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"As these parasites are eliminated we will see a significant lowering of housing, oil and food prices which will result in more spendable money for most of us..."
jesse,
That says it all. I am more optimistic this morning than I have been in years. Bravo!
As to buying GTC ... well, not yet.
>I believe you don't reside in the USA, but you knew what he meant by lowering his cost basis.<
I believe Lewis resides in New Mexico ... one of the United States of America. (New Mexico will celebrate its centennial in 2012.) However, he does reside in an area of New Mexico that was once a part of The Republic of Texas.
vinmantoo,
I do not know if Genzyme interceded with the EMEA or not, although I doubt it, but I do know that your facts are not straight either.
The EMEA excluded some childbirth patients in the European trial because GTC changed the protocol (from what was agreed to) during the trial. After GTC appealed, the EMEA gave ATryn what amounts to a "conditional" approval, for indications other than childbirth, with the understanding that GTC would provide additional data when the U.S. trial is complete. As a result, ATryn is NOT approved for childbirth patients in the EU at this time. That probably accounts for some of the slow sales to date.
>I have no idea what you're referring to.<
Never mind, apparently I don't either. There was a case a couple of years ago before the Canadian Supreme Court that arose out of a dispute over data exclusivity in the context of a NAFTA agreement with the U.S. I must have been thinking of that.
OK, but I'm a simple guy too so I need a simple definition. How about:
"Biosimilars or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, following patent expiry."
This is from Wiki, so it probably isn't gospel but I can understand it.
I also understand the controversy over data exclusivity, but didn't the Supremes give a way to resolve that to no one's satisfaction ... which is usually the best resolution possible?
Go seek, look in the DEF 14K dated 4/4/08, page 26. I think he may have been an interim CEO at one time, but I'm not sure. The Proxy Statement lists the $236K as Director compensation. There is a separate table for Officers, but I don't remember him being listed as one for 2007.
>No––this is not the definition. Rather, the definition of a FoB is a biopharmaceutical whose regulatory approval relies, in whole or in part, on the clinical data of a similar drug.<
Now, there is a self-serving statement if I ever heard one. I would have thought the definition of a biosimilar would refer to the finished product, not to the process to arrive at the finished product.
>The author of that piece is deeply confused<
Dew,
It sounds like you are saying that anyone with an opinion which differs from yours is "deeply confused". At this point is not the definition of "FOB" effectively "after the patent expires"? The requirements for FOB approval are yet to be determined. She has her opinion of what those requirements should be, and you have yours. She may very well have a bias, but so do you.
It all boils down to whose ox is being gored. Let's hope Congress and the FDA will not let it be the patient's ox. (I say "hope" because "trust" is a little strong for either Congress or the FDA.) It will probably boil down to which side has the most effective lobby. Would you agree?
Bladerunner, apparently not. EOM
Let's see if I understand.
On March 17, AVAN did a reverse split. Their stock was trading at 63 cents.
On April 17, AVAN announced a partnership with Pfizer that provided $40 million upfront, milestone payments and royalties for a possible $390 million total.
On June 2, AVAN received an enormous amount of publicity when they announced doubling survival in some brain cancers.
So, split adjusted the AVAN pps went from $.63 to $1.49 in just 2 1/2 months.
Yep, it must have been the reverse split that caused it.
Fair enough. Thanks. EOM
Dew, a serious question ...
You said:
"You should tell this to Genentech. They just spent $250M to build the world’s largest biomanufacturing plant in Vacaville CA:"
Are you saying that Genentech spent the last 5 years building a plant that became obsolete before it was finished, or that the Crucell science is not such a big deal?
I'm not being sarcastic. I would like to know if Crucell is really competition for GTC.
Thanks.
I have no idea, but if you do a little research you will see a post that specifically asked Dew "if we have been leapfroged" (paraphrased). His answer was "definitely not, but we had better keep an eye on the competition" (paraphrased). (That was in response to the March 08 PR. I have quoted verbatim his response to the February 07 PR.) None of the responses in March 08, (total of 2 as I recall) support your statement that, "He and others didn't think it was significant back then."
