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Something else to think about the arbitration. I don't know how it works exactly to know if this would play into it BUT if you recall earlier this month’s GPC consolidated their workforce and closed their Waltham, Mass plant. Maybe it doesn't play in but I can think of two negatives to GPC from this:
1-if I were going into arbitration in Mass. I don't think I'd be trying to be unfriendly to the locals.
2-Perhaps a disgruntled employee whose been let go wants to speak to some lawyers from the other side?
I'm sure they have good legal representation but I am wondering if GPC, being based in Germany, is affected by a difference in culture and perhaps their legal system as well which may be influencing management’s determination to proceed and not settle.
PHRM BOA Call?
Did they back out, maybe getting ready for ASCO? I can't seem to find a replay available.
Question Stroke Drugs in Trials -
For those companies with treatments beyond the 3-4 hour range why wouldn't they go after those outside the TPA treatment window? Is there anything approved for beyond this range?
The other concern I have (I follow Neurobiological a bit) is those companies with treatments beyond 3 hours is it more likely they get those patience in their trials and thus have a harder chance to get efficacy (even over placebo) if in fact the treatment window is not quite as big as they think it is for their drug?
BOA Calls -
Don't know if it could be this but I noticed on BOA calls that I heard it would cut out when the slides changed. It was browser related (was using FireFox) on IE it worked fine.
Yeah I saw the shareholders there weren't happy about the Genzyme buyout but I don't follow them (Bionevision) much so didn't know why. Thanks for the explanation.
Its not the first time Genzyme did a buyout on the cheap, anyone remember the fiasco with their track-stock for their Biosurgical division? I believe that ended up in a lawsuit. I remember an entertaining errr um dialog with a caller and Henri Termeer/
DDSS - I was just reading that and saw After hours its down quite more then the article points out (3.73 according to NASDAQ.com). I had looked at them quite some time ago and thought they had a few compounds in development. A quick look at yahoo (if accurate) indicates they have a decent cash position. Anyone follow them, is it worth looking into if it becomes a fire sale? Is the data bad for the extended release or a chance they'll work through it? TIA
Dew I'd probably listen but didn't get to it yet. I tried your link and it didn't work (I think they use cookies or something and that is why it may have for you). Was it at the BOA Conference or a different one? TIA
I have no position BUT this seemed interesting and relevant to the recent discussion on Cypress. iwfal appreciate your posts on the trials.
http://biz.yahoo.com/ap/070531/cypress_bioscience_hedge_fund.html?.v=1
Cypress Investor Opposes Stock Offering
Thursday May 31, 6:29 pm ET
Cypress Bioscience Hedge Fund Investor Asks Cypress to Abandon Public Offering
CHARLOTTE, N.C. (AP) -- A hedge fund investor on Thursday asked biotechnology company Cypress Bioscience Inc. to abandon its plans to sell 4.7 million new shares of stock in a public offering and instead institute a stock buyback program.
The hedge fund shareholder, called Black Horse Capital, issued a letter to Cypress's board of directors saying it does not think the proposed public offering is "in the best interest of shareholders."
The hedge fund said the company is having success with a new drug called Milnacipran, a treatment for fibromyalgia which is characterized by muscle pain and extreme tiredness. The fund added that since the drug is still in the testing phases, its value is not reflected in the stock price.
"Our major concern, is that Forest Laboratories, or some other smart strategic buyer will make a take out offer while your stock still is multiples away from reflecting the true value of your future milestone and royalty income for Milnacipran," the fund said in the letter. "The best thing that Cypress could possibly do with its cash is to buy back its own stock."
In the proposed public offering, the shares would be priced at $15.50, allowing Cypress to raise about $72.9 million. The company has said it will use the money to buy, license or invest in other companies, technologies or drugs.
Black Horse Capital owns about 1.2 million shares of the company's stock.
Cypress Shares fell 1 cent to $15.14 in electronic after-hours trading. During regular trading hours, the shares dropped $1.17, or 7.2 percent, to close at $15.14.
ZYNX:
1-On Dilution - The CEO owns a huge chunk and I don't think he wants to give away his shares. Agree they would like to raise capital to fund growth (sales force) but a year or so ago when this seemed like the direction (believe there was an 8k or PR) instead of raising a lot of cash decided to go the small sales force route. So I think they will incrementally build up sales force perhaps even funding through sales growth alone!
2-On Units being expensive - They are expensive for customers to buy. I don't think they cost them that much to purchase from mfg. Margin's are spectacular!
3-On AR write off - They had always taken reserves do to price being high and then reimbursement negotiated at a percent of the price. So as sales are ramping AR ramps. They do this every quarter and have always indicated it in the Q's/K's. The write off I believe came about because they adjusted the reserve amount.
I think yeah the company may have some issues. IF you look at the growth rate and the projections and if they keep reinvesting and adding sales force the top-line will continue to have some spectacular growth going forward.
Disclosure: I've been long ZYNX for some time.
GPCB/SPPI:
On the SPPI webcast of the FBR conference during the Q&A this morning they talk a great deal about the arbitration.
The link is http://www.wsw.com/webcast/fbr19/sppi/ it is about 25 minutes or so into the call that they talk about it.
I am not a lawyer and perhaps there is more to it BUT there is a real possibility that the contract between GPC and Spectrum could be terminated. Both GPC and Spectrum downplay this as likely, perhaps so. What doesn't make sense to me is this is binding arbitration. If the arbitrators deem that GPC violated the agreement then why wouldn't Spectrum's request to declare the contract null and void be allowed? [again I have no legal background but it sounds reasonable].
Now to the other side since GPC is not attempting to settle one could reasonable surmise that GPC thinks the risk/reward ratio doesn't justify settling. Since the risk could be total loss of the drug. They must think Spectrum's demand is much greater then paying them [us] off. So I'd summarize their view as:
1-Raj is asking too much
2-They believe there case is solid
3-Even if they lose they believe they would not lose total rights to the drug.
