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>Do your own DD-make your own decisions! Do not lose your stock to professional bashers led by any Senor worm, spamming MGB and FUD from his Mama's Villa and suspended & fined by NASD.<
I don't remember this quote from the Borat movie.
HTI, etc.
Depending on how the deal is structured, this approach is completely reasonable.
Under the terms of the agreement, Roche will pay Halozyme $20 million as an initial upfront payment for the application of rHuPH20 to three pre-defined Roche biologic targets. Over the next ten years, Roche will also have the option to exclusively develop and commercialize rHuPH20 with an additional ten targets.
So Roche is paying $20M to see if it works. Not even lunch money for big pharma.
Regarding my previous post, I guess I was mainly looking for companies that take existing products and reformulate them.
For example, NVD has reformulated nitroglycerin (now approved), ondansetron, zolpidem, sumatriptan, and a couple of other drugs as oral sprays, and is pursuing approval through the 505(b)(2) regulatory pathway after one or two simple, short-term, low-cost bioequivalence studies. They aren't going to hit a home run with any of these (except perhaps zolpidem), but 5 or 6 small products equals a mini-blockbuster.
XNPT isn't a reformulation company, but they take existing chemical entities, like gabapentin, and conjugate them to proteins that are actively transported. Right now they're working on the aforementioned gabapentin analog, a baclofen analog, and they are going to file for an additional compound in Jan 07. I should note, however, that the FDA considers these new chemical entities, so no easy 505(b)(2) for XNPT.
I'm looking at DEPO and BDSI, but there's got to be additional companies out there that do something similar. I'm particularly interested in companies that can get approval through 505(b)(2) (aside from SNUS).
HTI and other drug delivery companies
Surprised nobody has commented on the HTI deal. Up 59% today.
I've long thought that the drug delivery companies were ideal investments given the need to make the old new again. I own two: XNPT and NVD. Anyone have additional companies that they like in this space?
RPRX
That's a ridiculous comparison because in the NEJM study the dose of exogenous testosterone they used resulted in ~30 ng/dL increase in testosterone. Androxal results in an increase of just under 300 ng/dL (which is similar to the increase achieved with Androgel).
Androgel and Testim might be more appropriate comparisons. For your consideration: Wang C et al. J Clin Endocrinol Metab. 2004;89:2085-2098.
Yes, his name really is Wang.
Transdermal testosterone (T) delivery represents an effective alternative to injectable androgens. We studied 163 hypogonadal men who applied 5, 7.5, or 10 g AndroGel (T gel) 1% CIII per day for up to 42 months. Efficacy data were presented in 123 subjects considered evaluable. Continuous AndroGel treatment normalized mean serum T and free T levels. Mean serum 5alpha-dihydrotestosterone concentrations and 5alpha-dihydrotestosterone/T ratio slightly increased, mean serum estradiol/T ratio doubled, and mean serum FSH and LH levels were suppressed by T replacement. Sexual function and mood parameters improved rapidly and were maintained throughout T treatment. Lean body mass increased (P = 0.0001) and fat mass decreased (P = 0.0001), and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength. Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine (P = 0.0001) than the hip (P = 0.0004). Mild local skin irritation occurred in 12 subjects, resulting in discontinuation in only one subject. Except for the anticipated increase in hematocrit and hemoglobin, there were no clinically significant changes in blood counts or biochemistry. In three subjects with elevated serum prostate-specific antigen, prostate biopsies showed cancer. We conclude that continued application of AndroGel resulted in beneficial effects similar to those with injectables and other transdermal preparations. This study was neither placebo controlled nor powered to determine the effects of T treatment on prostate cancer risk. Thus, monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with T treatment of hypogonadal men.
You can also look at Dean et al. Rev Urol. 2004;6 Suppl 6:S22-S29.
