I did not see this anywhere, but the COMP issued a positive opinion on April 16 or so.
"Humanised anti-CD37 monoclonal antibody conjugated to maytansinoid DM1 for treatment of diffuse large B-cell lymphoma, ImmunoGen Europe Limited"
Much more probable than your suggestion is the likelihood that as they begin looking at the 6 mos data they halt the trial because of the 50-80% cure.
P3 primary endpoint is at 6 mos. Check the conversions from the P2 at day 168. The 25% conversion of th P2 was at 84. If you look at the April and March presentations, the P2 conversions (defined as 3 mos. negative cultures) after day 168...that is what I am talking about. You can see it in the data, but statistical derivation was not determined so they do not say it. Now the P3 is powered for day 180. This will likely come out between 50-80% conversion. How will the market react to news of 50-80% cured?
Designed for expectations of 20% conversion (3 cultures), but notice the P2 outcomes for the same period. Make no mistake...this is not for a 25% conversion rate! How will the market react to results showing 50-80% conversion? Wishful thinking? Check the P2.
BOSTON--(BUSINESS WIRE)--April 14, 2015--
Attorneys from Mintz, Levin,Cohn, Ferris,Glovsky and Popeo, P.C. represented ImmunoGen, Inc. in a $200 million non-dilutive royalty transaction with funds managed by TPG Special Situations Partners (TSSP).
In return for the payment to ImmunoGen, TSSP will have the right to receive 100% of the royalty revenue on Kadcyla commercial sales that would otherwise be paid by Roche to ImmunoGen until TSSP has received a total of either $235 million or $260 million, depending on timing. After this threshold is met, if ever, ImmunoGen will receive 85% of the Kadcyla royalty revenue and TSSP will receive 15% of the Kadcyla royalty revenue until this revenue stream ends.
I believe back in September or so the EMA instituted a new rule where orphan designated drugs would only be referred to by their composition name and not the market name. So, you won’t find Arikayce (or maybe even Arikace) with Insmed. I don’t expect to see anything in minutes until those of the May meeting at the earliest and that would be a reference to formulating questions by composition…something perhaps like “amikacin orphan.”
Not until they spend it. As long as the cash is in the coffers, it is free money to any buyer. But that won't happen.
I am looking for CRE, MSRA, and a couple of other indications in P3 or ready to start P3 as acquisition options. They could license at $20-30M or buy one of these indications under $60M.
The best! I love it when the science takes a back seat to impatience and opportunities to accumulate abound. "Wisely and slow. They stumble that run fast."
I was wondering the money was coming from to make their drug buy...well, I knew where it was coming from I guess, but now it is clear. They have funded their development and commercialization and will have plenty left in cushion. New drug for 20-30M perhaps. Plenty of cash now (around $350M) is a nice canvas for company painting a long bright future.
I would start with a validation of 2/26. The CHMP meetings go in reverse order with the official positive opinions rendered at the beginning Day 1 of the session (actual positive opinions are before the meeting and most PRs occur beforehand).
The CHMP meeting will clearly identify updates on the application including compilation of the day 120 list of questions, company request for extensions on day 120 (stop clock extension), company response to questions, etc. The EMA is great in that once an application is in, they are very open with the process. The meeting mintues will identify Arikayce (EMA approved product name) and Insmed.
The CHMP meets for 4 days beginning the second to last Monday of each month. The highlights from each meeting are usually posted immediately after the meeting, but for now we should be watching the minutes. Minutes are usually posted after 3-5 weeks.
We would likely post positions and continue business as usual, unless...
1) If an offer was on the table, filling positions would likely be suspended for multiple reasons including keeping expenses down, HR considerations, and out of consideration for potential new FTEs;
2) They wanted to sell.
I stand corrected and thanks for providing the specifics of your reference. Yes, they failed to meet a primary endpoint of a 7 point scale that had never been used before and was not considered the ideal measure by the FDA. The FDA accepted the design, but preferred clinical evidence of culture conversion. As you know, Insmed (and our now former CMO) did not believe culture conversion could be shown, so they added it as a secondary endpoint in the design. As luck would have it, efficacy was proven in the FDA desired endpoint. Had the primary been met and the secondary not (as Insmed had expected), we would probably be looking at a higher sp today with little chance of approval. If neither endpoint had been met, we would be sub 2 in my opinion. Instead, we have a near certain approval as followups continue to show sustained conversion.
Aha! I think you are referring to the NTM trial that met its primary endpoint of non-inferiority to TOBI. I think you are uniformed of FDA clinical requirements for approval with respect to comparisons against a standard of care. A non-inferiority trial is specifically designed to show a medicament is not inferior to the standard of care. It is what the FDA expects. A trial designed for non-inferiority is not the same as a trial designed to show superiority. It may be hard for you to grasp, but a non-inferiority outcome is not even a possible outcome of a superiority designed trial. Below is an explanation of Achaogen's Plazomcin phase 3 trial...notice 1) trials are designed for superiority or non-inferiority, not both. 2) Non-inferiority is the norm comparator for standard of care, except when the standard efficacy is poor.
"We have designed our pivotal Phase 3 trial for plazomicin as a superiority trial with a primary efficacy endpoint of all-cause mortality at 28 days. The trial will compare a plazomicin-based regimen versus a colistin-based regimen for the treatment of CRE bloodstream infections and pneumonia. Through the SPA procedure, the FDA has agreed that the design and planned analyses of the trial adequately address objectives in support of an NDA. Most antibiotics are approved based on demonstrating non-inferiority to the current standard of care in the treatment of a specific type of infection (such as cUTI, intra-abdominal infection, and pneumonia) caused by a range of pathogens against which both the treatment and comparator are active. By focusing the Phase 3 plazomicin trial on patients with a high unmet medical need where the efficacy of the current standard of care is poor, and enrolling based on infections caused by the target pathogen (CRE), we have the opportunity to demonstrate differentiated efficacy of plazomicin in the clinical setting."
If this is still unclear, your "truth" is only how you see it...and you are wrong.
I just noticed that the PIP for NTM has trial data extrapolated from CF instead of doing a trial. For the PDCO to accept this seems to indicate a favorable predisposition towards NTM...just more credence to a favorable view by the EMA for the joint filing.
The only difference I could find between the Sept 30 PIP and the January 30 PIP was Insmed’s address changed from NJ to UK.
Also, this is interesting:
PARI Pharma GmbH – Vantobra
“The CHMP concluded on 20 November 2014 that Vantobra was similar to TOBI Podhaler. Subsequently, the Applicant provided a derogation report justifying that Vantobra is clinically superior to the authorised orphan medicinal product, TOBI Podhaler, in the same therapeutic indication. On 22 January 2015 the CHMP concluded that Vantobra, although similar to TOBI Podhaler, is considered to be clinically superior due to greater safety in a substantial portion of the target population.”