Osiris Therapeutics

  • es zeigt sich wieder einmal,wenn es bei der Testphase 2

    keine oder eine ungenügend grosse Placebo kontrollierte Gruppe hat,sollte man generel die Finger von solchen Aktien lassen.Praktisch bei allen Pharma-oder Biotechaktien die Misserfolge bei den Testphasen 3 hatten,kann man dieses Muster beobachten.

    Auch die Involvierung der Aufsichtsbehörden bei der Testausgestaltung gibt einen Hinweis.Je später die Behörden sich einbringen,desto grösser ist die Chance,dass das Medikament durchfällt.

  • Osiris Therapeutics

    Demnext geht hier die Post ab - noch viel Luft nach oben vorhanden ;)

    Aktienkurs nimmt's schon vorweg!

    Last Change (%) Day Volume

    7.79 0.53 (7.30) 323,114

    Zulassung rückt näher!

    Prochymal New Drug Submission Granted Priority Review by Health Canada Prochymal

    New Drug Submission Granted Priority Review by Health Canada

    Health Canada to add first-in-class stem cell therapy to Register of Innovative Drugs providing eight years of market exclusivity

    Jul. 21, 2010 (Business Wire) -- Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced today that the Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review the company’s New Drug Submission (NDS) of Prochymal (remestemcel-L), an adult stem cell therapy for the treatment of graft vs. host disease (GvHD). Based on a separate review of summary clinical data, Health Canada has notified Osiris that the application has been granted Priority Review, shortening the examination period from 300 to 180 days. If successful, Prochymal would become the world’s first approved stem cell therapy.

    Priority Review is granted when Health Canada determines that the summary clinical data provided demonstrates substantial evidence of the drug’s effectiveness in treating a life-threatening condition. Priority Review candidates are subject to the same quality, safety and efficacy requirements as non-priority submissions, but are processed more quickly.

    The application is the first in Osiris’ global registration strategy for Prochymal. The NDS was filed in the electronic Common Technical Document (eCTD) format to facilitate review and allow for efficient submission in other territories. The submission marks the first application for full approval of a stem cell therapy anywhere in the world. Prochymal is currently available to patients with refractory acute GvHD in the United States under an expanded access program.

    As part of the review, Health Canada has also informed Osiris of its plans to add Prochymal to its Register of Innovative Drugs subject to a final review upon approval. Registration confers eight years of market exclusivity beginning on the date of Prochymal’s approval, during which no submission for a generic version of Prochymal will be approved.

    About Prochymal

    Prochymal (remestemcel-L) is a preparation of mesenchymal stem cells (MSCs) formulated for intravenous infusion. The MSCs utilized in Prochymal are isolated from the bone marrow of healthy young adult donors, avoiding the controversy surrounding embryonic and fetal cell sources. They are grown in culture, permitting large-scale production. Because the cells can be expanded, thousands of doses can be produced from a single donation. Studies indicate that MSCs are able to down-regulate severe inflammation and work at the cellular level to rebuild damaged tissue through the coordinated release of tissue-specific growth factors.

    Prochymal is being evaluated in clinical programs for the treatment of Crohn’s disease, acute myocardial infarction, type 1 diabetes and pulmonary disease. Prochymal has been granted Fast Track status by the FDA for GvHD and Crohn’s disease, and is the first stem cell product to receive FDA expanded access approval, making the product available now to patients with life-threatening GvHD. Prochymal also obtained Orphan Drug status for GvHD and type 1 diabetes from the FDA as well as Orphan Drug status for GvHD from the European Medicines Agency.

    About Osiris Therapeutics

    Osiris Therapeutics, Inc. is the leading stem cell therapeutic company focused on developing products to treat serious medical conditions in the inflammatory, autoimmune, orthopedic and cardiovascular areas. The Company's pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. Osiris is a fully integrated company, with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 49 U.S. patents each having one or more foreign counterparts. Osiris, Prochymal and Chondrogen are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIR-G)

    Osiris and Genzyme formed a strategic alliance for the development and commercialization of Prochymal and Chondrogen. Under the terms of the agreement, Osiris retains commercialization rights to Prochymal and Chondrogen in the United States and Canada. Genzyme holds these rights in all other countries except Japan, where JCR Pharmaceuticals holds rights to Prochymal for the treatment of patients with hematological malignancies.

  • Osiris - Zahlen Q3/ 2011

    Osiris Therapeutics Reports Third Quarter 2011 Financial Results

    COLUMBIA, Md. – November 4, 2011 - Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory and cardiovascular disease areas and wound healing, announced today its results for the third quarter ended September 30, 2011.

    Highlights and Recent Developments

    Filed a complete response to inquiries from the Biologics and Genetic Therapies Directorate of Health Canada about Prochymal New Drug Submission (NDS) and post marketing commitments.

    Third quarter Biosurgery revenue increased more than 150% over the previous quarter.

    Reported net income of $4.0 million for the quarter; $0.12 per diluted common share.

    Reported cash, receivables and short-term investments of $53.3 million as of September 30, 2011.

    “We are pleased with the continued revenue growth of our Biosurgery products,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics. “Sales and marketing efforts are currently underway to drive widespread adoption of these remarkable products in a number of therapeutic areas. As always, our commitment to patients with serious unmet medical needs is a top priority and we remain focused on making life-altering therapies available to the patients that need them most. “

    Third Quarter Financial Results

    Net income for the third quarter of 2011 was $4.0 million compared to $4.5 million in the third quarter of 2010. Revenues were $10.6 million in the third quarter of 2011, consisting primarily of the amortization of license fees from our collaboration agreements. Revenues in the third quarter of 2010 were $10.8 million. As of September 30, 2011, Osiris had $53.3 million of cash, receivables and short-term investments.

    Research and development expenses for the third quarter of 2011 were $5.0 million, compared to $5.5 million incurred in the third quarter of 2010. General and administrative expenses were $1.4 million for the third quarter of 2011 compared to $1.3 million for the same period of the prior year. Net cash used in operations for the three months ended September 30, 2011 was $4.4 million.