Fosamax

Bisphosphonates may weaken bones

Christe Bruderlin-Nelson — Wed, 16 Jul 2008 10:32:12 -0400

Build ‘em then break ‘em? Such may be the case for drugs like Fosamax, a bisphosphonate medication aimed at treating and preventing osteoporosis. However, long-term use might in fact lead to weaker bones in some individuals.

A series of case reports of a rare type of leg facture has called the medications into question. In the reports, some patients using bisphosphonates for five years are more show a rare fracture pattern that cuts directly across the tough upper thighbone, even in the absence of significant trauma.

Dr. Dean Lorich, associate director of orthopedic trauma surgery at NewYork-Presbyterian/Weill Cornell and the Hospital for Special Surgery published reports of 20 patients with the unusual fracture, 19 of whom had taken Fosamax for an average of almost seven years. The study appears in the Journal of Orthopaedic Trauma and follows last year's study in The Journal of Bone and Joint Surgery, where 9 patients out of 13 with non-traumatic bone fractures were on long-term Fosamax regimens.

Merck, the maker of Fosamax, defended itself by saying that this fracture type is a small percentage of fractures overall and that drugs such as Fosamax reduce fracture risk for the vast majority of patients. Other bisphosphonate drugs include GlaxoSmithKline's Boniva and Procter & Gamble's Actonel.

- read the New York Times story
- get more at News Inferno

Safety questions on Fosamax, Actos, et al.

Tue, 29 Apr 2008 06:59:56 -0400

It must be tough for pharma execs to open a newspaper these days. If reporters aren't going on about falling revenues and patent expirations, they're propagating news about potential safety problems. Take today: Three different studies are linking four big-name drugs to safety risks.

Women who take Fosamax for osteoporosis may be at increased risk of developing an irregular heartbeat, or atrial fibrillation. While the condition isn't necessarily serious, it can lead to stroke. Nevertheless, the Archives of Internal Medicine study concluded that for most women the benefits of Fosamax outweighed the risks.
The epilepsy remedy Dilantin may put young women at higher risk of developing osteoporosis, according to research published in Neurology. Women who took the drug for a year or more showed eight times the bone loss of premenopausal women who didn't take epilepsy meds. And calcium supplementation may not be enough to counteract the bone loss. Full disclosure: This was a small study--only 93 women--and it was partly supported by GlaxoSmithKline, which makes a rival epilepsy med, Lamictal.
Diabetes treatments Avandia and Actos double or triple the odds of non-spinal fractures, especially among patients who took the drugs for a year or more, another Archives of Internal Medicine study found. Previous studies established higher risk of fractures among patients using these drugs, but the new research shows the possible scale of the problem. The study authors said the link needs to be confirmed by additional research.

Now, none of these studies appears likely to send doctors rushing to their prescription pads to switch patients to new meds. But each represents one more obstacle to pharma marketers in an already-difficult environment.

- see the Fosamax coverage from the BBC
- check out the epilepsy story in the Washington Post
- read the diabetes-med news in USA Today
- find US News' take on two of these studies

Merck's Clark: Stay the course

Tue, 25 Mar 2008 07:59:56 -0400

Merck CEO Richard Clark (photo) has his work cut out for him this year. The turnaround miracle man lauded last year for pulling the embattled company out of a slump now faces new challenges: managing the fallout from the controversial Enhance study of blockbuster cholesterol med Vytorin; ushering two potentially big new drugs through FDA approvals at a time when the agency is increasingly cautious; withstanding a patent challenge on the blockbuster heartburn med Nexium; making up for Fosamax sales sure to be lost now that the osteoporosis treatment has gone off-patent.

Merck stock has dropped by about a third off its December high of $60.77 (but that's partly because of the overall decline of the market). And analysts are calling the next few months "critical" to the share price. "They'll determine whether the decline in the stock is an overreaction or a legitimate relection of the value of the company," one told the Wall Street Journal.

"I am frustrated," Clark told the WSJ, saying that he wants employees to stay focused on the five-year plan he set forth in 2005. But, he says, "[m]y responsibility is to take a long-term view, and not just a short-term one. The stock decline is a bump in the road, a setback, but our plan to win is long-term."

- read the WSJ article

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Wyeth makes its own Protonix copy

Wed, 30 Jan 2008 06:59:55 -0500

Wyeth decided to beat the copycats to the punch. The drug maker will launch its own generic version of the blockbuster heartburn med Protonix, more than two years ahead of its patent expiration.

You'll recall that Wyeth had been negotiating with generics giant Teva Pharmaceutical, hoping to settle a dispute over Protonix's patent. Late last year, a Canadian judge refused to stop Teva's launch of a copycat drug, even though the two companies' litigation was ongoing. But Teva agreed to a truce; it would stop shipping the generic to sit down with Wyeth for settlement talks.