A new transdermal preparation, Testim(R) 1% testosterone gel, has recently become available for normalization of serum testosterone in hypogonadal men. In short-term studies, it has been shown to reverse the clinical signs and symptoms of low testosterone and to be well tolerated with less application-site irritation than with testosterone patches. In 2 long-term studies with Testim, the predose early morning serum testosterone (T), dihydrotestosterone (DHT), and free testosterone (FT) levels were assessed. Serum T, DHT, and FT were all maintained in the normal range for up to 12 months. In these studies, involving a total of 371 hypogonadal men, evaluation by means of dual-energy x-ray absorptiometry revealed a significant increase from baseline in bone mineral density. A significant improvement was also observed in body composition (increased lean body mass, decreased fat mass, and decreased percent fat). In addition, significant improvements in mood and sexual function were maintained for up to 12 months of treatment. The parameters measured included sexual performance, sexual motivation, sexual desire, and occurrence of spontaneous erections. These data from the 2 long-term studies support the results of the 90-day studies with Testim showing that the gel significantly improves the signs and symptoms associated with low testosterone compared with placebo. The data also support the conclusion that these improvements are maintained for up to 1 year of additional treatment.
Anyway, we'll see...
RPRX
>He ascribes no value at all to the Androxal program: He says it will never pass FDA muster.<
I'd like to know his reasons for feeling this way.
Barring first entrants into a particular therapeutic category, new drugs are not approved in a vacuum.
Testosterone replacement therapies are here to stay. Regulators will compare the risk:benefit of Androxal with Androgel; based on the data we have so far, the comparison is very favorably weighted toward Androxal: no significant side effects, no partner risk, and no abuse potential. These differences are far from trivial.
Note that they will negotiate an SPA for Androxal at the appropriate time. Note also that ex-US requirements are likely to be less stringent.
Given that Proellex has $700M WW sales potential (I'm basing this number on estimates for asoprisnil) in a market with significant unmet need and Androxal has $200M to $400M potential, obviously Proellex is going to drive valuation. Nevertheless, don't discount Androxal.
>There is nothing magical about Niacin ER. Anybody can make it. I believe ABT paid too much and will get their clocks cleaned by MRK 524/A/B which will allow much higher dose of niacin.<
Agree with the first sentence. I don't understand the rationale for that acquisition.
Disagree with the second sentence. Although flushing is an important problem, raising the dose of niacin has a bunch of problems beyond flushing. Most importantly, high-dose niacin has serious dose-related issues with hepatotoxicity, increases in uric acid levels (predisposing to gout), and hypophosphatemia.
In other words, Merck's product probably won't be able to supply a higher dose of niacin. Reduced flushing will be welcomed, provided the flushing inhibitor doesn't have significant drug interaction or side effects issues.
Why can't I type today.
FMTI
It's nice to be right sometimes.
I just didn't see why it would take them months to examine and release the data from a phase 2 study. This just goes to show that they were taking time to data mine. Unfortuantely, not much there to be positive about.
Didn't take that flyer.
I don't know but I may have smoked it in graduate school
No, Forbes’ FM-VP4 is a cholesterol-absorption inhibitor somewhat like Zetia. Esperion’s drug is a synthetic variant of HDL-C.
I haven’t looked closely at FM-VP4 other than an initial look at its less-than-stellar efficacy, but I think it may have the potential to be combined with Lipitor in much the same way ezetimibe has been combined with simvastatin. It certainly won’t be used alone.
I seem to remember an issue with having to administer twice daily with food, but I may be wrong…it has been a while since I’ve looked at FMTI.
I’m looking into it more now…. Now that I think about it, I might take a very small flyer on FMTI. We’re talking 1% or 2% of my portfolio.
With the news on toreceptapib, unambiguously positive results (coming this month) could result in a multi- multi- bagger from here. There might even be money to be made between tomorrow and the results--the risk of course is we don't know when in December the results will be released.
Just a guess: FMTI is going to go nuts over the next few days.
