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I've thought that might be the case but what kills me are the dates on the applications. One of those applications was filed AFTER the CV and the commercial production applications.
Even if there were hard feelings shouldn't the website reflect all products and partnerships in the pipeline for the sake of accuracy to shareholders? I think something else is going on.
AND...
if the partnership is "soured" we are certainly entitled to that announcement. And isn't Libigel by definition 300 mcg of T in Antares' fancy gel?
Last December, when the share price crashed I found it very odd that Antares Pharma (our Libigel partner) removed the product from their website in spite of the fact that BPAX had announced their intention to pursue product approval and continue safety trials (with the FDA's blessing). It is just as odd that Libigel approval is still being sought and our CEO never mentions Antares Pharma (even on the website). Why the silent treatment? Are these two companies not on speaking terms or is it something else?
I find these 2 patent applications real head-scratchers especially because they are RECENT applications that are collaborations between the 2 companies: Simes and Lehman inventors for both, Antares assignee for both.
Discussion on the ATRS board (I am a shareholder) often speculates about the identity of a mystery product alluded to by the CEO that will be a PFE/ATRS partnership. Could the real secret be that we are part of that partnership as well?
Your thoughts...
http://www.freepatentsonline.com/y2011/0319376.html
http://www.freepatentsonline.com/y2011/0245215.html
When BPAX rallied in May it may have been from good news from one of its hidden "nuggets". I don't think this article was posted before and I wanted to remind everyone to check on Ceregene periodically. Thanks.
http://blog.michaeljfox.org/tag/ceregene/
I am keeping a positive view about Libigel. I believe we will be approved eventually and I will hold (at least) until then.
Testosterone performs many functions in the body and if we can prove a SAFE delivery to restoration levels we will be approved. Improvements in sexual functioning may be "modest but MEANINGFUL" (Dr. Susan Davis). That is still very important to the women involved.
TY for this info. I wondered about manufacturing rights. JTFM noted that it has been outsourced.
iclight,
One might assume that women seeking T prescription renewals from their doctors have found the hormone replacement efficacious.
Also from the FDA:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107836.htm
GLTA
Yes.
Do you have a good handle on the details of Elestrin?
Marketing rights belong to Jazz, yes? If sales increase exponentially, BPAX gets a huge royalty, yes?
What about manufacturing rights? I couldn't find anything. Currently manufactured by Jazz?
Can BPAX still manufacture?
Thanks.
I've tried to compose this post twice already but then I get distracted and it times out...
When Sandra Croak-Brossman came on board I thought Pfizer might be interested because of her expertise with the Viagra launch. Then came the crash and she was retained (which gave credibility to Libigel IMO).
Then, as JTFM mentioned, PFE financed the big article in Menopausal Medicine, a publication to educate doctors!
I think PFE might also be interested in Elestrin. PFE has a product Premarin that has been around forever as a treatment for hot flashes. On their website they claim it is the #1 prescribed estrogen, blah blah blah, but I wonder. I don't know anybody taking Premarin. It is made from horse urine and most women are horrified when they find out. Most women prefer estrogen products from plant sources. Animal rights groups have been on Pfizer about this for years.
Women who have had a hysterectomy can safely take estrogen without progesterone and Elestrin is a superior product that just hasn't had good marketing. IMO
Divigel is comparable to Elestrin but costs a fortune.
http://www.pfizer.com/files/news/HTT_BC_statement_031512.pdf
http://tuesdayshorse.wordpress.com/2012/01/05/premarin-and-the-ugly-truth-behind-the-label/
Nice clarification.
Any thoughts on the BPAX/ATRS relationship or lack thereof?
Prof,
Way back when, when AIS and BPAX were Libigel partners, the disorder was called HSDD.
http://www.biosantepharma.com/News-Releases.php?ID=081309b
Neither company mentions the other today and the disorder needing treatment is referred to as "FSD" (website).
If Libigel (300 mcg of T in a fancy suspension) gets an NDA for FSD and is eventually approved, AIS (now ATRS) gets big royalties for the patent(s) they hold, yes?
If Wellgel, Memorygel, Cardiogel, (300 mcg of T in a fancy suspension) gets an NDA for other health problems and is eventually approved, ATRS is out of the picture, yes?
Company could be waiting for patents.
Your thoughts??
Women already have access to T in most other countries.
This doctor is talking about what he gleaned from the Menopausal Medicine article (watch to the end).
If OB/GYN's have been reassured by that major article (google Menopausal Medicine Testosterone if you haven't read it) and are now PRESCRIBING off-label to a greater degree, we have a homerun!
http://kplr11.com/2012/06/05/testosterone-use-in-menopause/
By the way: Nobody is getting a deep voice or a beard from 300 mcg of testosterone. It is a tiny amount.
I don't believe the company wants to keep the price down. I think we are just stuck in the Bermuda Triangle for a while until real news arrives.
I think the company is trying to throw us whatever bones they can legally throw with info on the website about jobs, their intention to begin new efficacy trials, etc: all the pieces that we have tried to glue together. I'm actually not convinced that the new efficacy trials are required. The company has been so vague about the details. I've considered that they are just using that announcement as a way to tell us that 300 mcg of testosterone in a fancy time release gel is alive with more news to follow (called safety data).
The share price is low, granted. But let's face it, the share price was just as low before the r/s.
We just recieved non-specific news via Marketwire (for at least the 3rd time) that big pharma is in trouble with patent expirations and BPAX is ripe with patents. I believe big pharma wants our patents, 3 of which are still just applications, and of course, any of that conversation is mum.
