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Global market for osteoporosis $11.4 B by 2015 and growing at 9.2% per year. There is more then one sand box for Libigel to play in.
Osteoporosis
Yet another reason to continue the safety trials.
For those new to Biosante you may wish to check out the markets they are going for.
Biosante Target Markets
The results of the Bloom trials will prove very beneficial in the next trial. I expect to see an enhanced exclusion criteria, keeping only those that responded favourably. Intrinsa, in order to prove efficacy, had to look at subset data. I don't think that will be necessary with the next phase III trials.
Welcome aboard KD, if I am not mistaken Simes stated they looked at at 50 products with the aim of in-licensing. In their assessment it was too expensive and not enough return on investment. In the end Libigel was still their best bet.
Eventually the world will wake up to the fact that testosterone is presently prescribed for many treatments compounded off-label prescription and not all are HSDD.
Additional benefits of testosterone replacement therapy in women are increased muscle and bone strength and increased self-assertiveness. Current research is showing benefits of reducing the risk factors for heart disease, Alzheimer's, and diabetes.
Biosante is going for the whole enchilada by getting it approved for HSDD. Once they realize their are other treatments for which efficacy can be easily proved with no placebo effect. It will be an eye opener.
I don't think I ever used the word idiot. But until revenues catch up it is a possibility. Let's see how things develop.
Professor, what if the increase in enrollment in the safety trial was actually related to bringing the CV group who had Hypertension and Dyslipidemia to a phase III level. The 3000 patients would have been more than ample for naturally menopausal HSDD efficacy.
The timing of the 7th successful safety review in November, the purchase of the gel machine, the patent applications. And now the review of the un-blinded safety data which they are analyzing.
The sequence of events lines up nicely and the primary outcome of the trial shows efficacy from a CV standpoint "The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects."
Just a theory worth discussion.
Well said homeslice.
Macerimmer, I respect your opinion. But according to the conference call, if they are correct in identifying the special attention given to the patients and the daily diaries as the lead causes for the placebo effect. Then I believe their hands were tied. The FDA wanted that. They now know that the FDA may have been wrong and daily diaries is not the way to go. They would have reproduced the Intrinsa trials if allowed.
SPAs have the highest success rate from trial to drug approval. But you have to play by the FDA rules. To fire someone for following FDA requests would be looking for a scapegoat. To my knowledge the FDA was using Libigel to test their theory. If daily testing , etc.. had been successful, it no doubt would have been become the standard.
Mo-John, here is the link
Conference call
Jadite, I am the choir, not going anywhere!
Let us not forget that Biosante appears to have hired a Director of Quality Assurance. The job description does not appear to be focus on trials it has more to do with post approval activities.
This is obviously not for a product that will not be submitted for approval 15 to 18 months down the road. More news must be coming.
QA Director
Jadite, I agree and you know the numbers will only increase with an aging population.
Just so people realize how well things could go. What happens if the following scenario plays itself out.
1) Libigel phase III trial is started
2) NDA submission for Libigel Testosterone and CV benefits
3) Libigel cognitive trial results arrive announce intention for a phase two study (due end of year).
The price by year end should pop quite a bit.
Pete, you can't really compare the two PFE is a huge company teh success or failure of one will not sway the PPS the way it does for a small Biotech company.
Professor, obviously Biosante is still focused on the big prize HSDD. They have yet to mention that as a consolation prize the first female testosterone drug is within reach. The 4 million off-label prescription is nothing to sneeze at and none of this has been communicated. Definitely not priced into the PPS.
I agree professor, and I am not convinced they don't know when Bio-t-gel will be rolled out. Royalty revenues most likely will kick in during the trials, if not sooner.
I can't help but think like the professor, Jeff and many others, that there is more info to come.
If I am wrong, then I for one will contact the Board and stress the point that not one of the 833,000 shares should get distributed until insiders start buying again.
I agree Mo-John, it was a joke about his selective memory or use of the facts, to lighten the mood. I have no problem going against the crowd rather than chasing it. Worked well for Buffett.
It will be interesting to see AF pull a Mussolini, switch sides and start cheering for Biosante when efficacy is proven. It was only September when he was a proponent of Biosante.
Remember we still aren't above $5 yet, a trigger point for a number of funds. In addition, when the Board and Management start buying again the markets will look differently at Biosante, that is when some serious climbing will occur.
Al100, Biosante has regularly consulted with the FDA, KOLs and Placebo experts. They have a good idea how to wet up the next trials. They will get another SPA as the FDA wants them to continue with the safety trial. I expect the trials to start before an NDA submission for some form of treatment and the amendment will be made prior to decision. If there is a delay you are looking at a couple of months not 18 months.
