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In a remarkably critical report, PricewaterhouseCoopers analysts are urging pharma companies to shift money from marketing into research and tie drug prices to efficacy or face a collapse of an unsustainable business model. PwC's "Pharma 2020: The Vision" says the pharma business model is "economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets."
Drugs are coming off patent faster than the pharma companies can replace them, the report warns, as research fails to deliver. Companies have managed only a marginal increase in R&D spending as a percentage of their budget in recent years while sales and general administration costs have surged. In the meantime, PwC adds, the industry's reputation has been badly tarnished. Interestingly, the report also says that companies will move away from the classic model of drug development that ends in regulatory approval to "live licenses" that allow for narrow product launches followed by gradually expanding approvals as drugs are continuously tested. And regulators around the world will collaborate more on the approval process, possibly moving to a single global process by 2020.
On a brighter note, however, PwC says that worldwide sales of pharmaceuticals will double by 2020, hitting $1.3 trillion. The growth will be driven by aging populations, rising levels of obesity and a surge in demand from emerging markets.
http://www.fiercebiotech.com/node/7238
"But what do they accomplish by pushing down a low float issue with huge prospects?"
If I was shorting then I'd hope the economic data (CPI & PPI) released thurs and fri creates another market sell-off and I could cover. Looks like it was a good trade.
Shorts keep pushing the price down. Any buys are immediately covered with selling.
This stock is going to send me to an early grave. Down another .65 on 53K shares. Its getting difficult to keep my fingers off the buy button.
I subscribe to Biotech Stock Research. They frown on giving any details about their releases so I try and stay in their good graces. I wish they covered more stocks that I follow, but their insight into the working of the FDA is worth my subscription.
The stocks had a big run so once the slide started investors sold to lock in profits. I'm surprised it held up as well as it did considering the general market sell-off. Biotechs got hammered, I lost more on SGEN on a percentage basis then RPRX for no reason.
My newsletter mentioned that there might be some selling of RPRX on the release, but I blew it off as a bunch of dummies. Guess they were right, but the market played a big part in todays trading. They also said any selling would be a buying opportunity so I guess it nets out as a wash.
I think we trade sideways or even down until the FDA path for Androxal or pathology results are released. I see alot more questions on the board about safety, FDA, and delays so we may have lost some momentum. Hope I'm wrong.
Its not even 100K shares. Weak hands. No reason to panic, the positive data will generate buyers.
Sell the news mentality for biotechs. It doesn't matter if the news is good or not. We traded down during the morning hours after the Androxal update, but then we ended up .60 or .70 on the day. Hopefully we'll do the same today.
"Are we to infer that long-term Proellex increases endometrium thickness? Or is that simply compared to baseline and that without Proellex the thickness would have been even greater with time?"
The endometrial changes are expected with the cessation of menstruation (periodic shedding of the uterine lining). Thats why we are using the drug holiday.
I think we'll see a nice upward move tomorrow since the press release was reported after the market closed as opposed to a press release before the open tomorrow. This gives investors time to do a little research on the company. I'm going to be disappointed in a close below $16.
Headed over $15 this week on anticipation of Proellex final data. Light volume, but it looks like the shares are in stronger hands every day.
If the FDA does not require QOL's for NEBIDO how could they require QOL's for Androxal?
Low Testosterone puts men at risk of premature death.
http://abcnews.go.com/Video/playerIndex?id=3225583
Science & Technology June 5, 2007, 3:24PM EST
The Next Wave of Cancer Drugs
There's a buzz among doctors and researchers about new inhibitor drugs that target a tumor's resistance to primary cancer treatments
by Catherine Arnst
Technology
The next breakthrough cancer drug could be a pill that induces cancer cells to destroy themselves. Or it may be a drug that turns off the cancer cell's ability to multiply and spread. It may even be a vaccine that convinces the body's own immune system to attack tumors. These were among the dozens of novel developmental-stage drugs with early clinical results showcased this week at the world's premier cancer meeting.
Although most of the headlines at the annual American Society of Clinical Oncology (ASCO) conference in Chicago June 1-5 focused on new uses for cancer drugs already on the market, many scientists at the meeting say they are most interested in drugs that may not be ready for the center stage until 2008 or 2009. "We are not going to have big breakthroughs every year, and this is a quieter meeting," says George Demetri, a top researcher at Dana-Farber Cancer Center in Boston. "But I'm already looking forward to next year."
