Beckman Coulter expects the merger to be accretive to earnings starting in 2008. In the past four years, the two companies have collaborated in developing a B-type Natriuretic Peptide
[BNP] test that is used to diagnose and assess the severity of heart failure and the risk stratification of patients with acute coronary syndromes. Biosite soared 51%, climbing $28.42 to $83.80. But Beckman Coulter went the other way, dropping 7%. It fell $4.57 to $62.51.
Osiris Therapeutics (OSIR) said a stem cell treatment, Provacel, was safe and effective in a small Phase I trial for heart disease. Osiris is a recent biotech IPO that develops adult mesenchymal stem cell treatments for a number of different diseases. Provacel was given intravenously following a heart attack. The active drug cohort experienced fewer adverse events and their heart and lung function improved, along with their overall condition.
Although the mechanism of Provacel is not understood, it does not seem to rebuild heart tissue. Instead, it seems to stimulate the heart to repair itself. Osiris rose 16% on top of last week’s 35% gain. The company closed at $20.77, a gain of $2.87, and helped push up many of the biotechs that are working on stem cell treatments.
Lilly (LLY) was awarded orphan drug status in Europe for enzastaurin, a multi-targeted oral cancer drug for diffuse large B-cell lymphoma [DLBCL]. The drug is currently enrolling patients in a Phase III trial. Enzastaurin is given to patients who are in remission after a first-line therapy to prevent relapse. Most DLBCL patients relapse within 3-5 years.
Sanofi-Aventis (SNY) said its weight-loss drug Acomplia will face an FDA Advisory Committee panel on June 13, 2007. Acomplia, which is approved for use in Europe, received an approvable letter from the FDA in February 2006. Sanofi-Aventis responded with additional information to answer questions in the approvable letter, but it has never disclosed the nature of the FDA’s qualms about the drug. After European approval, some studies showed that Acomplia was associated with depression, and it may have caused one case of dormant multiple sclerosis to become active.
Merck (MRK) won approval in Europe for Januvia, its once-daily glycemic control drug for patients with type 2 diabetes. Januvia is the first dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor) to be approved in Europe. The DPP-4 class of drugs increases a patient’s response to elevated blood sugar. Januvia was approved in October 2006 in the U.S.
Schering-Plough (SGP) and Merck [MRK] will collaborate to develop another combination cholesterol drug. Schering-Plough will contribute Zetia (ezetimibe) and Merck will put in an atorvastatin. The goal will be to have a product when the patent on Pfizer’s Lipitor, or atorvastatin, runs out. Schering-Plough and Merck already have marketed Ezetrol, a combination of Zetia and Vytorin (simvastatin) for lipid management.
Indevus (IDEV), using interim data, predicted positive results from the Phase III trial of Nebido, a long-acting injected testosterone therapy for hypogonadism. Indevus in-licensed the product from Bayer (BAY), who markets the product outside the U.S. The trial will end in late May 2007.
Centocor, a Johnson & Johnson (JNJ) subsidiary, and Schering-Plough [SGP] received an extension in Europe of the indication for Remicade, which is now approved also for children, ages 6 to 17, who have Crohn’s disease. The approval was for use of Remicade as a second-line therapy.
Crucell (CRXL) and DSM Biologics, both biotech companies located in the Netherlands, have signed a non-exclusive license for the Development Center for Biotechnology, located in Taipei, Taiwan, to use their PER.C6 human cell line to produce recombinant proteins. This is the second out-licensing of the technology in Taiwan.
Isis Pharma (ISIS) reported data from a Phase II trial of ISIS 301012 at the American College of Cardiology, showing a high dose of the drug was effective in patients with high cholesterol. The high dose was well tolerated and increased the effect of the drug over the lower doses, whose results were previously reported. The next step for the drug is a longer-term Phase II study.
Biotech slipped slightly in the opening session of the week. The Centient Biotech 200™ edged 4 points lower to 3893, a decrease of .09%. The broad market was slightly higher, with the S&P 500 up by .10% and Nasdaq gaining .27%.