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Teva gets 2 generic drug approvals from FDA
The FDA approved a generic version of Ellence injection and granted a tentative approval of Revatio, both made by Pfizer.
Michal Yoshai 12 Aug 07 9:49
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained two approvals from the US Food and Drug Administration (FDA): Epirubicin Hydrochloride Injection, a generic version of Pfizer Inc. (NYSE:PFE; LSE:PFZ) Ellence Injection; and a tentative approval for Sildenafil Citrate Tablets, a generic version of Pfizer's Revatio Tablets.
Teva will begin deliveries of Epirubicin Hydrochloride Injection immediately. The company plans to begin deliveries of Sildenafil Citrate Tablets after obtaining final approval of the drug when the Revatio patent expires in March 2012.
IMS data indicate that Ellance, a is a supplementary therapy for patients with evidence of axillary node tumor involvement following resection of primary breast cancer, had $60 million in US sales for the twelve months through 2007. Pulmonary arterial hypertension (WHO Group I) to improve exercise ability had $93 million in US sales for the twelve months through 2007.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000242237&fid=942
OT-
Blade, I hear on the news that you were not the only one who took Debka too seriously
PLX-
And there's the biogenerics they are developing with TEVA, not in clinical trials yet but my guess is they are aiming to a much bigger market than the Gaucher.
What i don't understand is who is buying at $38?
Vol is 61k. Weird.
I do agree its MC should be around $600M.
Regarding this in-licensing deal, I did tried to contact the company for more details but they are avoiding contact...
I'm quite certain the price must fall down to earth.
>VPHM been trading +25 minutes at +- $10.50<
It is $8.1 now on this:
Aug 10 (Reuters) - ViroPharma Inc. said (VPHM.O: Quote, Profile, Research) said it and partner Wyeth Pharmaceuticals, a unit of Wyeth (WYE.N: Quote, Profile, Research), decided to end dosing with a drug to treat Hepatitis C virus (HCV) in a mid-stage trial due to safety concerns.
Shares of ViroPharma fell 16 percent to $8.60 in early morning trade on the Nasdaq.
ViroPharma said the drug candidate, HCV-796, was given along with pegylated interferon and ribavirin, which are the standards of care for HCV infection.
This decision follows a review of safety data which shows elevated liver enzyme levels in some patients after eight weeks or more of therapy with the combination, ViroPharma said in a statement.
Exton, Pennsylvania-based ViroPharma said the U.S. Food and Drug Administration has been notified that all patients on triple therapy will now be maintained on only pegylated interferon and ribavirin for the remainder of the clinical study.
ViroPharma said it and Wyeth will analyze data from the study to decide the drug's future. (Reporting by Varsha Tickoo in Bangalore)
http://www.reuters.com/article/marketsNews/idUKBNG28853220070810?rpc=44
OMRI-
No one expected OMRI to miss 2Q this badly, but Oppenheimer's upgrade came today and seems to soften the fall.
OMRI
(The stock fell 19% AH)
http://www.reuters.com/article/marketsNews/idUKBNG20163820070808?rpc=44
UPDATE 1-Omrix Biopharmaceuticals Q2 earnings fall, shares down
Wed Aug 8, 2007 7:35PM EDT
(Recasts; adds 2007 outlook, after-market share movement)
Aug 8 (Reuters) - Omrix Biopharmaceuticals Inc. (OMRI.O: Quote, Profile, Research) posted a 71 percent fall in quarterly profit partly hurt by certain unrecognized and deferred revenue and lowered its total product sales view for 2007, pushing shares down 20 percent.
The uncertainty related to future shipment of Intravenous Immunoglobulin (IVIG) to an European Union country, as well as related unrecognized revenue resulted in the company cutting its full-year product sales view, it said.
The biosurgical and passive immunotherapy products maker said it was facing administrative issues over about $3.0 million of IVIG shipments to the EU country, which it did not name.
Omrix said it was not certain as to when it could record the revenue or if it could even continue to sell the product in that country in 2007.
