The IN VIVO Blog

Waxman With A Zinger!

noreply@blogger.com (Ramsey Baghdadi) — Thu, 24 Jul 2008 17:45:00 +0000

There's clearly no love lost between House Oversight and Government Reforms Committee Chairman Henry Waxman (D-Calif) and North Carolina Republican Patrick McHenry.

But Waxman outclevered the more junior Republican this afternoon at the Medicare Part D hearing. During friendly questioning of Acting CMS Administrator Kerry Weems, McHenry was making the point that no way could you trust the government to negotiate better prices for drugs under Part D compared to the private sector.

"There are some shortcomings to the program, it's a government program, that's what government does very well, right? Inefficiency is what government does very well," McHenry said of the Part D program.

Weems answered the eventual question on negotiating savings.

Waxman waited until the end of Weems' testimony and then hit the audience with this one-liner:

"Thank you, Mr. McHenry. Mr. Weems, thank you very much for your participation, I know you're anxious to get back to the work that government bureaucracies do so poorly, according to our friends on the other side of the aisle, but I salute you for the work that you do," Waxman said with a smile.

Zinger Zam!

Chairman Waxman will be here all week, folks.

Taking Apart Part D: A Preview of 2009

noreply@blogger.com (Ramsey Baghdadi) — Thu, 24 Jul 2008 14:22:00 +0000

That was fast.

House Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.) didn't wait long to call out specific pharmaceutical companies at a major hearing on the Medicare Part D drug program.

Early in his opening statement, Waxman cited Johnson & Johnson and Bristol-Myers Squibb for the windfall profits they have made off the Part D program due to the switch of dual-eligible Medicaid patients over to Medicare.

"Johnson and Johnson earned over $500 million in additional profits, much of it from just one drug, the anti-psychotic medication Risperdal. Bristol Myers earned a windfall of almost $400 million, thanks to higher prices for the stroke medication Plavix," Waxman alleged.

He continued: "This is an enormous giveaway. And it has absolutely no justification. The drug companies are making the same drugs. They are being used by the same beneficiaries. Yet because the drugs are being bought through Medicare Part D instead of Medicaid, the prices paid by the taxpayers have ballooned by billions of dollars."

This was after he said the government was paying 30% more for the 6 million dual eligibles under Medicare than they paid under Medicaid.

Ranking Virginia Republican Tom Davis quickly noted that there are many drugs not available under Medicaid because of more stringent pharmacy rules. Gerard Anderson, director of the Center for Hospital Finance and Management, Bloomberg School of Public Health, Johns Hopkins University, disagreed, saying the Medicaid formulary is quite open, with a wide breadth of offerings. Davis didn't let up, pointing out that you can't fill as many prescriptions at the pharmacy under Medicaid.

Stephen Schondelmeyer, head of the Department of Pharmaceutical Care and Health Systems, University of Minnesota, waded into the numbers. States spent $43 billion in Medicaid spending in 2005. That number was cut almost in half in 2006 to $21 billion after the duals were switched to Medicare, so money was switched out of the state system, according to Schondelmeyer.

He noted that 18% to 19% of that Medicaid spending came back to states in the form of rebates. But the numbers are actually quite higher, he said. Individual states can negotiate further rebates under a supplemental law and many states are successful in getting larger rebates. Schondelmeyer cited rebates of 20%-21% between 2000-2003; 24% in 2004; and 28.8% in 2005. The University of Minnesota researcher said the Centers for Medicare and Medicaid Services has not released data for 2006 and 2007, but he estimates the rebates come in at 30% to 31%. A report released by Waxman late last year showed Part D was generating rebates of about 8%. A new report by the majority staff released today shows Part D rebates for 2007 had gone up to 14%, but still well below what the states can secure. To read the report, click here. There's a lot more to delve into.

In other words, even at 14%, states are able to negotiate more than double the rebates the government is getting under Part D.

Anderson made three major recommendations: 1) Greater Part D price transparency; 2) Drug pricing data should be readily available and accessible; and 3) All government agencies should be paying the same price for drugs.

Hmmmm. The drug and insurance industries aren't faring too well in the first part of this hearing. So what's the take home message? Expect even more of these types of hearings in 2009 and get to know the names of the witnesses who are testifying today. To see the list, click here. It's almost identical to the witness list at a Senate Finance Committee and prior House Oversight hearings in early 2007. In other words, these are the experts who Democratic lawmakers will be calling upon for advice and guidance when crafting policy.

How to Spend $44 Billion: Suggestions for Roche

noreply@blogger.com (Michael McCaughan) — Thu, 24 Jul 2008 13:49:00 +0000

We've given you our thoughts on why Roche wants to spend so much money ($43.7 billion to be exact) to buy out Genentech, a company it already controls. Of course, a key part of analyzing the deal is to consider other ways Roche could spend the money. So, herewith, we start a recurring discussion:

How else could Roche spend $44 billion?

A few initial ideas to get your creative juices going...

(1) Buy Bristol-Myers Squibb instead (current market cap=$44 billion). Why not get access to oncology/specialty products you don't already own?

(2) Buy Genzyme and Celgene (combined market cap=$50 billion). Two for the price of one!

(3) Buy majority stakes in Genzyme, Celgene, Biogen Idec, and a dozen small-to-mid-cap biotechs. If, as we keep insisting, the Genentech relationship was the most successful partnership in the history of the industry, why not repeat it on a grand scale?

(4) Buy Fannie Mae and Freddie Mac. Roche is a banker, after all, and these two depressed assets are surely a good value. Best of all (believe it or not) Roche could buy them both and still have over $20 billion left to shore up their cash reserves. America is saved!

(5) But a $16 Terrace Level ticket for dollar dog night at Citizen's Bank Park. Take in the Phillies vs. Marlins in a critical September showdown. Purchase 43,699,999,983 hotdogs. Tip the guy a buck.

How PhRMA’s Marketing Code Sells Itself

noreply@blogger.com (Michael McCaughan) — Thu, 24 Jul 2008 13:27:00 +0000

When it comes to marketing, packaging counts.

That also seems to be the case with marketing guidelines--at least, with the revised Code on Interactions with Healthcare Professionals from the Pharmaceutical Research and Manufacturers of America.

We've written a lot already about what the substantive changes to the code itself means, including its compliance mechanism, and new limits on pens, meals, speakers and CME. We’ve even offered three easy steps companies can take next to achieve a utopian future.

