web analytics

Allergan’s Botox, Ackman, Johnson & Johnson’s Mentor’s PurTox: Case Study Timeline

Allergan’s Botox, Ackman, Johnson & Johnson’s Mentor’s PurTox: Case Study Timeline

May 7, 2017

UPDATED:  Johnson & Johnson’s Mentor has a side deal with Valeant which could create a monopoly!

Fact-based evidence over time is a good indicator of the future-now let’s look at what we know as fact and apply that to what we predict could happen in the Allergan/Botox sale.  This is not 100% accurate by any means, but it’s a fun way to see if what we’ve been learning about PR Spin, the trends we’ve followed successfully are being applied correctly; and, in the event they’re not applied correctly we can see where errors were made to learn for the next Case Study.  Remember any information is good information it’s what we choose to do with it.

Johnson & Johnson logo final

Case Study Players:

Allergan’s Botox

Johnson & Johnson’s Mentor’s PurTox,

Johnson & Johnson& Ethicon’s Gynecare’s Transvaginal Mesh Trials overactive bladder

FDA Approval of Botox for overactive bladder

Johnson & Johnson’s Mentor’s possible decision to “piggyback’ PurTox bladder indication off of Allergan’s Botox (and possible denial from the FDA), and then decision to abandon PurTox

Speculation Johnson & Johnson announced the abandonment of PurTox too early suspecting they’d already secured the sale of Allergan/Botox.

The announcement of take-over Allergan (10% ownership by Ackman’s fund Pershing Square Capital Management) by Valeant seen as a pawn in a game.

Ackman introduced to Valeant by former Johnson & Johnson executive

Why would Johnson & Johnson’s Mentor abandon PurTox after spending so much money on the purchase and when results were going well which would allow them to compete in an over $2 billion market; and, the possible new market of overactive bladder? 

TIMELINE:

December 2008 PurTox

Johnson & Johnson spent $1.07 billion in cash to buy Mentor Corp., a supplier of breast implants and other cosmetic products, of which was PurTox a neurotoxin set to compete with Allergan’s Botox in a $2 billion industry.

February 2009 Purtox

The South Beach Symposium Dr. Otto Joseph Placik mentioned talk of the “soon to be approved ” Mentor product (PurTox) but no one (we’ll presume the information came from the company) had an accurate estimate. (that’s a bit of an understatement upon reflection).  Reps are often instructed by the companies to get the providers excited prior to launch.

Sometime in 2010 Purtox

Purtox anticipating FDA-approval as soon as 2010

July 2011 Purtox

One of the keynote speakers at the Aesthetic Plastic Surgery Symposium, Dr. Brian Kinney, assistant professor of plastic surgery at USC in Los Angeles and renowned reconstructive plastic surgeon, was one of the 12 investigational sites that just completed the Phase 3 FDA clinical trials for PurTox.

 “We moved into the phase 3C clinical trials with six or seven hundred patients in 12 different centers,” as Dr. Kinney describes the final FDA tests for PurTox“We completed that patient study in March and April (2011). It was a three year study and the best study I’ve ever done on patients. People love it.”

Late 2012 PurTox

Early results have been favorable however, PurTox will not be available in the U.S. until late 2012.

January 2013

Johnson & Johnson’s Mentor’s PurTox

Johnson & Johnson’s Ethicon’s Gynecare Transvaginal Mesh lawsuits pelvic floor/overactive bladder

and is a competitor to:

 Allergan’s Botox’s NEW FDA approval for overactive bladder.

Federally, more than 22,000 filed against GyneCare a subsidiary of Ethicon a subsidiary of Johnson & Johnson (that’s over half of the total 40,000 cases filed to date with 3,000 cases still added monthly)and products include:

  • Ethicon TVT
  • Gynecare TVT
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch
  • Secur

Johnson & Johnson’s Mentor planned to submit PurTox for approval by the end of the year after working through  “some regulatory issues.”  It is not uncommon for a company to try and ‘piggyback’ off  of another company’s indications. The FDA will often find that since the study was successfully done for one product and if two products prove to be similar enough they the second to gain clearance for their products.  We don’t know if that’s the case here or not but it would not be unlikely.  Folks in the industry please weigh in! 

FDA approves Allergan’s Botox to treat overactive bladder

April 2014 Johnson & Johnson’s Mentor’s PurTox

“After careful consideration, our Mentor business has decided to discontinue its neurotoxin program, commonly known as PurTox, in order to focus on its core breast surgery business, where we are an established leader and see greater opportunities to benefit patients and grow our business,” J&J spokesman Thomas Sanford said in an emailed statement.

What does all of this really mean?

We suspect Johnson & Johnson’s Mentor’s Purtox was going to try and ‘piggyback’ off of Allergan’s Botox’s FDA approval for overactive bladder and was denied.

In short:  The 22,000 transvaginal mesh cases are a huge problem that’s not going away for Johnson & Johnson’s, Ethicon’s, Gynecare anytime soon especially since an additional 3,000 cases are still being added monthly.  Allergan’s Botox is what appears to be a safer competitive solution to mesh.  IF Johnson & Johnson assumed they would automatically get the same indication as Allergan’s Botox for overactive bladder for Mentor’s PurTox and were denied by the FDA, it would reasonably explain why after careful consideration they decided to discontinue the quest for FDA approval of PurTox.  EVEN MORE SO IF Johnson & Johnson had prematurely showed their PurTox hand, aware that Allergan/Botox was for sale and thought they had already won the sale uncontested.  The Street:   According to people familiar with the situation, the groundwork for Ackman’s Trojan horse stake in Allergan was laid when a former Johnson & Johnson (JNJ_) executive introduced the hedge fund manager to Valeant.  Isn’t it also possible the same former Johnson & Johnson executive helped Ackman enter into talks with Johnson & Johnson as well?

The Wildcard Johnson & Johnson wasn’t counting on?  Possibly getting beat at their own game by ACKMAN

IF Ackman was insulted by Johnson & Johnson’s possible offer it’s possible Ackman’s fundPershing Square Capital Management, which acquired a 9.7% Allergan stake for $3.2 billion, used Valeant to send a message to Johnson & Johnson, and if Allergan sells it will be at least for double the $47 billion, reacted unfavorably to their offer and opened up the bidding to prove a point.  

The Hypothesis:

We predict Allergan will sell to Johnson & Johnson for around $100 billion.

No Comments

Post a Comment