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"my mom she is cool she don’t bug me too much"
Not even when you're base jumping or driving way too fast on that Harley?
tsafi there's plenty of time, many more places to see, lots of women to love. Don't hurry. In fact settling down in your state of mind would be a disaster. Now does that sound like your mom?
I'm sure tsafi is good in many things, so are we,
but we are much closer to our expiration date :)
tsafi is obviously too young to know that
(and we're old enough to know that perfect is a theoretical term)
Almost million shares were covered from Short Interest on Sep 14th
(someone lost a lot of money there).
http://www.nasdaq.com/asp/quotes_full.asp?mode=&kind=shortint&timeframe=&intraday=&c....
I think that the decline in the stock could have been a result of the 2 million share increase in short interest – selling pressure, and the increase in the stock price could have resulted from the buying pressure from short covering.
BTW Huge Volume of 922,200 (and 334,100 more AH) shares on Friday.
[This is still "at risk" launch and the IP validity of the active component will be ruled in court. Meanwhile, Teva has 6 month of exclusivity for the generic drug.]
Sept 28 (Reuters) - Teva said a U.S. appeals court denied Novartis' emergency motion for an injunction and it can now resume sales of its generic version of Novartis' herpes drug Famvir.
Guess it's one of those package deals ha?
OT- DNA markers and health care companies
I've just finished a fiction book called "Marker" by Robin Cook that deals with DNA markers in human population and how health care companies will have to deal with it in the future. He raises the possibility that since Health Care companies will have to insured the entire population in order to gain support and purchase more hospitals, there is a need to "eliminate" those carrying specific genetic markers that may require huge expenditure in future indications like cancer or heart diseases. The bottom line is that if health care insurance will not be nationalized, then we may expect the worst in terms of treatments because of costs and the abuse of genetic information for all kind of monetary considerations.
Training won't help unless you use neurosurgeon for the job...
No explanation other than the Y (why indeed) chromosome itself but there's a solution:
I sure hope so, but what about the strength of the ethical companies? They have dozens of patents and they will not give up easily. Will provide a lot of work for lawyers though.
I would think so and I guess that GSK agreed with them.
TEVA, GSK Settle US Patent Challenge on Avandia Franchise
>[The PR says Teva gets to launch generics “late in the first quarter, 2012,” which is exactly when pediatric exclusivity runs out on GSK’s 5002953 patent. Hence, it appears that the only concession by GSK is forgoing the additional exclusivity provided by the 5741803 formulation patent, which would have run out in 2015.]<
Claim 1 of GSK’s 5741803 patent compound refers to Rosiglitazone itself and its expiration date without extension is indeed 2015. So, if GSK agreed to give up 3 years exclusivity, I think they knew that the Rosiglitazone compound patent itself will not hold.
CIBC: Lev Pharmaceuticals
As of 9/27, we initiate coverage of LEVP at Sector Outperformer with a $3 tgt. We believe Cinryze, LEVP's C1 esterase inhibitor (C1-INH), will likely be approved in 1Q08 for treatment of hereditary angioedema (HAE), a small, Orphan indication. We expect LEVP to have significant pricing leverage.
LEVP recently reported positive results from 2 ph.III, placebo-controlled Cinryze trials, one in acute HAE and one in HAE prophylaxis. Cinryze demonstrated clear clinical benefits on all endpoints in these trials, with good safety. These results should be compelling to the FDA, in our view.
Other C1-INHs are in development for HAE, but we believe LEVP will likely receive 7 years of Orphan exclusivity in the U.S. for Cinryze. Non-C1-INH drugs for acute HAE could reach the market, but we believe LEVP will have 1st-mover advantage. In HAE prophylaxis, we believe Cinryze will dominate.
With the potential for Cinryze peak sales of $100M in acute HAE and $90M in HAE prophylaxis, we believe LEVP is an attractive investment opportunity at the current valuation. Our $3 price target is based on 30x our probabilityadjusted
2012 EPS estimate of $0.18, discounted 4 years.
FDA Rejects US Approval of Novartis Painkiller Prexige Used for Osteoarthritis
http://biz.yahoo.com/ap/070927/novartis_prexige_fda.html?.v=3&printer=1
BASEL, Switzerland (AP) -- The U.S. Food and Drug Administration rejected Novartis AG's application to approve the pain relief medicine Prexige to treat osteoarthritis, the Swiss pharmaceutical company said Thursday.
