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Jeff, if you look at the patents where AIS is the assignee, Simes was also an inventor.
It looks like there will be more then one product coming out of the trials instead of one product with multiple treatments.
I agree, interesting may be an understatement. You said earlier this was like a movie. Well, the plot thickens.
Professor, Biosante may be getting ready for both. Approach the FDA with safety efficacy as part of the 505(b)(2). If this doesn't fly, the prep-work for the Phase III trials will be ready to go and start the trials in the new year.
Just a thought.
Jeff, as you noted the patents applications for CV do not mention Antares. It is very likely the reason for the purchase of the gel filling machine.
Jeff, you may be right, however the following patent application filed Sept. 7, 2011 and posted Dec. 29, 2011 lists the following:
Inventors: Lehman; Leah M.; (Green Oaks, IL) ; Simes; Stephen M.; (Long Grove, IL)
Assignee: Antares Pharma IPL AG
METHODS AND APPARATUS FOR TRANSDERMAL OR TRANSMUCOSAL APPLICATION OF TESTOSTERONE
Abstract
Methods, formulations, and devices for providing transdermal or transmucosal delivery of testosterone to female subjects in need thereof. The formulations and methods treat symptoms of hormonal disorders including hypogonadism, female sexual desire disorder, female menopausal disorder, and adrenal insufficiency.
"No CV".
Patent
Jeff, I agree with your comments on management and the board being very capable and knowing the worth of the company and not letting it go cheaply.
It seems to me that with the number of employees floating back and forth between Abbott and Biosante. Abbott would be most aware of Biosante's pipeline value and I am almost certain that they do not want to see Libigel going to a competitor. Abbott is also partnered with BMS on cancer treatments.
I see Abbott as a strong front runner for partnership or a buyout which maintains the company as wholly owned subsidiary. Ironically if Biosante is bought by Abbott, this plan may revolve around the split of Abbott and the formation of the new pharmaceutical company AbbVie later this fall. If I am not mistaken Abbott first announced the company split in October 2011. This may be purely a coincidence but Biosante purchased the gel filling machine around the same time.
Promoting Patricia Fuller to Vice President of IT this early is premature, unless as the professor and others have pointed out the NDA submission is planned around the Safety Trial results later this year or early next year. Biosante has been able to monitor 3656 patients within the existing structure.
Now monitoring several million patients upon commercialization will require a team and improved database capabilities. This would more than justify the promotion.
Fuller
Jeff, they may not have to dilute. In 2008, when Tekeda and Cell Genesys partnered on GVAX prostate, the up front money was $50 million, plus up to $270 million in milestone payments and up to 26% in royalties. I can see similar agreement for Libigel. The upfront money could take them across the finish line. Remember the board and management have a number of shares and when they dilute, they are diluting their shares as well.
King, you are right and you notice that Biosante has most of the global rights,outside the US, to their approved products Elestrin (except Isreal, where it is also approved)and Bio-t-gel.
Libigel also plays nice with other medications. Below is the number of patients using different medications in the Bliss safety trial when 2889 out of 3656 patients were enrolled.
Concomitants info from Bliss safety trial
Medications, number of patients (%)
Antihypertensives 1071 (53.3%)
Aspirin 522 (26.0%)
Cholesterol-lowering agents 1068 (53.2%)
Estrogen alone 324 (16.1%)
Estrogen/progestins 60 (3.0%)
From a CV benefit perspective, I can see a recommendation to use Libigel concomitantly with the above medications to enhance results.
Bliss trial
Jeff, I agree the Board has some very well healed individuals who would take advantage of these prices, if they could. What is the info preventing them from purchasing? You mentioned a few good possibilities.
I hope we don't have to wait too long to find out.
Nice find Jadite, I particularly like the fact that testosterone levels gradually drops off over time. I see Libigel eventually being approved for post menopausal women. However, I see off label use expanding to menopausal women as well. Notice he also referred to cognitive benefits as well.
The potential just keeps increasing.
Dorian, Al100, I agree GC was great and a master in segwaying from one topic to another.
King, the 9th safety review is due for release mid summer.
Al100, I also looked at the Short Analytics site and it is definitely trending towards a drying up of stocks available for shorting.