On the Q&A portion they talk about the points of dispute [going by memory i may have missed one or more]
1. No part of Pharmion payment to Spectrum
2. Not mentioning Spectrum in PR's/promotion
3. Not sending Spectrum communications with FDA
4. Co-promote option to not have any benefit [i.e. Spectrum pays their own expenses and receives nothing more then agreed upon royalty]
5. Not mentioned in the call but I believe Spectrum also claims GPC did not move in an diligent fashion to get as Japanese partner.
Now obviously point 1 is the key basis of dispute and while it would set precedent for future milestone payments as well (their is also still Japan to license out). But point 4 may be key as well. Spectrum probably wants as much to a profit share as they can get. GPC obviously wants to give them nothing. Aside from that though I think GPC wants Spectrum total out of any involvement here so a payoff (if they lose) makes sense. The other possibility would be for GPC to license out US marketing in which case they wouldn't be as obligated [they still are required to attempt to seek co-promote on Spectrum's behalf]. This clause to me may actually weakens Spectrum's case of a profit share and at best give them true "co promote". So here is how I would score the 5 points.
1. GPC edge [Spectrum left a hole open as Dew and others have pointed out and GPC took advantage. However I think interpretation may give Spectrum a chance].
2. neutral. I think Spectrum may have a point but it may be deemed not significant enough to break the agreement.
3. Spectrum edge [I am talking Spectrum's word on this. Perhaps GPC can show otherwise]
4. GPC edge [I think Spectrum probably left a whole open here too. What Spectrum may argue is that is not typical or sensible and perhaps they have a chance].
5. GPC edge. I think GPC can show they are trying it takes time, blah, blah, blah...
So the little point of #3 to me could be key if the arbitrators deem GPC violated and allow Spectrum to terminate the contract!!
If the arbitrators go for a half way ground then I believe Spectrum would get something on points 1 and 4 how much is hard to say.
I should also add that in GPC's counter suit they are seeking to get the drug for free [i.e. not obligated to pay royalty] because of Spectrum's bad faith. I won't comment on this other to say while I think it is without any merit it is still a risk since there is binding arbitration.
They picked FOLD as the stock ticker because they claim to have expertise in protein folding, but that doesn’t mean it was a wise choice
I agree but hopefully it scared off some people from investing and kept the price below fair value. At 15 they'll have a market cap in the ~300 million range (they have almost 22 million outstanding now. I've included the overallotment and about 4 million in options)
A couple interesting things the talk about the Fabry market being potentially much larger then previously thought. TKT had hinted at this and also believed (and has since been shown to be true) that women get the disease. One group, the milder form, they could probably do a better job at targeting with their drug being oral.
The company is an interesting story outside of investment purposes. The founder help get Genzyme's Pompe drug moving because his children have the disease. I just recently got the book on his story
http://www.amazon.com/Cure-Million-Medical-Establishment-Children/dp/B000OH28QI/ref=pd_bbs_sr_1/002-...
Didn't even start it yet so no recommendation.
JB,
My opinion is for an open label study the results are unimpressive. The results aren't statistically significant and do not seem to show great promise. Yeah it will probably go into a larger Phase 2 placebo controlled trial.
I had been a bit leary when I did a little research and saw all those options in the .70's range (I guess they are in the 2.30's now with the reverse split). It doesn't seem they can make any money on Coprexa for Wilson's and so were counting on selling it off-label for IPF. While some can say InterMune did that with Actimmune, its not a good business model to do and I'd imagine they'll run into trouble (can't imagine a partner which they need, have to be very careful in promotion, etc.)
But after seeing the CEO's bio and companies he has been involved with directly and indirectly and other posters on this board being very critical of them (CTIC, DOR) not to mention the photo
http://www.investorshub.com/boards/read_msg.asp?message_id=19895832
I'd be very cautious investing here counting on Coprexa for IPF (perhaps something else in their pipeline has potential I don't follow them that well)!
Disclosure: I am long InterMune
lumpy I'm sure there are others who have better knowledge to answer. I can tell you another reason for doing it based on many of the biotech I follow. That is the disease/indication just does not have a lot of patients to run a large trial would require years to recruit. BMRN/UTHR are two companies that I follow and their trials are < 200 patients. I remember TKT (pre shire) had a trial planned for their Gaucher product that they had originally hoped they could have their trial act as P1/2/3 (I don't recall how they were getting away with this) and the number of patients was in the 10-15 range if memory serves. I believe they had pretty much an understanding they could do this and then before they were ready to begin FDA said that would not be enough so it was just done as a P1/2 trial.
There is a very well-known example that has been discussed on this board in the past, for a drug that would compete with Tracleer.
Do you know of any trials with an SPA where the results were statistically significant in the primary endpoint and met all requirements of the SPA, yet was turned down?
That would be Encysive's Thelin (sitaxsentan) as has also been pointed out here there is an unknown issue that the CEO will not reveal that has resulted in 2 approvable letters (technically the first approvable had a number of issues and the one that remained when the 2nd was given). FYI, they have a PDUFA of June 15 (3 days or so before GILD's PDUFA for a drug in the same class)
Thanks for the clarification.
Appreciate the comments Dew. In this and other Dry AMD posts you seem to suggest that treating the Dry form (as opposed to preventing the progression to Wet) is not a significant opportunity.
Its my understanding that Dry in-and-of-itself has several stages (beginning with the small yellow spots that do not effect vision) and even when a blurred spot appears it can become progressively larger, I'd think slowing this is beneficial to the patients even if they were to never progress to Wet. Perhaps not the best analogy but people with slight vision loss still buy glasses.
Dry AMD-
Appreciate your post on Dry AMD. I am very interested in this indication do you have any thoughts on the various companies mentioned in the article? TIA
They say a picture is worth a thousand words, it certainly would make me think twice about investing in companies he's involved with.
http://www.time.com/time/potw/20070510/ - 4th picture
courtesy of post
http://www.investorshub.com/boards/read_msg.asp?message_id=19893024
CYPB:
I had looked at them and thought it was too risky and Fibromyalgia seemed to be one of those indications that could result in a high placebo effect. If memory serves wasn't this the 2nd trial and the first one failed to reach significance? In fact if I recall correctly Cypress started the second trial before the results of the first were known much to Forrests disapproval. I wonder if this is enough for approval?
