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They have advanced since.
Protalix issues shares at disappointing valuation
http://globes-online.com/serveen/globes/docview.asp?did=1000267617&fid=942
The biomedical company hoped for a company value of up to $1B
Gali Weinreb 25 Oct 07 12:23
Protalix Biotherapeutics Inc. (AMEX:PLX) has raised $50 million at a company value of $328 million in an offering of ten million shares at $5 per share. The offering is a major disappointment to anyone who has monitored the company in recent months because the company’s market cap prior to the offering was seven times this amount.
Investors knew that Protalix would not hold the offering at a value of $3.7 billion, but they had hoped for a value of between $800 million and $1 billion. In the end, the company could not even meet the lowered expectations of $500 million value.
Protalix was able to issue twice the number of shares originally planned, and has given the underwriters a green shoe option on 1.5 million more shares. Even though there was heavy demand for the share, the price was far below expectations. Shareholders planning an offer for sale alongside the offering will probably forego the idea for now; Biocell Ltd. (TASE: BCEL), which owns 22% of the company, made no mention of an offer for sale in its notice to the TASE today.
Most of Protalix’s original shareholders have made handsome profits on their investments, although most of their shares are still vested. Philip Frost, who invested in the company at a value of $110 million, is making a three-fold paper profit on his $17 million investment. Pontifax Fund, which owned 4.6% of Protalix before the offering, Biocell, Marathon Venture Capital Fund (TASE: MARA) (a 10% holding in the company), and Technorov Holdings Ltd., with 9.4%, will make a ten-fold return on most of their holdings.
Protalix president and CEO David Aviezer, with a holding of 1.7%; Yosef Shaltiel, with 4.8%; chairman Eli Hurvitz, with 8.8%; and founder Zeev Bronfeld, with 22%, can also be pleased today.
Nevertheless, a study of the market dynamics that preceded Protalix’s offering, shows that the market believes that $328 million is fair value for a company in Protalix’s condition. The company has a biosimilar product, which is undergoing Phase III clinical trials, intended for a niche market where there is already one competitor. The company also has a good platform for the development of more drugs, and management with a proven track record.
In the face of disappointment, the offering is still the largest exit by a biomedical company this year, and a fine achievement for the company from Kiryat Shmona that invented pioneering technology and survived all of northern Israel’s economic crises of the past decade and even a katyusha strike on its laboratory.
Oops, should be #msg-21969705 in my previous post.
One more point: The controlling shareholders, private and companies (Biocell Ltd. (TASE: BCEL) and Marathon Venture Capital Fund (TASE: MARA)) will not sell their shares in the offering.
According to Biocell (22% share holder of PLX), the offering reflects a MC of $328M to PLX or about $380M after the money.
Much lower than my $600M estimation #msg-21966932.
Holy cow, what a discount! I didn't see it coming but lots of Biocell holders did.
I think that PLX at $390M market cap is under evaluated and so is Biocell when it reflects that value for PLX.
Marathon which I no longer hold, will have a good entry point too if it will drop some more today on the PLX news.
BIIB reported 3Q07 non-GAAP EPS of $0.58. Weak Avonex revs $455M,
Tysabri revs to BIIB were $63M, on worldwide end-user sales of approximately $93 million.
I don't know, sound a bit like gossip to me.
I don't think PLX will take anything under $800M, that the impression I got from their CEO in the presentation.
This is Citi's take on this #msg-23568930
This trial will probably lead to more market share captured by Copaxone.
There is still the BEYOND study of Betaseron vs. Rebif, data will be out by the end of the year.
<30% is a higher aggregate rate than I would have thought.>
About one in four patients receiving interferon beta-1b or subcutaneous interferon beta-1a and one in 20 receiving intramuscular interferon beta-1a will develop neutralising antibodies against the drug and within two years treatment will be less efficacious.8 9 If antibodies are not detected after two years then no further tests are needed. If antibodies are present the author’s approach is to switch patients to glatiramer acetate.
