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Anyone know when the winter meetings are this year? TIA
Sounds to me like someone who is finding the going price too high. Don't know whether "if" was used before or not. They didn't mention the GILD buyout of MYOG of the deals to me it seems LLY got the best value for the dollar at least in the near term.
http://www.marketwatch.com/News/Story/Story.aspx?guid=%7BE1E52282%2D1C51%2D4FFF%2D9C93%2D809E9F74B67...
Schering CEO: Drug M&A prices "breath-taking"
BOSTON (MarketWatch) - Schering-Plough Corp. Chief Executive Officer Fred Hassan said Wednesday that the prices being fetched in the recent wave of big pharmaceutical takeover bids are "breath-taking," and are reflective of how difficult it is for large companies to acquire quality drug candidates.
"The prices that are being paid by our competitors are breath-taking," said Hassan, in an interview with MarketWatch on Wednesday. "They would've been unthinkable five years ago."
Indeed, the price tags attached to the most recent deals appear to underscore Hassan's observations.
On Monday, Merck & Co. (MRK) announced it was paying a 102% premium for research group Sirna Therapeutics (RNAI) , which has yet to bring a product to market, in a deal worth about $1.1 billion in cash. Merck said it made the bid to gain a greater foothold in the promising area of RNAi research.
Merck's offer came just about two weeks after Eli Lilly and Co. (LLY) said it planned to buy biotech partner Icos Corp. (ICOS) , which co-markets its erectile dysfunction drug Cialis, for $2.1 billion in cash.
Big Biotech has also gotten into the game. In mid-October, Genzyme Corp. (GENZ) outbid Millennium Pharmaceuticals (MLNM) for AnorMed Inc. (ANOR) , agreeing to pay $580 million in cash for the development-stage company. The attraction, said Genzyme, was AnorMed's Phase III drug candidate Mozobil, which is being tested for use in stem cell transplantation in cancer patients.
According to Hassan, the takeover craze has been fueled by recent rash of patent expirations on some of the industry's biggest-grossing products, such as Merck's Zocor, Bristol-Myers' Pravachol, and Pfizer's Zoloft.
"The industry's R&D engines are struggling to keep up with the expirations," said Hassan, noting that the trend towards acquisitions has been in place for some time.
Hassan added that the windfalls seen by companies under the American Jobs Creation Act of 2004, which allowed U.S. companies to repatriate foreign profits at a special tax rate, has also powered the trend.
Under the measure, companies can use the cash for such purposes as mergers and acquisitions.
As for Schering-Plough (SGP) , Hassan said the company doesn't feel as strong a need to make a major merger or acquisition deal, "as our existing products [patents] go into the next decade."
Schering-Plough also hasn't been eager to jeopardize its highly-touted financial turnaround, which has been roundly credited to Hassan, in order to pursue a pricey deal. The company has recently returned to profitability after spending significant time in the red.
"Our financial discipline has been preventing us from doing deals recently," said Hassan.
If Schering-Plough were to pursue an acquisition, he said, it would be to complement its existing therapeutic product areas: cancer, inflammatory illnesses, hepatitis C, cholesterol-maintenance, and respiratory conditions.
But Hassan also thinks the company can grow with its existing pipeline. When asked which drug candidates he saw as being the biggest potential revenue drivers, he pointed to a blood-thinner currently in Phase II clinical trials that the company hopes will either rival or be used in combination with Bristol-Myers' blockbuster drug Plavix.
He added that three other major opportunities include its HIV treatment vicriviroc, currently in Phase II testing; a protease inhibitor to battle hepatitis C, also in Phase II; and golimumab, a Phase III candidate to the company hopes will be a successor to its popular rheumatoid arthritis drug Remicade.
When asked about rumors that Schering-Plough is eyeing a possible merger with Bristol-Myers Squibb (BMY), Hassan declined to comment.
"But it's nice that we're doing so well that people are talking about us that way," he added. End of Story
Don't know if it was posted but FYI they presented today.
http://www.wsw.com/webcast/sig3/sirtris/
Money has put him in a corner imo.
In a corner financial flexibility wise or isolating from teamates?
If the former isn't Texas paying some of his salary so he is a "reasonable" 16 million or so? If the latter, I tell you what as a Braves fan I would take him in a heartbeat over Chipper or Renteria! I am not worried about him "choking" down the stretch either. Would the yankees take Chipper for him... Hmmmmm Would Chipper veto and how can we get a little payroll flexibility :)
Since I am a Braves fan thought I would post some speculation I've read/seen on the NL East, don't follow the other divisions as I did in younger days. Appreciation reading what anyone else has heard or cares to speculate on.
NL East
Mets. I think they'll pickup Glavine's option if they have too (the Braves won't pay 8-10 million and that's the only other place he said he would go). It'll be interesting to see how high they go in the bidding for Zito especially if it turns into a bidding war with their cross-town rivals (personally I hope they break the bank bidding against each other). Wonder if they'd go after a "project" pitcher like Jason Marquis? I always thought he had good stuff with Atlanta but just saw his numbers in St. Louis especially K's down each year??
Phillies. Thought I read someplace they'd be interested in ARod... I don't see it happening (him leaving NY). I think Gillick is a good GM think they go after mid-tear fear agents and try to lighten the payroll (everyone says Burrell). Its interesting the coaching staff gets replaced with all former Managers. I think the team goes through some turmoil next year.
Braves. I don't think they'll make any big moves. Doesn't look good for Giles coming back. Can't figure out why the Braves didn't swap Giles and Renteria in the line-up seemed to make perfect sense to me? He probably would have had a much better year and Renteria had more stolen bases and higher on-base. Hopefully they don't do something stupid like trade Rameriz. Yeah an outfielder leadoff hitter type would fit the bill but I don't see an exceptional one out there on the cheap (no thanks to a return of Kenny Lofton at 40+). Still think a good lefty addition in the bullpen would be good too.
MarlinsI think they made a big mistake with Girardi, ownership should have swallowed a little pride maybe made Girardi rearrange his coaches or something to show him whose boss but I really think they will drop a lot from this years performance.
NationalsI am a big fan Bowden (other then that Drunk Driving incident). I think he does a pretty good job at getting good value in trades. OK maybe he held on to Soriano too long but he put up some pretty good numbers. Don't know why they can't find a manager. I don't think Bowden has enough to get the team turned around for next year.
Dew,
Isn't CytRx also dabbling in RNAi? Saw they are up a fair amount today too. PR today says on getting Orphan Drug designation. I don't know why smaller BioTech/Pharma seem to move big on this. If it is an Orpahn indication I don't see it as worthy of a 30% move.
http://biz.yahoo.com/bw/061031/20061031005288.html?.v=1
(I'd post the whole article but I'd put them in the too speculative category plus the couple conference calls I heard the CEO, didn't encourage me)
Thanks for the link. So I take it SGMO was the company in question?
I take it you like the company/HIV candidate? Any links to better understand the company? TIA
Sirna-027 has hardly anything in common with those early gene-therapy experiments. It is administered locally in the eye and does not use a viral vector
Didn't mean to imply Sirna's drug had Leukemia risks, just new technology wondering how much known about safety profile. I don't claim to understand the science to know the risks (if any).
Dry AMD per se is not such an awful condition that it warrants the kinds of aggressive interventions that are justified for people with the wet form of the disease.
It may not lead to blindness like wet, in and of itself but with greatly impacted vision leading to significant loss in quality of life oh and a much greater prevelance I think a drug for Dry AMD (not just stopping progression) would do quite well. Yeah a drug to stop progression would be nice too.
How has the safety looked (no pun intended)? Wasn't there a European trial a few years back that set back gene therapy because of leukemia in some patients?
It sure seems like a lot of people are working on wet AMD, does anyone know any promising dry AMD candidates (outside of treatments to stop progression to wet)?
I remember looking at them a couple years ago and thinking it was too speculative. A little older article but I'll post it and if its too dated feel free to delete it.
http://www.the-scientist.com/2005/1/17/28/1/
RNA Therapeutics Enter Clinical Trials
With human testing now underway, it's time for RNAi therapeutics to silence or shut up
Email: Amy Adams - aadams@the-scientist.com
The Scientist 2005, 19(1):28
Published 17 January 2005
SYSTEMIC RNAi:Citing concerns over efficacy, stability, and specificity, many researchers develop localized RNAi therapeutics strategies, such as for use in the eye. A novel variantion on this approach is being developed in which a patient's blood stem cells are transfected with a lentiviral vector expressing an anti-HIV siRNA. Those cells are then reintroduced to the patient, where the hope is that the cells will propagate and develop into mature blood cells capable of fending off HIV infection.
Traditional gene therapy is built on a simple premise: If the absence of a gene product causes disease, then adding the missing gene will cure it. But recently some researchers have turned that idea upside down, using gene therapy to silence genes gone bad. The approach takes advantage of a technique called RNA interference (RNAi) to specifically destroy a targeted mRNA and thereby eliminate the resulting protein.
An RNA-dependent, posttranscriptional gene-silencing process, RNAi has been shown to work in organisms from plants to nematodes, fruit flies to humans. But that was in cell culture. It was only in 2002 that scientists showed that short stretches of RNA could successfully squelch protein production in living mammals.[1] In that study Anton McCaffrey, then a postdoc at Stanford University School of Medicine, demonstrated RNAi's therapeutic value by targeting hepatitis C. Since then work has expanded, taking aim at other viruses, brain diseases, macular degeneration, and recently cardiovascular disease.
