Elan

Elan hires ex-Lilly exec Paya as new prez

John Carroll — Thu, 20 Nov 2008 10:44:18 -0500

After hunting the biopharma world for more than a year, Ireland's Elan has hired former Eli Lilly exec Carlos Paya as its new president. Paya will be in charge of the company's scientific, clinical and medical initiatives. Chief Scientific Officer Dale Schenk and Chief Medical Officer Ivan Lieberburg will both report to him. Paya had been vice president of Lilly Research Laboratories and global leader of the diabetes and endocrine platform.

Paya, 49, will be based in San Francisco, where he will also be responsible for commercial and marketing functions. The new hire deepens Elan's executive expertise. CEO Kelly Martin had held both titles previously.

- here's the release
- check out the AP report

Elan shareholders file lawsuit

Calisha Myers — Wed, 15 Oct 2008 12:23:50 -0400

Elan shareholders have filed a class action suit against the company. The biotech is being accused of making false and misleading statements regarding the development of the Alzheimer's drug bapineuzumab, which led to a significant loss in profits.

According to a statement released by the shareholders, Elan did not fully disclose the unfavorable results of a Phase II clinical trial conducted by Elan and its development partner, Wyeth. The companies announced in June that the drug wasn't effective in treating dementia in the overall study population, but the vaccine helped patients without a gene known as ApoE4, which is the case for approximately 70 percent of Alzheimer's sufferers.

Despite questions and criticism, Elan moved the drug into phase III trials. When the data was released in July, the inconclusive results caused more questions than it presented answers. Amidst concerns about the potential for FDA approval, the price of Elan's stock dropped from $33.75 to $19.63 in one day.

- see this release for more

FDA holds back approval for J&J schizophrenia med

John Carroll — Wed, 27 Aug 2008 10:11:34 -0400

The FDA has put up at least a temporary roadblock to J&J's schizophrenia drug paliperidone palmitate. A once-monthly injectable with the same active ingredient as Invega, a newly approved antipsychotic, the agency says it will need more information on the therapy before they can give it the stamp of approval. But it might not present a lengthy delay. J&J noted that the FDA is not asking for a new trial and says it will work with the FDA in answering all of its questions. The therapy uses technology from Elan, which stands to gain from an approval.

- check out the Johnson & Johnson release
- read the report from the Wall Street Journal

Cinven drops out of bidding for Elan division

John Carroll — Thu, 21 Aug 2008 11:02:10 -0400

The bidding war for Elan Drug Technologies, a division of the big Irish biotech, just lost a key player. The private equity player Cinven has dropped out of the auction, leaving Bain Capital and TPG. Apax and KKR haven't made a bid yet, but observers say they may yet.

The product development and manufacturing operation should fetch up to $1.5 billion. After the sale, Elan plans to concentrate entirely on biotechnology.

--read the story from the Financial Times

Elan considers selling division

John Carroll — Mon, 21 Jul 2008 11:29:45 -0400

Ireland's Elan is considering selling its development and manufacturing division for around $1.5 billion, a move that would leave the company devoted to its bio-pharmaceuticals business. Report

Alzheimer's drug results boost Elan, Wyeth

Maureen Martino — Tue, 17 Jun 2008 13:02:51 -0400

Wyeth and Elan's shares were up today as the companies announced potentially promising results from a phase II trial of bapineuzumab, an Alzheimer's treatment. The study did not attain statistical significance on the efficacy endpoints in the overall study population, but the vaccine helped patients without a gene known as ApoE4. About 70 percent of Alzheimer's sufferers don't have the ApoE4 gene. A spokesperson for the company said the results support the decision to move bapineuzumab into Phase III trials.

- see this release for more

Elan wins $55M judgment in patent scrap

John Carroll — Mon, 16 Jun 2008 07:38:16 -0400

Ireland's Elan won a $55.2 million judgment against Abraxis BioScience on Friday, prevailing in its case that Abraxis' breast cancer drug Abraxane uses a technology protected by an Elan patent. Abraxane was approved by the FDA three years ago. This fight is far from finished, as Abraxis says it plans to appeal the ruling.

