Abbott's Anti-Biosimilar Stance is Anti-Consumer

Abbott's Anti-Biosimilar Stance is Anti-Consumer

The pharmaceutical industry often wonders why it has such a bad reputation with consumers -- nearly as bad as the tobacco industry -- considering it saves lives, as opposed to the tobacco industry, which ends lives. Well, to understand why this is so, you need look no further than actions such as Abbott's April 2, 2012 citizen's petition against FDA approval of biosimilars (read more about that and find a copy of the petition here: "Abbott Labs Petitions FDA to Disallow Biosimilars").

According to the FDA (here):

The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.

The law protects the original biologic drug from copies for 12 years after approval.

"If the challenge succeeds," says WSJ, "less-expensive versions of complex biologic drugs couldn't go on sale in the U.S. for years, and consumers may never have access to facsimiles of existing treatments such as Abbott's rheumatoid arthritis therapy Humira, which had $3.4 billion in U.S. sales last year and is projected to be the world's No. 1-selling drug this year."

Abbott "contends that its drug isn't copyable under the law, because regulators would need its Humira trade secrets to approve a biosimilar and would thereby violate its constitutional rights. The company said it is protecting an investment of 'massive amounts of capital' and the 'great risk' it took developing the drug. In fact, Abbott contends that no biologic approved before the law was signed should be considered copyable."

"Critics of Abbott's position say that the argument lacks merit and is anticompetitive, and that trade secrets aren't necessary to prove that a copy will work like the original. The critics also contend Abbott is backtracking on its support for the legislation and ignoring the potential impact on the country's spiraling health-care spending."

Considering that Abbott Labs will soon have the NUMBER 1 selling drug in the world (see below) -- taking the crown from Pfizer's LIPITOR -- it makes perfect sense that Abbott should act NOW to protect its patented money-maker, years before it finds itself in the not-so-envious position of Pfizer, which fought on even after the bell rang on Lipitor (see "Pfizer Throws In the Lipitor Marketing Towel"). Note: Humira's U.S. patent expires in December 2016

With the filing of this petition, Abbott Labs may also take on another "crown" previously held by Pfizer -- the world's most hated pharmaceutical company. Good luck with that Abbott.

Booming Biologics
Abbott, however, is just the "poster boy" (or "patsy") chosen by the drug industry to take the shots by filing this petition, which really speaks for the entire industry. Patented biologics is a big business and represents the future of the pharmaceutical industry.

According to the WSJ, biologics "had $74.8 billion in U.S. sales last year, up 8.3% from the previous year, according to the IMS Institute for Healthcare Informatics. This year, seven of the 10 top-selling drugs will be biologics, with a total of $50.4 billion in world-wide sales, according to EvaluatePharma, which predicts that Humira will be No. 1 with $9.3 billion in world-wide sales."

Lipitor R.I.P. Infographic

Lipitor R.I.P. Infographic

Pfizer Throws In the Lipitor Marketing Towel. Repercussions in Job Market Will Be Swift

Pfizer Throws In the Lipitor Marketing Towel. Repercussions in Job Market Will Be Swift

Despite Pfizer's heroic and unprecedented effort to maintain Lipitor's market share after expiry last November and after spending "more than $87 million promoting the medicine, the world's biggest drug company is quietly giving up on its once-great cash cow for good because more generic versions will soon be going on sale" (see this Wall Street Journal story: "Farewell after all, Lipitor").

As I reported here on Pharma Marketing Blog on May 2 (see here), Pfizer's Lipitor co-pay card/PBM discount plan failed to meet its goal of maintaining a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched. As reported in the WSJ (op cit), Lipitor's U.S. market share is 33% after 5 months (more generics will come on the market after May 31).

Although Pfizer will say that its program was a succes, the program has not met its sales goal and is considered a public relations failure by some people in the industry. A pharmaceutical marketing VP attending a recent conference referred to my blog posts "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE" and "Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?"

But after spending more than $87 million promoting Lipitor in recent months, Pfizer officials told The Wall Street Journal that the company is "no longer negotiating new contracts to sell Lipitor to health plans, which are signing up to sell generic versions at far lower prices. The company recently stopped sending sales representatives to promote Lipitor to doctors and halted advertising in print, on television and online, which once commanded a $271.9 million yearly budget." Here's a chart showing Lipitor's direct-to-consumer (DTC) advertising budget over the past 9 years:

[Note the minuscule proportion allocated to "Internet" ad spending. I cannot see from this chart what the $ amount is!]

