Happy Independence Day

Tracy Staton — Thu, 02 Jul 2009 10:25:00 -0400

The news may never stop, but it does take a break. In celebration of Independence Day, FiercePharma will not publish tomorrow, July 3. We'll be back fresh from the long weekend on Monday. Have a safe and enjoyable holiday.

Elan did it: J&J sinks $1B into partnership

Tracy Staton — Thu, 02 Jul 2009 10:19:46 -0400

Elan's wish came true. The Irish company attracted a Big Pharma partner--Johnson & Johnson--to take a minority stake, just as it's been hoping for all along. J&J will sink $1 billion into Elan in return for an 18.4 percent ownership interest. Plus, J&J will assume Elan's partnership with Wyeth on Alzheimer's remedies; Elan will hand over its related assets to a new J&J affiliate company in return for a 49.9 percent stake in the venture's profits and royalties.

Elan has been seeking a jump-start since January, when it hired Citigroup to explore strategic options, including a sale of part of all of the company. Execs were crystal clear on their preference for a minority partner, however, even as rumors flew about wholesale buyouts. Among those said to be mulling an Elan deal were Lundbeck, Bristol-Myers Squibb, and most recently Sanofi-Aventis.

Meanwhile, management and the board of directors have been at each other's throats, with dissident shareholders complaining that CEO Kelly Martin and other Elan managers lacked the proper experience to pump the embattled multiple sclerosis treatment Tysabri and handle the company's other commercial efforts. Finally Elan invited its most scathing critic, the ex-Abbott Labs President Jack Schuler, to join the board, along with another Big Pharma ex, Charles Bryson, late of Eli Lilly.

Now Elan has a new lease on life--and Johnson & Johnson gets access to the much-watched bapineuzumab, a potential Alzheimer's remedy in late-stage trial. We'll have to wait and see what problem Schuler focuses on next.

- get the release from J&J and Elan
- read the Irish Times story

FDA moves pump life back into Sanofi

Tracy Staton — Thu, 02 Jul 2009 09:54:35 -0400

Finally, some good news for Sanofi-Aventis. The FDA has given its blessing to the French drugmaker's new heart medicine Multaq as a treatment for atrial fibrillation. The drug is a cornerstone of Sanofi's plans to shore up sales as it loses patent protection on drugs that account for some 20 percent of its revenues. And the agency gave a shot in the arm to Sanofi's Lantus drug as well, pointing to "inconsistencies" in new studies that raised the spectre of a link between cancer and the diabetes treatment.

And the good news couldn't come at a better time; the company has been burdened by bad press over the past week, with the Lantus safety concerns drawing fire. Stock analysts have pummeled the company as the new studies uncovered a potential link between Lantus and cancer risk. (Sanofi CEO Chris Viehbacher called the database analyses "junk science" and promised a clinical trial to disprove the risk.) Those worries sent shares tumbling by 13 percent or so.

Plus, this week Sanofi announced another round of job reductions, this time via "voluntary departures," which are being offered to 1,300 workers, mostly in Europe. It's part of a new strategy for R&D, which Viehbacher hopes will bear innovative fruit, but the plant closures and selloffs--not to mention the job reductions--are sure to cause internal turmoil in the short term.

Now, though, pharma analysts are perking up, even as the FDA launches a safety review of Lantus, saying it plans to look at multiple data sources as well as the newly published research. Investors are listening; Sanofi stock has started to recover, picking up 3.1 percent yesterday after the FDA's Lantus statement. "The worries over Lantus also are abating," Philippe Lanone of Natixis Securities told Bloomberg. "We can look at Sanofi's future more serenely now." Presumably Viehbacher and company have cheered up, too.

- get the FDA's Lantus statement
- see the release from Sanofi
- read the Bloomberg piece
- check out the Lantus news from Reuters

Glaxo grabs Bristol's Middle East unit

Tracy Staton — Thu, 02 Jul 2009 09:33:29 -0400

It's another generics-in-emerging-markets deal for GlaxoSmithKline. The drugmaker has snapped up Bristol-Myers Squibb's branded generics biz in the Middle East--Lebanon, Jordan, Syria, Lybia and Yemen, to be exact. The size of the deal isn't large, just $23.2 million, but it further underscores Glaxo's new strategy of hawking cheaper meds in developing countries. Already the company has bought portfolios of products from BMS in Pakistan and Egypt, and it inked collaboration deals with Dr. Reddy's Laboratories and South Africa's Aspen.

