Jiesen tries to take over the world

[jiesen]

VRUS is up $61 today to $134

Dang it, should have bought this one...

http://finance.yahoo.com/news/gilead-sciences-buy-pharmasset-11-122429948.html

Gilead Sciences to buy Pharmasset for $11 billion
Gilead Sciences agrees to pay $11 billion for hepatitis C drug developer Pharmasset

By Tom Murphy, AP Business Writer

INDIANAPOLIS (AP) -- HIV drugmaker Gilead Sciences Inc. will spend about $11 billion to buy Pharmasset Inc. in what one analyst termed an "amazing risk," a high stakes gamble that could yield billions of dollars in drug sales if a possible groundbreaking hepatitis C treatment pans out.
Gilead said Monday it will pay $137 per share in cash for Pharmasset, a Princeton, N.J., company with no products on the market and a stock that has traded as low as $20.49 in the past year. The announcement sent Gilead's stock tumbling and Pharmasset's soaring.
Analysts see promise in Pharmasset's lead candidate, a pill labeled PSI-7977 that has just started late-stage testing. They say it could become a preferred option for care if it works without the injectable drug interferon, which can leave patients with flu-like symptoms that last for months.
Before the drug reaches the market, though, it must pass through the largest and most expensive stage of clinical testing and receive Food and Drug Administration approval. Analyst Erik Gordon of University of Michigan's Ross School of Business said the price Gilead agreed to pay multiplies the risk in that process.
"At that price, everything had better work perfectly," he said.
Hepatitis C treatments represent a ripe opportunity for drugmakers. The virus can lead to life-threatening liver damage and is the main cause of liver transplants in the United States.
It is spread through the blood, and that can happen through sharing intravenous drug needles or having sex with an infected person. The disease, which can take years to manifest, also could be picked up from blood transfusions before 1992, when the blood supply began being tested for the virus.
Analysts expect the disease to become a bigger health problem due to the large, aging population of U.S. baby boomers, including some people who used intravenous drugs when they were younger.
Pharmasset has a total of three potential hepatitis C treatments in clinical testing, including PSI-7977. That one has already demonstrated its effectiveness in hepatitis C patients with genotypes 2 and 3, but analysts want to see how it works in genotype 1, the most prevalent subset in the Western world and the hardest to treat.
"It could be the dominant player in a new, non-injectable paradigm for the treatment of hepatitis C," Stifel Nicolaus analyst Maged Shenouda said. "That's the bet, but it's a big bet at $11 billion."
Earlier this year, the FDA approved two pills that offered the first new breakthrough treatments for the liver disease in 20 years. The Vertex Pharmaceuticals Inc. hepatitis C pill Incivek rang up about $420 million in this year's third quarter. Another pill, Merck & Co.'s Victrelis had $31 million in sales in the quarter.
Both of those drugs need interferon to be effective, noted Carol Werther, an analyst for Summer Street Research.
If PSI-7977 works in genotype 1 patients without the injectable, then the deal works out "beautifully" for Gilead, which could wind up with a drug that brings in several billion dollars in annual sales, the analyst said.
"That's the holy grail, that's what everybody wants, get rid of interferon," she said, noting that the drug would still have to be used in combination with other therapies, just not interferon.
Pharmasset plans to start two other late-stage trials in 2012 and hopes to file for marketing approval of treatment in the United States and European Union in the second half of 2013.
Gilead, based in Foster City, Calif., also is developing some of its own hepatitis C treatments, and Chairman and CEO John C. Martin said the deal will allow it to explore new combinations with its drugs under development.
Unlike Pharmasset, Gilead already has several drugs on the market. Its top-sellers include the HIV drugs Atripla and Truvada. Last year, Gilead earned $2.9 billion, or $3.32 per share, on $7.39 billion in revenue.
Gilead said it will pay for the acquisition with cash on hand, bank debt and senior unsecured notes. It expects the deal to close in next year's first quarter, and it forecasts that the deal could start helping Gilead's earnings by 2015.
Shares of Pharmasset soared 85 percent, or $61.47, to close Monday at $134.14, while Gilead's stock dropped more than 9 percent, or $3.62, to close at $36.26.

[jiesen]

VRUS cured Hep C?