The elimination of $220 or so million in Lipitor DTC advertising will, I predict, result in a 3% drop in overall DTC advertising in 2012 compared to 2011 (see "Lipitor Holds Key to DTC Ad Spending in 2012"). But that is only the tip of the Lipitor marketing budget, which totaled over $660 million in 2010. Included in that number is marketing to physicians and samples (see here).

When that much money is taken out of the Rx brand marketing equation, there are bound to be repercussions within Pfizer itself and within marketing communications companies that provide services to Pfizer. Meaning, of course, jobs will be lost. Perhaps that correction has already occurred. Or perhaps there are more layoffs to come.

What's Right Rx for Pharma Industry's Survival?

What's Right Rx for Pharma Industry's Survival?

Two commentaries caught my attention this morning. Both offered solutions to the drug industry's "fundamental problems."

Each solution, of course, defines the "fundamental problem" differently.

Solution #1 says the problem is the drug industry does not deliver "precisely what the world's health care systems need from it — therapies to materially advance the standards of care." The author blames top-heavy management populated with "protected dimwits and timeservers who fail to grasp the current dynamics."

"The management approach traditionally used by pharma also fails to hone the skills that the industry needs right now," according to the author (see "What pharma needs to evolve" here). "...it makes for a slow pace because, figuratively, everyone learns to raise his hand before going to the bathroom. Pharma, for example, generally frowns on setting up innovative, skunk works projects."

Solution #2 says successful pharma companies must drive revenue growth by acquisitions. Management is also to blame according to the author.

"The high-growth companies have clearly aligned their capital-deployment strategies with growth investments. They have done this instead of trying to achieve a balanced capital-allocation strategy that sacrifices reinvestment in exchange for greater dividends, buybacks, or cash accumulation" (see "The Prescription for Pharma Is Revenue Growth" here).

The first solution could be categorized as a "patient/customer" focused solution, whereas the second one can be said to be an "investor/stock holder" focused solution.

Which approach do you think can help pharma in the long run?

Which approach do you think can help pharma in the long run?
	Patient-focused approach: improved health outcomes
	Investor-focused approach: improved revenue growth
	I'm wishy-washy: Both
	I'm a pessimist: Neither
	I have no friggin' idea!

Lipitor Won't Go Gentle Into that Good Generic Night

Lipitor Won't Go Gentle Into that Good Generic Night

Today's Wall Street Journal reports that "Pfizer Inc. isn't rolling over and conceding the market for its cholesterol-lowering drug Lipitor after the blockbuster brand loses its U.S. monopoly at the end of the month" (read the article here). Pfizer has an aggressive co-pay card/PBM discount plan that it hopes will allow Lipitor to maintain a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched.

This has prompted me to man-handle Dylan Thomas's famous poem as an ode to Lipitor and its fight against patent expiry:

Do not go gentle into that good generic night,
Patent expiry should burn and rave at close of day;
Rage, rage against the dying of the innovator's right.

Though wise marketers at patent end know generic is right,
Because their words had forked no lightning their Rx brands
Do not go gentle into that good generic night.

Good Rx brands, the last wave by, crying how bright
Their frail market share might have danced in a greener pasture,
Rage, rage against the dying of the innovator's right.

Wild marketers who caught and sang cholesterol numbers in flight,
Learned, too late, Lipitor's fate, they grieve it on its way,
Do not go gentle into that good generic night.

Grave Rx brands, near death, that see with blinding sight
Off-patent drugs could blaze like meteors and be gay,
Rage, rage against the dying of the innovator's right.

And you, my Lipitor, there on the sad market height,
Curse, bless, your loyal patients now with your fierce tears, I pray.
Do not go gentle into that good generic night.
Rage, rage against the dying of the innovator's right.

Double-Dip Viagra Patent Means No Recession for Pfizer

Double-Dip Viagra Patent Means No Recession for Pfizer

Pfizer proves once again that it's not all about the science when it comes to "innovation." It's also nice to hedge your bets by winning patent infringement cases to keep marketing exclusivity for as long as possible.

Yesterday, for example, Pfizer prevailed in its Viagra patent infringement action against Teva Pharmaceuticals USA, Inc. in the United States District Court for the Eastern District of Virginia.