FYI I follow United Therapeutics quite a bit (The Remodulin Franchise is Key OvaRex would be a big bonus in my book) and the Posters they had at their Analysts/Investor day did show that OvaRex K-M curves separate on the 5 year survival data for both the overall treatment group and the Successful Front Line Therapy (SFLT) group (which is the retrospective subset they are basing the Phase 3 patient population on). Though it is notable that the p values are not statistically significant .2756 (Overall) and .1121 SFLT subset.
EDIT: I mention it because I believe OvaRex could be classified as an immunotherapy.
Another EDIT: Forgot to mention the most important thing! Going along with your discussion about separating late that is what appears in both curves (about 18-24 months they begin to separate)
OT: A bit off topic but I found this interesting. I have mixed feelings as I can understanding people who do a good job finding stocks then getting people to ride their coat tails isn't exacatly fair [but life's not fair] but as a small shareholder knowing who owns big pieces of my company is something I feel entitled to know
http://news.yahoo.com/s/nm/20070517/bs_nm/funds_disclosure_dc_1
Hedge funds step up challenge to SEC
NEW YORK (Reuters) - Hedge funds and other investment firms have been busily filing quarterly public reports to regulators in recent weeks, offering rivals a window into top manager holdings that sometimes moves shares.
ADVERTISEMENT
But don't look for any information from Bulldog Investors or Wynnefield Capital -- their so-called 13-F filings are largely blank.
The two funds are leading a charge to overturn the rules that require them to file quarterly holdings information, maintaining that such disclosures are trade secrets. Both have applied to keep their holdings confidential, but expect regulators to turn them down, forcing a court battle.
"We filed but it was blank," said Phillip Goldstein, a veteran investor who heads the $300 million-plus hedge fund group Bulldog Investors and affiliate Full Value Advisors. "We haven't heard back from the SEC."
Goldstein is no stranger to tangling with regulators. Last year he successfully challenged SEC rules requiring hedge funds to register as investment advisers. The U.S. Court of Appeals in June agreed, forcing the SEC to abandon the rule.
"Frankly I think we will win," said Goldstein of his latest effort. But he said "I suspect it will take a long time." Last year Full Value Advisors also asked for an exemption, but got no response from the SEC, he said.
If Goldstein succeeds and funds stop filing quarterly 13-F reports, investors could be denied an important investment tool: a quarterly window into what the world's best investors are holding, at least as of a particular quarter's end. And evidence shows that information is closely followed.
Yesterday, for instance, railroad stocks rose after investors
Warren Buffett and Carl Icahn disclosed that they held large stakes in major industry players. Icahn disclosed stakes in CSX Corp. (NYSE:CSX - news), while Buffett revealed stakes in Union Pacific Corp. (NYSE:UNP - news) and Norfolk Southern Corp. (NYSE:NSC - news).
Under SEC rules, institutional fund managers holding more than $100 million in assets must disclose their "long" holdings within 45 days of a quarter's end. Funds may apply to keep the information confidential if they can prove it reflects "trade secrets," and other criteria.
Bulldog and Wynnefield maintain that stock holding information is a trade secret akin to Coca-Cola's secret formula for Coke - the product of much original research that must remain undisclosed. Fund holdings, he said, can also reflect trading strategies that is valuable to competitors.
Public disclosure of this "unique intellectual property" violates the Fifth Amendment of the U.S. Constitution that bars the taking of property without compensation or due process of law, the two funds maintain.
Ron Geffner, a high-profile hedge fund lawyer and former SEC prosecutor, gave Goldstein a reasonable chance of success.
"Had I not known him and his prior successful action with the SEC, I would have dismissed him as having a very limited likelihood of success," said Geffner. "However, this time I would chose not to underestimate his abilities and the strength of his claims."
Goldstein said he is now waiting to hear from the SEC on his application for confidential treatment. He said he expects his bid will be rejected, which will likely lead to a court challenge.
A spokesman for the SEC declined to comment.
Yeah that too! But I don't see Raj as a financial genius or a gambler so believing he took the money while it was available I can believe. I think Dew has pointed out on this board the increased availability of funds in biotech this year [in response to a comment I posted a while back]. I think the financing boils down to Raj wanting to advance Eoquin AND Ozarelix alone in a more timely manner. Personally I would have preferred waiting a little then trying to partner.
Unless there is a (negative) suprise in the data I think this could actually be a very good opportunity for Satraplatin. It will allow for even more exposure. I wonder too if there is a feeling Doc's will use this (off-label) in front-line combo (with Taxotere) or stand-alone for patients who can't tolerate Taxotere so there is pressure to scrutinize the submission now. Keeping in mind this is an elderly population base so if you have efficacy anywhere near patients may prefer something that gives a better quality of life.
i am long spectrum primarily for Satraplatin (though I like getting Eoquin and Ozarelix too) but if I were to buy in to the ASCO leak theory the fact the GPC has been down consistently for a few days now would make me wonder. Of course if could be just people getting nervous about having the panel meeting. GPC has long stated they were preparing for that possibility so I don't think they were shocked by it. I thought the results being excellent and platinum's not being new to Oncology there wouldn't be a need. I'd like to think it is as palindromy suggests
1. ODAC wants to contrast positive outcomes for well-designed statistically robust trials to limit public criticism.. Don't know enough about what would necessitate an ODAC panel but the fact that Satraplatin is the first Oral platinum drug could be a factor too.
Thanks for the info on late breakers.
They have "late breaking" sessions for that.
In general, do you know how far in advance is usually required for a late breaker at conferences? Or in specific for CHEST in the fall? [I'm wondering if UTHR will have Inhaled Treprostinil results around this time but by my estimate the trial dosing period will not be done till about mid September and the Conference is late October so it doesn't give much time to gather the data and then file for an abstract.]
