Aradigm loses CEO, CMO and CFO following regulatory disaster; Omeros shares go up on positive results for blood clot treatment
→ As Aradigm $ARDM contends with the aftermath of a disastrous regulatory journey, it has let go of three of its top executives in an apparent measure to cut costs. CEO Igor Gonda, CMO Juergen Froehlich and CFO Nancy Pecota have resigned from all of their positions at the troubled biotech. John Siebert, current chairman of the board, will step in as executive chairman and interim principal executive officer. If Aradigm wants another chance at the FDA for its inhaled antibiotic Linhaliq, which it indicated it would like to do, it would need fresh cash to fuel a whole new PhIII program.
→ By comparing the performance of its drug against historical data in a Phase II study, Omeros has declared that OMS721 leads to a significant increase in median overall survival for patients with a type of blood clot associated with stem cell transplant. Among a total of 19 hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA) patients, the median OS was 347 days, a big improvement compared to the 21 days recorded in literature. The biomarkers also looked positive to researchers. Four deaths occurred, during the study, but the company said only one was possibly drug-related. Omeros’ shares $OMER edged up 12% in pre-market trading, slowly recovering from a Wednesday slump that some say were spurred by reports that their other drug will lose reimbursement under the new federal budget.
→ Vertex Pharma $VRTX says its Phase II study of the nonopioid pain drug VX-150 handily beat out a placebo in treating post-surgical pain. The success in Phase II helps clarify researchers’ plans for the next round of studies as it looks to advance a new approach to pain in the middle of an opioid addiction epidemic. Their drug clearly fell short of a comparator arm of patients given the commonly prescribed opioid medicine hydrocodone+acetaminophen, but may prove good enough as a substitute in many cases.
→ Switzerland’s Santhera Pharmaceuticals (SIX: $SANN) struck a deal with Polyphor to in-license POL6014, a clinical-stage therapy for cystic fibrosis and other neutrophilic pulmonary diseases such as non-cystic fibrosis bronchiectasis, alpha-1 antitrypsin deficiency and primary ciliary dyskinesia.