As a footnote, the March 08 PR came out a few days after the GTCB pps did its back flip from .70 to .50 and the infamous insider sales took place. At the time, no one could explain the drastic decline in pps. Coincidence? Maybe, maybe not.
>He and others didn't think it was significant back then.<
Really? Maybe you should go back to February last year and see the original PR which Dew prefaced with, "Something for GTC investors to keep an eye on…"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=17050443
That's the one that got my original attention.
jesse, I've wondered about this myself, although I don't know enough about it to do anything but wonder. From the Crucell website:
"Proteins
Recombinant Proteins – Recombinant proteins, such as blood factors, can be produced efficiently and safely on the PER.C6® cell line.
Antibodies – MAbstract® technology is used to identify strong binding and neutralizing antibodies for specific disease targets. Antibodies discovered in this way can then be produced on PER.C6® technology."
http://www.crucell.com/Research
>The finances are very shaky as well.<
GNVC also has some promising vaccine programs with government contracts ... a particularly promising one for Foot and Mouth Disease. These help in mitigating cash burn.
Also, management has been adept in timing their financings utilizing a standing line of credit.
bladerunner, I'll give it a try.
I've been following GNVC since December, 2006, when it reported promising preliminary results for TNFerade in pancreatic cancer. The stock price appreciated nicely for a few months, until their ASCO presentation last June. ASCO was underwhelmed, to put it mildly. Since then the stock price has lost most of its gains. I left where I came in to sit on the sidelines for awhile.
The "problem" as I see it ... and I am no kind of authority ... is administering TNFerade directly into the tumor. It is an invasive procedure, which makes it difficult to enroll patients, which drags the trial out forever. In the meantime, the SOC's are improving, which raises the bar for TNFerade. It looks like GNVC is perpetually chasing its tail.
The pancreatic Phase III trial (PACT) may get another preliminary look late this year. The hope ... and it is only a hope ... is that the results this time will be stat sig and the trial will be halted for an early FDA approval.
The esophageal Phase I/II preliminary results reported yesterday had the same problem. I suppose the data look good, but there are insufficient patients to be stat sig.
I think the science is promising, but I'll wait for some definitive results before possibly getting back in. If that causes me to miss out on some possible gains, so be it. (GTCB taught me a lesson.)
There is some good information on the GNVC Yahoo Board, believe it or not. It won't take long to identify the knowledgeable posters ... and there are quite a few.
>I do not think wjlknew and johnbits are the same person.<
I'll assure they are not!
I'm confused.
Are "many" watching and "they" focusing, or are "many" and "they" watching AND focusing? I suppose we'll have to wait for the "many say" after the watching and focusing lead to some conclusion.
Back to the grill ... what "many say" is a BBQ.
Seriously though, remember today the MANY heroes who gave their all so that we may enjoy this holiday with our friends and families. What THEY did for us should never be forgotten.
Have a good Memorial Day all.
johnbits, you make some excellent points. On the subject of NABI, you said:
"NABI has the cash to support GTCB programs, but what will NABI want in terms of a deal? This would be structured almost the same as a straight equity investment, there does not appear on the surface to be any synergies between NABI and GTCB. They could save on Cox's salary at NABI. So would the deal get done at 44 cents, higher or lower, great question, GTC does not appear to be in a position of bargaining strength"
My only reason for throwing NABI into the mix is that their BOD is talking like they would like to retire. They have a lot of cash from the sale of half the business and have indicated they would not be adverse to selling the other half ... the vaccines against nicotine addiction and staph infection, which are in Phase II I think. You are correct in that a deal, if any, would probably be structured like a straight equity investment, but my impression is that NABI might like it that way. They could merge and then go fishing while GTC continues on.
