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This could mean (based on mechanistic similarities), that other potential drugs in this class, such as liraglutide, will face similar labels requirements.
One more important Copaxone trial presented at ECTRIMS:
"The impact of Glatiramer Acetate on progression of disability over a decade of continuous therapy".
http://biz.yahoo.com/bw/071012/20071012005398.html?.v=1
Only thing I could spot there was this
Good choice to go underwater. That's what I call ocean view.
You forgot the npr.org popup this time :)
Piece of cake.
This one required an hour or so.
Fred, if that's what it takes to get you down here, we're going to rearrange the hotel so you can have a room with a view.
Can-Fite announced today that it will receive a $500,000 milestone payment from Seikagaku Corporation after submitting
the CF101 phase IIb results for the RA indication.
Guess the Japanese don't think the placebo effect in that trial is critical.
I think the FDA will eventually approve Tysabri for Crohn's disease but with a limited label (later-line patients, particularly those who have failed prior immunosuppressant
or anti-TNF therapy).
100,000 patients on Tysabri for both MS and Crohn's, I doubt that unless no new cases of PML will occur and no better therapies will make it to the market in the next 3 years.
Nothing's right in my left and nothing's left in my right :)
These vaccines are not in use here. Are any of them sold commercially in the US?
Thank you, I will pass the info but I guess these vaccines are not used broadly (Not in Israel for sure).
Fred, I finally got to talk to my immunologist friend who is also a vet and knows the biopharm area. Not surprisingly, he never heard of Cytogenix or its synDNA technology platform for vaccine production but much to my disappointment, he is not aware of any commercial DNA vaccines in the domestic animal arena and has very little faith in DNA vaccines. There are two other immunologists I know and will ask them when I'll get the chance, this may take some time so don't hold your breath. Sorry I couldn't add anything of importance. Regards, Idit
Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for TYSABRI(R) for Crohn's Disease
DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) and Biogen Idec (NasdaqGS: BIIB - News) today announced that the U.S. Food and Drug Administration (FDA) informed the companies that the Agency will extend its regulatory review of TYSABRI® (natalizumab) as a treatment for Crohn’s disease by up to 3 months.
The companies have been informed by the FDA that the Agency requires additional time to review information regarding the proposed TYSABRI risk management plan for Crohn's disease. Under this revised timeline, the companies anticipate action from FDA on or before January 13, 2008.
Any withdrawal symptoms?
I mean apart from the obvious one which is a dramatic decline in your daily average post production on iHUB:)
Aha! a man who appreciates the true qualities of life :)
How's your detoxification coming along Dubi?
I thought many British musicians move to the US for tax reasons.
If so, they must have been listening to your accounting professors in college.
True, but better late than never. CGEN had theirs earlier and still nothing.
They are Brits!
Could be interesting to try the other way around, even if that means to pay taxes.
Citi: Teva's Copaxone undisturbed by trial versus Rebif
Citi Investment Research rates Teva "Buy" with a $52 target price.
Globes correspondent 10 Oct 07 17:41
Citi Investment Research has publisheda review of Teva in the light of a study by Merck KGaA which pitted Teva's multiple sclerosis drug Copaxone against its Rebif. "Results from Merck KGaA's REGARD study missed the primary endpoint, failing to prove the company's multiple sclerosis drug Rebif superior to Teva's Copaxone," Citi analysts Andrew Swanson, Andrew Finkelstein, and Sara Moreno report.. The data will be presented at European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
"Although the data favored Rebif and a secondary endpoint was met, we believe there is no damage to Copaxone because it is already viewed as less effective than interferons like Rebif. Copaxone's position as a drug that can be used in interferon failures, that has a relatively benign tolerability profile, and that is somewhat less expensive is undisturbed, in our view," the report continues.
"The re-entry of Tysabri at a premium price allowed Teva to take a hefty Copaxone price increase but remain the low-cost option. After a price benefit in 2007, Teva benefits from improving economics in 2008 and 2010 as the Sanofi co-promotion ends. Thus, we expect Copaxone to contribute to Teva's growth even with modest volume gains," the analysts write.
Citi gives Teva a "Buy" recommendation, with a $52 target price. This compares with a current price on Nasdaq of $43.89. "We believe Teva's current valuation is insufficient reward for the advantages of its scale," the Citi report says.