RNAi could, of course, merely be the latest in a string of therapeutic strategies (see related story on p. 30) to be hyped and ultimately to fail. The technology has yet to produce a human therapy. But that's not keeping companies and research groups from racing to the bedside. Philadelphia-based Acuity announced in August the first human trial for an RNAi-based therapy, in this case, for macular degeneration. Boulder, Colo.-based Sirna announced its own Phase I trial shortly thereafter, also for macular degeneration, and other companies are hot on their heels with candidate therapies for HIV, hepatitis, and cancer, among others.
These trials will have to overcome significant hurdles. One obstacle, shared by traditional and RNAi-based gene therapy, is the ability to target the desired cell or tissue. "They talk about the 'magic bullet,' but magic bullets need magic guns," says William Pardridge of the University of California, Los Angeles. Other roadblocks unique to RNAi include issues of stability (the inhibitory RNAs must remain intact long enough to work), specificity, and lingering questions about whether RNAi induces an interferon response.
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STICKING WITH TRADITION
Much of the development in RNAi therapeutics builds on the foundation of traditional gene therapy, and with at least 15 years of research under its belt, the elder field has much to offer its descendant. Some groups are taking advantage of this experience by sticking with traditional gene therapy vectors. Beverly Davidson at the University of Iowa, for instance, uses adeno-associated virus (AAV) to deliver RNA into Purkinje cells in the brain. Expression of mutant proteins in these cells (among others) leads to neurodegenerative diseases such as Huntington and spinocerebellar ataxia.
"This virus doesn't normally go into mammalian brain," Davidson says. "When we directly injected them we had no way of knowing what kind of cells they would affect." As luck would have it, the virus infects Purkinje cells, but she admits this virus may not be ideal for all brain applications. "It's better to take the simple approach and use a virus that likes your cell," she says.
One advantage AAV offers Davidson is that it inserts its genetic payload into the host's DNA rather than transiently expressing the gene from the cytoplasm. In Davidson's experiments, the virus inserts a sequence coding for a short RNA that doubles back on itself like a hairpin (called a short hairpin RNA, or shRNA), which is then processed by the RNAi machinery to produce a functional short interfering RNA (siRNA).
Using this approach in a mouse model of spinocerebellar ataxia, Davidson found that the treatment improved muscle-coordination problems characteristic of disease.[2] McCaffrey, now at the University of Iowa, calls this result significant. "AAV is probably one of the more promising vectors," he says.
McCaffrey also uses traditional gene therapy approaches in his work on hepatitis viruses, using both viral vectors and naked plasmids expressing shRNA. But unlike Davidson, who injects her vector directly into the brain, McCaffrey and Mark Kay (McCaffrey's mentor at Stanford) have struggled to get their therapy into the liver in a way that is feasible for humans. Their animal approach involves injecting large amounts of virus into the tail vein of mice, or into an artery leading to the liver. "It's efficient but probably isn't going to work for humans," McCaffrey says.
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RNAi IN THE BUFF
One possible solution is to eliminate the vector and inject naked RNA instead – an attractive option for pharmaceutical companies, in part because of the control this gives over what they are delivering to their patients. The downside is RNA's instability, but McCaffrey says that with modification the double-stranded siRNA can survive long enough to have limited therapeutic effect.
Scientists have hit upon several effective chemical tweaks, including phosphorylation to protect against exogenous degradation, and methylation or fluorylation of the vulnerable 2' carbon to prevent endonuclease activity. "This allows us to stabilize the siRNA without loss of function," says John Maraganore, president and CEO of Cambridge, Mass.-based Alnylam Pharmaceuticals, which develops RNAi therapeutics.
The first RNAi-based therapy to go to clinical trial will actually do so without any modifications at all. Researchers at Acuity have found in mice that naked RNA survives long enough in macular-degeneration models to effectively shut down the excess VEGF protein that drives the disease. The company is now recruiting patients for a Phase I human clinical trial. Sam Reich, Acuity's senior director of research and development, says the entire testing regimen should take about four years, meaning the company could have a marketable drug sometime in 2009.
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TARGETING QUESTIONS
The decision by both Acuity and Sirna to target macular degeneration was certainly not accidental. The eye is a closed system, and Maraganore says naked RNAs will probably work best for localized illnesses in which the siRNA can be delivered directly to the target cells. For macular degeneration, that means injecting shRNA directly into the eye; in Parkinson disease, the nucleic acid is injected into the brain. Injections to both of these regions are already standard medical practice.
Other therapeutic strategies also may work best locally. Though proponents tout its surgical precision, RNAi's specificity is open to debate. Using microarrays to assess nonspecific inactivation, for instance, one paper found inhibition of only the targeted gene,[3] while two other groups observed non-specific effects.[4]
And then there's the question of whether systemic RNAi induces an interferon response. Though some researchers have made observations to the contrary, Mark Davis and colleagues at the California Institute of Technology recently failed to detect an interferon response when administering siRNAs through either the tail vein or intraperitoneally.[5]
Beyond these questions, many of the issues surrounding RNAi therapies, including questions of stability, dosage, and targeting, can be avoided if researchers employ local administration strategies instead of systemic ones.
Adopting the local approach, Davidson delivers her AAV-based therapy directly to the brain. Hitting the protein in all tissues may cause unexpected side effects, she says, especially if the treatment eliminates both the normal and mutated protein. "I would be concerned about off-target effects if it was being used systemically," she says.
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INNOVATIVE GUNS
Not everyone is committed to going local. Last November Alnylam described a way to deliver RNAi therapy both systemically and effectively, attaching its siRNA to cholesterol to ferry the molecule through the bloodstream.[6]
"It was an experiment that seemed unlikely," says senior author Hans-Peter Vornlocher. "It was unbelievably exciting." Vornlocher is also vice president of research at Alnylam Europe (previously Ribopharma), based in Kulmbach, Germany. The siRNA targeted apolipoprotein B, a key regulator of cholesterol metabolism whose levels correlate with an increased risk of cardiovascular disease. Mice receiving the modified siRNA had a statistically significant reduction in ApoB protein (37%), high-density lipoproteins (25%), and low-density lipoproteins (40%).
In an accompanying review article, John Rossi at the City of Hope Beckman Research Institute in Duarte, Calif., called the study a big step for RNAi therapy. In a separate interview, Rossi says, "Clearly this is the first published demonstration that you can systemically inject siRNA and have them be taken up by cells in several different tissues."
The cholesterol conjugate used in the study carried the siRNA to organs including the liver and jejunum, where most ApoB is produced. But other conjugates may target the therapy elsewhere, to organs such as the liver or kidney, says Rossi. "This is just the beginning. Other investigators are very interested in looking at a wide range of alternate conjugates," says Maraganore.
Rossi's own work takes another novel approach to RNAi therapy. Rather than trusting the siRNA to makes its way to the correct tissue – either as naked RNA or in a viral vector, Rossi transfects blood stem cells with a gene coding for an anti-HIV shRNA.[7] He plans to reinject those stem cells into patients, where they will mature into immune cells that produce HIV-thwarting siRNAs. Rossi hopes to use this approach in combination with other therapies in patients with HIV and lymphoma who need a bone marrow transplant after radiation therapy. "By treating these and giving them lifetime protection from the virus, you might be able to take people off some of the chemotherapy," Rossi says.
None of the techniques currently being investigated yet rises to the level of a magic gun. "Excitement has to be tempered with reality," says Rossi. His therapy, for instance, would require gram quantities of conjugated siRNA to work in humans. Nevertheless, all the strategies have shown promise in early studies. With a little luck, any of these could develop into a delivery device worthy of carrying the RNAi magic bullet.
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References
1. McCaffrey AP, et al.: "RNA interference in adult mice,".
Nature 2002, 418:38-9. [Publisher Full Text]
Return to citation in text: [1]
2. Xia H, et al.: "RNAi suppresses polyglutamine-induced neurodegeneration in a model of spinocerebellar ataxia,".
Nat Med 10:816-20. [Publisher Full Text]
Aug. 10, 2004
Return to citation in text: [1]
3. Chi J-T, et al.: "Genomewide view of gene silencing by small interfering RNAs,".
Proc Natl Acad Sci 2003, 100:6343-6. [Publisher Full Text][PubMed Central Full Text]
Return to citation in text: [1]
4. Jackson AL, et al.: "Expression profiling reveals off-target gene regulation by RNAi,".
Nat Biotechnol 2003, 21:635-7. [Publisher Full Text]
Return to citation in text: [1]
5. Heidel J, et al.: "Lack of interferon response in animals to naked siRNAs,".
Nat Biotechnol[Publisher Full Text]
doi:10.1038/nbt1038, Nov. 21, 2004
Return to citation in text: [1]
6. Soutschek J, et al.: "Therapeutic silencing of an endogenous gene by systemic administration of modified siRNAs,".
Nature 432:173-8. [Publisher Full Text]
Nov. 11, 2004
Return to citation in text: [1]
7. Banerjea A, et al.: "Inhibition of HIV-1 by lentiviral vector-transduced siRNAs in T lymphocytes differentiated in SCID-hu mice and CD34+ progenitor cell-derived macrophages,".