I don't know much about this stock, but if they've cured Hep C, there's bound to be a good profit in it...

check out Pharmasset's latest clinical results:

http://www.bloomberg.com/news/2011-11-07/pharmasset-rises-after-hepatitis-c-drug-shows-100-cure-rate-in-trial.html?cmpid=yhoo

Pharmasset Rises After Hepatitis Drug Shows 100% Cure Rate

By Elizabeth Lopatto - Nov 7, 2011 1:12 PM PT

Pharmasset Inc. (VRUS) climbed 4.9 percent after the company said its experimental drug for treating hepatitis C cured all patients in a study.
All 40 patients who received Pharmasset’s experimental PSI-7977 drug were responsive after 12 weeks, the Princeton, New Jersey-based company said yesterday the annual meeting of the American Association for the Study of Liver Diseases in San Francisco. About half the patients had been followed up to 24 weeks, and they were all cured. There were no significant adverse events.
“Although patient numbers are small, we believe the results are extremely impressive,” wrote Brian Abrahams of Wells Fargo Securities in a note to investors today.
Pharmasset gained $3.34 to $72.23 at the close in New York.
The drug was tested in combination with ribavirin, a medication currently used in treating the disease, in patients with hepatitis C genotypes 2 and 3. Genotype 1 is most common and hardest to treat.
There were four groups in the study: Those who were treated with no interferon and those who received four weeks, eight weeks and 12 weeks of it, according to the data. The study was initiated to see the shortest duration of interferon, which is injected, required for a response.
On Nov. 1, Pharmasset announced it began a Phase 3 clinical trial of the drug in combination with ribavirin, without interferon. That would be an all-oral regimen to treat hepatitis C.

[mrmarket]

Moved about a 1% position out of bonds and into an S&P index fund today. Times like these, when things look the worst are the times to be buying, imo.

I'm saving another 1% in case the S&P continues the dive to 1200.

Jiesen...I agree. I have 60% of my net worth in oil and cash....waiting to pounce.

[jiesen]

Market looks like @#%!#, time to buy.

Moved about a 1% position out of bonds and into an S&P index fund today. Times like these, when things look the worst are the times to be buying, imo.

I'm saving another 1% in case the S&P continues the dive to 1200.

[jiesen]

LJPC on the move

looks like someone has finally stepped in and started to nibble here...

http://finance.yahoo.com/echarts?s=LJPC#chart1:symbol=ljpc;range=5d;indicator=volume;charttype=line;crosshair=on;ohlcvalues=0;logscale=on;source=undefined

[Websman]

yep, it's killing me... on the upside, the dilution went mainly (81% or so) to the major owners, one of whom owns about 37% (Essex Woodlands) of the company now. but it's definitely a good thing you avoided the dilution by exiting on Friday. Wish I had been as prescient.

I'll consider getting back in when i see evidence of a bottom. This thing could still shoot through the roof.

[jiesen]

yep, it's killing me... on the upside, the dilution went mainly (81% or so) to the major owners, one of whom owns about 37% (Essex Woodlands) of the company now. but it's definitely a good thing you avoided the dilution by exiting on Friday. Wish I had been as prescient.

[Websman]

I sold my LJPC on Friday for two cents below my buy price. I know it's all for a very good cause, but they're killing the shareholders.

[jiesen]

Thanks, Riverbabe!

[riverbabe]

There actually is clinical data linking dsDNA antibody levels to rate of renal flare, though. Once this trial is complete, there will also be evidence that removing the antibodies reduces the flare rate. Of course there's a lack of *this* data because this is the first drug in Phase III clinical trials that reduces the dsDNA antibodies.

Super Jiesen! I wish you all kinds of good luck. Riverbabe

[jiesen]

La Jolla Pharm: Lazard continues to anticipate results from ongoing Phase III trial of Riquent will fail to meet primary endpoint of time to renal flare (1.81 )

Lazard says this morning LJPC reported additional interim antibody data from its ongoing Phase III trial of Riquent for lupus nephritis. The 12-month interim antibody data from the first 125 patients randomized indicate that Riquent led to dsDNA antibody decreases (measured by AUC) of 26.9% for 100 mg, 35.5% for 300 mg, and 37.7% for 900 mg, versus an increase of 7.5% for the placebo arm. Based on firm's analysis of the literature, there is a lack of clinical data linking reductions in dsDNA antibodies to clinical benefit in lupus nephritis. Thus, firm continues to anticipate that results from the ongoing Phase III trial of Riquent will fail to meet the primary endpoint of time to renal flare, mirroring the results of earlier Phase II/III trials.

From: www.briefing.com

There actually is clinical data linking dsDNA antibody levels to rate of renal flare, though. Once this trial is complete, there will also be evidence that removing the antibodies reduces the flare rate. Of course there's a lack of *this* data because this is the first drug in Phase III clinical trials that reduces the dsDNA antibodies.

[riverbabe]

On the Wires Today LJPC

La Jolla Pharm: Lazard continues to anticipate results from ongoing Phase III trial of Riquent will fail to meet primary endpoint of time to renal flare (1.81 )

Lazard says this morning LJPC reported additional interim antibody data from its ongoing Phase III trial of Riquent for lupus nephritis. The 12-month interim antibody data from the first 125 patients randomized indicate that Riquent led to dsDNA antibody decreases (measured by AUC) of 26.9% for 100 mg, 35.5% for 300 mg, and 37.7% for 900 mg, versus an increase of 7.5% for the placebo arm. Based on firm's analysis of the literature, there is a lack of clinical data linking reductions in dsDNA antibodies to clinical benefit in lupus nephritis. Thus, firm continues to anticipate that results from the ongoing Phase III trial of Riquent will fail to meet the primary endpoint of time to renal flare, mirroring the results of earlier Phase II/III trials.