BMRN:
Very Bullish article in WSJ about Kuvan. In it they mention a possible price, I had thought there was a chance it may be around this range but I believe analysts were looking at the 10-20K range. Some of my notes/comments precede clarifications given in the article but I left my comments as is. Here is the link curtsy of Google (I have a paper not on-line subscription)
http://online.wsj.com/article/SB117926372608703940.html?mod=googlenews_wsj
BioMarin Seeks
Approval for PKU Drug
By PETER LOFTUS
May 15, 2007 5:56 p.m.
For decades, people born with a rare genetic disorder have had to stick to restricted diets in order to avoid severe mental retardation and other problems.
But it's not easy to adhere to such diets, and some drug companies think a medical approach could help treat the condition, known as phenylketonuria, or PKU. One company, BioMarin Pharmaceutical Inc., is close to filing for U.S. regulatory approval to market a new drug, Kuvan, for PKU. BioMarin says the drug could help liberalize diets for some people with PKU, though it wouldn't be a cure.
If Kuvan is approved by early 2008 and its sales meet analysts' expectations, BioMarin's revenue could rise nearly 80% next year and the tiny, 10-year-old company might become profitable. BioMarin, Novato, Calif., has partnered with Merck Serono SA of Switzerland to comarket the drug. BioMarin would market the drug in the U.S., while Merck Serono would sell it in most countries outside the U.S. Daiichi Suntory Pharma Co. has rights to the drug in Japan.
But Kuvan could come at a high price for patients: potentially more than $30,000 a year, according to Emil Kakkis, BioMarin's chief medical officer. He emphasized that a final price hasn't been set. And it may not work for people with severe PKU, who account for up to half of all people with the disorder. [Actually BioMarin has said it may work for between 30 and 50% of patients to varying degrees
For some patients, however, Kuvan could "allow them to eat restricted diet of normal foods," Mr. Kakkis said. "We'd expect some patients to be near a normal diet."
PKU is a genetic disorder in which the body can't process part of a protein called phenylalanine, also known as Phe, according to the National Institutes of Health. The protein is found in nearly all foods. High levels of Phe can damage the brain and cause retardation, seizures and other conditions. About one in every 10,000 infants in the U.S. is born with PKU. BioMarin estimates there are at least 50,000 people in developed countries who have PKU.
Since the 1960s, nearly all newborns in the U.S. have undergone screening for PKU. Those with PKU are placed on a Phe-restricted diet, which has been successful in sparing many children the worst effects of the complications of PKU. Infants take special formulas, while older children and adults are supposed to stick to a diet heavy in fruits and vegetables and low-protein breads and cereals. Adults also can take special formulas. The restricted diets are meant to last for life.
But the diets can be difficult. Children with PKU may be tempted to try foods their friends or classmates are eating. Buying specialized, low-Phe foods can be costly, and the foods often have poor taste. Poor adherence to a restricted diet -- or abandonment altogether -- can cause declines in mental and behavioral performance, including attention-deficit hyperactivity disorder.[JJ Bienaime had a comment on the R&R Conference yesterday about parents spending 40K a year to send children to Ivy league and it not improving intelligence]
Over the years, scientists have found that a chemical compound called tetrahydrobiopterin, or BH4, could help treat PKU in some patients. A Swiss company called Schircks Laboratories sells tablet versions of BH4, but they aren't approved for sale as a PKU treatment by any national health regulators. In the U.S., doctors must apply for FDA clearance to order them, according to Schircks' Web site. A Schircks representative couldn't immediately be reached.
Kuvan is a purified, oral formulation of BH4. In a late-stage study of about 90 children between the ages of four and 12 years old, those on Kuvan were able to double their dietary intake of Phe, on average, over about 10 weeks, while maintaining controlled Phe levels in the blood. Those on a fake treatment were only able to increase their Phe dietary intake marginally.
But only about 30% to 50% of all PKU patients are believed to be responsive to BH4, the active ingredient of Kuvan. The rest have a more severe form of the disease and don't respond. BioMarin has said severe PKU may not respond to BH4 because their specific Phe mutations might prevent the compound's mechanism of action. BioMarin has another drug in development that might treat severe PKU, but it hasn't yet entered human testing and is likely several years away from reaching the market.[Altus has a preclinical compound also and it got me curious enough to start looking at the company]
Some side effects in the Kuvan study were reported, including headaches, abdominal pain, fatigue and diarrhea. The incidence and types of adverse events were similar in both the Kuvan and placebo groups, BioMarin said.
The Kuvan studies haven't directly shown that the drug can alleviate neurocognitive symptoms of PKU. Mr. Kakkis said it would take multiyear studies to show whether Kuvan could, for instance, have a benefit on patient IQ. But he said the relationship between Phe levels and IQ was "very strong," and BioMarin might study the relationship after receiving regulatory approval.
BioMarin expects to file for FDA approval of Kuvan by midyear,[JJ said in about 4 weeks at yesterdays conference] Mr. Kakkis said, with Merck Serono filing for European approval later in the year.[Merck is expected to file in Q3, I believe Biomarins milestone is 15 million] If the FDA application is granted priority review, FDA could take action as early as November.
Kuvan has received "orphan-drug designation" from both U.S. and European regulators, which means it would receive seven years of market exclusivity in the U.S. and 10 years in Europe, if it's the first drug approved to treat PKU.
BioMarin, which currently markets two other drugs for rare genetic disorders, hasn't set a price for Kuvan, but Mr. Kakkis noted that Wall Street analysts have predicted an annual price of $25,000 to $30,000. Mr. Kakkis said it could be higher than that.[Could be but I had not previously seen any estimates above 20K/yr prior to this article. My guess is they price the low dose on the low side but analysts (and I) expect docs to dose high since it has very mild side-effects in studies.] He said he expects insurers to cover the drug, and BioMarin would assist patients with no insurance.
Baird analyst Christopher Raymond estimates Kuvan could sell for $30,000 to $35,000 a year. He estimates BioMarin revenue from the drug will be $68 million next year, rising to $200 million in 2010. In addition to U.S. sales, BioMarin also would collect royalties from Merck Serono on non-U.S. sales of the drug.