Mol Ther 2003, 8:62-71. [Publisher Full Text]
Return to citation in text: [1]
Until the French come back and give their OK, just have to do with preclinical data. Mostly very promising...
http://biz.yahoo.com/prnews/061030/sfm104.html?.v=64&printer=1
InterMune Presents at Two Liver Disease Conferences Research on ITMN-191 in Hepatitis C
Monday October 30, 4:01 pm ET
Presentations Include Preclinical Data for the Combination of ITMN-191 and PEG-Interferon alfa-2a and new insights on ITMN-191 resistant sequence variations of the N3/4A protease
BOSTON, Oct. 30 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced today the presentation of preclinical research describing the synergistic antiviral activity of ITMN-191, its orally-available hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with PEG-Interferon alfa-2a (PEG-IFN alfa-2a, Pegasys®). These in vitro findings were presented at the American Association for the Study of Liver Diseases (AASLD) 57th annual meeting in Boston, Massachusetts.
The antiviral activity of the combination of ITMN-191 and PEG-IFN alfa-2a was evaluated in vitro in two replicon systems, the HCV genotype-1b and a derivative with reduced sensitivity to ITMN-191. Peak synergy was seen at predicted therapeutically relevant concentrations of each drug and was of greater magnitude than that observed for other experimental HCV protease inhibitors currently in development. In addition, PEG-IFN alfa-2a greatly improved ITMN-191 potency in both replicon systems, and the variant with reduced sensitivity to ITMN-191 demonstrated hypersensitivity to PEG-IFN alfa- 2a, suggesting that the combination of ITMN-191 and PEG-IFN alfa 2a, may exert combined antiviral effects that increase the barrier for the development of drug resistant variants.
"Our continued research designed to better understand the antiviral effects of ITMN-191, alone and in combination with PEG-IFN alfa-2a, provides important insight into the potential for novel treatment paradigms that will be explored further in clinical studies of ITMN-191," said Lawrence M. Blatt, Ph.D., Chief Scientific Officer of InterMune. "We anticipate that future therapeutic approaches to the treatment of chronic hepatitis C will involve multiple agents, likely in combination with interferon, and we are hopeful that these combinations will lead to improved, sustained virologic responses for patients who are in need of more optimal therapies."
Additionally, Scott Seiwert, Ph.D., Vice President of Discovery Research at InterMune, presented research at the 1st International Workshop on Hepatitis C - Resistance and New Compounds. The presentation detailed the selection of variants of the HCV replicon with reduced sensitivity to ITMN- 191. This research demonstrates that amino acid substitutions at position 168 of the HCV serine protease play an important role in reducing sensitivity of the HCV replicon to ITMN-191. While important, however, single substitutions at position 168 are not sufficient to confer resistant at concentrations that correlated to estimates of liver exposure following oral dosing of ITMN-191. Rather, substitution at multiple sites is required to confer resistance to ITMN-191, suggesting that the genetic barrier to resistance in patients following clinical dosing of ITMN-191 may be relatively high.
About ITMN-191
InterMune has successfully completed preclinical toxicology and pharmacokinetic studies in multiple species in support of initiating Phase I clinical studies of ITMN-191 for the treatment of chronic HCV. The European Clinical Trial Authorization (CTA) application, which InterMune filed in the third quarter of 2006, includes results of 28-day preclinical toxicology studies utilizing doses many-fold higher than those expected to be given to humans. These studies demonstrate that ITMN-191 has a favorable toxicology profile, allowing the compound to be studied in clinical trials over a range of doses predicted to have antiviral efficacy. ITMN-191 has also demonstrated high in vitro potency and specificity in biochemical assays and in assays utilizing the HCV replicon system. Moreover, ITMN-191 displays a favorable cross-resistance profile, including significant potency against variants of the NS3/4A protease that are resistant to other HCV protease inhibitors currently in development. Preclinical pharmacokinetic results support the exploration of twice-daily oral dosing in HCV patients. On October 16, 2006, InterMune signed a collaboration agreement with Roche for the research, development and commercialization of ITMN-191 and potential second-generation HCV protease inhibitor compounds.
About HCV and HCV Protease Inhibitors
According to the Centers for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected. According to the World Health Organization (WHO), it is estimated that there are 170 million people worldwide afflicted with this disease. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches. The HCV NS3/4 protease is an attractive drug target because of its potential involvement in viral replication and suppressive effects on host response to viral infection. Inhibitors of the HCV protease, such as ITMN-191, represent a promising new class of drugs for HCV.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF. The INSPIRE trial is evaluating Actimmune® and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes ITMN-191, the lead HCV protease inhibitor compound, a second- generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of our clinical trials and announcements of results thereof. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's annual report on Form 10-K filed with the SEC on March 13, 2006 (the "Form 10-K") and updates included in the most recent Form 10-Q filed with the SEC on August 8, 2006 (the "Form 10-Q"), and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to our intellectual property rights; and (v) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC.
At the time I thought maybe InterMune could have gotten a little more for it, but I wasn't upset to part with it given the direction HCV therapy was heading. I think the company had thought anywhere from 20 to low 30's based on Investigator studies and thought 25% would have made it widely accepted.
http://biz.yahoo.com/bw/061030/20061030005444.html?.v=1&printer=1
Valeant Pharmaceuticals Presents End-of-Treatment Results of DIRECT Trial for Infergen at the American Association for the Study of Liver Diseases 2006 Annual Meeting
Monday October 30, 8:30 am ET
COSTA MESA, Calif.--(BUSINESS WIRE)--Valeant Pharmaceuticals International (NYSE:VRX - News) today presented its 48-week data from the Infergen® (Consensus Interferon) DIRECT trial at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston. Dr. Bruce Bacon, the DIRECT trial lead investigator and Director of the Division of Gastroenterology and Hepatology at Saint Louis University, presented the data in the late-breaker poster session.
The DIRECT trial is evaluating the daily use of Infergen in combination with ribavirin for the treatment of hepatitis C in patients who were non-responsive to previous pegylated interferon and ribavirin therapy. The screening criteria for this trial were very strict, including the enrollment of only those patients who exhibited greater than or equal to 80% compliance with previous pegylated interferon and ribavirin therapy. Additionally, more than 75 percent of patients showed evidence of advanced fibrosis/cirrhosis (stage 3 and 4). Patients also were especially heavy, with an average weight of 89 kg (196 lbs.) and had been off therapy (the washout period) for a median of 395 days in the 9 ug group and 499 days in the 15 ug group. No patients in the study received growth factors for treatment of neutropenia or anemia.
The percent of patients who were virus negative at end-of-treatment (treatment week 48) for the Infergen 9 ug and 15 ug groups were 16 percent and 19 percent, respectively (TMA Assay). Response rates at end-of-treatment using the bDNA assay were 22 percent and 25 percent for the Infergen 9 ug and 15 ug groups, respectively.
An analysis of end-of-treatment response by fibrosis score showed patients with a fibrosis score of F0-2 had the highest response rates in the study, with Infergen 9 ug and 15 ug groups achieving response rates of 19 percent and 28 percent, respectively (TMA Assay). End-of-treatment response rates for patients with a fibrosis score of F3 were 16 percent and 19 percent for the Infergen 9 ug and 15 ug groups, respectively. Cirrhotic patients (F4, with or without F3) had end-of-treatment response rates for the Infergen 9 ug and 15 ug groups of 8 percent and 6 percent, respectively (TMA Assay).
The washout period (days from completion of at least 12 weeks of highly compliant pegylated interferon and ribavirin therapy to the first dose of Infergen in the DIRECT trial) had an impact on viral response as well. Patients receiving Infergen 15 ug daily with a washout period less than the 499 median days were more than twice as likely to be virus free at week 48 (26 percent vs. 11 percent by TMA Assay).
"The end-of-treatment response rates from the DIRECT trial are promising. There appears to be very little viral breakthrough between week 24 and end-of-treatment. The preliminary results suggest that a limited washout period from previous therapy may provide guidance on how to best optimize the use of Infergen and warrants further study," commented Dr. Bacon.
"The pegylated interferon and ribavirin non-responder population continues to increase each year. The DIRECT trial enrolled some of the most challenging non-responders. These were the most difficult to treat patients in the community in that they possessed multiple negative risk factors for response: high viral load, poor response to previous therapy despite compliance, high prevalence of fibrosis, long washout period, and high baseline body weight. In addition, these patients did not receive any adjunctive growth factor support for anemia or neutropenia during treatment," said Wesley P. Wheeler, Valeant's president of North America and global product development. "Based on the encouraging performance of Infergen in this challenging patient setting, we intend to pursue future multi-center studies and ultimately complete our registration strategy with the Food and Drug Administration."
About DIRECT
The DIRECT (Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy) trial is a Phase 3 open-label multi-center U.S.-based study enrolling patients who were previous non-responders and compliant with at least 12 weeks of pegylated interferon and ribavirin therapy. The 343 genotype non-2, 3 patients enrolled were randomized to receive either Infergen 9 ug/day plus ribavirin (1.0-1.2 g/day) or Infergen 15 ug/day plus ribavirin (1.0-1.2 g/day) for 48 weeks. The patients enrolled were required to have less than a 2 log10 decline in viral load while undergoing at least 12 weeks of previous pegylated interferon and ribavirin therapy or have detectable HCV RNA at the end of treatment, after completing at least 24 weeks of pegylated interferon and ribavirin.