The company said it had to defer the shipment of about $1 million worth of Evicel, a sealant to control surgical bleeding, to the third quarter due to a delay in expected regulatory approval.
The company expects total product sales, which comprises of revenue from its biosurgery and immunotherapy product lines, of $42 million to $47 million for 2007, down from its prior view of $50 million to $55 million.
For the second quarter, Omrix posted net income of $1.5 million, or 9 cents a share, compared with $5.3 million, or 38 cents a share, last year.
Total revenue fell 31 percent to $11.2 million.
Analysts on average expected the company to earn 21 cents a share, before exceptional items, on revenue of $12.8 million, for the quarter, according to Reuters Estimates.
Shares of the company were trading at $23.95 in late electronic trade, after closing at $29.98 Wednesday on the Nasdaq. (Reporting by Dilipp S. Nag in Bangalore)
I'm skeptic but watching them:
Biocancell completes Phase I clinical trial
http://www.globes.co.il/serveen/globes/docview.asp?did=1000241526&fid=942
The trial is for a prostate cancer treatment.
Gali Weinreb 8 Aug 07 17:23
Biocancell Therapeutics Ltd. (TASE:BICL) has completed a Phase I clinical trial for its prostate cancer treatment. The trial is for US Food and Drug Administration (FDA) registration. The company said that it had not yet received the final report on the trial, but preliminary data enabled it to assess that the trial achieved its goals to test the drug’s safety, to determine the recommended dosage, and to obtain indications about its toxicity.
Phase I trials of cancer drugs are conducted on patients, not healthy persons, because of the side effects characteristic even of good treatments. Trials are conducted on severely ill patients who have not responded to other treatments. Biocancell’s trial included 18 patients; patients who responded well to the treatment can opt to continue the trial for up to nine months. Other after this period will it be possible to report the full results of the trial.
The preliminary results were enough for Biocancell to apply to the FDA to conduct a Phase IIb trial, which the company hopes to begin by the end of the year. Biocancell CEO Avi Barak said that the company had sufficient cash to complete this trial.
They have an interesting approach to treat melanoma:
GammaCan product gets FDA orphan drug designation
http://www.globes.co.il/serveen/globes/docview.asp?did=1000241500&fid=942
The company anti-cancer immunotherapy, VitiGam, is designed to treat melanoma.
Gali Weinreb 8 Aug 07 17:02
GammaCan International Inc. (Bulletin Board:GCAN.OB) has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its anti-cancer immunotherapy, VitiGam. Orphan Drug designation entitles GammaCan to exclusive marketing rights in the US for VitiGam for up to seven years should the company be the first to receive marketing approval for this therapeutic drug product. The company plans to apply to the FDA for a Phase I/II clinical trial by year-end, and initiate clinical testing of the drug in early 2008.
The Orphan Drug Act provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The purpose is to encourage the development of treatments for small markets when the investment in drug development is high to point of being uneconomical for the company under ordinary circumstances. Subject to certain criteria, the developer of an orphan drug is eligible for tax credit and marketing incentives.
VitiGam is an anti-cancer immunotherapy for the treatment of Stage III and Stage IV melanoma. It is manufactured from the plasma of donors with Vitiligo, a benign skin condition affecting up to 2% of the general population. Vitiligo attacks the skin pigments, causing white skin blemishes, but has no other effects. An injection of an immunotherapy into these cells should help cancer patients
<Is a GTBC-like co. capable of the genetic engineering to pull of the MASSIVE quantities of this immunoglobulin therapy that will be called for?>
From what I understand this is a whole lot of globulins. As such it cannot be produced in transgenics. You need a defined molecule.
Protalix BioTherapeutics Signs Agreement to License Acetylcholinestrase Development Technology
Press Release Source: Protalix BioTherapeutics, Inc.
http://biz.yahoo.com/prnews/070808/nyw056.html?.v=100
Wednesday August 8, 9:30 am ET
Protalix BioTherapeutics to Explore Biodefense and Civilian Applications with Researchers from Hebrew University of Jerusalem
CARMIEL, Israel, Aug. 8 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. (Amex: PLX - News), today announced it has signed an agreement with the Yissum Research and Development Company, the technology transfer arm of the Hebrew University of Jerusalem, Israel, and the Boyce Thompson Institute for Plant Research, at Cornell University, Ithaca, New York, to develop a proprietary plant cell-based acetylcholinestrase (AChE) and its molecular variants for the use in several therapeutic and prophylactic indications, including a biodefense program.
