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imo RPRX appears to be getting shorted today on low volume (and past week). I notice sale of stock on the uptick, and then the stock price ask is lowered immediately afterward. So the seller is happy with the price, and the acquiring shorter gets a higher ask to purchase their short shares. Thoughts?
So much for the uptick rule.
Oscar Schafer's call on Flamel (FLML) for 2007......
looks like a "Flame"l out! ;)
http://finance.yahoo.com/q/bc?s=FLML&t=1y
Clip from Barrons roundtable on recommendation of Medivation (MDVN) by Oscar Schafer.
Schafer: My second company is Medivation. Its market capitalization is only about $400 million. It is a bio-pharmaceutical company focused on acquiring and developing small-molecule drugs. Its lead compound, Dimebon, is designed to treat Alzheimer's and Huntington's disease. Its other product is a once-daily oral treatment for prostate cancer. Alzheimer's affects about five million elderly people in the U.S. and the incidence is expected to grow as the population ages. The current market for Alzheimer's treatments is estimated at about $4 billion. There are a four primary drugs for treating Alzheimer's, from Pfizer [PFE], Forest Laboratories [FRX], Novartis [NVS] and Johnson & Johnson [JNJ]. All have limited efficacy and will be going off-patent in the next few years. Is Dimebon in clinical trials?
Schafer: The Phase II data are spectacular, showing a statistically significant improvement over the placebo in all five of its endpoints, including measurements used by the Food and Drug Administration for approval of other Alzheimer's drugs. Side effects were minimal. The primary concern has been that the compound was discovered in Russia and the Phase II trials were done there, where the drug already was approved as an antihistamine. The trials were designed by two of the leading U.S. experts in Alzheimer's who were involved in pivotal studies of the two largest FDA-approved Alzheimer's drugs. These experts trained the investigators of the trial, and the study itself was conducted by a U.S.-based contract-research organization. The Phase II study has been accepted for publication by a leading peer-reviewed medical journal. Medivation also is conducting a Phase II trial of Dimebon in the U.S. for treatment of Huntington's. As for its other drug, more than 200,000 new cases of prostate cancer are diagnosed in the U.S. each year. In November 2007 the company released early data from its ongoing Phase I/II study of patients who had failed standard hormonal therapies. Its drug showed significant reductions in PSA, the marker for potential prostate cancer. While the reports are from a small sample, they are encouraging. The stock is 14 and could rally five or six times in the next two to three years.
Does the company earn money?
Schafer: No, but it has enough cash to get through Phase III. It could also partner with a larger company. The large drug companies have lots of cash and no big, new products.
RPRX Institutional buying and selling
I put this list together using current nasdaq listing (Joe P's 1/10 slide show) and compared it to yahoo's Sept. 07 institution list to show net % change in RPRX share ownership.
http://www.nasdaq.com/asp/Holdings.asp?symbol=RPRX&selected=RPRX&page=holdingssummary
http://finance.yahoo.com/q/mh?s=RPRX
Institution 9/07 ..... 1/08 .... % change
Efficacy Capital: 1,680,413; 2,465,513 ; + 43
Orbimed: 789,100; 1,002,300 ; + 27
Great Point Partners 921,594; 921,594 ; 0
Jay Jeffrey: ????; 921,594 ; new ??
(Question - are these guys same as Great Point? They own same number of shares as Great Point, but both are listed at nasdaq site)
Visium Asset 860,788; 860,788 ; 0
ProMed Management 663,114; 663,114 ; 0
Franklin Advisors 486,100 ; 486,300 ; nil
Wall Street Assoc. 275,000 ; 275,000 ; 0
UBS AG 221,792; 0 ; -100%
And a few others that haven't changed so I haven't listed them. It looks like there is almost a net increase of 1.8 million shares of RPRX from the fall 07 period until 1/08 (efficacy, orbimed and Jay Jeffrey) into institutional hands. And the institutions appear to be holding on strong to their positions.
Still trying to understand who was selling in early Dec, as well as who is currently shorting. The institutional positions don't really show much selling (I see only UBS AG) unless these institutions just haven't filed their appropriate forms for selling in early Dec ? I see total institutional ownership (doesn't include mutual funds) of ~8 mil shares (almost 66% of float!)
Thanks for anyones thoughts or ideas regarding filing timelines/update schedules for institutions holding <10% postions.
David, by the way, was there much of a showing of people at Repros' presentation (JP Morgan conf) near the tailend of the conference? t.i.a.
