In our study in combination with KEYTRUDA after advancing into the second dose cohort we recently submitted a protocol amendment to the FDA based on bleeding events observed in heavily pre-treated relapsed gastric cancer patients. These events were not classified as dose limiting toxicities or determined by investigators to be related to PEGPH20.
It is unsettling that such a quality person sees a need to go silent. I know you'll watch, and look forward to your return. In the meantime,,buy the new book out on McCartney, and read it between innings.
I personally think Iplex will provide a great return for someone. Unfortunately, possibly not for INSMED. This drug requires full attention, and a flawless execution in it's trials.
Most don't truly (myself included) understand all the avenues of opportunity for Iplex..Sad, but it is what it is.
Historian..of all the posters here, I truly have no desire to cause you any consternation. While I too wish Iplex to be something,,I can't bring myself to that conclusion at this time simply because the terms of the lawsuit still hang over our heads...And when the terms do expire,, we don't have with any certainty any written knowledge that the situation will be resolved. The other party can file for an extention of their existing patent protection, and string this out for more time. We have to focus almost completely on Arikace at this time...regards.
I went back and re-read the entire 10-k and can't find the script you offer...Maybe you have a different 10-k
While I want Iplex to be something as much as you may,,I don't think it's in our best interest to quote a
10-k from some years ago, and try to make it appear current...But I did find this,,and it's from the current 10-k
and it may help the discussion.
There is considerable time and cost associated with developing a potential drug or pharmaceutical product to the point of regulatory approval and commercialization. Historically, we have funded our operations through public and private placements of equity securities, through debt financing, from the proceeds from the sale of our follow-on biologics platform to Merck in 2009 and from revenues related to sales of product and our IPLEX expanded access program, which was discontinued in 2011. We expect to continue to incur losses because we plan to fund research and development activities and commercial launch activities, and we do not expect material revenues for at least the next two years.
Next Expected Milestones
ARIKAYCE for adult � We are advancing the � We expect to
patients with refractory CONVERT study, a randomized, achieve our enrollment
NTM lung infections open-label global phase 3 objective in the CONVERT
caused by MAC clinical study of ARIKAYCE study in the second half
in adult patients with of 2016.
treatment refractory NTM � We expect to
lung disease caused by MAC. participate in an oral
� We recently submitted explanation meeting with
our written responses to the the CHMP in the second
CHMP's 180-day list of quarter of 2016 and the
outstanding issues (LOIs) CHMP to render an
and we have requested an opinion on our MAA
oral explanation meeting to around the middle of
add clarification to our 2016.
responses. The 120-day and � If approved, we
180-day communications are expect ARIKAYCE would be
part of CHMPs official the first inhaled
review timetable. antibiotic specifically
� The US Food and Drug indicated for the
Administration (FDA) has treatment of NTM lung
designated ARIKAYCE as an infections in North
orphan drug, a breakthrough America, Europe, and
therapy, and a qualified Japan.
infectious disease product � If approved, we
(QIDP). Breakthrough therapy plan to commercialize
features intensive guidance ARIKAYCE in certain
on efficient drug countries in Europe, the
development and offers the US, and eventually
potential for a rolling Canada and Japan and
review. A QIDP-designated certain other countries.
product qualifies for fast
track designation and is
eligible for priority
� The European
Commission granted an orphan
designation for ARIKAYCE for
the treatment of NTM lung
INS1009 (nebulized � We recently completed � We expect to
treprostinil prodrug) a phase 1 study of INS1009. present the results of
for rare pulmonary The phase 1 study was a our phase 1 study of
disorders randomized, double-blind, INS1009 in healthy
placebo-controlled single volunteers at a medical
ascending dose study of meeting in the second
INS1009 for inhalation to half of 2016.
determine its safety,
pharmacokinetics in healthy
On 28 January 2015, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Tobramycin VVB. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Tobramycin VVB can be granted marketing authorisation in Lithuania and in the following Member States of the EU: Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Expand all items in this list
What is Tobramycin VVB?
Tobramycin VVB is an antibiotic for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older who have cystic fibrosis. Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily and cause infections. P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.
Tobramycin VVB is to be available as a nebuliser solution (300 mg/5 ml) to be inhaled. The active substance in Tobramycin VVB, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides’. It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria which eventually kills them.
Tobramycin VVB is a ‘hybrid medicine’ that has been developed to be comparable to a ‘reference medicine’ containing tobramycin called Tobi (300 mg/5 ml nebuliser solution).
Why was Tobramycin VVB reviewed?
UAB VVB submitted Tobramycin VVB to the Lithuanian medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Lithuania) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance Bulgaria, Estonia, Hungary, Latvia, Poland and Romania).
However, the Member States were not able to reach an agreement and the Lithuanian medicines regulatory agency referred the matter to the CHMP for arbitration on 14 October 2015.
The reason for the referral was a disagreement over whether Tobramycin VVB is clinically superior to Tobi Podhaler, another medicine containing tobramycin. Demonstration of clinical superiority is required because Tobi Podhaler is an orphan medicine and was granted market exclusivity in the EU at the time of its market authorisation in July 2011. This means that during the period of market exclusivity similar products, such as Tobramycin VVB, cannot be placed on the market; there are, however, exceptions such as where clinically superiority over Tobi Podhaler can be shown.
What are the conclusions of the CHMP?
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Tobramycin VVB is clinically superior to Tobi Podhaler because a substantial proportion of patients are intolerant to Tobi Podhaler but can be treated with Tobramycin VVB. The CHMP therefore recommended that Tobramycin VVB be granted marketing authorisation in Lithuania as well as in the other concerned Member States.
The European Commission issued a decision on this opinion on 04 April 2016.
While I as much as anyone wish this could be the case, and I hate to throw cold water on a good
dream...I don't see this happening as INSM has not trialed IPLEX for ALS..I am not sure what a trail for that would cost, and I'm not sure if it would have to be a phase 2 or if they've got enough history to engage in a phase 3...I think the only avenue for IPLEX is as a partner with another larger bio.
One whose got the capital, and the clout...Because we all know there are those that would certainly like to keep IPLEX out of the market for anything for fear it may be marketed for other indications.
I was about to ask that same question..This is why we open ourselves up to criticism of being over zealous with this..I do have a question for you, as you do seem to have a good
grip of the regulatory scheme of things..When do you think we will hear from the EMA
on the PRAC?