Actelion Gets PAH Exercise Claim

Long-time readers of Pharm Aid know of my interest in PAH – pulmonary arterial hypertension.  Today, there was a new development as the FDA approved Actelion Pharmaceutical’s sNDA application for Veletri (epoprostenol) for an “improved exercise capacity” claim.

"This is one example of our continued and long-term commitment to patients with pulmonary arterial hypertension," said Shal Jacobovitz, President of Actelion Pharmaceuticals US, Inc. "Second generation VELETRI provides patients and their caregivers a treatment option that allows patients to have more flexibility in their daily lives."

It’s not a NME for Actelion, but will provide added flexibility in the clinical routine and benefit patients who really struggle with the disease.

Source:  Actelion press release

MRI Birth Video

I found this video today and I thought this was pretty amazing.

The German hospital Charité University Hospital in Berlin captured the birth of a baby using an MRI.  The video shows the final moments of labor.  This video is stunning.

Supreme Court Upholds ACA

This morning, the U.S. Supreme Court issued their long-anticipated ruling on the Affordable Care Act (ACA; a.k.a. Obama-care), deciding that the main provisions of the ACA are constitutional and will go into effect.  Millions of Americans are shocked and millions are feeling smug.  As a bright person said this morning – America won, but Americans lost.

The healthcare industry has turned the corner on a major uncertainty that has been hanging over the U.S. healthcare system.  The elimination of that uncertainty will help thousands of physicians, providers and hospitals move forward.  Yet, this decision will also create new uncertainties.  ObamaCare, and specifically the individual mandate, is very unpopular with many Americans and is likely to embolden their efforts in November.

And now, the pundits are going to spend the next week blowing hot air.  Time for a vacation!

Let’s Make a Deal – User Fee Agreement Reached

It’s a sure sign that when politicians put politics out of the way, things can happen that are in the best interest of the country.  In true bipartisanship, both the House of Representatives and the Senate have now approved the “Food and Drug Administration Safety and Innovation Act.”  The bill goes to President Obama for signature.

The five-year deal generates billions in user fees for the FDA.  The fees will speed innovation, while also providing valuable funding for inspections of foreign facilities – many of which have been central to drug counterfeiting, some resulting in patient deaths.

President Obama has indicated he will sign the law.

J&J’s Woes Continue – Sale of Gynecare Prolift Vaginal Mesh Continued

In August 2007, the U.S. FDA ordered Johnson & Johnson’s Ethicon unit to stop selling its Gynecare Prolift vaginal mesh product until the agency had evaluated its equivalency to other marketed products (J&J’s Gynemesh was the reference product).  So, what are you to do as America’s most distressed pharmaceutical company?  You ignore the FDA order.

And that’s just what J&J did.  The company ignored the August 24, 2007 letter from the FDA.  The company ignored the 16 identified potential product deficiencies, and kept right on selling the device.

J&J’s Gynecare Prolift has been a mess for company.  The FDA has noted numerous instances of “organ perforation” – or punctured vaginas with the product.  If you’re a male senior leader sitting in New Brunswick, it may not seem like a big deal.  But it is.

Now, the men in New Brunswick sitting atop the glass ceiling feel they were justified.  Nearly 10 months later, the FDA did ultimately clear the vaginal mesh implants.  However, J&J clearly lost another important round in the court of public opinion – consumer’s faith in its products.

It’s worth noting that J&J faces over a 1,000 lawsuits of women who claim to have suffered perforated vaginas and other impairments as a result of the product.  Trial lawyer Adam Slater noted in an interview:  “If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it.  It’s egregious that J&J was selling the device without clearance.”  And that just about sums it up.

J&J’s corporate spokesperson Matthew Johnson has said:  “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.”

This looks like another big settlement that J&J’s shareholders get to pay for.

Source:  Bloomberg

When?

In Fort Washington, Pennsylvania, less than a mile from J&J’s shuttered McNeil plant, there’s a blue house that used to have a big sign on it that said, 'McNeil Has Ruined Our Lives.'  McNeil employees know the house - hundreds of them used to drive right by this house...or at least they did when the facility was operating and before the FDA's Consent Decree.  That sign has gone away and been replaced with a smaller one, black letters on a blood red background, that says simply, “When?”

And it’s a good question – When?  When will J&J’s senior leaders right the troubled ship?  When will J&J’s senior leaders start cleaning the middle management house – including problematic managers enthroned in the Weldon-era who have made multiple bad decisions, yet somehow linger to self-inflict more damage on the once-trusted company?  When will J&J’s Board realize the problems went far deeper than just William Weldon?  When?  Big questions.

Frankly, I’m surprised we’re still asking them.  If I were a betting man, I would have thought many of these issues would have been resolved.  Yes, J&J's share price is up (a little).  Yes, Weldon got spanked and sent packing at the last Shareholder meeting (with an embarassingly large parachute).  But the company is a mere shadow of its former glory - from the most trusted healthcare brand to the most tarnished.

It's a serious question for J&J's new CEO Alex Gorsky - when?

