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.
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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?
I don't have clarity on this,,and certainly if this happened, it wouldn't be a problem,,,It's just I've had my hopes built up too many times over the years, and don't want to get over zealous..nothing more..
I think we do ourselves a disservice with this kind of conjecture. We don't know what the decision is yet..and we certainly can not with any clarity decipher a revenue stream by the end of the 2nd Quarter. We line ourselves up for a disappointment with statements like this..let's wait until next week when we could possibly have some concrete news, and maybe if all goes well, we could then celebrate...
Caution should prevail.
I too feel there is a lot of value in Iplex, the biggest difference between you and I is I am not sure we all understand what it would take to bring it to fruition. Without question, prior management dropped the ball in their
methodology in how Iplex was formulated,,and then added insult to injury by not having good counsel in
relation to the lawsuit. I think they could have done us all a better service by trying to get the case moved
to an east coast court, and not in Genetech's backyard...With all that said,,I think it would probably take
5 years, and about 350,000,000.00 to bring it to market, and that would be for short stature..Yea I know
it was approved for that indication already, but that was before, and there is new competition in that market.
Iplex will probably be licensed out from INSM, and we more than likely never see it offered by INSM directly,
as they focus on Arikase.....just my humble opinion,,,and worth what you paid for it...
Despite these changes, the regulatory agency still favors addressing certain ailments over others. According to the report, cancer treatments, drugs for infectious diseases (such as hepatitis C) and rare ailments were more likely to make it through the approval process at a faster pace.
The FDA considers some pharmaceuticals breakthrough therapies, which requires the agency to expedite the approval process. Typically, this designation—which caps the review time at 60 days—is reserved for serious or life-threatening medical conditions and the preliminary clinical data suggests the new drug may be more effective than existing treatments. In 2013, only oncology and infectious disease drugs received this designation. Beginning last year, however, some candidates labeled as breakthroughs were drugs to treat respiratory illnesses and diseases of the eyes and blood. Obtaining FDA priority for certain conditions, especially those of the endocrine, gastrointestinal and central nervous systems, is still a challenge.
As a result, many states have started passing “right to try” laws. So far, lawmakers in 25 states have enforced policies that allow terminally ill patients to access treatments and devices that are not yet FDA approved. This typically occurs after a patient has exhausted all other available options. It takes an average of 12 years for a drug to make it through the clinical trial process and receive approval for sale in the U.S.
The FDA reviews these requests from individual physicians on a case-by-case basis. Unfortunately, drug manufacturers aren’t necessarily required to provide the treatment to a patient once the FDA signs off on the request. And access to these therapies comes with a serious risk, because in many cases the treatment hasn’t been fully evaluated.
Yet, as the new report suggests, the FDA is making progress, which for some patients could mean the difference between life and death
Market watchers seeking income should invest in master limited partnerships (MLPs) as oil prices have stabilized, according to Global X Funds' CEO Bruno del Alma on Monday.
"MLPs are probably the best asset class in our opinion," del Alma told "Closing Bell." "If you look at the infrastructure side of master limited partnerships, they're somewhat isolated from oil prices." He added that these companies are generating income at about 7 percent.
Still, market watchers remained cautious as just a year ago MLPs were deemed attractive but substantial share price fluctuation burned eager investors.
"We think it's worth it," del Alma said about possible risks, "We think it's one of the most attractively priced asset classes right now."
The CEO also warned against exploration and production names, but encouraged investments in infrastructure and pipeline companies in the sector.