No position, and I don't believe the data for their drug will be great, but I think the perception will be that Pfizer needs a pipeline filler in the cholesterol space.
RPRX
I’ll answer that with the caveat that Dewophile would probably provide better perspective on what actually goes on in the clinic.
Uterine fibroids: Primarily surgical (hysterectomy, selective myomectomy). Both procedures have obvious implications for reproductive-age women.
Endometriosis: GnRH analogs, progestins, oral contraceptive pills, androgens, and aromatase inhibitors. After a trial of an oral contraceptive, GnRH analogs are apparently the standard of care.
Lupron has obvious drawbacks, including need for injection, and of course all the problems that come with down-regulation of estrogen. GnRH analogs are indicated only for short-term use.
Danazol (synthetic androgen) can also be used but it has a bunch of nasty side effects, and there are also surgical procedures that can correct endometriosis.
My understanding is that none of these treatments are particularly effective.
Asoprisnil was in the pipeline, but was terminated because of an excess of procedures related to endometrial thickening. Notably TAP made a business decision to terminate this trial even though the DSMB disagreed, so some day this one might come back.
Mifepristone might also be effective in endometriosis, but this is a non-starter for political reasons.
Testosterone replacement: primarily testosterone gels/creams, which have a bunch of very serious limitations. Although my primary concern would be shrunken testicles, there is also partner risk, abuse potential, and an issue with worsening of secondary hypogonadism. There is also the option of administration of exogenous testosterone with all of its attendant problems.
In addition, Clomid could be used, but its cis isomer (Androxal is just the trans isomer) has estrogenic effects and the half-life from hell.
RPRX
Oh, I know...and I'm the last person on BV that wants to start a pointless argument.
If you can demonstrate a trend between the number of employees a biotech has and its potential as an investment, then you have a valid argument. As far as I know, no such correlation exists.
Some of the best money I've made (in terms of profit/time) was in YMI, a company that was similarly 'virtual' before the acquistion of Eximas. With a staff of 11 or so, they managed to keep a handle on a dozen trials.
Unless a company has a platform technology (eg, SGMO, XNPT, etc), the valuation is primarily dependent on the drugs they have in the pipeline. I don't think that anyone attributes real value to 30 scientists randomly mucking around in a poorly funded lab on a variety of personal science projects.
I know from personal experience that if you have a CRO managing your trials, it doesn't take more than 1 person on the pharma/biotech side to keep a handle on the study. In fact, I wonder what those 7 people RPRX employs do all day.
In short, not having more staff on hand than needed keeps the burn ex-clinical trials extremely low. Why support dead weight?
I know Dew has a bias against 'virtual companies' which I have never understood. I have to admit a bias toward these companies, since I run my own business in much the same way.
RPRX
I don't understand why RPRX being a 7-person company has anything to do with risk. If you'll do a little more DD, you'll find that their trials are managed by a CRO. In other words, they keep their burn as low as possible. Would you prefer that they blow money on a small research staff?
The company exists only to sell the Proellex and Androxal programs to the highest bidder at the appropriate time.
RPRX
Notable: more insider purchases at RPRX.
As someone noted on another board, the CEO's insider purchases over the past year account for ~20% of his after-tax income. Not bad.
FMTI
...my take on the program. No position.
http://www.investorshub.com/boards/read_msg.asp?Message_id=14083210&txt2find=fmti
Dewophile,
Should have mentioned that my sole practical experience with reproductive hormones is my girlfriend's PMS, so forgive me if I oversimplified.
In fact, progesterone-only pills like Cerazette have been tested for endometriosis. My understanding is that they haven't shown significant efficacy, so there's something else going on here as you suggest.
RPRX
Dewophile,
>any idea why the higher dose of proellex would have an inverse correlation with endometrial thickness? <
Briefly: Proellex is a selective progesterone receptor antagonist that has potent antiproliferative and pro-apoptotic properties. However, it takes time for Proellex exert its antiproliferative effects.