Several analysts are optimistic the drug will be approved by the FDA. Some note that the agency recently allowed BioMarin to widen access to the drug beyond those who participated in the clinical trials, which analysts say implies there were no major safety issues.[BioMarin reportedly is allowing up to 500 patients early access and said heavy demand could support much higher figure, I believe they said 1000]
Another company, Altus Pharmaceuticals Inc., is in the early stages of developing its own treatment for PKU. The company is testing its compound, ALTU-236, in animal models, so it's several years behind BioMarin in development.In listening to their calls they are at least a year or so away from IND enabling studies if they decide to go ahead with the program which they'll decide later this year]
Write to Peter Loftus at peter.loftus@dowjones.com
Brean Murray Conference Today
http://www.breanmurraycarret.com/healthcareBioTech07.html
Did anyone by chance register for this. Are there webcasts?
I am guessing no so I didn't bother to register. If anyone knows otherwise appreciate knowing.
I lurk don't post or own GTC but thought some of you may be interested in this article if you haven't seen it.
http://www.usatoday.com/news/health/2007-05-14-livestock-ailments_N.htm?csp=34
Q: The biggest drug/biotech story of the past six months is:
is biggest deliberately being left to the survey takers to interpret?
I'd check out the poster from the link I provided. While nothing clear cut, lets say I won't be rushing to buy Pipex anytime soon based on these results (I don't follow the company closely enough to comment on its value was just following their IPF program).
Here is the text:
[3:15 pm] A Phase I/II Trial of Tetrathiomolybdate for Patients With Idiopathic Pulmonary Fibrosis Refractory to Previous Therapy, [Publication Page: A497]
K.R. Flaherty, M.D., M.S., G.J. Brewer, M.D., A. Andrei, PhD., S. Murray, ScD., G.B. Toews, M.D., F.J. Martinez, M.D., M., Ann Arbor, MI
Rationale: IPF is a fatal disorder without effective therapy. Tetrathiomolybdate (TM) is an anti-Copper drug developed for the treatment of Wilsons disease. TM is effective in modulating the fibrotic response in a Bleomycin mouse model of pulmonary fibrosis.
Methods: We treated 23 patients with IPF that had evidence of disease progression despite treatment with prednisone +/- cytotoxic therapy with TM for 1 year. Patients were monitored for adverse events, change in pulmonary function and walk distance. When pre-treatment FVC values were available the course of pre-treatment FVC (slope) was compared to the post-treatment FVC at 6 and 12 months.
Results: The initial three patients developed severe nausea and withdrew from the study prior to reaching a therapeutic copper level. In response, the induction dose was modified and TM was well tolerated in the remaining 20 patients. Dose-related nausea and cytopenias were the most common and expected adverse reactions. Three patients did not complete the trial (patient preference n=2, anemia n=1), 2 patients died during the trial. There was no significant change in FVC % predicted between baseline and 12 months (61 + 13 vs 59 + 13, p=0.18, paired t-test). Average walk distance declined from baseline to 12 months of follow up (871 + 358 vs 646 + 444 feet, p = 0.02, paired t-test).
Conclusion: Treatment with TM for patients with IPF was well-tolerated and associated with a trend toward stabilization in FVC. Further exploration of the therapeutic efficacy of TM through a placebo controlled trial is warranted.
Pretreatment - Posttreatment slope FVC % Predicted 6 Month p value 12 Month p value
Pre-Post Trajectory -0.82 + 1.5 0.06 -0.66 + 1.6 0.12
Session Info: [**] Mini-Symposium, [B91] ILD: THERAPEUTIC INTERVENTION
Session Time: 1:30 PM - 4:15 PM
Presentation Time: 3:15 PM
Room: Room 250-262 (West Mezzanine), Moscone Center
Funny comment by JJ on the Rodman Renshaw Conference this (early) AM. In talking about the pricing for Kuvan and the "value of an IQ point" he pointed out that parents spend 40K a year to send their children to an Ivy League school and then said not sure that improves intelligence.
Link for the presentation:
http://www.wsw.com/webcast/rrshq11/bmrn/
FYI there is a poster available on the ATS website about the Phase 1 Tetrathiomolybdate IPF trial.
If the link works here it is:
http://www.abstracts2view.com/ats07/search.php?search=do&query%5B%5D=Tetrathiomolybdate+&whe...
The other Merck is in the news too. I thought after their problems and management changes Acambis would have been acquired. Actually I thought Acambis may be a big player in the Vaccine market, thankful I never invested in them.
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070513:MTFH19596_2...
GENEVA, May 13 (Reuters) - Merck & Co. Inc. (MRK.N: Quote, Profile , Research) is keen to acquire small and medium-sized companies to propel its growth, particularly in vaccine development, but is not pursuing a "mega merger," a company executive said on Sunday.
Stefan Oschmann, Merck's president for Europe, the Middle East, Africa and Canada, said the U.S. drugmaker was interested in expanding its portfolio with the purchase of biotechnology firms with late-stage products or mid-sized pharmaceutical companies with promising research platforms.
He told a small group of journalists in Geneva that large-scale consolidation was likely not in Merck's interest, especially given that market valuations of companies in the sector are so high.
"Mega mergers have in most cases not delivered what they had promised," Oschmann said. "We don't necessarily think that a mega merger is the right thing."
Merck signed 35 acquisition and partnership deals in 2006. Oschmann said Merck, ranked seventh in the industry for sales last year, is investing heavily in developing an HIV vaccine and sees large promise in its HPV vaccine Gardasil for cervical cancer prevention.
I am not familiar with this company. It sounds as if they are early stage but may be interesting to keep an eye on
http://biz.yahoo.com/prnews/070514/ukf050.html?.v=1
Nautilus Biotech Receives FDA Approval for Phase 1 Clinical Trial in the USA for Oral Belerofon(R), its Long-Lasting, Interferon-Alpha Drug
Monday May 14, 4:00 am ET
PARIS, May 14 /PRNewswire/ -- Nautilus Biotech, a leading biotechnology company, has announced that it has received clearance from the US Food and Drug Administration (FDA) to carry out a Phase 1 clinical trial for Oral Belerofon® in the USA.