Demetri and other scientists are particularly intrigued by a new class of drugs that target a cell defense mechanism called heat shock protein 90, usually referred to as HSP-90. The mechanism springs to action when a cell is exposed to heat and other stresses such as a toxic anticancer drug. In tumors, HSP-90 keeps the cells from dying off. Disable it, and the cells essentially commit suicide.
Advanced Trials Up Next
As Demetri describes it, HSP-90 looks something like a lobster claw that wraps itself around those parts of a malignant cell that help it to spread and grow—a sort of chaperone or bodyguard that allows the cancer to survive attacks. Armed thusly, cancer cells can develop resistance to drugs, so a number of companies have developed HSP-90 inhibitors to help the primary treatment do its job. These inhibitors, designed to work on a broad range of cancers, help ensure that tumors do not learn to resist the primary treatment.
Kosan Biosciences of Hayward, Calif., has based most of its research on HSP-90 inhibitors, designing them to work in combination with a number of primary treatments. At ASCO, the company presented data on several ongoing studies of its two main drugs, Tanespimycin and Alvespimycin (cancer drug names tend to be as complex as their mechanism of action). Tanespimycin is being tested against the blood cancer multiple myeloma, in combination with Velcade, a primary treatment made by Millennium Pharmaceuticals (MLNM).
Kosan Chief Executive Officer Dr. Robert Johnson says the interim results from an early-stage clinical trial with 56 patients found enough antitumor activity to warrant moving the drug into advanced trials this summer, with a goal of applying for Food & Drug Administration approval in the next year or so. "It could be the first HSP-90 inhibitor to reach the market," he says.
Optimism and Interest
It is not the first HSP-90 inhibitor to be developed, however. The National Cancer Institute has spent more than a dozen years testing a similar drug, called 17-AAG, but with little progress, because the inhibitor was not easily absorbed into the blood. Infinity Pharmaceuticals of Cambridge, Mass., has come up with a water-soluble version of 17-AAG called IPI-504 that it is developing in partnership with MedImmune (MEDI). IPI-504 is designed to overcome resistance to Novartis' Gleevec, the most effective treatment for a stomach cancer called GIST.
Data presented at ASCO from an early-stage trial of IPI-504 involving 21 GIST patients showed that it was able to decrease tumor activity or cause the disease to stabilize in a majority of patients, with minimal side effects. "We're really pleased with this drug so far," says Demetri, a principle investigator of the drug. "It certainly warrants further study."
Whether any of these drugs, or the hundreds of others presented at the meeting, will reach the market is far from certain—some 90% of experimental treatments fail in clinical trials. Still, says Larry Norton of Memorial Sloan-Kettering Cancer Center in New York, "I think next year's meeting will be very interesting."
Are you kidding me. It would be a walk-off grand slam.
REPROS VALUATION QUESTION AGAIN
I think your on the right track. Find drugs with comparable stages of development, estimated revenues, and competition to determine the potential buy-out target.
ILY101 has estimated revenues of $500 million to $1 billion by 2015. Competition by Renagel, from Genzyme which is also working on an improved version.
Proellex has estimated revenues of $1 billion + by 2015. No competition.
The buy-out from Amgen was $420 million. Looks like you should take that figure and increase it substantially for Proellex. I'm estimating $600 - $800 million.
Androxal is further along in development, revenues at least $500 million, competition from transdermal. Buy-out in the $300 - $400 million range.
ot-POZN, I've been in the stock for awhile, but I recently added a couple K so I would take a significant hit on negative news.
I don't know enough about KOSP to compare it to POZN's pipeline development. No one talks about the stock since they missed the bottom, but its worth a serious look. I don't see too many analysts give 80% chance of drug approval, oh yea, there was that 80% chance for Provenge's approval, but I won't mention it.
Spar, you got any POZN. Take a look at one of the presentations if you've never had the chance. Pretty exciting company, and FDA decision on Trexima expected Aug/01.
Here's a pretty good post off the yahoo board.
I believe Trexima is going to get approved. I even think I know what the safety issue was. I would not state 80% chance of approval...that was one analyst (Citibank) that put a probability percentage on it. Read the other articles (forecasting approval) and do your own reasoning (dd) ... the probability is much higher than 80%. I've analyzed the heck out of this stock, drawn my conclusions...I'm convinced the FDA will approve Trexima.