From: www.briefing.com

[riverbabe]

Guess I missed that post...But that is why I asked...I didn't want you to get in any trouble...I know for a fact that some companies monitor what their employees say on the Net

As long as he no longer has access to insider info, he should be free and clear. River

[jiesen]

good news for LJPC (and me)

from:
http://biz.yahoo.com/bw/080423/20080423005376.html?.v=1

La Jolla Pharmaceutical Announces Positive 12-Month Interim Antibody Data and Provides Update for Ongoing Riquent(R) Phase 3 'ASPEN' Lupus Trial

Wednesday April 23, 7:30 am ET
Significant Reduction in Antibodies Demonstrated
SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (NASDAQ:LJPC - News) today announced positive 12-month interim antibody data from its ongoing double-blind, placebo-controlled, randomized Phase 3 study of Riquent® (abetimus sodium), its drug candidate for systemic lupus erythematosus (“SLE” or “lupus”). Analyses of 12-month interim antibody data in the first 125 patients randomized in the study indicate that for all patients treated with 900 mg, 300 mg, or 100 mg of Riquent per week compared with placebo, there were significantly greater reductions in antibodies to double-stranded DNA (dsDNA, p < 0.0001).

Summary of Antibody Data

The data show a dose-response curve for antibody reduction and also show that the 300 mg and 900 mg doses appear to be near the top of the antibody-related dose-response curve, thus supporting the choice of doses for this study. Antibody levels in the placebo-treated group remained around baseline levels throughout the 12 months. The rate at which antibody levels were maximally reduced appeared to be more rapid in the 900 mg dose group than in the 300 mg or the 100 mg dose groups.
“Treatment with all doses of Riquent resulted in significant and sustained reductions in antibodies to dsDNA during the entire one-year treatment period,” said Michael Tansey, M.D., Executive Vice President and Chief Medical Officer of La Jolla Pharmaceutical Company. “Equally important, antibody levels observed in the placebo-treated patients remained around or above baseline and did not drift lower over time as occurred in the previous Phase 3 study. These data, which were generated in patients already receiving background immunosuppressive therapy, suggest that the appropriate doses were chosen for the current study and that overall, the 300 mg and 900 mg doses appear to be more effective than the 100 mg dose in the sustained reduction of antibodies to dsDNA.”
“The 12-month interim antibody data confirm that over the dose range being studied, treatment with Riquent resulted in significant reductions in antibodies to dsDNA,” said Richard Furie, M.D., Chief of Rheumatology, North Shore-Long Island Jewish Health System, and an investigator in the study. “These antibodies are strongly implicated as a primary cause of lupus renal disease, and prior studies have demonstrated that reductions in these antibodies strongly correlate with a reduction in the risk of renal flare.”
Each individual dose group was significantly different from placebo (p < 0.0001). An area under the curve (AUC) analysis, which reflects the effect of the drug on antibody levels over time, showed significantly greater antibody-lowering effects for the 300 mg and 900 mg dose groups compared with the placebo group (decreases of 26.9% for 100 mg, 35.5% for 300 mg, and 37.7% for 900 mg, compared with an increase of 7.5% for placebo).
The AUC analysis provides additional evidence that the higher doses of Riquent suppressed antibodies further than the 100 mg dose group. The proportion of patients achieving a 50% or greater AUC reduction was 0.0% in the placebo and 100 mg groups, 23% in the 300 mg group, and 30% in the 900 mg group.
The 12-month antibody analysis assessed the impact of treatment with Riquent or placebo on antibodies to dsDNA. Antibody levels were measured every two weeks for the first 16 weeks of the study and then monthly for the remaining 36 weeks. All demographics and baseline characteristics were comparable across dosing groups.
Phase 3 Trial Update
The Phase 3 ASPEN trial (“Abetimus Sodium in Patients with a History of Lupus Nephritis”) appears to be progressing well; more than 140 sites are active and more than 670 patients have been enrolled. Compliance with weekly visits has been high and the drop-out rate remains low. The Independent Data Monitoring Board (DMB) has completed three reviews of the safety data and has not indicated any safety issues.
The study is an event-driven trial designed to be completed when 128 renal flares have occurred. The current overall renal flare rate is lower than the original trial assumption. As a result, in an effort to shorten the time to achieve the required number of renal flares, the Company will continue enrollment beyond the initially targeted 740 patients and extend the treatment period beyond 12 months until the required number of renal flares is achieved. The Company now estimates that at least 800 patients will be enrolled in the study. Based on these changes, the Company expects the trial to complete in the second half of 2009.
The Phase 3 trial includes two interim efficacy analyses, each with target p values of p < 0.001 and a final p value of p < 0.05. The Company has added a futility analysis to each interim efficacy analysis. The interim efficacy analyses have been moved to occur later in the study when a greater number of renal flares will have been observed. As a result, the first interim efficacy analysis is expected to occur around the fourth quarter of 2008, and the second interim efficacy analysis is expected to occur about midway between the first analysis and the expected end of the study.
