Tysabri

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

FDA more friendly to approvable than approved

Thu, 10 Jan 2008 06:59:57 -0500

You've probably already heard that FDA approvals took a nasty dive last year, with analysts pondering a variety of reasons for the poor performance. Interestingly, Eye on FDA cites new research from Sargient showing that as approvals were sliding, approvable letters from the FDA were spiking--up 40 percent! Michael Hay, senior analyst and product manager for BioMedTracker, says that "The FDA has received a lot of criticism over several high profile adverse events cases including Vioxx, Tysabri and Avandia. This has triggered an overly cautious approach to new drug approvals at the FDA. Other potential reasons for the decline in approval rates cited in our report include an increase in adverse event reports, increased workload for FDA employees, and a high rate of turnover at the FDA."

Meanwhile, investors are less likely to bid up a stock when they see news of an approvable letter, largely because they are less likely to believe that the drug will be approved. Given the fact that some approvable letters contain a lot more bad news for biotechs than good news, it's likely that investors will be increasingly wary of their impact.

- here's the press release
- check out the report from Eye on FDA

Related Articles:
'07 drug approval record raises worries. Report
Dry spell or parched desert for NME approvals? Report
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. 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

Biogen stock sinks as investors do reality check

Wed, 14 Nov 2007 06:59:58 -0500

Maybe all those high-flying expectations about a big-dollar buyout for Biogen Idec were a tad inflated. The Boston Globe is splashing a bucket of cold water on the idea after Biogen's stock price sagged--closing at $70.83 yesterday, down from its euphoric high of $84.75. DealReporter is saying that Roche and Sanofi-Aventis, among others, have dropped out of the bidding. And just weeks after a buzz of giddy speculation pushed Biogen's stock price into the stratosphere, outside observers are now counting all the obstacles that lie in wait for any would-be suitor. It could be, says one unnamed "observer," that there won't be any buyout at all. It may all come down to expectations and concerns about Tysabri, which has been regaining its footing in the MS market after being pulled in the wake of a major safety scare. Or, it could be that the big pharma players out there would like to see the price drop a few billion before the serious bidding gets underway.

- read the report from The Boston Globe

Related Articles:
Tysabri: The comeback kid. 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

SPOTLIGHT: No new PML cases for Tysabri

Fri, 12 Oct 2007 06:59:53 -0400

As of September, there have been no new cases of the potentially fatal brain disease PML among patients taking Tysabri. The drug was pulled from the market last year after several patients taking the MS treatment developed PML. Release

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

ALSO NOTED: NPS sells facility; NICE backs Tysabri; Xolair gets black box warning;and much more...

Tue, 03 Jul 2007 00:01:30 -0400

> As part of its restructuring, NPS Pharmaceuticals has sold its Salt Lake City facility to the University of Utah for $21 million. Report

> The National Institute for Health and Clinical Excellence in England has endorsed Tysabri for MS patients. Release

> The FDA has added a black box warning to Genentech's Xolair for asthma. Report

> Novartis says it will increase its U.S. supply of Fluvirin flu vaccine by 30 percent to 40 percent. Report

> The FDA has approved Tamiflu in 30 mg and 45 mg. Report

> Patients with inoperable non-small cell lung cancer who receive an initial high dose of chemotherapy before their treatment begins can expect an increase in overall survival, according to a new study. Release

> In a remarkable breakthrough for weight research, scientists have reported the discovery of a neurochemical pathway that stimulates the accumulation of fat in animals laboring under chronically high stress and exposed to a diet of junk food. Report

> The heart drug propranolol can be used to interfere with the way the brain stores memories, offering a new approach to treating people with post traumatic stress disorder. Report

And Finally... The first half of 2007 has been tough for biotech stocks. Report

New warning issued on Rituxan for lupus

Mon, 18 Dec 2006 19:01:34 -0500

Biogen Idec and Genentech have warned doctors that two patients taking Rituxan for lupus have died of a rare brain infection called progressive multifocal leukoencephalopathy, or PML. Rituxan is approved for non-Hodgkin's lymphoma and rheumatoid arthritis and cancer patients have already been warned about their risk of PML. One analyst noted that the new risk for lupus may make it harder for the companies to gain approval to use Rituxan for lupus and M.S. Biogen Idec has also had to deal with the risk of PML raised by its MS drug Tysabri. That drug was withdrawn until a new safety program was assembled.

- read the FDA's warning on the drug
- here's the report from The New York Times

Related Articles:
Rituxan data encourages researchers. Report
FDA approves Rituxan for rheumatoid arthritis. Report
FDA allows Tysabri back on the market. Report

ALSO NOTED: Elan, Biogen submit Tysabri for Crohn's; Affymax prices IPO;and much more...