(Photo: http://www.newscom.com/cgi-bin/prnh/20070514/257054)
Source: Nautilus Biotech
· FDA Approves Phase I Clinical Trial of Naudilus Biotech
· Click Here to Download Image
Belerofon, a proprietary variant of human Interferon-alpha with a single amino acid replacement, has been designed by Nautilus Biotech to lower the susceptibility of Interferon-alpha to proteolytic degradation and make it longer-lasting in serum. Belerofon is intended to be used in the treatment of a range of conditions, including chronic Hepatitis C.
A Phase I clinical study for injectable, subcutaneous (SC) Belerofon began in Texas, USA last month and the results of the trial are expected to be completed in Q3 2007. In February Nautilus Biotech submitted an Investigational New Drug (IND) application for oral Belerofon to the FDA.
Oral Belerofon is the same molecular entity as SC Belerofon, but it has been formulated to be administered by mouth. In animal models, appropriate oral doses have shown that Belerofon can be absorbed from the intestine into the bloodstream and reaches blood levels comparable to those obtained by subcutaneously injected Interferon-alpha products. Oral Belerofon is formulated as enteric-coated tablets containing the lyophilized Belerofon protein.
The oral Belerofon phase I clinical trial will take place in the USA and will begin later in 2007. The trial will be an open-label, ascending dose study of four doses of oral Belerofon. The primary objective of the trial is to evaluate oral Belerofon in healthy adult subjects for safety, tolerability and pharmacokinetics.
Commenting on the announcement, Nautilus Biotech's CEO, Dr Manuel Vega, said: "We are pleased that the FDA has given us the go-ahead to start a Phase 1 clinical trial for oral Belerofon. This is an important milestone in the development of treatments for a range of therapeutic diseases - all currently marketed Interferon-alpha drugs are administered by injection and oral Belerofon is expected to result in improved safety and patient compliance".
Dr Paul Martin, Nautilus Biotech's Vice President Strategy, commented: "The development of an orally administered Interferon-alpha highlights the potential of Nautilus Biotech's technology platform. It represents the promise of a third generation of therapeutic protein drugs that can be taken more easily and have great commercial potential to replace established injectable products".
Notes to Editors:
About Hepatitis C
Hepatitis C (HCV) is the most prevalent liver disease in the world. HCV infection causes chronic inflammation in the liver that can lead to cirrhosis, liver failure, liver cancer or death. HCV infection represents a significant medical challenge worldwide. Currently, there is no vaccine that can prevent hepatitis C.
According to the World Health Organization, more than 170 million people worldwide suffer from chronic HVC. With only half of all HCV patients benefiting from current therapy, there is considerable market potential for new medical solutions. The HCV market is expected to grow from US$2.2 billion in 2005 to US$4.4 billion in 2010 and US$8.8 billion in 2015 due to improved market penetration and improved diagnosis rates (source: Datamonitor).
About Nautilus Biotech
Nautilus Biotech is a leading biotechnology company with a novel pipeline of next-generation therapeutic proteins with superior profiles. The Company's protein engineering technology improves the pharmacology profile and administration route of important blockbuster protein drugs.
The therapeutic proteins market is currently valued at over US$35bn, and is growing at a rate of 10-15% per annum. Nautilus Biotech has created a portfolio of next-generation products with improved profiles, including long-lasting Interferon alpha (Belerofon®), hGH (Vitatropin®), Interferon beta, Erythropoietin, Interferon gamma, Clotting Factor IX (in collaboration with Wyeth Pharmaceuticals) and HMGB1-BoxA (in collaboration with Creabilis Therapeutics). Nautilus Biotech has established a strong intellectual property position covering enhanced versions of these multibillion dollar molecules and is rapidly moving these products into clinical development.
Nautilus Biotech is a private company with headquarters in Genopole® biopark, (Evry, France). For more information about Nautilus Biotech visit www.nautilusbiotech.com
Thanks for the reply and your thoughts on the deal.
Some slightly relevant news. It'll be interesting to see the markets reaction to the deal.
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070514:MTFH32526_2...
UPDATE 1-India Matrix shares surge on Mylan's Merck deal
MUMBAI, May 14 (Reuters) - Shares of India's Matrix Laboratories (MAXL.BO: Quote, Profile , Research) rose as much as 15 percent to a three-month high on news that Mylan Laboratories Inc. (MYL.N: Quote, Profile , Research), which controls the firm, will buy the generics unit of Merck KGaA (MRCG.DE: Quote, Profile , Research).
Analysts said Matrix was expected to play a key role in Mylan's strategy after the $6.6 billion deal, announced on Sunday.
"It looks very positive. I think they would be utilising Matrix to a very large extent for synergies after the merger," said Rohit Bhat, an analyst with Mumbai-based Batlivala & Karani Securities.
Mylan, which edged out Israel's Teva Pharmaceutical Industries (TEVA.O: Quote, Profile , Research) and Iceland's Actavis (ACT.IC: Quote, Profile , Research) to snatch the deal, is buying a business with operations in 90 countries and limited overlap with its own activities.
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India's Ranbaxy Laboratories (RANB.BO: Quote, Profile , Research) had initially expressed interest in Merck's generics business but later said it was "economically unjustifiable".
At 0740 GMT, Matrix shares were up 13 percent at 224.65 rupees while the benchmark index <.BSESN> was up 1.3 percent.
Courey seemed quite concerned about the Generic business when they were trying to acquire King a while back I thought they may seek to diversify outside or perhaps get into Bio-generics.
Dew from your posts you seem to follow the generic business quite a bit. Thoughts on Courey aside are you familiar with the Merck KG Generic business, do you think it is a good deal for MYL or just "empire building" at the expense of diluting shareholders? TIA
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Biogen R&D Day
5/14 - 5/15 Rodman Renshaw http://www.investorshub.com/boards/read_msg.asp?message_id=19581382
BIIB 5/17 8:30AM R&D Day http://www.investorshub.com/boards/read_msg.asp?message_id=19581596
GSK 6/18 Time TBA (Oncology R&D Day)
MCU 5/14 9:35 Rodman R http://www.medicure.com/
---
Procedure For Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.