During the time it takes to exert its antiproliferative effects, estrogen goes unopposed, causing endometrial thickening. Thus, the thickening effect is an early effect of treatment; by administering a relatively high dose up front, the antiproliferative effect of Proellex is established before estrogen causes significant thickening.
Two points worth noting:
1) In the uterine fibroid trial, they double-dosed up front to achieve saturation
2) I obviously don't have access to their protocol, but presumably there was a provision for early unblinding if an excess of endometrial thickening occurred. They had this provision in the endometriosis trial, which is why we saw early interim results. This has not happened, suggesting that it wasn't a concern in this trial.
Also note that having estrogen around is a benefit of Proellex because estrogen is involved in maintaining bone and protecting women against CV events. Lupron (the current standard of care) is essentially chemical castration for women, which accounts for its adverse effects on bone.
DVAX
I sold my DVAX today. That makes two round trips. I'm waiting for $8.50 or so to repurchase.
I think that the Heplisav results move DVAX close to the top of any list of acquisition targets. If the Tolamba results are positive, I predict this company will be acquired shortly thereafter.
RPRX
Spartex--no idea whatsoever, and I don't think that management knows in what order they will be released.
Presumably they will have to report as the data are delivered by their CRO, therefore it is unlikely that the results will be released as a single PR.
Based on the fact that the results will be reported for patients enrolled as of Sept 1, 2006 and the number of patients enrolled, I'd guess the most likely order will be 1) endometriosis, 2) uterine fibroids, and 3) Androxal.
RPRX
December is a big month for Repros. The interim results of three trials will be reported, followed by an analyst conference in early January. Just thought I’d write a field guide to the trials and potential outcomes.
The majority of this information comes from the Oct 06 presentation, which is available on the Repros website (www.reprosrx.com)
I’ve tried to separate this into facts and commentary. Feel free to criticize.
Trial 1: Phase II/III Uterine Fibroid
*Enrolled 150 women with signs/symptoms of uterine fibroids
*Patients receive 0, 12.5, or 25 mg Proellex
*Three-month multicenter study with open-label extension
*Primary end point: bleeding
*Secondary end points: pain, quality of life, and fibroid size
*Safety: endometrial effects and bone loss
Previous results from an active-controlled, 12-week trial suggest that all dosages of Proellex will be superior to placebo for the primary end point of bleeding.
The key safety end point is endometrial thickening. I believe this is a non-issue for two reasons 1) there is an inverse dose-response for endometrial thickening, eg, the highest and most efficacious dose is least likely to cause this concerning side effect; 2) even if there is thickening it should be manageable by intermittent withdrawal to permit bleeding.
Best potential result: Superiority to placebo for bleeding and no endometrial thickening at any dose
Second best potential result: Superiority to placebo for bleeding and no endometrial thickening at 25 mg Proellex
Expected result: Superiority to placebo for bleeding and minor endometrial thickening, with a trend toward less thickening at the higher dosage.
Trial 2: Phase II endometriosis
*Enrolled 40 women with endometriosis, conducted in Eastern Europe by physicians who drink too much vodka
*Patients treated for 6 months with double-blind Proellex at dosages of 12.5, 25, and 50 mg
*Active-controlled with Lupron
*Primary end point: pain
*Secondary end point: bone loss
Early interim results indicated slam-dunk efficacy for the 50-mg dose (1 day of pain vs 19 days of pain for Lupron) and efficacy similar to that of Lupron for the 12.5 and 25 mg doses. Endometrial thickening was observed with the 12.5 and 25 mg dosages, no thickening was observed with the 50-mg dose. However, there was some suggestion that the aforementioned Eastern European physicians were not measuring endometrial thickness at the same time in each cycle, so this result is open to question.
Again, there is an inverse dose-response for endometrial thickening—the highest, most efficacious dose is least likely to cause this side effect.
