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12:00 AM
Mar 24, 2008
 |  BioCentury  |  Finance

Ebb & Flow

Amgen has shed $61 billion, or 58% of its market cap, over the last three and a half years and last week found itself slipping into third place among top tier biotechs, giving up the second slot to Gilead.

Amgen (NASDAQ:AMGN) fell on news about Mircera methoxy polyethylene glycol-epoetin beta from Roche (SWX:ROG), which would compete with the biotech's Aranesp darbepoetin alfa and Epogen epoetin alfa.

At the same time, Gilead (NASDAQ:GILD) got a boost on a positive opinion from EMEA's CHMP to expand the label for Viread tenofovir to include chronic HBV.

Gilead ended the week worth $45 billion. Amgen, which had a market cap of $104.6 billion three and a half years ago, ended last week at $43.6 billion(see "Amgen vs. Gilead").

Last week, Amgen shed $4.7 billion in market cap when it and Roche submitted briefs to the U.S. District Court for the District of Massachusetts, which is considering modifying a preliminary injunction to enable Roche to sell Mircera even though the pharma's product has been found to infringe three of Amgen's erythropoeitin patents related to composition and method of manufacture (see BioCentury, Oct. 29, 2007).

The court would allow U.S. marketing of the drug if Roche agrees to pay Amgen a 22.5% royalty; sell Mircera at an "average selling price" equal to or less than that of Epogen; and meet other conditions.

Amgen is still seeking a permanent injunction. The court is expected to make a final decision by April 1 on whether to modify the injunction. If the judge decides to do that, then Roche has to the end of May to submit a detailed plan.

Mircera is marketed in Europe and was approved by FDA in November but its launch has been delayed by the litigation.

In the U.S., Amgen markets Aranesp for cancer and renal indications and Epogen for chronic renal failure.

Gilead, meanwhile, tacked on about $800 million to its market cap with the Viread opinion from CHMP. The company expects a decision by the end of next quarter. An sNDA for the indication has an Aug. 11 PDUFA date in the U.S.

The company already markets the nucleotide analog prodrug reverse transcriptase inhibitor in the U.S. and EU to treat HIV infection.

Gilead finished the week up $0.88 to $46.43, while Amgen slid $4.35 (10%) to $40.11.

Double trouble

UCB (Euronext:UCB) suffered a double dose of bad news with a product recall for Neupro and a negative MAA opinion for Cimzia on Thursday that prompted a selloff. The stock dropped E3.28 (12%) to E23.18 on the day.

The company is recalling its Neupro rotigotine in the U.S. and certain batches in Europe due to an undisclosed deviation from the approved product specifications.

The dopamine D2 receptor agonist patch is approved in the U.S. and Europe to treat early Parkinson's disease (PD), approved in Europe and under review at FDA as an adjunct to levodopa in advanced PD, and under review at FDA and EMEA to treat moderate-to-severe restless leg syndrome (RLS).

The recall will cause an out-of-stock situation in the U.S. by the end of April.

UCB said...

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