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Yep, I am both puzzled and surprised by their action.
Clearly they have inside info relating to their joint products with MNTA, included, but not limited to patent office expectations, Glatopa acceptance and sales, 40 mg likelihood of FDA approval. To sell now suggests a bit of urgency. While the optimists are hoping for good news later this month, which if it were to occur would suggest a slight bump at least in the stock price, selling now appears to make no sense. I can understand the registration to sell so NVS could take advantage of a major pop, but selling shares already suggests that is not their intent or expectation. They certainly are in no need for cash as $55 million has to be chump change for them.
Trying to figure out why now. Could NVS be planning to spin off Sandoz and wants to clean its books of any Sandoz partner holdings prior to a spinoff? Just wildly speculating.
Keep inmind that one of the possible competitors in the Copaxone market is MYL, so they clearly would drop their Mylan-copaxone filing. Certainly may be forced by the feds to sell it to someone else.
Seemingly there is something out there. Nothing in CC to account for today's action.
Given recent numbers, etc., I remain perplexed as to why MYL partnered with MNTA rather than buying the company. They get the science, assuming 40 mg gets approval and legal clearance can probably book $250 million in annual profit from all copaxone sales, can dispose of redundancy and within 6 years pay off a $1.5 billion investment easily.
Given relatively low volume and given MNTA's past innocent bystander-victimization by FDA leak, could be leak of preliminary musings from within US Patent Office.
While I realize developing new drugs and new drug candidates is a crap shoot, MNTA simply does not have a good track record in selecting viable candidates. Clearly the sample pool is small, but M118 was likewise a very poor candidate in a relatively crowded and limited use field at the time.
Well, it's that time again.
How much of a disappointment will tomorrow bring?
Doubt if we will see any significant increase in Glatopa sales and any positives would be spin on litigation.
Does anyone know if Visium still owns any MNTA shares? Could not find a current filing. Also, if they do, I have to wonder if they dumped a bunch 6/1 and 6/17 to account for high volume and sell off near Friday's close in preparation for unwinding the fund.
May be ripe for a short term jump.
Thanks.
Probably a result of new 2016 health care plan design and formularies.
My take is that people are neither buying nor selling based on a possible partnership. Mostly people selling for tax loss reasons with a number of them having purchased at the ATM price from a few months ago.
pretty disappointing "earnings."
I have no idea what the current pricing is; however, when it first came to market it was priced 2% below daily 20 mg Copaxone. If it is currently priced below Glatopa, I would say there should be no viable market for either TEVA's or NVS/MNTA's 20 mg product. Given that there is a market for the latter two products, I would doubt current 40 mg pricing is below total treatment cost of Glatopa.
Price, as is the case with any generic. There would be no market for any generic if pricing was level with any branded product.
I believe that some insurers/plans will no longer cover thrice weekly Copaxone or the 20 mg Copaxone and begin to financially direct those users to Glatopa.
Two groups that I work with appear to be planning this and one of these never went to thrice weekly Copaxone as a formulary drug, recognizing a generic 20 mg formulation had a decent chance of approval.
I may be wrong on this, but I would surmise that a number of plans will have Copaxone listed as non-formulary, so there would be no benefit available for branded Copaxone regardless whether or not the copay is being covered by TEVA. One of the many reasons for a copay is to have the patient/member own some of the cost and oftentimes the decision to use a certain medication.
Two large groups that I work with have such a benefit.
I am expecting plan design changes will take place 1/1/2016 which will steer patients away from thrice weekly Copaxone back to daily dosing. Would not surprise me if TEVA had raised the thrice weekly pricing to take advantage of the coming erosion.
I am confused. What is the definition of a new prescription? Is it a new start, a reissued paper or electronically submitted script for refills that had run out, etc?
There are approximately 10000 new cases/diagnoses of multiple sclerosis annually in the US, btw.
My guess is that results are easily measured, i.e. number of plaques, size, etc., rather than other diseases that include quality of life, function, joint involvement, fatigue ,etc. I expect they have discussed this with FDA and response to treatment will be used as a proxy for other disorders and if approved, will be approved for an array of disorders if biologically the "same."
What you state is true for low cost drugs such as anti glaucoma drops which are stocked by all hospitals and relatively cheap. Hospitals need to identify every pill that comes in the door, which is one reason they generally do not allow patients to take supplements, etc, particularly when they come in unsealed bottles; however, for high price pharmaceuticals they will either encourage patients to wait a few days until discharged to resume these meds if not lifesaving or to bring in their own supply.
Examples include the Hep C drugs, various chemotherapeutic agents, IV Reclast timing, MS meds, etc.
Given the relapsing, remitting aspects of this disorder, and thus the classification, any concerns about efficacy for a recently switched over user could be related to disease progression/activity rather than ineffectiveness of Glatopa.
On another issue, saw a patient who had run out of her Copaxone 8 days ago, had an elective procedure at another hospital and then was admitted to where I attended her. Our hospital does not typically stock Copaxone ( as just like many they play the game of encouraging the patient to bring in their own supply and use that and cost shift onto the patient or the patient's insurance if under a bundled payment model ) and our facility had to purchase a 1 month supply to be started tomorrow. The quoted price to the hospital for 30 days of 20 mg daily Copaxone was $5800 for the month.