Best potential result: Large differences in number of days of pain with the 50-mg dose vs Lupron and no evidence of endometrial thickening at the 50-mg dose.
Second best potential result: Small difference in number of days of pain with the 50-mg dose vs Lupron and minor endometrial thickening
Trial 3: Androxal phase III
*Enrolled 200 men with testosterone levels <300 ng/dL
*Patients randomized to treatment with 2 different doses of Androxal, placebo, and open-label Androgel
*6-month treatment period with open-label extension
*Primary efficacy end points: testosterone levels, libido,
*Secondary end point: “distress”
Best result: It’s a given that Androxal will increase testosterone compared with placebo, but I’d want to see restoration of testosterone levels to normal levels and not much greater. Libido and distress should at least trend toward superiority over placebo.
I know everyone says Androxal is a “lifestyle drug” and may therefore have trouble making it through the FDA. However, you should note that there are other drugs for similar indications that are already approved and have numerous major shortcomings (eg, partner risk, potential for abuse, causing supra-normal testosterone levels, infertility and [ouch] testicle shrinkage).
I believe that when juxtaposed against currently approved alternatives the FDA will be much more favorably disposed toward this drug than people think.
That’s all for now on RPRX.
>Heplisav is destined to be one of those names that gets mispronounced. The temptation is to say “Hepislav.”<
That will be the brand name in Russia.
I need more DVAXes and less POTPs. Guess it will be time to sell again tomorrow.
Abraxane
According to the label 13% of patients experience ocular side effects, 1% serious. Haven't seen the 22% to 25% data.
http://www.rxlist.com/cgi/generic3/abraxane_ad.htm
Guess that Rodman and Renshaw analyst reads I-Hub.
http://www.investorshub.com/boards/read_msg_ig.asp?message_id=14932121
Now hear this: RPRX, NVD, XNPT, and DVAX are takeover targets
>The problem with Atheist or people who develop personal codes of morality is that there are never any consequences for not obeying them<
Oh please. The principle of morality is empathy; what differs are our approaches to that principle, and how we interpret our feelings of empathy in order to make a coherent system. In short, atheists can be just as, if not more, moral than the religious.
Contrast this to the fundamental Christian approach: pray sincerely and you can be forgiven for anything. That, to me, is the ultimate lack of consequence.
Since Genmab is a Danish company, I assume they have expats in their New Jersey and UK offices. Paying bonuses to expat executives to compensate for taxes isn't unusual.
GenMab
ACUITY statistics challenged
No immediate investment implications in this article, however, I am posting it for posterity because MDCO seems to like spinning data and including end points in their trials designed to make their drug look better than it is.
Not that I'm saying bivalirudin isn't a good drug. It really is. MDCO would be well served by cutting the spin and designing their trials appropriately. All they've done with ACUITY is alienate the medical community.
Also like the quote.
Chicago, IL - The statistics on which the ACUITY trial of bivalirudin was based were challenged by cardiologist Dr Sanjay Kaul (Cedars Sinai Medical Center, Los Angeles, CA) at a session during the American Heart Association 2006 Scientific Sessions yesterday.
In a talk entitled "Noninferiority in ACUITY lies in the eyes of the beholder," Kaul suggested that the definition of noninferiority used in the trial was not strict enough and that the drug would not have met the criteria he considers more appropriate. But ACUITY investigators countered that the clinical benefit of bivalirudin shown in the trial was the most important issue.
The ACUITY trial, which was reported for the first time at the American College of Cardiology meeting in March 2006, showed that bivalirudin monotherapy was "noninferior" to heparin or enoxaparin plus a GP IIb/IIIa blocker in ACS patients heading to the cath lab. The main primary outcome was a composite of safety and efficacy, and the benefit of bivalirudin was driven entirely by the safety component, with the drug showing a slight increase in ischemic events but a large reduction in bleeding compared with heparin/enoxaparin plus a GP IIb/IIIa blocker.
