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With the trial to begin on Wednesday, do you think we can gather any sense of M-copaxone's FDA process/status based upon the defense that MNTA will have to present?
Also, on a different subject, but related to all the posts about t-enox, TEVA's nefarious ways, etc, one need to look no further than TEVA's comments in late January after MNTA's earnings report when MNTA had great earnings, but when TEVA announced the same day that their t-enox was imminent and we dropped 20% that day.
Clearly TEVA simply wants to punish MNTA and will be unlikely to withdraw t-enox unless a deal is worked out for m-copaxone. It would not be collusion, but simply TEVA making a case that ultimately t-enox was not approvable.
With all the messages about MNTA and its cash hoard and its December 2010 offering, it will be interesting to see what happens if the stock drops below the $14.35 offering price. Will the company repurchase a like number of shares, at perhaps an even lower price to cover costs, thus making it a profitable "round trip?"
Very interesting article. Appears as if TEVA likes to "shoot from the hip" and colors their positions in an attempt to influence the outcome, even though they know they are in the wrong (as related to punitive damages). Not withstanding that TEVA is allowed to plead or influence their case, this type of behavior has been employed by TEVA frequently in the skirmishes with MNTA/NVS and the FDA.
Hope it all comes back to bite them!
Am I incorrect in the belief that the 9/7/2011 trial is a result of TEVA's action against NVS/MNTA and Mylan for patent infringement and that the judge bundled the defendants in a single trial? If so, can the judge find for TEVA against Mylan, yet against TEVA related to the MNTA/NVS side? If MNTA has reversed engineered Copaxone, might MNTA have a better defense than MYL, aside from arguments regarding TEVA's "patents?"
Operating on the "half-full theory," having the judge side with TEVA on claim construction issues leads to one less opportunity for appeal by TEVA down the road.
She tosses them a small bone, being sensitive to larger issues.
FYI and update.
Just saw my first patient taking Xarelto for post-op DVT prophylaxis following total knee arthroplasty. Given the earlier indicated VHA pricing for Xarelto, seems as if the company has become aware of the pricing conundrum, particularly related to hopeful Afib indication in future and price comparison with Pradaxa.
New VHA pricing for Xarelto is $6 a tablet and the local street price is $10 a pill. The patient's PBM would not cover Xarelto and required her to use warfarin, so the family purchased it out of pocket for $100 for a ten tablet supply.
That was simply a very old thread with a single, recent posting that made it appear to be new "news". There is no further secondary. I believe it was from everybody's new friend, Investorgold2002.
...and start them all on DVT prophylaxis!
I am uncertain as to whether earnings have ever been a disappointment; however, the conference calls have either been a disappointment or did not meet expectations. Rarely have they ever offered the dogs a bone.
I respect that I may be in error. Simply a thought and a guess/observation on a slow day. We'll find out in a few days.
It is my belief that the pre-arranged, established selling from the insiders occurs over a very short period of time, regardless of the price of the stock at that moment. Also, it tends to often (not always) cluster toward the last 5-10 days of the month.
I am willing to be wrong in this case, but only time will tell as far as any filings.
If today's "dump" was related to insider selling, I still think CW, officers, and directors need to reassess the current program.
Today's action, particularly around 2:30pm, looks like continued insider selling plan action. If we see filings over the next few days, it may be time for CW and the boys to suspend the selling if allowed under regulations.
They need to show some support to the shareholders.
Apologize if already posted, but just found out the pricing for Xarelto utilizing the VHA purchase program is $21.60 a 10mg tablet when purchased in lots of 100 pills. Purchase price is higher when purchased in lots of 30 pills. Interesting to see that it is priced higher than both Lovenox and M-enox for DVT prophylaxis dosing.
As discussed much earlier, will be interesting to see if purchase price drops once it obtains FDA approval for Afib to compete with Pradaxa.
Correct. Did not mean to imply that TEVA was the only one raising prices, simply that the increased in revenues probably significantly influenced by pricing rather than increase market penetration or scripts alone.
The annual or semiannual increase in prices for all MS drugs has frankly been shameful!
If I can add on...any idea what these numbers would be if one "backed -out" price increases? TEVA has not been shy about raising prices significantly for the last several years. I am guessing that a lot of the "growth" is not organic or increase in usage, but primarily related to higher pricing.