Given that Cox is the Chairman of the BOD of NABI and one of the other directors (Castaldi) was the founder of BioSurface Technologies (which was devoured by Genzyme), maybe NABI is in a position to be the white knight ... especially if Cox and Castaldi have any misgivings toward Genzyme, which I have no knowledge of but some on the board will know I'm sure. Also, NABI apparently hasn't much to do with their cash because they have embarked on a stock buy back program. (When was the last time you saw a small biotech do that?)
Just a thought.
Unless it's the Tooth Fairy, a "finance only" partner will uudoubtably want something in return. If the "something" is interest, it's called a loan (like GE). If the "something" is a piece of the pie, it's called a partnership (like Leo and LFB). If the "something" is stock to play with, it's called a placement (like take your pick).
(I would think "silent partner" has no place in a public company.)
What other possibilities are there? Well, there is a buyout either by another public company or a private entitity to take it all private.
Or there is a merger vis-a-vis Genzyme and BioSurface Technology.
My vote goes to the merger ... Genzyme, Pharming, Pharmathene, whoever. However, if it was my decision to make I would try for the RS instead ... to reload for more financings/dilutions until some milestones are met.
Disclosure: I am not presently a stockholder so I can be a little more objective, but I may become a stockholder again ... depending on how this all plays out. My concern at this point is that Genzyme will play Pacman and leave stockholders wondering what hit them.
cro, that was said tongue-in-cheek. Of course he won't do it. Actually, I think it more likely that he will be out the door with another $1.3 million or so in his pocket from his golden parachute. At least, I hope so.
Where do you apply to become a member of the Director/Officer set? What a racket.
(There is an article in our local paper this morning about American Airlines raising fares, adding fees for all sorts of things, laying off thousands of employees, cutting domestic routes .... oh, and by the way, raising management'a option bonuses. I am definitely in the wrong business.)
It would be difficult for Cox to take a cut. I see from the Proxy that his total 2007 compensation from GTCB is only $645,118. Add his total 2007 compensation from NABI of only $236,800 for chairing their Board of Directors and you can see the man is almost destitute. (I hope he doesn't have to pay his own expenses for the annual Monte Carlo trip.)
Maybe he will voluntarily forgo his annual increase for 2008. That would help.
>The fact that the RS-authorization proposal doesn’t adjust the number of authorized shares is indeed irrelevant from a practical standpoint.<
I guess we are hung up on semantics. To me, the above statement is relevant because future financings are easier to accomplish. I think we're saying the same thing.
>Pharming is cash-rich too.<
That they are, but Pharming has a lot on their plate right now. Nabi on the other hand came into a pocket full of cash about the same time Pharming received their bad news. Nabi is also apparently anxious to find a date for the prom. Maybe the Chariman of their BOD has an available daughter?
Maybe Cox will convince NABI to come to the rescue and the RS will be moot. NABI made it public a few months ago that they are interested in being acquired/merged/partnered/whatever ... and NABI has almost $200 million in cash.
johnbits, you should be ashamed ... "misquoting" Dew in your irrelevant post. Of course, your post is entirely relevant, from a practical or any other standpoint.
What it boils down to is the existing stockholder would have a smaller piece of a larger pie, while the company and its management could keep on keeping on indefinitely. (In your example, existing shares could eventually be worth anywhere from 10 cents to 50 cents pre-split adjusted. Of course that, or less, looks like what they will be worth without the reverse split.)
To be honest, if I was management I would go for the reverse split too. What choice do they have ... outside of a takeover by some entity with deep pockets to see them through the next three years of insignificant revenues. Atryn HD revenues ain't gonna cut it (it took 2 or 3 years to get 31 Phase III patients), and at this point a Leo type partnership will be nothing more than a band-aid.