Glaxo chief Andrew Witty has made headlines with his push toward emerging markets and generics, as well as his commitment to cut prices in poorer nations--a move intended to offer more drugs to more people at a lesser cost, sure, but also a strategy for boosting sales on volume rather than on price. Just this week, the company's Asia Pacific exec predicted sales in that region would double over the next five years.

Of course, Glaxo isn't alone in its new love for the up-and-coming drug markets of the world. Sanofi-Aventis has been quite active in buying drugs and drugmakers in developing nations, and other Big Pharma firms are targeting China, India, Brazil--any market pegged to grow more quickly than the stagnating U.S. and Europe.

- see the GSK release
- read the news from Reuters

Doc-gift bans take effect in New England

Tracy Staton — Thu, 02 Jul 2009 09:22:09 -0400

Today's D-Day in Massachusetts and Vermont--Doctor-gift-law Day. In both states, new legislation takes effect that totally overhauls the rules governing everything from logo notepads to expensive junkets and everything in between. Even free meals will be verboten in Vermont. And though these two states now have the most restrictive pharma-doctor rules in the country, other states are considering similar bans.

As you know, the debate over financial relationships between drugmakers and doctors has really heated up over the last year or so. Congress has been investigating ties among pharma, doctors and academic researchers; lawmakers at the federal and state levels are mulling disclosure rules; medical schools and their teaching hospitals have been overhauling policies on gifts, free samples, speaking fees and consulting, and more. "There is a genuine recognition within the medical profession that the financial entanglements with industry have become problematic," said Allan Coukell, director of the Pew Prescription Project, told the Wall Street Journal.

Some, however, think the pendulum is swinging too far in the opposite direction. As the WSJ points out, some prominent physicians have banded together to oppose the restrictions, saying that financial relationships between doctors and industry aren't bad in and of themselves. What do you think? The WSJ Health Blog is running a "question of the day" about the gift bans, so go on over and have your say. While you're at it, let us know, too.

- read the WSJ story
- check out the Health Blog post

More Seroquel suits dropped on Delaware ruling

Tracy Staton — Thu, 02 Jul 2009 08:39:52 -0400

Two more cases have been dismissed in Delaware in the sprawling litigation over AstraZeneca's antipsychotic drug Seroquel, as plaintiffs' attorneys voluntarily dismissed cases that had been set for trial in November. Report

Pfizer, GSK's stop-smoking meds get warning

Calisha Myers — Wed, 01 Jul 2009 13:14:18 -0400

Federal regulators have ordered new safety language on the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The two meds are getting the toughest warning added to their labels, alerting doctors and patients to potentially severe mental health risks, including behavioral changes, depression, hostility, suicide, and suicidal thoughts, as well as warnings about allergic and skin reactions.

The FDA has been reviewing Chantix safety since 2007, after hundreds of reports of erratic, aggressive and suicidal behavior. But as the agency notes, it's difficult to confirm these drugs are directly responsible, because nicotine withdrawal itself can be very difficult to endure. There's also the possibility that Chantix exacerbates symptoms of underlying mental illness rather than causing them--a problem that would have gone undetected in clinical trials because they excluded patients with a history of mental illness.

Hence the new trials FDA is requiring both Pfizer and GlaxoSmithKline, Zyban's maker, to undertake. Pfizer says it's currently conducting a safety study involving patients with schizophrenia and is in talks with the FDA regarding comparative studies. Glaxo will also be required to study Zyban's mental health effects on patients, including those with pre-existing mental problems.

"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research. "Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit."

Pfizer won't yet say how the warning might affect its financial forecast or its Chantix sales force, but promises an update July 22 on sales figures for its primary care unit, in tandem with its earnings report. Meanwhile, GSK hasn't released a statement at all, despite the fact that the warning goes onto two of its meds: Zyban is sold as an antidepressant under the brand name Wellbutrin, and that drug gets updated "boxed warning" language added to its current "boxed warning" of suicidal thoughts and behavior. Generic versions, too. But Glaxo doesn't make much off Zyban, while Chantix is one of Pfizer's top selling meds, bringing in $846 million last year.

