alternative for men who cannot take the existing oral medications. Second, clinical studies have shown that Vitaros® works in minutes, compared to a reported onset time of 30 minutes, or longer, for oral medications
Currently there are only 3 drugs approved for erectile dysfunction for sale in the U.S. These are Viagra, Cialisand Levitra. A forth drug, Avanafil has won FDA approval. Each of these medications are taken orally as a tablet. Vitaros is applied directly on the penis.
If such great news it will move the pps if non news, it will not. I say not. Looks like pps says non news as well.
I spoke to Lourdes. I called the san diego number on the apricus website and spoke to (DINA) i said i called yesterday and she remembered.She said she was not sure if she gave Lourdes my message.She then transferred me to Argo Partners.I spoke to Lourdes and asked who was the Biotech company on the 8-k.I said it was not on the 8-k and asked is it a secret or something? She responde well gee im not really sure i know who it is but hold on im not sure if it is public info hold on for a minute.She said i will have to Email the C.F.O because i do not know if it is public info.She said she would call back tonight or tomorrow.We shall see.
Interesting.
TopGeek
Posts: 154
Group Leader
This is a relatively new prostaglandin product that has been teasing us for a few years already. It's a sort of topical version of Caverject and claims to rapidly induce an erection by application to the glans. It was approved in Canada in 2010 but has still not been marketed there or anywhere else. The marketing licence has changed hands more than once and it was subjected to a fast-track approval process in Europe in Spring 2013.
Vitaros is the 'invention' of one of those biotech companies that seem to specialise in developing products that challenge a unique market position that is currently held by a major manufacturer. The big boys buy up the new product just to keep it off the market until their leading brand's patent expires. That makes a lot of money for the biotech boys who then move on to develop another challenger.
As the patents are soon due to expire on Viagra, Cialis and Levitra, we can only hope that Vitaros will appear in the not too distant future.
Group leader in the ED and Essential Tremor groups but not a medical professionsl! I am a writer and translator of medical and non-medical material so I have access to authentic medical resourses. Any advice or information that I provide does not substitute for proper medical consultation.
TopGeek
Posts: 154
Group Leader
This is a relatively new prostaglandin product that has been teasing us for a few years already. It's a sort of topical version of Caverject and claims to rapidly induce an erection by application to the glans. It was approved in Canada in 2010 but has still not been marketed there or anywhere else. The marketing licence has changed hands more than once and it was subjected to a fast-track approval process in Europe in Spring 2013.
Vitaros is the 'invention' of one of those biotech companies that seem to specialise in developing products that challenge a unique market position that is currently held by a major manufacturer. The big boys buy up the new product just to keep it off the market until their leading brand's patent expires. That makes a lot of money for the biotech boys who then move on to develop another challenger.
As the patents are soon due to expire on Viagra, Cialis and Levitra, we can only hope that Vitaros will appear in the not too distant future.
Group leader in the ED and Essential Tremor groups but not a medical professionsl! I am a writer and translator of medical and non-medical material so I have access to authentic medical resourses. Any advice or information that I provide does not substitute for proper medical consultation.
That's great and all, but speaking only for myself, i prefer facts over opinions = (GUESSING) We could fill the board up with everyones opinions = Yahoo message board, don't you think?http://buyalprostadilcream.com/vitaros-cream-alprostadil-topical-facts-for-erectile-dysfunction/
Info on Sprout=http://www.prnewswire.com/news-releases/sprout-pharmaceuticals-confirms-resubmission-to-fda-of-flibanserin-for-treatment-of-pre-menopausal-hypoactive-sexual-desire-disorder-213175721.html RALEIGH, N.C., June 26, 2013 /PRNewswire/ -- Sprout Pharmaceuticals, the Raleigh-based pharmaceutical company developing flibanserin, a treatment being evaluated for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women, confirmed today that the company has resubmitted the New Drug Application (NDA) for flibanserin earlier this year and expects US Food and Drug Agency (FDA) action before the end of 2013. If approved, flibanserin would be the first FDA approved treatment for HSDD in pre-menopausal women.
HSDD, a form of female sexual dysfunction, is defined as a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty. The 2012 Prescription Drug User Fee Act (PDUFA) V identified addressing female sexual dysfunction as one of 20 priority areas in the FDA's Patient-Focused Drug Development Program.
Sprout's announcement comes in connection with the recent publication of positive results of a Phase 3 clinical trial involving more than 1,000 patients in the Journal of Sexual Medicine. Study 511.147 was a key component of the company's resubmission in response to the FDA's 2010 Complete Response Letter to the original flibanserin NDA.
Study authors (Molly Katz, MD; Leonard R. DeRogatis, PhD, et al) concluded that flibanserin resulted in statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo. Flibanserin was further associated with significant reductions in distress associated with low desire, a hallmark characteristic of HSDD.
Study 511.147 was a randomized, placebo-controlled trial in which nearly 1,100 pre-menopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100 mg once daily at bedtime or placebo for 24 weeks. Co-primary end points were the change from baseline to study end in number of satisfying sexual events and increases in desire as measured by the Female Sexual Function Index (FSFI) desire domain score. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, and the FSDS-R Item 13 score, which measures distress associated with low desire on FSDS. Further, clinical meaningfulness of outcomes was assessed using the FDA recommended Patient Global Index of Improvement (PGI-I). All endpoints achieved statistical significance.
The study's authors found the drug to be well tolerated during patients' 24 weeks of use. The most frequently reported adverse events in the flibanserin group were somnolence, dizziness, and nausea, with adverse events leading to discontinuation in 9.6% of women receiving flibanserin vs. 3.7% on placebo.
"In cases where there is a bio-chemical component to sexual dysfunction, women, unlike men, have no biopharmaceutical options," commented Dr. Sheryl Kingsberg, Chief of Behavioral Medicine at University Hospitals Case Medical Center and Professor in Reproductive Biology and Psychiatry at Case Western Reserve University School of Medicine. "The consistency of flibanserin's statistically significant effect on satisfying sexual events and desire, while decreasing the distress of women experiencing HSDD, is very encouraging."
"This additional data, which is a key part of Sprout's resubmission of the flibanserin NDA, is responsive to feedback received from FDA previously," said Cindy Whitehead, chief operating officer of Sprout. "With this study, and other information included in our resubmission, Sprout believes that it has addressed the concerns raised by the FDA during its previous review. We look forward to working with the Agency during the ongoing review process."
About Sprout Pharmaceuticals
Founded in 2011, Sprout Pharmaceuticals is wholly focused on women's sexual health. Based in Raleigh, NC, the company is the owner and developer of flibanserin, a novel, non-hormonal, treatment for distressing low sexual desire in women. For more information, visit www.sproutpharma.com.
SOURCE Sprout Pharmaceuticals
Ecomans response to this question-
cartonet Member Level Sunday, 11/17/13 10:13:15 AM
Re: None
Post # of 11560
We, along with our scientific advisers, believe that shareholder interest will be best served by advancing Femprox in the U.S., only after this decision by the FDA, regarding this FSD product is known, which we expect to occur around year end.
Anyone know which product they are refering to?
eicoman Member Level Sunday, 11/17/13 11:31:48 AM
Re: cartonet post# 11209
Post # of 11560
http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=182739307
Flibanserin from Sprout Pharma
Would be nice if others could post links to back up their claims.Second one I have posted concerning time frame for erection.2-0 http://www.edguider.com/edblog/2011/07/26/a-drop-of-vitaros-pde1-applied-topically-can-help-ed-fast/