But beyond the message PhRMA is sending though the content of the code, there’s the image the association is projecting through the formatting of document itself. The precepts in the revised code are basically a progression from the 2002 code, but the layout is stunningly different.
The most obvious change to the code’s formatting is the color palette and design motifs. The blocks of black and red had been replaced by blues and grays in spiral patterns. What do those changes mean?

Well, we asked some of our designers their opinions. Overall, the design of the 2002 code is “forceful” and intense, they tell us, while the 2008 code is relaxed, though still “peppy.”

The new document also tones down PhRMA’s self branding. In the old version, the association’s acronym was the biggest thing on the cover page, and it towered over every question in the Q&A section. In contrast, the PhRMA logo only appears three times in the new version. Those changes may reflect an industry that now feels its size and strength make it a target for criticism. Blue is also a “loyalty color,” we are told, and the new code may in fact be bathed in Patone’s “Dispense As Written Azul.” The 2008 version also boasts a table of contents – how’s that for transparency?

Another formatting change may be evidence of industry belt tightening. Even though it contains more words, the page count of the 2008 code is 36 pages, while the old one weighed in at 58. Like marketing departments everywhere, it’s doing more with less.

Despite the reduced page count, the text in the revised version is larger and more readable than the previous version, but it uses a sans-serif font. While clean and easy to look at, a sans-serif font (like Helvetica) does not fit with the eye the way a serif font (like Times) does. According to the experts, when reading large amounts of text, people are better able to absorb it if it comes with the complex features at the tops and bottoms of the character strokes.

If that’s not an endorsement of industry’s shift towards biotech products, we don’t know what is.

– M. Nielsen Hobbs

For Amgen's Nplate, No News is Good News

noreply@blogger.com (Kate Rawson) — Thu, 24 Jul 2008 13:00:00 +0000

In case you didn’t have it circled on your calendar, July 23 was the user fee deadline for Amgen’s romiplostim (Nplate). And according to Amgen, FDA didn’t pick up the phone yesterday with a final answer on the platelet drug.

Without delving into specifics, Amgen says it was told by FDA that the agency will miss Nplate’s Prescription Drug User Fee Act deadline. The company says it is “optimistic that a final decision will be made soon,” but wouldn't speculate on exactly when the agency will be making an approval decision.

Maybe Amgen won’t speculate, but we will. We think the delay is actually good news for Nplate, and signals that—barring any last-minute surprises—an approval is just around the corner.

Simply put, if FDA weren’t pretty confident of the approvability of Nplate, it would have issued an “approvable” letter outlining its concerns with the BLA. Amgen would need to address FDA’s questions, submit a response and wait to hear back. (We should note that starting August 11, FDA will start sending "complete response" letters for all rejections.)

In this case, the review group is taking advantage of a new policy giving them the discretion to miss PDUFA deadlines. And it is fairly easy to see why the final review might take a bit longer than expected: Nplate will have a mandatory Risk Evaluation & Mitigation Strategy, or REMS, a new feature of the regulatory process created by legislation enacted last year. FDA is setting precedents with every REMS, and the agency has already extended or missed several deadlines for products covered by that authority.

There is a major caveat: when it comes to drug time lines, industry is treading in somewhat unknown territory these days. So while past history would suggest that a missed deadline would mean that approval is imminent, there is always a chance that the agency will let the application hang for a while.

That is certainly happening with FDA’s Cardio-Renal division, which has missed user fee dates for at least three NMEs this year: two anti-arrhythmics—Cardiome/Astellas’ vernakalant (Kynapid) and Solvay’s tedisamil (Pulzium)—and The Medicines Company’s clevidipine (Cleviprex) for acute hypertension.

But the oncology group has no history of letting applications linger. Quite the opposite: FDA doesn't always approve applications for cancer and related therapies, but it almost always acts quickly.

One thing is clear: as last week's slip-up by Business Wire illustrates, Amgen is ready to issue the approval press release whenever FDA is.

Roche-Genentech: A Defensive Play on Follow-On Biologics

noreply@blogger.com (Kate Rawson) — Wed, 23 Jul 2008 14:55:00 +0000

If a generic competitor was waiting in the wings with an improved version of Genentech’s Avastin, how much less would the company be worth in the eyes of Roche?

Probably a lot, you’d say. Probably a lot less than $44 billion, which as everyone on the planet knows by now, is what Roche bid to acquire the remaining 44% of Genentech earlier this week.

We’re not suggesting there is anyone waiting in the wings to undercut Avastin at this very moment. And when it comes to analyzing Roche-Genentech, FOBs probably isn’t the first thing that jumps to mind. (Which is why, incidentally, we’ve already blogged on the deal here and here. And why we’re planning all kinds of great coverage in this week’s issue of “The Pink Sheet.”)

Indeed, there are lots of other questions: Does Roche’s price justify the quality of the R&D portfolio it would acquire? Is the timing of the deal more about financial strategy than innovation, as Roche claims? And does any of that matter if the acquisition results in a massive walkout in South San Francisco?

But given where follow-on biologics are headed these days—and how much money is at stake for a company like Genentech—the impact of follow-on biologics on the timing of the deal is worth considering. So here’s our take:

There’s no doubt these are hard times for pharmaceutical companies—low approval rates, a stalled R&D engine, payor pressure and the risk of health care reform. And while that’s hit across Big Pharma and Big Biotech, biotechnology companies have enjoyed one major upside: infinite product exclusivity.

That honeymoon is about to be over.

We’re just not talking about Congress authorizing a regulatory pathway for follow-on biologics. Or even competition from generic companies. The biggest threat to the biologics industry may come from within Big Pharma itself—a group that is incredibly experienced in manufacturing products, has money to invest, and is desperate for a few more dollars on the bottom line.

As we’ve written in The RPM Report, Big Pharma companies haven’t been shy about their interest in developing “me-betters” that get around IP issues with existing follow-on biologics.

Indeed, some of the biggest names in Big Pharma have acquired technology platforms that could be used create ther own versions of existing large molecules: GSK (Domantis); Bristol (Adnexus); Wyeth (Haptogen); and Teva (Cogenesys). And some executives (like JP Garnier and Jeff Kindler) have acknowledged plans to do just that.

So what does that all have to do with Roche-Genentech?

It’s clear FOBs are a major threat to biologics IP. Even if Congress doesn’t pass legislation authorizing a follow-on biologics pathway, FDA will continue to approve “me-too” large molecules on a case-by-case basis. And if the technology platforms Big Pharma has been snapping up lately is any indication, we’ll start to see the March Of The “Me-Better” Biologics—and the pricing pressure that follows.