Thu, 14 Dec 2006 19:01:30 -0500

> Shares of Elan and Biogen Idec were on the rise this morning after the two developers announced that they had submitted Tysabri as a therapy for Crohn's disease. Report

> Affymax priced its IPO of 3.7 million shares at $25 a share. Release

> Advancis Pharmaceutical has filed for FDA approval of its antibiotic, Amoxicillin Pulsys, 18 months after it was pummeled by investors following the drug's failure in clinical trials. The company's Pulsys technology provides patients with doses of therapy throughout the day. Advancis--which mounted a new trial for the therapy--wants the FDA to approve the antibiotic as a once daily therapy for strep throat, compared to the standard treatment of amoxicillin three times a day. An approval could come in October. Report

> Chutes & Ladders: Sanofi-Aventis has named research director Gerard Le Fur as its new CEO. Report

> The Committee for Medicinal Products for Human Use has reversed its stand on Tarceva and recommended Roche's therapy for metastatic pancreatic cancer in combination with gemcitabine chemotherapy. Report

> Lipoxen has agreed to license its PolyXen technology to Baxter International to boost the effectiveness of its hemophilia drug Factor 8. Lipoxen gains a million dollars up front and up to $75 million in milestones. The CEO of Lipoxen also said he expects to sign more of these drug pacts. Release | Report

> Merck has blueprinted a $100 million expansion of its North Carolina vaccine operation. Report

> Omrix has priced its offering of 2.25 million shares at $32 a share and expects to raise $44.4 million from the offering. Release

> Schering-Plough has reformed its corporate governance rules, ending the board's right to launch a poison pill defense against a hostile takeover and changing the way directors are elected. Report

> Canada's MethylGene announced that after reviewing its recent R&D successes in its small molecule oncology programs, it will not pursue additional clinical trials for MG98, its second generation antisense compound targeting DNA methyltransferase. Release

> Antisoma has raised £26.3 million in an offering. Report

> A University of Minnesota Cancer Center study has found that children who beat leukemia are living longer lives. Report

> Does the FDA do enough to regulate drug ads? The GAO doesn't think so. Report

And Finally… U.S. breast cancer rates plunged 15 percent from mid-2002 to the end of 2003, and experts believe that the sudden reversal in cancer rates could be attributed to the sudden drop in the use of hormone therapy for menopause. Article

Biogen Idec considering sale of cancer drug

Tue, 31 Oct 2006 19:01:34 -0500

Biogen Idec touted significant growth in its third quarter income and said it is evaluating "strategic options" for its older cancer drug Zevalin that includes a possible sale of the therapy. The growth in revenue--from $596 million a year ago to $703 million this past quarter--was due largely to the return of Tysabri and increased revenue from Rituxan, which has emerged as the "gold standard" in the treatment of rheumatoid arthritis.

- here's a report on Biogen Idec from the Boston Business Journal

Related Articles:
Biogen, UCB ink $200M development deal. Report
Genentech and Biogen Idec in talks over Rituxan. 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

ALSO NOTED: Wyeth releases Tygacil data; Eurand inks deal with GSK; and much more...

Tue, 03 Oct 2006 20:01:30 -0400

> Wyeth has released data from a Phase III trial of Tygacil that shows a statistically similar ability to treat community acquired pneumonia as an existing therapy. Tygacil cured 89.7 percent of patients compared to 86.3 percent for levofloxacin. One infectious disease expert says that new therapies for CAP are needed as antibiotic-resistant strains emerge. Report

> Eurand has inked a licensing deal with GlaxoSmithKline to use its tablet technology in the development of a new formulation of an existing GSK drug. Eurand stands to earn up to $42 million in milestone payments. Their goal is to be ready with an FDA application by the end of 2007. Report

> UCB has expanded its licensing deal with Jazz Pharmaceuticals for the narcolepsy drug Xyrem, doubling the number of countries it has marketing rights to and adding an indication for chronic pain characterized by widespread musculoskeletal aches. Xyrem is in Phase III pain studies. Report

> SkyePharma announced positive late-stage results for a reformulated version of Lodotra for rheumatoid arthritis. Report

> Canadian regulators have approved Tysabri for multiple sclerosis. Report

> Keryx Biopharmaceuticals has struck a licensing agreement with Japan's Kyowa Hakko Kogyo to develop Kyowa's mid-stage cancer therapy, UCN-01, in markets outside of Japan. Report

> Nanogen will pocket $20 million from a deal to sell five years of royalties from its MGB technology to Drug Royalty. Report

> Baxter International is touting the latest preliminary data for its experimental H5N1 vaccine. Report

> Shares of Quest Diagnostics were hammered after the company announced the loss of a contract with UnitedHealthcare. Report

> Acorda Therapeutics announced plans to raise $31.5 million in a private placement. The money is earmarked for pipeline development and sales and marketing. Release

> Schering and Biogen Idec have launched a late-stage trial of their lymphoma drug, Zevalin. Report

> Dynavax Technologies is raising $27 million in a private offering. Report

> Isotechnika says its immunosuppressive therapy ISA247 has won a European patent. Report

And Finally… After seizing more than 40,000 packages of prescription drugs bound for the U.S., Customs says it will stop its program of confiscating the drugs. Article

ALSO NOTED: Analysts question J&J copycat; Novartis seeks Rasilez approval in Europe;and much more...