RPRX Institutional buying and selling
I put this list together using the nasdaq listing and comparing it to yahoo's Sept. 07 list to show net % change in RPRX share ownership.
http://www.nasdaq.com/asp/Holdings.asp?symbol=RPRX&selected=RPRX&page=holdingssummary
http://finance.yahoo.com/q/mh?s=RPRX
Institution 9/07 ..... 1/08 .... % change
Efficacy Capital: 1,680,413; 2,465,513 ; + 43
Orbimed: 789,100; 1,002,300 ; + 27
Great Point Partners 921,594; 921,594 ; 0
Jay Jeffrey: ???? 921,594 ; new ??
(Question - are these guys same as Great Point? They own same number of shares as Great Point, but both are listed at nasdaq site)
Visium Asset 860,788; 860,788 ; 0
ProMed Management 663,114; 663,114 ; 0
Franklin Advisors 486,100 ; 486,300 ; nil
Wall Street Assoc. 275,000 ; 275,000 ; 0
UBS AG 221,792; 0 ; -100%
And a few others that haven't changed so I haven't listed them. It looks like there is almost a net increase of 1.8 million shares of RPRX from the fall 07 period until 1/08 (efficacy, orbimed and Jay Jeffrey) into institutional hands. And the institutions appear to be holding on strong to their positions.
Still trying to understand who was selling in early Dec, as well as who is currently shorting. The institutional positions don't really show much selling (I see only UBS AG) unless these institutions just haven't filed their appropriate forms for selling in early Dec ? I see total institutional ownership (doesn't include mutual funds) of ~8 mil shares (almost 66% of float!)
Thanks for anyones thoughts or ideas regarding filing timelines/update schedules for institutions holding <10% postions.
I believe there will be a couple papers on Proellex presented at conferences (first one end of Feb in Italy), as well as being prepared for journal submission/publication. I think there will be at least one for Androxal to be presented at a conference as well as being prepared for publication. The below link (corrected for AUA meeting for only one Androxal paper) is direct from RPRX management. I'm not sure which drug is involved for the submission to Fertility and Sterility journal?
http://investorshub.advfn.com/boards/read_msg.asp?message_id=25837684
OT: Nerf, sehr gut! Hmmm, I don't remember seeing such lovely maidens when I was at the Spaten bier tent 21 years ago during Oktoberfest in Munich. ;)
GTCB .....but pic is of a shark and llamas so maybe I'm wrong?
I agree, very high potential revneue value from Proellex and these new projections are really astounding.
Stock is dead quiet the past few days. Low volume.
Doesn't look like Efficacy Capital nor the shorts are
interested/concerned at the moment.
Pfizer, Glaxo Drug Research Success Fails to Impress Investors
By Michelle Cortez
Jan. 11 (Bloomberg) -- Pfizer Inc., GlaxoSmithKline Plc and Sanofi-Aventis SA are testing a record number of experimental drugs, and so far shareholders are unimpressed.
There are about 1,425 potential therapies in the drug industry's research pipeline, 50 percent more than a decade ago, according to Cowen & Co., the New York securities firm. The treatments, for diabetes, cancer and brain disorders, may help offset an industrywide revenue decline commencing in 2011, when drugs generating $150 billion annually face generic competition.
``This is the golden age of drug discovery, not only for Pfizer, obviously, but for the pharmaceutical industry in general,'' said Martin Mackay, president, global research and development at New York-based Pfizer, the world's largest drugmaker. ``We've got the science, we've got the technology and we've got the knowledge. Our challenge is a simple one -- we must now deliver those compounds.''
The Standard & Poor's 500 Index of 14 drugmakers rose only 1.7 percent in 2007, less than the 3.5 percent return of the S&P 500. Investors may be taking a wait-and-see approach after the U.S. last year cleared the fewest number of drugs since 1983 and regulators delayed approval of medicines including Sanofi's weight-loss pill Zimulti.
``With so many failures this decade, investors' confidence levels are down,'' said Jon Fisher, who helps manage $22 billion, including drugmakers' shares, at Fifth Third Asset Management in Minneapolis.
This Week's Rise
Drug stocks are starting to rebound as investors buy companies less reliant on economic growth amid concern that the U.S. economy will slow. The S&P drugmaker index is up 4.7 percent this week, more than the less than 1 percent gain for the broader S&P index.
``We've been asking clients to look at pharma for the last six months,'' said Quincy Krosby, who helps manage $330 billion as chief investment strategist at the Hartford in Hartford, Connecticut. ``These companies have a lot of money and we expect that cash to be put to work and to see those pipelines be filled with new and potential blockbuster drugs.''
