Avalon will select and optimize candidates up to the pre-clinical candidate selection stage, at which point Merck will assume development duties. Avalon could receive milestones that exceed $200 million plus royalties. The news sent Avalon 15 cents higher to $4.78.
CV Therapeutics (CVTX) reported that Ranexa (ranolazine) failed a Phase III trial in patients with acute coronary syndrome. The drug was given to patients within 48 hours after they experienced ACS-related angina, and they were also given standard care. Ranexa is approved for patients with chronic angina as a second-line therapy. CV Therapeutics gave up 24% of its value, dropping $2.90 to $9.40.
Insmed (INSM) settled its patent dispute with Tercica (TRCA) and Genentech (DNA) over a short-stature drug. Insmed will withdraw Iplex from the U.S. market and also pull its approval application from European authorities, leaving the field open to Increlex, the short stature drug from Tercica and Genentech. Some patients preferred Iplex because it required only one shot per day, versus two for Increlex.
Tercica and Genentech will allow Insmed to seek additional, potentially more lucrative, indications for Iplex, including insulin resistance, myotonic muscular dystrophy and HIV associated adipose redistribution syndrome [HARS]. But Tercica or Genentech will be given an opt-in right to these indications after Phase III data are announced. In exchange for Insmed’s retreat, Tercica and Genentech agreed to give up the $6.3 million in fines they were awarded by a jury. The news boosted Tercica to a 20% gain; it rose $1.00 to $5.88. But the settlement was devastating to Insmed, which fell 43%, dropping 66 cents to $.89.
Compugen (CGEN) extended its agreement with Biosite (BSTE) to develop biomarkers. Under the new arrangement, Biosite will have more potential diagnostic biomarkers available to select from, and it will have access to Compugen’s inventory of immunoassay biomarkers. The agreement also covers more disease areas. Terms were not disclosed. Compugen was off a penny at $2.59.
The FDA will not require ZymoGenetics (ZGEN) to conduct a Phase III trial of its recombinant human thrombin (rhThrombin) spray product for approval. The product, which is designed to control bleeding during surgery, is close to finishing its Phase II test. After approval of its Biologics License Application for rhThrombin, ZymoGenetics can submit a Prior Approval Supplement to get the spray product approved. ZymoGenetics estimated the decision will reduce the timeline by 18 months. Spray formulations constitute about one-third of sales for the bovine thrombin product already in use. ZymoGenetics moved up 22 cents to $14.91.
Encysive (ENCY) won approval of Thelin for patients with pulmonary arterial hypertension [PAH] in Australia. Thelin has been approved in Europe, but Encysive has not been able to get past the approvable stage in the U.S. Encysive closed at $3.46, an increase of 6 cents.
Biotech slipped further south in yesterday’s session. The Centient Biotech 200™ dropped 17 points to end at 3817, a loss of .44%. The S&P 500 was off by .25% and Nasdaq was down .44%.
Disclosure: Centient management holds a position in Genentech shares and does consulting work for Genentech.