By continuing the safety study they will most likely have enough efficacy data to include the CV benefits to prevent Hypertension and Dyslipidemia. Biosante hasn't said boo about this, but they have submitted two patent application in relation to Libigel's CV event reduction capabilities.
This, I believe is part of the future Libigel releases the professor was talking about.
Feelin, couldn't agree with you more. Good post!
Professor I read all your posts, I agree with you and I think buddy from Leer Swank was right on the efficacy for naturally post menopausal HSDD being tested in the safety trial.
I believe this will be the one they originally file the NDA submission and when the new trials are completed they will amend the NDA submission. If this is plan the timeline for approval doesn't change there is a slight increase in cost.
Should they sue him or the doctor that dropped him as a baby?
While reviewing the patent application for commercial production I noted these two points of interest
[0006] In the United States, no FDA-approved testosterone therapies are available for the treatment of hypoactive sexual desire disorder (HSDD) in women although in 2009, according to IMS data and independent market research more than 4 million testosterone prescriptions were written "off-label" for women. The unapproved testosterone formulations currently used to treat women have disadvantages. Proper administration, dosing, and daily compliance are a concern when using products for unapproved uses. For example, compounding pharmacies do not follow cGMP processes that are mandated by the FDA for commercial production of pharmaceutical products.
I know the professor has stated this before, but is nice to see in the patent application.
[0007] Thus, there remains a significant need to reliably produce formulations comprising a therapeutically effective amount of a hormone at large scale in the volumes required for broad commercial availability. The methods herein desirably accomplish the following attributes at this large scale: 1) complete solubilization and uniform distribution of hormone compound; 2) adequate dispersion of the gelling agent with a subsequent optimum neutralization of the gelling agent; and 3) a final mixing step conducted in a vacuum to prevent entrapped air during gelation and evaporation of the alkanol. The methods herein overcome these issues by providing sufficient quantities of a transdermal gel containing the appropriate amount of a hormone to be used for HSDD, hot flashes and other post-menopausal disorders in a production process according to FDA's cGMP requirements. The resulting gel formulation can be used to deliver transdermally a therapeutically safe and effective amount of a hormone over 24 hours as proven using, in FDA approved clinical trials, the formulation produced by this method.
Looks like Biosante also wants to start producing Elestrin.
Jeff, you raise a good point. Since Simes and company put most of the money behind Libigel as the lead product to financial respectability. They knew it was a potential blockbuster. They wouldn't lightly give up 40% of the company unless it made sense.
Jeff, Professor other esteemed board members.
I just realized that the Form 10Q for the period ending September 31, 2011, made no reference to a gel filling machine.
October 11th, 2011
BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data Review in Phase III Program
BioSante reported that with 3,656 women enrolled and over 4,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 29 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.60 percent
PR
On November 16th, 2011
BioSante Pharmaceuticals Announces Positive LibiGel® Pharmacokinetic Study Results
The pK study results indicate that LibiGel increases levels of free testosterone (the active testosterone component) in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women. (Top line results from September 12, 2011)
PR
In the year end 10k filing the gel filling machine is listed as having been purchased.
There is a strong possibility that Management pulled the trigger on the gel machine based on the testosterone and maybe even the CV results.
Jeff, Pete, the contributors on the ihub and yahoo boards have collected enough information that has yet to be officially disclosed to the public.
Examples of insider trading cases that have been brought by the SEC are cases against:
Corporate officers, directors, and employees who traded the corporation's securities after learning of significant, confidential corporate developments;
It could be easily argued that the reason the company chose not fight to stay above $1 and avoid de-listing and passively assisting in effecting a R/S can be considered insider information. So it tied the employees hands for picking up shares.
I have been researching what constitutes relevant information that must be disclosed to the public and what is deemed public disclosure.
Apparently posting items om the website in many cases to be deemed public knowledge. As long as the information stays there long enough. Even though the Director of Quality Assurance was only up on their site briefly position when taken with the other positions up for grabs it shows they are hiring. Therefore this probably passes the public info test.
Website
I an still researching it having a patent application listed on the patent websites is considered. Suitable notification of public information. I did discover that Biosante can legally post patent application info on their websites or up 18 months even of they are facing patent infringement challenges (unless an injunction prevents it)
The FDA discussions, the extension trial results and any other discussions (i.e., partnerships, buyouts etc....) have yet to be disclosed. Until all these cards are on the table they are are at risk of insider trading should they start trading. Remember they are looking for FDA approval. The last thing you want is another federal agency SEC messing things up.
Like I stated earlier if the news is good an they don't start buying it can only mean there is more news to come.