Also...Trexima sales will garner big money for Pozen. (which is why it should double on approval) I believe it will double...based not only on the projections of Trexima revenue..but the added validation factor re: Pozen's drug combination technology and what that means for the PN-400 arthritis (huge market) drug (backed by Astra Zeneca) entering Phase III trials in the 3rd quarter.
Don't listen to the shorts when they talk about Immitrex going off patent and therefore migraine patients will just take 2 separate pills, generic immitrex and alleve. (naproxen) What follows comes from one of my many conversations with Fran Barsky:
Trexima is 85 milligrams of summatriptan (Immitrex) with 500 mg of naproxen. Trexima also incorporates Glaxo's RT (rapid release technology) technology..which is in the status of "patent pending".
The RT technology significantly improves absorption and disintegration of the drug. The fact that it is "patent pending" right now means that generic versions of immitrex will not be able to copy this rapid release technology. (per Fran Barsky)
Also, Fran said that Immitrex dosages consist of 25, 50, or 100 milligrams. These are the only dosages that generic versions (once Immitrex goes off patent) can replicate. Note that Pozen's Trexima is 85 mg of Immitrex, combined with 500 mg of naproxen. Pozen believes that it is this dose (85 as opposed to 50 or 100) that is most effective, when combined with the 500 mg of naproxen and incorporated with the rapid release technology.
The response from the medical community has been positive...doctors will prescribe ONE proven PILL of Trexima with the RT Technology...as opposed to "experimenting" (read lawsuits) with lower or higher dosages(remember...when immitrex goes off patent in 2009, manufacturers of generic immitrex will not be allowed to produce 85 mg pills, which is the dosage used in Trexima) of generic immitrex and a SECOND naproxen PILL. Patients will be more likely to take one pill as opposed to two. (I know, sounds circumspect but that's the reality...doctors know that patients are more likely to follow a prescription that contains one pill as opposed to two)
Punk Ziegel seems to be the only firm covering RPRX. They mentioned the impressive top-line results for Androxal as reported on brief.com today. Significant 2007 catalysts include: full trial data for Proellex, discussions with the FDA to define the regulatory paths, and a potential partnership for Androxal.
I don't understand why a few more analysts don't pick us up since there's alot of money to be made advising on any pipeline sales transactions.
Its laughable to think we could be up less then DNDN today after positive news. They have a $730 million market cap and we have $180 cap. The projected sales of our pipeline has to be equal or greater with less competition. The timeframe for approval would probably be comparable unless they could use interim data.
30K & 8,900 @ $13.90 were the biggest trades. (both buys). Trading as expected. Few traders selling the news, but looks more like accumulation. Headed higher in the next few weeks as the market digests the new data. Hope we get Proellex before the end of month.
Yes, but even in the worse case scenario the QOL's would not be needed in the EU. Someone correct me if I'm wrong.
Androxal, restores or maintains fertility whereas Androgel has the opposite effect.
Spartex, I bought some JAV last week after thinking it was a hype stock. I've come to the realization that they have a sharp management team.
I didn't think Dylojet could compete with Toradol in the U.S. market, but if the clinical study shows a better profile for platelet function then it could gain a significant share. They got a nice break with nasal Ketamine since they don't have to do Phase III for the initial indication. I also think there's a good market for the nasal morphine.
I'm looking to buy some more shares, but I don't know if we'll see the low $6's again.
How often do any of us get the opportunity to ride a stock up like this? I'm sure all of us would say seldom which makes trading the stock tricky. Its got such a low volume that its hard to predict the movements, except for the trend which is higher.
I'm sure some people want to swing any news, but they may get burned with such a thinly traded stock and positive catalysts.
Looks like ASCO is going to bring some added attention this week. Collaboration with OncoGenex is producing some impressive clinical results. I'm going to be adding this week if I can get more under $10.00.
Study Presented at ASCO Shows Encouraging One-Year and Overall Survival Results for Phase I/II Trial of OGX-011 in Non-Small Cell Lung Cancer
Sunday June 3, 9:00 am ET
VANCOUVER, BC and CARLSBAD, CA, June 3 /PRNewswire-FirstCall/ - OncoGenex Technologies Inc. and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS - News) today announced encouraging preliminary data from a Phase I/II clinical trial of OGX-011 in first-line combination therapy for advanced non-small cell lung cancer (NSCLC). Data were presented by Janessa Laskin, M.D., a medical oncologist at the BC Cancer Agency, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
In this single-arm, open-label study, 81 patients with Stage IIIB (18 percent) or Stage IV (82 percent) NSCLC were treated with OGX-011, 78 of whom were treated at the Phase II dose of 640 mg per week by intravenous infusion, in combination with a standard first-line NSCLC chemotherapy regimen that included gemcitabine and either cisplatin or carboplatin.
