Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Biosante management may in fact be brilliant!
Biosante presented at the 2011 Jeffries Global Health Care Conference. This year the Jeffries Global Health Care Conference is being held in New York City June 4-7.
Jeffries Global Health Care Conference
This should be around the time the results of final Data Monitoring Committee review of Libigel is released. If so, and the review results are consistent with the previous eight reviews and this coincides with the last person being registered over a year ago (both conditions to NDA submission).
Don't be surprised if we see a media release indicating their intention to present followed by another media release just prior to event announcing their intention to move forward with an NDA submission for Libigel and how exactly they will proceed (HSDD and/or CV). What better place then New York City (Home of the Nasdaq Stock Exchange) to hold an audience and field questions.
Obviously they would study in greater detail all the safety data and prepare for an NDA submission most likely sometime in the fall.
More info on the CV safety study.
Libigel Safety Study
I have started differentiating between the CV and HSDD purposes to promote awareness.
Firstly, all that sits between applying for NDA approval on the CV benefit is the the results of the final independent Data Monitoring Committee (DMC) unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study. The previous seven reviews have passed without modification. And in the eight review the DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification, as there were no general or specific safety issues based on their unblinded review of adverse event. One would think that issues would have surface by now. (I believe this is now their biggest play and they are playing like an ace up their sleeve) They don't have a placebo effect to deal with as it kicked placebo's butt.
Secondly, Biosante will have to work a little harder to overcome the placebo effect in relation to HSDD. I believe the diary data that they have analyzed will negate the placebo effect and permit the NDA application to move forward. Interestingly, though this was the original intent of the Clinical trials and still remains highly lucrative, the CV benefits will prove the greatest money maker.
Thirdly, discussions with the FDA will identify the best way to submit the NDA. These discussions will determine if both CV and HSDD are covered under one NDA or if would they be better served under separate NDA submissions.
More on Libigel CV vs Libigel HSDD, people will cut back on HSDD treatment for a number of reasons (ie, death of a partner, physical mobility etc..) since risk factors increase with age, the need for Libigel CV will only increase with age.
Thanks for the update.
I agree. The patent application refers to mass production of Libigel
Considering they released the efficacy results mid december. They would not have gone ahead with the purchase unless they were certain they had a viable product (HSSD and/or Testosterone Replacement and/or CV reduction.
The ducks are lining up nicely.
Good pick up on the 10k. I agree with your assumption. Libigel success and the revenue the CV and HSDD benefits could generate would allow Biosante to acquire or create a Marketing Division for the company. This would be a big step towards playing with the big boys allowing to keep more of the profits. Remember Biosante still has the Global rights to Elestrin an Bio-t-gel outside the U.S.
Libigel CV benefit potentially 465% bigger then Libigel HSDD and only one safety trial review out of nine remains.
I have not received a response to my e-mail from Scott Henry of Roth Capital. But his 5 star rating will do. I have since sent the same info on the Libigel Connecting the Dots to the other analysts covering Biosante.
Let's see what happens over the next couple of days
Interestingly someone linked to my original post on the Yahoo board under Great Find on ihub and the link. I think most did not realize the info of what was contained in the link and never looked. Interesting to see if the info resurfaces and starts to spread. (Viral would be nice)
Sent the following e-mail to Scott Henry analyst covering Biosante for Roth Capital
Hello Mr Henry
It is my understanding that you cover Biosante. If so, I have provide a link breaking down the background activity on Libigel which has not been made public by the company. (Note links have been provided to corroborate the findings )
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=73235821
If my findings as laid out in the attached ihub post are accurate, you should come to same conclusion that the majority of the investment community has grossly undervalued the true market potential and viability of Libigel and in turn Biosante.
Thank you for time
Just to add to connecting the Libigel dots. Biosante in all likelihood is sitting on this CV story until meeting with the FDA regarding subset analysis. If positive they will release the information of subset analysis, this will cause a big bump in price. Once the final safety hurdle is passed they will probably confirm the CV benefit and the potential market in addition to the safety results.
Seeing that in October 2011 Biosante had an average 1 year target price of $6, with Libigel closer to NDA submission, the CV benefit and consider that GVAX was a non issue just coming off a HOLD. Your guess is as good as mine as to how high BPAX could go.
Very tasty food for thought.
Connecting the Libigel Dots.
