Yesterday The Globes published a 3 page article about PARS,
the official translation is not yet issued,and herewith
an unofficial translation ,quite reflecting its essence;
Gytit Pinkas Globes, December 8 by: isrdeu 12/08/04 08:09 am
Msg: 116855 of 116888
Marijuana with a 1B$ potential
The Poker game of Pharmos, the dream that launched it by hundreds of percents and dropped it with steep measures, is nearing the last line. Until the end of the year it will be cleared which route its Dexanabinol drug for TBI treatment is channeled. If Pharmos will pass this hurdle successfully,the sky is the limit.
By Gytit Pinkas Globes, December 8, 11:02 Tel Aviv
Time is almost up. The poker game of Pharmos, the story accepted almost as binary one, the dream that launched it by hundreds of percents and dropped it with steep measures, is nearing the last line.
Until the end of the year the code of the phase III of the clinical study with its Dexanabinol drug to treat TBI in the hours after the trauma, is due to be unblinded, and this is the event that the company warms engines since the ninties and maybe even earlier. If Pharmos passes this hurdle successfully, than at the first half of 2006 it will start marketing the drug and from there on the sky is the limit.
Professor Chaim Aviv, Chairman of Board, the CEO and its CTO and as one most identified with Pharmos than anybody else, does not agree necessarily with the definition we attached to the company, “A binary almost story”, and does not agree with the estimations widespread the market along the years by which the significance of the results of the Dexanabinol for the company are to live or die. “We have so many other things in the pipeline”, he says. “It is true that the importance of the Dexanabinol and the indications to be derived of the study results are central, but despite that, Pharmos has in stages of work other development items less prominent, and therefore I don’t want to raise high expectations on one hand, but on the hand I really do not agree with the definition”.
This way or otherwise, one thing is beyond doubt: if results will be positive and statistically significant, by the book, Pharmos enters through front door into a promising market of one billion Dollars per year worldwide or 500 million Dollar in the USA. If the study fails or partially succeeds, it will be difficult to realize the dream pillar of the company, Pharmos will retreat three years back and shrink back into a miniature start-up dimensions. And if it happens, the prime economists and analysts, that back this company today, will find difficult to justify a market cap of 320 million Dollars.
Three scenarios
Teva is acknowledged as the “people’s share”, and in a small scale Pharmos too gains popularity. Everybody speaks about it, everybody heard about it, and everywhere you’ll go you’ll find someone that invested in it. He will be glad to tell you how he bought it in 1995 at 1 Dollar pps, or how to his grief he caught it at the climax of 13.5 Dollars at the Nasdaq 5000 days. How many of the investors know what is Dexanabinol is of minor importance.
The coming weeks are one of the most crucial periods for the company historically, and the fact we are here is compelling an examination of three scenarios. The first one we shall title the clear skies scenario, where statistically significance is proved and the company shall submit the Dexanabinol to treat TBI for FDA approval. The second one we shall title partly cloudy with scattered showers where significance is proved but not along all the study’s route, and the third one – skies overclouded and torrential rain. No proof, no significance, hopes are hoarded and the curtain falls.
Last years Aviv did not spare investors with his vision that includes very large hopes and the converting the drug discovering company he manages into a giant company.
“The optimistic scenario is that we shall get statistically significant results for phase III, within one year of this occasion we shall apply for FDA approval for the drug and half a year or maybe a year later the approvals shall be granted”, says Aviv. “The mid scenario speaks about results not significant statistically. There is the possibility that part of the sub-populace will not support the expected results or results will be partial that the conclusion of them will be that the development of the drug is worthy, but its horizon will be drawn away in to more years. Additionally, in such a case there is a chance that we shall have to repeat phase III partially or in full scale”.
The worst scenario, that by estimations its likelihood is the lowest, is that no statistical significance is proved at all. “There were already cases where phase 2 of study was successful and phase 3 aborted the procedure”, he says. Beyond that, I do not think that if Dexanabinol for TBI fails there is no future for the company. It should be remembered that we are developing other products, but it is true that Dexanabinol is the most advanced and it has implications for shortsighted investors. The work we do is to create more assets is enough to justify our value even without the TBI”, he assumes.