Thanks, jesse. EOM
jesse, as a doctor I would be interested in your take on the following, which was posted by HobGlobulin on the Biotech Values board a couple of days ago:
http://genengnews.com/news/bnitem.aspx?name=35835163
>> May 18 2008, 1:48 PM EST
Ashwell receptor reduces mortality during sepsis
Contact: Debra Kain
ddkain@ucsd.edu
619-543-6163
University of California - San Diego
In research that solves the longest-standing mystery in glycobiology a field that studies complex sugar chains called glycans researchers at the University of California, San Diego School of Medicine have discovered that a molecule in the liver of all animals, called the Ashwell receptor, is critical in helping the body fight off the abnormal and lethal blood clotting caused by bacterial infection. Until now, it was suspected that this receptor might serve to remove abnormal proteins from circulation, but it wasnt understood which proteins were affected or what biological purpose this receptor served.
The study, published online in advance of publication in the June issue of Nature Medicine, shows that the Ashwell receptor plays an essential role in reducing coagulation abnormalities during infection and sepsis, significantly improving the probability of survival.
Sepsis, a life-threatening complication of bacterial infection in the blood, remains a major cause of death worldwide, according to the studys principal investigator, Jamey Marth, Ph.D., UCSD Professor of Cellular and Molecular Medicine and Investigator with the Howard Hughes Medical Institute. One of the major factors contributing to death in patients with sepsis is a condition called disseminated intravascular coagulation, which accelerates blood clotting.
UCSD researchers discovered that a protective response, triggered by the Ashwell receptor in the liver, limits this lethal side effect by reducing the levels of circulating blood coagulation factors, including platelets.
The bacterial pathogen Streptococcus pneumoniae (pneumococcus) is a leading cause of sepsis, especially in the young, the elderly and the immuno-compromised. The pneumococcus makes an enzyme called sialidase, which removes sugar molecules called sialic acid from host cells, and helps facilitate spread of the pathogen through the body. Using a mouse model of sepsis, the researchers found that the pneumococcal sialidase also removes sialic acid from circulating host factors involved in blood coagulation, including platelets and a glycoprotein called von Willebrand Factor (vWF). When this occurs, the Ashwell receptor recognizes the change in the glycoprotein structure and removes those pro-coagulation factors from circulation before they can cause increased blood coagulation.
The researchers made a breakthrough when they discovered that platelet counts and vWF that are reduced during pneumococcal infection remained high and unchanged in the absence of the Ashwell receptor. Pivotal results came when mice lacking the Ashwell receptor developed severe tissue and organ damage due to increased coagulation and died at significantly higher frequency and more rapidly than expected.
This finding contradicts the prevailing notion that the low platelet count of sepsis is due to the consumption of coagulation factors caused by the pathogen and is therefore harmful, said Marth. Rather, this low platelet count is due an adaptive response by the Ashwell receptor that is beneficial by reducing tissue damage and organ failure and thereby improving the chance of survival.
More than 35 years ago, researcher Gilbert Ashwell and colleagues discovered that the liver controls the removal of proteins in the bloodstream. The Ashwell receptor also known as the hepatic asialoglycoprotein receptor was the first glycan-binding receptor, or lectin, ever discovered in animals.
The Ashwell receptor is turned on after birth, and this was a clue that it is needed for environmental and pathogenic challenges, said Marth.
This research provides a whole new way of thinking about coagulation problems in sepsis produced by pneumococcus and related pathogens said Victor Nizet, M.D., UCSD professor of pediatrics and pharmacy whose laboratory assisted in the study. Drugs designed to support the normal capabilities of the Ashwell receptor in the liver would represent a new approach to limiting mortality in these life-threatening conditions.
###
Additional and important contributors to the study include lead author Prabbjit K. Grewal, at the Howard Hughes Medical Institute and UCSD Department of Cellular and Molecular Medicine; as well as Satoshi Uchiyama, at the UCSD Department of Pediatrics; and David Ditto, Nissi Varki, and Dzung T. Le in the UCSD Department of Pathology.
Funding for the research was provided in part by the National Institutes of Health. Dr. Marths work is further supported by the Howard Hughes Medical Institute. <<
You can assume anything but that is very dangerous. Unfortunately, many investors assume too much and fall into the trap of wishful thinking.
