12:00 AM
 | 
Sep 10, 2001
 |  BioCentury  |  Finance

Ebb & Flow

A big week for FDA panel reviews will provide a major test for the biotech space in the wake of last week's post-Labor Day let-down.

The big newsmakers will be Tuesday's Oncologic Drugs Advisory Committee review of the BLA for Idec's Zevalin ibritumomab radiolabeled antibody to treat non-Hodgkin's lymphoma (NHL) and follicular NHL refractory to IDPH's Rituxan, followed on Wednesday by the Anti-Infective Drugs Advisory Committee discussion of Eli Lilly's Xigris sepsis biologic.

Both reviews will be watershed events for the categories, as the difficult course for radiolabeled antibodies and sepsis treatments both are well-chronicled. And even though Xigris is not a biotech company drug, both meetings may be taken as major litmus tests by investors who increasingly believe that the leaderless FDA has become a major drag on the industry.

Matrix's FDA review posted Friday portended a rough start of the ODAC agenda today. MATX lost $0.90 (12%) to $6.79 through Thursday prior to its trading halt on Friday, when the FDA released its medical review of the NDA for IntraDose cisplatin/epinephrine injectable gel to treat head and neck cancer, which recommended against approval (see BioCentury Extra, Friday Sept. 7).

Guilford (GLFD) also will be in front of ODAC, which on Tuesday will consider the sNDA for GLFD's Gliadel wafer as a first line therapy for malignant glioma. Gliadel is approved to treat recurrent glioblastoma multiforme. The stock was off $1.10 to $10.95 last week.

Front-running sellers also pushed IDPH down $1.66 to $57.61 on the week.

Pre-heated

Last week's NewsMakers in the Biotech Industry investor conference provided mixed messages for the sector, with record numbers of investors crowding into company presentations while outside the venue the equity markets were taking a bath.

By Ebb & Flow's tally, at least three presenting companies - Cubist (CBST), Dendreon (DNDN) and Interneuron (IPIC) - announced completion of patient enrollment in their Phase III studies (see "Milestone Watch," below). And several others - including Scios (SCIO) and Millennium (MLNM) - provided guidance forecasting breakeven results as early as 2003.

John Maraganore, MLNM's vice president of strategic product development, told the audience that the gene-based drug developer is on track to hit its $220-$240 million 2001 revenue estimate and end the year with $1.5 billion in cash, with a shot at breaking even in the '03/'04 timeframe.

SCIO is hoping to post $10-$12 million in Natrecor nesiritide revenue this year, following last month's FDA approval of the compound to treat congestive heart failure. SCIO is on track to lose $65 million this year, but told the audience it believes it can reach breakeven in '03 and be profitable in '04. The company promised additional details on its third quarter conference call on Oct. 25.

ImClone (IMCL) confirmed it's on track to complete its BLA submission in the fourth quarter for IMC-C225 antibody to treat colorectal cancer. COO Harlan Waksal told the audience that the company is hoping for approval in the first half of next year, which "assumes an oncologic advisory panel date in February of '02."

But good fundamental news in front of a big audience was not enough to offset the swooning markets, which saw the NASDAQ Composite drop 6.5% as investors digested further news of economic woe.

Biotech was hit relatively less hard, with the BioCentury 100 falling 4.8%. But BioCentury London Index fell 8% on the week as European markets took a tanking, which also was reflected in the the Neuer Markt's NEMAX 50 hitting an all time low of 923 and the NEMAX biotech index hitting its all time low at 71.25 on Friday afternoon.

Biobanker Mark Simon of Robertson Stephens also warned...

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