Published by Globes [online], Israel business news -
Optimata Shifts Business Emphasis
Executive Q&A By John Russell Bio-IT World, Oct 10
Founded in 2000 by bio-mathematician, Zvia Agur, Israel-based Optimata has spent the intervening years developing its Virtual Patient platform, a simulation engine for drug development and for delivering personalized medicine. Last October, Optimata reported results of a proof-of-concept project with cancer researchers at the Nottingham City Hospital, U.K. The Virtual Patient platform was able to predict breast cancer patients' response to chemotherapy drugs with 70 percent accuracy - substantially greater than many physicians using the same data. Another pilot with Lilly , this time supporting development of a new compound, went well, and Lilly extended its collaboration last January.
But turning its solid science into profit has been a challenge, as it is for many firms whose main business is fee-for-service. Now Optimata is changing gears. The company won't abandon fee-for-service, but it will concentrate on drug development, focusing on cancer compounds that made it through Phase 1 but failed for other reasons. CEO Guy Malchi talked with SBNL editor John Russell about the change and steps needed to make the move successful. (See Optimizing Optimata, Bio-IT World, November 2005, for more company background.)
JR: Why is Optimata shifting its business model, and what is the shift?
Malchi: Well, we believe that the majority of the value will be created from having some royalties on products or other ownership position, right? I'm telling you something you already know, how difficult it is to create value in the systems biology space these days. And we are trying to learn from other people's difficulties and build on the confidence that we gathered in the last year and a half from our clinical collaborations and commercial collaborations.
We learned that in practice the Optimata Virtual Patient technology is capable of navigating direct drug development into the right direction. So we want to be able to capture the value that it creates, and I believe we have identified what we hope is the sweet spot, which means to try to identify these oncology compounds that were proven to be safe in man, so passed successfully Phase I.
We would then license them after, of course, a very meticulous screening process in trying to see the fit of our technology to try to do something with this compound. We will license them and use the Virtual Patient to find a new direction in terms of indication, patient population, drug regimen, and then actually go out to carry out the Phase II that's to validate our prediction. With a view of being successful, we will be able then to out-license the compound.
JR: You wouldn't take it through Phase III, though. At Phase III you'd pass it to someone else?
Malchi: I think this is the general idea. We are [also] hearing some suggestions of different sorts. A lot of people are saying, since Optimata, as you're well aware, has very good modeling capabilities on the toxicity side, we should be able to deal with compounds that actually did not reach Phase I or failed Phase I. As a drug salvage mode, we can do that as well. I think the reason we're deciding not to start there is just from in terms of investment appeal for people who are able to see a quick turnaround time for a given compound, but we are definitely going to explore that [later].
JR: Why talk about it now, and what steps have you taken to move forward?
Malchi: We decided to talk about it because we've made some progress. The first thing [we've done] is to actually screen the database of failed compounds in oncology. We started with more than a thousand, and I can tell you that we have now a list of less than a hundred compounds that we believe that we can re-purpose, and are in the process of approaching those companies. This actually will begin this month. The second thing is we recruited a vice president who has some experience in biotech, from the Israeli biotech industry, who is taking charge of this effort.
JR: Are some of the companies who own those compounds also companies with whom you already do business?
Malchi: Yes.
JR: How soon do you expect to actually license some compounds?
Malchi: Well, this is a key question. So some of them [companies] will brush us off and will not be interested to talk to us at all. Some will be very keen. I would hope that we're talking about a matter of months. I can't exactly put a number to it. Obviously, with companies that we work with, the discussions are more direct to the point because we know exactly who we need to speak to.
JR: I assume you've initiated some discussions already?
Malchi: We are progressing in some, yes.
JR: Who is the new VP?
Malchi: His name is Dr. Alex Chausovsky. He's known in the Israeli biotech community. He used to be a vice president R&D for a company called Zetiq, and a company called NVR. He brings in his industrial expertise in terms of preclinical development and even into the clinic.
JR: Are there particular areas in the oncology space you'll focus on?
Malchi: At this stage it's easier to say where we are not going to target, and I don't want to expand too much. But at this point, we're less interested in immunotherapeutics. We have been and are working on all the rest, so small molecules, targeted therapeutics, certain antibodies, cytotoxics, cytostatics, you name it, and combinations.
JR: How long have you and your colleagues at Optimata been discussing this business shift?