Kaul made several points as to why he was uncomfortable with the statistics behind the trial.
First, he suggested that ACUITY should not have had a noninferiority design at all. "The ACUITY trial pitted bivalirudin against an active control (heparin or enoxaparin plus a GP IIb/IIIa blocker) that had not been previously proven reliably and consistently to be superior to heparin in terms of the primary efficacy end point—a composite of death/MI/urgent revascularization. Because of this, strictly speaking, the ACUITY investigators should not have done a noninferiority study. They should really be looking for superiority," he explained to heartwire.
Second, he said that noninferiority designs should not be used for trials that have a composite end point including both safety and efficacy measures. "There is a fundamental problem of combining safety and efficacy as the main outcome in a noninferiority study. The unconventional use of a composite efficacy and safety outcome biased the assessment of noninferiority in favor of bivalirudin. Typically, the noninferiority claim should be confined to efficacy alone. Although combining efficacy and safety into one composite outcome might be desirable to inflate the event rate and enhance trial feasibility, it can often be misleading because drugs that are ineffective but safe can be made to appear better than effective drugs."
And third, Kaul believes the noninferiority margin used in the study was too wide. "The ACUITY investigators decided on a wide noninferiority margin (25%) on the basis of clinical judgment among the trial committee members, given the advantages of the drug—it is easier to use and cheaper and safer than heparin plus a GP IIb/IIIa blocker. Statistical reasoning for this 25% margin is not apparent. This 25% margin means that they were willing to accept a 25% worsening in outcome, because of the other benefits. In my view, the 25% margin for noninferiority was too wide. Recent major noninferiority trials in ACS have used much smaller margins than this—for example, SYNERGY utilized a margin of 10%, and the A to Z trial used a margin of 11%."
Kaul noted that the previous bivalirudin trial, REPLACE-2, used a higher margin than 25% and also had a composite end point that was driven by safety. "Because of these design flaws, the FDA did not accept that noninferiority had been met in REPLACE-2," he noted. "The methodological deficiencies in ACUITY may have similar implications for regulatory acceptability.
"The noninferiority margin in ACUITY is better than the one in REPLACE-2, but my argument is that this should not have been a noninferiority trial in the first place, and, if they insisted on doing an noninferiority trial, they should have had much tighter margins to minimize the chances of falsely concluding noninferiority (a type 1 or a false-positive error)." Kaul suggested that 15% would have been more appropriate as a noninferiority margin and presented analyses showing that the results would not have met these criteria.
During the discussion period, ACUITY chief investigator Dr Gregg Stone (Columbia University, New York, NY) said his head was spinning from Kaul's presentation. Kaul commented to heartwire later: "Actually, my talk was intended to 'unspin' the ACUITY spin."
Stone was quick to defend his trial. "A p value is no replacement for a brain.You need to think about the clinical benefit of the drug rather than just statistics. Bivalirudin is simpler to use and is cheaper than a IIb/IIIa blocker, and it reduces bleeding dramatically. You can argue whether a small and nonsignificant increase in ischemia is relevant, but overall the safety advantage clearly tips the balance in favor of bivalirudin," he told heartwire.
Another member of the ACUITY steering committee, Dr Harvey White (Auckland City Hospital, New Zealand), voiced similar views. "The steering committee decided that 25% was an appropriate margin, and the trial fulfilled that margin. You have to look at what the trial showed from a clinical point of view—a 0.5% increase in ischemic events vs a 3% reduction in major bleeding that was much more prognostically important."
But cochair of the session, Dr Christoph Bode (University of Freiberg, Germany), was supportive of Kaul. "He gave a provocative talk. We need to be more aware of what the statistics mean and where the boundaries are. It's good that he raised awareness of this," he commented to heartwire.