Thanks
A Modest Proposal:
What follows is from memory. I did not research exact numbers so approximate numbers utilized.
On July 22, 2010, MNTA was closed at $11.93. There were approximately 46 million shares outstanding and as I can recall, the company may have had around $60 million in cash (or about $1.50per share). They had no drugs on the market and had two in front of the FDA for approval.
Fast forward to today. Including accounts receivables, available cash is around $310 million at end of June 2011, i.e. over $6.00 a share in cash. MNTA one drug on the market, and one still in front of the FDA. MNTA is adding $20 million in cash monthly which will probably be impacted to some extent by Xarelto.
Adding an additional $5.00 a share in cash, compared to the pre-market approval stock price still gets us to just below $17 a share using historic pre-m-enox valuation numbers. This is not far off the current stock price.
The purpose of this exercise is that I believe all the shorts will have a rude awakening, regardless of m-copaxone outcome. Clearly the shorts are primarily betting on T-enox approval and a collapse of MNTA share price. If the market were logical, the price should not be much lower than $17 a share, given previous levels, FDA approval process and adjusted for cash on hand. Even with a third entrant for enoxaparin, MNTA should receive something like 9% of $500 in m-enox revenues (assuming a total market in the US of $1.5 billion for enoxaparin) or $45 million annually which would cover greater than 50% of annual operating costs. Given the paltry returns on cash, will not count on any returns on the cash equivalents although some exists. While the stock price may dip much lower than $17 on T-enox approval due to market/herd reaction, I do not believe the shorts will be able to buy enough shares to cover their positions, and that is when a short squeeze will occur.
Therefore, if T-enox is not approvable or if m-copaxone is approved alone, there is the likelihood of a short squeeze and if T-enox is approved, there will be a quick drop, a short buying opportunity and a short squeeze.
Yes the glass can be more than half full twice...and yes, I did indulge in the proverbial 2 martini lunch!
For all intents and purposes, we will have an approximate earnings estimate on July 19.
While not expecting Mylan/MNTA/NVS to win this round given that it has recently been made more difficult to succeed with this strategy, I am interested in hearing their arguments.
Hope a synopsis could be posted somewhere.
If one knew the total percentage of prefilled enoxaparin scripts for each dosage available, one could determine the amount of scripts used for prophylaxis of DVT versus treatment of acute DVT, PE and "bridge therapy". Essentially 100% of all 30mg and 40mg dose fills would be for prophylaxis, and 100% of all other dosages would be used for treatment of acute DVT or PE or bridge therapy.
I would estimate 6-10% of outpatient enoxaparin prescriptions are used to treat DVT as an outpatient. A patient may have a one day observational stay, or simply an ER visit, instructed on home use of enoxaparin at 1mg/kg twice daily, sent home and simultaneously started on warfarin. These people typically require 5-7 days of enoxaparin until therapeutically anticoagulated with warfarin.
Enoxaparin is also used in the hospital and for outpatient treatment of pregnant women with DVT/PE or who typically require longterm warfarin use. [not a big market, but it certainly exists]
Sorry for such a stupid question, but noticed it is TEVA's suit, so clearly they go first. Other questions still in play.
Thanks.
In my experience, there is significant seasonality related to elective hips and knees. Although regionally climates vary, most people in the northern part of the country will elect to have surgery in the fall or winter due to physical down time. We also see a pickup in Oct-early December due to people having met deductibles and out-of-pocket maximums. Regardless, at present, no real competitor to enoxaparin prior to Xarelto.
Guess we'll have to wait until July 19 to get more exact numbers for total M-enox business.
I am not a legal expert and wonder what actually is presented and who goes first in such a hearing relative to "Mylan's inequitable conduct affirmative defense?"
Also, anyone know at what time the trial begins and is there any expectation that some analyst/follower will post "musings" as the trial unfolds?
On another issue, agree with Dew's comments from the other day that Pradaxa has had no significant impact on enox sales. This "bridge therapy" concept is overdone. If a person were to present with an embolic stroke and atrial fibrillation, a vast majority of doctors would treat with either intravenous heparin for a few days and overlap warfarin or treat with enoxaparin and overlap with warfarin. I am unaware of the data in a subset of patients who present with acute embolic event and are started on Pradaxa alone. Doubt if that meets standard of practice. Uncertain if a patient were to receive LMWH or UFH what duration of treatment would be necessary until the Pradaxa "kicks in." With LMWH or UFH, one can follow the INR and decide to stop the LMWH or UFH once INR therapeutic for 24-28 hours.
