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I just got back to a computer. I was reading this in a garage (kindle) while having my oil changed and couldn't post! I think it's a big step toward approval:
From the American Congress of Obstetricians and Gynecologists published today, August 1, 2012, a training seminar on Testosterone Replacement in Postreproductive Women:
Check out the learning objectives! The OB/GYN's are on board!
http://www.acogupdate.com/?gp_page=p_onecourse&gp_skey=330
Jeff,
How do you know that 1.49 is propped up? I was hoping it was a bottom.
Hey Pete/JTFM
Will we be able to view institutional ownership tomorrow? How long does it take to update?
Very interesting connection. Thanks!
JTFM,
It justs seems the planets have aligned:
*CDC updating T lab tech with emphasis on testing women (Abbott funds)
*ASRM does May issue of Menopausal Medicine on promoting prescribing T for women with low T symptoms (directed to OB/GYN's) (Pfizer funds)
*Biosante mysteriously quiet
*Compounding pharmacies busier than ever w/T scripts indicating that doctors are already on board with a substance they would prefer to be FDA approved.
26 employees laid-off (great post by the way!) indicates safety data will soon be available. Could indicate other things too: good or bad.
...and Wednesday is August 1st.
Very cool! Do you own ABT?
Updating is in progress and that's great. Every month new labs are added to the certified list. I don't think the FDA wants to approve a product until standardization is set and serum levels are guaranteed to be accurately quantified. That will be the case very soon.
Listed as a 2012 accomplishment listed in the CDC's 2013 Congressional budget request:
? Improved the accuracy and comparability of numerous laboratory measurements, including the Hormone Standardization (HoSt) Program's new testosterone test that more accurately diagnoses polycystic ovary syndrome, adrenal cancers, and other diseases of androgen excess and deficiency.
If I owned ABT I would be very excited about their investment in lab tech. Doctors are testing everyone's Vit D level now. When everyone T level is checked ABT stands to make big $$. BPAX is going to be VERY successful.
Slice,
I'm a tad cynical and I continue to mull around the possibility that this is all smoke and mirrors and that our real hold up is the time for Abbott to set up their testing lab technology. Wouldn't it be like selling shovels during the gold rush? or metal detectors?
If current testing is as inaccurate as it has been described and efficacy is truly establishing T levels consistent with those of younger women, and those levels have not been established because the Center for Disease Control (with Abbott's funding) is only now establishing a standard...
That standard will be a range and I believe the emphasis will be on not exceeding the numbers in the range (which BPAX has already shown time and again). Look at the ridiculous rules that have been put in place for (brand-new) T testing for female Olympic athletes. I would love to know if this is Abbott's pilot project. lol.
That gives hedge funds ample time to ride this down like an elevator (see Prof's post on YB) and then up again. I don't believe there is much more of a ride down. Do you?
See info below from May 2012 issue Menopausal Medicine which is THE go-to journal for OB/GYN's.
http://www.sart.org/uploadedFiles/ASRM_Content/News_and_Publications/Journals_and_Newsletters/Menopausal_Medicine/2012/MenMed_0512.pdf
"Two major challenges have been (1) determining which symptoms reflect testosterone deficiency in women and (2) establishing a serum testosterone level cutpoint for testosterone defi- ciency. As in men, symptoms of tes- tosterone deficiency in women over- lap with other medical conditions. For example, while testosterone insuffi- ciency may underpin loss of libido, flat mood, and fatigue, these symptoms may also be explained by depression, iron deficiency, and hypothyroidism. Debate continues regarding the lower limit of “normal” testosterone for men. For women, an absolute cutoff level that defines serum testosterone deficiency is unlikely to be established."
It would not surprise me in the least if a new efficacy trial is not required after safety is revealed (again). My bet is that the FDA wants a T standard in place as part of their definition of safety. That is happening now and it has been made a priority.
Hi,
I read it on the ATRS YB the other day and then checked it myself. I guess it has only been there for 2-3 days tops.
Prof,
Thanks for the recap!
ATRS management is more forthcoming with info than BPAX's (perhaps for reasons that cannot be disclosed). ATRS puts anticipated "mystery" drugs in their pipeline.
I think something happened that prompted them to add Libigel back. News is coming IMO.
Is BPAX/ATRS preparing to launch (and provide manufacturing for) Libigel abroad? Hence, we are back in the ATRS pipeline?
Thoughts...
Hi Prof,
Thanks. I thought the info on the Antares site was noteworthy too.
I know BPAX isn't an earnings-as-big-news company yet but isn't it weird that they haven't done a pr yet and it is 9:49 ET?
I don't recall this ever happening before.
I just read on the ATRS board that Antares has put Libigel back on their website pipeline chart.
