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PLX - I see that Protalix will be manufacturing the drug and are expanding their manufacturing capabilities (est cost of $25M). I'm going to call IR tomorrow to discuss this further. I'd like to know where they stand with this and if the $25M is all on them or all/some to Pfizer too.
PLX - I saw in there that they expect a decision sometime in 2011 for each country and are filing to ROW. I really liked seeing that the French gov't paid for the treatment of their patients and allowed a temporary approval. The fact that countries around the world are already using the drug is pretty big.
PLX - in addition to the upcoming U.S. PDUFA catalyst, they filed for regulatory approval for Taliglucerase alfa in.....
Israel June, 2010
Europe, November, 2010
Brazil, November, 2010
Does anyone have any idea how long the process takes in each of these 3 countries? Each of these will also serve as catalysts.
PLX - unlike ABT w/DEPO, Pfizer does have PLX's drug mentioned on their website....see page 10 of 22
http://www.pfizer.com/files/research/pipeline/2010_0927/pipeline_2010_0927.pdf
In addition, Pfizer has global (except Israel) rights to Taliglucerase alfa. Anything is possible, but I feel that this relationship is on sturdy ground, so I don't think we'll see a repeat of what we just went through with ABT/DEPO.
HGSI ($24.17) - looks like she's starting to reverse here.
Human Genome Sciences (HGSI $23.85) - watching closely for a reversal here. They have a PDUFA of March 10, 2011 for Benlysta for Lupus. If approved, Benlysta would be the 1st new drug for lupus patients in 50 years. GlaxoSmithKline(GSK) will co-market Benlysta. The FDA's approval decision date was pushed back three months from Dec. 9, 2010.
PLX - I read that there is some bad blood between this guy Dr Frost, the one who is selling his shares, and PLX. Heard he got mad when they didn't go with TEVA for taliglucerase alfa and chose Pfrizer instead. No idea if this is true, but it's clear he's been unloading his shares. We'll need to continue to watch his selling and looking forward to him being out of shares.
Some PLX DD:
Protalix BioTherapeutics, Inc. (AMEX:PLX & Tel Aviv Stock Exchange)
http://www.protalix.com/ http://stockcharts.com/h-sc/ui?s=plx
Current PPS: $9.44
1st Resistance: $9.61
2nd Resistance: $9.78
1st Support: $9.29
2nd Support: $9.14
Short Interest: 5,588,700 (about 9.4% of float)
O/S: 81,211,718 (+ S3 Reg on 1/10/11 for $150M of common stock)
Cash: $44M in cash as of the last 10Q with a burn of $12M per Q
About:
We are a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based
on our proprietary ProCellEx™ protein expression system. Using our ProCellEx™ system we are developing a pipeline of proprietary
recombinant therapeutic proteins based on our plant cell-based expression technology that target large, established pharmaceutical markets and that rely upon known biological mechanisms of action. Our initial commercial focus has been on complex therapeutic proteins, including proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. We believe our ProCellEx™ protein expression system will enable us to develop proprietary recombinant proteins that are therapeutically equivalent or superior to existing recombinant proteins currently marketed for the same indications.In addition, we believe our ProCellEx protein expression system will enable us to express and produce bio similar or "generic" versions of other
recombinant proteins not protected through patents in a cost effective manner. Because we are targeting primarily biologically
equivalent versions ("Biosimilar versions") of highly active, well-tolerated and commercially successful therapeutic proteins,
we believe our development process is associated with relatively less risk compared to other biopharmaceutical development
processes for novel therapeutic proteins.