Seeing that Libigel has a target audience of up to 9 million , according to page 17 of Biosante's Market Data presentation
And
Today, an estimated 50 million women in the United States have reached menopause. Most women will spend at least one-third of their lives in or beyond menopause. With an average life expectancy expectancy over 80 years. That equates to over 26 years of post menopause per person. Post menopause is considered a risk factor in Heart Disease
Post Menopause
Heart Disease Risk Factors in Women
Now look at the most recent patent application in relation to Libigel including:
- Methods for decreasing cardiovascular risk in postmenopausal women
- Methods for treating sexual dysfunction while decreasing cardiovascular risk
- COMMERCIAL SCALE PRODUCTION METHODS FOR TRANSDERMAL HORMONE FORMULATIONS
Libigel Patents
By following the trail I have just provided, Libigel is one safety result (and the regulatory process) away from becoming a very lucrative product.
Note: Libigel is still being evaluated for cognitive benefits in Australia and I have not mentioned the proven testosterone replenishment market including targeting Osteoporosis.
Biosante and Libigel have many options, they will continue with HSDD and compliment that with the other target audiences. Even if HSDD does not fly Libigel has potentially become over 465% more lucrative then its original intention and if HSDD is accepted, Libigel only becomes more valuable.
For those who question the value of the Libigel's testosterone CV event reduction. Abbott seems to be looking for an in on the potential discovery
Testosterone Therapy in Heart Failure
10k filing should be out soon, last year's was filed March 16, 2011.
Here is last years 10k
Since Roth Capital is one of the analysts that cover BPAX (according to Biosante's Website), it will be interesting to see how Roth Analyst assesses BPAX after the presentation.
Analyst
Position statement from the North American Menopause Society on Testosterone Therapy on post menopausal women.
Position Paper
Biosante have no doubt been examining the following psychosocial issues and psychological disorders in the subset analysis of Libigel's efficacy trials
Psychosocial issues
Previous attitudes toward sex
Social customs and religious beliefs regarding sex
Poor partner relationship
Feelings toward partner
Length of relationship
Partner’s decreased capacity for sexual activity
Partner’s loss of interest in sex
No available partner
Life stressors from work, family, relationships
Negative body image
Psychological disorders
Depression
Anxiety
Other psychiatric illness
Medical conditions
Vaginal atrophy
Vasomotor symptoms
Incontinence
Chronic illness, including cardiovascular disease, diabetes mellitus, arthritis, renal failure
Cancer, particularly gynecologic or breast cancer
Pharmacologic agents
Psychotropics: selective serotonin-reuptake inhibitors, tricyclic antidepressants, benzodiazepines, barbiturates, anxiolytics, sedatives
Cardiovascular: beta-blockers, clonidine, methyldopa, spironolactone
(which has antiandrogenic properties)
Hormones: gonadotropin-releasing hormone agonists and antagonists, corticosteroids,
antiandrogens
Recreational drugs: alcohol, marijuana, cocaine, heroin, methadone
This is the Clinical trial exclusion criteria
A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
Any systemic skin diseases or local skin abnormalities in the area of application
Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
A medical condition that could affect or interfere with sexual function
Using a systemic transdermal gel or cream estrogen therapy.
Another and probably most important person to have succumbed to pancreatic cancer is Dr. Ralph Steinman,the winner of the 2011 Nobel prize in medicine, who died only three days before the award was announced. In the last few years of his life, he made himself into an extraordinary human lab experiment, testing a series of unproven therapies - including some he helped to create - as he waged a very personal battle with pancreatic cancer.
GVAX among those tested
Interesting theory on early trial buyouts posted by Drugexpert of yahoo board on 28-Feb-12 11:40 am
Why BPAX is strong buyout target
Phase I, II, III etc are secondary not the core things. If the drug's theory and design are correct , technological implementation is correct - then it will work no matter which phase it is in. That's the main point & key to success. GVAX Pancreas cancer vaccine, Phase 1B showing strong performance which means the drug is designed and developed in right way. No brainer it will show strong performance in Pahse II and III. Exactly for this reason Bristol Mayers bought INHX for $2.5B for its Phase-II HepC drug.
BPAX will be winner. Huge multibagger in few months.
FDA Regulatory Information on Off-Label Drugs
Off Label use of Marketed Drugs
Guidance for Institutional Review Boards and Clinical Investigators
Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects.
HSDD is an unmet need. Seeing that there was no distinguishable difference in relation to efficacy between Libigel and the placebo (subset analysis aside), both worked well. It is then reasonable to assume that the onus placed on physicians to justify the use of Off Label" drugs would be lifted through the approval of Libigel.
The compelling argument for FDA approval of Libigel would include the following:
- Safely filling an unmet need of treating HSDD.
- Reducing the onus on physician who feel compelled to write off label prescriptions as a treatment.
