FDA Issues Complete Response Letter for Cinryze in Acute HAEOn June 3, 2009, the U.S. FDA issued a complete response letter (CRL) relating to ViroPharma's (VPHM) supplemental biologic license application (sBLA) on Cinryze for the treatment of acute attacks of hereditary angioedema (HAE). The CRL requests an additional clinical study, due to the FDA's opinion that the placebo controlled study submitted in support of the sBLA lacked robustness.We note that the phase III data submitted with the sBLA contained data from a 71-patient trial. ViroPharma also submitted data from an 82-patient open-label program along with the phase III trial.At this point it is difficult to assess just how much more data the FDA would like to see. We note that the phase III program for DX-88 (ecallantide) submitted by Dyax Corp. contained data from 143 unique patients before the open-label program. This ...

div style="text-align: justify;"Oppenheimer is out downgrading span style="font-weight: bold;"Cubist Pharma (NASDAQ:CBST)/span to Underperform from Mkt Perform, span style="font-weight: bold; color: rgb(255, 0, 0);"seeing downside to $18-$19 range./spanbr /br /According to Oppenheimer the downgrade is based on concerns that the near-term product in-licensing is likely to be outside core markets and may result in material dilution. CBST has identified licensing a late-stage or commercial product as a high priority. Based on firm's review of acquisition candidates in CBST's core anti-infective market, they see few compelling opportunities and believe CBST may be forced to expand outside its core market. On valuation, CBST trades at 22.0x '09 fully taxed pro forma EPS compared to 16.1x for a universe of profitable biotechs. View the absence of composition of matter patents for Cubicin as a chronic high-impact risk factor justifying a lower PEG than peer group.br /br /Opco points to the acquisition of Ecallantide from ...

Emerging Biotech & Pharma Index: 36 More Cos. The accompanying table [click to enlarge or download] includes the 36 remaining companies in the ETF Innovators [ETFI] Emerging Bio-Pharma Index with market caps between $150M-$1.5B, which were not included in the previous two articles I wrote about the group – featuring the Top 40 Rated Companies and companies below the $150M market cap cutoff. However, several of the companies included in the remaining group of 36 have been in the news recently due to FDA related news. Late last week, Ligand Pharma (LGND) received approval along with its collaboration partner Glaxo (GSK) for Promacta while Theravance (THRX) received a positive panel review for its antibiotic telavancin. Previously, ...

Dyax Corporation, a Massachusetts biopharmaceutical company, has announced third quarter revenues of $5.5 million, compared with $2.6 million for the comparable quarter in 2007, an increase of 111%. In addition, revenues for the nine-month period ending September 30, 2008, increased to $12.0 million, compared to $7.9 million for the comparable nine-month period in 2007, an increase of nearly 52%.

The dramatic increase in revenue was due largely to returns from license and collaboration agreements, including $2.5 million received under the company’s Licensing & Funded Research Program (LFRP). Dyax has also received $38.2 million from licensing and collaboration agreements for its proprietary programs, exclusive of LFRP, though all but $1.6 million of that is deferred to future payments.

Dyax was founded with the goal of developing and commercializing innovative biopharmaceuticals, with a focus on medical advances in the areas of cancer and inflammation. Current therapeutic product candidates include fully human monoclonal antibodies

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Dyax Corp. (Nasdaq: DYAX) focuses on the advancement of novel biotherapeutics, such as those for the treatment of hereditary angiodema (HAE), a rare and potentially life-threatening condition that occurs in about one in every 10,000 to 50,000 people. The condition is associated with swelling in various parts of the body (including hands, feet, face and airway), abdominal pain, and nausea and vomiting.

Dyax today announced the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax’s flagship product, DX-88 (ecallantide), for the treatment of HAE.

“The submission of the DX-88 BLA is a major milestone for Dyax,” Henry E. Blair, chairman, president and CEO of Dyax stated in the press release. “We believe DX-88, a recombinant, subcutaneously administered therapy, has many characteristics that match well with the needs of HAE patients and physicians for a therapeutic option. We look forward to working

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Dyax Corp. (Nasdaq: DYAX) is a clinical-stage drug company focused on the discovery, development and commercialization of biotherapeutics for oncology and inflammatory conditions. The company today announced positive topline results from its second phase-3, placebo-controlled trial, EDEMA4, for its lead product candidate DX-88 (ecallantide) for hereditary angioedema (HAE), or the rapid swelling of the skin.

The trial utilized the participation of 96 patients and was conducted at 42 sites in the United States and Canada. The company’s anticipated goal was to determine the efficacy and safety of a fixed 30 mg. subcutaneous dose of DX-88 in the treatment of moderate to severe acute HAE attacks.

The EDEMA4 trial was conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA) and marked significant improvements in the intent-to-treat population in primary and secondary endpoints. The trial was consistent with outcomes of the first phase 3 placebo-controlled trial (EDEMA3) for

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