Recommendations Should Lead to Increased Aranesp and Neulasta
Sales in Europe
Amgen's (NASDAQ: AMGN) long-acting bone marrow cell stimulants, Aranesp
(hyperglycosylated recombinant darbepoetin alfa) and Neulasta (pegylated
recombinant filgrastim, pegfilgrastim) both received a recommendation for
approval from the European Committee on Proprietary Medicinal Products (CPMP) late yesterday, virtually assuring their E.U. marketing approval for
expanded use in cancer-related indications. Aranesp (also branded as
Nespo), a long-acting erythropoeitin (epo) formulation that stimulates red blood
cell generation, has been recommended for use in the treatment of anemia in
adult cancer patients with solid tumors receiving chemotherapy. Neulasta
(also branded as Neupopeg), a long-acting granulocyte colony-stimulating
factor (G-CSF) that stimulates white blood cell generation, has been recommended for use in reducing the duration of neutropenia
(infection-predisposing low white blood cell count) and the incidence of
febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and
myelodysplastic syndromes). In both cases, the CPMP's recommendation will be
forwarded to the European Commission, which will make the final decision on
Aranesp and Neulasta approval.
Aranesp
Aranesp is approved for use for the treatment of chronic renal failure-related anemia in both the U.S. and Europe, and is in U.S.
regulatory review in the oncology setting. It is a second-generation version
of Epogen (also from Amgen) and Procrit (from Johnson & Johnson, NYSE:
JNJ). Aranesp's recommended starting dose is administered intravenously or
subcutaneously once weekly, and it should be administered once every two
weeks to patients currently receiving Epogen or Procrit once per week. Several studies suggest that Aranesp can be used once every three weeks, or
even once a month. This extended dosing schedule is likely to be approved in
2003, and will allow Aranesp administration to coincide with many chemotherapy regimes, greatly accelerating Aranesp's cannibalization of
Epogen and Procrit.
Hematologists are also beginning to treat "asymptomatic" anemia of chronic
disease - including anemia associated with hypothyroidism, rheumatoid arthritis, coronary artery disease, and chronic obstructive pulmonary
disease - in the same way they treat anemia associated with renal failure.
This will be yet another growth opportunity for Aranesp, first with off-label use and accelerating upon label expansion. Overall, the market for
epo products is likely to grow from $5.3 billion in 2000 to $8.3 billion in
2005, with Aranesp capturing up to $2 billion of this market by 2005.
Neulasta
In late January, Neulasta was approved in the U.S. for use in cancer patients whose ability to fight infection has been weakened by chemotherapy.
The drug should expand into most, if not all, of the clinical indications of
Amgen's Neupogen, its short-acting counterpart. The agents are effective and
have very few adverse effects. Neupogen and Neulasta should continue to dominate the neutropenia marketplace for the foreseeable future, reaching
annual sales of $1.7 billion by 2005. Although many agents are in preclinical or early clinical trials for similar indications, none appear to
have significant efficacy benefits over Neupogen or Neulasta.
BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
June 4, 2002
RETURN
TO INDEX
BTECH NEWS, published by Btech Investor, Inc., highlights selected events in
the life sciences sector that the Btech Investor team believes are particularly relevant to biotechnology investors. The Btech Investor team
combines scientific, clinical, and business experience to perform comprehensive analysis of the biotechnology industry and to identify future
industry leaders.
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