For Roche, staying ahead of that curve means finding a way to make biologics faster and cheaper. And the best way to do that is through post-merger synergies. So contrary to the message Roche is sending to investors, the timing of the deal probably has less to do with “innovation” and more to do with squeezing out savings.

At the very least, it’s another sign that that Big Pharma companies are thinking about follow-on biologics in dealmaking—either by acquiring companies with the technology to make me-betters, or by positioning themselves in a way to compete with any competing large molecules that may come down the pike.

It's one more pressure that will make biologics less profitable in the long run—and one more reason for Roche to head it off at the pass. Genentech created Roche’s pipeline—and propelled the company to the number-one growth stock despite what is arguably the worst R&D in the industry. Now it needs to protect that investment.

Next Steps for PhRMA and Marketing (Part 3): Let the Sunshine In

noreply@blogger.com (Michael McCaughan) — Wed, 23 Jul 2008 14:00:00 +0000

Concluding our series of proposals for pharmaceutical marketing to reclaim the high ground. We've already suggested re-defining the mission and combining the Pharmaceutical Research & Manufacturers of America's various codes of conduct.

Today, step three: Let the Sunshine In

“Transparency” is now everybody’s favorite buzzword in Big Pharma. Merck CEO Richard Clark urged his colleagues to embrace the call to "create transparency" during his inaugural address as chairman of PhRMA.

Indeed, the immediate impetus for PhRMA’s effort to update the marketing code came when Congress got serious about pushing “sunshine” legislation. (And the Code is already a success, since that initiative did not make it into law this year.)

The problem with transparency: by definition, you can’t see it. Obstruction you can see. Transparency is invisible.

Since the calls for transparency are motivated fundamentally by mistrust of industry, how will the public (or at least its elected representatives) ever be satisfied that industry is in fact being transparent? Put another way, if industry chooses to hold anything back—for competitive reasons or otherwise—why wouldn’t the assumption continue to be that some ugly truth is being hidden away?

Our suggestion: invite the public in to those conversations. Every pharma company should appoint a transparency committee, a group of independent outsiders--preferably well-known critics. The transparency committee (though we prefer the name "sunshine band") would have carte blanche to review anything and everything related to the company's procedures on information disclosure. They would be empowered to make recommendations that the company would be obliged to respond to. (Not necessarily implement--but at least acknowledge and explain a decision not to implement.)

The transparency committee should report directly to the board—or even better, to a central transparency committee convened by PhRMA. We even have the perfect chairman: Cleveland Clinic Cardiologist Steve Nissen. (He may have bigger plans for his career that rule him out, but still.)

Nissen is a particularly articulate critic of industry on issues like publication bias and clinical trial result reporting. But he is also a clinical investigator and an experienced author of academic research, so he understands the importance of protecting information as well.

That whole idea may sound crazy, but give us a second, we're just getting warmed up.

Industry could go yet one step further than letting its critics shape disclosure policies: it could ask them to review and approve its marketing plans in the first place. Now we know this sounds crazy. Pharma companies went ballistic over a provision in an early draft of the FDA Amendments Act that would have explicitly authorized FDA to review a company’s marketing plan in the context of assessing a proposed Risk Evaluation & Mitigation Strategy.

That provision came out--but the spirit lives on. In fact, we would argue that a suitably motivated FDA can and will demand access to marketing plans for drugs under the REMS authority. And even if FDA doesn't push that way on its own, the fact that Congress thought about it once means it is likely to come up again later.

More to the point: industry says marketing is about delivering valuable scientific information to doctors and patients. It is about education. So why not ask those being educated to review and respond to the curriculum? Who knows, they might even get excited about the new medicine...

Enough opining from us. What do you think?

Next Steps for PhRMA and Marketing (Part 2): Combine the Codes

noreply@blogger.com (Michael McCaughan) — Tue, 22 Jul 2008 14:00:00 +0000

Continuing our free advice for Big Pharma marketing groups on ways to reclaim the high ground. (And yes, you do get what you pay for...)

Yesterday, we suggested a new mission statement for marketing.

Today, step two: Combine the Codes

PhRMA has statements of principle governing professional promotion, direct-to-consumer advertising and clinical trial disclosure. But industry’s critics do not see them as separate issues. Neither should industry.

Let's start with the two "marketing" codes, one for DTC and one for interactions with physicians. It is easy to see why there are two: there are very real differences in the regulatory oversight of DTC and professional promotion, reflecting the fact that DTC is a "new" phenomenon (at least in the sense of broadcast television ads), while sales reps calling on doctors is a venerable industry institution.

But when it comes to defending marketing in the political realm, it is silly to try to differentiate. Indeed, association CEO Billy Tauzin acknowedges that many of the public perception issues facing the industry require addressing both DTC and professional promotion. So PhRMA is upgrading its principles of consumer advertising too.

In an era when informed patients often know more about their medical conditions than the physicians who treat them, it is also absurd to argue that there is a fundamental need to craft different messages based on who has the MD. (Different messages based on knowledge level yes, but sometimes that means dumbing it down for the docs and engaging more scientifically with patients.)

We might also highlight the danger for industry if doctors—not the biggest fans of DTC in the first place—begin to really get upset about it now that they spend more time in front of the TV and less time at industry sponsored dinners.

Updating the DTC code is a nice first step. But PhRMA and its members should go further. In age when Big Pharma is rethinking everything (or should be), it is time to challenge the mindset that professional marketing and consumer promotion are two different activities. A sales rep visit is indeed different than a TV commercial during the Super Bowl. But both are probably equally inefficient.

If industry wants to reclaim the high ground for marketing it must take a stand on who the marketing is supposed to benefit. The updated PhRMA code does that, by the way: "Our relationships with healthcare professionals are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine."

If the goal is to benefit patients, then it is nonsensical to consider sales force activities and DTC as in any sense separate. If either the patient or the physician lacks the necessary information to make an informed therapeutic choice, then the marketing campaign failed.

The code of conduct for clinical trials is less obviously part of the same picture, but PhRMA would do well to look at it in that light. Industry bristles at claims that its big R&D budgets are really just to support marketing. But let’s face it: the questions asked and answered by clinical trials and other industry sponsored research are indeed the primary source of information about medicines—and so the very essence of all industry marketing.

Put another way: no one objects to industry sponsored research. They object to the perception that the results are skewed or hidden based on a commercial agenda. In other words, they think marketing trumps R&D.