While New York-based Pfizer fell 14 percent in 2007 and Paris-based Sanofi slipped 10 percent, Merck & Co., which introduced six new drugs in the past two years, jumped 37 percent even after revenue of its best-selling drug, Zocor, was cut more than 80 percent by generic rivals.
Many Failures
It won't be easy replicating Whitehouse Station, New Jersey-based Merck's success, said Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development in Boston, in a telephone interview.
``There is no question there is an increase in products reaching the early stage of development,'' Kaitin said in a telephone interview. ``The overall likelihood of success isn't any better and there are a host of other factors making it harder for the industry now.''
Merck's achievement is a result of ``building up our scientific strength,'' said Peter Kim, the company's head of research, in an interview. ``I can't emphasize that enough.''
400 Cheaper Rivals
The U.S. Food and Drug Administration, under attack by some lawmakers, consumer groups and doctors for not taking a harder line on safety, approved just 19 new drugs in 2007, down three from a year earlier. In contrast, it cleared for sale about 400 rival generic drugs, according to the Cowen report.
More than a dozen targeted tumor-fighting drugs have been approved in the past five years. Herceptin and Avastin, sold jointly by Genentech Inc. and Roche Holding AG, as well as GlaxoSmithKline Plc's Tykerb, Pfizer's Sutent, and Bristol-Myers Squibb Co.'s Sprycel helped drive the death rate from cancer down two years in a row - the first time ever, according to the American Cancer Society.
A record 600 cancer therapies are in development worldwide, according to the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America.
``You'll see those same breakthroughs in the next few years with neuroscience and neurodegenerative diseases that we're seeing in oncology as we understand more about the mechanisms,'' said Pfizer's Mackay.
CEOs Spend
John Lechleiter, the newly appointed chief executive officer of Eli Lilly & Co., said in an interview that the sheer number of drugs in development for conditions including Alzheimer's, schizophrenia and cancer is cause for excitement. Still, companies can't become complacent, said David Brennan, chief executive officer of AstraZeneca Plc, which has doubled the number of drugs in late stage development in the past five years.
``I don't know that I'd ever be satisfied, but I think we've made progress,'' Brennan said in an interview. ``The industry is going into a period in 2010 to 2011 where $150 billion worth of brand name drugs are going off patent. It's not obvious that anyone has solved the issues.''
That may offer rewards to investors willing to gamble again on the pharmaceutical industry, said Jake Dollarhide, chief executive officer of Longbow Asset Management Co. in Tulsa, Oklahoma, in a telephone interview.
``Health care has been out of favor for so long that there are some great bargains out there,'' he said. ``In the mid- 1990s, investors would give a pharmaceutical company credit for a compound if it had the right profile, and almost assume at some point in the future they would make money on it. Now it's a reverse mentality.''
Industry executives say looming patent expirations and development setbacks make them leery about giving assurances.
``I'd like to under-promise and over-deliver,'' said Pfizer's Mackay. ``I have great faith in our pipeline, but by the same token this is a hard business. Even good drugs can die. The skepticism is appropriate until we deliver.''
To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net
Last Updated: January 11, 2008 00:21 EST
http://www.bloomberg.com/apps/news?pid=20601109&sid=atJmjcrbLL8s&refer=home
RPRX presentation slides for today as posted by Julescat on RPRX board (below). Some nice updates on the trial schedules as well as potential marketplace value for Proellex.
8k today including slides from today's presentation
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5382057
Dew, question on recent buying of RPRX by Efficacy.
Is there a reason why Efficacy would be aggressive buyers of the stock (other than for value purposes) the past month (up to their 20% limit) prior to this agreement with RPRX to allow them to now purchase up to 33%?
Thanks
RPRX presentation minor correction:
There is only one abstract (not two) to be presented at the AUA meeting in the Androxal program.
PS: I believe Efficacy did their last open market share purchase yesterday before this news announcement. I was a little concerned about what was going to happen once they hit the 20% limit.
The only question in my mind now is if/when there will be some new serious institutional buyers of the stock.
RPRX: This indicates that the largest shareholder of RPRX continues to be bullish and will be able to purchase an even greater % of the company at the open market. Essentially removing shares from a lot of the weaker hands.
And, imo, RPRX may still broker an endo partnership deal with a Japanese company which includes not only funds for RPRX, but also a purchase of RPRX stock way above current market prices (think recent REGN and ISIS deal). In other words, covering all of their cash needs for Androxal and Proellex trials.
