Singulair

Analyst gloomy on Merck trends

Tracy Staton — Thu, 11 Sep 2008 11:22:30 -0400

An influential pharma analyst downgraded Merck shares, saying they've hit their price ceiling. Why? The reasons can be summed up in four drugs: Singulair, Gardasil, taranabant, and Vytorin.

Sanford Bernstein's Tim Anderson wrote to investors that Singulair scrips are sluggish, and an ongoing FDA safety review could depress them further when it wraps up at year's end. Plus, Teva might launch a generic competitor next year even though it would be on shaky patent ground. Gardasil sales trends have been weak, too, Anderson says. Vytorin--and its sister cholesterol drug Zetia--have been suffering under controversy since the beginning of this year.

And then there are pipeline troubles, symbolized by the obesity drug taranabant's psychiatric side effects. Anderson thinks there's a good chance the med won't be approved. But, he says, Merck could turn this pipeline perception around in December with some good news at its annual R&D update. Guess we'll have to wait and see.

- see the Pharmalot post

Singulair gets off suicide free

Christe Bruderlin-Nelson — Wed, 03 Sep 2008 03:37:57 -0400

Despite Merck's revision of Singulair's prescribing information to include reports of tremors, depression, suicide and anxiousness, a new study by the American Lung Association finds that patients taking Singulair (montelukast) are no more likely to suffer from depression or to have an increased risk of suicide.

The independent researchers re-analyzed previous data and report their findings in the next issue of the Journal of Allergy and Clinical Immunology, but the study wasn't actually designed to assess suicidal ideation or suicide risk.

FDA approved the drug over a decade ago to treat seasonal allergy symptoms and asthma, but announced last March that it had received reports of suicidal thoughts and suicide, as well as mood and behavior changes, in patients taking the drug.

Two of the researchers disclosed financial ties with big pharma: Norman Edelman, MD owns stock in Johnson & Johnson, while Janet Holbrook, PhD, MPH has received research funding from Astra-Zeneca and Takeda. The American Lung Association says it has a strict policy against endorsing any product.

This year, the FDA has been expanding its look into the role medications play in psychiatric disorders, and are broadening their search beyond the usual suspects--psychiatric drugs--and looking at medications for asthma, seizures and smoking cessation.

- check out the press release
- see the AP report
- read the Pharmalot blog entry

Can Merck boost Singulair sales?

Tracy Staton — Thu, 07 Aug 2008 11:13:09 -0400

One of the shining stars over at Merck has been Singulair, the allergy and asthma med that pulled in some $4.4 billion last year. Well, for the most recent quarter, sales actually slipped by 1 percent as patients have defected to the new over-the-counter Zyrtec sold by Johnson & Johnson. Plus, the FDA's March announcement of a probe into a potential link between Singulair and suicidal behavior--and a fairly mild spring allergy season--didn't help. Merck acknowledged the flattening sales, lowering its forecast to a range of $4.4 billion to $4.6 billion from its previous estimate of $4.6 billion to $4.8 billion.

What can Merck do to turn it around? The company is offering $20 coupons for Singulair on its website, and it extended its spring ad campaign into the summer. "[W]e are taking additional steps to further support the brand," the company said late last month. Third-quarter sales figures will show just how successful those efforts turn out to be.

- read the story in CNN Money

Analyst: Singulair drop threatens Merck

Tracy Staton — Tue, 10 Jun 2008 10:22:04 -0400

Just what Merck doesn't need: Its asthma-and-allergy med Singulair is losing ground, with new scrips down year-over-year for 13 weeks straight. For the week ended May 30, the drop was 16 percent, and year to date, Singulair has fallen off by 4 percent. That's according to Sanford Bernstein analyst Tim Anderson, who's worried that Singulair performance might seriously undermine Merck's projected 2008 sales growth. The company has projected worldwide year-over-year increases in Singulair sales of 8 percent to 13 percent.

Anderson speculates on possible causes for the reversal. A light allergy season? Competition from a newly OTC Zyrtec? Headlines about the FDA's flagging Singulair as having a potential psychiatric problems? (Merck says safety isn't the reason for the slowdown.)

"As Singulair is Merck's single biggest drug--with 2007 sales of $4.3 billion, up 19 percent year-over-year, and representing 18 percent of total company sales--these trends are worrisome," Anderson writes in a note to investors. "Internationally, Singulair performance may well be better, but the U.S. accounts for nearly three-quarters of total Singulair sales." Even if scrips stopped dropping now, he notes, the drug would have a tough time making those sales goals.

- read the Pharmalot post

FDA nixes Merck, Schering allergy combo

Mon, 28 Apr 2008 06:59:56 -0400

In another blow to the Merck/Schering-Plough joint venture, the FDA rejected a proposed allergy and asthma treatment that would have combined Schering's Claritin and Merck's Singulair into one pill. In announcing the "not-approvable" letter from the FDA, the two companies wouldn't say why the med was rejected or whether the venture intends to resubmit.

Claritin was a heavy-hitter drug for Schering until it went off-patent and over-the-counter. Singulair, of course, is among Merck's best-sellers, with $4.3 billion in 2007 sales. The combo wasn't expected to be a home run, but losing the opportunity to sell it at all will no doubt cost millions. So why not try again? "We're still looking at it, and still evaluating the future of the joint venture as well," a Schering spokesperson said.