Pricing should take place today.
PLX down 16% on a normal vol but Biocell (TASE: BCEL) down 17% on huge vol (about 10 times its usual).
This will make you happier:
Can-Fite to Conduct a Confirmatory Phase IIb Trial in Early 2008 as Part of Ongoing Development of CF101 for the Treatment of Rheumatoid Arthritis
Can-Fite's Clinical Advisory Board has recommended this advanced trial as further evidence for the efficacy observed in a previous trial; this will give green light to the final phase of development Prof. Pnina Fishman, CEO of Can-Fite, said that "the confidence expressed by the Clinical Advisory Board (CAB) members in the CF101 drug, the advantages of the drug over currently available medications and its potential as an antiinflammatory drug, motivates us to proceed vigorously with the development plan for the indication of Rheumatoid Arthritis and for other recently reported indications of CF101 and CF102."
Can-Fite BioPharma Ltd. will conduct in early 2008 a confirmatory Phase IIb trial as part of the ongoing development of CF101 for the treatment of Rheumatoid Arthritis (RA). This is in line with recent recommendations made by Can-Fite's CAB which took place in Boston under the chairmanship of Prof. Weinblatt. The CAB recommendations were endorsed last night by Can-Fite's Board of Directors. In July, Can-Fite published the results of a Phase IIb study with CF101 in combination with Methotrexate (MTX) indicating that the ACR20 response, which
was the primary efficacy end point of the study, showed no difference between the CF101-treated and placebo groups. However, a substantial difference in favor of CF101 was seen in the ACR50, the ACR70 and the EULAR “Good” response measures.
Now, that the CAB has made its recommendations, Can-Fite intends to commence in the first quarter of 2008 an advanced trial similar to the previous one. This trial will include the two dose groups with the best results from the previous trial, in comparison to a control group, and patients will be treated for a period of 12 weeks. The trial will be conducted using a tablet formulation, which was lately developed by the company.
Can-Fite estimates that the trial will be initiated at the first quarter of 2008 and may take about 1 year to complete, including data analysis. Can-Fite will soon file an application with the FDA for this trial, which will be conducted under FDA inspection. If the results are favorable, this would mean that Can-Fite has paved the way towards the final phase of drug development. Can-Fite has sufficient financial resources to complete this trial in parallel to other ongoing clinical studies. This progress in the development in CF101 was preceded by recent reports on the successful completion of pre-clinical trials in the US with CF102, Can-Fite's second molecule in the pipeline, which is the foundation of a drug for the treatment of several indications in the Hepatology arena, i.e., hepatocellular carcinoma, hepatitis, liver regeneration. Can-Fite estimates that Phase I clinical trial with CF102 will commence in the coming months.
http://www.canfite.com/pr/2007-10-23%20CAB%20Recomendations%20-%20English.pdf</a</a</a
Merrill Lynch: Teva will beat estimates
The US investment house gives Teva a "Neutral" recommendation.
http://globes-online.com/serveen/globes/docview.asp?did=1000266102&fid=942
Erez Wollberg 22 Oct 07 15:09
Like WR Hambrecht last week, Merrill Lynch expects the quarterly results of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) to exceed its estimates. The US investment house, which gives Teva a "Neutral" recommendation, now says it believes that Teva's revenue and earnings per share for the third quarter will exceed its original estimates of $2.43 billion and $0.64. The earnings per share estimate is already $0.01 above the analysts' consensus.
"We believe that the stock should continue to do well if Teva continues to exceed estimates on the top and bottom lines," analysts Gregg Gilbert, Haim Israel, and Sumant Kulkarni write.
"We also believe that most investors assume that 2007 is "in the bag" based on generic Lotrel, Oxycontin, and the respiratory franchise. We are maintaining our Neutral rating as we await further visibility on 2008/2009 opportunities," the report says.