These modifications to the trial have been discussed with the FDA, and the trial continues to be conducted under the FDA’s Special Protocol Assessment.
“The interim results from the ASPEN trial are very encouraging,” said Deirdre Gillespie M.D., President and CEO of La Jolla Pharmaceutical Company. “At this point in the trial enrollment remains strong, the overall renal flare rate is lower than the original trial assumption, and the safety data appear to be consistent with data from our previous trials. These new data appear to show that the 300 mg and 900 mg doses of Riquent reduce antibodies to dsDNA more than the previously studied 100 mg dose.”
Dr. Gillespie added, “We continue to make great progress and believe that the additional refinements to the study will hasten its completion and possibly enable us to observe a definitive outcome earlier.”
Conference Call
The Company will host a conference call on April 23, 2008, at 1:30 pm Pacific Time/4:30 pm Eastern Time. If you would like to listen to the conference call, please access the link on La Jolla Pharmaceutical Company’s Web site at www.ljpc.com.
A replay of the conference call will be available the day of the call on the Company’s Web site www.ljpc.com and will be archived for several weeks. In addition, a replay of the conference call can be accessed by dialing 888-286-8010 (US) or 617-801-6888 (international). The passcode for the replay is 78768082.
Phase 3 Study Design
The Phase 3 study is designed to assess the ability of Riquent treatment to prevent or delay the time to renal flare in lupus patients with a history of renal disease and with antibodies to dsDNA. Equal numbers of patients are being treated with 300 mg per week, 900 mg per week, or placebo. A small number of patients are receiving 100 mg per week. All patients continue to receive standard of care which can include background immunosuppressive therapies.
A lupus renal flare is a potentially life-threatening increase in inflammation of the kidney due to lupus. A renal flare often requires treatment with immunosuppressive agents which can have severe side effects. Riquent is also being studied to assess whether drug treatment decreases proteinuria, as was observed in previous clinical trials. Proteinuria, or protein in the urine, is a common problem for patients with renal disease and is an indicator of renal damage.
Riquent has received an Approvable Letter and Fast Track status from the Food and Drug Administration, and has Orphan Drug designation in the United States and Europe.
About Riquent
Riquent is being developed to specifically treat lupus renal disease by preventing or delaying renal flares, a leading cause of sickness and death in lupus patients. It is also being studied to assess whether Riquent treatment improves proteinuria, as was observed in previous clinical trials. Proteinuria is an indicator of abnormal renal function. Riquent has been well tolerated in all 14 clinical trials, with no overall difference in the adverse event profiles for Riquent-treated patients compared with placebo-treated patients. Riquent specifically reduces circulating levels of anti-dsDNA antibodies and is also designed to specifically suppress the B cells that make these antibodies. Decreases in these antibodies are believed to be associated with a decreased risk of renal flare. Although clinical benefit has not yet been proven, Riquent treatment has significantly reduced these antibody levels in all clinical trials in which they were measured.
About Lupus
Lupus (systemic lupus erythematosus) is a chronic, potentially life-threatening autoimmune disease. About 90% of lupus patients are female, and many are diagnosed with the disease during their childbearing years. Approximately 50% of lupus patients have renal disease which can lead to irreversible renal damage, renal failure and the need for dialysis, and is a leading cause of death in lupus patients. Latinos, African Americans, and Asians face an increased risk of serious renal disease associated with lupus. The current standard of care for lupus renal disease often involves treatment with high doses of corticosteroids and immunosuppressive drugs that can cause severe side effects including diabetes, hypertension, and sterility and may leave patients vulnerable to opportunistic infections. To date, no lupus-specific drug has been approved in the U.S.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The Company’s leading product in development is Riquent®, which is designed to treat lupus renal disease by preventing or delaying renal flares. Lupus renal disease is a leading cause of sickness and death in patients with lupus. The Company has also developed potential small molecule drug candidates to treat various other autoimmune and inflammatory conditions. The Company's common stock is traded on The NASDAQ Global Market under the symbol LJPC. More information about the Company is available on its Web site: http://www.ljpc.com.

[IIC]

I really only started posting anything about this company after I left, since doing so beforehand would have likely gotten me in trouble.

Guess I missed that post...But that is why I asked...I didn't want you to get in any trouble...I know for a fact that some companies monitor what their employees say on the Net