Short Analytics
As izler stated, I doubt this captures naked shorting.
Only 1000 shares available for shorting - posted on yahoo board
Available Bpax for shorting
Dorian, I agree and when you consider Big Pharma has publicly admitted it is hunting for patent rich companies. Biosante's extensive patent portfolio is not even considered in the equation.
Jeff, I agree that there is extreme manipulation of this stock price. One has to wonder, why?
The following is purely conjecture:
From 1994 to 1997, Mr. Simes was President, Chief Executive Officer and a Director of Unimed Pharmaceuticals, Inc., which was sold (currently a wholly owned subsidiary of Abbott Laboratories)
We know over the years Biosante has kept some type of relationship with Abbott with employees jumping back and forth between the two companies.
We also know that Abbott is about to split the pharmaceutical division, forming a new company (AbbVie), from the rest of the company.
Could Abbott be looking to acquire Biosante as a wholly owned subsidiary of the newly formed AbbVie? It could explain why Biosante is running operations like a regular company but seems less concerned about elevating the share price. It just seems that if they truly wanted to get share price moving (i.e. better informing shareholders, analysts, etc..)they could. It could also explain the lack of insider buying.
Homeslice, I agree fully with your assessment, should Libigel, the GVAX portfolio and Pill Plus all materialize into blockbuster products, reaching full potential, your 5 year estimate might even appear conservative.
Simes and company may have decided to make a play for CV benefit of Libigel back in 2009
Safety trial sequence of events
Oct 20th, 2009
BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in
Phase III Program
"This review of unblinded LibiGel safety data by the DMC gives us even greater comfort about the safety of LibiGel, said Michael Snabes, M.D., BioSante's vice president of clinical development. We have known, based on blinded data, that the rates of cardiovascular and breast cancer events in the study are lower than expected in women at the higher end of cardiovascular risk for the intended population. This recommendation by the DMC, after their confidential review of unblinded data, to continue the study without changes, is a validation of the safety to date of LibiGel in the treatment of female sexual dysfunction (FSD) in menopausal women, our target patient population. This outcome represents a significant advance for our LibiGel clinical development program," Dr. Snabes continued.
PR
Clinical trial changes
November 12th, 2009
Clinical trial is changed to go from postmenopausal women with at least one risk factor risk for cardiovascular disease to postmenopausal women with at least two points of cardiovascular risk and it adds the following line 2011 primary outcome analysis for NDA submission
June 7th, 2011
Anticipated enrollment increases from 2900 to actual enrollment of 3656 patients (Why enroll an extra 26% patients if very safety review has indicated proceed without adjustment?)
Safety trial changes
Patent filings
June 29, 2011 -Methods for treating sexual dysfunction while decreasing cardiovascular risk
July 20, 2011 - Methods for decreasing cardiovascular risk in postmenopausal women
August 17, 2011 - COMMERCIAL SCALE PRODUCTION METHODS FOR TRANSDERMAL HORMONE FORMULATIONS
Fall of 2011 Biosante purchases a gel filling machine.
Jeff, in my opinion with less available shares the MM's are not getting enough activity from sellers so they may be finished accumulating downward. They may have started the next phase of their accumulation. This time on the way up by taking advantage of the frustrated investors who just want get back to even. This week should give us a good indication if they intend on letting it run or control it upwards.
Even though future Libigel phase III efficacy trial information may be off in the distance. You are well aware of the number of possible catalyst which could shorten the window for manipulation.
As for Jeffries:
December 15th, 2011 Jefferies & Company has published a research report on BioSante Pharmaceuticals (NASDAQ: BPAX) downgrading the company from Buy to Hold and lowering the price target from $5 to $0.70. (After this Biosante was off the radar)
On June 14
Jefferies reiterates its Hold rating on BioSante Pharmaceuticals (NASDAQ: BPAX) and raises its price target from $0.70 to $2.
Jefferies says, "BPAX officially announced new Ph III trials for LibiGel, believing that efforts to minimize placebo responses will ultimately lead to trial success this time around. We've put LibiGel back into our model (assuming a 2016 launch), while also making other wholesale model revisions. As a result, our new PT is $2."