Pharma R&D Improving

A new report, the 2012 Pharmaceutical R&D Factbook, from Thomson Reuters says that pharma R&D may be (finally) improving.  According to their analysis, NMEs have soared to 31 launched in 2011, nearly double the rate from five years ago.

Many of the drugs were for significant medical issues like cancer, hepatitis C or lupus.  In 2011, the standout companies were Roche, BMS, GSK, Merck and Vertex.

Pharma’s still up against the patent cliff.  Last year, the industry generated record sales of $880 billion, but it can’t replace those sales fast enough as blockbusters go generic.  Even pharmaco’s getting into the generics game hasn’t slowed the erosion enough to make an impact.  This report should provide some amount of cautious optimism.

"The pharmaceutical industry touches all of our lives, whether directly or indirectly. Having insight into the drivers of the outcomes in Pharma R&D is critical in planning strategies and operational improvements," said Jon Brett-Harris, executive vice president, Thomson Reuters.  "This year's Factbook provides a unique view into the industry at a point when many pharma leaders are developing new strategies for growth. It unveils our thought-leaders' findings from extensive and proprietary data and is a valuable resource for clinical operations, project management, portfolio managers, licensing executives, venture capitalists, and pharmaceutical executives alike."

Link:  Thomson Reuters press release

Pfizer, BMS Get Complete Response on Eliquis

The last 7 days have been challenging for the blood thinner market.

Last week, the FDA put the breaks on J&J’s Xarelto and gave them an approvable on their risk prevention claims.  Now this week brings bad news for Pfizer and BMS’ Eliquis (apixaban).

Today, the FDA gave Pfizer and Bristol-Myers Squibb a complete response letter on their blood thinner Eliquis.  Good news is that the FDA is not looking for new trials, only clarifications on existing trials and data.  But it is still going to be a costly delay for both companies, which are already smarting from major patent expirations.

FDA Advisors To Meet on Hip Implants

Later this week, an FDA Advisory Committee will meet to look at metal-on-metal hip implants.  The devices, manufactured by Johnson & Johnson as well as Zimmer, have been plagued by high-failure rates, excessive numbers of replacement surgeries and also product recalls.  J&J’s DuPuy division has noted that nearly 1 in 7 of its devices failed.

One interesting outcome of the advisory committee meeting could be a recommendation for more use of medical imaging, namely MRIs.  This recommendation is at odds with current policy to diminish reimbursement rates for imaging and reduce utilization.  I’ll be curious to see what the advisory committee recommends here.

However, there are few scenarios that from this meeting that will not add additional fuel to the product litigation fires facing J&J’s DuPuy unit.

J&J's Best Product

Over the last two decades, it may well be that Johnson & Johnson's best product has been it's managers.  The company has developed rigid training and management programs that have created a cult-ish like conformity.  And that was a good thing when the company behaved ethically.  However, J&J's business model under William Weldon took a decidedly darker turn, and J&J managers were willing to cut corners for short-term profits and engage in legally-suspect behavior.  A mountain of FDA violations and court cases are the legacy of the culture that Weldon created at J&J.  However, J&J has also turned this into an export-industry.

Nobody is feeling that pain better than Avon Products.  Avon bought the J&J mystique and is paying the price.  When J&J passed over Sherilyn S. McCoy for the CEO role in favor of the more traditional male candidate, McCoy bolted.  She went to head up Avon Products and try to turn around the failing company.  And, to be fair, Avon was in deep trouble before Sherry McCoy showed up.

Prior to McCoy's arrival, the company announced The U.S. Securities and Exchange Commission was investigating its disclosures to analysts, resulting in the dismissal of the CFO.  Ouch.  Add to that a Foreign Corrupt Practices Act (FCPA) investigation and the company is in a world of trouble.  Double Ouch.  So Avon brought in McCoy as their Band-Aid to clean up the mess.  Unfortunately, things haven't gone smoothly since her arrival.  As I used to tell the kids - 'You don't hire the fox to watch the chickens.'

I've never met McCoy and I've got nothing against her personally.  She did an amazing job rising through the ranks at Johnson & Johnson and she recognized the potential elsewhere.  But now Avon's shareholders are paying the price.

To be fair, McCoy isn't the only "J&J export" to have run into trouble elsewhere, she's just the highest profile.

J&J Gets Complete Response on Xarelto

J&J’s Janssen division received a complete response from the FDA to its sNDA for Xarelto (rivaroxaban) for risk reduction in patients with acute coronary syndrome.  The agency was evaluating Xarelto as a clot-prevention measure individuals with acute coronary artery disease, which an increase the risk of heart attack.

The FDA based its decision on the recommendation of its advisory committee, which noted that some information was missing from the company’s supplemental new drug application.

“We will continue to work with the FDA to fully address their questions as quickly as possible,’’ said Paul Burton, vice president, J&J’s Janssen division.

Ref:  Janssen press release

Pfizer's Lyrica Gets Spinal Indication

Today, Pfizer announced the FDA has approved Lyrica (pregabalin) for pain associated with spinal cord injury.  More than 100,000 U.S. patients with spinal cord injuries suffer from neuropathic pain and, to date, lack an adaquate treatment for their injuries.