- read the report from RTT News

ALSO: Investors are anxiously awaiting a Phase II update from Elan and Wyeth on bapineuzumab, a potential blockbuster drug targeted at the root causes of Alzheimer's. Significant success in the clinic would pave the way for a new drug to compete against therapies that offer little long-term benefit. Report

Icahn accuses Biogen of lying about sales process

Thu, 05 Jun 2008 06:59:55 -0400

Hell hath no fury like Icahn scorned. Frustrated by Biogen Idec's decision to take itself off the market, Carl Icahn (photo) is now accusing the biotech giant of lying about its prospective buyers. Icahn says Biogen Idec's documents filed with the SEC are full of "inconsistencies" and "untruths." Contradicting the SEC documents, Icahn's group says that the company's board had little input in the sales process and rejected the company's claim that it did not stand in the way of talks with its drug partner Elan.

"It appears at least one potential bidder was denied its request to talk to Elan before submitting a binding offer, which may have caused that bidder to walk away from the process," states Icahn's filing.

- check out the AFX story

$117M venture firm takes flight in Europe

Wed, 30 Apr 2008 06:59:55 -0400

A group of Elan veterans in Ireland have launched a €75 million ($117 million) venture fund for life sciences companies. Fountain Healthcare Partners, based in Dublin, plans to sink anywhere from €500,000 to €7 million in a variety of companies in Europe, with a big focus on Ireland. And the principals expect considerable demand for the cash.

"For companies looking to raise $10 to $15 million to undertake a phase I or phase II study, they really don't have dedicated venture capital funds to raise that money," says partner Aidan King.

- see this release
- read the report in the Wall Street Journal

Wyeth, Elan suspend Alzheimer's vaccine study

Fri, 18 Apr 2008 06:59:54 -0400

Wyeth and Elan have suspended dosing patients in a mid-stage study of the experimental Alzheimer's vaccine ACC-001 after seeing one of the patients in the study develop skin lesions. Studies of ACC-001 that have been mounted outside of the U.S. have also been suspended. Researchers, though, quickly sought to reassure investors that another late-stage program for AAB-001 wasn't affected by the unexplained case of lesions. AAB-001, or bapineuzumab, has demonstrated an improvement in cognitive function in Alzheimer's patients in a small study and is being closely followed by the investment community.

- read the story in the Wall Street Journal
- read the story in TheStreet.com

Icahn aims for Biogen control

Tue, 29 Jan 2008 06:59:58 -0500

Carl Icahn says that Biogen Idec essentially ran a sham when it put itself up for auction recently, putting in place barriers that warded off serious bidding by Big Pharma companies. "The process was run to placate us and other large shareholders," he wrote in a filing with the SEC. Biogen Idec--which hotly disputed the notion--had a provision in place that prospective bidders couldn't gain access to the company's books unless they agreed in advance not to approach Elan and Genentech, each of which have enormous stakes in Tysabri and Rituxan, two big Biogen drugs. Change of control agreements inked with each of those companies could have prevented a buyer from gaining rights to those drugs. Biogen Idec says that any avid bidder could have opened up talks with Elan and Genentech after a binding offer was on the table and, anyway, could have made any bid contingent on the outcome of subsequent talks.

Icahn, of course, shows no sign of letting Biogen Idec off easily. Analysts say that his bid to place three new directors on Biogen's board is aimed at gaining control of the company--and presumably any subsequent takeover talks. Icahn triggered the brouhaha around a Biogen takeover when he expressed interest in buying out Biogen Idec at $80 a share. Later, after the buyout talk hit the papers, he said that it would be more appropriate for a Big Pharma company to buy the company. Of course, a cynic might suggest he just wanted to stir the pot and get the stock up.

- see this release on Icahn's board nominations
- read the report from The Wall Street Journal
- here's the article from The Guardian

Related Articles:
Biogen CEO: Pharma too wimpy to deal. Report
Biogen shares deflate as it gives up on sale. Report
What's Biogen Idec really worth to Big Pharma? Report
Biogen Idec in play after Icahn makes his move. Report

Biogen shares deflate as it gives up on sale

Thu, 13 Dec 2007 06:59:58 -0500

After ratcheting up expectations of a takeover and a hefty premium for stockholders, Biogen Idec pulled the rug out from under investors with its announcement that it will go it alone. The market's retribution was swift. Biogen stock plunged more than 27 percent, dropping $21 of the $75.88 price on Wednesday's close. The fallout was also quick, spreading to Biogen Idec's collaborator, Elan. Elan experienced its worst single-day drop in 18 months, shedding 13 percent of its value as investors took a nanosecond to consider that the Irish company will no longer stand to gain from Biogen's sale. A Biogen buyout would have allowed Elan to acquire all rights to their MS drug, Tysabri. Analysts started speculating that the biotech had found buyout talks tough going, with its collaborations involving Elan and Genentech complicating any talks with Big Pharma. Biogen launched its review after Carl Icahn took a stake in the company and began talking buyout.