- Providing a proven safe method of testosterone replacement for post menopausal women.
- Providing another method to reduce cardiovascular events thereby saving lives.
Of course, this is based on the assumption that Libigel safety trials results will be consistent with the previous 8 evaluations.
Very good point.
Global Cancer Treatment Forecast to 2012
The following is an excerpt from the above noted research article.
Global Cancer Treatment Forecast to 2012
High number of unmet needs and an ever-increasing prevalence of cancer has created a gold rush among drug companies to enter the cancer market. Here, launching a drug successfully is risky, however, if launched, commercial gains completely surpass the expenditures incurred, says 'Global Cancer Treatment Forecast to 2012”, the new research report from RNCOS.
Cancer represents the fastest growing therapy segment in the pharmaceutical market. This segment has become the centre of focus for drug firms and investors, and has garnered more attention than any other therapy segment; nearly every mid-size and large pharmaceutical/biotech company today is linked to a cancer pipeline.
Key Findings
-From more than 12 Million newly diagnosed cancer cases in 2007, the number of newly diagnosed global cancer cases is expected to reach over 17 Million by 2020.
-Growing at a CAGR of 12.3% between 2007 and 2012, the global market for cancer drugs is expected to cross US$ 78 Billion by 2012.
If this growth rate is sustainable it will reach $156 billion in 6 years. Capturing only 1% of this market equates to $1.56 billion a year in revenue.
-Cancer vaccines and antiangiogenics will record the fastest growth rate between 2007 and 2012.
GVAX and other Biosante treatments are well situated to take advantage of this trend.
-Drug manufactures are now focused on developing target therapies. These drugs attack target cells and thus limit the severity of side effects.
Biosante through Cell Genesys has been concentrating on this for a number of years and have already taken GVAX to phase 3 trial which was aborted as they have since learned that the cancer within many of the patients had advanced to a late stage where GVAX alone could not help them. Taking what was learned from the phase 3 trials GVAX is now finding success with earlier intervention in combination various other drug (ie, chemo).
-The US is the largest market for cancer drugs, followed by Europe and Japan.
-Drugs for cancer represent the largest therapy area under clinical development; however, when it comes to approval rates, drugs for cancer have the worst approval rates.
By partnering with John Hopkins University Biosante has increased the chance of finding success while diffusing the financial risk. They won't benefit as much from successes but will not be penalized as much by the failures. The successes will set up long term deep revenue streams
Globally, Elestrin, Bio-t-gel and ,yes, Libigel will increasingly generate various revenue streams in the near future (1 to 3 years). The cancer portfolio will create larger long term revenue streams.
With a cash runway of almost 2 years. The business strategy will come into focus as time progresses. Do your own due diligence and just be happy you got in ahead of the crowd.
The attached link explains the Advanced Transdermal Delivery used in Elestrin. Once this is truly understood the market will expand, Jazz has elevated the profile of Elestrin to make it the lead Women's Health product in their portfolio. They obviously see the revenue potential of this product. True Biosante did give up some royalty revenue in exchange for cash, but they still have milestone payments. If Jazz continues on this path should create a revenue stream in the future.
Elestrin aside, it is my belief that the same Transdermal Advanced Delivery system enticed Teva into partnering for Bio-t-Gel. Over time, Teva will market Bio-t-Gel and they will gain a larger market share than most have projected.
The technology allows for lower doses to be used to gain the benefits. This lowers the cost of production which will allow for greater profits.
One must remember that Biosante still owns the global rights to both Elestrin and Bio-t-Gel. Long term the US market is small potatoes. Many have chastised Stephen Simes(Biosante CEO), but I see him as visionary. Global wealth is growing at a much faster rate then US. However,the US FDA approval process is the gold standard. He looks to getting products approved by the FDA. But eyes the global revenue stream as the greatest benefit to the company. This is why you see the geographical division of rights for each product.
Libigel
Libigel also uses a similar Transdermal Advanced Delivery system and will be Big revenue generator if it meets safety approval which we will find out by the end of May. Presently there is a greater than a 90% chance of exceeding the safety end points.
Even though Libigel failed to significantly surpass the placebo results, the efficacy trials have proven superior to Intrinsa, which is presently the global standard for treating HSDD outside the US. Even without subset data proving superior efficacy or another efficacy trial which only includes the targeted HSDD patients, Libigel an compete with Intrinsa outside the US and be very profitable
The efficacy trials proved excellent testosterone replenishment to pre-menopausal levels. This is a medical treatment in itself and goes beyond HSDD. Very profitable marketing opportunity
The safety trials proved the added benefit of reduction of Cardiovascular Events by 70%. Very profitable marketing opportunity
The Pill Plus
Pantarhei Bioscience is conducting the clinical trials on pill form. Biosante realizing that Advanced Transdermal Delivery is actually a superior method of delivering drugs kept the non pill form of delivery.