PhRMA’s current clinical trial code covers issues related to reporting and disclosure, but Congress has already taken that issue much further. If PhRMA wants to reclaim the high ground, the association will need to take another look at that policy—especially in the context of even bigger steps to rebuild its reputation.

Tomorrow: Step Three—Let the Sunshine In

Roche/Genentech: When Independence Costs Too Much

noreply@blogger.com (Ellen Licking) — Tue, 22 Jul 2008 12:30:00 +0000

It's already Tuesday but that won't stop us from our penchant for Monday morning quarterbacking--especially when it comes to the biggest deal we're likely to see all year: Roche's unsolicited bid for the remaining 44% of Genentech it didn't already own. So why do it?

Certainly, Roche’s earnings are slowing and buying the remainder of Genentech will allow it to consolidate 100% of Genentech’s profits, not merely 56% of them. And there may be, as one banker noted, obscure tax reasons pushing a deal: Roche has always had a complex financial structure.

But ultimately Roche’s acquisition rationale must out-argue the one big reason not to do the deal: this has been the most successful relationship in pharmaceutical history. Neither company would likely exist as an independent entity without it. Genentech was an acquisition waiting to happen back in 1990 when it managed to keep at least managerial independence by selling Roche 60% of its shares. Without Genentech, the Swiss giant would most likely be part of another Swiss giant, Novartis (which still owns a small stake in the pharma.)

It's worth remembering that in 2007, Roche got 28% of its sales from Genentech-sourced products, which include the large molecule trifecta Herceptin, Rituxan, and Avastin. Moreover, one third of its Phase II and III pipeline is comprised of Genentech programs. Meanwhile, Roche's 56% ownership of Genentech accounts for roughly a third ($55.2 billion) of its $154 billion market cap, the second biggest in Pharma after Johnson & Johnson.

In case you aren't getting it, let's be clear: Roche’s success is largely due to Genentech.

By buying Genentech – and no one we spoke with figures this deal will end up any other way, as we noted yesterday the only question is the ultimate price tag– Roche is betting that this unique relationship has already borne its best fruit. The independence that kept Genentech productive has simply become too expensive.

Sure, the Roche press release made the obligatory soothing noises about Genentech’s independence and culture. Severin Schwan, Roche's CEO even went so far as to say “I would like to reiterate from my side how big [our] respect is for Genentech’s achievement, how big the respect [is] for Genentech’s culture” on a same-day conference call announcing the news. “We have sent very, very strong signals to Genentech [about] how much we appreciate the strength Genentech brings into our organization," he said.

I'll say. Actions, as your mother taught you, speak louder than words. And the manner of Roche's bid does much to destroy any future positive collaborations between the two companies. Apparently, Genentech CEO Art Levinson only learned of the deal on Sunday, July 20th, the day before it was announced.

If the intent was to preserve the Genentech culture, wouldn't Schwan's team have first outlined the positive rationales for the deal to Levinson and his board, and allowed them a window of time in which to suggest alternative governance structures that might have preserved Genentech's independence? Instead the announcement was sprung upong Genentech as a fait accompli.

The deal, in short, has more of the hostile flavor of the Ventana takeover. That shouldn't be too surprising: the Ventana acquisition, which took seven months from start to finish, was also spear-headed by then diagnostics-leader Schwan. Moreover, Greenhill & Co., the boutique bank that advised Roche in that high stakes gambit, is also advising on the Genentech tender offer.

Few people we talked to figure that Genentech’s best scientists will stick around. In the first place, most of those responsible for the marketed and later-stage products are already gone or wealthy enough, thanks to Genentech options, to chance a start-up. “They’ve already got their nest eggs,” says one former Genentech executive. “I suspect most would stay if Art Levinson does,” says a senior Genentech executive. “But they won’t if he doesn’t.”

And the early betting is that he won’t. “This deal humiliates him,” says one banker. “They didn’t talk to him first.” Adds a Big Biotech CEO: “Even if they let him run the pharmaceutical operations, do you think he’d want that? I certainly wouldn’t.”

Perhaps David Hamilton of bNet Industries is correct when he writes that Roche "has vastly underestimated both the difficulty of managing biotech operations and the risk that Genentech’s scientists will simply walk away at their first opportunity." They certainly aren't the first Big Pharma to take the biotech plunge that's faced significant cultural issues--MedImmune, anyone?

But Roche is populated by extremely smart folks, so our guess is Schwan's team has probably figured the likelihood of mass exodus into its deal calculus. Instead, it’s betting that the strategic and financial flexibility complete ownership permits are more valuable than the theoretical continued R&D productivity achieved by keeping Genentech at arm’s length.

Indeed, a financially strong Roche is buying Genentech at a time “when the house of Pharma is burning,” says one Big Biotech CEO. With Genentech, Roche will be be much larger by market cap than all of its pharma rivals and far out of reach of its Swiss nemesis, Novartis, ensuring freedom from takeover threats.

Which gets to what we suspect is the real point of the deal: industrial efficiencies. Roche’s last major pharmaceutical acquisition– of Syntex, in 1994, for $5.3 billion– worked out quite well, if not exactly as the pharma company imagined. Roche cut massive costs out of the operation, saw their shares rewarded for the expense reductions, and netted themselves, in the transplant drug CellCept, one of their most important products outside of the Genentech collaboration.

Today, Genentech is one of the few large companies Roche could buy without angering Wall Street, which has come to see the large cost-cutting horizontal mergers characteristic of the 1990s as value destroying. But the aura of the Genentech pipeline allows Roche to make a horizontal acquisition–with plenty of opportunities to cut significant expenses and thus increase earnings (Roche’s PR estimates savings of $750 - $850 million a year).

And while a number of analysts were angry over the deal’s terms, Roche shares were up on the announcement. “It may not create value long term,” says the Big Biotech CEO, “but it lets Roche do what these deals used to do – cut costs – and live to fight another day.”

Indeed, Schwan’s vision of the pharmaceutical future is one in which large companies will compete on the basis of industrial efficiency, not the kinds of innovations Genentech is known for. The value of such innovation is too unpredictable and perhaps growing more so as payors increasingly question the high prices charged for a cancer drug like Avastin which provides, on average, only a few extra months of life.

It's likely Roche took a look at the price of its current Genentech relationship--with its manufacturing transfer prices, up-front fees and royalties, and most importantly no ability to leverage its investment in the US marketplace where the economics of oncology marketing look more and more like primary care--and figured those costs outweighed the innovation it would lose if Genentech's world class talented departed as a result of a takeover. Just as no primary-care force can afford to sell a single product, Roche can’t afford a US oncology operation selling only Xeloda.

