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Biotech / Medical : Biogen -- Ignore unavailable to you. Want to Upgrade?


To: Harold Engstrom who wrote (1143)10/15/1999 11:52:00 AM
From: Beltropolis Boy  Respond to of 1686
 
fwiw, some press out of cbs.marketwatch (with the standard investment-advice denouement).

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Biogen
A compelling biotech story

By Courtney Smith, CBS MarketWatch
Last Update: 11:05 AM ET Oct 12, 1999

NEW YORK (CBS.MW) -- There are 750,000 people with multiple sclerosis in the U.S. and Europe. Until recently, the best treatments were so poor that only about 6 percent were treated. Then Biogen (BGEN) launched their treatment for MS, Avonex.

The product was so well received that they quickly gained 60 percent market share in the U.S. and 42 percent in Europe. There are now over 75,000 people taking Avonex.

I'm looking for even more growth in sales. Avonex is still the best product on the market and the competition is weak. More doctors are getting comfortable with the product and are prescribing it earlier in the disease cycle.

Rebif from Ares-Serono is the only real competition. However, Rebif has three main problems. First, the side effects are strong enough that it has to be administered in low doses. Second, it has to be injected three times each week, compared to once a week for Avonex.

Finally, the Food and Drug Administration rejected the Ares-Serono application to sell Rebif in the U.S. This means that it will only compete with Avonex in Europe. This gives Avonex clear sailing for at least another four years.

But Avonex isn't the only story. Biogen has a strong pipeline of future products. Next up will likely be Amevive, a treatment for psoriasis that should come to market in 2001. After that should be Antova, a treatment for various auto-immune problems such as lupus and transplantations. Look for Adentri to follow after that for the treatment of congestive heart failure.

Another solid prospect is an inhaled version of Avonex (sure beats getting a shot!) that is being developed with Inhale Therapeutics.

Consistency and future products

This creates a solid and consistent stream of new products. Investors like this kind of consistency, particularly with biotech companies that tend to flash in the pan. They will basically have one new drug on the market per year for the next several years.

While the other drugs are coming on stream, Biogen is developing more indications for Avonex. They have eight clinical trials for such markets as glioma and monary fibrosis.

Financial blockbuster

The sales of Avonex are creating a financial blockbuster. The company announced their quarterly results Oct. 8. Revenues rocketed 43 percent to $208.4 million, and earnings almost doubled to $62 million ($.39 per share) from $37.6 million ($.24 per share) in same quarter last year. Cash flow is growing at roughly the same rate as the earnings.

This growth is being driven without debt. The debt-to-equity ratio is only 7 percent. This means that the company is being very conservative with their balance sheet.

There has been a big run up in the stock this year so the stock is not cheap. It currently trades at 66 times trailing earnings. However, you can see that it is growing earnings at about that rate. In addition, I believe that the market is rewarding companies with strong and consistence earning power and Biogen falls into that category.

I think that the best strategy might be to buy some here and wait for a dip to buy some more later.

cbs.marketwatch.com



To: Harold Engstrom who wrote (1143)10/15/1999 12:00:00 PM
From: Beltropolis Boy  Respond to of 1686
 
"biopharmaceutical warfare"

did you catch this too? at least he's got a sense of humor.

i guess it's not as bad as hitting up the shi'ites.

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Kahn said he sought money last week from Teva, but not Biogen or Schering AG (which markets the drug Betaseron), in the belief that the Israeli company would agree to pay money to promote its drug since it fared favorably in the trial.

"In this biopharmaceutical warfare, companies want to exploit information," Khan said. "I don't see where else we were going to get the money."

cnetinvestor.com



To: Harold Engstrom who wrote (1143)10/21/1999 4:57:00 PM
From: Beltropolis Boy  Respond to of 1686
 
harold.

this out after the close. any idea how badly it'll bite us in the ass?

-chris.

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Biogen Says It Has Halted Several Trials of Anti-CD40 Ligand Monoclonal Antibody
October 21, 1999 04:34 PM

CAMBRIDGE, Mass., Oct. 21 /PRNewswire/ -- Biogen, Inc. (BGEN) said today that it has halted several trials of its anti-CD40 ligand monoclonal antibody compound until the Company has completed addressing issues relating to adverse events. The Company said it was working closely with the FDA on reviewing data and determining when trials could be resumed. The adverse incidents involved thrombo-embolic events.