Thu, 28 Sep 2006 20:01:30 -0400

> The Wall Street Journal looks at the case of J&J's schizophrenia drug paliperidone, which the FDA is expected to decide on today. The therapy is a close version of its bestselling Risperdal. Analysts see the new drug, which simply removes the need for the body to metabolize the active ingredient, as a way for the company to extend its control of the therapy by five years. But others see little medical advantage coming from an officially sanctioned copycat drug. Article (WSJ sub. req.)

> Novartis is out to gain European for a new blood pressure therapy developed with Speedel. Researchers are staking their application on the results of a 7,800-member trial that demonstrated Rasilez's ability to lower blood pressure in four weeks. It would be the first new blood pressure therapy in 10 years. Report

> Elan has released new data on Tysabri illustrating that the drug offers a sustained benefit on relapse rates for up to three years. Report

> The Motley Fool offers some incisive analysis on ImClone's recent travails, noting that ImClone's shares actually ended up higher after Amgen announced the FDA's approval of a new competitor for Erbitux that will be priced at a 20 percent discount. Investors, they say, are looking to rebel investor Carl Icahn to shake things up now that he's on the board. Article

> The European Commission has approved Pfizer's anti-smoking therapy Champix. Report

> A.P. Pharma has pushed back its timeline to release data on its experimental therapy to treat the side effects of nausea, citing problems enrolling patients and preparing trial sites. Data is now expected in the second half of 2007 instead of the first quarter. Report

> Minneapolis-based CoAxia announced that it has reached terms with Canaan Venture Partners, Prism Venture Partners, Affinity Capital Management, and Baird Venture Partners on an $11 million Series C round of financing. Release

> Basilea Pharmaceutica's experimental antibiotic Ceftobiprole demonstrated cure rates of up to 92 percent for patients with staphylococcal infections. Report

> GlaxoSmithKline will invest more than €500 million in a new vaccine plant in France. Report

> Wisconsin Governor Jim Doyle is offering free stem cell licenses to firms sponsoring research in the state's non-profit and academic institutions. Report

> TAP Pharmaceutical has signed on to co-promote Novartis' genital herpes drug Famvir. Report

> DOR BioPharma has won two additional grants from the National Institute of Allergy and Infectious Diseases totaling approximately $5.3 million. Release

And Finally… While the FDA is harshly criticized for infighting and poor drug oversight procedures, more and more drug company execs see an agency that has been steadily tightening the reins on new approvals. Article

Teva launches pivotal MS drug study

Wed, 26 Jul 2006 20:01:37 -0400

Teva has launched a pivotal study of a new higher dose of 40 mg/day dose of glatiramer acetate (GA) to the currently approved COPAXONE (GA) 20 mg/day to see if it can replicate positive results from a Phase II trial. In Phase II, patients taking the higher dose of GA had a 38 percent greater reduction in mean cumulative number of gadolinium (Gd)-enhancing lesions as measured by magnetic resonance images of the brain compared with those taking the COPAXONE (GA) 20 mg/day dose. In addition, compared to annual relapse rate prior to entry, patients taking GA 40 mg/day experienced a reduced mean on-trial relapse rate of 77 percent, whereas patients taking COPAXONE (GA) 20 mg/day experienced a 62 percent reduction. GA 40 mg/day was well-tolerated with a safety profile similar to the currently COPAXONE (GA) 20 mg/day.

- see the release on Teva's plans

ALSO: Analysts have been debating the impact of Teva's new MS drug research on Tysabri sales. Report

ALSO NOTED: TransPharma raises $18M; Biogen Idec, Elan re-release Tysabri; and much more...

Sun, 23 Jul 2006 20:00:50 -0400

> TransPharma Medical, which is developing a new drug delivery technology, has raised $18 million in financing. Report

> Biogen Idec and Elan have re-released Tysabri for MS in the United States. Report

> Researchers are exploring the effectiveness of a combination of cancer-drug mitoxantrone and copaxone to treat aggressive MS. Release

> Biovail and Athpharma have terminated a development pact for four cardiovascular drugs. Report

> Barr Pharmaceuticals says it is confident that it can meet any requirements the FTC may have as a condition for buying Pliva. Report

> Nektar Therapeutics announced that it received $17.6 million from Affymax for a previously undisclosed licensing deal. Report

And Finally… Scientists at the Max Planck Institute for Evolutionary Anthropology plan to crack the genetic code of Neanderthals in order to better understand why they became extinct while modern man thrived. Article (WSJ sub. req.)

Europeans OK Tysabri's return to MS market

Wed, 28 Jun 2006 20:01:37 -0400

Elan and Biogen have gained another regulatory victory in their effort to return Tysabri to the market, winning European approval for use of the drug to delay progression and reduce the frequency of relapses. The FDA recently allowed the use of Tysabri as a second-line therapy for patients who hadn't responded to other therapies. When Tysabri was introduced, researchers believed that it represented a major advance for MS patients, but the drug was quickly pulled after it was linked two several cases of a rare brain disease. Regulators seem content to allow it back on the market, so long as patients have been made aware of the potential risks and rewards Tysabri offers.

- here's the AFX report in Tysabri