Survival Results:
- At the time of analysis, the estimated median overall survival was 14
months, with follow up ongoing. For comparison, published studies
using a platinum-based regimen plus gemcitabine as first-line
chemotherapy for advanced NSCLC report median survivals of 8 to 11
months.
- The one-year survival rate for the 46 of 81 patients who had been
followed for at least one year was 54 percent; published data
document one-year survival rates in the 33 to 43 percent range.
- The 18-month survival rate for the 22 patients who had been followed
for at least 18 months was 36 percent, with follow up ongoing.
Objective Response Results:
- Among the 81 patients in the study, 26 percent experienced objective
tumor responses, 40 percent experienced disease stabilization, 28
percent experienced disease progression, and response was not
assessable in 6 percent.
"The one-year survival rate of 54 percent and the estimated median overall survival of 14 months compare favorably with previously reported studies and support further evaluation of the potential for OGX-011 as an additional combination therapy for advanced NSCLC," said Dr. Laskin.
"The progression and survival data are very encouraging. As we've previously communicated, we plan to convene an expert NSCLC advisory panel to discuss these data, and we will consider both the data and the panel's recommendations in our planning for upcoming pivotal studies to confirm the efficacy of OGX-011," said Scott Cormack, president and CEO of OncoGenex.
The investigators concluded that the treatment with OGX-011 was generally well tolerated in combination with this chemotherapy regimen. The most common grade 3 or 4 non-hematologic toxicities were hyponatremia (23 percent), fatigue (15 percent), infection (10 percent), nausea (10 percent) and vomiting (10 percent). The most common grade 3 or 4 hematologic toxicities were neutropenia (47 percent in combination with cisplatin and 60 percent in combination with carboplatin), lymphopenia (35 percent in combination with cisplatin and 20 percent in combination with carboplatin), thrombocytopenia (25 percent in combination with cisplatin and 45 percent in combination with carboplatin) and anemia (9 percent in combination with cisplatin and 20 percent in combination with carboplatin). In general these toxicities were consistent with the adverse event profile for gemcitabine in combination with a platinum-based regimen in this population. The addition of OGX-011 to gemcitabine/platinum-containing regimen may have increased the frequency of grade 3 or 4 neutropenia and thrombocytopenia compared with published data, but with the addition of OGX-011 there was no increase above the expected frequency of treatment with growth factors and platelet transfusions or the expected incidence of infection and febrile neutropenia.
OGX-011 is designed to specifically inhibit the production of the cell-survival protein, clusterin. Clusterin production is associated with treatment resistance in many cancers and in response to various cancer treatments, including hormone ablation therapy, chemotherapy and radiation therapy. Preclinical studies have shown that inhibition of clusterin can disable the tumor cells' adaptive defences, render the tumor cells susceptible to attack with a variety of cancer therapies, including chemotherapy, and facilitate tumor-cell death. OncoGenex and Isis are collaborating on development of OGX-011.
http://biz.yahoo.com/prnews/070603/to471.html?.v=19
Deadly spider’s venom may yield super virility
SANTIAGO, Chile - Scientists have discovered a potentially marketable contraceptive in the venom of Chile’s black widow spider, whose bite is fatal to many but can also cause prolonged, painful and involuntary erections in men.
The venom of the Latrodectus mactans, a variety of black widow found only in the south of Chile, has spermicidal properties not found in black widows in other regions of the world, Chilean Dr. Fernando Romero said.
Romero heads a research team that has studied the spider’s venom for seven years, prompted by tales of Chilean farmers who acquired superhuman virility after being bitten by the black widow.
Initial studies focused on taking extracts from the venom to treat erectile dysfunction, but they soon discovered it had a molecule that also made it an effective contraceptive.
“This is a great business opportunity, we are the creators of the spermicide,” Romero told Reuters by telephone.
He said he believes the molecule’s natural properties are superior to those of synthetic spermicides currently on the market.