Moreover, Roche is clearly not convinced that Genentech’s productivity would have continued at the rates it has in the last decade. And there are plenty of people who agree. “We all know that Amgen is now a Big Pharma. We talked about it eight years ago. But I think Genentech has now sneaked over that line too,” says the CEO of one of Genentech's peer Big Biotechs.

Without having spoken with him for this story, we suspect Severin Schwan’s vision of the pharma future looks a lot more like the cost-constrained world he knew at Roche Diagnostics – where innovation was rare and rarely paid for; where extraordinary business acumen counted for more than outsized research capabilities. Roche’s first gamble on Genentech was all about R&D. Its new gamble: business synergies will drive the next wave of pharmaceutical success.

--By Roger Longman

Roche/Genentech: End of an Era

noreply@blogger.com (Chris Morrison) — Mon, 21 Jul 2008 14:21:00 +0000

OK, readers, have at it. Roche's proposed acquisition of the 44% of Genentech that it doesn't already own is going to dominate the biopharma chatter for the foreseeable future. So give us your initial impressions, and we'll give you ours.

Why is now the right time for Roche to move, considering that it risks screwing up what is generally considered the most successful alliance in the history of the industry? Certainly Roche probably feels like the price is right--and that it mightn't ever get righter. The dominant theme elsewhere in the media will very likely be about Roche bioteching itself with Genentech's capabilities; you might also be reminded of AZ's own increasingly precarious experience doing the same with MedImmune.

But let us suggest that this deal, for all the talk about innovation, in the end has more in common with Big Pharma megamergers--cost cutting, savings, gaining access to the US market and potentially Roche better positioning itself for the twin futures of personalized medicine and follow-on biologics.

We also realize that the price is likely to change, if today's early reaction from the market is any indication. But Roche has been there before with Ventana and it can leverage that experience. This isn't a done deal, but Roche is likely to eventually prevail.

Watch this space and our sister publications "The Pink Sheet" DAILY and "The Pink Sheet" for ongoing coverage.

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Next Steps for PhRMA and Marketing (Part 1): Define the Mission

noreply@blogger.com (Michael McCaughan) — Mon, 21 Jul 2008 14:00:00 +0000

Our hats are off to the Pharmaceutical Research & Manufacturers of America task force on professional practices. It is no simple matter to get three dozen companies to agree on anything—much less something as politically and commercially sensitive as the rules governing marketing to physicians.

And to do so in a way that addresses real-world, day-to-day operations is so much tougher. PhRMA’s updated Code on Interactions With Healthcare Professionals wrestles with the nitty gritty details of how physician marketing works, and doesn’t shy away from tough, specific directives on everything from pens to meals.

So no one can say PhRMA is hiding behind bland statements of principle rather than addressing the real world.

But perhaps you can say the opposite: that in getting into the weeds of how marketing works, PhRMA has lost site of some bigger principles. Debates over pizza and pens may help in that cause, but they don’t come close to justifying marketing as a vital, necessary activity for society.

In that spirit, may we suggest three modest proposals of our own?

Step One: Define the Mission

It is time (past time, perhaps) for PhRMA and its members to redefine the role of marketing and reclaim the high ground.

Every marketing organization should have a mission statement that it can embrace and brag about. The goal cannot be simply to increase sales. The goal should be to ensure the widest appropriate use of life-improving or life-extending medicines. Marketing done right means a medicine reaches more of the right people; it maximizes the benefit society receives from medical science.

PhRMA’s updated code on interactions with physicians suggests this mission in the preamble: “Appropriate marketing of medicines ensures that patients have access to the products they need and that the products are used correctly for maximum patient benefit.”

Hopefully, every marketing organization believes that already. The hard part is convincing the rest of the world to see it that way.

To do that, you can’t just say that’s what marketing is—you have to mean it. For example, do companies compensate marketing personnel based on “maximum patient benefit”? Its hard to say yes if sales reps get bonuses for boosting prescription market share in their territory: that is compensation based on maximizing revenue.

Of course, coming up with bonuses tied to maximizing appropriate use requires some real creativity, and probably a complete rethinking of the marketing effort.

But that’s only step one.

Tomorrow: Step Two--Combine the Codes

While You Were Joking

noreply@blogger.com (Chris Morrison) — Mon, 21 Jul 2008 07:00:00 +0000

Yes we know that the anti-hero that has taken the cinema world by storm this weekend is The Joker, but indulge us as we play The Riddler for a quick and question-filled weekend roundup:

What's up with Roche? The Swiss pharma has moved its earnings report up from Thursday to Monday. No reason was given for the change. We suppose by the time you read this we'll know if there was any drama. (UPDATE: Roche is offering to buy the 44% of Genentech that it doesn't already own. Pricetag? For now it's $43.7 billion.)

What happened to Pharma Giles?

Why did Shire cross the Irish Sea? (To get to the lower taxes.)

When is it Shark Week? Not yet, Greg Norman.

Prasugrel: My August Looks Free…and So Does My September

noreply@blogger.com (Ramsey Baghdadi) — Fri, 18 Jul 2008 23:00:00 +0000

Eli Lilly’s prasugrel team may have some free time on its hands in August and September if FDA’s advisory committee calendar is any indicator.

After FDA extended the priority review deadline of the novel anti-platelet drug by three months on June 23—the deadline was June 26—to September 26, speculation began in earnest around whether the drug would be required to go before the agency’s Cariovascular and Renal Drugs Advisory Committee.

August 19-20 had been tentatively blocked off for a meeting of the Cardio-Renal panel and Wall Street, FDA watchers and industry stakeholders pointed to the dates as a strong possibility for a prasugrel review.

Well, a quick look at FDA’s advisory committee calendar shows the blocks have suddenly disappeared. Moreover, September is completely free of any advisory committee meetings and no new Cardio-Renal meeting has been added to the end of July. We should note that a tentative Peripheral and Central Nervous System Drugs Advisory Committee meeting blocked off for August 6-7 has been postponed.

Do with that what you want. Of course, FDA can add a meeting at any time.

But, if FDA sticks to the extended review deadline and the calendar remains as is, it appears that prasugrel will not go before an advisory committee before a final decision on the application is made. That’s probably a positive sign for Lilly because the committee would have been used to address uncertainties with the application and the postmarket surveillance REMS program.

If, however, FDA adds a meeting in late August or early September, that almost certainly means the prasugrel review will miss another deadline.