Update on RPRX presentations at scientific conferences and paper submission at journals from an email response from RPRX regarding my inquiry.
Looks like a busy March - June period.
RPRX will have two major presentations at the 13th World Congress on Gynecological Endocrinology in Florence on Feb 28-March 2. Those abstracts will be available at that date. There should be a major paper that comes out of that meeting authored by George Mutter and other pathologists concerning the endometrial biopsy data. RPRX wants to write a second paper on the data that they present at that meeting on fibroids and endometriosis.
RPRX is also submitting a paper to Fertility and Sterility this month. They are working on a second re-submission of a different data set.
They are also trying to get a co-author to complete a manuscript on Androxal.
RPRX also has two presentations accepted to the American Urology Association meeting in Orlando , FL on May 12-14.
The Endocrine Society meeting in June is just now taking abstracts.
Update on RPRX presentations at scientific conferences and paper submission at journals from an email response from RPRX.
Looks like a busy March - June! io_io, can you put this information into the RPRX calendar? Many thanks!
RPRX will have two major presentations at the 13th World Congress on Gynecological Endocrinology in Florence on Feb 28-March 2. Those abstracts will be available at that date. There should be a major paper that comes out of that meeting authored by George Mutter and other pathologists concerning the endometrial biopsy data. RPRX wants to write a second paper on the data that they present at that meeting on fibroids and endometriosis.
RPRX is also submitting a paper to Fertility and Sterility this month. They are working on a second re-submission of a different data set.
They are also trying to get a co-author to complete a manuscript on Androxal.
RPRX also has two presentations accepted to the American Urology Association meeting in Orlando , FL on May 12-14.
The Endocrine Society meeting in June is just now taking abstracts.
Thanks, here's the 13G link.
http://www.sec.gov/Archives/edgar/data/897075/000110465908001299/xslF345X02/a4.xml
I would like to believe someone else other than Efficacy is buying RPRX today.
Probably "less than that" not more imo. Stock has consolidated nicely the past few weeks and sellers have dried up. Buyers of interest will have to move the price up to get some shares.
Joe P. speaks tomorrow at 3 pm EST at the JP Morgan conference so maybe there is a little buying interest before that event as well.
OT: Countrywide Financial (CFC) stock just halted. Rumors on the street regarding company possibly seeking bankruptcy filing.
VRUS up 50%, $30+, hitting high of $33.9
Very small short position too. Looks like MoMo players getting involved. Happy times for rfj! ;)
AP Sector Snap: Biotech Up on Outlooks
Biotechnology Shares Rise on Better-Than-Expected Profit, Sales and Development Outlooks
NEW YORK (AP) -- Biotechnology stocks jumped Monday after several companies, including Celgene Corp. and Biogen Idec Inc., forecast higher-than-expected profit in 2007 and a continued rise in sales of key drugs.
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The announcements, made as dozens of companies gather in San Francisco at the annual J.P. Morgan Healthcare Conference, drove the sector higher in midday trading. The American Stock Exchange Biotechnology index rose 10.52 points to 784.13, while the Nasdaq Biotechnology Index, which tracks a range of small- and midcap stocks, rose 8.59 to 831.71.
Late Sunday, Celgene said its 2007 profit will double on higher sales of cancer drug Revlimid, and forecast that the drug will continue to drive profit throughout 2008. Shares of Summit, N.J.-based Celgene rose $1.75, or 3.5 percent, to $51.38.
Meanwhile, shares of Cambridge, Mass.-based Biogen Idec rose $2.14, or 3.9 percent, to $57.36 after the company said 2007 profit will likely beat prior estimates on the success of cancer drug Rituxan and multiple sclerosis treatments Avonex and Tysabri. Biogen also forecast strong revenue growth through 2010.
Wall Street maintained a mostly positive outlook for the sector, with several analysts expecting larger firms to remain somewhat insulated from a possible economic slowdown. Midsize companies, however, are expected to provide the most dramatic growth opportunities in 2008.
"We expect the 2007 trend of midcap out-performance to continue as companies which graduate to the $1 billion size are typically entering a high-growth phase and are key targets for acquisition by pharmaceutical companies," said Credit Suisse analyst Michael Aberman, in a note to investors.
He upgraded shares of Foster City, Calif.-based Gilead Sciences Inc. to "Outperform" from "Neutral", and said he expects the stock to hit $54 in the next year. Sales of the company's HIV treatments, which include the first daily three-in-one treatment Atripla, will likely continue rising at a higher rate than expected.