While "bridge therapy" can also refer to some sort of treatment initiated for afib to prevent embolic events while waiting for warfarin to achieve therapeutic INR, the risk of embolism remains quite low for any 5-7 days prior to full anticoagulation and the vast majority of physicians would not start LMWH as a "bridge" until INR therapeutic in patients who do not present with embolic manifestations.
FYI, based on my clinical experience, about 50% of my atrial fibrillation patients first presented without any cardiac symptoms at all. Often an incidental finding (and usually on a Friday afternoon!).
Sorry for the delay, picnic with the grandkids.
Truly have no idea why B-I has not gone after the DVT indication. If truly "only" a $100 million annual market, and if to be split two or three ways, perhaps they felt it was not worthwhile pursuing.
Another thing about Xarelto approval, as discussed months ago on this board, is that orthopedic surgeons are all over the map in how they provide DVT prophylaxis, and I doubt if the FDA's duration of treatment and basis for approval will be followed by a majority of orthopedic surgeons.
Non-coverage is simply a PBM cost control/reporting issue. Warfarin a lot cheaper and PBMs can report to their business customers that their pharm costs have been effectively managed.
Clearly does not take into effect cost of warfarin monitoring, etc.
Nothing to do with marketing, simply a dollar issue.
No, but given how some PBMs are not covering Pradaxa for Afib, they will have internal challenges if they were to cover Xarelto for post-op ortho DVT prevention and NOT cover it, or similarly Pradaxa, for its other indication (in the future for Xarelto) for Afib. They could require a pre-authorization for using Xarelto in post-op DVT prevention if they wish not to cover it for any future Afib indication.
One way or another, a possible administrative nightmare and one filled with physician and patient dissatisfaction if the PBMs were to selectively allow any of these drugs for one FDA indication, yet not for another present, or future, FDA indication.
Purpose for making this point originally is that several PBMs are listing Pradaxa in the "non-covered" category for atrial fibrillation presently.
An unknown in the outpatient arena remains drug formulary coverage for Pradaxa, and now Xarelto. Although formularies vary, even within a single insurer, many still do not have Pradaxa on formulary. On 7/1/2011 I received a fax from United Healthcare, stating that Pradaxa was non-formulary for a patient with atrial fibrillation.
PBMs will have a tough time listing/approving/covering Xarelto (or perhaps Pradaxa in the future) for post-ortho DVT prevention and turning around and not covering it for chronic Afib.
Are you talking about an "unduly bullish" effect on a mildly bearish, though fully expected FDA approval?
Dew, thanks for your comprehensive analysis. In Paragraph A, you mention Lovenox's "lower cost." Have you seen anything related to the cost of Xarelto? If used for 35 days psot-op, there may be significant total cost, but I am guessing that the daily dose will be priced much lower than a daily dose of enoxaparin. The pharm companies may have a dilemma on their hands with the pricing. Article the other day on Bloomberg mentioned that the market share for Xarelto for DVT prophylaxis for present indication may be $100 million annually, while if later approved for Afib, the market may approach $2 billion. To compete in the Afib market, they will have to price Xarelto comparable to Pradaxa for a total daily cost, whereas, for the present indication, if they were to price Xarelto near the Pradax cost, they will be leaving "money on the table." If stuck with their present indication for a period of the time, they could actually undercut Lovenox/m-enox by 20% initially, and once they receive an indication for Afib, they could drop the price to compete with Pradaxa.
Dew,
The main action of Zetia is to lower LDL.
I believe you meant to state that Zetia lowers LDL, rather than raises HDL. Zetia is very effective in lowering LDL, yet the study (if I recall correctly) showed increased, rather than decreased intimal thickness.
....and all this adds credence to MNTA's M-118 reason for being. Whether or not its proposed use in ACS is enough to have big pharma pony up the dollars for a study is another issue.