Under the agreement, Protalix has licensed the technology underlying acetylcholinestrase from Hebrew University and Boyce Thompson.
The initial feasibility research on AchE has demonstrated the potential for the enzyme and its variants in multiple therapeutic fields. In vitro experiments have also shown that the AChE protein expressed in Protalix's plant cell ProCellEx(TM) system demonstrates promising biological activity at both the biochemical and the cellular levels.
The work is based on research conducted in the laboratory of Professor Hermona Soreq, Dean of Faculty of Science at the Hebrew University of Jerusalem, Israel, a world leader in the field of acetylcholinestrase research.
Professor Soreq said, "After many years of research, we have come to understand the many translational benefits which can be achieved from using the AChE protein for therapeutic applications. We look forward to working with the Protalix team, and we are confident that its plant cell-based technology enhances our ability to address the many applications for this enzyme and its specific variants."
Dr. David Aviezer, President and CEO of Protalix, added, "We are excited to be able to collaborate with Professor Soreq and her colleagues on this project, and that they recognize the value of Protalix's plant cell-based technology platform. We believe the development program for AChE has significant potential, both in the growing biodefense market and in the civilian pharmaceutical arena."
Nava Swersky Sofer, President & CEO of Yissumn noted, "We are delighted to collaborate with Protalix to commercialize the discoveries made by Professor Soreq and her team. Protalix's technology platform is an excellent fit for Professor Soreq's discoveries in the field of AChE for use in the biodefense area and in other therapeutic applications, and we also feel confident that the Protalix's strong team can develop these technologies to products. Yissum is particularly pleased to bring another one of Professor Soreq's discoveries to a commercial partnership with a strong partner."
About Protalix BioTherapeutics, Inc.
snip
Biolite in a free fall today after announcing that the anti obesity drug had no significant effect in Phase II.
IDEV-
CIBC thinks it is commercial risk meaning Esprit is not trying hard enough to market.
Idit
IDEV- "any idea why the stock is going down?"
Maybe low expectations from earnings tomorrow.
Jon, any idea why the stock is going down?
Is it just the market trend?
Idit
I know that there were talks between PLX and TEVA few years ago and I thought a bid is on its way, but TEVA was not serious enough. Later they met again and collaborate to develop a compound together. Using the PLX platform to produce biosimilar product has the advantage of not having to wait for the patent to go off and the production amounts are much higher than those you get from CHO cells, so price can be lower . And of course less troubles with the FDA since it is a biosimilar.
Enbrel sounds like a good bet, matches at all points.
How about Avastin and Herceptin, do they fit to the time frame with their off patent dates? They do fit in sales size and being produced in CHO.
Regards, Idit
I know that there were talks between PLX and TEVA few years ago and I thought a bid is on its way, but TEVA was not serious enough. Later they met again and collaborate to develop a compound together. Using the PLX platform to produce biosimilar product has the advantage of not having to wait for the patent to go off and the production amounts are much higher than those you get from CHO cells, so price can be lower . And of course less troubles with the FDA since it is a biosimilar.
Enbrel sounds like a good bet, matches at all points.
How about Avastin and Herceptin, do they fit to the time frame with their off patent dates? They do fit in sales size and being produced in CHO.
Regards, Idit
"Cerezyme"?
You mean other than the one PLX is working on?
When will Enbrel go off patent? Is it also produced in CHO cells?
"If biogenerics is not a robust area for biotech investing, then nothing is"
I think that Teva's president and CEO Shlomo Yanai agrees with you.
I was surprised to find out that Procognia can do heparins and of course this could add more weight to Teva's ANDA but Momenta was focused on heparins for years and I think they have the advantage there.
