12:00 AM
 | 
Mar 17, 2008
 |  BioCentury  |  Finance

Ebb & Flow

Amgen investors were initially relieved after Thursday's votes by FDA's Oncologic Drugs Advisory Committee not to remove chemotherapy-induced anemia from the labels of erythropoiesis-stimulating agents. The stock closed the day up $2.19 to $47.18.

But on further reflection on what the restrictions might mean for Aranesp oncology revenue, the shares gave back their gains on Friday, as the stock closed off $2.72 to $44.46. The shares were still up $0.28 on the week, adding $304.4 milion in market cap.

ODAC voted 13-1 against removing all indications for chemotherapy-induced anemia (CIA) from the labels of ESAs, but did say that CIA indications should be narrowed(see "Cover Story").

In the U.S., Amgen (NASDAQ:AMGN) markets Aranesp darbepoetin alfa for cancer and renal indications and Epogen epoetin alfa for chronic renal failure.

In 2007, oncology indications accounted for $1.55 billion of U.S. Aranesp sales, which were already down 26% from $2.1 billion in 2006. International Aranesp oncology sales grew to about $550 million from about $500 million.

Aranesp oncology sales accounted for 13.5% of U.S. revenue and 19.2% of international revenue.

Overall, sales of the drug fell last year by 12% to $3.6 billion from $4.1 billion, while Epogen sales held steady at about $2.5 billion.

For 2008, Amgen has guided to revenue of $14.2-$14.6 billion from $14.8 billion in 2007 and an EPS of $4-$4.30 from $4.29 last year.

In better news earlier in the week, ODAC voted unanimously (10-0) that Amgen's Nplate romiplostim (AMG 531) has a favorable risk-benefit profile for idiopathic thrombocytopenic purpura (ITP) (see "Nplate a Template," A8).

Still, since the ODAC meeting on ESAs was first announced on Jan. 24, Amgen's market cap has slipped $1.8 billion, from $50.3 billion to $48.5 billion.

Overall, its market cap has been slashed by about $40 billion (45%) since Jan. 25, 2007, when Amgen first disclosed negative data on Aranesp in anemia of cancer (see BioCentury, March 12, 2007).

In that same time, Gilead (NASDAQ:GILD) has gained $15 billion (52%) in market cap from $29 billion. At $44 billion, it now is poised to overtake Amgen as the second largest biotech.

Venturing into CNS

MedImmune Ventures made its first deal last week specifically targeting the interests of its parent company, AstraZeneca (LSE:AZN; NYSE:AZN).

The firm participated as a new investor in a $30 million B round for neurogenesis company BrainCells. The deal falls outside the indications of oncology, infectious and inflammatory diseases that had been MedImmune's focus prior to its acquisition(see BioCentury, Jan. 18).

This is a first close, with the possibility of an additional $5-$10 million in a second close. The initial amount would provide two years of financing, while the additional funds would extend that to three years.

MedImmune Ventures joined existing investors Bay City Capital; Oxford Bioscience Partners; Technology Partners; Pappas Ventures; and NeuroVentures in the round. MedImmune's William Bertrand will join BrainCells' board.

BrainCells' lead candidate, BCI-540, is expected to start Phase II testing this year to treat depression and anxiety. The compound, which has an undisclosed dual mechanism, is licensed from Mitsubishi Pharma.

"AstraZeneca has a great deal of interest in drugs for the treatment of mood disorders," MedImmune Ventures Managing Director Maggie LeFlore told Ebb & Flow.

"Scientists at AstraZeneca have been following neurogenesis quite closely, in particular how it relates to depression," she said. "But it is too early to develop an in-house program. It makes much more sense to follow the progress outside the walls of AstraZeneca and to preserve internal funds for programs at a later stage of validation."

Other AstraZeneca focus areas that could be targets for MedImmune Ventures include diabetes, obesity and cardiovascular disease, LeFlore said, as well as additional neuroscience opportunities.

Last year, AstraZeneca brought in $5.3 billion from CNS products, most of...

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