Patient demographics in the trial include patients with a mean age of 50 years, 71 percent male, 68 percent high viral load (greater than or equal to 850,000 IU/ml), 94 percent genotype 1, a mean weight of 89kg, 17 percent African Americans, 67 percent Caucasians, and 77 percent with evidence of advanced liver disease, including bridging fibrosis or cirrhosis on biopsy. The median washout period was 395 days for the Infergen 9 ug cohort and 499 days for the Infergen 15 ug group.
The most common adverse events were fatigue, flu like symptoms, nausea, headache and neutropenia and were similar between groups. The percent of patients modifying their Infergen dose due to adverse events were 29 percent in the Infergen 9 ug cohort and 43 percent in the Infergen 15 ug group. Neutropenia was the most comment adverse event leading to Infergen dose modification and occurred in 14 percent in the Infergen 9 ug cohort and 22 percent in the Infergen 15 ug group. Growth factors were not used in the study.
About Infergen
Infergen or consensus interferon is a bio-optimized, selective and highly potent type 1 interferon alpha originally developed by Amgen and launched in the United States in 1997. It is currently indicated as monotherapy for the treatment of adult patients suffering from chronic hepatitis C viral infections with compensated liver disease and is dosed three times per week. Infergen is the only interferon with data in the label regarding use in patients following relapse or non-response to certain previous treatments.
Infergen is being studied in ongoing clinical trials to evaluate its potential for daily use with ribavirin. Enrollment in the Phase 3 IHRC-001 (DIRECT) trial was completed in mid-2005 with 515 patients at 40 sites in the United States. The DIRECT trial, which should be completed in 2007, is evaluating the safety and efficacy of both 9 ug and 15 ug doses of daily Infergen in combination with ribavirin in non-responders.
About Hepatitis C
According to the Centers for Disease Control and Prevention, an estimated 3.9 million Americans (1.8 percent) have been infected with the hepatitis C virus (HCV). HCV causes an estimated 10,000 to 12,000 deaths annually in the United States and is the leading cause of the need for liver transplants. The prevalence of HCV is increasing and approximately half of all patients with compensated liver disease do not respond to first-line treatment. There are approximately 250,000 of these non-responder patients currently in the U.S. and the number is growing by an estimated 50,000 each year.
Important Safety Information
Alpha interferons, including Interferon alfacon-1, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.
Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many but not all cases, these disorders resolve after stopping Interferon alfacon-1 therapy.
INFERGEN® is contraindicated in patients with known hypersensitivity to alpha interferons or to any component of the product, in patients with decompensated hepatic disease and autoimmune hepatitis. Development of or exacerbation of autoimmune disorders (e.g. autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis) have been reported in patients receiving alpha interferon therapies, including INFERGEN.
Treatment with INFERGEN should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse experiences requiring dose reduction, temporary dose cessation, or discontinuation of further therapy.
Severe psychiatric adverse events may manifest in patients receiving therapy with alpha interferons, including INFERGEN. Depression, suicidal ideation, suicide attempt, and suicide may occur. Other prominent psychiatric adverse events may also occur, including psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and relapse of drug addiction. INFERGEN should be used with extreme caution in patients who report a history of depression. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted.
Bone Marrow Toxicity: Alpha interferons suppress bone marrow function and may result in severe cytopenias including very rare events of aplastic anemia. It is advised that complete blood counts be obtained pretreatment and monitored routinely during therapy. Alpha interferon therapy should be discontinued in patients who develop severe decreases in neutrophil (less than 0.5 x 109/L) or platelet counts (less than 50 x 109/L).
Hypertension, tachycardia, palpitation, and tachyarrythmias have been reported in patients treated with INFERGEN. INFERGEN should be administered with caution to patients with preexisting cardiac disease. Supraventricular arrhythmias, chest pain, and myocardial infarction have been associated with alpha interferon therapies.
Pneumonia and interstitial pneumonitis, some resulting in respiratory failure and/or patient deaths, have been induced or aggravated by alpha interferon therapy, including INFERGEN. Patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment should discontinue treatment with INFERGEN.
Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation when treated with alpha interferons, including INFERGEN. During treatment, patients' clinical status and hepatic function should be closely monitored, and INFERGEN treatment should be immediately discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin, are observed.
Ophthalmologic Disorders: Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, and papilledema are induced or aggravated by treatment with INFERGEN or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. INFERGEN therapy should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Ischemic and hemorrhagic cerebrovascular events including hemorrhagic stroke have been observed in patients being treated with INFERGEN. In addition, transient ischemic attack has been reported in young patients being treated with INFERGEN without other reported risk factors.
INFERGEN should be discontinued immediately and appropriate medical treatment instituted if hypersensitivity reactions occur. INFERGEN should be administered with caution to patients with a history of endocrine disorders and should be discontinued immediately in patients who develop signs and symptoms of colitis. In addition, INFERGEN should be suspended in patients with signs and symptoms suggestive of pancreatitis and discontinued in patients diagnosed with pancreatitis.
The most common adverse events reported for INFERGEN during clinical studies were headache (82%), fatigue (69%), fever (61%), myalgia (58%), rigors (57%), body pain (54%), arthralgia (51%), nausea (40%), insomnia (39%), pharyngitis (34%), nervousness (31%), infection upper respiratory (31%), diarrhea (29%), depression (26%), anorexia (24%), injection site erythema (23%), granulocytopenia (23%), dizziness (22%), cough (22%), dyspepsia (21%), thrombocytopenia (19%), anxiety (19%), sinusitis (17%), influenza-like symptoms (15%) and leucopenia (15%).
Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile and the box warning by visiting www.infergen.com.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX - News) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
Infergen is a registered trademark of Amgen, Inc., and Valeant Pharmaceuticals North America is the exclusive licensee from Amgen of this mark. All other trademarks are the trademarks or the registered trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including, but not limited to, statements regarding the company's ability to successfully complete the DIRECT trial and obtain FDA approval for daily use of Infergen with ribavirin. These statements are based upon the current expectations and beliefs of Valeant's management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, market conditions and other factors beyond Valeant's control, adverse events that would require clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Infergen is not advisable, and the risk factors and other cautionary statements discussed in Valeant's filings with the U.S. Securities and Exchange Commission. Valeant wishes to caution the reader that these factors are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. Valeant also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this release. The company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes.
Contact:
Investor Contact:
Valeant Pharmaceuticals
Jeff Misakian, 714-545-0100, ext. 3309
or
Media Contact:
Valeant Pharmaceuticals
Angie McCabe, 714-545-0100, ext. 3381
I'll keep that in mind. Biowatch said the same thing too (but I don't subscribe yet to PM)! Sorry just getting the hang of this board.
FYI, If I subscribe I think Ihub should give you a cut. I find it a bit unfair to pay for the same thing (as SI) when they are owned by the same company that is why I am delaying it but this board may justify it.
Updates: general IPF info, Roche transaction, Q3 financials, links and misc. cleanup
InterMune http://www.intermune.com/
Focus on Pulmonology and Hepatology. In Pulmonology focused on Idiopathic Pulmonary Fibrosis (IPF) and in Hepatology Protease Inhibitor recent collaboration with Roche and an undisclosed preclinical compound (in collaboration with Array).
IPF
• Scarring of lungs, unknown cause
• Median survival from diagnosis 2-5 years
• US Prevalence 128,000, Incidence 48,000 each year http://tinyurl.com/u6kgo, journal abstract http://tinyurl.com/tqd6m (old prevalence incidence 83K US and 30K incidence; In 2000 it was believed prevalence was 50K US).
• No approved therapy steroid and immune suppressants used with little effect. Drugs used include: Imuran (Azathioprine), Cellcept (Mycophenolate mofetil), Rheumatrex (Methotrexate) and Prednisone along with off-label use of Actimmune. Other off-label use include: Remicade (Infliximab), Enbrel (Etanercept) and Gleevec (Imatinib).
Actimmune http://www.actimmune.com/
• Interferon Gamma 1B naturally occurring protein administered by sub-q injection (200mcg, 3x week for IPF patients in protocol for INSPIRE study)
• IP Protection (http://tinyurl.com/yawz9q) announced today that it has been issued two composition of matter patents that together cover the manufacture, use and sale of Actimmune(R) (interferon gamma-1b) in the United States. These patents, USPN 6,936,694 and USPN 6,936,695, expire in 2022 and extend a portfolio of intellectual property rights relating to Actimmune(R), which includes another composition of matter patent that expires in 2014.
• Investigational Studies being conducted in Idiopathic Pulmonary Fibrosis. Had failed prior phase 3 trial with composite endpoint and subject to controversial debate on benefits of interferon gamma results and letter in NEJM. INSPIRE Trial is current Phase 3 trial aimed at showing survival benefit in IPF patients. January 8, 2005 NEJM “A Placebo-Controlled Trial of Interferon Gamma-1b in Patients with Idiopathic Pulmonary Fibrosis” http://content.nejm.org/cgi/content/full/350/2/125. October 21, 1999 NEJM “A Preliminary Study of Long-Term Treatment with Interferon Gamma-1b and Low-Dose Prednisolone in Patients with Idiopathic Pulmonary Fibrosis” http://content.nejm.org/cgi/content/full/341/17/1264 criticism of the study http://content.nejm.org/cgi/content/extract/342/13/974
• Approved usage (Past 10-K’s) ACTIMMUNE has proven to be safe for patients since its approval in 1990 for the treatment of chronic granulomatous disease. There are an estimated 400 patients with chronic granulomatous disease in the United States, and there is no FDA-approved treatment for these patients other than ACTIMMUNE. Based on the indicated dosage levels, the annual cost per patient is approximately $25,000. There are approximately 400 patients with osteopetrosis in the United States. The FDA approved Actimmune for the treatment of this disease in February 2002. Based on expected dosing levels for osteopetrosis patients, we expect the annual cost per patient would be approximately $25,000.