A Lilly official says the company still has not been informed by FDA that prasugrel will require an advisory committee review. FDA says there is no Cardio-Renal panel scheduled as of right now. We still think prasugrel will be approved on its first cycle.

We’re not going to rehash our reasoning but you can read it by clicking here and the follow-up is here.

Deals of the Week: All Star Break

noreply@blogger.com (Chris Morrison) — Fri, 18 Jul 2008 17:00:00 +0000

In a week when the AL (again) defeated the NL 4-3 in a marathon 15-inning All-Star game at Yankee Stadium (thanks, Billy Wagner, for blowing the save and losing home field advantage for the World Series-bound Phightin' Phils), there were a few all-stars in the pharmaceutical world as well.

The buzz word this week was diversification, with health-care behemoths Johnson & Johnson and Abbott Labs posting better-than-expected quarterly results. J&J was buoyed by its consumer products business and Abbott had both stents and Humira to thank for its performance. On the other hand Novartis--an increasingly diversified company--grew in spite of its non-branded Rx divisions: its consumer medicines and Sandoz generics business enjoyed only moderate success thanks to tough times in the key US market, but that didn't stop the Swiss company from posting solid second quarter numbers. (We'll have more to say on Big Pharma business models and the yin and yang of focus and diversification in an upcoming IN VIVO piece.)

Keeping with the baseball theme: we're not a blog to steal signs but we couldn't help but pick up on something earlier this week. On Tuesday we gave you all free access to the denosumab record from Elsevier's Inteleos database and noted that Amgen has suggested it would be open to licensing the project, at least for the primary care indication of post-menopausal osteoporosis (PMO).

The challenge? For all of you expert dealmakers out there to add your two cents regarding the value of the project and potential deal strategies for Amgen. We can only assume that the dearth of comments suggests that all of you are in preliminary or even final-stage negotiations with Amgen and therefore recuse yourselves from the prize-less competition. Wink wink, we get it. Slackers.

You know who hasn't been slacking off? Those intrepid dealmakers responsible for ...

GSK/Actelion: The week started off with a bang when on Monday Glaxo fronted CHF 150 million ($148 million) in a worldwide (ex-Japan) co-development and co-promotion pact with Actelion for the Phase III orexin receptor antagonist almorexant. The Big Pharma pledged an additional CHF 415 million in pre-commercial milestones for the drug’s first indication of primary insomnia and an absolutely filthy figure for total milestones in two additional indications. Reactions to this deal were varied, to say the least. One analyst called it "the largest-ever partnering deal in the history of the industry," while others pronounced themselves decidedly "underwhelmed." Certainly you can't please everyone. But allow us to be the voice of reason, the voice of moderation, the voice of baby bear, when we say that GSK's figure was probably "just right." Why's that? Well forgetting the non-insomnia terms and taking into consideration the fact that GSK will help Actelion get its primary care field force off the ground by paying it to promote an undisclosed GSK drug prior to almorexant, the upfront payment may have been low for a Phase III primary care drug circa 2000-2003, but not anymore. The few primary care drugs available for licensing in Phase III, with novel mechanisms of action designed to treat non-life-threatening diseases, come saddled with higher than ever clinical development hurdles and increased regulatory scrutiny. GSK’s ante for almorexant—though large enough to put the deal in the upper echelon when it comes to guaranteed money—might seem small were it not for those circumstances. The fact that the Big Pharma is only chipping in for a minority of almorexant’s pivotal development program (which aside from the ongoing RESTORA 1 study will include at least two more Phase III trials) is further evidence that GSK is hedging its bets here.

Genzyme/PTC: We'll spare you the "London buses" reference but suffice to say it's unusual to see one $100 million+ upfront licensing deal and to see two in a week--well, that's plain crazy. But score another one for the orphan drug seekers. On Thursday, Genzyme paid $100 million to PTC Therapeutics to enter into a global collaboration to develop and commercialize PTC124, PTC's novel oral therapy in late-stage development for the treatment of genetic disorders due to nonsense mutations. The drug is in Phase IIb trials for Duchenne muscular dystrophy and is scheduled to enter a Phase IIb in cystic fibrosis later this year. PTC will cover the cost of 124's remaining Phase II program--which is slated to include four trials--and from there the parties will split development costs 50/50. PTC is eligible for $165 million in development and approval milestones and $172 in sales milestones. PTC will commercialize in the US and Canada (where it is responsible for all commercialization costs) and Genzyme takes responsibility for marketing and associated costs for the RoW. In addition to Genzyme's up-front contribution PTC pulled in up to $25 million from the non-profit Cystic Fibrosis Foundation the day before the deal was announced to support development of '124 in CF.

ViroPharma/Lev: Specialty pharma outfit ViroPharma announced it was entering the hereditary angioedema (HAE) space with its $443 million acquisition of Lev Pharmaceuticals. The linchpin of the deal is Lev's C-1 esterase inhibitor Cinryze, a biologic that has been available in Europe for 35 years to treat this rare and life-threatening condition, which causes inflammation of the larynx, abdomen, face, and extremities. Lev filed a BLA for Cinryze in July 2007, seeking approval for both prophylaxis and acute treatment of HAE. The product faces competition from CSL Behring's C1 inhibitor Berinert and Jerini's Firazyr. Our sister publication Pink Sheet Daily has more on the HAE market and Cinryze's chances of success. For ViroPharma, the deal marks a shift away from the antiviral space, which has long been its focus, into the hospital/ transplant arena. And with the addition of a soon-to-be marketed product, it continues the company's trend of playing to an investor base attracted to fully-baked and largely derisked assets. Recall this is the company that made a tidy profit on Vancocin, a decades old product it inlicensed from Eli Lilly, to treat Clostridium difficile outbreaks. ViroPharma's timing on Vancocin was exquisite. It brought in the product just when very nasty strains of the bacterium were causing large scale hospital outbreaks of the disease; given the market forces, ViroPharma was able to raise prices of the drug considerably. It is currently working on a follow-on to Vancocin, NTCD. Meantime, there's little information available about ViroPharma's hepatitis C program: ViroPharma discontinued its HCV-796 program, partnered with Wyeth, earlier in the year. According to ViroPharma's website, the two companies continue to exlore follow-on molecules to treat the disease.--Ellen Foster Licking