Jeffries never adjusted for the R/S (couldn't bother). The release should have read that they raise their price target from $4.20 to $12.00. Note they are assuming a launch date of 2016, though we all know it will be sooner than that as the professor clearly pointed out.
On June 11
Rodman & Renshaw reiterates market perform.
BioSante announced plans to initiate two new Phase 3 trials on LibiGel [a product to increase sexual desire in women]. The decision was based on feedback by consultants in female sexual dysfunction, and an in-depth analysis of the previous Phase 3 efficacy results. Management intends to institute protocol changes to the new studies, mainly to minimize the greater-than-expected placebo response that was seen in both of the completed prior Phase 3 LibiGel trials. We keep our Market Perform rating without a target price for BioSante shares.
I expect the other analyst to pipe in and once the outperform ratings start kicking in, BPAX will be back on track.
Since one of the issues in the failed Bloom trials is attributed to the amount of clinical intervention and the daily diary entries among other issues. I believe both are mitigated in the in the Bliss trial.
The Bliss study includes a screening period of up to 8 weeks and a 60-month treatment period.
The following is the timeline:
Screening (day 1 through week 8 - clinical visit)
Starting point - Randomization (week 8 - clinical visit)
Week 6 (phone contact)
Month 3 (clinical visit)
Month 6 (clinical visit)
Month 9 (phone contact)
Year 1 (clinical visit)
Followed by phone contacts every three month and an annual clinical visit)
I am not certain what schedule they stipulated for diary entries but seeing that they referenced the Intrinsa trial, one would hope they used a similar weekly diary. If the efficacy portion of the Bliss trial is consistent with the above schedule, we should see significant efficacy for post menopausal women.
Note the Study procedures, I am curious as to what the laboratory measures they are monitoring (HDL levels, Blood pressure, Free testosterone levels ect...)
At each scheduled contact, participants are asked about adverse events and health care and hospitalizations; questioned about specific androgenic side effects, potential CV events, and breast cancer; and undergo other assessments of safety and tolerability as well as laboratory measures
Interesting article on How Different Brokers Handle Lending Shares To Short-Sellers.
Lending Shares To Short-Sellers
In the author's opinion lending out shares is never a good idea because it makes your shares work against yourself, and even if you earn a bit of income, you'd probably make more from a rise in the stock price which you'd help with by not making your shares available for shorting.
Good find, Biosante presents June 20th @ 10:45 AM - 11:00 AM
Presentation
Yet, another use for Libigel- Female Chronic Pain Management.
Testosterone - Pain Management
The 4 million off-label prescription presently issued for HSDD may prove to be the tip of an iceberg. Once the safety data is released and Libigel is approved for one treatment or another. I expect many physicians presently using testosterone for off label use while treating conditions other then HSDD to switch to Libigel as well.
None of this market has been factored into Biosante's estimates and obviously analyst have not picked up on this possibility.
Jeff, all the confusion could be easily avoided if companies and analyst use the market cap followed buy the price per share. Market cap is what really matter as price per share is impacted by splits, R/S, dilution etc... Though dilution is a concern, the estimated market cap (when not manipulated) provides a true barometer of the companies future prospects.
I agree on share price and it will come, those who did their homework and saw through the crap of the last 6 months will be well reward, how well remains to be seen.
Double Die, I have been busy at work and by the time I get home, much of what has to be said has already been covered. The quantity of quality contributors has increased, which is great.
I am presently looking for clues that might point to Biosante having committed to a location from which to manufacture. You have to put the gel filling machine somewhere. In January 2011 they expanded their office space to 20,000 square feet with a 3 year lease. Likewise, if the office space requirements expands again, it will point the projected increase in the size of their operation (more hiring to come).
Lease info
I am trying to ascertain where they relation to this statement from year end 10k
Manufacturing
We currently do not have any facilities suitable for manufacturing on a commercial scale basis any of our products nor do we have any experience in volume manufacturing. We currently use third-party current Good Manufacturing Practices, or cGMP, manufacturers to manufacture our products in development in accordance with FDA and other appropriate regulations.
Happy Father's Day to yourself as well.