- read the FDA announcement
- here's Pfizer's response
- get more from CNBC
- check out the story in the New York Times

Most profitable drugmaker? Not a Big Pharma

Tracy Staton — Wed, 01 Jul 2009 10:22:15 -0400

Which pharma is the most profitable? You might be surprised. A new analysis of net margins by EvaluatePharma tagged companies for profitability, and the winner wasn't one of the biggies. Not Pfizer, not Johnson & Johnson ... but PDL BioPharma. Yep, that little drugmaker that managed a net margin of 68.9 percent in 2008, posting a profit of $203 million for the year.

In fact, when you look at EvaluatePharma's net margin numbers, you'll crawl down below the top five to get to the first Big Pharma. Pfizer came in at seventh with a net margin of 33.9 percent, up 2.5 percentage points from 2007. (Profits for the No. 1 drugmaker by sales amounted to $16.4 billion.) Merck captured ninth place with a net margin of 32.2 percent (and profits of $7.67 billion). Check out the list for more.

- see the list and analysis at Seeking Alpha

AZ wins on Iressa, could lose on Crestor

Tracy Staton — Wed, 01 Jul 2009 10:09:55 -0400

It's a mixed bag of AstraZeneca news today: The drugmaker finally won the Euro-OK for its oral cancer med Iressa. Thumbs up, yes? But the Crestor developments weren't so happy. One, a self-appointed patent watchdog group said it had evidence that Crestor's patent was invalid. Two, a JAMA study found that C-reactive protein isn't the risk factor for heart disease that it's been made out to be.

How does that last bit affect Crestor? Well, the new data calls into question the big Jupiter trial, which showed patients with extremely low LDL and CRP had a lower chance of heart attacks. That may be so, experts now say, but it doesn't mean everyone should be tested for CRP. Doh! AstraZeneca had hoped to push CRP screening so that any and all patients with high levels could be put on Crestor.

As for the patent problem, Article One Partners announced that it had a "prior art" that applies to Crestor, which means that there could be a problem with that patent. Essentially, Article One is saying that it has evidence that the technology underlying Crestor's patent was previously patented itself. Of course, that claim has to bear up under scrutiny, but Article One has been successful at getting U.S. regulators to re-examine drug patents. And AstraZeneca is already defending its rights to Crestor exclusivity; several generics makers are salivating after copycat versions of the cholesterol fighter.

But to end on a high note. Iressa nabbed an important approval in Europe, gaining authorization as a treatment for adults with locally advanced or metastatic non-small cell lung cancer whose tumors have an EGFR mutation. It's a mouthful, but it's also a glimmer of hope for the oral drug, which initially was hailed as a potential blockbuster, but then it failed a major trial and AstraZeneca withdrew its application for approval in Europe. Two new trials comparing Iressa with chemotherapy changed regulators' minds, apparently. Now the drugmaker just has to convince doctors and pathologists to look regularly for that mutation.

- see AZ's release
- check out the CRP story from the Wall Street Journal
- read more on the Crestor patent from Reuters
- get the Iressa news, also from Reuters

ALSO: AstraZeneca chief David Brennan--who's also this year's PhRMA chairman--sets out his prescription for healthcare reform in today's Washington Post. Report

Sutent fails in colon-cancer trial

Tracy Staton — Wed, 01 Jul 2009 09:46:13 -0400

Once again, Pfizer calls an early halt to Sutent research--and it's not good news. The cancer drug failed as an add-on to chemotherapy in first-line treatment of colon cancer, the company said, proving no more effective than standard chemo alone. "We are disappointed with this result, but trial successes and failures are an integral part of cancer drug development and contribute to a growing body of knowledge on improving patient care," Dr. Mace Rothenberg, head of clinical development and medical affairs for Pfizer's oncology unit, said in a statement.

You'll recall that a few weeks ago, Pfizer stopped a breast cancer trial because Sutent wasn't likely to meet its endpoint; in that study, Sutent plus chemo was pitted against Roche's Avastin plus chemo. The Pfizer med also failed another head-to-head trial, this time against Roche's Xeloda. Two other late-stage breast cancer trials are ongoing, though, looking at Sutent in combo with Xeloda and in combination with Sanofi-Aventis' Taxotere. Results from both are expected either late this year or early next.

Meanwhile, on the positive side of the ledger, Sutent performed admirably in a pancreatic cancer study this year. Pfizer stopped a study in March because the drug clearly increased progression-free survival for patients with a rare form of the disease, pancreatic islet cell tumors. The data was presented last week at a gastointestinal cancer summit in Europe.

- see the statement from Pfizer
- read the Reuters story
- check out the pancreatic cancer article at mediLexicon