Malchi: I joined Optimata in order to find a business model that will work. That's the reason I joined, which was in early 2005. It took a long time to analyze what's going on out there in terms of how to create value. The first thing we wanted to do is to engage with companies that would benefit from the technology in order to make it not a theoretical exercise but to understand exactly the needs of the other side of our partners, and also understand our capabilities versus those needs. Last summer we completed this analysis and developed this new strategy. It took us over a year to prepare it in terms of the screening and the recruitment and so on, and now we are ready to march forcefully into it.
JR: Will more funding be needed as you move forward?
Malchi: I don't believe that we would be able to finance Phase II on our own, and this is something that would require financing as we have compounds ready to be licensed.
JR: As I understand Optimata's Virtual Patient platform, it's a very powerful tool in terms of evaluating drugs based on their pharmacokinetic and pharmacodynamic properties, but it has little connection to genomics of the patient. Yet increasingly in oncology, using genetics and biomarkers surrounding genetics to identify responders and non-responders is important. Is that still the case with the platform?
Malchi: We are using genetic information as input. I can say that it is something that we are doing indirectly. It's fair to say that the technology is designed on the protein level, not on the gene level. And again, the reason being is that so many attempts in terms of gene expression have not materialized on the protein level. So we're remaining on the protein level. However, if there are some specific gene expression data that are relevant to, let's say efficacy data, we have a way to, let's call it, manipulate it as input into the system.
JR: Can you mention companies to whom you're talking about their compounds?
Malchi: I prefer not to because it will just raise their price.
JR: One emerging trend in the broad modeling systems biology space is the effort by companies to have some laboratory capacity so they can conduct experiments. Optimata does not have a wet lab. Are there any thoughts about acquiring wet lab capability?
Malchi: No. You can never say never, but currently I find it highly unlikely that we would set up a wet lab on our own. We are leaving some room in our financial plan to include some extra preclinical experiments we would like to complete on a particular compound that we feel are needed, but it's quite minor.
JR: How will the near-term effects of the shift affect Optimata? Will the company grow?
Malchi: The company was around 20 when I joined. It went [down] to around a dozen. It climbed up in less than a year to 20. Probably we would grow to, I would imagine, between 30 and 40 people, something like that. We had to change the DNA of the company from a company which is science-based, science-oriented, to a science-based marketer-oriented organization. We had to grow our bio-simulation group to enable us to invest also in our modeling group. I think that the most important thing is that we would like to eventually set up a base in the U.S., on the East Coast somewhere, because that's where the party is. That's where the merchandise [compounds] that gains dust in the archives is.
JR: Do you have any full-time presence in the U.S. now?
Malchi: No. I'm here [in the U.S.] about one week in a month, and it's not enough. We're working very hard to bring on a very good American consultancy to help us in that respect [but] haven't signed the contract yet, so we can't say who yet. But that's, again, an interim solution. We need to put someone on the ground here, and I know there are very good people that could help us, and this is something we need to work - continue to work on.
JR: What do you see as the biggest challenge?
Malchi: That's a very good question. I think the biggest challenge is the fact that we need to continue to enhance our core competency, whilst introducing completely new capabilities into the organization, because to carry out Phase II is a totally different ballgame. You need to bring in regulatory and clinical expertise. You need to have a very strong handle on pharmacology. We'll have to bring [these] in, and for some of them we'll use consultants. Israel is very good in drug discovery - you don't hear a lot about that and I hope that will change - but we don't have a lot of clinical development expertise. It means that the pool of knowledge in Israel is limited, and we have to look outside.
JR: Will Optimata still pursue fee-for-services kinds of collaborations?
Malchi: The answer is absolutely. I had a very interesting chat with Keith Elliston [CEO] from Genstruct [another modeling firm] and we actually share very similar views about how little value [for us] is created with so much effort from our side. I think that the fee-for-services, or let's call it the collaborations with biotechs and big pharma, are important to us. They continue to establish our name and to recognize our brand. And I must admit we also learn a lot from them.
JR: Who are you currently collaborating with?
Malchi: The two companies we can mention are Eli Lilly and BioLineRX, which is really the most promising Israeli biotech company. They have now 14 projects working, I think three or four already in the clinic. They are very fierce in terms of dropping projects early and bringing new ones in. We have a relationship with this company not only in the field of cancer but also something else that is quite new for us. We worked with them on their leading compound in schizophrenia.
JR: What haven't I asked that I should about this shift in emphasis for Optimata?
Malchi: I think the most important thing for us right now is to have a good first compound that we will bring in - let's call it renavigate and out-license. Because if this out-license deal is successful, we will basically show the world it works. It doesn't really matter if I split my royalties with a partner.