The gel machine/new positions: another possible angle
There has been a testosterone shortage for a while with companies unable to procure "the raw material" due to manufacturing violations cited by FDA.
Testosterone cypionate is a viscous gel. Maybe Biosante is planning to manufacture the raw material RELIABLY to sell to other vendors while waiting for their approvals.
If so, smart move.
http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=638
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm281843.htm
http://genderoutlaw.wordpress.com/2012/02/20/sandoz-suspending-production/
interesting. Thanks.
From the website:
The Pill-Plus United States patents for oral use are licensed by BioSante to Pantarhei Bioscience, a Netherlands-based pharmaceutical company, for development and marketing in the United States. BioSante retains rights to the Pill-Plus for transdermal development and marketing.
Hi Jeff,
Nothing is obvious. Gearing up for Libi production for foreign markets before there is approval in the States?
I actually think that negative findings on recent research on the use of standard oral contraceptives might be creating an urgency to approve the Pill Plus but we haven't heard anything from our company. IMO that product is the real sleeper!
Jadite
I've been away from the MB's.
Did someone already post that 3 new position searches were added to the website yesterday? All high level VP's.
http://www.biosantepharma.com/Careers.php
It's not what is happening with Biosante. It's a larger issue.
What would happen if Libigel was approved now: A post menopausal woman goes to her OB/GYN and complains about lack of libido, wondering if Libigel was an option and asks to have her T level checked. Doc Response: We don't do that at your age. You have ovaries.
Some women (even post surgical) are told that their adrenal glands should be producing enough. Not quantified.
If the woman had no ovaries, the doc will assume that the levels are low.
All over the country men are having their T levels checked. All men, not just those post-surgical. More easily tested with naturally higher levels.
Just because Biosante was able to test for serum levels for their trials does not mean that the average woman and her doc have access at this point to the same testing.
The positive point of the article is that testing will be available, standards will be set and testosterone testing (vs other hormones) has been made a priority.
Maybe OUR company and OUR product has prompted this!
Did you guys read this article? Please see my post from last night.
I woke up this AM wondering if the FDA is dragging it's feet because testing labs are unavailable. The inability of lab equipment to quantify tiny amounts of serum testosterone (even at normal levels 7-25 ng/dL)is beyond the scope of the Libigel trials, yet, a critical factor in the "safety" equation.
http://www.nlm.nih.gov/medlineplus/ency/article/003707.htm
The articles cites Vitamin D testing as an example. Very few doctors were testing those levels 5 years ago and now that levels can be quantified and compared to a standard, testing is done routinely, which has lead to an explosion of Vit D supplementation.
This might be a hardware (or maybe software)problem.
lol.
I know that and I appreciate your posts!
JTFM,
I know lots of women who have compounded scripts. Many haven't had hysterectomies either. Just symtoms.
We just need continued patience. This will be a huge success.
Hang in there!
I'm not at all discouraged by the news. There is NO WAY Libigel would be scrapped at this point.
I think what happened to the sp is a lttle discouraging.
I am trying to research the # of compounded scripts written for T in my state (NY) and you'd think I was asking for the combination to open Fort Knox. My hunch is the # is exploding! Writing scripts for non FDA approved anthing makes doctors uncomfortable. They are also uncomfortable when their patients are crying and begging for this unapproved med that works.
Doctors want this. It will happen. Anyone with shares is out of their mind to dump them now.
Perhaps our extensive safety data analysis was a strong influence to prompt the Center for Disease Control to create a Hormone Standardization Program beginning with testosterone.
According to this journal article, only 6 institutions hold the certificate that indicates they can accurately measure serum testosterone levels. Accurate testing is already available for estradiol.
Women without ovaries needing testosterone is no-brainer. Soon accurate testing will be available for others.
http://www.aacc.org/publications/cln/2012/June/Pages/Testosterone.aspx#
Hey, today was discouraging but there is so much encouraging news about the importance of testosterone for women and men.
Does that mean Biosante could use Intrinsa efficacy data for NDA since the FDA was content with that but wanted additional safety data?
P.S. Thank you all for talking everyone off the ledge with the r/s.
I hope everyone anxting about what to do Monday realizes that Friday's Seeking Alpha article was all about getting hold of our shares on the cheap! It ain't happenin'.
GLTA
I hadn't considered that!
The Florida Legislature passing a resolution about the importance of the hormone controlling libido is just funny on so many levels.
The important question is whose money backed the resolution to promote screening and the subsequent writing of scripts. That is where the good news comes in.
Bio-T-Gel! And then women will get their own resolution.
You may not be aware of this but it is Low Testosterone Awareness Day in the State of Florida. I believe that we have picked the correct hormone to invest in.
http://www.myfloridahouse.gov/Sections/Bills/billsdetail.aspx?BillId=49074
http://www.myfloridahouse.gov/Sections/Documents/loaddoc.aspx?FileName=_h9061__.docx&DocumentType=Bill&BillNumber=9061&Session=2012
That was an inspiration Sunday morning post. Because I've ventured here I guess that makes me a shark, which begs the next question: What happens to the slowest, dumbest sharks?
lol
Good luck to all of us next week!
Jadite
Hi Prof/Jeff/JTFM,
Is Testim's new patent a threat to Abbott which could be a(real or perceived) threat to Bio-T-Gel? I wondered if this could be a factor in today's action.
http://www.sacbee.com/2012/05/17/4496478/auxilium-pharmaceuticals-inc-and.html
http://www.freepatentsonline.com/8178518.pdf