Finally the Cancer portfolio
Biosante has developed strategic partnerships to move the portfolio forward. By partnering with the Hussman Foundation though the John Hopkins University. They have been able to diversify and advance their portfolio of cancer treatments and a much quicker rate then if they went it alone. Their agreement is for approximately 30% of royalties John Hopkins receives. Assuming the University would pick up a 30% royalty for a cancer treatment that is a 9% royalty at of all cancer treatment sales moving forward on all successful partnerships that John Hopkins forges.This equals an unknown potential revenue stream but the potential is huge Best of all Biosante's costs going forward are minimal. They are now just waiting for a return on this investment. In the meantime Biosante is also moving forward on other cancer research outside of the licencing agreement.
Objective investors will agree that Biosante is grossly undervalued. I leave it to you to determine how undervalued the stock truly is.
It is all hype and rumors. No one has provided any link to validate it. Thought the idea can make sense, it will depend on what Teva offers. They are talking $3 to $4 offer, which if you truly researched the company's pipeline and compared it to other biotech companies you will agree does not make any sense. If Libigel is a go and/or if the CV benefit is to be marketed (which in the end will be a bigger market). Any offer would have to be north of $6/share especially since the general consensus among analyst pegged the 1 yr target for BPAX at $6 in November. At that time the impact of lifting the hold on GVAX had not been fully understood and factored into the price. The Safety trial for Libigel was given a 70% -80% chance of passing.
Bottom line any info is being kept close to the vest. We will find out in due time BPAx's future.
First make the distinction between and actual lawsuit and advertisement. There is very little substance to the claims. The efficacy was proven clinically by Intrinsa and Phase II results. The market potential was covered by the the size of the target audience post menopausal women with HSDD and the Independent surveys that were conducted. Combine this with the fact that the insiders were still buying shares. shoots holes in any claim. Likewise if the product gets approval Those who are suing shot themselves in the foot by selling prematurely.
Biosante Survey
With all due respect Joshuri. Insiders would not have been buying shares in August and November if they were lying to the public. They would have been selling. The placebo did better then ever imaginable on a subjective endpoint, therein lies the problem.
Insider trading
With patience you will be rewarded and I believe more then you had ever planned. As I understand it your break even was around $1.39.
I hope you don't have a sell order in. Once this starts to climb I would hate to see you bail out prematurely.
Very good question. I would not be surprised if Biosante and Teva are not thinking the same thing. I don't know the difference in the composition of the two products but it is definitely worth exploring.
First they must get the safety study completed around the end of May. Before they can get approved a NDA submission must be completed. Then I believe the FDA has up to 10 month to make a decision. This is the PDUFA date you see. Who will make the submission and take care of the regulatory hurdles remains to be seen. Will it be a partner or will Biosante take it to the end. They have talked about a cash runway? Was this the reason?
My research confirms what Nutsyprofessor has said all along. Biosante can use Intrinsa research data along with all the other data that confirms the relationship between elevated testosterone levels and improvement of HSDD. This should counter the neutral efficacy results between Libigel and the placebo. If not then a more stringent trial could be done with the target audience being the focus. The Bloom trials was very broad and had many participants for which Libigel was not the intended audience.
There is still the issue of such an elevated result from the placebo. I am not exactly convinced it was the placebo alone that did so well, possibly the combination of the placebo along with the diary log and the regular clinical visits caused the elevated results. Remember this was the only subjective variable being measured, the rest were objective.
No doubt the discussion with FDA will revolve around proceeding with the evidence of CV benefits.
Bottom line approval (PDUFA Date) is probably in early to mid 2013 unless a further trial is required to confirm the target audience(s) Then you can tack on up to an additional 6 month.
This is for those still in doubt about Libigel's viability. For the unmet need of HSDD, the following should be a compelling argument to not only approve Libigel for it's intended purpose, but also allow for an expanded use regarding the CV benefit.
New Drug Application (NDA)
Introduction
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:
1 - Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
The Bloom trials Libigel equaled but did not beat placebo in the increase sexually satisfying events (a subjective result) but Libigel beat them hands down in restoring testosterone to pre-menopausal levels (an objective result)
The safety trails proved the 70% reduction in cardiovascular events which is now supported by two patent applications, the placebo provided no benefit.