Technology:
ProCellEx™ is our proprietary production system that we have developed based on our plant cell culture technology for the
development, expression and manufacture of recombinant proteins. Our expression system consists of a comprehensive set of
capabilities and proprietary technologies, including advanced genetic engineering and plant cell culture technology, which
enables us to produce complex, proprietary and biologically equivalent proteins for a variety of human diseases. Our protein
expression system facilitates the creation and selection of high expressing, genetically stable cell lines capable of
expressing recombinant proteins. The entire protein expression process, from initial nucleotide cloning to large-scale
production of the protein product, occurs under cGMP-compliant, controlled processes. Our plant cell culture technology
uses plant cells, such as carrot and tobacco cells, which undergo advanced genetic engineering and are grown on an industrial
scale in a flexible bioreactor system. Cell growth, from scale up through large-scale production, takes place in flexible,
sterile, polyethylene bioreactors which are confined to a clean-room environment. Our bioreactors are well-suited for plant
cell growth using a simple, inexpensive, chemically-defined growth medium as a catalyst for growth. The reactors are custom-designed and optimized for plant cell cultures, easy to use, entail low initial capital investment, are rapidly scalable at a low cost and require less hands-on maintenance between cycles. Our protein expression system does not involve mammalian or animal components or transgenic field-grown, whole plants at any point in the production process.
Our ProCellEx™ system is capable of producing proteins with an amino acid structure practically equivalent to that of the
desired human protein, and with a very similar, although not identical, glycan, or sugar, structure. Our internal research
and external laboratory studies have demonstrated that ProCellEx™ is capable of producing recombinant proteins that exhibit
a glycan and amino acid structure similar to their naturally-produced human counterparts. In addition, proteins produced by
our ProCellEx™ system maintain the biological activity that characterizes the biological activity of naturally-produced proteins.
In collaboration with Israel's Weizmann Institute of Science, we have demonstrated that the three-dimensional structure of a
protein expressed in our proprietary plant cell-based expression system retains the same three-dimensional structure as
exhibited by the mammalian cell-based expressed version of the same protein (Shaaltiel et al, Plant Biotechnology J. 2007).
Based on these results, we believe that proteins developed using our ProCellEx™ protein expression system have the intended
composition and correct biological activity of their human equivalent proteins.
The Catalysts:
#1: On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to develop and commercialize taliglucerase alfa. Under the terms of the agreement, Pfizer received exclusive worldwide licensing rights for the commercialization of taliglucerase alfa,
while Protalix retained the exclusive commercialization rights in Israel. Upon FDA approval $25M payment to PLX and another $25M for European approval. 60/40 profit sharing (40% to PLX).
Taliglucerase alfa was granted orphan drug designation by the U.S. Food and Drug Administration. A New Drug Application (NDA) for taliglucerase alfa has been accepted by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011. They are also working with the FDA under a Special Protocol Assessment (SPA).
Taliglucerase alfa is available to patients with Gaucher disease in the United States under an Expanded Access protocol as well as to patients in several member states of the European Union, Israel and other countries under Named Patient provisions.
#2: Monday November 29, 2010 Pfizer Inc. (NYSE:PFE - News) and Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX, TASE: PLX)
today announced the submission of a Marketing Authorization Application to the European Medicines Agency for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD)for the treatment of Gaucher disease. Taliglucerase alfa was granted Orphan Designation by the European Commission for the treatment of Gaucher disease on March 23, 2010.
What is Expanded Access Protocol?
Answer 1: Expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a
patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment
options.
FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial. They also permit expanded access for large groups of patients who do not have other treatment options available, once more is known about the safety and potential effectiveness of a drug from ongoing or completed clinical trials.
Just as in clinical trials, these investigational drugs have not yet been approved by the FDA as safe and effective. They
may be effective in the treatment of a condition, or they may not. They also may have unexpected serious side effects. It
is important for you to consider the possible risks if you are interested in seeking access to an investigational drug.
Answer 2: Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances,
to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess the safety and efficacy of new drugs. Data from these trials are used to determine whether a drug is safe and effective, and serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these controlled trials because of other health problems, age, or other factors, or are otherwise unable to enroll in such trials (e.g., a patient may not live sufficiently close to a clinical trial site).
For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug, FDA regulations enable manufacturers of such drugs to provide those patients access to the drug under certain situations, known as “expanded access.” For example, the drug cannot expose patients to unreasonable risks given the severity of the disease to be treated and the patient does not have any other satisfactory therapeutic options (e.g., an approved drug that could be used to treat the patient's disease or condition). The manufacturer must be willing to make the drug available for expanded access use. The primary intent of expanded access is to provide treatment for a patient’s disease or condition, rather than to collect data about the study drug.