“For us in Chile, this has opened a window of opportunity to an incredible market, since currently there are no naturally based spermicides that have the properties of this discovered molecule,” Romero said.
Romero, based at the Universidad de la Frontera in the southern city of Temuco, has already applied for a patent for his erectile dysfunction medicine.
‘Spider-bitten’
His team discovered the property after looking into Chilean folklore that describes a virile man, one known to have spectacular sexual energy or many sexual partners, as being ”spider-bitten.”
The Chilean black widow is also known as the wheat spider for the wheat fields it inhabits and where its farmer-victims receive their often fatal bite.
The spider’s bite can kill children and the elderly, but among strong young farmers it leads to erections that can last for days and involve involuntary ejaculations.
At the end of the ordeal, the man is left sexually energized and feels physically stronger, the saying goes.
RPRX valuation - I don't think any of us are ignoring your question its just that there are any number of factors to consider when trying to estimate a buy-out price which are beyond back of the napkin computations.
Yea, wish you had caught it within my 15 min. Nice day for RPRX. You should have bought some AIS when we talked about it. Trading over $2 with lots of interest.
Did you discuss QOL's for Proellex? What about partnership discussions and time frames?
Looks like somebody has decided to do a little accumulating. Hope we get some volume to take out the traders. $18 by the end of the month is in the cards.
INGN - got to give them credit for trying. Todays PR looks great initially.
The data (Abstract #380), which were presented today at the annual meeting of the American Society of Gene Therapy, showed that in this 22-patient trial, INGN 241 induced killing in all treated tumors, including in those patients who failed prior therapy with other anti-cancer agents. INGN 241 was well tolerated, and a maximum tolerated dose was not reached. Tumor growth control was observed in 44 percent of treated tumors. Two of five patients treated at the highest dose showed objective responses (greater than 50 percent reduction in tumor size). Increases in the number of immune cells known to mediate anti-tumor effects were also observed in all patients, consistent with the immune-stimulating activity of INGN 241.
And then you read.
Although INGN 241 was administered directly to tumors, evidence of distant biologic activity was observed, suggesting that this therapy may have utility in treating primary tumors as well as metastatic disease. INGN 241 treatment in combination with radiotherapy is being evaluated in an ongoing Phase 3 trial in solid tumors, including patients with head and neck cancer.
http://biz.yahoo.com/bw/070601/20070601005126.html?.v=1
I know what your saying, but it really boils down to the trial not meeting its primary endpoint. If the trial was stat sig. then I'm sure the data could have been validated upon review. These problems only occur when trial results are less then anticipated. They have been working on the data for two months, its impossible to retroactively change the diaries so I doubt anythings going to change.
Past history says that the trial will fail, but you never know till the fat lady sings.
"The main concern was patient symptom diaries." Ok, say the diaries on both arms do not indicate allergy symptoms due to low allergens. This would not be the first time that a clinical trial for allergies failed due to this, see Dynavax.
http://www.medicalnewstoday.com/medicalnews.php?newsid=63770
The trial could fail even though PreHistin works.
I did bail on the initial delay. I like to follow stocks after I sell in order to determine if it was a good move and as a learning experience. I have to think that management knew the results were poor when they made the announcement of the initial delay.
Hope you didn't get hit to hard.
I think the next announcement will be the trial failed. Could have been due to poor trial design, questionaire, lack of training, below average allergen, etc. Hope your correct, but I think this dog has seen its last days.
Wiz, you can't ever fault a guy for taking profits so I won't try. RPRX has been one of my most profitable stocks over the last year, but I sure don't see it as over extended.
Good Luck trading.
Bloodbath? Companies are given the clinical trial results which are immediately released if they are statistically positive. If the results were not as expected then the companies review the data in order to resolve any discrepancies. There may be some control issues, but it doesn't look good.
Spartex, I saw one of your posts on the Biotech value board concerning DNDN. Looks like your one of the few that has played the swings correctly. Congrats.
RPRX - I didn't see any selling today, but all it takes is a little market weakness to take us back to the $12.50 number. I can't understand why a large fund is not grabbing every share available which would stop these swings. I know JPs busy negotiating the Androxal sale (LOL), but a little more analyst coverage wouldn't hurt.
Why would you sell all your shares when RPRX could get a $10 pop to the upside at any time and the downside risk is minimal since the next clinical data will just be an extension of interim results? I swing a few shares, but I would never think about not holding a core position.