• Method of Action (Company presentations) Immunomodulatory, Anti-fibrotic, Anti-infective – Antiviral, Anti-proliferative
• Pricing (Company presentations) based on dosing in INSPIRE for fully compliant IPF patient would equate to $60,000/patient for year of therapy. Medicare Part D would be operative because 70 percent of patients are over 65.
• Partner (http://tinyurl.com/y4m3gz) outside US, Canada and Japan, Boehringer Ingelheim with InterMune option to promote where BI does not.
• Patient Population (Company presentations) When numbers were reported as 83K prevalence and 30K incidence in US company estimated that 50K would be mild to moderate and 80% of newly diagnosed patients would fall into that category. This is significant because the “mild-to-moderate” is what the company is targeting in the INSPIRE study.
• Prior Studies supporting INSPIRE GIPF-0011 (NEJM, Jan 2004) 330 ITT, follow-up 1.4 years Deaths in Actimmune 16/162 (9.9%), Deaths in Control 28/168 (16.7%), relative reduction 41% p=.08. Ziesche2 (CHEST, Nov 2002), 18 ITT, 5 years follow-up, Deaths in Actimmune 2/9 (22%), Deaths in Control 7/9 (77.8%), relative reduction 71% p=.01. Antoniou3 (ERJ, April 2006), 50 ITT, follow-up ~2 years, Deaths in Actimmune 5/31, Deaths in Control 7/18 (38.8%), relative reduction 70% p=.028.
INSPIRE Trial http://www.inspiretrial.com/
http://www.clinicaltrials.gov/ct/show/NCT00075998
• Trial Randomized, Double-Blind, Placebo-Controlled, 2:1 Randomization – Actimmune: Placebo
• Administration Subcutaneous 3x week injections, 200 micrograms
• ~81 Sites – U.S., Canada and Europe
• Primary Endpoint Survival Time
o Greater then 90% power to detect 50% difference of mortality over 3 years
o Greater then 80% power to detect 40% difference in mortality over 3 years
• Patients – Mild to Moderate IPF (forced vital capacity ≥ 55% and carbon monoxide diffusing capacity ≥ 35%)
• Treatment Period 2 Years after randomization of 600th patient. 600th patient enrolled in November 2005. Completed enrollment April 2006 (826 patients total). Rational for increasing enrollment http://tinyurl.com/y53xcb
• INSPIRE Trial Update (Company Presentations, Q3 2006 Call recent update). 2 Interim efficacy analysis in protocol (not clear if any have yet occurred). When asked about “drop-out” company did not specifically address but stated extremely pleased with “study conduct” which includes dropout, staying on medication, etc.
Pirfenidone
• Administration Orally active small molecule 3x day pill of either 267 mg capsules (CAPACITY 1) or 267 mg or 133 mg (CAPACITY 2)
• Acquired NA and EU rights from Marnac, http://www.marnac.com/ for Fibrotic Indications. (PR http://tinyurl.com/yy2qao and 10K’s) In March 2002, we licensed from Marnac, Inc., a privately held biopharmaceutical company, and its co-licensor, KDL GmbH, their worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases, including pulmonary, liver and renal fibrosis. Under the terms of the agreement, we received an exclusive license from Marnac and KDL in exchange for an up-front cash payment of $18.8 million and future milestone and royalty payments.
• Method Of Action (Company presentations) Preferentially binds to and disables the kinase p38-gamma. Significantly inhibits TGF-beta synthesis (fibrosis), Also inhibits TNF-alpha synthesis (inflammation)
• IP Protection (Conference call) Older compound patent from Marnac licensed covering anti-fibrotic uses 2011 expires. Basis of exclusivity more on Orphan drug. Granted in US (7 years) and Europe (10 years) after approval.
• Other Indications being studied in a number of trials (not all by InterMune). InterMune is seeking approval in Idiopathic Pulmonary Fibrosis. It is also conceivable that they later seek a broader approval for Fibrotic disease of the lung. Most notably an NIH study in Hermansky Pudlak Syndrome.
• Shionogi Phase 2 Results PR http://tinyurl.com/y5nwel Stopped after 6 months (efficacy). Treatment of 9 month. Observation/ Placebo/ Pirfenidone: Improved Minimal O2 Oximetry/6.1%/24.2% Declined Saturation/33.3/18.2% P=.016 Vital Capacity Improved/0%/9% Vital Capacity Declined/36.4%/13.4% P=.003
• InterMune Phase 2 Results PR http://tinyurl.com/y49zp7
CAPACITY Trials, http://www.capacitytrials.com/
http://www.clinicaltrials.gov/ct/show/NCT00287729
http://www.clinicaltrials.gov/ct/show/NCT00287716 - Three Arm Study
• Primary endpoint is change in forced vital capacity (FVC) after 60 weeks of treatment
• Two concurrent, multi-national trials CAPACITY 1 and CAPACITY 2
• Approximately 580 patients
• Randomized first patient April 27, 2006
• Expect enrollment to conclude around the end of 2007, with top-line data expected in early 2009
• Exploring European partnering opportunities
• CAPACITY Trials Update (Company Presentations, Q3 2006 Call recent update). Enrollment proceeding at a brisk pace. Hinted could complete before end ’07 target.
InterMune 191
• Collaboration began with Array BioPharma http://tinyurl.com/y75d42
• Royalties Described as “mid-single digits”. Array describes their royalties as 3% (generally speaking about royalty deals they have in past not just 191). As pointed out by rkrw (SI) and Dew other 3rd party royalties Chiron/others (~2%?)
• High affinity for and stability in the liver
• Favorable pharmacokinetic profile potential BID dosing.
• 28 day preclinical tox suggests safe over dose range predicted to have anti-viral effect for chronic Hepatitis C patients.
• Potency of ITMN compound is maintained against mutations that show resistance to other protease inhibitors
• HCV replicon EC50 = ~2nM (VX-950=402nM, SCH-503034=200nM)
• Liver exposure in Rat/Primate (30 mg/kg) nM concentration 2,680/188 Log Drop in replicon RNA 3.23/2.08 (after 12 hours!)
• HCV protease selectivity is high
• Good safety margins for: Body weights, organ weights, Clinical chemistry, clotting parameters and hematology, Renal, neurologic, gastrointestinal, immune and cardiovascular systems
• There were no significant effects on microscopic histopathology on any organ or tissue, including heart and liver
• 9/26/06 CTA submitted to the French Medicinal and Biological Products Evaluation Directorate http://tinyurl.com/yevhgh
Roche Collaboration http://tinyurl.com/y2e87x
• 60 million on closing, assuming successful develop in US and other countries will receive up to 470 million in milestones. 530 million total. Potentially 35 million (of 470 million) in next 12 months.
• Cost sharing – Roche responsible for 67% global development costs including all related mfg costs.
• Royalties outside US Roche commercializes all products from collaboration InterMune Royalties “mid-high teens %” depending on net sales level
• In US commercialize and share profits on 50/50 basis.
• Same economic terms would cover any 2nd generation PI’s developed and commercialized, roughly doubling value.
• Roche responsible for World-wide formulation development and manufacturing any compound.
• InterMune has 3rd party royalty obligations that total in mid single digits. Split 50/50 with Roche in US, InterMune responsible for them outside US
• Development self funding through development. Beyond significant post development milestones.
• Can opt out of either co-development or com-commercialization. If do so would receive higher x-US royalties and same royalties replace profit share in US.
• Expect to close pending Hart-Scott-Rodino around mid November
Other Pipeline/Interests
• Early stage preclinical program partnered with Array (undisclosed indication in Hepatology). Royalty described by Array as high single digits. Array Responsible for creating clinical trial and all synthetic process. InterMune take into clinical development through commercialization.
• Equity interest in Targanta Therapeutics, http://www.targanta.com/ as a result of selling Oritavancin in December 2005. (http://tinyurl.com/yznhod)
• Early stage work on PEGylated version of Actimmune (with Maxygen), does not appear to have much effort as this time. (http://tinyurl.com/yn4e4z)
• PEG-Alfacon (PEGylated version of Infergen) appears unlikely to be further developed.
• Research work in both Hepatology and Pulmonology
Financials
• Cash 169.2 million (end of Q3 2006)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• 33 million shares outstanding
• 2006 Guidance
o Revenue 85– 95 million.
o COGS 21-23%.
o R&D 90-105 million (Does not factor any savings by Roche cost share, if closes in mid November). Including 5-10 million for est. FAS 123R.
o SG&A 30-45 million including 5-10 million for FAS 123R (not including 30 million for settlement).
• Government settlement for past Actimmune promotion (http://tinyurl.com/y3wa8a) . The company will pay $36.9 million plus 5% interest over five years. The first annual installment is $5 million and will be paid this year. Note some acceleration terms exist should InterMune receive 150 million in partnering/licensing (capped at $10 million/year).