Some investigational drugs are available for treatment use from pharmaceutical manufacturers through expanded access programs
listed in ClinicalTrials.gov. If you or a loved one is interested in treatment with an investigational drug under an expanded
access protocol listed in ClinicalTrials.gov, review the protocol eligibility criteria and inquire at the Contact Information
number. If there is not an expanded access protocol listed in ClinicalTrials.gov, you or your health care provider may contact
a manufacturer of an investigational drug directly to ask about expanded access programs.
For additional information on expanded access programs, please see the FDA website at
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/default.htm .
For instructions on viewing all expanded access programs listed in ClinicalTrials.gov, see “How do I find information on
Expanded Access Studies in ClinicalTrials.gov?”
Link to PLX's info on taliglucerase alfa on clinicaltrials.gov: http://www.clinicaltrials.gov/ct2/results?term=+taliglucerase+alfa
Here you will see they are doing another trial for those under 18 and a switchover trial, which is to test those switching from a competitor drug. I understand initial results from the switchover were very positive, which is a great thing.
Partnerships:
Pfizer Inc
In December 2009 we entered into an agreement with Pfizer Inc. to develop and commercialize taliglucerase alfa, a plant-cell
expressed form of glucocerebrosidase (GCD) in development for the potential treatment of Gaucher's disease. Under the terms of the
agreement, Pfizer will receive exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix will retain the exclusive commercialization rights in Israel. Taliglucerase alfa is the first enzyme replacement therapy derived from a proprietary plant cell-based expression platform using genetically engineered carrot cells.
Teva Pharmaceutical Industries
In September 2006, we entered into a Collaboration and Licensing Agreement with Teva for the development and manufacture of two
proteins, to be identified by Teva and us using our ProCellEx protein expression system. The agreement also identifies additional matters for collaboration between Teva and us. Subsequently, two proteins were identified to be researched and developed under the agreement but in 2009, both of the projects were terminated for commercial reasons. These proteins were not part of our current product development pipeline. Pursuant to the agreement, we have agreed to collaborate on the research and development of the two proteins utilizing our ProCellEx protein expression system. If the research and preclinical development efforts for either protein are successful and if Teva elects to pursue clinical trials for the development of either protein through our ProCellEx protein expression system, we have agreed to grant to Teva an exclusive license to commercialize the products developed based on the protein in return for royalty and milestone payments payable upon the achievement of certain pre-defined goals. We will retain certain exclusive manufacturing rights with respect to the active pharmaceutical ingredient of the proteins following the first commercial sale of a licensed product under the agreement and other rights.
Weizmann Institute of Science
In March 2006, we entered into a Research and License Agreement with the Yeda Research and Development Company Limited, the
technology transfer arm of the Weizmann Institute of Science, pursuant to which Yeda is using its technology to design a next
generation of GCD for the treatment of Gaucher disease that can be expressed using our ProCellEx™ protein expression system and
that may have certain benefits over first generation treatments, including improved dosing. The technology licensed from Yeda
provides a methodology for the rational design of an improved drug for the treatment of Gaucher disease by enzyme replacement
therapy, based on the three-dimensional crystal structure of GCD that was solved by scientists from the Weizmann Institute of
Science. In consideration for Yeda's research, we agreed to pay a fixed research budget amount. Yeda's activities under the
agreement are also funded by a grant by the Magneton program of the Ministry of Industry and Trade of Israel, a program created
to support the transfer of emerging technologies from academic research to industrial commercialization. Yeda has granted us a
license to use their technology and discoveries for the development, production and sale of enzymatically active mutations of GCD and derivatives thereof for the treatment of Gaucher disease. We are responsible for commercializing the products developed under the license. Under the agreement, we are obligated to pay certain minimum royalty amounts and varying fixed royalty amounts on net sales of products developed using the licensed technology for the treatment of Gaucher disease and other indications as well as for sublicensing revenues. Accordingly, we will have certain payment obligations to Yeda even if we were to fail to generate any revenue from the licensed technology.