The Merrill Lynch analysts say their estimates for the third quarter could be conservative given the exclusive launch of generic Lotrel in May and the launch of generic Famvir, both launches at risk. "Teva’s respiratory franchise could also provide upside," they write.
Clal Finance's pre-results review of Teva opens by saying that "the third quarter of 2007 will not be as good as the corresponding quarter," attributing this to the four exclusive launches in the third quarter of 2006 compared with only one that will impact the current quarter, namely Lotrel.
Meanwhile, Teva reports that it has reached a settlement with Astellas Pharma Inc. and King Pharmaceuticals, Inc. (NYSE: KG) over the submission by Teva subsidiaries of an abbreviated new drug application (ANDA) for a generic version of Adenoscan (adenosine injection), a pharmacologic stress agent.
Under the settlement agreement, Teva will be able to launch its generic version of Adenoscan pursuant to a license in September 2012, or earlier under certain conditions. The financial terms of the settlement were not disclosed.
Kamada applies for FDA approval for clinical trial
http://globes-online.com/serveen/globes/docview.asp?did=1000265435&fid=942
The company commenced clinical trials of the intravenous version of the drug in February.
Adi Ben Israel 21 Oct 07 11:55
Biopharmaceutical company Kamada Ltd. (TASE: KMDA) has filed for US Food and Drug Administration (FDA) approval to commence Phase II clinical trials of the aerosolized form of its Alpha-1 Antitrypsin (AAT) product to treat Cystic Fibrosis (CF). The company applied for approval from the European Medicines Agency last month. Earlier this year Kamada commenced Phase III trials of the intravenous version of AAT.
Kamada CEO David Tsur said, "There is significant potential for the inhaled version of AAT, in view of the number of CF suffers and carriers, estimated by the US-based Alpha 1 Association to total 200,000 worldwide. According to an external survey, just 5,000 of these are currently receiving treatment. The cost of administering a drug by inhalation will be lower than that of intravenously administered drugs. In addition, parallel to the use of the drug in the treatment of CF, there is now increasing evidence of the drug's efficacy in treating other respiratory diseases and as a consequence, we are now working on the development drug for other indications, in cooperation with leading doctors in the field."
Kamada’s inhaled AAT has been designated an orphan drug for the treatment of CF, in both Europe and the US.
October 21, 2007 Press release
CF102 Drug is Effective in Promoting Liver Tissue Regeneration; Clinical Trials with CF102 in the Treatment of Liver Cancer are Due to Commence in Early 2008
http://www.canfite.com/pr/2007-10-21%20Liver%20Regeneration%20-%20English.pdf
Can-Fite BioPharma Ltd. announced today that its CF102 drug, which is being developed for the treatment of viral hepatitis and liver cancer, was tested in preclinical trials and shown to be effective in promoting liver tissue regeneration following partial hepatectomy. The Company filed a patent application on this innovative findings and will include this indication in further clinical development of CF102.
Partial hepatectomy is usually performed in patients with primary or metastatic liver cancer. Rapid liver regeneration is crucial in these conditions and determines future liver function and chances for successful recovery. Regeneration of normal liver tissue is also needed to preserve liver function in patients with liver failure.
No drugs are currently available to speed up the regeneration process; therefore, developing a drug for the treatment of patients undergoing hepatectomy or patients with liver failure is at need.
Similar to CF101, Can-Fite's first drug which is currently in Phase IIb Clinical studies, CF102 specifically attacks liver tumors and hepatitis infected cells. The novel indication for regeneration of normal liver tissue extends the use of CF102 to include treatment of patients undergoing partial hepatectomy and patients suffering from diseases leading to liver failure.
Can-Fite also announced that preparation is currently underway for a phase I trial with CF102, which is due to commence in the US in the first quarter of 2008. This trial in healthy volunteers will allow the Company to push the drug into advanced phases for the abovementioned indications, including liver cancer, hepatitis and the novel application of rapid liver regeneration.
