When the EMA Says No, Try, Try, and Try Again

Give VIVUS (NASDAQ: VVUS  ) an A+ for effort.

The biotech is on its third attempt to get its obesity drug, Qsymia, approved in Europe. The European Medicines Agency's Committee for Medicinal Products for Human Use rejected Qsymia last year. VIVUS appealed the decision, but that was also turned down in February.

Last week, VIVUS said it asked the EMA for advice on using pre-specified interim analysis from its AQCLAIM cardiovascular outcomes trial to support the resubmission of its marketing authorization application.

AQCLAIM, which VIVUS plans to start in the first quarter of 2014, is part of its post-approval commitment to the FDA. It certainly makes sense to ask the EU for advice in designing the trial so VIVUS can double dip and use it to gain approval in the EU.

VIVUS didn't actually say when the interim data might be available to submit to the EMA, but we can take a guess based on Orexigen's (NASDAQ: OREX  ) clinical trial testing Contrave's cardiovascular safety, which began in June 2012  and is expected to produce interim results by the end of the year. Assuming VIVUS had approximately the same path, interim data might be available in 2015.

Is that all you've got?
While I'm sure the AQCLAIM trial will help EU regulators feel confident that Qsymia isn't causing cardiovascular problems, the issue was just one of many that they had with Qsymia. The first negative recommendation cited the potential for central nervous system effects associated with long-term use and birth defects in pregnant women.

For the most part, the EMA tends to be more stringent about safety issues than its U.S. counterpart because the EMA doesn't have the kind of post-approval regulation that the FDA has through its REMS program.

Quite frankly, if Arena Pharmaceuticals' (NASDAQ: ARNA  ) Belviq, which has a much milder side effect profile, couldn't get past the EMA, it seems unlikely that the Qsymia will be able to without extensive additional studies.

Orexigen might have the best chance of approval in the EU since it'll have cardiovascular data in hand when the CHMP reviews Contrave. Assuming, of course, that the data show no increase in cardiovascular issues.

Investor confidence
Honestly, I think this announcement has more to do with regaining investor confidence than VIVUS actually being worried about a long-term potential to gain approval in the EU.

VIVUS has undergone two management changes this year. Investors can't have all that much confidence that the biotech can turn things around quickly.

Sometimes, looking like you've got a plan is half the battle.

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Read/Post Comments (7) | Recommend This Article (3)

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  • Report this Comment On September 24, 2013, at 2:18 PM, gazoo99 wrote:

    Before....RSR, RSDriver, Driver, Dribble, ETC. spouts off again,

    Here are the facts, "DIRRECT" from VVUS.

    Approved by FDA, Obesity Drug Qsymia Rejected in Europe!

    A new obesity drug manufactured by Vivus, Inc., approved by the FDA for sale in the U.S. under the brand name Qsymia, has not received approval from a European drug regulatory agency.

    According to Vivus, the European Medicines Agency chose not to approve the drug, going by the name Qsiva overseas, because it contains the appetite suppressant phentermine, which in combination with other drugs has been linked to dangerous side effects in the past. Specifically, phentermine was combined with fenfluramine in diet drug “fen-phen,” which was recalled from both U.S. and European markets due to a high risk of side effects, including serious heart damage.

    Vivus Inc. (VVUS)’s obesity drug, approved in July in the U.S., failed for a second time to gain the backing of European regulators because of its potential side effects.

    The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended against approving Vivus’s pill in October because of concern about the long-term effects on the heart and nervous system. Vivus appealed, and the Mountain View, California-based company said today in a statement that its request was rejected.

    The agency, called CHMP, said Vivus must conduct a cardiovascular trial to show the drug, which would be called Qsiva in Europe, is safe before it could be approved.

    “We are disappointed with the CHMP decision regarding Qsiva and the position the committee adopted with respect to the need for a pre-approval cardiovascular outcomes trial,” Peter Tam, president of Vivus, said in the statement.

    First Manhattan still must deal with this, nothing has changed!

    NOW THAT SHOULD KEEP RSR QUIET.

    The facts "real ones" usually do!

  • Report this Comment On September 24, 2013, at 2:29 PM, AreaRich wrote:

    Phentermine is not currently approved in the EU. It has been around since 1957 and if that does not change then Qsymia certainly will not be approved.

    Simple as that.

  • Report this Comment On September 24, 2013, at 2:39 PM, WallSTcz wrote:

    There is a different culture and different rules apply for this sh*t "serotonergic drugs" by the ARNA etc. It's not a "healing therapy" and yet is serotonergic drug. So fat people take this pill for "depression"....with numerous side effects, to be able to lose weight? Crazy world :) This drug will not never approved in EU

    "Wallst" in EU 24.9.2013

  • Report this Comment On September 24, 2013, at 3:48 PM, RSRdriver wrote:

    Wall st, you have a better chance of explaining that to your dog! He is a lot smarter than the typical Areniac too!

    All anyone has to do is search 2C serotonin receptor drugs banned in Europe!

  • Report this Comment On September 24, 2013, at 6:59 PM, mrrock99 wrote:

    Is Dr. Quack writing this article or what? Really, comparing Q with Belviq's milder side-effects? Let's reflect on the EMA response about Belviq's withdrawl: Although a MODEST benefit in terms of weight loss was seen in the main studies, the Committee was concerned about the potential risk of tumours, particularly with long-term use, based on the results of laboratory tests. The CHMP also had other safety concerns, including the potential risk of psychiatric disorders (such as depression) and valvulopathy (problems with the heart valves), which were seen in some patients during the studies. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Belviq did not outweigh its risks.

    Let me recap, Belviq doesn't work well enough to were even a CVOT study could get it approved in the EU. But Qysmia with a good CVOT with input from the EMA will get approve. Watch Contrave results, that should give us the answers.

  • Report this Comment On September 24, 2013, at 9:12 PM, gazoo99 wrote:

    OOOHHHHH "Rockstar"

    You are SSSOOOOO wrong.

    Nothing new with either VVUS or OREX!!!!!!!!!

    All are old rehashed drugs.... nothing new, or "Novel"

    Go back to your guitars please!

    Recap all you want! Qysmia has a "closed door"

    in Europe because of "phentermine".

    It's BANNED IN THE EU!!!!!!!!!!!!!!!!

    How do you get by that when it's a primary component!!!!!!!!!!!!!!!!!!!!!!!!!!

    Can't wait to here that response "ROCKSTAR"

  • Report this Comment On September 24, 2013, at 11:11 PM, RSRdriver wrote:

    Some of you Areniacs really live for attention and a pat on the back from your fellow idiots.

    Who are you trying to impress besides yourselves. You do nothing but make fools out of yourselves at every opportunity.

    Someone should really dig deeper into how so many of you were rounded up and pointed in the direction of Belviq and Arena.

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