- see Biogen's release on the decision
- here's the AP report on the about face

Related Articles:
Is Big Pharma souring on Biogen deal? Report
Sources: Biogen gets bidders, with Pfizer in lead. Report
What's Biogen Idec really worth to Big Pharma? Report
Will Big Pharma buy Biogen Idec? Report
Biogen Idec in play after Icahn makes his move. Report

Sources: Biogen gets bidders, with Pfizer in lead

Thu, 08 Nov 2007 06:59:56 -0500

The Financial Times is reporting some tantalizing details about the bidding for Biogen Idec, the biotech based in Cambridge, MA, that sent stock analysts into an uproar when it put itself up for sale a few weeks ago. Unnamed sources told the London newspaper that the sequence of events leading to that surprise announcement actually began with Pfizer offering $80 per share for the company. Investor Carl Icahn (photo) then made a counter-offer, and the company retained financial advisors to conduct an orderly sale. Even now, Pfizer remains one of the front-runners for Biogen, the sources said, along with Merck and Johnson & Johnson.

Some other buyers have already dropped out of the race, spooked by the "nosebleed prices" expected. Icahn offered $23 billion, so the winning bid is likely to be higher. Are Biogen's assets worth that much? They include the multiple sclerosis drug Tysabri, in partnership with Elan; the lymphoma and arthritis remedy Rituxan, in collaboration with Genentech; and the MS drug Avonex, which is wholly owns. It also has a pipeline of drugs in development, including two promising MS products.

Meanwhile, headhunters are getting calls from Biogen types expecting a sale to lead to the layoff ax. The non-executive staff is anxious, recruiters said, even though the company continues to hire new workers.

- check out the buyout report from the Financial Times
- read about Biogen staff seeking shelter at Inside Recruiting

Related Articles:
Biotech stocks surge as investors anticipate buyouts. Report
Speculation soars over Pfizer's interest in biotech. Report
What's Biogen Idec really worth to Big Pharma? Report
Will Big Pharma buy Biogen Idec? Report
Biogen Idec in play after Icahn makes his move. Report
Who should Pfizer buy? Report

Biogen Idec in play after Icahn makes his move

Mon, 15 Oct 2007 06:59:58 -0400

Biotech powerhouse Biogen Idec has brought in some of Wall Streets top dealmakers to explore a possible sale of the company, which would fetch well over $20 billion. In fact, says Biogen Idec, the company already has one interested suitor in Carl Icahn (photo), who recently acquired 2.7 million shares of Biogen Idec and reportedly offered $23 billion for the company last week. Icahn recently took effective control of ImClone, but only after roasting its executives for months. Biogen Idec's next step will be to determine if any of the big pharma companies that have been spending big bucks for biologics will rush in to bid against Icahn. The company says that any sale is contingent on a number of factors, and may never happen, but bringing in Goldman Sachs and Merrill Lynch clearly puts the company in play, raising issues about its partnership with Elan on Tysabri.

Elan, meanwhile, has brought in Lehman Brothers to give it advice. The Irish company owns half of Tysabri, which has been rebuilding its MS sales after being pulled from the market shortly after it was introduced. Elan--which also saw its shares rise on the news from Biogen Idec, could acquire Biogen Idec's share in the drug for "fair value," sell their interest or maintain the current position. Investors loved what they heard and immediately rushed to push up shares of Biogen Idec by 18 percent in after-hours trading on Friday.