Evaluating the future of the joint venture, you say? Inquiring minds want to know whether that last phrase was just a throwaway comment--or a harbinger of change.

- check out the Schering press release
- see the item at PharmaGossip
- read the Associated Press story

Under pharma earnings, basic problems

Wed, 23 Apr 2008 06:59:55 -0400

You've heard of see-through buildings. How about see-through pharma earnings? Though drug makers have been reporting increases to their bottom lines, investors are looking past the foreign-currency gains and one-time earnings boosts to the fundamental problems the industry faces.

"Each company generally has had somewhat of the same narrative... limited pipeline visibility, patent expirations, and decelerating growth in their main products," one analyst told the Associated Press. Thus Wyeth lost Protonix revenues; Roche suffered from falling Tamiflu sales; Merck's Singulair, Vytorin, and Fosamax dropped off; Pfizer saw Zyrtec and Norvasc decline; and Lilly's top seller Zyprexa deflated.

Of course Big Pharma also confronts a larger problem, just as most other U.S. companies do: the economy. As Steve Brozak of WBB Securities pointed out, the lackluster quarter is just one more sign of an overall market shift. "This proves to us that we're in a recession," he said.

- read the Associated Press story

Emerging markets drive global growth

Wed, 16 Apr 2008 06:59:56 -0400

Without emerging healthcare markets like China and India, global pharma would be in a world of hurt. The global market for meds reached $712 billion last year, according to a new report from IMS Health, up $178 billion over five years before. But the rate of growth is slowing--6.4 percent compared with 11.8 percent in 2001. And without the big engines in Asia, that figure would be lower still. China, South Korea, and India grew by 25.7 percent, 10.7 percent, and 13 percent respectively. Russia and Turkey, 20.2 percent and 17.2 percent. The U.S.? Just 3.8 percent.

The IMS report also included the top 10 sellers worldwide (drum roll, please):

Lipitor, $13.5 billion, Pfizer
Plavix, $7.3 billion, Sanofi-Aventis
Nexium, $7.2 billion, AstraZeneca
Seretide/Advair, $7.1 billion, GlaxoSmithKline
Enbrel, $5.3 billion, Amgen and Wyeth
Zyprexa, $5 billion, Eli Lilly
Risperdal, $4.9 billion, Johnson & Johnson (Janssen)
Seroquel, $4.6 billion, AstraZeneca
Singulair, $4.5 billion, Merck
Aranesp, $4.4 billion, Amgen

Note that Aranesp made the top 10 despite a 12.9 percent drop in sales on safety worries. And the biggest gainer of the year was Plavix, the anti-clotting med; it racked up a 20.5 percent increase in sales.

- see the item at Pharmalot

ALSO: In response to the growing overseas market, DIA is opening an office in India. Release

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FDA issues early-warning trifecta

Fri, 28 Mar 2008 07:59:56 -0400

It was a busy day yesterday for FDA safety reviews, with a trifecta of announcements raising questions about drugs for everything from allergies to HIV. They're all "early communications," which means they're notifications that the FDA spied some troubling research but hasn't yet decided how significant/valid/action-worthy the data is. Here's the Cliff's Notes version:

Merck's blockbuster allergy-and-asthma med Singulair is under investigation for a possible link to suicide. The FDA is reviewing a handful of reports of mood changes, suicidal behavior and suicide. Just in the past year, Merck has updated the drug's labeling four times to include info on reported side effects, including anxiousness, depression, and suicidal behavior. Now, the agency wants Merck to dig into its Singulair data for evidence of links to suicide. The review could take up to nine months.
New data on Johnson & Johnson's foot and leg ulcer drug Regranex seems to show that patients have a higher death rate from cancer. The FDA is reviewing the study, conducted between 1998 and 2003. It's a larger study than the 2001 research that showed a higher cancer risk in patients who took Regranex.
Data pooled from a 33,000-patient study showed that those using GlaxoSmithKline's Ziagen and Bristol-Myers Squibb's Videx had a greater risk of heart attack than patients using other HIV meds. The new study may prompt labeling changes for the drugs, the FDA said, but stressed that it's still looking at incomplete data. GSK and Bristol said their own review of the info showed no increased risk.

Of course all these FDA reviews may end happily, with no new warnings or labeling changes. The "early communication" is part of the FDA's bid to be more transparent and notify the public earlier when concerns about various products arise. We'll keep you posted.

- see Merck's statement on the Singulair review
- read the Singulair story in the New York Times
- check out the J&J article at CNN Money
- check out the WSJ story on the AIDS meds
- get more details from Pharmalot on the HIV drugs

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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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SPOTLIGHT: Merck profits jump by 62 percent

Mon, 22 Oct 2007 06:59:52 -0400

Merck & Co. saw its profits soar by 62 percent to $1.53 billion, on a 12 percent jump in revenue and lower admin and overhead costs; Singulair was the big seller for the quarter at $1 billion. Release

Merck, Schering to combine blockbusters

Tue, 28 Aug 2007 06:59:57 -0400

Why not build on success? Schering-Plough and Merck are asking the FDA to approve a pill that combines the active ingredients of Singulair, the blockbuster asthma-and-allergy remedy, and Claritin, another best-selling allergy drug that went generic and over-the-counter in 2002. Under development by a joint venture of the two companies, the new product has been accepted for the FDA's standard review process.

- see the release on the combination package

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