Just for the record ...
I am not negative anything but the company itself. To the contrary, I think the science (ip, whatever you wish to call it) offers more opportunity than anything else I can think of. What I am negative on was watching my dead money decompose.
I will be an intent spectator until at least some of the uncertainty is gone.
I understand all that, but ...
The problem is that someone having the right of first negotiatin can be an impediment to negotiations with other parties. In your example, while Abe and Carl are trying to reach an agreement all other prospects are blocked out, and that is not good. It is particularly not good in GTC's case because time (spelled money) is running out on them.
A right of first refusal, as opposed to a right of first negotiation, woud be better for GTC. However, even that has a chilling effect on other negotiations. Ask any real estate agent.
Moreover, GTC even says as much in their last 10-K.
Help me, anyone.
"First Negotiation Right for Commercializing ATryn®
If we choose to commercialize ATryn® with a marketing partner outside of Asia, Genzyme has an exclusive first right of negotiation for exclusive commercialization rights. This right is triggered on an indication-by-indication basis at such time as we apply for marketing approval with a regulatory authority. This right does not apply if we have already entered into a collaboration or other agreement with a prospective research, development and marketing partner prior to such regulatory submission. It also no longer applies to the LEO territories."
According to the above, GENZ will have an "exclusive first right of negotiation for exclusive commercialization rights" for ATryn if GTC has not partnered with someone else by the time the a BLA is submitted for each indication ... outside of Asia and the Leo territories.
This is certainly not new news, but it would appear to be more important every day, since GTC plans to complete the BLA submission in July, and there is no partner in sight at this time. (Since the BLA is a rolling submission, I wonder if GENZ could argue that GTC has already "applied for marketing approval" without a partner.) At the least, it looks like GTC is in a real bind ... either take whatever deal comes along from a prospective partner (if that is still an option), or negotiate with GENZ like it or not, or delay completing the NDA submission (if that is still relevant)... all with nearly empty coffers.
Am I reading this right? If so, could GENZ be the eventual winner in this little drama ... assuming LFB would hold still of course? Any thoughts?
I think you answered your own question: "Apparently investors feel JAV will deliver."
And, JAV's pps has gone up over 40% in the week since the placement ... in which the JAV's management participated ... was announced.
Hi jesse. You may call me wj. Of course you're not all wrong, but you do tend to stretch it a little on occasion.
I didn't say GE would not like their money back, only that they would not suffer terribly if they do not get it.
If Leo's collaboration with GTC is not a loser, tell me how much profit Leo has made to this point.
Pharmathene may or may not make another transgenic protein, but at any rate their contract with GTC is over in a few months (sometime in the third quarter this year). I'll bet PIP is already making other arrangements for processing their product. However, if Protexia ia a commercial success, GTC (or its successor) WILL receive a royalty from the license.
The thing some of you guys don't seem to realize ... or want to admit ... is that a GTC bankruptcy will NOT cause all their assets to go poof. Someone else will pick up the pieces and deal with whoever is still interested ... like Merrimac for instance.
Just hope the GTC stockholders will get a few crumbs. That is not a slam dunk.
jesse, I respect your opinions but ... in the interest of accuracy ...
The money GTC owes is not even pocket change for GE. Leo could probably walk away from ATryn and save money at this point. I suppose Merrimac is dependent for their product, but GTC does not provide product for LFB or Pharmathene (for Protexia). The LFB collaborations are all still pre-clinical and Pharmathene receives only consulting services from GTC. (Pharmathene has their own goat herd.)
Maybe Merrimac will pull GTC's chestnuts out of the fire.
jesse, drunk or not doofus is probably right.
""we now have broader interest from additional potential partners"
My guess is that GTC is now "negotiating" with a potential "partner" who wants to buy all or part of the operation.