Gilead's stock rose $1.37, or 3 percent, to $47.27, nearing an annual high of $47.90.
Jefferies & Co. research analyst Eun K. Yang said the "sweet spot" for biotechnology investors has been mid- and large-cap companies, which have showed a 10 percent gain in value during 2007. Though the sector had a weaker than expected finish in during the year, he said, it is still the engine of innovation for the drug development industry and companies could remain attractive as large pharma buyout targets.
Also gaining ground Monday were shares of Brisbane, Calif.-based InterMune Inc., which rose $3.15, or 23.5 percent, to $16.53 in midday trading. The company said it will advance development of its chronic hepatitis C drug candidate after reviewing positive study data.
Rockville, Md.-based Emergent BioSolutions Inc. lifted its revenue outlook Monday, saying it expects to report revenue growth of 20 percent for 2007 and again in 2008 on the proceeds from a federal contract for anthrax vaccine BioThrax. The stock rose $1.66, or 33.5 percent, to $6.66.
Many congrats to ISIS and VRUS shareholders. An early champagne day in 2008!
Pharma and biotech sector looks like it is starting to draw in some $$$ from other poor sectors.
Doc and others -- regarding RPRX raising funds in 2008
Joe P. mentioned on the Dec 4 call that he would raise funds by Q2 via either a secondary or if the price of the stock stagnates, via a partnership deal with the Japanese on endo trials.
Question: Do you think that RPRX would be able to broker a deal conceptually similar to what REGN did with Sanofi-Aventis (where Aventis paid a 50% premium over the trading price of the stock for ~20% share of the company, as well as provide $$$ for Regeneron's trials in the anti-body area)?
I'm just thinking of a way where RPRX could not only issue shares at a solid price but also pick up the balance of their cash needs through a partnership deal. If anything, it would really make sense for the longstanding investors and institutions that hold the stock and will help gain more visibility and confidence of the company by the investing community imo.
Thanks for your thoughts. Seems like the trading volume is drying up on the stock right now. Efficacy is at 18.5% of shares outstanding, so they can only buy another 150k more shares before reaching the 20% level.
For Anemia trials, does RPRX have to first submit a trial design to FDA for their review and approval before this trial can commence?
The Anatomy Of An Approved Drug
http://www.fool.com/investing/high-growth/2007/12/31/the-anatomy-of-an-approved-drug.aspx
Very interesting article posted in Biovalues by genesi on retrospective analysis of FDA drug approvals. Seems to indicate that RPRX would have a much better chance of getting approval on their Anemia or other Proellex indications if they are working with a partner, and they file their NDA in Q1-3, rather than Q4. Thoughts?
Brian Lawler December 31, 2007
Ever wondered what a drug that gets approved by the FDA looks like? What are the most common types of drugs that the agency approves, and what other characteristics improve a drug's chances for approval? If you've pondered these questions, then you're in luck: In 2006, the FDA released a review examining the drugs that get approved by the agency and their characteristics.
Every five years since 1992, Congress has had to renew the Prescription Drug User Fee Act (PDUFA), which allows the FDA to get cash from drugmakers in return for reviewing the marketing applications related to their drugs. The latest PDUFA renewal, which occurred earlier this year, was covered by my fine Foolish colleague Brian Orelli.
In conjunction with the previous PDUFA renewal, the FDA hired an independent auditor to take a look at all drugs that were up for approval from 2002 to 2004 and determine the characteristics of drugs that were approved. Some of the auditor's findings will come as a surprise, while others weren't so unexpected. Below is a useful summary of the review, which can be found here: http://www.fda.gov/ope/pdufa/pdufa1stcycle/default.htm
This is an approved drug
Overall, 47% of the 77 drugs reviewed from 2002 through 2004 were approved the first time they went up for approval; 23% were approved after resolving approvable-letter concerns; 5% were issued not-approvable letters; and the remainder had approvable-letter concerns that had not been resolved by the time the report was issued. Cumulatively, then, at least 70% of drugs making it to the FDA review process went on to get approved.
The Milken Institute (opens PDF http://www.maricopa.edu/bwd/pdfs/biotechpb.pdf) pegged the approval rate for new molecular entities under review at 81% in an earlier 2002 report. The FDA report cited 73% of drugs treating a life-threatening condition with a new mechanism of action as getting approved on the first go-round from 2002 through 2004. A drug like Genentech's (NYSE: DNA) Avastin falls into this category.