2. Make your additions or modifications, inserting any new items in alphabetical order.
3. Post the updated text in a new message in reply to the message with the old list.
I find these investor days pretty useful to refer to. Sometimes a subtle comment is made that could be important later on.
http://biz.yahoo.com/bw/070511/20070511005361.html?.v=1
Biogen Idec Announces May 17 Webcast of Research & Development Day
Friday May 11, 9:18 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec Inc. (NASDAQ:BIIB - News) announced today that its Research & Development Day will be webcast live via the Internet. The webcast will begin at 8:30 am (ET) on May 17, 2007, and will last approximately 4 hours.
ADVERTISEMENT
To access the live webcast, please visit Biogen Idec's homepage, www.biogenidec.com. An archived version of the webcast will be available for 30 days following the presentation.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit: http://www.biogenidec.com
Rodman Renshaw
http://www.rodmanandrenshaw.com/Conferences.asp?CID=conf20&ACT=confwebcasters&BGCOLOR=wht
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Advanced Cell Technology, Inc. (OTC BB: ACTC)
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Alteon, Inc. (AMEX: ALT)
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Amarin Corporation plc (NASDAQ: AMRN)
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Antisoma plc (LONDON: ASM LN)
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Avalon Pharmaceuticals, Inc. (NASDAQ: AVRX)
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AVAX Technologies, Inc. (OTC BB: AVXT)
http://www.wsw.com/webcast/rrshq11/avxt
Avicena Group, Inc. (OTC BB: AVGO)
http://www.wsw.com/webcast/rrshq11/avgo.ob
Axcan Pharma, Inc. (NASDAQ: AXCA)
http://www.wsw.com/webcast/rrshq11/axca
BioLineRx, Ltd. (Tel Aviv: BLRX)
http://www.wsw.com/webcast/rrshq11/biolinerx/
BioMarin Pharmaceutical, Inc. (NASDAQ: BMRN)
http://www.wsw.com/webcast/rrshq11/bmrn
Biomira, Inc. (NASDAQ: BIOM)
http://www.wsw.com/webcast/rrshq11/biom
Bioniche Life Sciences Inc. (TSX: BNC CN)
http://www.wsw.com/webcast/rrshq11/bnc.to
Biosante Pharmaceuticals, Inc. (AMEX: BPA)
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BioXell, Spa (SWX: BXLN)
http://www.wsw.com/webcast/rrshq11/bxell
C & O Pharmaceutical Technology (Holdings) Limited (SGX: COPT SP)
http://www.wsw.com/webcast/rrshq11/copt.sp
Celgene Corporation (NASDAQ: CELG)
http://www.wsw.com/webcast/rrshq11/celg
Cell Genesys, Inc. (NASDAQ: CEGE)
http://www.wsw.com/webcast/rrshq11/cege
Cell Therapeutics, Inc. (NASDAQ: CTIC)
http://www.wsw.com/webcast/rrshq11/ctic
CEL-SCI Corporation (AMEX: CVM)
http://www.wsw.com/webcast/rrshq11/cvm
Ceragenix Pharmaceuticals, Inc. (OTC BB: CGXP)
http://www.wsw.com/webcast/rrshq11/cgxp.ob
Ciphergen Biosystems, Inc. (NASDAQ: CIPH)
http://www.wsw.com/webcast/rrshq11/ciph
CombinatoRx, Incorporated (NASDAQ: CRXX)
http://www.wsw.com/webcast/rrshq11/crxx
CoMentis, Inc.
http://www.wsw.com/webcast/rrshq11/comentis
Crucell N.V. (NASDAQ: CRXL)
http://www.wsw.com/webcast/rrshq11/crxl
Curidium Medica plc (LONDON: CUR LN)
http://www.wsw.com/webcast/rrshq11/cur.ln
Curis, Inc. (NASDAQ: CRIS)
http://www.wsw.com/webcast/rrshq11/cris
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC)
http://www.wsw.com/webcast/rrshq11/cycc
Cytogen Corporation (NASDAQ: CYTO)
http://www.wsw.com/webcast/rrshq11/cyto
CytRx Corporation (NASDAQ: CYTR)
http://www.wsw.com/webcast/rrshq11/cytr
Depomed, Inc. (NASDAQ: DEPO)
http://www.wsw.com/webcast/rrshq11/depo
DOV Pharmaceutical, Inc. (OTC US: DOVP.PK)
http://www.wsw.com/webcast/rrshq11/dovp
DURECT Corporation (NASDAQ: DRRX)
http://www.wsw.com/webcast/rrshq11/drrx
Elite Pharmaceuticals, Inc. (AMEX: ELI)
http://www.wsw.com/webcast/rrshq11/eli
Emergent BioSolutions, Inc. (NYSE: EBS)
http://www.wsw.com/webcast/rrshq11/ebs
Encysive Pharmaceuticals, Inc. (NASDAQ: ENCY)
http://www.wsw.com/webcast/rrshq11/ency
EntreMed, Inc. (NASDAQ: ENMD)
http://www.wsw.com/webcast/rrshq11/enmd
EpiCept Corporation (NASDAQ: EPCT)
http://www.wsw.com/webcast/rrshq11/epct
Evotec AG (XETRA: EVT GR)
http://www.wsw.com/webcast/rrshq11/evtgr
Galapagos N.V. (LONDON: GLPG LN)
http://www.wsw.com/webcast/rrshq11/glpg
GammaCan International, Inc. (OTC BB: GCAN)
http://www.wsw.com/webcast/rrshq11/gcan.ob
Generex Biotechnology Corporation (NASDAQ: GNBT)
http://www.wsw.com/webcast/rrshq11/gnbt
Gentium S.p.A. (NASDAQ: GENT)
http://www.wsw.com/webcast/rrshq11/gnt
Geron Corporation (NASDAQ: GERN)
http://www.wsw.com/webcast/rrshq11/gern
Glycadia Pharmaceuticals
http://www.wsw.com/webcast/rrshq11/glycadia
GPC Biotech AG (NASDAQ: GPCB)
http://www.wsw.com/webcast/rrshq11/gpcb
GTC Biotherapeutics, Inc. (NASDAQ: GTCB)
http://www.wsw.com/webcast/rrshq11/gtcb
Haemacure Corporation (TSX: HAE CN)
http://www.wsw.com/webcast/rrshq11/hae.cn
Hana Biosciences, Inc. (NASDAQ: HNAB)
http://www.wsw.com/webcast/rrshq11/hnab
Hemispherx Biopharma, Inc. (AMEX: HEB)
http://www.wsw.com/webcast/rrshq11/heb
Hollis-Eden Pharmaceuticals, Inc. (NASDAQ: HEPH)
http://www.wsw.com/webcast/rrshq11/heph
Idera Pharmaceuticals, Inc. (AMEX: IDP)
http://www.wsw.com/webcast/rrshq11/idp
ImClone Systems Incorporated (NASDAQ: IMCL)
http://www.wsw.com/webcast/rrshq11/imcl
Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV)
http://www.wsw.com/webcast/rrshq11/idev
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
http://www.wsw.com/webcast/rrshq11/infi
Inovio Biomedical Corporation (AMEX: INO)
http://www.wsw.com/webcast/rrshq11/ino
Intellect Neurosciences, Inc.