At this time, studies in Factor VIII inhibitor syndrome, islet cell transplantation and multiple sclerosis have been placed on hold. Patients already receiving the drug in the renal transplantation program will continue on therapy, and those patients who have benefited from therapy in the ITP (Immune Thrombocytopenic Purpura) study can continue treatment. The Company is still discussing the continuation of the lupus trial with the FDA.

Jim Vincent, Biogen's Chief Executive Officer, said, "While these data are not clear yet, we are being very proactive because we are dealing with patients in these clinical trials who are at a substantially elevated risk for thrombo-embolic events. It is very complicated to determine whether the events that have been seen are connected to our drug or not. In the interests of patient safety, we have asked the investigators participating in the affected Phase II trials to stop dosing patients at this time."

Humanized anti-CD40 ligand monoclonal antibody (hu5c8) is a novel immunomodulator that selectively binds to CD40 ligand, an important co-stimulatory molecule found on activated T cells.



To: Harold Engstrom who wrote (1143)10/22/1999 2:22:00 PM
From: Beltropolis Boy  Read Replies (1) | Respond to of 1686
 
hot off the presses: "JP Morgan goes out on limb -- practically flips coin!"

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Biogen Shares Fall After It Halts Antova Drug Trials
10/22/99 10:04:00 AM
Source: Bloomberg News

Cambridge, Massachusetts, Oct. 22 (Bloomberg) -- Shares in Biogen Inc., one of the world's biggest biotech companies, fell as much as 14 percent after the company said it halted most trials of its experimental drug Antova because some patients suffered blood clots.

Shares fell 8 3/4 to 63 13/16 in midday trading of 13.2 million, almost six times the stock's three-month daily average. The stock was the sixth most active on U.S. markets.

Antova, designed to treat immune-response-related diseases like lupus and organ-transplant rejection, is one of two experimental Biogen drugs analysts say could become blockbuster products. The other, psoriasis treatment Amevive, is about to begin late-stage trials.

Biogen's announcement yesterday sparked concern that it will have trouble developing products to keep profits growing.

"We give it a better than 50-50 chance that we aren't going to see a restart of Antova studies," said Franklin Berger, a biotechnology analyst with J.P. Morgan Securities. "There is a lot of work to be done."

Berger downgraded his rating on Biogen's stock this morning to a "market perform" from a "buy." He said that the delay or loss of sales for Antova could make it difficult for the company to meet growth expectations in coming years.

Biogen issued a statement late yesterday saying it's stopped trials for Antova for treating multiple sclerosis, patients with a hemophilia-related condition called Factor VIII inhibitor and recipients of pancreatic-cell transplants.

Risk for Other Drug

The snag in Antova's development also highlights the risks in bringing any new drug to market -- risks which could still affect Biogen's other key drug, Amevive, analysts said.

"People rightly or wrongly say, 'If this could happen to Antova, it could happen to Amevive,'" said Craig Parker, a Donaldson Lufkin & Jenrette analyst with a "buy" recommendation on Biogen. "Everybody's perception of risk in the whole pipeline goes up."

The company, which also makes Avonex, the world's best- selling multiple sclerosis treatment, this month said it was testing Antova in six so-called Phase 2 trials, the second of three stages of testing that the U.S. Food and Drug Administration generally requires before it will consider approving a new treatment.

Hopes for Two Drugs

Neither Antova nor Amevive has entered the final stages of study, and the drugs weren't expected to contribute to Biogen sales until 2002 or 2003. Still, the two drugs together were expected to make up for an anticipated slowdown in the sales growth for Avonex, which Berger expects to have a sales increase of about 57 percent in 1999.

Biogen said it's not clear whether the blood-clotting is connected to its drug. The company said that many of the patients taking the experimental medicine were already at high risk for potentially life-threatening blood clots, though it's working with the FDA to investigate the situation.

Still, with problems occurring in more than 5 percent of all patients and across several different uses, the clotting poses a significant roadblock. And researchers don't understand the clotting problem yet, which could make it harder to isolate and address any role Antova plays, Berger said.

"Amevive and Antova allowed us to look forward to keeping the price-to-earnings ratio high," said Berger of J.P. Morgan Securities. "With the loss of Antova, we lost one of the legs of the tripod."

Kidney transplant patients can continue taking the drug, as can patients suffering from a blood disorder called immune thrombocytopenic purpura. Biogen said it and the FDA are still discussing whether patients with lupus can continue taking the therapy.