MacroGenics/Raven: Raven Biotechnologies finally found a buyer in MacroGenics. Last November, Raven announced a tie-up with VaxGen worth about $39 million. But VaxGen's shareholders revolted and scuppered the deal this past spring. MacroGenics, in turn, has been working to build a fully integrated biopharmaceutical company (how quaint) around its Fc antibody engineering and dual affinity re-targeting (DART) programs. It has a large deal with Lilly to develop and commercialize its anti-CD3 mAB for use in the treatment of autoimmune diseases, icluding recent onset-type 1 diabetes. On July 17, MacroGenics and Raven announced their tie-up. Financial terms weren't disclosed but it seems unlikely that Raven got more than what VaxGen originally offered. For MacroGenics, the acquisition provides additional preclinical assets, including more than 1300 monoclonal antibodies that Scott Koenig, CEO of MacroGenics, claims can rapidly be developed using their optimization platforms. In addition, the deal gives MacroGenics access to a portfolio of proprietary cancer stem cells from many types of primary tumors that could be an important addition to MacroGenics R&D capabilities. --EFL

Teva/Barr: What's $7.6 billion buy these days? Maybe a top-five starting pitcher, but those are hard to come by. No, this week it was Barr Laboratories. This late-breaking deal of the week is the latest chapter in the ongoing consolidation of the generics sector, but the bigger story here is the combination of Teva and Barr's biologics programs. Teva also noted Barr's legal prowess and at-risk launch capabilities. Under the terms of the deal, each share of Barr common stock will be converted into $39.90 in cash and 0.6272 Teva ADRs and Teva will assume Barr's $1.5 billion in debt, to boot. In other generics news, Czech generics play Zentiva is now telling investors to reject Sanofi-Aventis' attempt to up its stake in the company, saying the $2 billion play is a lowball offer.

photo by flickr user mori claudia used under a creative commons license.

The Enemies You Keep

noreply@blogger.com (Kate Rawson) — Thu, 17 Jul 2008 21:05:00 +0000

Former Rep. Bill Thomas sure has it in for Amgen.

First, as chairman of the House Ways and Means Committee, Thomas made life difficult for Amgen by siding with sworn enemy Johnson & Johnson during the now-resolved EPO bundling dispute.

Thomas wasn’t particularly happy with allegations that Amgen gave large rebates for Aranesp (which competes with J&J’s Procrit) when purchasers committed to buying Neulasta and Neupogen.

And just before retiring from public service in 2006, Thomas teamed up with Rep. Pete Stark to criticize the Centers for Medicare & Medicaid Services’ reimbursement policy for Aranesp, in the hopes of making anti-Amgen changes in the way that the product was covered under Medicare Part B.

But while the Amgen/J&J feud has finally ended with a $200 million payout to J&J, Thomas can’t quite bury the hatchet.

This time around, he’s working against Amgen on the issue of follow-on biologics. Thomas has teamed up with Insmed Inc.—a company you might remember from a moderately infamous YouTube video—but that also just announced the results of a study demonstrating bioequivalence between its INS-19 and....wait for it...Amgen’s Neupogen.

Insmed has a long way to go on INS-19—that bioequivalence study was a Phase I trial. But the company says it is planning to petition FDA to commence Phase III studies of INS-19, and wants to move another “me-too” biologic, INS-20, which Insmed says is a “generic form” of Amgen’s Neulasta, into Phase I. (Are you sensing a pattern here yet?)

How Thomas’ vision for a follow-on biologics framework is different than the bipartisan legislation that’s already out there is unclear. It’s also unclear how the Congressional Budget Office’s scoring of the Senate’s version of the bill will affect the chances for near-term passage of any legislation.

But what is clear is that there’s no love lost between Thomas and Amgen. Conventional wisdom would suggest that it took a pretty sweet fee for Insmed to get Thomas on board as a strategic advisor. But given Thomas’ history with Insmed’s main target in the war on follow-on-biologics, maybe it didn’t take too much convincing.

Wacky World of Generics: Painful Historical Parallels Edition

noreply@blogger.com (Michael McCaughan) — Thu, 17 Jul 2008 17:45:00 +0000

New details about a pending Justice Department investigation of Ranbaxy recall some painful memories from veterans of the generic drug scandal in the US at the end of the 1980s.

It is amazing to think—at a time when generic drugs are the political golden child, everybody’s favorite starting point for reining in costs, and everybody’s hope for controlling spending on biologics—that it was just two decades ago that generic drugs were perceived as inherently suspect. Company after company was accused of fraud, and dozens of products were withdrawn from the market.

So no one in the generic sector wants to read that the government is alleging “systematic fraudulent conduct” on Ranbaxy’s part.

Ranbaxy, of course, wants to read that least of all—certainly not while a $4.6 billion merger with Daiichi Sankyo is pending. (PharmAsia News has all the details on what is known about the investigation, and the speculation that it might affect the pending merger of the two companies.)

The companies say the deal is not in jeopardy. The bottom line for proceeding: Ranbaxy says the scope of the investigation is fully understood by Daiichi and the risks to the business as a whole aren’t worth worrying too much about.

Daiichi better hope so.

The alternative is not pretty. The downside risk may best by captured by considering what happened to Fujisawa went it bought out Lyphomed in 1989. The transaction came after a Lyphomed faced a round of manufacturing compliance issues that had seemingly been resolved.

The deal was a disaster on every level for Fujisawa. It turned out that FDA wasn’t done with Lyphomed by a long shot, not as the full extent of issues related to fraud in the generic drug sector started to come to light.

How big a disaster? Well, Fujisawa paid about $1 billion to buy Lyphomed, and ended up writing off $575 million when it finally unloaded the business in 1998. (The buyer? APP, which is being acquired itself a decade later.) Fujisawa spent millions cleaning up the business along the way, including withdrawing many products it acquired because of questions about potential fraud in the applications. Worst of all, Fujisawa’s own products were held up as a result of FDA’s concerns, putting its relationship with Medco Research for Adenoscan in jeopardy.

And strategically, it certainly didn’t help Fujisawa achieve its primary goal of building in the US. Fujisawa has since merged with Yamanouchi, and the new company—Astellas—is still working on that goal.

Painting by Renee Dixon

It's Not DTC, It's HBO

noreply@blogger.com (Chris Morrison) — Thu, 17 Jul 2008 16:53:00 +0000

GlaxoSmithKline Consumer Healthcare and its team that promotes the over-the-counter weight loss drug alli have to be rooting for HBO’s recently announced pilot “Fat Sells” to make it to the air.

The cable network will air “Fat Sells” (get it?), a “one-hour family drama set in the world of the $46 billion herbal supplement weight loss industry,” with Academy Award winner Forest Whitaker to executive produce.