GTC's only alternative is the RS and further placements to stay afloat from one placement to the next. (The prelim proxy clearly states the reasons for RS authorization are to avoid delisting and to facilitate future financings.) The problem with this is by the time there is enough revenue to avoid further placements, the existing shareholders will be diluted into oblivion.
If the RS authorization fails, GTC is out of options. The fire sale is on, or else.
Also, I have not seen anyone comment that Leo is in the driver's seat with Atryn until after FDA approval in HD ... which is anticipated after the present financial crisis is past, one way or the other, and is not lucrative enough to allow GTC to stay afloat anyway. Remember, Leo owns the EMEA approval ... GTC transferred it to them. Leo also owns the Phase II trial for AD ... GTC may only see the data ... and Leo can presumably continue into Phase III and beyond in Europe, the Middle East, and Canada, with or without GTC. The only card GTC holds with Leo is control over the product itself. Leo is certainly aware of GTC's plight, and that may explain their slow progress to date.
LFB, on the other hand, is the 800 pound gorilla in influencing how any shareholder vote goes.
And, even if there is a conventional partnershipe for Atryn in the U.S., any reasonable upfront payment will only put off the inevitable. (I'm sure there are any number of potential partners who would be willing to buy lunch in return for a piece of the pie ... but probably would not be willing to offer much more in this environment.)
There are sevetal possible scenarios, but they all hinge on the RS authorization. That may be why Cox has put off any decision with a "second choice partner" until after the annual meeting. I think the current GTC management desperately wants the RS to happen so they can keep on keeping on until they run out of options.
All this uncertainty is why I chose to become a spectator until the smoke clears. I can testify that role is infinitely more relaxing than being a player. Let the games begin.
oldberkeley,
You asked, "I'm assuming you're leaving with a loss. It's totally OT, FWIW, and something no one is ever proud of, but would you mind giving an approximate percentage"
I don't mind in the least. I sold out this morning at probably a 30% loss on that position, which I acquired over the past two years to replace about 3/4 of a position I had the good judgement to sell out the day before ATryn was rejected by the CHMP in February, 2006. Today's loss was more than offset by that sale two years ago.
I decided to sell out that day in 2006 because things just did not smell right. There had been delays in getting the CHMP decision, and the delays had been explained away by some hard to believe excuses. Does that sound familiar? As it turned out, the delays were caused (through ignorance, arrogance, or both) by GTC changing the protocol in the middle of a Phase III trial. The real story was not disclosed to shareholders until after the damage was done. GTC appealed the CHMP decision and got it reversed ... with the limitation that Atryn cannot be utilized in childbirth in Europe until more data are submitted. As a result Leo has a very limited market in which to sell HD Atryn in Europe at this time, which might explain the disappointing revenues to date.
The stock price took a 100% haircut the next day and never did recover. My perception of management's credibility also took a 100% haircut the next day and never did recover either.
I sold this morning for three reasons. First, I don't think there will be a lucrative partnership anytime in the near future. Second, I think the reverse split (1:4 or 1:5) is an absolute certainty, and for Cox to say otherwise is an insult to our intelligence. Third, I think the reverse split will allow management to begin another series of dilutive financings which will be desperately needed to stay afloat, with or without a partnership, because there will be hardly any revenue for the next two years. (I think the only thing that will change the above is either a buyout or merger, but I am not willing to wait any longer for that possibility.)
If history teaches us anything, the net result in two years or less will be a share price about where it is today, with each of today's holders having significantly fewer shares.
Count me out of that scenario. I will watch the company for the next two years and re-evaluate my position at that time ... IF they are solvent and profitable.
Again, good luck. Maybe I'll be wrong. If so, it won't be the first time. (I can recount other stories where I did not come out as well.)
I am old enough and experienced enough to know when I am being bullshitted. If I thought there was a chance this company would be bought out, I would probably hang in there. However, I am convinced the current management will hang on until the bitter end to save their lucrative jobs ... or at least so long that the company is worthless.
I am gone! Good luck.