By J.M. Lawrence
Boston Globe Correspondent
Ms. Engdahl’s doctors recommended she try a promising new drug called Iplex, not yet approved for ALS patients. But quantities of the drug became severely limited because of a patent dispute. The maker, Insmed Inc., stopped making the drug in the settlement.
The FDA rejected Ms. Engdahl’s “compassionate use’’ claim for leftover vials of the drug, finding she had missed the application deadline by a few days, said Walsh, who is a nurse. But Walsh said an exact deadline was not publicized. The FDA denied Ms. Engdahl’s appeal of its decision in July and said it would take no more ALS patient requests for Iplex.
“It was just very disheartening,’’ said Walsh, who cared for Ms. Engdahl almost daily. “She felt for the first time she wasn’t a person, she was just a statistic.’’
A. If Insmed had already made arrangements with a contract manufacturer to begin the process of manufacturing IPLEX, that would be a material event that would have to be reported, and it undoubtedly would have required the payment of some upfront cash that would have shown up on the Q1 or Q2 10Q.
B. Increlex is a far simpler substance than IPLEX, and still there were substantial batch failures early in production.
C. Insmed has ample cash resources, but "Time may be money, but money won't buy you time." The 12-18 month time frame is a statement from management, not my idea. They didn't say we could manufacture a little bit in 6 months and more in 18. They said it would take 12-18 months to get a contract manufacturer up and running. Period. Would there be any FDA hurdles to be overcome? If there are, even if you manage to produce a small amount in a new location, that would not be usable until the FDA said so.
Once manufacturing is in place, THEN we start to talk about trial design and enrollment.
I believe the delay in finding and announcing a new contract manufacturer is a function of the lack of a decision on overall corporate strategy. If Insmed is to be sold, manufacturing will become a concern of the buyer. If Insmed invests substantial funds in a new drug, there may be fewer resources available for IPLEX, and the pace and size of the manufacturing undertaking may be smaller and slower than it would have been otherwise.
I just want a buyout, dammit, and let someone else worry about these things.
A. The clock for arranging a new supplier may have started last February or even earlier.
B. Lonza already makes Increlex at their new facility. The deal was struck in May 2008 and the first batch was started in January 2009. The PR is documented on this board.
C. The initial amount on IPLEX needed to initiate additional studies is small and not a big drain on resources to make. There is time to ramp up production later.
Just because you repeat 2 years, does not make it true. You have been posting on this board too long. Reality has its advantages, try it.
I'm not quite sure I get your extremely subtle point, penny.
When the results were announced, it was said that the study was never designed for an endpoint that would be Phase-III-enabling. Yet, as I recall, back in 11-07, GA said that it would be precisely that.
Was he right at the time, or did he overstate the case? There were other things that were supposed to happen around that time, like FOB partnership and an update on ALS that didn't develop.
Semantics, indeed. Your words suggested that they said that they would never do more clinical trials with IPLEX. They, in fact, said that they will not initiate more trials at this time, leaving future trials to future decisions.
Sorry, but I am a stickler for words, and I find that Insmed usually chooses theirs rather carefully. What they say -- and certainly what they don't say -- seems to be carefully thought out.
Perhaps the BOD was unhappy with Allan when he fell afoul of policy by saying that the MMD trial was to be Phase-III-enabling.
My concern is not with cash. My concern is with the two years or more that is likely to transpire before anything of substance can be achieved with IPLEX, if, indeed, anything is ever going to be achieved.
In the intervening months, who knows what the heck the BOD will decide to do with all that cash burning holes in their pockets? I remain long in the hope that they will sell or, wonder of wonders, engage in a merger or acquisition that actually adds to shareholder value in a period measured in weeks or months, not years. I don't trust this BOD to make intelligent decisions that take years to come to fruition.
"I dispute your doomday prediction of 2 years."
Can you explain to me how something of substance can be done with IPLEX in a shorter time frame?
I do not feel the need to press the panic button.
INSM has money.
If a compelling research result is revealed, INSM can use its cash to push the production of new IPLEX.
You seem to be stuck with the old perception of INSM. The one where they were running low on cash and at risk for dilution.
Those of us with money know that, if we want something, it can be had for a price.
I dispute your doomday prediction of 2 years. My opinion. There is no need to impress me with exclamation points.
"it will take 6 months to a year to initiate a trial. The lack of new supply is not a big issue."
There will be no IPLEX in six months to a year. There has not even been an announcement regarding a date in the future when there will likely be more IPLEX.
You are being very unrealistic. There will likely be NO new IPLEX trials for two years or more.
There may be a reason INSM did not pump out a large quantity of 'old' IPLEX before selling the Boulder plant.
A proper study of IPLEX for ALS is best done with 'new' IPLEX from the new supplier.
The same applies to a Phase III study of 'new' IPLEX for ROP; INSM will need to use drug from a new supplier to substantiate the effectiveness of the med made in a new location. Therefore, any notice of progress regarding a new supplier can be read as good news for investors.
I still like IPLEX for ROP. I believe a phase II study was initiated during Q2, but I have no proof beyond Dr. Smith's April 15 lecture and the joint PRs from INSM and Premacure earlier this year. You need to make your own decision regarding the future prospects of IPLEX and invest accordingly. I am currently long INSM. However, I will also gladly sell on good news. It is called investing.
"A proper study of IPLEX for ALS is best done with 'new' IPLEX from the new supplier."
What new supplier? It has been six months since Boulder was sold, and there is no news of a new supplier. And, it will take 12-18 months before a new supplier can manufacture IPLEX.
Last we heard, Insmed was evaluating IPLEX and how (whether?) to proceed with it.
I suspect you are getting a little ahead of yourself and a little ahead of the BOD.
I"am confused, if insm couldn't sell Iplex and make a profit why would they keep making it. I don't think anybody on this board would keep making somthing if they could not show a profit right Tm.