"Until now, no FDA approved treatment options were available in the U.S. for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling," said Steven J. Romano, MD, senior vice president and head, medicines development group, Global Primary Care Business Unit, Pfizer. "The approval of Lyrica for this indication is a significant milestone, exemplifying Pfizer's commitment to pursue scientific advancements that address unmet medical needs."

Pfizer's stock (PFE) is down 0.26% in pre-market trading.

Families USA Study Fabrication

A new pseudo-study by Families USA and timed beat the Supreme Court to the punch, finds that over 26,000 Americans die as a result of not having health insurance.  But is it true?  Turns out its a fabrication.

The fact checkers at Forbes looked into it and the "bad data" that Families USA used to generate the sensational headlines is nearly 20 years old.  It's true.  Don't believe me?  Look up the methodology on the "DYING FOR COVERAGE:  The Deadly Consequences of Being Uninsured" report on the Families USA website.  Families USA is claiming their pseudo-study has the same pedigree as the IOM report, but differences exist.

The Families USA "estimate" is as grounded in the real world as an estimate of ZERO patient deaths or a billion patient deaths.  An estimate based on nothing is worth nothing - but nothing will get you sensational media headlines.  And Families USA is definitely trying to get headlines.  The group issued numerous press releases in States with key elections (namely, races where Democratic candidates who favored the Accountable Care Act, but are running very poorly in the polls).

In the press releases issued by Families USA, their leader Ron Pollack noted:  “The Affordable Care Act lets us wake up from this terrible health care nightmare of premature death. Wiping out health reform means the nightmare will continue for [insert state name] and other Americans.”  It's everything we've come to expect from a Ron Pollack initiative - lots of unsubstantiated claims and half-truths, and heavy on the partisan rhetoric.

In other words, this is a meaningless estimate made for political purposes by a partisan organization who backed a piece of legislation that the majority of Americans detest and they needed to fabricate a "study" to try and back it.  And that basically sums up Families USA.

Countdown to the Supreme Court Decision

The Supreme Court has just two weeks to announce its decision on the Accountable Care Act (ACA; aka ObamaCare).  No single piece of legislation has been more hyped and more vilified in the last 50 years.  Proponents of government health care say the law didn't go far enough and Obama lacked backbone.  Opponents have been critical of...well...everything.

But now, The Supremes are going to tell us whether it stands and how much will stand.

This hasn't stopped a flood of vendors from sending out spam e-mails assuring us all, "No matter what The Supreme Court decides, we're here to help you navigate troubled waters."  Vomit.

That said, I applaud The Supreme Court for wading into this tough issue.  And I give thanks to the Founding Fathers for giving us government with checks on power.

J&J Searches for Redemption with Synthes

J&J's still searching for redemption and its hoping Synthes is the ticket.  Although the $19.7 billion acquisition, which got the greelight today, is raising eyebrows for its tax evasion methodology.  J&J is hoping to add 3-5 cents per share to its 2012 earnings, reducing the impact of its OTC product mess.

J&J will buy Synthes via an Irish subsidiary, so it can buy the firm with funds that haven't been repatriated and avoiding U.S. taxes.

The Synthes acquisition makes sense for J&J, but we've spent so long by being disappointed by J&J, it's like waiting for the other shoe to drop.

GE’s (Almost) Alzheimer’s Agreement

Yesterday, GE announced a major research initiative with the Australian Commonwealth Scientific and Industrial Research Organization for its investigational PET imaging agent [18F]Flutemetamol.  Only….here’s the thing…it looks like there isn’t actually an agreement.

GE issued their press release on June 11.  Approx. 23 hours later, GE issued a full kill and retraction of the announcement.  The retraction from the vendor BusinessWire noted:
“GE Healthcare requests that their press release NewsItemId: 20120611005522 (issued June 11, 2012) entitled ‘GE Healthcare Furthers Research and Development Efforts in Alzheimer’s Disease with Australian Government Partnership’ be killed.  The release was issued prematurely by GE Healthcare.”

One can come to one of two possible conclusions.  First, Flutemetamol is encountering significant headwinds in the trial process.  This is probably the case.  Last year, GE’s Ger Brophy made a lot of strong claims about Flutemetamol and GE has become very silent recently about Flutemetamol.  Second, this press release was a big “oops” and there never was an agreement with the Australian government.  One has to wonder if heads will roll over this and if this was a mistake by Aleisia Gibson or someone else.

TEDMED 2013

Back in April, I attended TEDMED 2013 in Washington, DC.  Unlike previous TEDMEDs in San Diego, this one had a different focus and a changed format.  The venue of the Kennedy Center was spectacularly beautiful, but the content was much weaker than past TEDMEDs.  There was more of a focus on entertain and less of a focus on the vibrant, rich, scientific innovations that we’ve seen from past TEDMEDs.  Hopefully, they can iron out the kinks for future TEDMEDs.