Hillarious
Bush's latest appointee
http://www.abstinence.net/pdf/contentmgmt/EricKeroackPresentation2003.pdf
Politics aside, has any adminstration been worse for science?
Dave,
Just on initial review of SGMO, I agree that they have a fascinating platform with considerable potential, but I'd like to see two or more of their drugs showing good results in at least phase II before I invest.
That said, once SGMO provides clinical proof-of-concept, I'd guess it would become a serious takeover target. Not that I'd invest based on takeover hopes, but the technology appears novel and much more practical than RNAi.
I skip most (but not all) of the aesthetic medicine posts too, but that doesn't mean they are not valuable.
I'd prefer not to split the attention of those who are interested in aesthetic medicine. It's not a big deal to skip over an occasional post on breast implants. A bigger deal is the volume of cut n' paste spam.
After you gave me the hint. Otherwise I wouldn't have guessed.
Although I have some experience in this therapeutic area, I don't have time to follow everything I work on on a day-to-day basis. I've worked on 83 different drugs and 18 launches or label extensions over the past four years, so as you might expect data tends to go in one ear and out the other shortly thereafter. Hence the reason I couldn't remember that 1000 mg was a normal daily dose for naproxen.
Um, The Medicines Company?
RPRX
Spartex,
I have no idea why the stock suddenly dropped. As far as I know it was not UBS, which if I recall correctly owned about 630,000 shares at last report.
That said it is obvious that one or more major holders got cold feet over the past few months.
It has been hypothesized (by someone who is knowledgable) that there was portfolio manager turnover at an institution or hedge fund and this person made the decision to sell. I have checked with my contacts--I have a bunch of friends in the industry--but have not been able to confirm.
A couple points:
1) It is possible that some of the drop is associated with tax-loss selling from all the people who bought into the $14 frenzy earlier this year
2) Few people want to take a position ahead of both the three trials that will report in December and the financing in January or February. So there's little support right now and even small sells take the stock down significantly.
3) Initially, some institutions felt that Proellex would be sold off in 2007 and the proceeds used to develop Androxal. While this is the scenario I'd like to see, management seems to have changed their mind about this and will develop through phase III. This strategy increases both the risks and the rewards.
4) I retain my enthusiasm for RPRX, and I've already demonstrated a willingness to dump stock at a moment's notice if the facts change. A good example of this was that I was buying YMI at the beginning of their analyst day and dumping it wholescale by the end of the day. And boy am I ever glad I did.
Anyway, that's my view. What will be the opposing effects of positive results in December vs the financing? I don't know. When friends and collegues ask about it, I say put a little fun money in now, a little more after the results, and, provided everything goes well, buy buy buy after the financing.
One more point: insiders have been buying stock...in relatively small amounts (~4000 shares for the CEO at an average price of ~$7.20 and one other officer), and there have been no insider sells.
>They only have to get aggrastat to about 30 million by taking share from integrilin and reopro.<
One would think that Merck would have the capabilities, resources, and cash to market Aggrastat much more effectively than Medicure, yet they failed miserably.
That's not to say Aggrastat isn't a perfectly good drug. It is. But Medicure has to be willing to spend big bucks to compete in the GP IIb/IIIa market to take any market share away from either Integrilin or ReoPro. And they need experienced marketing professionals on staff. Do they have the money and staff to do this right? Doubt it.
Here's where the opporunity exists for Aggrastat: because it is relatively cheap, they could focus on the benefits of use with bivalirudin, particularly in higher-risk patients (bivalirudin is currently indicated only for elective PCI). Neither Integrilin nor ReoPro has a chance for combined use because of their high cost.
I doubt the combination of bivalirudin and Aggrastat will reduce short-term adverse outcomes signficantly. However, they need to focus on subclinical events (eg, mild periprocedural elevations in CK-MB and other cardiac markers) and raise awareness around the impact of these events on long-term outcomes.
They won't necessarily need to run new trials; they may be able to mine existing data for this information.