Prof. Ran Tur-Kaspa, a world wide expert in liver diseases from Rabin Medical Center, said that "Treatment with CF102, which binds specifically to the A3 Adenosine Receptor, marks a breakthrough in the development of liver regeneration agents. The profile of this drug, which has several applications in the field of liver diseases, is unique and should provide a solution for patients with these debilitating conditions."
Can-Fite estimates that the market for drugs that promote liver regeneration mostly derived from patients with hepatitis B and C. Out of 130 million patients with hepatitis C and 350 million patients with hepatitis B, 100 million patients are at high risk for developing liver failure or liver cancer, and may need drugs that speed up the regeneration of their infected liver during the course of disease.
snip
The standards for approval on bioequivalence are generally the same in Europe as in the U.S. However, the European regulators have been concerned about differences in dosing of Truvada compared to Sustiva, since Sustiva is taken on an empty stomach and Viread was taken with food in the initial studies.
GILD doesn't have data from a controlled trial specifically designed to demonstrate fed/fasted pharmacodynamics. The Europeans are concerned about an increase in virological failure or HAART discontinuation, therefore they will approve for stable patients (and not to those who had prior virological failure or mutant strains).
Yourself?!
Have no fear Freddie old boy, You can refrain the former by using dark places.
Looks better on you whatever they are :)
Yes, and you may also put your cloth on.
Sorry mn but someone asked me to ease on the elderly, come back another time.
You've just passed the test, congrats!
Who are you calling old? I want names!
If you do want my opinion, there's no way I can give you that without a full physical ya know.
<(Maybe it's just simply, older & slower.)>
Yeah, this must be it. Your older and I'm slower
Trouble with these men is you don't know if they're coming or going.
And thanks much mn for opening our eyes (and ears).
<I didn't hear that!>
Well I'm not surprised.
I've just found a possible cause to the severe hearing loss experienced by some distinguished posters on this board.
http://money.cnn.com/2007/10/19/news/companies/ED_Drugs/index.htm?source=yahoo_quote
“It's like the Wild West — anyone can stake claim to a biomarker.” Sam Hanash
Missing the mark By Virginia Gewin
Published online 17 October 2007 | Nature 449, 770-771 (2007)
http://www.nature.com/news/2007/071017/full/449770a.html
Genetic tests to detect cancer are feasible. But with researchers drowning in a sea of biomarkers and little financial incentive to get the tests on the shelves, the idea is floundering.
The genomic revolution brought in its wake the promise that it would be possible to detect —and arrest — the earliest signs of cancer. By tapping in to molecular biomarkers, initial signs of disease would be seen and effective treatments implemented. That promise remains resolutely unfulfilled.
In laboratories around the world, the discovery of candidate biomarkers continues apace. But the process of developing them into diagnostic tests is stalling. No early detection diagnostic test has so far been approved by regulatory bodies. Industry observers say a major problem is that there is no way to validate candidate biomarkers with the certainty that would merit their development into a marketable test. And the sheer number of candidates makes it hard to select which ones should be more fully developed.
For their part, doctors want tests that identify the proper treatment course for individual patients. It is unclear whether they will adopt biomarker tests that serve only as diagnostics and don't point the way to specific therapies.
“Biomarkers are only as good as their ability to link to the treatment or pathology of the disease,” says Harvey Pass, a clinician working on detection biomarkers for mesothelioma at New York University Medical Center.
Back in 2000, the US National Cancer Institute established the Early Detection Research Network (EDRN) in a bid to bridge the validation gap. The network sought to establish some of the infrastructure needed to test and validate candidate biomarkers. This is complicated by the fact that diagnostic tests often need to feature several markers to ensure that they are statistically significant.
On trial
In its draft assessment, the network reports movement on several fronts. Of the thousands of candidate biomarkers so far discovered, the EDRN is backing 120 in various stages of development. Among these, biomarkers for five cancers — mesothelioma, and liver, bladder, prostate and lung cancers — are in their third and final phase of development, and are being tested for effectiveness in large-scale human trials.