And what if this scenario becomes real? “Even then, it is impossible to degrade our experiencing the procedure, the capabilities that the company has and the 60 million Dollars that we have, but I flatly agree that such a situation will withdraw the company two to three years backwards. People must know that the warning notes we insert within our documents are not legalistic argumentations. There is no way ever to know whether the success will be 100%”.
Except the Copaxone of TEVA aimed to treat sclerosis, there never developed in Israel a drug with such public importance that reached to stage of sales and is recognized as “Blockbuster”. Although FDA approval was received also in the offices of Savient (SVNT) that BTW was founded by Aviv, or the Interferon of Serono which is an Israeli invention (while sales were not by Israeli company) or for example the biologic glue of Omerix. But an such enormous effort aimed for such huge market at such promising stage there is none except the Copucson.
Professor Aviv an expert of molecular biology in Weizman Institute, was partner when company was founded 1990. Ten years before, he was partner in founding the Biotechnology company that many years crowned itself the obligating crown of “The only Israeli biotechnology profitable company” –Savient (SVNT), -named BTG in the past. One of Aviv’s hobbies is investing in Israeli biopharmaceutical companies that all of them he exposes. He is the major share holder of Avitech, a member of the Ben-Gurion University board of Beer Sheva and also in Yeda the commercial body of Weizman institute.
Back here and now: In coming weeks the weighted results of the study will be published, that encompassed 860 injured patients at near 70 medical centers. Its conduct was in the standard of Double Blinded studies, meaning that none of the participating parties , including the implementing physicians and the company itself, has any information and it is beyond their capabilities to predict the over-all results. They even do not know which of the patients treated by them is administrated with Dexanabinol and which of them was “treated” by placebo. Therefore, none of the parties has the capability to extrapolate the data.
A market of billion Dollars is certainly enormous mainly where there is no any drug that supplies solution to TBI and therefore Pharmos was granted many alleviation graces by the FDA. The thumb rules speak about a gross profit that will be 85% of the sales and a net profit of 35%-40% of sales. And if so, we are speaking about huge net profits – a potential of 350-400 million Dollars for a company under the assumption of full market penetration. These figure are airy and not real, but are the hope of investors.
Other products under development
The competition to the drug is very limited and at this stage does not exist at all. “We have a five year advantage at least compared to other companies”, says Aviv when asked about competition, “No chance that there will be someone else in our trail”. Pfeizer and Bayer, both in the frame in the past, and today, as much as known, Bayer finished Phase I study with a drug (named BAY 387271) but there is no clarity about how much it is advanced.
The pile up of developing products includes the next generation the Dexanabinol, aimed to treat patients with cognitive damages that were bypassed, where its phase II study results are defined by Aviv as “Impressive and promising”. Those looking for a short termed success with this drug, better shall do it at other places, since only in five years period it will be actual to discuss its being a drug to be marketed, and in any case, in sight of its early stage the risk level is high.
The hopes of investors are high also with the drug of Pharmos aimed to treat pains, a territory related by the Viox drug removed lately of the shelves. The company performed pre-clinical studies (the temporary name of the drug is PRS 211.375) and hopes to enter phase II within half a year. There definitely exists the opportunity that Pharmos will be compelled to broaden the scope of the first phase of studies or repeat part of them – uncertainty no drug can avoid. The 375 is an imitation of the Cannabis and at the beginning the drug will be tested with cancer patients or patients that suffer sever backaches, so it also supposed to help in attenuating inflammatory processes.
Pharmos is also involved with a research about the whole spectrum of materials that communicate with receptors and works about further Cannabis mechanism molecules. In this regard we can comment that Sanupee company lately announced a drug originating with Cannabis as appetite suppressor, but here it is an antagonist compared to Pharmos drug that is supportive. Another promising domain that is seldom discussed by the company is the drug aimed for sclerosis where, as said is already present, the Pharmaceutical giant TEVA with the Copaxone that its sales rate is a billion Dollars per year. Everything Pharmos has in the pipe, as known, is specially long ranged – many years on. The Dexanabinol for TBI is the only that is at this stage at immediate touch.
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A long and insightful article with no real NEWS,and seems to me only published due to INCREASED interest in the ISRAELI market.
When/if official translation is issued,will post it here,
however no (major)difference expected.
Midas |