Interestingly, only 42% of drugs developed in-house and not partnered out received approval the first time they went up for FDA review, whereas 65% of drugs that got partnered out received approval on the first go-round. The reviewers surmised that drugs that get partnered are exposed to more scrutiny prior to partnering, and thus may be of higher quality than the average in-house drug. This bodes well for a drugmaker like Exelixis (Nasdaq: EXEL) if partner GlaxoSmithKline (NYSE: GSK) is able to get cancer treatment XL880 through phase 3 testing.
As most investors would probably suspect, drugs subjected to an advisory-committee hearing fare worse than drugs for which the agency doesn't hold a panel hearing. Of drugs subjected to a panel hearing, 31% get approved on the first go-round, whereas 46% of those without hearings get approved immediately. Even though Theravance's (Nasdaq: THRX) Telavancin has already been subject to an FDA review, this is why investors took Theravance shares down 9% last Friday after it announced an FDA panel hearing may be convened to discuss its lead drug.
Unsurprisingly, positive past experience with the FDA matters. 51% of drugs submitted for approval by drugmakers who had already received marketing approval for other drugs got approved on the first go-round, compared to 30% for drugmakers without any previous FDA approvals. This is good news for drugmakers like CV Therapeutics (Nasdaq: CVTX), which is awaiting a regulatory decision on its second drug early next year.
Other experience-related variables also matter. Large U.S.-based pharmaceutical firms received approval for their drugs at a 64% rate without needing to give the agency additional information, compared to a 43% rate for foreign pharmas. U.S.-based biotechs did even better, with an 86% first-time approval rate, while small biotechs only received approval at a 33% rate on the first go-round for their drugs.
An article in SIGNALS Magazine (one of the best biotech investor resources on the Web, by the way) highlights the unpredictable nature of drugs receiving "fast-track" and priority review designation. The FDA stats from 2002 to 2004 show that 62% of drugs with a priority review designation received FDA approval without the need for any more data, compared to 34% of non-priority reviewed drugs. This doesn't account for the huge amount of fast-tracked drugs not making it to an FDA review, though.
Finally, one of the more interesting data points from the article is that "between two and three times as many applications are submitted in the fourth quarter of each calendar year than any other quarter." Only 26% of drugs submitted during this time receive approval on the first go-round, compared to 64% of drugs submitted during the other three quarters.
The reviewers hypothesized that the huge strain on agency resources that all these fourth-quarter applications present is probably what affects the fourth-quarter submissions' success rate. Considering the rash of drugs receiving extended review times in the fourth quarter (not the same as a fourth-quarter submission, but similar), like Novartis' (NYSE: NVS) Galvus and Encysive Pharmaceuticals' (Nasdaq: ENCY) Thelin in 2006, and this hypothesis doesn't sound too far off.
The ideal drug for approval
It's important to remember that this list only covers drugs making it to the FDA New Drug Application or Biologics License Application stage, and does not detail the characteristics of a drug in clinical trials that will make it to approval.
Nonetheless, the above characteristics of approved drugs will be helpful for investors who like to make bets on drugs awaiting FDA approval. If you want to maximize the odds that a drug will get approved the first time it's up for review, you should look for a large U.S.-based biotech that in-licensed a compound that didn't have to go through an advisory panel hearing; a drug that treats a life-threatening disease such as cancer; and a marketing application that wasn't submitted in the fourth quarter.
Video link to Mike Huckman's picks.
http://www.cnbc.com/id/15840232?play=1&video=616407070&__source=yahoo%7Cheadline%7Cquote%7Cvideo%7C&par=yahoo
CNBC's Mike Huckman will give 2008 Pharma forecast in just a few minutes. Tune into your telly for the coverage!
Update: Sorry, Mike Huckman's picks are more for recommended trades going into 2008, not really a 2008 Pharma outlook.
Medical Devices: Medtronic (MDT) and Abbott (ABT) in regards to their coated stents and pending decisions thereof.
Big Biotech: DNA and its upcoming FDA decision in Feb 08 on Avastin for breast cancer. If approved, could add $1 bil to their revenue stream.
Small Biotech: Our most controversial darling, old Dendreon ;)
DNDN anticipates intermin results in mid-08. Could really move the stock around (high volatility) this year as it awaits the outcome of their Provenge trial for prostate cancer
Docbanker, any idea for the rationale leading to this substantial increase in RPRX short interest? (now around 850k from 550k from end of Nov)
Any positive news could create a nice short squeeze. If these positions were established in the low $8's range they are under water right now around 12%.
t.i.a.
David, I see the same price for AH on IDEV.