Jeff, I have attached the pdf outlining the efficacy program. It stipulates the use of a daily diary.
Leer Swank report states the same.
BPAX is also using a daily patient diary as a primary instrument to measure sexual activity
in postmenopausal women with HSDD, whereas P&G used a weekly diary. Recall that the
endpoint measures (sexual events, desire, distress) are determined by patient questionnaires
(sexual activity log). Since patients’ recall may be better when data is recorded daily as opposed
to weekly, this may decrease variability, thereby increasing the study’s powering since a more
sensitive instrument allows for greater precision in determining differences in efficacy.
I agree with your comment on the lack of emphasis. You can bet the employees want to increase their position as well. But the company's strategy has prevented them from doing so.
I believe at in two weeks to the end of the month, it all gets released and allows their employees to participate in acquiring shares at these low prices. If there is a bunch of positive news and they don't jump in. It could only mean there is more news to follow (ie. partnership, etc...). These prices are well below any stock option prices they have received over the years.
NSP, this is an excerpt from A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder.
"There are additional aspects of the BLISS study that make it unique among recent women's health studies. First, the study not only is attempting to rule out a preapproval level of risk after an average of 2 years (range, 1-4 years) of treatment but also includes a postapproval commitment to follow participants for a total of 5 years each including a period after the primary regulatory analysis and potential approval. In addition, use of an adaptive design to determine sample size and predictive probability to determine correct enrollment have rarely been used in studies of this nature. Furthermore, the indication for LibiGel will initially be in oophorectomized women, but the study is also enrolling naturally menopausal women to explore the safety of LibiGel in a broader population and is based on agreement with FDA. Finally, the CV composite outcome in the BLISS study is expanded compared with other recent studies of CV safety of noncardiac agents, including venous thromboembolic events, because testosterone is an obligate precursor of estradiol, a molecule that can be thrombogenic."
Bliss trial
The FDA wants to keep collecting safety data on testosterone. Therefore at the very least, Libigel will be approved for testosterone restoration. And rest assured that Biosante will pursue the CV benefits of Libigel in addition to proving HSDD efficacy. Libigel has also shown to improve cognitive function (Alzheimers) and is being tested in Austarlia.
Study
Professor, Jeff, I noted that Intrinsa trials used a weekly diary Sexual Activity Log (SAL) whereas the Bloom trials were using daily diaries. I remember Simes eluding to this as a possible cause for the elevated placebo.
I believe the Bliss trial are testing efficacy similarly to how Intrinsa had tested. If so the un-blinding of data on or about June 1st should give them enough preliminary efficacy data to tilt the diary argument in their favor.
I think it was Jeff who was informed that the safety trials could not be used to prove efficacy. It will be interesting to see if it can be used to disprove the placebo effect. Which could be equally as effective.
The Bliss trial also had some estrogen concomitant patients. It appears like a good insurance marker to have in the event the Bloom trial as set up would run into problems
Their placebo effect expert may able to present the argument that the daily diary created a forced thought process on sexual activities. That it was a flawed test as shown by Intrinsa's placebo results using SAL vs Libigel using the ISED.
It will be interesting to see how much weight the FDA gives to the objective results of elevated testosterone.
It appears, since Libigel is under an SPA the FDA hands were all over the trials. No concomitant with estrogen, daily vs weekly diaries. Which brings us to the 505(2)(b) NDA submission as the professor has clearly explained.
Biosante played along, now lets see if they are rewarded.
John, can't say that I have heard of it.
NSP, Libigel is more then just a treatment for HSDD.
The Bloom efficacy trials where Libigel failed to meet endpoints was due to the placebo effect. Libigel acted expected the placebo was off the charts compared to historical placebo results.
Unlike many new drugs Libigel has the benefit of P&G Intrinsa approved. They passed an FDA voted 14-3 in favor of Intrinsa's efficacy but wanted further safety trials. P&G balked and went to Europe and got approved.
Keep in mind that the women in the Intrinsa trial wee on estrogen as well.
Libigel uses the same testosterone dosage as Intrinsa.
Refer to FDA tracker they lay it out pretty good.
Now, the second item is testosterone replacement therapy which is truly the primary market Biosante is after. To replace the more then 4 million off-label prescriptions being written annually. There is no approved female testosterone drug in the US. Trials showed that Libigel restores testosterone to pre-menopausal levels. Placebo doesn't move the needle.
Look at Market data for more info on Libigel.
Now finally one thing you won't see in the market data is that during the safety trial (which P&G did not do) Biosante discovered that Libigel (testosterone) reduces the risk of Cardiovascular events by approx. 70%. Biosante presently has two patent applications for the CV benefit and a patent application n the commercial production of Libigel none of this has been made public in a release.