Judging from body language I would not think they are working on heparins for Teva, my bet would be antibodies. but who knows?
Unlike Momenta, Procognia is not a drug developing company. They are more of sub contractors for glycoanalysis projects. Customers can pay for analysis work or make them a minor partner (Teva).
Bristol is still evaluating the technology and it is not known yet if they will have a long term agreement like Teva.
The third agreement is with Nutricognia in the R&D and manufacture of nutritional commodities, they will get fat royalties for 15 years but this is not a big issue for the time being.
They also have a marketing agreement with Qiagen for their low resolution device for scientific research, not a big issue either.
Procognia- notes from a presentation
They have a powerful tool that gives high resolution glycoanalysis using a lectin array-based method.
Currently used methods for glycoanalysis- mass spectrometry and HPLC,are complex, typically requiring high levels of expertise and days to provide answers, and are not readily available to all researcher.
They have several advantages over MS and HPLC:
Supernatant samples with no or minimal enrichment, or no purification at all.
Binding of an intact glycoprotein to the arrayed lectins (no need to prepare or use enzymes before).
Fast (few hours).
Several samples at the same time.
Less expensive.
They have performed verification of their system by comparing their glycosylation profiles of reference glycoproteins to MS and HPLC.
Different glycoproteins and different variants of those glycoproteins were compared. For most cases the match between glycosylation profiles was very high. So their method is applicable for analysis of recombinant monoclonal antibodies, FSH, clotting factors, complex biopharmaceutical glycoproteins such as erythropoietin and interferons.
Their platform works best for antibodies.
Can do also heparins (in opposed to what MNTA thinks).
Can't do monosacharides. Can't do plant driven proteins, need other lectins because their system was designed to work with mammalian cells. Analyzing plant proteind is doable but will be very expansive, that explains why PLX took their glycoanalysis business to another lab.
They know MNTA but do not see them as competitors due to the differences between their business models. They say MNTA guys were very confidential about what they do, so they never really talked.
Up to date, they have 3 big customers. The one their future depends upon is Teva.
They have an agreement with Teva to develop 2 biogeneric drugs that have annual sales of $xB and will go off patent in about 3 years (that's a nice quiz). Teva is paying all expenses and Procognia will get milestones payments, payments for significant savings in clinical trials costs and single digit royalties for 10 years.
Success In this project will get Procognia a nice stream of revenue and not less important - recognition for their method by the FDA.
Their early stage R&D focuses on quantitatively analyze changes in glycoprotein abundance and detect the extent of glycosylation alteration as well as the carbohydrate structure that correlate with cancer biomarkers for diagnosis.
Teva's president and CEO Shlomo Yanai said on the last CC that Biogenerics will be one growth engine for Teva, I think that for Procognia it will be the jump start.
I did not ask him but i believe it is Baxter which launched ARALAST also in 2003. BTW, Baxter partnered with Arriva Pharmaceuticals on a recombinant AAT but as far as i know they are no longer backing them.
"Why does Kamada have an orphan designation for the inhaled form of AAT but not for the injected form?"
Because there are already 3 approved AAT drugs for IV use in the market but none for use by Inhalation.
(Reply given by their CEO)
Given Imaging posts Q2 profit:
http://maya.tase.co.il/bursa/report.asp?report_cd=283829-00&CompCd=2200&Type=Pdf
TEVA had a good Q2
http://investorshub.advfn.com/boards/read_msg.asp?message_id=21719139
Teva 2nd-quarter net rose 5.3% on 9.9% higher sales:
TEVA REPORTS SECOND QUARTER 2007 RESULTS
Jerusalem, Israel, August 1, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today
announced its financial results for the second quarter ended June 30, 2007.
Second Quarter Highlights
· Record-breaking quarterly net sales of $2,386 million, up 10 percent over the second quarter of
2006—a quarter which included the launches with exclusivity of Simvastatin and Pravastatin,
among the largest launches in the industry’s history.
· Net income of $515 million compared to net income of $489 million and adjusted net income of
$541 million in the comparable quarter of 2006.