Antares is still missing from our site.
BPAX is the only thing green today in my portfolio.
Jeff,
I have no idea who they are trying to lure with that bait! And secret is right. Patent applications don't have to be published. Who knows what kind of news we could get at any given moment.
This is my personal favorite from the current website. It hasn't been pulled or modified and it states that Libigel will be launched in 2012. Hey. Who am I to point out an inconsistency? A 2012 launch works for me!
http://www.biosantepharma.com/downloads/BioSante-Investment-ExecSummary.pdf
Everything is held up because of testing technology issues. That's my story and I'm sticking to it!
Jeff,
That patent is owned by Antares. Biosante made the announcement. Maybe legally, that's how it had to be.
http://www.biosantepharma.com/News-Releases.php?ID=112911
Today I'm thinking that the interested parties have failed to disclose that what we really are dealing with is an infrastructure problem.
Come on, over 4 Mill off-label scripts back in 2010, probably doubled by now. The compounding pharmacy near here went from 1 pharmacist to 2(full-time), and that's almost all they do.
That's why the CDC is rushing to get these testing labs outfitted.
Hi Jeff,
I do remember that. Is there something new about the method of use?
When Libigel is approved ABT is going to get rich (er) on testing women for T because they developed the testing equipment/procedure.
Maybe this is their connection. Is developing the testing equipment and owning the company that provides the cure a conflict of interest? Probably not.
Excerpt from 2010 article emphasizing need for testing and that current testing sucks:
http://www.aacc.org/publications/cln/2010/august/Pages/CoverStory1.aspx
"Representatives from both Abbott Diagnostics and Beckman Coulter agreed that manufacturers have a crucial role in improving testosterone assays. “Clinical laboratories look to diagnostic manufacturers to provide reagents and instrumentation which lead to the best and most accurate results for medical diagnostics,” said Linda C. Rogers, PhD, DABCC, FACB, manager of market development for Beckman Coulter. In the end, “physicians need to be able to trust low concentration testosterone measurements. However, current research shows that immunoassays in the lower ranges are no better than random number generators,” added Stuart Blincko, PhD, principal research scientist at Abbott Diagnostics.
Rogers indicated that Beckman Coulter has conducted feasibility studies to evaluate the development of a highly sensitive testosterone assay, while Blincko stated that Abbott is developing a direct immunoassay that will measure both low and high testosterone concentrations. The latter will be designed to align with the method listed in the Joint Committee for Traceability in Laboratory Medicine. Abbott does not plan to pursue a direct pediatric claim for this new assay, according to Blincko."
BPAX/ABT/FDA might really be saying "let's not have the cart before the horse".
I think this is huge. Libigel is only for women with low T and there isn't a standard set for levels and testing? Hello!
The CDC wants to have accurate T testing in place by the end of 2012. This may be the elephant in the room that BPAX hasn't mentioned because it's out of their hands.
No wonder Abbott put up the cash. The FDA is all about data and quantification. They approved T for men because they had a serum standard set and levels could be measured before and after. The goal of treatment was simply to raise the level to an appropriate standard. Why would it be different for women?
Will Abbott make money on testing?
JTFM,
Remember the post about the Center for Disease Control making T testing a priority because low levels (women) can only be tested accurately at a handful of high tech labs?
Guess who's is paying for the Center for Disease Control's T lab upgrade project?
"The Hormone Standardization Project aims to address current challenges in clinical research, including lack of comparability of data across studies and measurement systems as well as lack of appropriate performance of assays, especially at low concentrations, such as testosterone levels observed in women and children. The project is a collaborative effort between CDC and others involved in hormone testing, test interpretation and use and is funded by a gift to the CDC Foundation from Abbott Products, Inc. (formerly Solvay Pharmaceuticals)."
http://www.cdcfoundation.org/what/program/testosterone-measurement-harmonization
Estratest was a pill containing both E and T. FDA pulled it because of efficacy not safety, according to this letter. Weird.
http://jamesasimonmd.com/forms/estratest_info.pdf
JTFM,
Nice digging!!!
I think this is describing a product that is a combination of (at least) estrogen and testosterone (possibly progesterone too).
In that Elestrin and other estrogen products are already commercially produced and readily available and are known to reduce hot flashes, paragraph 0007 is about T and E, together.
"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. "
A gel=one gel, right?
The extension trial after Bloom allowed estrogen. Perhaps the upcoming trial will too.
I wonder if Bio-T-Gels failure to launch (TEVA) could be due to logistics. This site tracks drug shortages and shows Paddock and Watson with no T cypionate injections and Paddock attributing the shortage to lack of raw material.