First, please keep in mind that my estimate is for an increased utilization of only the 30mg and 40mg prefilled syringe dosing for inpatients only. This is not an "across the board" increase for all LMWH or of all the 30mg or 40mg dosing as some of that continues in the outpatient setting for various indications.
Most hospitals that I am familiar with initiated an educational process by late 2009 and probably rolled out order sets by late 2010, so the baseline would be right around when m-enox was approved.
Also, if this initiative is effective in preventing DVT and/or PE, there will be less usage of 1mg/kg/12hour LMWH, but this decrease utilization will be consistent with a "rounding error."
Does this address your concerns? Again, simply my stab in the dark.
I wouldn't know the degree of increased utilization, but would make a guess that it will be in the 8-12% range. As far as significant bleeding risks with DVT prophylaxis dosing, it is not used in spinal operations as mentioned in the WSJ story, rather SCDs are often utilized. Also, many episodes of bleeding can be traced to polypharmacy, including concomitant or recent use of aspirin, Plavix or NSAIDs along with either heparin or LMWH.
While many patients received DVT prophylaxis of one type or another for years, given the threat of non-reimbursement and additional penalties, most hospitals have either initiated facility-wide education and/or pre-printed orders requiring opt -in/opt-out decisions.
This will drive increase utilization of DVT prophylaxis dosing of enoxaparin.
Related to the other issue, DVT prophylaxis dosing does not require reversal prior to an invasive procedure. At most, you hold the scheduled dose prior to the procedure.
If multiple generics of Lovenox are approved (i.e. t-enox, then the rollout of an authorized generic), it still may bring $50 million annually to MNTA. While MNTA's annual overhead is approximately $72 million, they would operate at a loss; however, if NVS were to purchase the entire MNTA-enoxaparin business, it would bring immediate additional cash of $50 million annually to NVS without adding any additional cost to NVS.
So even with multiple generics, MNTA could possibly sell m-enox to NVS and pocket $500-$600 million assuming a purchase price of 10-12 times the annual payment to MNTA.
Add that to the expected $300 million in the bank (or on its way to the bank) by July 1, 2011, MNTA could have a cash hoard of $800-$900 million at that time.
MNTA would still be left with m-copaxone and its IP.
Not sure, but believe a decade ago pre-diabetes was defined by a fasting glucose greater than 110. Agree that hemoglobin A1c did not enter into the definition.
Believe the earlier pre-DM designation was that people between 110-126 had greater than 50% more likelihood of developing DM than a population below 110.
DM researchers/educators/supporters/fanatics have often been overly aggressive in scaring people about the disease (although it is a major health challenge). I remember going to a national conference on DM education and the expert listed 11 categories of individuals that should be referred for DM education. I questioned her as the list was comprised of every living American (and strangely,that was not the point she was trying to make and she later sheepishly conceded that her list was all encompassing).
Generally agree, which is why I DID buy TEVA premarket as mentioned. Consider it the better deal at the time.
Agree. This is inappropriate collateral damage. It really affects TEVA's oral drug in development, rather than Copaxone unless proven to be far superior to Copaxone. We've known for the last two years that the orals are coming (and have come), so there should be no direct negative on MNTA. Additionally, any possible negative for Copaxone is 2-4 years down the road.
You buy when stocks go on sale. Actually purchased TEVA in pre-market for a daytrade.
Or perhaps missing the cash receivable from NVS after the fourth quarter 2010 numbers reported.
On a side note, just started a patient on enoxaparin 100mg prefilled syringe this morning for DVT. Was a Sandoz label, but a bit disppointed that the package did not cantain a glossy instructional sheet for the patient. Would cost all of $.25 and would be nice for patients.
Given that there wasn't anything particularly new in the Cowen report, I am not convinced is was the catalyst. Indeed, there may not have been any specific event that led to Friday's rise, but by court order, TEVA and MNTA have been in discussions, and perhaps there was some sort of additional filing asking for a delay to file from the plaintiff's (MNTA) side, given the ongoing, court ordered discussions. Just a guess, not trying to start a rumor.
Related to Friday's MNTA action, I believe 4/15/2011 was the deadline to serve upon TEVA what MNTA felt were the patents infringed upon regarding t-enox and how they were infringed. Any thoughts as to whether this info influenced the stock price that day?
Is this document public?
Thanks.