I will see tomorrow whether or not the patient will be receiving Copaxone or Glatopa.
Ain't no lawyer but it looks like Amphastar should have developed a different method to establish the ring structure. I doubt that the FDA required them to use MNTA's patented method but required Amphastar to authenticate the structure. Amphastar violated the patent by using MNTA's process rather than develop and authenticate one of their own.
Could this be interpreted somewhat differently, in so much that they are not predicting 4-5 ANDA approvals occurring between the 18th and 24th month from now but are predicting a total of 4-5 ANDAs being approved by either 18 or 24 months. Such that one may be approved in 2 months, one approved 4 months from now until you reach the 4-5 approvals around 18 or 24 months from now. I truly doubt they would predict that all the approvals would occur within a 6 month period.
Just a thought.
And is the worse case scenario that MNTA actually loses the case but given the SG opinion, MNTA will not be responsible for any damages as MNTA had a valid argument and the argument supporting the temp order was not frivolous?
All of this is true, but one aspect that PBMs and employers will have to address is the out of pocket maximums as both drugs will quickly get you there, so the individual will not pay more for the branded product than Glatopa in a given year as many out of pocket maximums are $1000-$2000 per individual.
One way to address this would be not allowing the dollars paid for the higher priced drug (most likely Copaxone) to be applied to out of pocket maximums but this would require a change in plan design. Whether they will grandfather current users of the daily 20 mg Copaxone or the thrice weekly 40 mg users is another issue.
Given that it would be illegal to behave the way you suggested, I would flabbergasted if a Wall Street banker behaved in such a fashion!
also, a very large short interest number, the highest I can recall in quite some time. Number was before the announced stock sale also, so unrelated to recently sold shares.
One guess is that GS will rate it a buy Monday and this leaked late today to some of their clients.
Short interest was only down 100,000 the day before Glatopa approval when compared to two weeks earlier. Will be interesting what the number is when reported again in two weeks.
May be some buying by the American Academy of Neuologists today and more from their friends tomorrow.
So when will TEVA file against the FDA? I am guessing this week ( much like SNY and enoxaparin).
I have worked wioth them for many years. They were not specifc, but I would assume it would be related to patient co-pays by placement on different tiers. May also recommend changes to out of pocket maximums for a pharmaceutical carve-out.
FWIW, I had a meeting with representatives from Express Scripts about a month ago and during our discussion about generic Copaxone, they mentioned that for most of their book of business they have a strategy already planned to incent people to the 20 mg daily dosage from the thrice weekly regimen.
My guess is that aside from those already on the 20 mg daily dosing and naive patients, the plan design to move people from the thrice weekly regimen to the daily Glatopa will problably not be enacted until the indiviual's plan year starts anew.
Considering that I Have neither listened to nor read the SC transcripts and am not a lawyer; however, in my experiences before the court as an expert witness must say that often a judge (justice) will pose the harshest or most difficult questions to the party that represents the side to which he/she is leaning, perhaps partly to help convince him/her of or "write" his/her decision. Given this, I tend not to rely on the give and take in the courtroom as an indicator as to where a judge/justice stands on the matter before the court.
Thanks. I was coming from the angle that even though they can and certainly will ask for more info at a future date, that they would not accept an application for a similar compound that is under active review with known deficiencies.
Can we infer that because the 40mg thrice weekly dosage was accepted for review, there are no major outstanding issues for the 20mg daily dosage, otherwise would the FDA not accept the 40mg application, perhaps stating that it was incomplete?
Their signing of the lease extension suggests they will still be in business for 4 more years, contrary to the Doubting Thomases!
Would have thought we would have popped 3-4 points today with the positive news!
I have a friend whose son works in the Mylan mail room. I'll see if he remembers any such letter.
Also, if MNTA feels that news such as this is meaningful, they should also disclose this info if they received a similar communication. Absence of MNTA disclosure is a positive. I remain baffled by the slowness of the FDA with a review that could have started 5+ years ago relating to a very expensive brand product. Not sure if the community good is being represented well.
Not an attorney, but isn't "fair prospect" more of a legal tenant based upon prior case law as cited by Roberts and thus listed by Roberts? I don't think he is commenting on anything specific point in this case.
Now I am confused. If they maxed out on out of pocket costs, they may wish to switch to thrice weekly as it eliminates 4 injections a week ( a convenience factor ) all the while not increasing the individual's cost as it would be covered at 100%.
The maximum out of pocket resets annually, so if generic Copaxone becomes a Tier 2 drug, current maximum out of pocket for drug costs in this plan is around $2500; however, if it were on the third Tier, presently none of the cost is applied to out of pocket maximum and next year, theoretically if there were no other medical costs (including other pharm costs) the total maximum out of pocket costs for all health care related charges is somewhere in that $12000-$14000 range (for a family I believe).
Note that I just reread your note and perhaps they will not switch to thrice weekly simply because they are now conditioned and would have to switch back the next year anyway; however, I am not certain the majority of people think that far ahead. They may still go with the perceived convenience factor.