Remember the gel filling machine and the manufacturing and QA positions? Other web sites show both a shortage and unreliable vendors. Could BPAX be planning to provide their own raw material?
http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=638
Note the last sentence of the abstract:
"T therapy should become an integral part of hormone therapy in selected postmenopausal women in the future."
BTW: South Africa is one of the countries where we have product rights.
From Biotech Due Diligence(Chimera):
Licensed from Antares Pharma $AIS (click here for research page) for the following countries: U.S., Canada, New Zealand, South Africa, Israel, Mexico, China (including Hong Kong) and Indonesia. Owe regulatory and development milestones payments, 4.5% royalties, and 25% of sublicensing income to AIS. AIS also owns manufacturing rights and has the right to use BPAX's data in other territories (ie, the EU). Click here to read the entire redacted license agreement
New article. South Africa "gets it".
http://www.ncbi.nlm.nih.gov/pubmed/22757734
Thanks JTFM. This is a really interesting post, especially because our CEO sits on the board of Ceregene, a major Parkinson's Disease Research and Development Co. in which PBAX is a major investor and stands to profit with their success.
By the way, Ceregene has filled both of their advertised positions.
Jeff/PeteRose/Prof/JTFM et al:
Thanks and keep enjoying this hot summer. Headed to the beach for a few days w/ my sisters in Cape Ann, MA. My favorite rain or shine.
Bringing my kindle: great for reading, horrible for posting.
Go BPAX!
I realize that flibanserin is not testosterone-based, it's an anti-depressant, which is why the FDA rejected it stating that HSDD is physiological and not a psychological problem.
I was trying to add a little humor (but failed) in trying to say that once a woman's T levels were established the same outcome might be produce with a g&t (instead of F).
If F is approved for HSDD before Libigel, we are are headed back to the Victorian era. You can find me on the fainting couch.
This drug may have its place once testosterone levels are confirmed!
Once T levels are established, a gin and tonic might work just as well.
I hear the commercials promoting T for men. I haven't heard one for women.
Restoring testosterone levels is the point. That's why I think this article that I posted a while back is a big deal:
http://www.aacc.org/publications/cln/2012/June/Pages/Testosterone.aspx
Testing technology isn't widely available and what is available is often unreliable. It's amazing with all of the serum hormone level testing that is done, accurate testosterone testing is now being made a priority by the Centers of Disease Control.
Another study showing that testosterone improves lean body mass for post menopausal women (taking estrogen):
http://edrv.endojournals.org/cgi/content/meeting_abstract/33/03_MeetingAbstracts/S18-5
Jeff,
Thank you for sharing the email responses from the company. It was a great idea to share the questions that you were planning to ask ahead of time, so that anyone on the board could add their question or ask to modify one of your questions BEFORE you sent your email.
Again, thanks for sharing. Jadite
I believe it is still possible that the FDA will say that the new efficacy trials are unecessary once safety is established.
In the announcement of the new trials it was never stated that the FDA was REQUIRING a new trial.
"BioSante plans to initiate two new LibiGel Phase III efficacy trials to demonstrate the efficacy of LibiGel. This decision is based on an extensive analysis of previous efficacy data, consultation with key opinion leaders (KOLs) in female sexual dysfunction, testosterone therapy and placebo effects, as well as a meeting with the U.S. Food and Drug Administration (FDA)."
This post is from an old (questionable?) source but look who it's about...
This seems like his MO.
http://www.growthstockwire.com/1729/How-to-Make-10-Times-Your-Money-in-a-Single-Day
Jeff,
Someone may have already posted this but Ceregene is hiring:
http://www.ceregene.com/careers.asp
Jeff,
Thanks very much.
Tang wants the lowest possible share price, just like all of us. Probably has much better resources for calling that low price.
Jeff/Prof/JTFM,
If one of you are feeling generous, would you explain what this recent note conversion really means? Talk to me like I'm in the 7th grade. lol.
If this is happening, is the pps at the bottom?
Good morning fellow BPAX enthusiasts,
It was just about the money when PFE acquired Wyeth in 2009, although Abbott was also seriously courting. Interesting because Wyeth and Abbott also had competing RA products (Enbrel/Humira) although different chemical formulas which may make for a different situation, legally. Anyhow, PFE had the bigger offer, not to say that history must repeat itself.
http://blogs.wsj.com/health/2009/03/30/with-wyeth-gone-will-company-x-seek-another-deal/
I wonder who has the patent application(s) for testosterone for cognitive issues now that we know that Abbott is doing clinical trials (men/Androgel) and Susan Davis has been doing her research? Those applications can be submitted secretly and go unpublished. This is going to be a very interesting summer.
JTFM-Thank you for all the digging. It really appeals to my inner Nancy Drew! Jeff-Thanks for the Tang info. God luck everyone. Let's have a big week!