"Everyone is looking for that Magic Pill to change their lives ... We're taking a world not regulated by the FDA and breaking it wide open," says co-creator Dave Broome.

According to a report from Variety, the story “will center on the head of a weight loss behemoth (and his family) and how his life starts to unravel when the FDA begins investigating the company's claims.”

We can only hope the show can even begin to capture the excitement of a real-life FDA inspection.

Depicting weight-loss supplements as being sold as “magic pills” fits right in with Glaxo’s pitch for alli, our colleagues at “The Tan Sheet” report here. But we’re predicting we won’t see any product placement.

Glaxo, which launched alli (an Rx-to-OTC switch of orlistat, Roche’s Xenical in the prescription market) in 2007 has marketed the drug as part of a program that includes lifestyle changes such as diet and exercise. Glaxo positions alli as as “the only FDA approved” OTC weight-loss product, and an alternative to products in the supplement market that do not have to go through pre-market approval and that make more aggressive weight-loss claims.

In fact, in a move back in April that would take a large number of competitors off the market if successful, Glaxo filed a citizen petition in May asking FDA to require pre-market approval for supplements making weight-loss claims. Read about that here.

Supplement firms likely won’t be happy if Fat Sells airs, considering creator Broome, also an executive producer, has already called it an unregulated industry, an impression widely repeated in the press, and one that companies and trade groups are constantly trying to correct. And from the description of the show, it sounds like the firm depicted will be exactly the kind of company that mainstream supplement industry members have been working hard to distance themselves from, via self-regulation and public relations efforts.

On the other hand, if the show is the next “Six Feet Under,” supplement firms –and hopefully FDA – could see the same kind of uptick in job applicants that the funeral industry saw from that show.

Meanwhile, we’ll be here trying to pitch HBO some follow-on hits from the exciting world of FDA-regulated products. Keep an eye out for “The Detailers,” “Hoodia Love” and “GMPs: Miami.”

--Christopher Walker

Big Pharma as the “Good Guys”: One Reason to Embrace Tropical Disease Research

noreply@blogger.com (Michael McCaughan) — Wed, 16 Jul 2008 21:40:00 +0000

Here are words you don’t hear too often at Washington, DC press conferences (ed. note: or anywhere else for that matter): “The pharmaceutical companies are really the good guys.”

But that is what Global Network for Neglected Tropical Diseases executive director Peter Hotez said July 16 during a briefing at the National Press Club to announce the appointment of former Health & Human Services Secretary Tommy Thompson (pictured right) as the non-profit partnership’s new “global ambassador.”

Thompson was equally effusive in his praise for industry. “The pharmaceutical companies…are doing a wonderful job,” he said.

At a time when industry needs all the good press it can get, Hotez and Thompson sure made involvement in the campaign to eradicate rare tropical diseases (think hookworm, etc.) sound like a case where industry can do well by doing good.

We would add another reason for industry to pay attention to tropical diseases: a new incentive program that rewards sponsors of drugs approved to treat a qualifying condition with a priority review voucher—good, in theory at least, for a faster FDA review of another, more commercially vital, project.

The RPM Report has just published an analysis of the new voucher program. (Non-subscribers can click here for a free trial.)

That voucher program is not the focus of the Global Network, per se. They are concentrating on raising awareness (and funds) to get already approved medicines to the afflicted patient population.

Thompson singled out four companies in particular—Pfizer, Merck, Novartis and Johnson & Johnson—for donating drugs to treat infectious diseases as part of a “rapid impact package,” making it possible for the program to treat the seven most common tropical diseases for just 50 cents per person per year.

He gave special praise to a fifth company—Sanofi Aventis—which “is not even an American company” but sent executives from France to attend and support the initiative. He praised Sanofi at length for setting up a dedicated division to fight neglected diseases.

Thompson has not always had such kind words for industry: he jawboned Bayer over the pricing of Cipro after the anthrax attacks in the US in 2001 and memorably lamented the fact that the Medicare prescription drug benefit did not give HHS the authority to negotiate prices more broadly as he left the agency in 2004.

In the context of the Global Partnership, though, Thompson has nothing but good things to say about the industry. For instance, he recalled a trip to Africa he took as HHS Secretary, where he visited an orphanage along with then-Pfizer CEO Hank McKinnell. Thompson recalled seeing McKinnell being moved to tears while holding an HIV-positive newborn. “He was so moved he wrote a check,” Thompson said.

Talk about putting a caring face on Big Pharma!

Still, the combination of the voucher program and the public relations opportunity to join in a global campaign to alleviate tropical disease is already causing companies to look more closely at tropical disease research. Hotez says one goal of the Global Network is to raise awareness so that the names of the most common diseases of poverty are "household words." That may be ambitious, but it sure sounds like there is a strong case to make them boardroom words.

Jumping the Gun on Nplate

noreply@blogger.com (Kate Rawson) — Tue, 15 Jul 2008 18:00:00 +0000

Whoops.

It seems like that’s all that can be said about the premature announcement of FDA's still-pending approval of Amgen’s platelet drug romiplostim (Nplate).

Business Wire erroneously sent out a press release yesterday morning announcing that the biologic had been approved for the treatment of thrombocytopenia. Amgen quickly retracted the release, saying that the Nplate application was still under FDA review, and Business Wire acknowledged its error.

It's pretty obvious that FDA and Amgen are wrapping up final details on Nplate and that approval is imminent. But that shouldn’t come as much of a surprise, given that FDA was handed a unanimous recommendation for approval by the Oncologic Drugs Advisory Committee in March.

FDA still has more than a week to approve Nplate by its July 23 user fee deadline; the review was extended by three months to allow time for the agency to consider Amgen’s Risk Evaluation & Mitigation Strategies (REMS) plan, which was submitted as a major amendment to the BLA in March.

So what, if anything, can be gleaned from the retracted release? Well, as reported in “The Pink Sheet” DAILY this morning, Amgen’s REMS program for Nplate will include the Network of Experts Understanding and Supporting Nplate and Patients, or NEXUS, program. We’ve written extensively about the lessons learned from the first REMS in The RPM Report; you can access those stories here and here.

But perhaps the best news out of the Nplate slip-up is for branding firms: NEXUS pretty much guarantees that REMS programs (like major clinical trials) will continue to be referred to as acronyms-that-are-not-quite-acronyms. (Some of our favorites include TOUCH, IDEAL and CIMplicity.)

While some might liken that craft to seeing religious figures in pancake batter, we suppose someone has to come up with those clever (silly?) names.

Photo courtesy of Flickr user dejajib under a creative commons license.