Late Tuesday, the FDA increased the options available in Type I Gaucher disease by approving Elelyso (taliglucerase alfa), a recombinant version of the hydrolytic human lysosomal enzyme glucocerebrosidase. The compound was discovered by Protalix BioTherapeutics Inc., which is partnered with Pfizer Inc. on development and commercialization outside Israel. Read More
Gilead Sciences Inc. began a Phase III trial of its PI3K inhibitor, GS-1101, in chronic lymphocytic leukemia (CLL). If successful, the company could add a cancer candidate to its powerhouse lineup of products currently led by its HIV and hepatitis C virus franchises. Read More
LONDON – Evotec AG landed its second out-licensing deal in China, taking a small up-front payment, with €60 million (US$78.8 million) to come in milestones, followed by double-digit royalties on sales if EVT 401 makes it through to Chinese marketing approval. Read More
For companies working in orphan diseases, support from patient advocacy groups and foundations is critical, both in terms of providing much-needed funding and building relationships with the small patient communities. But 2011 start-up Halo Therapeutics LLC credits its connection to patient groups to the company's actual formation. Read More
• Mirna Therapeutics Inc., of Austin, Texas, reported data demonstrating that microRNA-34 (miR-34) mimics inhibited tumor growth in an animal model of B-cell lymphoma. The data, published in Leukemia, complemented those generated by Mirna and academic collaborators in animal models of lung and prostate cancer. Read More
• Versartis Inc., of Redwood City, Calif., said it completed patient enrollment in a Phase I trial of VRS-317, a once-monthly form of recombinant human growth hormone. The primary objective of the study is to evaluate the safety and tolerability of a single subcutaneous dose of the drug. Read More
• Allon Therapeutics Inc., of Vancouver, British Columbia, completed a brokered private placement equity offering, resulting in gross proceeds of C$10 million (US$10.1 million). The company sold 15.6 million equity units and 24.4 million subscription receipts convertible into units on a one-for-one basis, both priced at C25 cents each. Read More
• Meda AB, of Goteborg, Sweden, said the FDA approved Dymista, a nasal spray formulation of azelastine hydrochloride and fluticasone propionate, for treatment of seasonal allergic rhinitis. Read More
• AMAG Pharmaceuticals Inc., of Lexington, Mass., reported first-quarter revenues of $15.5 million, including $13.6 million in net revenues from Feraheme (ferumoxytol) injection in iron deficiency anemia (IDA). Net Feraheme product revenues for the first quarter were $13.6 million, compared to $10.9 million in the first quarter of 2011. Provider demand for the intravenous drug during the first quarter was approximately 26,600 grams, representing a 30 percent increase over the first quarter of 2011 and a 10 percent increase over the fourth quarter of 2011. Read More