JR: Is that something that will take two, three years to do?
Malchi: Yes, that's it. We're benefiting from that respect because oncology, out of all the leading therapeutic areas, requires the least amount of patients in a Phase II trial in order to demonstrate efficacy. And the time that it takes, it depends. It's usually exactly that. It's around two and a half years. And we would, of course, try to practice what we preach in terms of designing a trial that will be agile and nimble and all of these nice adjectives
By all means.
(and tax free)
Or that
This report, by its very length, defends itself against the risk of being read
It gives the perspective of the HHS on the past and (mainly) future work (who is doing what) that lies ahead to achieve personalized health care.
The Health and Human Services Department (HHS) report on personalized health care. (more than 60 pages).
http://www.genome.gov/Pages/Policy/PersonalizedMedicine/DHHSReportPersonalizedHealth.pdf
Oh please let me watch when you do so.
Great post Larry!
Do not hesitate to contribute more of this kind :)
In this case, I would recommend that you do the talk and kill the messenger.
Sorry for interfering but why don't you guys try google talk or messenger?
idit
TEVA ANNOUNCES APPROVAL OF GENERIC ACTONEL®
http://maya.tase.co.il/bursa/report.asp?report_cd=299419-00&CompCd=629&Type=Pdf
Jerusalem, Israel, October 8, 2007 – Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA)
announced today that the U.S. Food and Drug Administration (FDA) has granted final approval
for the Company's Abbreviated New Drug Application (ANDA) to market its generic version
of Procter and Gamble Actonel® (Risedronate Sodium) Tablets, 5 mg, 30 mg and 35 mg.
Teva’s AB-rated Risedronate Sodium Tablets are indicated for treatment and prevention of
postmenopausal and glucocorticoid-induced osteoporosis, and treatment of Paget’s disease.
The brand product had annual sales of approximately $1 billion in the United States for the
twelve months ended June 30, 2007, based on IMS sales data.
Teva is currently in patent litigation concerning this product in the U.S. District Court for the
District of Delaware. A trial was held in November, 2006 but a decision has not yet been
reached. In connection with the pending patent litigation, Teva agreed to provide 30 days
advance notice to Procter & Gamble of any launch activities and has not yet provided such
notice.
As the first company to file an ANDA with a Paragraph IV patent certification, Teva has been
awarded 180 days marketing exclusivity for this product, which will begin to run from the date
of commercial marketing.
About Teva
snip
Teva receives tentative FDA nod for generic Valtrex
Final approval to market the generic drug is expected in December 2009.
Globes' correspondent 7 Oct 07 9:23
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the firm to market its generic version of GlaxoSmithKline's antiviral product Valtrex (Valacyclovir Hydrochloride) Tablets.
Final approval of Teva's application is anticipated in December 2009.
The brand product had annual sales of approximately $1.5 billion in the United States for the twelve months ended June 30, 2007, based on IMS sales data.
Antiviral drug Valtrex is used to treat genital herpes, shingles, and cold sores.
Shares in Teva were unchanged on Friday in Nasdaq trading, closing at $43.84. The price gives the generic pharmaceuticals firm a market cap of $33.4 billion.
Published by Globes [online], Israel business news - www.globes.co.il - on October 7, 2007
Topspin Medical applies to FDA for IVMRI catheter approval
The intravascular MRI catheter won EU CE Mark approval a few months ago.
Erez Wollberg 7 Oct 07 10:25
Topspin Medical Inc. (TASE:TOPMD) has applied to the US Food and Drug Administration (FDA) for marketing approval for the company’s first-generation imaging intravascular MRI (IVMRI) catheter. The company has completed laboratory tests, preclinical and clinical trials for the catheter.
Topspin CEO Yaron Tal said, “We’re pleased to announce that we’ve applied to the FDA for marketing approval for the IVMRI catheter in the US after completing all the tests and trials necessary for the application. FDA approval will give the company access to the US market, which is the largest market in the world for invasive cardiology procedures.”
In July, Topspin signed a distribution agreement for the IVMRI with Johnson & Johnson Israel, under an exclusive three-year contract. Topspin did not disclose the terms of this contract. The IVMRI catheter won EU CE Mark approval a few months ago.
CIBC raises Omrix Q3 profit forecast
The bank reiterates its target price of 14% over Friday’s close for the Israeli biotech firm.