Novartis said it would continue discussions with the FDA, and believes clinical trials show Prexige has fewer side effects than other treatments.
Novartis was forced to remove the drug from the Australian market in August after two patients died and two others underwent liver transplants.
Prexige is currently sold in more than 50 countries, Novartis said.
Sales of the drug reached $52 million in the first half of the year, according to the company.
Shares in Novartis closed down 0.6 percent at 64.00 Swiss francs ($54.57) in Zurich.
Well look at the bright side, first there's more of you now, second you know who can lend you a space suit in case you ever feel like moon walking again.
Ha, I wish.
still owe you a ride someday but I see that you found an alternative way to go to the moon :)
Haha Dubi. On the topic:
A young magician started to work on a cruise ship with his pet parrot. The parrot would always ruin his act by saying things like, "He has a card up his sleeve" or "He has a dove in his pocket."
One day the ship sank and the magician and the parrot found themselves alone on a lifeboat. For a couple of days, they just sat there looking at each other. Finally, the parrot broke the silence and said, "Okay, I give up. What did you do with the ship?"
And for my own kind:
Why thank you Dubi, yours also fits you well, but not for long :)
You may but don't expect me to reply :)
A better bet is ido (long time nickname of mine).
Last time they spoke about their nucleoside CF102, was August 19, 2007. They said they completed the preclinical trials in collaboration with Temple University in Philadelphia which showed that CF102 is also active against the hepatitis virus. They want to start clinical trials by the end of the year.
I am going to meet with the company after the holidays, will add any more useful data provided at the presentation.
The simple truth is they don't know why their prGCD came out with the correct glycosylation (unlike GENZ's product from CHO that needs further post-translational modification). PLX were extremely lucky this time but they are well aware of the glycosylation issue.
Protalix files for shelf offering of 5.7 mln shares
Mon Sep 24, 2007 9:45am EDT
Sept 24 (Reuters) - Protalix BioTherapeutics Inc (PLX.A: Quote, Profile, Research) said on Monday it may periodically sell up to 5.7 million shares.
The company intends to use the proceeds for research and development expenses, clinical trials, establishing an internal sales force and general corporate and administrative purposes, it said in a filing with the U.S. regulators.
Under a shelf registration filed with the U.S. Securities and Exchange Commission, a company may sell securities in one or more separate offerings with the size, price and terms to be determined at the time of sale. (Reporting by Esha Dey in Bangalore)
Teva was not included in this piece but it is interesting:
Industry Audit 2007
Our sixth annual report dives deep into the numbers to discover the industry's true top performers—and how the cookie really crumbles
Sep 1, 2007 By: Bill Trombetta Pharmaceutical Executive
http://www.pharmexec.com/pharmexec/content/printContentPopup.jsp?id=455802
For the sixth year in a row, Pharm Exec invites Professor Bill Trombetta of St. Joseph’s University to analyze the pharma industry's financial performance with a battery of business metrics, old and new. The highlights: Genentech pulls ahead of its longtime rival, Amgen. Forest delivers another strong performance, despite dropping revenue. Schering-Plough is building enterprise value. Biogen Idec racks up a stellar profit margin. And Merck? Well, Merck is back, baby. And the winner is…
Pharmaceutical Executive's Sixth Annual Industry Audit analyzes the 2006 performance of 16 companies that are publicly traded on stock exchanges and file 10-K reports with the Securities and Exchange Commission (or 20-F reports, in the case of foreign companies). As in past years, the audit goes beyond standard accounting and financial statements, drawing on newer and—arguably—more meaningful metrics, such as sales per employee and percentage of income driven by intellectual capital. Data were gathered primarily from 10-Ks and 20-Fs. In addition, we consulted databases, such as finance.yahoo.com and Hoovers, and secondary sources, such as Fortune, Business Week, In Vivo, the Wall Street Journal, and the New York Times.
Methodology
Aiming to compare companies' performance, this report omits a few companies that are or appear to be publicly traded but that are not comparable with the rest of the group: extremely diversified firms (such as Procter & Gamble), narrow-focus companies (such as Novo Nordisk), companies that manufacture primarily generics (such as Teva), firms with unconventional ownership structures (like Roche), and companies whose financial reporting doesn't mesh with US standards (like Japanese drug firms).
Companies were assigned scores based on their rankings over 15 metrics. The company that ranked first in a given metric received a rank score of 16, the second place company had a rank score of 15, and so on.