Apparently, the two companies couldn't come to terms, and Wyeth came out swinging. "We believe the Protonix compound patent is strong and we will vigorously pursue out litigation against Teva and other infringing generics," President and CEO Bernard Poussot said in a statement.

Teva, on the other hand, says Wyeth nullified the truce by launching its own generic. The company's statement doesn't specify whether it would continue to ship the copycat version. Given the fact that Sun Pharma--which shares 180-day marketing exclusivity for the generic with Teva--is now launching its Pantoprazole product, it's hard to imagine Teva holding back. But, of course, any generics maker that sells a copycat form of the drug risks paying triple damages to Wyeth if its patent is upheld.

Wyeth's move is emblematic of the challenges drug makers face as their top-selling products attract generic competition. Copycat drug makers like Teva and Sun are increasingly aggressive in disputing patents; they start early and keep pushing. And Wyeth isn't the only company to launch its own authorized generic to capture at least some of the copycat revenues for itself. Two weeks ago, Merck announced that it would partner with a generics maker on an authorized version of Fosamax, whose patent expires in February. With billions in revenue at stake--Protonix sold $1.43 billion worth in the first nine months of 2007--who can blame them? But even with an authorized generic going out the door, Wyeth sales will take a big hit. Analysts expect flat revenues for all of 2008, and the company is looking to cut jobs to save some bucks over the next three years.

- read the statement from Wyeth
- check out the release from Teva
- see the report about Sun's Pantoprazole launch in the Economic Times
- find this piece in the Wall Street Journal

Related Articles:
Wyeth mulls 5,000 job cuts. Report
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Drug name psychology, or the power of Z

Fri, 18 Jan 2008 06:59:56 -0500

You know about those product-naming experts who charge hundreds of thousands for just the right combinations of vowels and consonants. Well, the Associated Press today draws the curtain aside to reveal just which levers these experts are pulling.

For instance, did you know every letter has a personality? There's Z for speed -- think quick relief from cholesterol with Zocor, from depression with Prozac and Zoloft, from allergies with Zyrtec. Then there's L, R, and S to calm and relax; why else would so many mental health drugs lean on them? Hard consonants like P, T, and K connote effectiveness; hence effective clot-busting with Plavix, effective germ-fighting with Tamiflu, effective HIV-busting with Kaletra. Then there's the all-important letter X, the science guy. Naturally, it graces many names with a white-lab-coat feel: Lexapro, Xolair, Celexa, Zyprexa, Fosamax.

From letters, we move to syllables--two or three--and overall symbolism. Last month, Eli Lilly dubbed its new heart drug Effient (think efficient). Overt symbolism like that is better, the experts say, than the type that plucks at the subconscious. No matter what subliminal advertising nuts claim.

- read the article from the Associated Press

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SPOTLIGHT: Doubt cast on Fosamax link to jaw decay

Wed, 16 Jan 2008 06:59:52 -0500

A new study by a Harvard dental professor may cast doubt on some claims that Merck's osteoporosis drug Fosamax caused some patients' jawbones to decay. The study shows that IV forms of the drug may have contributed to jaw disorders, but oral forms--which are far more commonly prescribed--actually reduced that risk. Report

Merck joins Fosamax copycats

Mon, 14 Jan 2008 06:59:55 -0500

Merck won't be outdone on Fosamax. The company has struck a deal with an unidentified generics supplier for an authorized, copycat form of the osteoporosis drug. The Merck-blessed generic could go on sale as early as next month.

You'll recall that Fosamax's key patent is due to expire Feb. 6, and two generics makers--Teva Pharmaceutical Industries and Barr Pharmaceuticals--are first in line. Because they were first to ask the FDA for approval for their versions of Fosamax, they have six-month exclusivity. But that exclusivity doesn't apply to Merck itself, which could sell its own generic form or do so with a partner.

This type of arrangement--for an authorized generic--has come under fire as more and more pharma companies have begun to engage. Critics say they destroy the competitive advantage that six-month exclusivity is designed to confer; now, the Federal Trade Commission is studying the deals

- read the Wall Street Journal article

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Merck expects $1.8B hit on Fosamax. Report
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Merck expects $1.8B hit on Fosamax

Tue, 04 Dec 2007 06:59:58 -0500

We all knew that losing patent protection on Fosamax would cut into Merck's sales next year. We just didn't know how much. Now we do, or at least we know Merck's best estimate: about $1.8 billion. The drug maker issued its initial earnings outlook for 2008 today, and in it specifies Fosamax sales at $1.1 billion to $1.4 billion, down from $2.9 billion to $3.1 billion in 2007.

