patent expirations

J&J nabs Topamax patent extension

Tracy Staton — Fri, 25 Jul 2008 09:52:25 -0400

Johnson & Johnson's epilepsy med Topamax won't go off patent in September as scheduled because the FDA has extended market exclusivity for one year based on a new pediatric indication for the med. Report

Pfizer, Ranbaxy settle Lipitor patent dispute

Maureen Martino — Wed, 18 Jun 2008 10:08:52 -0400

Pfizer and Ranbaxy have come to an agreement that will end most of their five-year battle over the generic production of Lipitor, the world's best-selling drug. Ranbaxy will have a license to sell generic versions of Lipitor and Caduet in the U.S. effective November 30, 2011, and on varying dates in seven additional countries. Lipitor's patent expires in 2010, but two patents covering the production of the drug don't run out until 2016. Pfizer had argued in the past that Ranbaxy's plans to produce a generic version of the $10 billion-a-year drug violated those two patents. Under the agreement, Ranbaxy gets access to all the patents it need to product generic Lipitor. Ranbaxy will have exclusive rights to the generic drug for the first six months of its production.

"This agreement is a win-win-win because it is pro-patient, pro-competition and pro-intellectual property," said Ian Read, president of Worldwide Pharmaceutical Operations for Pfizer. "The agreement provides patients with access to a generic product much earlier than if Ranbaxy were unsuccessful in obtaining approval for its product and overcoming the relevant patents."

Daiichi Sankyo, of course, just made a $4.6 billion bid for Ranbaxy. Just one day after that deal was announced, reports circulated that Pfizer would consider a counter-offer, based partially on the fact that Ranbaxy was planning to launch a generic version on Lipitor.

- see this release for more
- here's the Wall Street Journal article

Silver lining to Big Pharma's cloud?

Fri, 09 May 2008 06:59:56 -0400

Some people see the Big Pharma glass as half-full instead of the alternative. In an investor's-eye look at the industry, Kiplinger ticks off the usual criticisms: patent expirations, tough generics competitors, skyrocketing R&D costs, picky regulators, and election-year political pitfalls. But it also says that beaten-down pharma stocks are so cheap, for some there's no way to go but up.

Institutional investors tell the magazine that "gloomy" Pfizer can only get better, that Johnson & Johnson has consumer healthcare and devices as hedges, and that Schering-Plough is dirt cheap and, given its comparative lack of copycat exposure, poised to rise. The whole sector has several forces pulling in its favor, too. Strong cash flow that could be even stronger if they'd cut unproductive R&D, there are the undeniable demographics of the baby boom, and Big Pharma possesses the kind of marketing muscle that smaller drugmakers will pay dearly for. Not to mention the propensity for pulling rabbits from empty hats: "It always seems like they have nothing in the pipeline...Then they always come up with something."

- read the Kiplinger article

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

Lundbeck poaches CEO from Wyeth ranks

Tue, 29 Apr 2008 06:59:55 -0400

Wanted: CEO who can find a new "cash cow" to push a Danish drugmaker past impending patent expirations. Found: Ulf Wiinberg, lately of Wyeth, to take over Lundbeck. Soon to be ex-president of Wyeth's operations in Europe, the Middle East, African and Canada, Wiinberg also had been charged with strategic oversight of Wyeth's biopharma. Can Wiinberg deliver for Lundbeck? No doubt we'll soon see what he can do.

- read Lundbeck's release
- check out the brief at Money AM
- see the item at PharmaGossip

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

SPOTLIGHT: The top five layoffs of 2007

Tue, 16 Oct 2007 06:59:52 -0400

2007 has been a rough year for a number of the pharmaceutical and biotech industry's biggest players. Concerns about patent expirations, falling sales due to drug safety concerns, redundancy from acquisitions and a general need streamline operations contributed to these companies' decisions to cut employees. Check out this list of the top five pharma and biotech layoffs of 2007 for more. Report

Moody's downgrades pharma industry

Thu, 11 Oct 2007 06:59:58 -0400

As if Big Pharma didn't have enough challenges. Moody's Investors Services has downgraded the entire industry's credit rating, cutting its 12-month outlook to "Negative" from "Stable."

Upcoming patent expirations affect some 40 percent of most pharma companies' revenue, Moody's analyst Levesque noted. Big Pharma has been doing deals with biotech firms in hopes of boosting their pipelines--deals that require lots of cash. And though the industry has a lot of cash on its books, the rate at which it's burning it is a concern.

And then there are safety problems: liability-related, as with Merck and Vioxx; and FDA-related, with the agency increasingly asking for more information and new studies before approving new drugs.

- see the report from the Houston Chronicle
- check out this company-by-company risk breakdown

Related Articles:
PwC to pharma: Adapt and invest or die. Report
Patent 'cliff' looms for Big Pharma. Report
Where's the ROI on drug R&D budgets? Report
Is pharma's drug discovery model sustainable? Editorial
M&A activity heats up as biotech IPOs struggle. Report

Pfizer, Wyeth merger bad idea?

Mon, 27 Aug 2007 06:59:55 -0400

Fortune writer John Simons opines that a rumored merger of Pfizer and Wyeth would be all wrong for both companies. In his view, a merger would amount to a marriage of weaknesses. Pfizer needs blockbusters to overcome looming patent expirations and Wyeth has recently been failing to deliver.

"Would the idea behind the merger be that misery loves company?" says Standard & Poors pharma analyst Herman Saftlas. "Most mergers in this sector haven't panned out from an earnings growth perspective. But even worse, these two companies are in the same boat."

- read Simon's opinion piece

Related Articles:
Wyeth buyout a good deal for Pfizer? Report
What's next for Pfizer? Report
Wyeth stumbles badly trying to develop new drugs. Report