· Diluted EPS of $0.63 compared to EPS of $0.59 and adjusted diluted EPS of $0.66 in the prior
year quarter.
“This was an excellent quarter for Teva,” said Shlomo Yanai, Teva’s President and CEO. “We are
especially pleased with our record-breaking sales figures, which show an increase of 15 percent over last
quarter, and 10 percent over the second quarter of 2006--a quarter which included two of the largest
launches in our company’s, and the industry's, history. Our results this quarter were driven by strong
performances across all our business units and geographies, by record-breaking sales of Copaxone®,
and by a very successful early launch of Amlodipine/Benazepril.”
snip
I'm not sure the link to RASE works:
http://maya.tase.co.il/bursa/report.asp?report_cd=283479
I'm in @3.0 (Sold most of my ILMN few days ago).
GPC Biotech Withdraws Satraplatin
http://biz.yahoo.com/ap/070730/gpc_biotech_fda.html?.v=1&printer=1
Monday July 30, 10:37 am ET
GPC Biotech Withdraws FDA Application for Cancer Treatment Candidate Satraplatin
NEW YORK (AP) -- GPC Biotech AG said Monday it is withdrawing its Food and Drug Administration application for the cancer drug candidate satraplatin, following an advisory committee recommendation.
The FDA advisory committee, last week, recommended the agency not approve the drug until the company submits full survival data. GPC Biotech said it expects overall survival results to be available within six months, but that timing could change.
GPC Biotech licensed rights for the drug candidate from Spectrum Pharmaceuticals in 2002. GPC is responsible for development and regulatory costs. Pharmion Corp. holds European rights to the drug candidate.
"While we were very surprised and disappointed by last week's ODAC outcome, we need to move forward," said Bernd R. Seizinger, chief executive of GPC Biotech. "Thus, we are focusing our efforts on the overall survival results from the satraplatin SPARC trial and integrating these data into the strongest possible NDA submission."
The company said that if this data is positive, it plans to submit a new drug application to the FDA as quickly as possible.
U.S.-traded shares of Germany-based GPC Biotech rose $1.55, or 15 percent, to $11.90 in morning trading. The stock has traded between $10.25 and $37.79 over the last 52 weeks. Shares of Irvine, Calif.-based Spectrum rose 5 cents to $4.05 while shares of Boulder, Colo.-based Pharmion rose 42 cents to $24.84
The 2Q07 CC in 2 days.
I read that some analyst here are already writing notes to lower the high estimations meaning they are covering their bottoms.
Dubi seen this?
http://www.globes.co.il/serveen/globes/docview.asp?did=1000237399&fid=942
"(Lifewave)announced today that there may be delays in the execution of its contract in Germany due to the sudden death of the manager and co-owner of the German distributor."
Think he could not handle the movements of the stock? :)
Today they announce some corporation agreement with PFE, they will let PFE use their device in clinical trials of liver disease. This might get BreathID some recognition. An important step IMO.
TopSpin Medical signed a 3 years distribution agreement with JNJ for its IVMRI catheter. JNJ will pay for the Post Marketing Surveillance.
"PLX, down to earth ???"
We are nearly there.
You are absolutely right,Intrond are often not necessary for the expression of a cDNA in transfected cells. However, in transgenic animals,GTCB use the goat casein gene (that has enough introns in it) into which they inserted their cDNA and that construct allow a high and reliable expression of the foreign gene.
I'm afraid i did not explain this properly.
The GTCB expression cassette contains the goat casein gene into which they inserted their cDNA of interest. That cDNA was intron-less, but there are enough introns in the casein gene cassette and 3' sequences.
I'm sure. cDNA constructs are lousy expressors because for unknown reasons mammalian cells require splicing for stability and efficient transcription. In many cases including the first intron is sufficient. In other cases you need more introns.
Quiz: Who is the leading seller of generic Norvasc for the U.S. market?
TEVA
aslan,
They are expressing GENOMIC DNA. cDNA constructs are lousy expressors. Fortunately, there is no indication for alternative splicing in their genes. But even if it were, they could construct the genes in a way that will eliminate the non relevant ones.