Time-Line
• Late Q4 ‘06/Early Q1 ’07 Shionogi Pirfenidone Phase 3 trial top-line results (InterMune has data sharing agreement but it is not clear if the results will be released to the public… the market will know!)
• Mid Q4 ’06 Hear back from EU about 191 submission.
• Late Q4 ’06 Start dosing patients with 191
• ???? ’07 Interim look in INSPIRE. Company said likely would not disclose unless it was material (i.e. trial stopped)
• November ’07 INSPIRE trial ends (2 years after 600th patient enrolled)
• Q4 ’07 CAPACITY Trials enrollment targeted completion
• Q1 ’08 INSPIRE data released
• Q4 ‘07/Q1 ’08 CAPACITIY (Pirfenidone) treatment period ends
• Q1 ’09 Top line results from CAPACITY
Some Arguments For Investing in InterMune
1. It is my impression that some of the criticisms of Actimmune are side effects and limited efficacy. The fact is IPF is a disease with no good therapy and Actimmune has the potential to lengthen lives. While it does not appear to reverse the disease for some patients (treated early) it helps to keep it in check longer. To me a comparison should be more akin to some of the harder to treat cancers (The company also uses PAH as a model I think PAH therapies are much further ahead then IPF treatment options). With no treatment available one would hope the FDA does not place an extremely high hurdle and one would think patients would be very receptive.
2. Both Actimmune and Pirfenidone are potential Billion dollar drugs.
a. Actimmune:
i. Price for fully compliant patient 60K (lets use 50K)
ii. Using OLD incidence of 30K (25K mild-to-moderate) and say 25% penetration
iii. Say average patient stays on therapy 3 years
iv. The math then: 50K * 6250 * 3 = 937,500,000
v. This is VERY CONSERATIVE and VERY doable
1. If approved reimbursement by Medicare for large percent of patients (2/3 > 65)
2. Does not take into consideration incidence (OLD numbers of 50K mild-to-moderate)
3. Feel free to use
a. Higher penetration rates
b. Account for some of the 83K (50K mild-to-moderate) prevalence
c. Longer time on therapy (after all if successful Actimmune will extend life expectancy)
d. NEW prevalence and incidence numbers of 128,000 and 48,000
b. Pirfenidone:
i. Price 30K (estimate based on discount of Tracleer pricing in PAH)
ii. Again using OLD incidence but say 33% penetration (as patients may be more willing to take this as it is an Oral therapy)
iii. Again using 3 years average on therapy
iv. The math: 30K * 8333 * 749,970,000 + EU royalty? Or if market themselves
c. Some preclinical work done and it appears the compounds do not antagonize each other. In fact suggests the compounds may be complimentary if not synergistic.
d. The company has < 35 million shares and even if you include the convertible (due 2011) that adds about 8 million more shares. I’d work out the EPS numbers for you but you wouldn’t believe me, so you can plug in the numbers yourself. The COGS for Actimmune have been in the 21-23%. Sales force would be targeted (50 – 100 people say 200K each). SG&A 30-45 ’06 guidance (feel free to add a fair increase). R&D 90 -105 in ’06. Oh and the company has over 450 million in NOL’s
3. If Actimmune is successful one would think the PEGylated version becomes more of a priority to extend the product and gain patients with an easier to tolerate treatment. Also this may open the door to pursuing some other indications.
and Some Risks…
1. Actimmune failed in its previous Phase 3 and INSPIRE is based in part on retrospective analysis (everybody loves those!)
2. Actimmune has been tested and failed to progress in a number of other indications, most recently a Phase 3 trial in Ovarian Cancer was stopped (company states combo with chemo too toxic and Actimmune group did not receive Full Chemo to account for poorer results)
3. Actimmune is an injectable and has some side effects, though it is approved and has been used safely for a number of years.
4. If the dropout rate is high or compliance to dosing in INSPIRE is low (if one is injecting themselves thinking they are doing so with a Placebo it may be hard to keep on schedule)
5. Pirfenidone causes light sensitivity and may have some liver monitoring requirements
6. I believe the CEO was working (consulting?) for Warburg Pincus and they have a couple of board seats and a big position.
7. Other companies looking at IPF include Genzyme (collaboration with what was CAT) in Phase 1, Bosentan (Tracleer) from Actelion, Phase 2 failed in their endpoint proceeding with Phase 3 different end point, Imatinib (Gleevec), I believe it failed Phase 2 not sure of status going forward. Ilhprost (Ventavis) from CoTherix (PAH patients with IPF), others?
Nice article on the Roche/InterMune deal with some info on HCV. Don't recall what I guessed in the quiz but I don't think I expected a 90% chance of cure in HCV! Will try to update readme in the next couple days
http://www.insidebayarea.com/portlet/article/html/fragments/print_article.jsp?articleId=4535372&...
InterMune virus fighters attract Swiss drug giant
By David Morrill I Business Writer
Inside Bay Area
Article Last Updated:10/23/2006 07:22:58 AM PDT
BRISBANE
ROCHE is known for making great decisions with its investments and strategic alliances. So when executives at the Switzerland-based health care giant called executives of Brisbane-based InterMune Inc., they listened.
The biotech company has been working on a protease inhibitor program that targets hepatitis C (HCV), and Roche was interested.
More than a year later, those talks paid off last week when Roche said it would pay InterMune $60 million upfront, and potentially $470 million more to collaborate on the protease program.
"They are the world leader in drugs and clinical development, so the prospects of working with them is enormous," said Dan Welch, president and chief executive of InterMune. "It's definitely much better to work with them than have to later compete against them."
Roche conducts antiviral research at its Palo Alto campus, which is the division that will work with InterMune.
The centerpiece of the program is a candidate called ITMN-191. Even though it hasn't begun clinical trials yet, good readings of its potency at the test-tube level have given both companies confidence that it will translate well into human results. A protease inhibitor keeps the body from replicating viruses in the body.
InterMune will carry the
DRUGSIBusiness 2inhibitor through Phase I, and then Roche will help with its expertise in subsequent phases, said Nick Cammack, who heads Roche's virology group in Palo Alto.
"For me as the virology head, it's just a fantastic deal, and we can't wait to get going with them," Cammack said. "We are just going to assist where we can as it goes through Phase I, and hopefully work with them more if it comes out the other end (as an approved drug)."
It's not the first time Roche has pursued a Bay Area biotech company.
In 1990, Roche saw potential in a South San Francisco-based biotech company that made its mark in cancer studies. Roche spent $2.1 billion to have a controlling interest in it. That company was Genentech Inc., which today is the world leader in cancer product sales.
With InterMune, Roche couldn't resist the opportunity to get into a protease program because it's a complimentary fit to its other virology areas.
Because InterMune already has expertise in the protease program, Roche felt a partnership made more sense than an acquisition.
"We don't go around swallowing people up, because we're not arrogant to think we know best," Cammack said. "It would be insulting for us to tell InterMune what to do when they know this molecule in their sleep."
Said Welch: "This deal may not allow us to become the size of Genentech, but directionally I hope we will be able to advance our science like they have."
Analysts say that Roche's confidence in InterMune's protease program is clear because it is willing to share the profits 50-50 if any of the drug candidates ever make it to market.
"HCV is a huge chronic market opportunity that pharmaceutical companies like Roche are salivating to try to get at, so I'm not surprised with the deal at all," said John McCamant, editor of Berkeley-based Medical Technology Newsletter.
Although not as widespread as cancer, hepatitis C presents a solid market opportunity to Roche and InterMune.
The global hepatitis C market is expected to grow from $2.2 billion in 2005 to $4.4 billion in 2010 and $8.8 billion in 2015, according to LeadDiscovery, a U.K.-based life sciences firm.
"About 1.8 percent of the population is infected with HCV," said Larry Blatt, chief scientific officer of InterMune. "What that means is if you know 100 people, that means you probably know two that have HCV."
Worldwide, about 170 million people are infected with hepatitis C, according to the World Health Organization. Other protease inhibitors targeted at hepatitis C could reach the market before InterMune's. Vertex Pharmaceuticals Inc. has one called Telaprevir that is currently in Phase II clinical trials. In June, Vertex announced a deal with Johnson & Johnson's Janssen Pharmaceutica N.V. to collaborate on Telaprevir.
Still, even if ITMN-191 is not first to market, InterMune believes its candidate has the potential to be the "best of class." The hope is that trials will show that ITMN-191 can be effective taken in 12-hour intervals instead of eight, is more potent and has fewer side effects.
If the clinical trial process and subsequent approval process run smoothly, Cammack hopes that ITMN-191 could make it to market in six years. In the meantime, just in case it fails, Roche and InterMune will be looking for other molecules that could be effective against hepatitis C as well.
"What's exciting for this field is that if some, or any, of these molecules make it, we will one day be able to tell any patient that if you take this combination, you'll be completely cleared of the virus with a 90 percent success rate," Cammack said.
Shareholders have shown confidence as well as InterMune's stock has jumped more than 30 percent since the deal was announced.
InterMune was established by Palo Alto-based biopharmaceutical company Connetics Corp. to develop Actimmune, a stimulator of the human immune system licensed from Genentech.
Connetics spun off InterMune in 1999. Along with the spinoff, InterMune received exclusive U.S. product rights for Actimmune, which brought in $107.6 million in revenues in 2005.