Not all metrics are equal. Some charts have been included to provide context, but they didn't factor into the rankings. The rest were weighted from 3 to 7, with 3 reflecting the lowest and 7 the highest weight. For example, if a company received a score of 12 out of 16 on a metric weighted at 5, it would receive 12 times 5—60—points. A company's points over each of the metrics were then totaled for a final score.
Drug Revenue
Once again, Pfizer leads the pack at $45.1 billion, and Biogen Idec brings up the rear at $1.8 billion.
The key point here is not absolute revenue but change in revenue. Maureen Dowd, in her weekly New York Times column, reminded us of the importance of growth. She recalled the classic Woody Allen movie Annie Hall, where Woody Allen's character says to Diane Keaton's character: "A relationship is like a shark. It has to constantly move forward or it dies. And I think what we got on our hands is a dead shark." Some companies in our sixth annual report are resembling dead sharks. Grow or you die.
Three firms—Bristol-Myers Squibb, Abbott, and Forest—dropped in drug revenue, and another five failed to hit the average growth rate of 8.3 percent. It is important to note that the Price to Earnings Ratio reflects expectations of future earnings growth (see page 90). That growth can come from higher sales, increased profit, or both. But today's investors seek evidence of top-line growth and the quality of those top-line sales numbers. Profits that come from cost cutting and ever-increasing efficiency are not as valuable as earnings that come from internal, organic sales growth, because sales revenue increases are considered more sustainable.
You might think it's tough to produce revenue growth if you are Pfizer at $45 billion in sales or GSK or Sanofi-Aventis. Consider GE and Procter & Gamble, at $160 billion and $72 billion revenues, respectively. Yet each company seeks, and is achieving, organic growth: GE at about 8 percent and P&G at 4 to 6 percent. That means that GE has to come up with $13 billion of new revenue a year and P&G, almost $4 billion. That makes Pfizer's and GSK's situations look like a day at the beach.
It is a breath of fresh air to see how Jeffrey Immelt, the CEO of GE, imagines growth: GE has a $17 billion healthcare business that competes in a $4 trillion industry that's growing 8 percent a year; he thinks GE Healthcare can grow 8 percent a year. In the United States' $13 trillion economy, Pfizer's $45 billion is a grain of sand in the desert.
Enterprise Value
If you were alone on an island and could bring only one metric with you, Enterprise Value would be it: The Mother of All Metrics. Enterprise Value takes into account a firm's market capitalization (number of shares outstanding multiplied by the price of the stock on a given day) plus liabilities minus cash, or about what it would take to buy a company. Enterprise Value to Sales (that is, Enterprise Value normalized for scale) and Change in Enterprise Value are critical metrics.
Schering-Plough, Merck, and Abbott set the pace in Change in Enterprise Value, while seven of the Sweet Sixteen saw shareholder value erode in 2006.
Meanwhile, in Enterprise Value to Sales, Genentech—at 9.39—is double most of its peers.
Gross Margin
Gross Margin tells you how good you are at pricing. The higher it is, the better. And no industry sports higher gross margins than the drug industry. Biogen Idec serves as the yardstick for 2007, with a GM of almost 89 percent, followed by Genentech and Amgen. No surprise here, with the three classic biotechs capitalizing on super-high-priced biologics. And then Pfizer—noted for never, ever competing on price—comes in at number four. With the average GM for the Sweet Sixteen at 75 percent, note how Abbott and Schering-Plough continue to struggle in pricing.
But the interesting pattern here is how stiff the rankings are from year to year. That is, the placements are almost identical from 2005 to 2006 with minor flip-flops here and there. The significance of this is that there is no price competition among the big pharmas. If I can spot this, so can the Department of Justice and every state antitrust section very concerned over very high drug prices and the absence of any price competition (except for the generics). The recent conviction of three drug firms on reimbursement overcharges should be a wake-up call to the industry to make pricing a strategic priority and not just a tactical routine.
Return on Assets
When you multiply the profit margin (Profit/Sales) by Sales/Assets, you get a very important metric: Return on Assets, or Profit to Assets (P/A). Remember the old chestnut about a triple threat in football: someone who was good at passing, running, and kicking? The point is that it is difficult to excel in any one of these skills, let alone two or three. Pharma should look for the Double Threat: excellence in margin management (P/S) and asset management (S/A). It is tough enough to excel in just one of these metrics, so special recognition should go to those firms that do well in both, resulting in superior performance.