Erez Wollberg and Globes’ correspondent 7 Oct 07 13:56
CIBC World Markets has raised its third quarter sales forecast for Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to $12.1 million from $11 million, and doubled its and earnings per share (EPS) forecast to $0.08 from $0.04, thanks to an early launch of Evithrom. However, the bank has lowered its fourth quarter sales forecast for the company by $1 million, and kept its 2008 forecasts unchanged. The bank notes that its forecasts do not include a second drug, VIG, which provides a likely source of upside, possibly as early as the fourth quarter.
CIBC reiterates its “Sector Outperformer” for Omrix with a 12-18 month target price of $43, 14% above Friday’s close of $37.95. CIBC also notes that Omrix has been a strong performer, rising 30% since August, but there are “some interesting developments that keep us positive in the long term.”
CIBC noted that “Evithrom (Thrombin) was launched in September in the US, and that Johnson & Johnson (NYSE:JNJ) is aggressively mobilizing its sales force ahead of a possible approval for ZymoGenetics Inc. (Nasdaq: ZGEN) in January, and that Johnson & Johnson is pricing at a notable premium to King Pharmaceuticals Inc. (NYSE:KG) Thrombin JMI.
“As for VIG, a bid by Omrix to the French government was submitted and a decision is coming later this month. Cangene Inc. (TSX:CNJ; Pink Sheets:CGNOF) is the only other competitor and Omrix’s chances look good… We estimate the contract size at $20 million over 18-24 months.”
CIBC predicts that Omrix will post a net profit of $8.5 million on $51.7 million revenue in 2007 and a net profit of $29.4 million on $86.7 million revenue in 2008.
Published by Globes [online], Israel business news - www.globes.co.il - on October 7, 2007
Protalix road show underway
The company will offer 5% of its stock at a value expected to be between $800 million and $1 billion.
http://globes-online.com/serveen/globes/docview.asp?did=1000260654&fid=942
Gali Weinreb 7 Oct 07 19:30
At the end of last week, Protalix BioTherapeutics Inc (AMEX: PLX) published a prospectus for a first offering on AMEX of about 5% of its share capital. In addition, existing shareholders will make an offer for sale amounting to about 1.7% of the company.
On the basis of the company's current market cap, it will raise some $121 million, while the offer for sale will be worth $37.4 million. However, the offering will probably not be made at the current valuation, which partly derives from the deal in which the company was merged into a stock market shell. The price remained at that level among other things because of the low liquidity of the stock (less than 1% of the stock is marketable). Nevertheless, a year after the merger, it can't be said that the $2.2 billion market cap is solely based on that deal. Someone on the market has been buying shares at that price every day, even if in low volume. It is estimated tha the company will seek a valuation of $800 million to $1 billion in the offering, but there is no telling what the final price will be, or even if the offering will succeed, until the response of the investors is known. The lead underwriters are UBS and CIBC.
If the prices being mentioned on the market are correct, Protalix will raise $55 million, and the offer for sale will bring the shareholders $17 million. Although the offer for sale is small, on the basis of this scenario the shareholders show large gains on paper. The most recent investor in the company, Philip Frost, will make a tenfold return on his investment if the offering is at this price.
Shares of Biocell (TASE: BCEL) (formerly Orazit Ltd.) and Marathon Venture Capital Fund (TASE: MARA), which own 20% and 9% of the company respectively, fully diluted, have risen since the road show began. Biocell, whose only holding is Protalix, is traded at a market cap of NIS 414 millon, which implies a valuation of $1 billion for Protalix.
There must be a way to unteach your student,
erase his memory perhaps :)
PLX on a roadshow here in Tel-Aviv and its holders (Biocell, Marathone and Biomedics) are flying today at TASE (15%, 11% and 7% respectively).
Thank you Tzafi for a nice example of the Homo erectus.
I liked the Zobur pic the best, you have a certain humble, sweet expression there.
Satisfied or not I will modestly pass on your kind offer as I'm having enough nightmares imagining my kids riding motorcycles and/or jumping off cliffs.
Have a great week, Idit
Please read again your own post #msg-23460482,
this time not under the influence of those green chemicals :)
"if you look good on the HUB you can find pic` of me"
I meant a link to your pic.
tsafi you're not even barking up the wrong tree, you are in the wrong forest. My post was not addressed to you and I can't imagine anyone on the board and beyond, ever thought you look like that pic, dead or alive :)
Just in case, why don't you link a real one?