When Welch joined the company as CEO in 2003, it was focused in five areas. Over the last three years, it stopped investing in the areas of cancer, autoimmune disease and infectious disease, and instead centered its attention on the two it currently targets, pulmonology (lungs) and hepatology (liver).
"We are now a fairly well integrated small biotech company at this stage with about 200 employees and a $700 million market cap on Nasdaq," Welch said. "We're excited about the opportunities we have."
Not only will the Roche deal bolster InterMune's hepatology division, but the upfront money will help push through drug candidates in the pulmonology division as well.
One development program, called Inspire, is in its Phase III clinical trial. It targets treatment of patients with a deadly lung disease called idiopathic pulmonary fibrosis and hopes to extend a person's survival.
Its second program, called Capacity, targets the same disease, but improves lung function. This program completed its Phase II trial in 2005 and started a Phase III trial in April.
Because the cause of this disease is unknown, and it only infects about 83,000 people in the United States, most pharmaceutical companies have backed away from working on products targeted at this area. The financial potential of treating other diseases could be more lucrative.
"It's not the garden variety diseases like hypertension or asthma, but rather much more focused to a smaller patient group," Welch said. "But for a biotech company like us, trying to help this huge unmet medical need is something we feel we can do."
Business Writer David Morrill can be reached at (925) 416-4805 and dmorrill@angnewspapers.com.
I usually root for the National League team but I am really not much of a fan of LaRusa. Haven't been watching much this year.
I take it those are real Red Sox tickets? Sorry don't know history well enough to know if those were historic games? I guess you'd have to add a zero to the price now.
I'm a Braves fan go back to the Buzz Capra, Pepe Frias, Bif Pocoroba. I was pretty young then so don't remember them as much I can relate more to the late 70's and 80's battling the Giants or Padres for last almost every year but at least we won our share :).
So no one wants the Nationals Managerial Job? First Lou says their rebuilding, Pendelton says its too far from home and now Girardi says he's looking at a couple different options (I thought for sure he would go there) after Lou went to the Cubs!
FYI, Biowatch I don't have PM capability here. Good to see Biotech fans are baseball fans too!
It’s much more common for a company to overestimate the speed of enrollment than to underestimate it.
They have been overestimating it for about a year, its about time they under estimated :)
Not sure if anyone here follows United Thereapeutics (sorry gofish I should have mentioned it before today, right :)) but this seems related to the topic of passing on an interim look.
In their medley of things United announced yesterday, they also cancelled the interim analysis of their TRIUMPH study (inhaled treprostinil) they said enrollment picking up was the reason. Given the pick-up in enrollment I estimate waiting till 200 (UTHR thinks about 220 will ultimately be enrolled) rather then if the interim is done at about 150 would be about 3 months. When they tried to get the protocol changed to have an interim at 100 they were told that even if statistically significant 100 patients may not be enough for secondary end-points. I think with among other things the excellent results of the open-label study recently published the likelihood of success are high, and (hopefully) the CEO is being cautious. A small trial and a low P value I think I'd want to be cautious. I don’t think Dr. Rothblatt has been enjoying getting grilled every call about enrollment numbers and the length its taken, and often has said didn’t want to have to do another trial (implied P < .01 1 trial is needed or presumably 2 with < .05).
If I could add a little from notes (not memory), I think it is dead unless Valiant is interested from the 11/29/05 call when they divested Infergen, indicated the following (not an exact quote from my notes):
80 patient trial Infergen + Actimmune in light of Infergen divesture decided not to go to expansion phase effectively terminating.
This was a very complicated study with the primary objective to evaluate two dose of Actimmune 50 and 100 and Infergen 9 and 15 with and without Ribavirin. Was to try to find optimal dose for expansion:
(Phase 2b Combo study)
. 3 cohorts but reality 8 arms
. 20 patients Alpha 9 mg daily with 50-100 Gamma TIW (2 arms)
. 15 mg daily with 50-100 Gamma TIW another arm starting to use 9 mg Ribavirin Gamma 50-100
. 15 mg daily with 50-100 Gamma and addition of Ribavirin
Treatment period is 48 weeks and 24 week observed for SVR.
The trial was encouraging though maybe not too well tolerated an Investigator sponsored trial found the following in my notes from past calls:
Dr. Carol Leevy study combining two in PEG non-responders in patients who did not have 2 log drop in 12 weeks. App. 44% HCV negative awaiting sustained biological response data. Encouraging as taking patients who had no response and getting 6 log drop in over 40% of patients.
and
When combine interferon’s worry about side effects. ALP within normal limits overtime. Hemoglobin was rising over time and having healthy amount by week 24 and also case at week 48. Biggest worry neutropenia saw a lowering of neutropfils but no severe grade 4 (< 500 neutrophils) some had grade 3 (less then 750 neutrophils) so gave growth factors in 8 patients out of 50. - From Dr. Maria Sjogren talk at an Investor Day
Had hoped (OK wishful thinking) Roche may consider doing something with Actimmune and Pegasys but absolutely no mention and I think it is a real long shot!
FYI, don’t have any other sources but InterMune would say generally believed non-responders retreated with other PEG have about 5-10% SVR.
A bit off topic...
Just was at http://www.clinicaltrials.gov/ to check on a couple of things and noticed they have a survey out to improve the sight. I am sure many here may have some good suggestions as well, hopefully they'll follow through on some of the feedback.
My biggest gripe isn't so much with the sight itself but the content. Wish companies (and for that matter institutions, i.e. NIH) would be required to provide more info AND keep it up to date. Would be great if they were required to post results too (even doing it after info published/presented would be very valuable historical reference)
So if everyone’s drug works (I know big IF)
Some combination of PEG-Intron + Ribavirin + 950
Vs.
Some combination of Pegasys + Copegyasis + 191 + R1626
Seems it would be a lot to pay and speculation would be the Roche regiment is more potent. Is SGP’s 503034 that much worse (heard they had trouble with non-responders but thought more trial design problem) then 950?
I didn't hear the SGP call yet but did Fred say he wants to do a deal in general and posters on investor village think an HCV one or did Fred say in that area?
Why would they be interested in Vertex is their (SGP's) protease inhibitor thought to be that much worse then Vertex's? I would think with Roche having a Polymerase Inhibitor that would be more the area of focus.
Since the 10K says ITMN191 royalties due to ARRY, specifically, are “low single-digit” and the CC comment was that ITMN191 royalties due to third parties in general are “mid single-digit,”
OK I say Uncle. I listened again and took notes they word 3rd party royalties in the plural don't say Array and it is "mid single digits" according to that call. Also, rkrw on SI (sorry I don't have search here to know if on this board too) reminded me about everyone owing Chiron royalties. I had only vague memory of hearing that before (plus I actually am not too familiar with them to have known PI's are covered).
Anyone know what the Chiron royalties are thought to be and what specifically they cover? (Not to say ITMN may not have even others besides Array+Chiron).
FYI, went back on some (recent) Array calls and they describe their 3rd party royalties (in general not just InterMune) as around 3%. They did say going forward are seeking to get high single digits and it sounded like the 2nd target with InterMune falls in that category. I got the impression since its described as a second target this is NOT under the Roche deal. If not clarified soon I'll try contacting IR.
Array actually sounds like a pretty interesting company (if there royalties do get better) and I could get it back in the six range but a shelf for half their market cap doesn't entice me to look at it further at this point. It seems to me a lot of Biotechs are having very large shelfs (as a percent of market cap) lately.
10K reports do not have to disclose every business relationship—only the ones considered material.
Not an expert in disclosure and not even doubting that there are other 3rd party royalties or even a big bonus to some Doc who invented it... but could it be just a wording by a new CFO who has been there just a couple of months (old one left to become CEO at a startup company)? In particular I believe in the call when talking about US royalty obligation (I believe they said to Array) it was stated it would be shared equally. When I make notes I'll pay particular attention to see if it was RE Array or general (While possible I don't think Roche would pay 1/2 Royalties to Array but not other 3rd parties).
Not that a few percent x-US is meaningless (based on potential market opp.) but either way Array gets peanuts and InterMune still gets potentially extremely nice profit share in US and meaningful royalty x-US
FYI on InterMune Royalty to Array. I thought I had seen/heard them being refered to in this way. I think they are < 5% will have to see if I have anything else from Array things I have.
From the 10K
http://www.sec.gov/Archives/edgar/data/1087432/000089161806000108/f17856e10vk.htm
Array BioPharma Inc. (Small Molecule Therapeutics)
In 2002, we entered into a drug discovery collaboration agreement to create small molecule therapeutics targeting hepatitis with Array. We fund drug discovery research conducted by Array based on the number of Array scientists working on the research phase of the agreement and we are responsible for all development and commercialization. Array will be entitled to receive milestone payments based on the selection and progress of clinical drug candidates, as well as low single-digit royalties on net sales of products derived from the collaborative efforts. The original term of this agreement expired in September 2004 and has since been extended to August 2006, subject to certain conditions. In addition, in December 2004, the agreement was amended to provide a mechanism for us to purchase certain intellectual property rights arising from the collaboration. In April 2005, we initiated a second research collaboration with Array with respect to a new hepatology target. This research collaboration extends through March 2007.