- see Biogen's release on the $23 billion bid
- here's the AP report on the dealmaking
- MarketWatch looks at the implications for Elan

ALSO: Take a look at the Big Pharma companies that are most likely to make a bid for Biogen. Report

Related Articles:
Biogen Idec's CEO nets bonus despite bad year. Report
Biotech CEOs face rising fury of angry investors. Report
Biogen inks $220M deal for Cardiokine drug. Report
Biogen launches late-stage study of galiximab. Report

Read more on: Biogen Idec | Carl Icahn | Elan

Watchdog endorses use of Tysabri for severe MS

Wed, 22 Aug 2007 06:59:54 -0400

Biogen Idec and Elan won an important endorsement for Tysabri with a recommendation from Britain's cost-effectiveness watchdog--the National Institute for Health and Clinical Excellence--that the drug be made available to patients with the most severe form of the disease. Tysabri has been making a steady comeback since the therapy was derailed in early '05 after patients taking the drug developed a rare brain disease. Regulators ushered it back onto the market after adding some restrictive guidelines on its use after a large contingent of MS patients demanded access to the therapy.

- check out the release
- read the report from the Irish Times

FDA committee backs Tysabri for Crohn's

Wed, 01 Aug 2007 06:59:56 -0400

Elan and Biogen Idec have won the backing of an FDA expert committee in its quest to gain regulatory approval for Tysabri as a therapy for Crohn's disease. The backing came for the use of Tysabri for Crohn's patients that either haven't benefited from existing therapies or can't tolerate them. The vote marks another careful step forward for Tysabri, which has been linked to a deadly nervous system disease.

- check out the release on the approval
- here's the AFX report on the vote

After reintroduction, Tysabri builds patient base

Mon, 23 Jul 2007 06:59:54 -0400

A year after Tysabri was reintroduced for multiple sclerosis, its manufacturers say that 14,000 patients are now taking the drug. Tysabri, once viewed as a major breakthrough for MS, was pulled after the drug was linked to a risk of PML, a viral infection of the brain. Elan and Biogen Idec make the drug.

- read the report from Finfacts

Related Articles:
FDA allows Tysabri back on market. Report
FDA allows limited trial of Tysabri. Report
Tysabri may spur better risk/reward evaluation. Report
Elan hammered on reported case of PML. Report

Archemix and Pfizer forge discovery pact

Mon, 08 Jan 2007 19:01:36 -0500

Archemix has agreed to employ its know-how in discovering aptamer-based drugs for Pfizer in a new drug discovery pact. The details were kept confidential, but Archemix gains an unspecified upfront payment along with research funds and milestones in exchange for identifying drug candidates for thee targets specified by Pfizer. Aptamers target proteins that trigger diseases, thwarting the process. The Cambridge, MA-based Archemix is already engaged with Elan in a separate discovery pact.

- see the press release for details
- read the report on the deal from The Boston Globe

Related Articles:
Nuvelo expands collaboration pact with Archemix. Report
What's next for Pfizer? Report
Pfizer to axe 2,200 sales jobs in realignment. Report

Crohn's data indicates long-term Tysabri benefits

Mon, 23 Oct 2006 20:01:37 -0400

New data on a group of patients in remission for Crohn's disease after 12 months of treatment by Tysabri shows that 93 percent stayed in remission for another six infusions and 83 percent were in remission after an additional 12 infusions.

"What is truly exciting is that patients who enter remission on Tysabri may remain in remission in the long-term without loss of efficacy over time. These data are a significant advance for the field and suggest that Tysabri may be an alternative biologic outside the anti-TNF class for patients suffering from Crohn's disease," said Remo Panaccione director of the Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Canada. Tysabri is being developed by Elan and Biogen Idec.

- here's the AFX report on Tysabri

ALSO: Doctors are unexpectedly leery about prescribing Tysabri for MS, forcing analysts to lower sales projections. Report

Related Article:
FDA allows Tysabri back on market. Report

Transition signs $200M Alzheimer's licensing deal

Tue, 26 Sep 2006 20:01:37 -0400

Toronto-based Transition Therapeutics has licensed out an Alzheimer's drug candidate to Elan for $15 million in guaranteed payments and up to $185 million in milestone paydays. Transition will get $7.5 million this year and the same next year. The pact covers AZD-103, which is in Phase II. The drug is intended to break down beta amlyoid fibrils, a common characteristic of Alzheimer's. The companies will share the costs and the profits from any approved product. Elan already has an Alzheimer's program working with Wyeth.

"The AZD-103 program represents a significant addition to our scientific portfolio and continues to reinforce our commitment and leadership in bringing more therapeutic choice to patients and their caregivers suffering from Alzheimer's around the world," said Kelly Martin, CEO of Elan.

- here's a report on the deal from The Globe and Mail