Medicure also needs to provide clear information on dosing. Because there were some issues with dosing in early trials, there is still the perception that the proper dosage remains to be determined.
Cost efficacy vs both other GP IIb-IIIa and bivalirudin should also be addressed.
They also need to clearly differentiate Aggrastat from bivalirudin. Seems like a no brainer since bivalirudin is an anticogulant and Aggrastat is an antiplatlet, but some physicians seem to think they're interchangable. Anticoagulation is not enough.
And one more thing...they can make a big deal about the short half-life of tirofiban relative in particular to ReoPro. Because the Medicines Company has made a big deal out of bleeding with GP IIb-IIIa inhibitors, the ability to withdraw the drug and rapidly get it out of the patient's system is a big plus...as long as they are clear on the impact of renal function on clearance.
ghmm,
You're welcome. I'm actually on the hunt for one or two more biotechs to add to my portfolio, so I'd welcome new ideas.
I've been looking at ALTU, but unfortunately I didn't buy it and it has since gotten away from me.
ZioPharm,
I haven't been following them but was intrigued by your "safe" arsenic comment so I took a quick look.
Looks like ZIO-101 (the "organic arsenic" compound) is in phase I/II. From what I can see on ASCO, grade 2+ toxicities in patients with advanced solid tumors included fatigue (not a big deal), vomiting (could be a big deal), and anorexia (in the context of cancer treatment, not that bad).
In patients with hematologic malignancies, toxicities again seemed reasonable; however they may have to give much higher dosages as efficacy was modest.
To be honest, I don't find these data exciting right now.
ZIO-102 is an ifosfamide analog with potentially improved tolerability. This might be very interesting as the metabolites of ifosamide are really nasty.
ZIO-301 is an antimitotic agent just like taxane and the epothilones. The anti-tubulin class is crowded with currently marketed agents and a whole bunch of wannabes. However, 301 is oral, so it also has some potential.
It looks like all of these drugs are unpartnered, but from my perspective (which is from the industry side) the data aren't yet compelling enough to warrant partnership.
In short, I think all of these drugs are interesting. As an investment, I wouldn't touch it for a few years, but that's just me.
Just my quick take.
I think iwfal was asking a rhetorical question, but beyond multi-infarct or stroke-related dementia, there's vascular dementia, parkinsonian dementia without overt parkinsonian features, lewy body dementia, progressive supranuclear palsy, cortical-basal degeneration, infectious dementias (eg, caused by cryptococci) and of course everyone's favorite, Creutzfeld-Jacob disease and Kuru, or the "laughing death." Etc.
Speaking of which, I wonder if Avanir's Zenvia works for emotional lability associated with Kuru. Might be a bigger market.
>endometriosis<
Yes, absolutely a typo. I'm embarassed.
I agree that efficacy is pretty much a slam-dunk for both Proellex and Androxal. Unfortunately the story isn't that simple because--as you point out--the endometrial thickening issue with the lower dosages of Proellex--and the stupid secondary 'distress' end point of the Androxal trial. Both of these issues are easily overcome, but if there are negative signals may limit the pop we might get with positive results.
NVD: As usual, my stocks that go up the most are the ones that I have the smallest positions in. This could double or go to zero and I'd still be in the normal daily variance of my portfolio...oh well. I bought it for the Ambien oral spray; however, the main risk is the Zensana approval. Might buy more after that.
How about you? Any stock suggestions? I'm looking for one more. I'm currently in RPRX, XNPT, NVD, and got back into DVAX a few days ago.
ALNY
Can anyone tell me why ALNY is not a good short right now? Aside from the fact that the biotech market is in a general upswing.
$650 million is quite a market cap for one product in phase I and a $150 million shelf hangover.
I realize that part of the valuation is blowback from the acquisition of RNAI. Doubt this one is going to be taken over any time soon, given that 5 of their programs are partnered.
No SoxFan left behind