Hebrew University of Jerusalem and the Boyce Thompson Institute for Plant Research
In January 2007, we entered into an agreement with the Yissum Research and Development Company, the technology transfer arm
of the Hebrew University of Jerusalem, Israel, and with the Boyce Thompson Institute, Inc., which is affiliated with Cornell
University, pursuant to which we are developing a proprietary plant cell-based acetylcholinesterase (AChE) and its molecular
variants for the use in several therapeutic and prophylactic indications, as well as in a biodefense program. Pursuant to the
terms of the agreement, we licensed the technology underlying the developed acetylcholinesterase from Yissum Research/Hebrew
University and Boyce Thompson. We have performed several early animal studies demonstrating the safety and efficacy of our
protein. Results from such tests in animals demonstrated the protein to be both safe and efficacious. Additional studies
designed to evaluate these parameters are in process.
Analysts:
CANACCORD Genuity Ritu S. Baral
Capstone Investments Difei Yang
Hapoalim Securities Jon Lecroy
Noble Financial Capital Markets Raghuram Selvaraju
Oppenheimer Bret Holly
UBS Research Chris Schaefer
WBB Securities Daniel T. Mallin
Pipeline:
http://www.protalix.com/pipeline_products.html
Just got back and saw the DEPO news! Sweeeet Ginger Brown!!!!!!! Excellent team effort here with regards to the DD, both on the pros and cons side of the fence.
We'll be doing this again for DEPO for Serada too, but first thing is first...Monday morning baby!!
and.....PLX next up WITH an SPA!!! Have a great weekend!!!!
This actually ties right into DEPO's Serada drug. Thanks for posting.
It appears the FDA is very interested in orphan drugs. They recently announced that they are having their fourth FDA orphan drug designation workshop between Feb. 28 - March 1, 2011. They had 3 in 2010.
OREX PDUFA also this weekend.
PLX - also added shares down here.
Wow, market getting creamed here. -169 now.
F -13% wow! Shorting the earnings plays (most) seems to be the way to go.
F - I don't see it going under the 50 day ma, which is $17.14.
DEPO short interest increased by 10%
Prior: 2,684,800
New: 2,954,900
There are other fish in the sea...lol!!! I agree it's not ideal what ABT pulled at the alter, but with approval, there is an excellent market and DEPO will work out something one way or another. What I like is they already have 2 drugs on the market and Serada finishing up Phase 3. They are not a one hit wonder and people need to keep that in mind.
Pretty sure CLDA didn't/doesn't have a partner and they got quite a Pop ($15 to $26).
ABT - my thought is they won't talk about it, since they are in "discussions" with DEPO.
PLX - insider selling:
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=7348539
It's good to see the longs win once in a while in the biotechs.
I owned it recently and sold too. Was feeling leary on approval and was afraid of a bear raid. Instead, I got an ABT raid and CLDA gets approved...lol.
CLDA short interest = 3,136,100
Yes indeed. Next Friday or that Monday will be our time.
Yup, bout 4-5k shares went off.
Major shorts and nice share structure. Could be an explosion.
CLDA - approved...strike 1 to me..lol
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm240642.htm
CLDA - started shooting up 2 mins ago, then halted....interesting.
RGEN - yes, I agree with you. Think it's moved up too much at this point.
My predictions:
I was bearish on MNKD and they received a CRL.
CLDA - predict a CRL due to the fact that they did not do enough trials at different doses.
OREX - predict a CRL. The FDA appeared to have a lot of concerns, regardless of how the panel voted.
DEPO - Approval (see all of my prior posts).
I'm only in DEPO, but we'll see how my predictions go.
I had one in at $1.50 lol - shorts covering like mad here.
The big boards are becoming like penny stocks...wow!
They won't show up until 5:25.
MNKD - quotes at 5:25 and opens back up at 5:30.
MNKD - the CEO was buying up 700k blocks like crazy. I can't imagine how much he will lose here. I know he's a billionaire, but still...yikes.
I'm starting to think we might do better becoming cubs on the short side.
MNKD - I still don't see anything for them yet:
http://www.nasdaqtrader.com/Trader.aspx?id=Tradehalts
MNKD - this was their silver bullet. I can't imagine how ugly this is going to get when it opens back up. I hope no one on this board is in MNKD, unless you're short.
MNKD - blows the bear raid = approval theory out of the water with the CRL.