FierceBiotech

A fierce response from readers

John Carroll — Thu, 02 Jul 2009 10:23:02 -0400

When we ran the 2009 Fierce 15 report at the beginning of this week, we expected a big response. But even the optimists among the editorial crew here were surprised by the hard numbers. Monday provided the biggest single daily haul of page views in FierceBiotech's history. And Tuesday offered another bumper crop of readers. It all helped us make June the single biggest month ever for Web traffic.

It's always a lot of fun to go out and select a list of developers doing exciting things in the world of biotechnology, and we appreciate your clear interest in the project. As I mentioned earlier in the week, I start a new Fierce 15 once the report is posted. I've already received a number of suggestions and I encourage you to add your voice to the process.

On another note, we're preparing for the July 4th weekend and won't be publishing on Friday. We'll see you again on Monday. Enjoy the holiday. - John Carroll

Eisai creates jobs, readies Aricept NDA

Maureen Martino — Thu, 02 Jul 2009 09:45:01 -0400

Japan's Eisai has completed construction of a European Knowledge Centre in the UK, which could bring up to 250 jobs to the region. It's part of a £100 million effort to launch a strategic base giving Eisai it's first manufacturing facilities in Europe.

In addition to the manufacturing capabilities, the project includes a research laboratory and offices. Eisai will move its R&D activities, drug production and marketing to the new headquarters, where 500 people are expected to be employed. Half of those will be newly-created positions.

In a separate announcement, Eisai said that it's planning to submit an NDA for a new formulation of it's Alzheimer's drug Aricept in August or September. The existing version of Aricept makes up 40 percent of the company's sales, and will be going off-patent next year.

- read the Business Weekly report
- see this report on Aricept

King, Acura get FDA response letter

Maureen Martino — Thu, 02 Jul 2009 09:10:03 -0400

The FDA has issued a Complete Response Letter to King Pharmaceuticals and Acura Pharmaceuticals regarding their NDA for the pain drug Acurox. The agency has questions about the potential abuse deterrent benefits of Acurox, which the two companies say they can address without having to conduct additional clinical trials. Report

J&J to invest $1B in Elan, scoops up drug program

John Carroll — Thu, 02 Jul 2009 08:22:21 -0400

After months of rumors regarding potential deals, Ireland's Elan Pharmaceuticals announced this morning that Johnson & Johnson will invest a billion dollars into the company while taking control of Elan's rights in a key Alzheimer's drug program.

J&J is taking over Elan's rights to the Alzheimer's program, which is partnered with Wyeth, through a newly formed company, initially committing $500 million into the development of the drug. And Elan will keep 49.9 percent of the new company, with a share of the profits and the royalties.

"This transaction will leverage Elan's unique scientific and clinical work and leadership in bringing treatments to market that potentially slow the progression of Alzheimer's disease," said Elan CEO Kelly Martin in a statement. "The Elan commitment to scientific innovation and patients remains absolute and we will continue to build upon and expand our leadership in the fields of neuroscience and immunology."

"Johnson & Johnson's development capabilities, commercial experience and global reach will provide the foundation to accelerate the AIP Program development, and increase its potential availability for patients globally," said Sheri McCoy, worldwide chairman, pharmaceuticals, Johnson & Johnson.

- check out J&J's release

Sanofi-Aventis wins big with Multaq approval

John Carroll — Thu, 02 Jul 2009 08:05:58 -0400

After a long, dry spell, Sanofi-Aventis' pipeline has finally produced a winner. The FDA has approved its blockbuster heart therapy Multaq.

While expected, the news Thursday morning raised a swift cheer from the ranks of stock analysts. Sanofi has estimated Multaq's earnings potential at more than €1 billion a year. And some of the analysts' estimates go higher than that.

"The drug is now approved, ending Sanofi's streak of pipeline futility," Gbola Amusa, an analyst with UBS, tells Dow Jones. Amusa believes that Multaq can earn €1.4 billion annually.

While the road to an approval has been a long one, the news also bolsters Chris Viehbacher, who was recently brought in to help shake up the pharma giant and make it more productive. And he's already announced a major reorganization in its R&D arm. "The FDA approval of Multaq is an important milestone in the management of atrial fibrillation or atrial flutter that demonstrates the commitment of Sanofi-Aventis to provide patients and physicians with important new medicines," said Viehbacher.

- check out the report from Dow Jones

Sepracor depression drug flunks a mid-stage test

John Carroll — Thu, 02 Jul 2009 07:46:43 -0400

Sepracor ran into an unexpected setback on a mid-stage therapeutic for depression. Researchers say that the drug--SEP-225289--failed to deliver positive data in a trial that dosed 514 patients over eight weeks.

The developer says that the drug levels that reached patients' bloodstreams were lower than they had seen in earlier studies and that the side effect profile that emerged was different as well. And on top of that, U.S. regulators ordered a halt to two trials of the insomnia drug Lunesta in children. Regulators have concerns about non-clinical data that could be relevant in pediatrics. The double whammy cost Sepracor about 15 percent of its share price.