In addition, the safety trial had an HSSD efficacy component and is set up a little differently, including allowing women with estrogen. This efficacy testing one was more in-line with the Intrinsa trial.
Basically there is a lot of ammo still make an 505(2)(b) NDA submission for one or more treatments. Worse case scenario they do a slightly different efficacy trial to prove HSSD. But the testosterone treatment should go ahead as planned.
Finally you may wish to read the following release where "Dr. Shames stated that the FDA acknowledges testosterone’s efficacy in treating HSDD and the need for testosterone products to be approved for women affected by this condition."
PR
Bottom line, it was always about safety.
Professor, I hope you are eluding to the top line HSSD efficacy data in the safety trial.
I did the math on the Bliss safety trial published at the 2800 patient mark and they had 384 patients enrolled on estrogen.
If the ratio remains consistent they should have approx. 501 patients enrolled on estrogen. It will be interesting to see what results these patients produce.
I may be wrong but I believe the efficacy testing in the safety trial has less clinical intervention. If so this may help counter the placebo effect in the bloom trials. Just a thought.
I had thought Biosante had yet to turn a profit but in 2006 Biosante actually made a net profit of $2,791 million on revenues of $14,439 million. .
Historical data
12/24/2007 they had a share price of $6.55 and 23,480,000 outsanding shares.
Let's hope Libigel will be the ticket to create long term profitability.
I agree Jeff, the hedge funds would probably know more or are playing both sides of the game so they are covered. The individual shorts may get caught.
Not all the private sector is performance based. With most small businesses, I will agree with you but approx. 30 years ago, the average CEO made approximately 30 times what the average worker made. now it is closer to 300 times. There in lies one of the greatest problems. It is perverse.
I also read that the US has in the vicinity of 1 lawyer for every 300 persons. I believe a country like Japan has one for every 9000 persons. This has created a very litigious society, hence the ambulance chasers.
The President makes less then most professional athletes, how sane is that?
We are all partly to blame, myself included, for buying shares in companies which overly compensate their CEO and management team and watching sports.
All to say that if Biosante explodes we will think they are suitably compensated. If it tanks, then your comments about the incentives are bang on.
Pete, regardless of the percentage of shorts they will want to cover as the pps starts to climb. Last time I looked they were looking at about 8 to 9 days to cover. But that is not an exact science. If much of the volume has been funds selling back and forth to each other it may be artificially high. If so it could take much longer then 8 or 9 days to cover.
It all comes down to supply an demand. The greater the news, the greater the demand and since people will want to hold onto their shares and new buyers will be attracted. There will be less supply which pushes the prices even higher.
Ironically management has given them a window to escape, by giving an approximate date of the announcement on Libigel.
I am pretty certain that is based on pre R/S data. 2.85 million would make more sense. There are only 20.1 million outstanding shares now.
Just to make sure the horse is dead.
I listened to the conference call again and if you listen to the subtleties you can pick stuff out.
Simes didn't say we will be making a decision on whether to proceed with Libigel later this month.
Simes said we will announce our firm decision later this month. Which indicates to me they already know what they are going to do and they are waiting for the clearance from the 9th Safety Data Review (which should present no surprises) to proceed.
JMHO
Running, I just listened to the Biosante CC. I didn't hear anything about Teva and other litigation, or were you referring to a Teva CC.
But they a looking forward to hearing of a launch date.
I read on another board (cafepharma, I think)that the agreement was to give Abbott 1 year to get their Androgel users switched over to Androgel 1.62% and in exchange Teva was given an undisclosed amount of money. No idea if there is any truth to this, but it is feasible and could explain the info blackout by Teva. If so then January 2013 could be the launch date.
Running, I fail to see the connection. Teva settled with Abbott in December. Terms of when they can start marketing Bio-t-gel have yet to be disclosed publicly.
We are all waiting on that news.
$2.60 was yesterdays close???
Zeppo, it just dawned on me that since Biosante is well positioned with enough cash to take them into late 2013. This has allowed them to concentrate on the science which at the time was their priority. Most companies without cash have to pump their companies to survive. It also allowed the pps to get to a level which supported the R/S. If an NDA is submitted, the laws of supply and demand should kick in and since there will be fewer shares people will be paying a premium for the shares, in the end the R/S may prove to be a blessings. You have to question if they are functioning like other small biotech companies in relation to shareholders or do they have a purpose behind their action or in this case inactions.
Leading into an NDA submission, expect them to remove the cone of silence and start pumping their products again. When they start pumping, they have a lot of held back information to enlighten investors.
For now they have to cross that safety hurdle to get the ball rolling.