PDUFADate.com

This past week, the FDA told Santarus, Inc. that it was extending the review period for their ulcerative colitis drug UCERIS by 3 months.  The FDA extended the PDUFA Date to January 16, 2013 because they need more time to complete the review.

I usually don’t comment on share price or share price moves but I’m making an exception here.  The stock dipped on this news.  I can’t figure these things out.  It might not be negative news.  I don’t think the FDA has a mind set that says “This application won’t be approved but we need more time to review the bad data”.  I think the contrary holds.  If the FDA sees some merit in an application, it will take the extra time to support the approval.  There is still a PDUFA report card and extending the review period for a drug that will eventually be rejected doesn’t make sense.

Those of you who read our Special Report on Diet Drugs got a heads up on both the extension of the QNEXA PDUFA Date and the easy time that LORQESS had with the FDA Advisory Committee last week.  But now it’s crunch time and the folks at Vivus and Arena Pharmaceuticals are supplementing their diets with fingernail sandwiches.  Arena has the shorter wait at this time, June 27, 2012 is still their PDUFA Date for LORQESS.  By virtue of the extension, Vivus has to wait until July 26, 2012.

Neither the FDA nor the Advisory Committees have questioned the efficacy of either drug.  Neither set of reviewers have tried to say one is more efficacious than the other.  I agree and would call them equally efficacious.

Both drugs have reported or perceived cardiovascular side effects.  According to the Advisory Committee earlier this year, such drugs should be required to have cardiovascular studies performed before approval.  However, both drugs were submitted for approval and under review when the recommendation, and it is only a recommendation, by the Advisory Committee was made.  That being said, the FDA has a certain degree of leeway in forcing this requirement as an approval requirement.  In my opinion, the FDA will give both companies a break and allow the required study to be done as a condition of approval.  It will be the most closely watched event since the OJ trial.  One might think that QNEXA has the leg up on this because they went to the Advisory Committee first, but in this case, one would be wrong.  Both companies got the information at the same time – from listening to the Advisory Committee live and in person.  Who has the edge on having the protocol in final form?  I don’t know and neither does anyone else except maybe the FDA and I heard they ain’t talking.

FDA doesn’t have to talk about the cardiovascular protocol race because the race isn’t about the cardiovascular side effects, its about the teratogenicity risk.  FDA is breathing a sigh of relief with the data from Arena and the positive vote from the Advisory Committee for LORQESS.  The pressure is off – they have a viable diet drug alternative to QNEXA to satisfy those screaming for a new drug.  And they have an alternative that is not a teratogen.  Even if LORQESS gets an extension of the PDUFA Date from FDA to tidy up their cardiovascular study protocol, they will still be ahead of Vivus who has a somewhat longer struggle with the teratogencity issue.

Correction to this Post.  

The comments from our previous post earlier today may have been misunderstood.  The post may be incorrectly giving investors the impression that Navidea Biopharmaceuticals, Inc. has not been given an “official” PDUFA date.  They have indeed been given a firm PDUFA date.  That date per the FDA’s official correspondence to the Company is June 10, 2012.  This is the date they have disclosed in their press releases and SEC filings and it is official.  However, as previously noted,  June 10th is a Sunday.  It is understood that  is that this date is calculated based on 10 months from the date the NDA was accepted, August 10, 2011.  As far as the actual “date”, it is unclear in this case since the PDUFA date falls on a Sunday whether or not the FDA would communicate the NDA status to Navidea before the weekend or on the next business day.

Original Post: Brent Larson, CFO of Navidea Biopharmaceuticals, Inc. (NAVB), told me today that they have not yet received a firm date from the FDA for the company’s PDUFA Date regarding Lymphoseek (Tilmanocept).  There has been confusion because the FDA issued a June 10, 2012 date in a letter to the company.  This date has been used in company press releases and its Form 10-k.

June 10, 2012 is a Sunday.

The company is hoping the actual PDUFA Date is close to the original date provided by the FDA. Past experience has shown the probable PDUFA Date will be the Friday before the intended date.

Last month, the FDA Advisory Committee recommended approval for the HGSI/GSK drug BENLYSTA for the treatment of lupus, the first new treatment for lupus to come down the road in decades. We pointed out the difficulties the FDA would have with conveying the safety and efficacy information into a meaningful package insert.  The Committee either looked beyond that or thought the regulatory obstacles facing the FDA as they try to write the package insert could be easily overcome.  While we provided some wording suggestions at the time, we don’t think the FDA can resolve this issue in a timely manner, certainly not before the PDUFA Date of December 9, 2010 unless HGS and GSK both want this approval so badly that they roll over with a very restrictive package insert.

October 11, 2010 is the PDUFA Date for Alexza Pharmaceuticals STACCATO loxapine, an inhalation formulation of loxapine intended for rapid treatment of schizophrenia and bipolar disorders.  The company reports that this is the first NDA that it has submitted using the STACCATO inhalation technology.  Phase III clinical studies are reported as having been submitted that support both indications but few details are available other than reports that both primary and secondary endpoints were met.  Getting approval for both indications using new technology seems like a bit of a hurdle for a company that is submitting its first NDA.

October 3, 2010 is the scheduled PDUFA Date for Javelin Pharmaceuticals DYLOJECT for the management of post operative pain.  The company has been silent on any actions that may have been taking place with the FDA on this submission.  One possible source of a delay on the approval of this application could be gaining assurance that the problems that led to the withdrawal of the product in the UK earlier this year are not potential problems in the US.

October 4, 2010 is the PDUFA Date for the Human Genome Sciences product ZALBIN for hepititis C.  We’ve not seen anything since the company announced that it had received a Discipline Review letter from the FDA on June 6, 2010.  The FDA cited Benefit/Risk issues for the dosing regimen.  The company indicated at that time that they thought licensure was unlikely.

The PDUFA Date for GILENIA (fingolimod) is September 21, 2010.  This Novartis drug for the treatment of multiple sclerosis was reviewed by the FDA’s Advisory Committee in June of this year and received an overwhelmingly positive endorsement.  There is little reason to believe that the FDA won’t be concurring with the Committee’s recommendation and approving this drug.

September 14, 2010 is the PDUFA Date that’s been set for Savient’s KRYSTEXXA (pegloticase) which has been submitted for the treatment of gout.  The BLA was resubmitted earlier this year after receiving a Complete Response Letter last summer which highlighted a number of manufacturing deficiencies.  The company met with the FDA and agreed on a way forward that resulted in the resubmission which addressed the manufacturing issues but also included a safety update from their clinical trial data base.  The company recently announced that it had submitted the final stability update on July 28, 2010.

It all looks good on paper.  There’s lots of articles out there providing the safety and efficacy data from a lot of the clinical trials.  The company has met with the FDA and provided a resubmission of the requested manufacturing information.  So, why doesn’t it feel good to us?  We don’t really know for sure but with all of the problems that we’ve seen with recalls for manufacturing related issues and the growing list of products that are in short supply because of these problems, it just follows that the FDA chemistry reviewers and the inspectors just might be spending their time elsewhere.  It is a close call but we wouldn’t be surprised to see a 3 month delay on this PDUFA Date to allow the FDA some breathing room.