It wasn't, however, your typical patent infringement case. Pfizer actually has TWO patents for Viagra. One patent, which expires in March 2012, covers sildenafil (Viagra's active ingredient) for use in treating heart-related conditions such as high blood pressure. During the clinical trials, however, Pfizer discovered that the drug can improve erectile dysfunction (ED), the condition for which it eventually received marketing approval from the FDA.

In 2002, however, Pfizer double-dipped into the US patent office and received a NEW patent for Viagra to treat erectile dysfunction. It was THIS patent, which expires in October 2019, that was upheld in court yesterday.

According to a Wall Street Journal article (here), "In siding with Pfizer, Judge Smith wrote that in the early to mid-'90s, a person trained in the art of drug development 'would have no expectation that oral administration of such compounds would be successful in treating ED, and thus such method was not obvious to try.'"

Hmmmm... But Pfizer filed for the ED patent in 2002, when it obviously KNEW full well that oral administration of Viagra would be successful in treating ED. Pfizer obviously also knew that it would be successful in the 90s because it stopped the cardiovascular trials and pursued the NDA for ED.

In court, Pfizer essentially argued that it was not technologically savvy enough to know that sildenafil could treat ED while at the same time it pursued FDA approval PRECISELY for that condition. Talk about having your cake and eating it too!

If the court decision is not challenged on appeal, Pfizer will enjoy "continued market exclusivity" that will boost earnings by "roughly 3% annually between 2013 and 2018, a period in which profit otherwise would be under pressure due to the expected loss of exclusivity later this year for Pfizer's top-selling Lipitor cholesterol pill."

It's good to be the Pfizer! Pfizer shares were up 2.2% to $18.25 in early afternoon trading Monday on the New York Stock Exchange.

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Will Avandia Failure Lead to More Closely Supervised Clinical Studies and Longer Patent Life for New Drugs?

Will Avandia Failure Lead to More Closely Supervised Clinical Studies and Longer Patent Life for New Drugs?

In a BMJ editorial, editor Fiona Godlee contends that Avandia "should not have been licensed and should now be withdrawn." She cites problems that FDA discovered with the RECORD post-marketing study and finds fault with regulatory agencies' oversight of such studies.

Regulators should "should require a higher quality of evidence," Godlee says, "including proof that new drugs are better than existing drugs before being licensed. And if they do ask the manufacturer to undertake post-marketing trials, they must do a better job of overseeing the way these trials are designed and done."

Godlee also called for other reforms, including "far greater transparency from industry and the regulators, including access to raw data and funding for independent trials..."

Holding out a carrot in front of this stick, Godlee suggested that "the patent for new drugs should be extended, from the current 20 years to perhaps 25 or 30."

Personally, I don't think it's a good idea to extend the patent life by up to 50% for "greater transparency" by the drug industry. But Godlee is also calling for "funding for independent trials" as part of the deal. Is she talking about post-marketing trials like RECORD or the clinical trials upon which first approval for marketing is based? Where does the funding come from? I suppose she means that drug companies should somehow pay for "independent trials." That's going to be a problem even bigger than the problem of funding "independent" physician continuing medical education.

No matter how independent the pre-marketing trials are, the data are limited to a small population, which is often not representative of the population at large that will be exposed to the drug once it's on the market. That means additional studies may still be required after the drug is on the market to evaluate the safety among a larger population.

Perhaps having a drug on the market while additional studies are still underway is NOT as big a problem in Europe as it is in the U.S. where direct-to-consumer (DTC) advertising plays a big role in driving millions of consumers to their doctors to demand new medications. As online marketing begins to play a bigger role in marketing to consumers, this effect can be heightened. A recent study by About.com, for example, revealed that online health ads activate consumers as a result of seeing a healthcare (ie, drug) ad online:

• 44 percent researched medication in more detail as a result of seeing a healthcare ad online, up from 36 percent in 2009.
• 35 percent talked to their doctor after seeing an online healthcare ad.

IMHO, a better solution -- in the U.S. anyway -- might be to temporarily prohibit DTC advertising of drugs that require additional studies until those studies prove that the drugs are safe and effective as used in the marketplace. The carrot can still be an extended patent life as Godlee suggests. I have suggested this before -- see "Restrict DTC, but Extend the Patent for New Drugs" -- and the topic may arise again in my upcoming debate with DTC advocate Bob Ehrlich (see "The Great DTC Debate. Round 1: Are Drug Marketers an Endangered Species?").