At 4:15 pm (16:15) there were two trades (only 400 and 100 shares) at the 3.50 and 3.51 price. Otherwise, most other trades were in the upper 6's and even a few in the 7.1 region.
So that writeup link by Dew paints an overly negative picture based only on these two low volume trades minutes after the news was released. The Reuters editor should correct that piece to reflect the more modest AH price decline in the $6.8's region "late" in the session. (info below from nasdaq afterhours)
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
19:59 $ 6.50 100
19:01 $ 6.81 900
18:56 $ 6.82 100
18:07 $ 6.82 466
17:06 $ 6.88 100
17:06 $ 6.88 3,000
17:06 $ 6.90 100
17:06 $ 6.89 100
16:54 $ 6.87 100
16:43 $ 6.81 100
16:43 $ 6.81 100
16:43 $ 6.81 100
16:40 $ 6.81 100
16:34 $ 6.80 1,000
16:34 $ 6.80 1,000
16:33 $ 6.83 100
16:33 $ 6.83 100
16:29 $ 6.84 100
16:29 $ 6.88 100
16:29 $ 6.89 900
16:29 $ 6.85 100
16:29 $ 6.85 100
16:29 $ 6.85 100
16:29 $ 6.85 700
16:27 $ 6.78 100
16:27 $ 6.78 100
16:22 $ 6.76 100
16:22 $ 6.76 400
16:20 $ 7.16 11,192
16:19 $ 6.75 100
16:19 $ 6.75 100
16:19 $ 6.75 100
16:19 $ 6.75 100
16:19 $ 6.75 700
16:19 $ 6.75 100
16:19 $ 6.75 100
16:19 $ 6.75 400
16:18 $ 6.50 100
16:18 $ 6.57 600
16:18 $ 6.65 100
16:17 $ 6.29 100
16:17 $ 6.29 3,464
16:17 $ 6.30 100
16:17 $ 6.30 100
16:16 $ 7.1538 700
16:16 $ 5.29 600
16:16 $ 5.29 100
16:16 $ 5.90 200
16:16 $ 6 100
16:16 $ 6 100
16:16 $ 6 400
16:15 $ 6.99 200
16:15 $ 6.99 200
16:15 $ 6.95 100
16:15 $ 7 100
16:15 $ 6.81 1,300
16:15 $ 6.81 200
16:15 $ 6.81 1,100
16:15 $ 3.51 100
16:15 $ 3.50 400
16:14 $ 7.1536 2,700
16:13 $ 7.1536 1,200
16:11 $ 7.1536 4,500
16:09 $ 7.1546 1,000
Nerf, thanks for your views. I'm trying to understand why Efficacy Capital is taking such a highly concentrated position in RPRX versus the other institutions. It is somewhat unusal in light of the thinly traded nature of RPRX.
Yes, I agree, they are effectively removing a large part of the RPRX float. I'm just wondering if someone knows their track record on biotech investments or not??
Doc or others:
Do you know much about Efficacy Capital, as well as why they are accumulating such a significant position of RPRX shares?
Thanks!
io_io, I can't find a link at rprx company site for the Dec 4th conf call. I've gone to this link (below) the past few days. Do you see one when you go there? I see links for the Nov 5th and 6th webcasts and they work. I listened to the Dec 4th call live but one to review the call again.
http://www.reprosrx.com/presentations.htm
Thanks!
OT: An Overnight Three-Bagger
Interesting that RIGL still has a bunch of safety issues associated with some of their patients on this pill, yet the Street is overlooking it right now, as well as the rich marketcap. While RPRX's potential may not be quite as high as RIGL's, it is still high enough to warrant more attention by the street on RPRX's value and risk/reward potential imo
By Brian Orelli December 14, 2007
It's not often you see socks triple in one day, but that's what Rigel Pharmaceuticals (Nasdaq: RIGL) did yesterday. You might be surprised, however, as to why the developmental-stage drugmaker shot up like a rocket ship.
It didn't find the cure for cancer, or even get its first drug approved; all it did to cause the bump in price was release positive phase 2 clinical trial results for its rheumatoid arthritis (RA) drug candidate, R788.
Now, don't get me wrong -- the results looked pretty good. The two highest doses of R788 caused statistically significant reductions in subjects' ACR scores, which measure the signs and symptoms of RA. But these are results of a phase 2 trial; there are still plenty of things that could go wrong, and Rigel is still years away from a marketed drug.
In fact, the safety profile was less than stellar. Patients experienced low white blood cell counts, signs of liver issues, and gastrointestinal (GI) side effects, although most of the subjects were able to continue in the trial on a lower dose.