In my books that is 2 wins & 1 tie for Libigel vs 2 losses & 1 tie for placebo.
.
2- Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
To be determined
3 - Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
This is addressed by the most recent patent application on mass production.
The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. The following resources provide summaries on NDA content, format, and classification, plus the NDA review process:
This allows the use of the Phase 2 trial in the application which Libigel did very well in efficacy and the placebo acted more in line with other placebo's
NDA GUIDELINE FOR APPLICATION
Section F allows for the presentation of other studies (i.e, Intrinsa)
F. Other Studies and Information [21 CFR 314.50 (d)(5) (iv)] 25
1. Overview 25
2. Format/content 25
a. Table of all studies and other information
b. Reports of individual studies - order of presentation
c. Reports of controlled or uncontrolled study of uses
not claimed in the application
1) Synopsis
2) Protocol, CRF, amendments
3) Publication
4) List of study participants/compliance with parts 503 56
5) Report of study
d. Reports of commercial marketing experience
e. Overall summary
I don't know all the details but the formulation would be different as they are treating different problems Bio-t-gel treats Hypogonadism and would contain more Testosterone while Libigel is designed to treat HSDD it would have less testosterone in the formula.
That is correct.
The following excerpt from the patent application confirms this
[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.
This might cheer you up folks dated today
New Patent application for Commercial production of Libigel
Is this the runway Biosante was talking about by freeing up cash.
This article is for those wishing to better understand the GVAX vaccine and what has been learned from the failed Phase III trials under Cell Genesys and how it being used differently today. This explains why the GVAX hold was lifted and the direction it is headed.
Chemotherapy and Immunotherapy Combination in Advanced Prostate Cancer
Good point. The establishment of treatment diversity can mitigate the impact of theses shortages by giving oncologists more options.
The benefit of Biosante deal to partner with John Hopkins University and the Sidney Kimmel Comprehensive Cancer Center. At no additional cost to Biosante.
Identification of Annexin A2 (ANXA2) as a Pancreatic Cancer Antigen
In addition it is not the same type of product.
An oral enteric formulation acting on the central nervous system (CNS) with therapeutic characteristics that benefit sufferers of sexual health disorders. It is intended as a treatment for HSDD both as a standalone and as an adjunct to testosterone therapy for the disorder.
It does nothing for testosterone replenishment or CV benefits which has been identified by Libigel. And a along way off.
Follow up on MPR12001 (Yahoo Board)and SEC complaint
I told you I had filed with the SEC going through a friend of mine about the malipulation and fraud being committed on BPAX. The individuals and hedge funds involved are in a lot of trouble. Besides not having shares to cover their shorts they have commited outright lies about the company. This will take time, but I am assured I am not the only one who has been taken noticed of by the SEC about BPAX. He could not provide me with whom it is or how many but it is assured this is being investigated. My case is HO::~00195451~::HO
in case you too want to file. Mention this case ID.
Thanks for the referral.
Found this article in the American Heart Journal
A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder
Safety trial
I don't know if the results are starting get out but there seems a definitely increase in interest. The article lays out the process and rational in easy to understand language.
I found this statement in the conclusion interesting. Don't know if it refers to future product development,expansion of the target audience or for general consumption by other researchers.
Conclusions
The BLISS study is an important and novel study for establishing the safety of LibiGel testosterone therapy in postmenopausal women with HSDD. The operational principals of this study may be applicable to conducting safety studies for other drugs in other populations with low event rates. The study has been ongoing since 2008 and has been actively enrolling and randomizing participants. The BLISS study is designed to document the efficacy and safety of LibiGel for treatment of HSDD, a common condition for which there is no FDA-approved pharmaceutical treatment in women.
This is probably true with most industries but less so in the biotech industry. In the biotech industry they also rise on their potential for future revenue. I counted 38 companies trading above Biosantes' market cap all with less annual revenue than Biosante.
One being Pharmasset with a market cap of $10.36 Billion which was bought by Gilead.
In what world does a company like Sangamo get a market cap of $279.68 Million and Biosante has to fight for a Market Cap of $86.50 Million?
Sangamo Pipeline
There are many more Sangamo's out there.
I'll take my chances with Biosante, thank you very much.
You are correct it is only an application at this point. But it is the information within the application about CV efficacy which should make us sit up and take notice. At least 70% risk reduction in CV events
As for the patent application this an area where they excel, based on the Patent Board's Scorecard ratings for Biosante the last couple of years, they are well versed in the process of obtaining patents and very capable of obtaining this one.
Top 15 2010
I would love to be a fly on the wall at the FDA meetings.