But Merck expects overall sales to grow by 4 percent to 6 percent through 2010, with a gross margin in 2008 of 77 percent to 78 percent. What drugs will account for this growth? Singulair, for one, and Cozaar/Hyzaar blood pressure meds for another. Vaccines will also contribute to growth. Analysts weren't thrilled with the numbers, though; overall, the forecast fell below market expectations.

Meanwhile, the drug maker is paying $670 million to settle claims that it sold drugs to Medicaid at inflated prices. At issue is "nominal pricing," in which Merck gave big discounts to hospitals that helped grow market share on certain drugs--but didn't give the same discounts to Medicaid as it's required to do.

- see the release from Merck
- read the Wall Street Journal story
- get more on Merck's nominal pricing in the Wall Street Journal's Health Blog

ALSO: Take a look at Merck's pipeline. Report

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ALSO NOTED: Amgen drug fails breast cancer trial; Patients want class status in Fosamax suit;

Mon, 03 Dec 2007 06:59:50 -0500

> Amgen's anemia drug Aranesp failed to shrink breast tumors in an early-stage trial of the drug against breast cancer. Report

> Lawyers for patients who say their jaws were damaged by Merck's osteoporosis drug Fosamax argued for class-action status, saying the company should pay for dentists to monitor the patients for complications. Report

> The FDA gave the nod to Alcon's new Triesence injectable drug for use in eye surgery. Report

> The Chinese company that suspended its contaminated methotrexate product in September says it will compensate victims who experienced side effects. Report

> Following an investment in Regeneron, Sanofi-Aventis' Marc Cluzel (photo) reiterated the company's plans to aggressively pursue biotech buyouts. "If there is a good deal to be done, we will do it. We are very pragmatic," Cluzel told investors. Report

> The Massachusetts Biotechnology Council has two big projects in the works: it's upping its lobbying spending and at the same time kicking off an ad campaign to boost its profile in the state. Report

And Finally... Early warning of what's next in cosmeceuticals: A skin patch that blocked the effects of a single gene reversed skin aging in mice. Report

Pharma growth sinking to historic low

Thu, 01 Nov 2007 07:59:58 -0400

Here's statistical confirmation of the gloom-and-doom facing Big Pharma. Worldwide sales growth will slow next year to around 5 percent from 6 to 7 percent this year, according to a new report from IMS Health. In the U.S., growth will hit a historic low of 4 to 5 percent as generics march in to battle with brand-name drugs like Johnson & Johnson's Risperdal and Merck's Fosamax. And because of increased FDA scrutiny, new drugs aren't likely to fill the void.

Meanwhile, emerging markets will account for one-quarter of the increase in pharma sales--but they'll be buying generics because they can't afford brand-name meds.

- check out the release from IMS Health
- read the article from the Washington Post

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Roche, Teva square off in patent fight

Tue, 11 Sep 2007 06:59:55 -0400

To brand-name drug makers, Teva Pharmaceuticals is something of a Big Bad Wolf: I'll huff and I'll puff and I'll blow your patents down!

Of course, Big Pharma is no defenseless little pig--just witness Novartis' successful (at least for now) shutdown of Teva's copycat Famvir. Now, Roche is suing Teva for producing a generic version of its osteoporosis treatment Boniva, whose patents begin to expire in 2012. The drug racked up $314 million in sales just in the first half of 2007, so it's well worth the legal expense. Roche is asking a New Jersey court to keep Teva's generic version off the U.S. market.

- read the article from the International Herald Tribune

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IMS lists best drug launches of all time

Wed, 22 Aug 2007 06:59:58 -0400

It's not easy being a global pharmaceuticals company. First, you have to develop drugs--and then you have to sell them, not only to your home country, but around the world. And there lies the rub, according to a new study from IMS Health.

The research firm found that, of 4,225 drugs launched, only 35 landed near the top of the heap in more than one country within two years. Why? Very few companies customized their sales pitches country-by-country. Tailored marketing isn't necessary only for cultural reasons, but also because different countries have different ways of paying for drugs: private insurance, state health services, and so on. In some countries, doctors have more influence--including the U.S., of course, but also in Italy and Japan. In others, doctors let regulators make their drug choices for them. Too often, drug makers ignore these distinctions; IMS concluded that only 15 percent of the drug launches successfully adapted to local markets.

The best launches of all time? Pfizer's Lipitor and Viagra, and Merck's Fosamax. IMS also included Eli Lilly's launch of Zyprexa and GlaxoSmithKline's of Avandia on that list, but we think they're disqualified. Hiding adverse safety data (Lilly) and black-box warning labels (GSK) will negate a successful start-up every time.

- read the report on the drug sales report from CNN

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