http://www.wsw.com/webcast/rrshq11/intellect
Iomai Corporation (NASDAQ: IOMI)
http://www.wsw.com/webcast/rrshq11/iomi
Lev Pharmaceuticals, Inc. (OTC BB: LEVP)
http://www.wsw.com/webcast/rrshq11/levp.ob
Lorus Therapeutics, Inc. (AMEX: LRP)
http://www.wsw.com/webcast/rrshq11/lrp
MacroChem Corporation (OTC BB: MACM)
http://www.wsw.com/webcast/rrshq11/mchm
Manhattan Pharmaceuticals, Inc. (AMEX: MHA)
http://www.wsw.com/webcast/rrshq11/mha
Maxygen, Inc. (NASDAQ: MAXY)
http://www.wsw.com/webcast/rrshq11/maxy
Medgenics, Inc.
http://www.wsw.com/webcast/rrshq11/medgenics/
Medicure, Inc. (AMEX: MCU)
http://www.wsw.com/webcast/rrshq11/mcu/
Medical Marketing International Group plc (LONDON: MMG LN)
http://www.wsw.com/webcast/rrshq11/mmi/
MediGene AG (Frankfurt: MDG GR)
http://www.wsw.com/webcast/rrshq11/mdg.gr
Medivation, Inc. (NASDAQ: MDVN)
http://www.wsw.com/webcast/rrshq11/mdvn
Metabasis Therapeutics, Inc. (NASDAQ: MBRX)
http://www.wsw.com/webcast/rrshq11/mbrx
Modigene, Inc. (OTC BB: MODG)
http://www.wsw.com/webcast/rrshq11/modigene
Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
http://www.wsw.com/webcast/rrshq11/mnta
MorphoSys AG (Frankfurt: MOR GR)
http://www.wsw.com/webcast/rrshq11/mor.gr
Neoprobe Corporation (OTC BB: NEOP)
http://www.wsw.com/webcast/rrshq11/neop
Neose Technologies, Inc. (NASDAQ: NTEC)
http://www.wsw.com/webcast/rrshq11/ntec
Neuro-Hitech, Inc. (NASDAQ: NHPI)
http://www.wsw.com/webcast/rrshq11/nhpi
Novadel Pharma, Inc. (AMEX: NVD)
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Novavax, Inc. (NASDAQ: NVAX)
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Novelos Therapeutics, Inc. (OTC BB: NVLT)
http://www.wsw.com/webcast/rrshq11/nvlt.ob
Oculus Innovative Sciences, Inc. (NASDAQ: OCLS)
http://www.wsw.com/webcast/rrshq11/ocls
Omrix Biopharmaceuticals, Inc. (NASDAQ: OMRI)
http://www.wsw.com/webcast/rrshq11/omri
OncoVista, Inc.
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Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR)
http://www.wsw.com/webcast/rrshq11/optr
Osteologix, Inc. (OTC BB: OLGX)
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http://www.wsw.com/webcast/rrshq11/pa8.gr
Palatin Technologies, Inc. (AMEX: PTN)
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http://www.wsw.com/webcast/rrshq11/pars
Pipex Pharmaceuticals, Inc. (OTC BB: PPEX)
http://www.wsw.com/webcast/rrshq11/ppxp
Prana Biotechnology Ltd. (NASDAQ: PRAN)
http://www.wsw.com/webcast/rrshq11/pran
ProMetic Life Sciences, Inc. (TSX: PLI CN)
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Pro-Pharmaceuticals, Inc. (AMEX: PRW)
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ReNeuron Group plc (LONDON: RENE LN)
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Repligen Corporation (NASDAQ: RGEN)
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ITMN:
For any interested on the weakness in InterMune. While I am sure some is disappointment with the (slight) delay in 191 and any "surprise" is always taken with some caution, I think a Pirfenidone poster at ATS is of some concern too, IMHO
If you go to the ATS website and search (use "Pirfenidone) you can get to it. The one of concern is:
[Poster Board #B30] Pirfenidone Discontinuation in Patients with Idiopathic Pulmonary Fibrosis (IPF) Results in a Decline in Lung Function, [Publication Page: A142]
In it the study notes that
"Following pirfenidone cessation there was a decline in the DLCO (p=0.002). No trend or difference in FVC slope was noted with drug discontinuation." [This is the end-point in the CAPACITY Trials]
I must admit to being concerned but there are several things to keep in mind most notably this study was with just 9 patients. I am of the belief that the PI program news is more good then bad and InterMune/Roche may be formulating a slightly different approach that could gain them some additional competitive advantage against PI's that are ahead of them in development. [I have no concrete basis for this just speculating based mostly on listening to InterMune's last CC]
Just an FYI for any following InterMune.