Assuming that all of the remaining milestones under these agreements are achieved, we will be required to make milestone payments of $9.0 million. Total research and development expenses related to this agreement were $7.5, $5.7 million and $2.1 million for the years ended December 31, 2005, 2004 and 2003, respectively. Included in the $5.7 million is a one-time non-refundable fee of $2.5 million paid in connection with securing the right to purchase Array’s ownership interest in certain collaboration patents.
One more thing about InterMune then I'll be quite (promise). I am not into this stuff but one may have predicted the price today as there is a convertible note of 170 million with a conversion price of 21.63 hmmm. Maybe BSR David or someone more knoweldgeable about this stuff can explain how that works?
But bear in mind that this board has a large number of lurkers and some of them are probably looking for good info about ITMN right now.
Thats OK I am a long-term investor and I am not looking for a quick out on the stock :)
The peg-interferon battle between Roche and SGP reminds me of the negative ads in some political campaigns.
Good analogy. If memory severes, I believe SGP did a head-to-head where they claimed supriority because Pegasys is fixed dose and PEG-Intron is weight-based... some how I think they had a lot more of the heavier people in that trial.
Dew,
Since the Q3 call is next week (and I likely won't even make notes to this call for a few days) if you don't mind I'll do it in a couple weeks. I'll try to clean up the links with tinyurl.
I don't think that I would go that far with Vertex but I certainly don't expect SGP or Roche to be overly cooperative and the PEGs certainly don't seem to be going anywhere.
Its interesting that InterMune mentioned the importance of Pegasys remaining in the body longer [I presume more than PEG-Intron] and that would be favorable to assist in cross-resistance and they have a presentation I believe AASLD with some preclinical work with it.
Thanks for the fda info/link. I will wait for the book :)
That will hardly make a dent in the hundreds of millions of milestones ITMN could receive.
I agree just didn’t want to be accused of (over) hyping InterMune.
ITMN refers to ARRY as their “partner” rather than their “licensor.” How is it that ARRY is getting so little out of all this? T.i.a.
My take is they are being gracious which is more then I can say for Array. The compound was started in InterMune labs and not jointly for one. Array was bought in to help with the Chemistry (InterMune doing the biology). They have also said Array helped with the modeling and GMP manufacturing. I don’t have a science background and never heard ITMN detail their (Array’s) contribution beyond that to know how much it is worth. I get the impression array is sort-a a biopharma consulting company where they contract out their scientists. I got the impression on one of their recent presentations that they want to do more in-house development (maybe they feel that 5% royalties aren’t where its at!)
Its interestingly when Array refers to their partnership they say InterMune has refocused the whole company around it. Yes, I will agree this is by far the highest profile item and you get the Pulmonology candidates at very low cost in the valuation however Actimmune generating 90-100 million in revenue isn’t exactly nothing!
I looked through my InterMune notes and couldn’t find a reference to the royalty beyond “small”. I know today they gave the impression of mid single digits. I thought I had somewhere com across low single digits but don’t quote me on that maybe it was in an Array presentation and that’s why I can’t find it?
Have a lot of thoughts on what this deal means for HCV drug development especially for Vertex (surprised others aren’t speculating) but I won’t count my chickens I know there is still a long way to go and Vertex has successfully passed milestones we have yet to approach! Its good to know InterMune has a much wider array of backup compounds should 191 run into something in the clinic.
Does anyone know if there will be anywhere that we can get information on what the FDA decides for HCV clinical development in the meetings the next couple days? thanks.
Interesting that Array is basically unchanged today with InterMune up mid-upper twenties. OK the nasdaq is down big and the company has had a nice rise year to date and I didn't like the shelf they filed...
I don't know enough about it but they seem to be a nice little company with a lot of potential royalties and starting to develop their own compounds too.
In fairness to my guess the rate goes up if they decide not to copromote in the US (granted it sounds like InterMune isn't going to give that up). The Array royalty should not be counted against me too :), in fact I was suprised that they only have to pay half in the US (if they copromote) I would have expected all. Just so no one is suprised I am fairly certain Array will also get low-mid
single digits of Milestone payments too.
Thought there were just 5 preclinical candidates didn't realize they have a larger number! No one asked (and I assume not) but would InterMune get milestone payments equivalent to 191 on a second generation PI or just the royalty/profit share being equal.
Thanks. If the Shionogi Pirfenidone Phase results out in a couple of months are anywhere near as good as the Phase 2 I'll be even happier!
Thanks. If Dan does a deal for Pirfenidone (EU) if it is shown to be successful I hope it is another good deal!
Forgot Elaprase (Shire's drug For Hunter Syndrome) and the Fabry treatments. So if I can rerank them:
1. Cerezyme
2. Naglazyme
3. Elaprase
4. Aldurazyme
5. Replagal / Fabrazyme
6. Remodulin (IV use anecdotally upwards of 250K)
if you owned itmn an they turned down 20 or 30 million up front for and a parnership with Roche would you have been upset?
I am an ITMN shareholder and I would have been upset if they accepted just 60 million up front! Its not the up front but the whole package (in my book) and I don't know the royalty rate and when the milestones are payable to say for sure. One would assume the rate is mid 20% outside the US and if they opt out of co-promote the same neighborhood US and that they receive a big chunk in milestones at approval/first commercial sale. Some reasons why I like it and why I don't think Roche overpaid.
1-Roche has access to a compound estate not just 191 (I believe the company reported 5 compounds in a prior call when 191 was unnamed).
2-Look at some of the deals done at various stages and payments along with what stage the compounds were at and I don't think its too high. Once they filed the CTA it took a lot of risk off the table. InterMune had said they could have done 2 deals at the preclinical stage BUT were not on the terms of a Phase 1+ deal which is what we were looking for. Could Roche have felt a little heat to do it sooner rather then later? Maybe, but the 60 million up-front isn't as high as some of the other deals so I think it is fair.
3-Its not like InterMune doesn't know a thing or two about HVC! Infergen (Interferon alfacon-1 also known as consensus interferon) is used in HCV (primarily PEG failures). Not only was it sold by InterMune for a couple years (before selling it to Valiant) but the co-inventor is Dr. Larry Blatt who is now CSO at InterMune and no doubt had a big role in its development. Plus the development took more of a rational drug design; they didn't just "luck in" to the compound. I think Roche saw a lot of data and science behind the compounds.
4-As a former ENZN shareholder, I saw Roche come in and really eat up PEG-Intron. (Now) I can give them credit for doing a good job against SGP and since SGP (along with JNJ/Vertex) are in this market and if all 3 are successful ITMN/Roche would be 3rd so a track record in coming late and gaining market leadership helps (and many consider Pegasys equivalent to PEG-Intron, 191 could very likely have several advantages over the other 2 PI's).
5-It appears combination therapy (with a PEG) will be prevalent for a number of years. Schering will push PEG-Intron with their PI obviously... Roche will push Pegasys and VX-950???
OK I can't sleep either maybe I can think of a good quiz? Well actually I have been curious about something but don't know the answer for sure to make it a quiz (maybe someone else does?) I was curous what the most expensive drugs on the market.
My guess is Cerazyme, Naglazyme, Aldurazyme, Remodulin. Anyone else know for sure?
This really shouldn't have come as a big suprise to anyone who follows the company. It was clear InterMune was going to do deal the question was just when, what if any part they'd keep and how much they'd get (even that one could make a good educated guess).
http://www.investorshub.com/boards/read_msg.asp?message_id=13924302
I don't think it is too rich an price. You need to balance they are late (3rd PI) vs. potential better safety, efficacy and maybe dosing. I think InterMune being in a cash burn situation wasn't going to do a deal with at least some up-front cash.
Happy Birthday Dew,
Maybe I'll turn some of my ITMN into ihub subsciption (I still don't like paying for both iHub and SI).
Just reading the PRs. It'll be interesting to see some of the details. Some thoughts...
- Class of compounds. Before 191 became 191 it was part of a class of compounds. They are also working on an undisclosed indication with Array (very early preclinical).
-A little suprised that InterMune did not sell off more of the rights. I like the fact that they have flexibility to turn it into a royalty if they want.
-Now Roche and SGP get to keep fighting for another decade :)
-Doubt it but I wonder if PEG-Infergen has any hope (OK this is a long shot) or the possibility of studying Actimmune in combination with Pegasys??
Dew/Gradstudent,
Not to butt in on your good discussion but a question on MAB's. I do not have a science background and was wondering on your thoughts on the different types of MAB’s in particular Murine. I am familiar with the Nature Biotech article that is critical of the poor success ratio of Murine MAB’s (“Monoclonal antibody successes in the clinic” http://tinyurl.com/y66766) but it is my understanding that a mouse MAB would be something the body would (more easily) recognize as foreign and thus more likely to mount an attack against it which seems desirable in an indication like cancer. Not sure if that is how Zevalin/Bexarr work but it sounds logical to a non-science guy anyway.
I guess what I am getting at is do you feel one type of MAB (Human/Humanized) is better in general (could be unfair to generalize I know) or are there characteristics of Chemeric and Murine that make them suited for certain indications.
Thanks in advance!
There is something perversely satisfying about
the notion that hedge funds may be paying big
money to subscribe to a site like this in return
for information that may be bogus.
I agree. In recent years with conference calls and analysts meetings being more readily available to "common" shareholders the playing field is getting a little more level... But some companies don't allow shareholders to ask questions and give 1-1 interviews and other preferential treatment to the bigger players.