Forest is in a class by itself in asset management and just average on margin management, but the strong performance on Sales to Assets propels it into first place overall on Profit to Assets.
Genentech has really kicked up performance in Sales to Assets since last year, along with its high gross margin and margin management, placing the company third in Profits to Assets.
Johnson & Johnson is mediocre at margin management and weighed down a bit by lower margins on the 30-plus percent of revenues accounted for by OTC. But its strong second-place ranking on S/A take it to number four on Profit to Assets.
Sales Per Employee
This metric is difficult to manipulate—there's no smoke and mirrors here. Just a basic ranking of which company does the best job at getting the most out of its employees. The biotechs win hands-down here, with their 80 percent markups and $50,000-a-year biologics using small sales forces to call on niche specialty physicians. Having said that, note Forest's outstanding performance coming in third. Pfizer is the best major pharma in productive employees at fifth place, followed by J&J. Just as an interesting point of comparison, IMS's employee productivity is approximately $400,000 per employee.
Return on Invested Capital
If you were stranded on your island but you could have a second metric, it would be return on invested capital (ROIC). Return on Investment is a lot like family values. It is in the eye of the beholder and just as difficult to measure. But ROIC does cover some hard measures, like the cost of debt and of stock (like the classic Stern Stewart Economic Value-Added rationale). In other words, if you put EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) over total debt plus value of common stock, that return should at least cover the Weighted Average Cost of Capital (WACC). Given the approximate WACC at around 12 percent, a number of the Sweet Sixteen are not enhancing shareholder value. The average ROIC of the Sweet Sixteen is 12.7 percent for 2006. Forest is out front at double WACC, followed closely by J&J and Pfizer. If a company is not at least covering the weighted average cost of capital, it is destroying shareholder value.
Which Big Pharma Is the "Smartest"?
In an industry driven by innovation, we need a metric that takes into account a company's intellectual capital. Such a metric would encompass the value of drug brands, the corporate brand, the pipeline, and other indicators of innovation that may not be limited to technology or science.
One such approach is based on the work of Baruch Lev, an accounting professor at New York University's Stern School of Business (see "Accounting Gets Radical," Fortune, April 16, 2001, for an excellent, user-friendly article on his methodology).
Lev starts with a firm's net income before taxes. Then he allocates how this income is derived over the three basic kinds of assets that produce sales: cash assets; property, plant, and equipment; and intellectual property. According to Lev, cash assets earn an average of 4.5 percent. So 4.5 percent multiplied by a firm's cash assets gives an approximation of income due to cash assets.
Property, plant, and equipment over the years, net of depreciation, gets a similar treatment. They earn, on average, 7 percent. So 7 percent times the value of property, plant, and equipment gives you the income driven by these assets. To calculate the Return on Intellectual Property, take net income before taxes, subtract the return on income due to cash assets and income due to property, plant, and equipment, and divide by net income before taxes.
For 2006, the average percentage of earnings or EBITDA driven by brands, pipeline, or just sheer innovative ways of doing business is about 85 percent. Sanofi-Aventis, Forest, GSK, and J&J set the pace on this very important metric.
Some Final Comments
What explains superior performance? Well, we know what doesn't:
Scale and size Only Merck and AstraZeneca made the top five.
Top-down or decentralized model Yes, J&J is decentralized, but so is Schering-Plough.
R&D Pfizer spends the most on R&D, and the cupboard is bare. Amgen outspends Genentech, but Amgen has nothing to show for it, with the possible exception of denosumab (but a fire-breathing Roche is waiting in the wings to launch a competitive erythropoietin). Forest spends the least on R&D and yet continues to ride high. And this R&D impact, or lack of impact, should not come as a surprise. Even Apple has one of the lowest ratios of R&D spend.
Merger and acquisition This remains a siren song. But better to grow organically. Just ask Apple, Toyota, GE, and P&G.
Enterprise Value throws everything into a cocked hat. For example, Amgen is almost double Genentech's size. Amgen is a very profitable company, but growth will be hard to come by for Amgen, while Genentech is rolling it up. But Genentech's EV to Sales is double Amgen's. What is going on? Big used to mean superior. Until the mid-1990s a firm's market value usually tracked its sales. But then Microsoft came along with a market cap higher than IBM, even though Microsoft's sales were 5 percent of IBM's in 1993.