One of the EDRN's collaborators is Cangen Biotechnologies of Baltimore, Maryland, which hopes to put the first DNA-based early detection test for bladder cancer on the market. Cangen is confident that its test — a panel of 15 DNA segments — can identify tumours well ahead of existing diagnostics. But although detection may come a little earlier, a patient's primary treatment option remains the same: surgery. That means that the overall impact on patient survival rates may be relatively small.
For Eddy Agbo, Cangen's research director, linking the test to new drug therapies that could combat these early tumours is the next step forward. But in the absence of such therapies, there isn't a huge incentive for doctors and the health-care insurers that pay for most medical services in the United States to buy the tests.
Given its resources, the pharmaceutical industry would seem to be well placed to take candidate diagnostics tests through to approval. But rather than early detection tests, the industry seems more keen on using biomarkers to pinpoint patient suitability for treatment with particular drugs. There have been isolated successes for this approach, notably the targeting of the breast-cancer drug Herceptin, made by Genentech in South San Francisco, California. Herceptin targets patients who over-express a particular receptor and had sales of US$1.3 billion last year.
Everyone is looking for a dramatic demonstration of biomarker success, says Sam Hanash, a molecular biologist at the Fred Hutchinson Cancer Research Center in Seattle, Washington. The bottleneck isn't the lab-based discovery science, but the ability to efficiently weed through the overwhelming number of candidate genes, proteins and even microRNAs that could be clinically useful. “It's like the Wild West — anyone can stake claim to a biomarker,” says Hanash.
Setting standards
The EDRN has done what it can to find some of the most promising markers and get them into trials. The network has made available cancerous and control reference tissue, serum and blood samples for lung, breast, ovarian, prostate and colon tumours. These can be used as the first step in validation by scientists claiming a biomarker. The EDRN has also established quality-control for validation testing, a standardized system for presenting data, and, with other groups at the National Cancer Institute, has established the beginnings of large-scale human biosample collection.
These steps are necessary, specialists say, but may not be sufficient to bring biomarker tests to market. The EDRN provides a valuable but incomplete resource, says Mike Gillette, a proteomics researcher at the Broad Institute in Cambridge, Massachusetts. Further validation steps require large-scale trials on broader populations, which are expensive and so temper industry interest.
In July, the US Food and Drug Administration (FDA) addressed industry concerns about the approval process by publishing draft guidelines for tests that use multiple biomarkers. Yet to be finalized, the regulations make an important distinction: class II tests, which are merely diagnostic or prognostic, can be validated using trials on tissue-bank samples. But class III tests, which are those that also indicate which therapies should be used, must undergo a more costly trial in which patients are tracked in the future.
The shallow pockets of most diagnostic testing companies can't support the multimillion-dollar costs of even the class II trials. “You need pushers and drivers to develop biomarkers,” says Pat Price, a clinical researcher for Cancer Research UK at the University of Manchester, “and those are usually the drug companies.” Price predicts that the drug industry will become steadily more interested in biomarkers as it comes to see its future in more segmented markets for drugs effective in particular genetic subpopulations. She says that, in general, the middle ground between biomarker discovery and the clinic is neglected by funding agencies and so is unattractive to researchers.
The EDRN is an exception — but it spends its $28-million budget validating only diagnostic or prognostic biomarkers. According to Pass in New York, collaboration with the network has been invaluable to develop early detection biomarkers for mesothelioma. He and others are now pushing for the EDRN to develop biomarkers for therapeutic prediction to complete the continuum of treatment.
Murray Robinson, a senior vice-president at AVEO Pharmaceuticals in Cambridge, Massachusetts, says that the success of Herceptin has made parts of the pharmaceutical industry sit up and take notice.