Sepracor says it's evaluating the mid-stage drug program before deciding how to proceed. SEP-225289 is a triple reuptake inhibitor based on its activities at the serotonin, norepinephrine and dopamine transporters.

"While we are clearly disappointed with the findings from the analysis of the preliminary study results, we are in the process of further analysis of the dose response and secondary endpoints to determine how or if we will take this novel mechanistic approach forward," Mark Corrigan, Sepracor's executive vice president of research and development.

- read the Sepracor release
- read the report from Reuters

Discovery Labs shares pummeled on new Surfaxin roadblock

John Carroll — Thu, 02 Jul 2009 07:30:45 -0400

Discovery Laboratories lost more than half of its stock value yesterday afternoon, plunging to 52 cents a share after investors got news of a new roadblock at the FDA for its respiratory drug Surfaxin.

After a four-year quest to gain an approval on the drug, Discovery Labs said that regulators had changed course in a meeting in early June, saying the developer had not offered enough data to gain an approval for the therapy - designed to treat respiratory distress in premature babies. And that would make it unlikely to get an approval with existing data. The FDA had declined to approve Surfaxin in April, but added that it felt it had supplied the agency with the necessary data to address its concerns.

"At the recent June 2 meeting," the company stated, "Discovery Labs learned that the FDA will now apply a newly defined standard to determine whether Discovery Labs has adequately demonstrated comparability of Surfaxin clinical to commercial drug product. This new standard represents a significant hurdle for approval of Surfaxin." The agency suggested that a new limited clinical trial would help its chances for gaining an approval.

In the short term Discovery Labs plans to focus on its other programs and will wait to further analyze a full record of its discussions with the agency before deciding on its next step.

- check out the report from Dow Jones
- read the press release

Discovery Labs: Surfaxin approval unlikely

Maureen Martino — Wed, 01 Jul 2009 22:27:19 -0400

Following an end of review meeting with the FDA, Discovery Labs said yesterday that it is unlikely that its lung drug Surfaxin will gain the agency's approval anytime soon. The company was dealt a blow in April when the FDA rejected it's application for the drug, saying that certain aspects of a Surfaxin biological activity test (a quality control stability and release test) had to be resolved before the Surfaxin can win approval. The drug is intended to treat premature infants with Respiratory Distress Syndrome.

At a follow-up meeting in early June, the FDA said it was applying a newly-defined standard to determine whether Discovery Labs had adequately demonstrated comparability of Surfaxin to commercial drug product. In a statement, the company said the FDA's new standard represents a "significant hurdle" in their quest for Surfaxin's approval, adding that it is unlikely that Discovery will be able to satisfy this requirement with existing preclinical comparability data. That virtually ends the drug's chances of near-term approval.

Discovery may appeal the FDA's decision, but in the meantime it will focus on two pipeline programs--Surfaxin LS and Aerosurf. According to the company's CEO Robert Capetola, the issues raised by the FDA regarding Surfaxin do not apply to the company's other programs.

- here's Discovery's release
- see the Reuters report

FDA wants more info on Novartis' Menveo vax

John Carroll — Wed, 01 Jul 2009 11:06:55 -0400

The FDA has asked Novartis for more information on its meningitis vaccine Menveo, which is likely to push back any approval date to late this year or early in 2010. And the manufacturer was quick to note that the agency is focused on questions regarding production, not safety or efficacy. That means no new clinical trials are needed to satisfy the agency's request.

It's a setback for Novartis, but not a serious obstacle. "While the financial impact is small, the setback is nevertheless a disappointment," said Vontobel analyst Andrew Weiss. But with prospective annual sales of $650 million, any delay is likely to sting. Menveo has demonstrated it can guard against the four most common types of meningitis.

- read the report from the Wall Street Journal

Are biotech CEO's worth what they're paid?

John Carroll — Wed, 01 Jul 2009 10:22:30 -0400

With a number of UK biotechs struggling to find cash to stay afloat, investors are raising some sharp questions about the pay packages that executives in the industry earn. A recent survey by Nature Biotechnology concluded that the average CEO in the UK earned close to half a million dollars in annual compensation, modest compared to many U.S. salaries.

But that figure doesn't sit well with many of the investors being asked to bail out shaky developers. The pay doesn't live up to actual performance, critics say.

"There are quite a number of companies paying really quite substantial sums to CEOs and board members when they have very poor prospects. It cannot be helpful for the companies to have people draining cash out of them in this way," William Bains, associate faculty member at the Institute of Biotechnology, University of Cambridge, tells the Wall Street Journal.

"We can't allow the industry to just disappear, and then say that part of the problem was executive pay," Robin Davison, an analyst at Edison Investment Research in London, says.

- read the report in the Wall Street Journal

Related Article:
CEO pay: Who makes what in Big Biotech?