Biosante will be attending the JMP Securities Healthcare Conference 7/12/2012 – 7/13/2012 New York, NY, USA
Conference
Hopefully, they too will start covering Biosante and upgrade the pps.
The Trout Group is excited to host its 8th Annual Wall Street Unplugged seminar in New York City on August 1, 2012 at the NASDAQ MarketSite, where Biosante will also be attending.
Unplugged participants
Everyone, please back to BPAX.
Most countries have positives and negatives. Unless we have travelled the world extensively and lived among the people of different countries, we really can't give an honest assessment. The world through ABC, CBS, NBC, FOX, BBC, Al-Jazeera, etc... is all skewed to sell. Whatever we say will be relative to our experience.
The one thing we have in common is BPAX, so back to BPAX.
Jadite, I agree. Pantarhei is presenting at 12th Congress of the ESC, the European Society of Contraception and Reproductive Health, from June 20-23, 2012 in Athens, Greece
Pantarhei
True Professor, but don't the Quality Assurance Director and CAPA Manager lean more towards manufacturing with the new gel filling machine?
JohnNewen, by reading the article they were speaking from a pre-split price. The were factoring in an approval and a product launch date of 2016. The price target should be $12. The late stage buying today indicates some, know the intention of the article and are starting to cover before the correction comes out.
Jeff, I know I looked last night, they must have put them up late or this morning. I too, flip though the Biosante site daily followed by patent searches and clinical trials.
I'll take that as a compliment! I am crunched for time, but will put something together this weekend and put it up on the board for editing by the group. We might as well work on it as group, our collective knowledge is far superior to my memory.
Pete, the 8 to 9 months include the recruitment and the the trail itself lasts 6 months. They will then analyze the data and present their findings (if positive) in an NDA ammendment to the existing NDA from the safety trial (if this has been done) In the meantime they will be writing up the protocol and getting FDA on board to get an SPA for the two phase II trials. That is why they stated they hoped to start at the end of this year or early next year. I don't believe they will require a trial extension for persistence of use (to see what happens when they are taken off the drug). The one they have completed should suffice.
Jeff, I agree until pps is respectable, dilution is not on their radar. I find it hard to believe that Simes doesn't know when Teva will launch Bio-t-Gel. But obviously as per agreement with Abbott it is not up for disclosure. However, Biosante as an affected party would have a right to know.
If, as I suspect, the launch is in the new year it will not only elevate the PPS, it will also extend their cash run up. Which may negate the need for dilution.
I also foresee a signing bonus from a partnership as a strong possibility which will also negate the need for dilution.
If they rely on Tang, it will be interesting to see what their post NDA steps will be.
Pete, Simes stated between 8 and 9 months. It depends on how long it takes to recruit the women.
Professor I just listened to the most recent CC and the Jeffries CC. I didn't hear anything about staring an NDA before the trials were completed. Though I though the 9th Safety Review results would be available soon but Simes stated later this summer.
The primary analysis of the safety trail will be available by years end, if not sooner. Seems to me if all they were looking for was reported CV events and cancerous events it would not take that long to tabulate. Now, if they are looking for efficacy, then it makes total sense.
If this is indeed the case, we might hear a decision on an NDA submission regarding safety trail data by years end. Followed by the a phase III trial starting in the new year. During the phase III trial they would submit the NDA application and supplement that with the phase III trial results.
I agree with Jeff, the independent Data Monitoring Committee should announce a positive 9th Safety Review shortly. Hopefully at this point the company will elaborate on what they will be looking for within the safety trial data (efficacy).
Thanks Jeff, I agree, the only possible explanation I can see is that it is only 4600 people a year that are diagnosed in the US. For this reason no one wants to take it on to bring it to the next level. This is a case where the FDA needs to sweeten the pot create a cost recovery mechanism for companies that wish to move these forward. From a global perspective it could make sense.
Professor, if the Bliss safety trial shows efficacy, I can't see the FDA requesting them to do another efficacy trial for post naturally post menopausal women with HSDD. The Bliss Safety trial is a multi-centre, multi-country trial with sample size that is over 3 times the size of the two efficacy trials combined.
What more in the world could they possibly want to prove efficacy?