Larger companies, such as Roche of Switzerland, are vigorously exploring the co-development of biomarkers for particular diseases and drugs to treat them. That approach may have diminished the firm's interest in stand-alone tests developed by smaller companies. René Bernards, chief scientific officer of Agendia, a cancer-diagnostics company in Amsterdam, is disappointed by the lack of interest drug companies have shown in his firm's test. MammaPrint, which predicts the likelihood of breast-cancer recurrence, is the first multigene prognostic test to be approved by the FDA.
“If it's clear that the FDA is going to regulate this space of biomarkers, and ours is the only company to clear a multigene biomarker through the FDA, you would think a few large pharmaceutical companies would want to collaborate,” he says. But Bernards is still waiting for someone to bite; and patients may wait many years yet for the true dawning of the age of personalized medicine.
Right, so we both tend to the same direction.
Wonder what rkrw thinks.
It's a tricky one, both arguments have a point. Being long both means I tend more to the hedge side in the overall picture.
How about yourself?
I'm long MNTA but not so much for Copaxone. I think Copaxone will loose the market to new and better drugs currently in late stage of clinical trials.
I'd say 6-12 months.
I think VRTX is a few months ahead of SGP in development and will probably be first to market.
The efficacy in treatment-naive pts appeared very similar to telaprevir. In the two effective arms, one in which boceprevir was initiated in conjunction with Peg-IFN/RBV and one in which the drug was initiated after a 4-week Peg-IFN/RBV run-in period, the undetectable rates at week 12 were 70% and 79%, respectively. This compares to week 12 undetectable rates of 70%-79% observed in the ph.IIb PROVE studies of telaprevir. SGP used a slightly looser definition for "undetectable" (<15IU/mL vs. <10IU/mL).
As for safety, rash was not observed with boceprevir, GI side effects were the most common reason to discontinuation of the drug. The rate of discontinuation due to AEs was 9-12%, vs. 11-13% for telaprevir.
Meanwhile we should see positive effect on Teva's third quarter 2007 financial results.
Please read the released again. It presents results from a trial that was designed to collect long-term efficacy & safety data on patients in Argentina treated with glatiramer acetateanswer and had 3 endpoints.
It did not compare responders to non responders but one of its secondary endpoints was to compare the disease course in ongoing patients vs. those who withdrew from the study (they were on the drug for more than 3 years during which they were obviously responding).
The rationalization behind the study comes from the fact that MS can follow different patterns of evolution and variable rates of disability accumulation. Follow up of long term relapse and disability outcomes of patients treated with disease modifying drugs is important since it provides useful information on the prognosis of MS and thus helps treatment decisions.
<Is this meant to be a serious exchange in views ?>
Definitely not, since you came here to bash and quarrel.
<Before we continue this exchange>
No worries mate, this ends here and now.
>diabetics in general have increased risk for pancreatitis <
It is so for cats and dogs, I'm not sure about humans.
The other risk factors for acute pancreatitis mentioned in the FDA alert were gallstones, severe hypertriglyceridemia, and alcohol use.
You're right, the prevalence of pancreatitis is not high enough to be detected among the liraglutide cases yet.
BTW, In the FDA review of Byetta , 27 of 30 cases had at least 1 other risk factor, overall risk appears low.
io,
Just my view:
Primary endpoint was to evaluate long-term effect of GA on relapses and disability progression.
Secondary endpoints were
(1) time to EDSS4, 6 and 8
(2) compare the disease course in ongoing patients vs. those who withdrew from the study
(3) analyze reasons for treatment discontinuation.
Patients were aged between 18-55 years, had experienced two or more relapses in the previous two years and had EDSS disability score below six.
This trial did not compare survival curves for the responders and nonresponders.
Also in the trial, patients discontinued treatment after an average of 3.7 years which is quite long as studies have shown significant dropouts from therapy in the first 2 years and sometimes within the first 6 months.
Apart from changes in relapses, the important issue of prevention long term disability, shown by the fact that 76% of patients who remained on GA were still walking unaided after an average of 20 years of disease duration, is a very good outcome (I mean if you are an MS patient, not a Teva shareholder).
Best, genisi