What's not to like about J&J? What were you doing in 1944? I was around then, but I was just getting potty-trained. Had I been precocious, I might have purchased one share of J&J when it went public in 1944 for $37.50. That one share is now worth about $950,000.
Novartis is also very frustrating. In terms of new drug introductions, Novartis is the innovator: From 2000 to January 2005, Novartis gained 13 new drug approvals. The only companies that even came close were Pfizer and Sanofi-Aventis, with nine each. And yet Novartis gets no respect. To quote Seinfeld's Frank Costanza, Merck seems to be back, baby: It launched five new drugs in 2006, with substantial run-ups in key metrics for 2006.
We'll be back same time next year with a new, improved Pharmaceutical Executive Industry Audit for 2007.
Bill Trombetta is professor of pharmaceutical marketing and strategy at St. Joseph's University. He can be reached at dtrombet@aol.com
>The following firms are actively selling the 100mg, 300mg, and 400mg gabapentin capsules<
I think some of them get the API from Teva.
Dunno, they vanished before I could ask.
My intuition is with you Fred.
(but I can't wait till he verifies)
PFH will have to prove that TEVA manufactures its drug with less than 20ppm salt. Knowing TEVA, they would not have made it even as close to "doctrine of equivalence", meaning the probably used a safe higher level of say 23ppm or so.
This is the Dutch way of informing the public about new time table:
Good thinking on their behalf.
Instead of blaming the placebo they will start testing patients before the trial.
This is a wise step towards personalizing the drug and increasing its response rate.
Gives them a better chance to get stat sig next time...
BTW, did you notice that the stock made a move a day before the news were out?
Now how could that possibly happen unless there are psychics in the crowd? :)
Still watching them:
BioCancell Therapeutics, Inc. announced today the results of the obligatory part of the Phase I/IIa clinical trial.
The Trial was designed to determine the optimal dose and assess the safety and preliminary efficacy of BC-819 complemented with PEI (a transfection enhancer) given as intravesical infusions into the bladder of patients with superficial bladder cancer expressing the H19 gene, who had previously failed at least one standard treatment type.
In the obligatory part of the Trial each patient received six weekly treatments with BC-819.
Eighteen patients were enrolled in the Trial and split into five groups, with each group receiving a higher dosage than the previous. Escalating doses consisted of 2, 4, 6, 12 and 20mg of BC-819. The mean number of previous tumor recurrences after treatment in patients entering the Trial was 5. The results can be summarized as follows:
afety
No Serious Adverse Events relating to the treatment were detected at any dose given. This is of critical importance, as it is the side effects of current treatments that cause many patients to abandon therapy, resulting in sub-optimal healing.
Optimal Dose
There was no dose-limiting toxicity at any dose given, so the optimal dose to be used in Phase II is 20mg, the maximum dose which was administered to patients in Phase I/IIa.
Primary Efficacy
At the beginning of treatment, all tumors except one (measuring 0.5-1.0 cm in diameter) were surgically removed from the patient’s bladder. The remaining tumor was left as a marker to observe the effect of BC-819, despite the fact that the standard of treatment does not involve the leaving of a tumor marker. The primary efficacy is categorized by tumor recurrence, tumor marker ablation and disease progression.
It is recorded for all patients – including those not receiving the optimal dose.
In total, 72% of patients responded to treatment. The preliminary evaluation of the efficacy of BC-819 suggests that it has the ability to cause tumor ablation and regression at doses that are well tolerated.
Recurrence: 56% of patients remained free of new tumors. Recurrence mainly occurred in patients receiving a dose significantly lower than the optimal dose.
Ablation: The tumor marker was ablated or reduced by at least half in 44% of patients. This shows that BC-819 is tumoricidal in superficial bladder cancer patients.
Progression: One patient showed disease progression (increase in stage of cancer or appearance of high-grade tumors) while 17 had no progression.
Based on these positive results, BioCancell plans to begin Phase IIb in the fourth quarter of 2007. The aim of the phase will be testing the efficacy and safety of BC-819 at a dose of 20mg. The treatment of 33 patients will take place in approximately 6 medical centers in Israel and one in the U.S., pursuant to an IND approval from the FDA.
Does that make you a good servant?
That's why the procedure is usually being performed on 8 days old infants. Very few places to go to at this age.
Sorry Dubi and good night.
Hehe to you too Fred.
Dubi are you having withdrawal symptoms?
Margaret Thatcher-Iron lady :)
Please call me Margaret.
Bear with me a while Teddy