So why are investors so excited about phase 2 results? Essentially, it boils down to the fact that the drug is taken orally. Currently, the main RA drugs available to patients -- including Enebrel, which is co-marketed by Wyeth (NYSE: WYE) and Amgen (Nasdaq: AMGN); Rituxan, from Biogen Idec (Nasdaq: BIIB); and Genentech (NYSE: DNA) and Abbott Laboratories' (NYSE: ABT) Humira -- are either injected or given by transfusion. Since not too many patients like needles, an oral compound could compete exceptionally well in the crowded RA market.
While the results certainly look promising, I don't think they justify the almost $900 million market cap investors have bestowed upon the company. Rigel isn't ready to go into an expensive phase 3 study, so it plans to do a larger six-month phase 2 study to confirm that it has the right dose. With no drugs in phase 3 trials, investors are taking a lot of risk buying in at this level.
http://www.fool.com/investing/high-growth/2007/12/14/an-overnight-three-bagger.aspx
Updates for RPRX calendar? io_io or others
Does anyone have a good idea of the nearterm updates we may receive from RPRX in the next 3 months? I see from the calendar that we are supposed to get an update on the Uterine Fibroids Proellex safety trial where there are 41 patients enrolled (July 2007), One year interim extension data anticipated (4Q2007).
Is this interim extension data just for safety, or also a continuation on efficacy of Proellex over time?
T.i.a.!
Also, after RIGL's news on P2 results for its rheumatoid arthritis drug candidate, and subsequent move of 250% up in 2 days (now marketcap of $850 mil!!!), I wasn't too surprised to see RPRX back up over $10 (pleasantly pleased yes) and expect it to be significantly higher once we get news on the anemia P3 proposal with the FDA. Once this apparent "safety" cloud diminishes around Proellex (with additional information over the upcoming year), the stock should go well north of $20 imo.
http://biz.yahoo.com/ap/071213/rigel_pharmaceuticals_mover.html?.v=3
<<UK’s NICE Caps Cumulative Reimbursement for Lucentis >>
Interesting. This could be considered potentially bullish for REGN's AMD drug under development (if eventually approved) since it may only require 1 shot every two months rather than monthly as prescribed for Lucentis.
Regeneron eyes drugs for heart, diabetes, asthma
Wed Dec 12, 2007 2:54pm EST
NEW YORK, Dec 12 (Reuters) - The chief executive officer of Regeneron Pharmaceuticals Inc (REGN.O: Quote, Profile, Research) on Wednesday said the company is interested in widening its focus to possible treatments for cardiovascular problems, diabetes, asthma and allergy.
"We are looking more broadly with our resources and the cardiovascular area is certainly an area we have an interest in, and we can certainly also develop antibodies that might address diabetic conditions," as well as asthma and allergy, Leonard Schleifer said in an interview.
Regeneron, whose genetically modified mice produce fully human antibodies capable of blocking disease-causing proteins, has already begun preclinical trials of possible drugs to treat diabetes, asthma and allergy, Schleifer said.
Schleifer said Regeneron expects to have cash reserves of about $850 million by the end of 2007, which he described as a comfortable cushion given that the company "burns" only $50 million to $100 million a year for research and related expenses.
In addition to developing more drugs of its own, Schleifer noted that Regeneron is obligated to put two to three new medicines into clinical trials each year under an $872 million drug-development deal reached late last month with French drugmaker Sanofi-Aventis (SASY.PA: Quote, Profile, Research). (Reporting by Ransdell Pierson, editing by Gerald E. McCormick)
http://www.reuters.com/article/marketsNews/idUKN1264293320071212?rpc=44
MNTA - movement after 30 days tax loss selling on Nov. 6th?
http://finance.yahoo.com/q/bc?s=MNTA&t=3m&l=on&z=m&q=l&c=
Could be one of the reasons for strong interest beginning yesterday??
OT: My only biotech shelter right now is REGN
Tough day today for us longs. This sharp of a decline will unfortunately also cause retail holders on margin to sell shares too. Not sure how long this will pressure the stock.
cleverrox, I was just asking "doc" in his own words (from earlier message) whether he was buying more rprx during this selloff that occurred this morning when someone dumped around 40k shares. Sorry if you misunderstood my comments. I wasn't making fun or criticizing anyone on this board, nor do I ever have a record of being a bad poster.
Wholesale dump going on now. Is the hoover vacuum cleaner working this morning doc??