|Incyte blood cancer drug meets study goals. Seattle Genetics earns collaboration fee. Aegerion Pharma gets Orphan designation|
|By Mary Davila|
|Tuesday, 15 March 2011 19:06|
Incyte Corporation’s (Nasdaq:INCY) announced today that the second pivotal Phase III trial of investigational Janus kinase (JAK) inhibitor, ruxolitinib (INCB18424 or INC424), has met its primary endpoint of significantly reducing spleen swelling in patients with myelofibrosis (MF), when compared to best available therapy. This trial, known as COMFORT-II, was conducted by Novartis as part of the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib, an oral JAK1 and JAK2 inhibitor and is intended to support approval in Europe. Myelofibrosis is a rare cancer of the blood that causes symptoms including bone marrow failure and enlargement of the spleen. Incyte reported that patients that were treated with ruxolitinib were shown to have at least a 35% reduction in spleen size after 48 weeks.
Shares of Incyte gained 51 cents or 4% to $13.88.
Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502.to), has paid an undisclosed fee to exercise an option to designate a second antigen target under the parties’ existing antibody-drug conjugate (ADC) collaboration. Seattle Genetics entered into this collaboration with Millennium in April 2009, at which time Millennium obtained an exclusive ADC license to an initial antigen expressed on solid tumors as well as two options for exclusive licenses to additional targets. Seattle Genetics is entitled to milestone payments and potential royalties on future sales. It will also receive supply and annual maintenance fees as well as research support payments for assistance provided to Millennium.
In heavy trading shares of Seattle Genetics were up 18 cents to $14.78.
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders, announced it has received orphan drug designation from the FDA for its lead drug candidate, lomitapide, for the treatment of familial chylomicronemia (FC), a rare genetic disorder that leads to extremely high levels of triglycerides in the blood. Lomitapide is currently being evaluated in an ongoing pivotal Phase III clinical trial for the treatment of Homozygous Familial Hypercholesterolemia (HoFH), and the Company expects to launch a separate clinical trial to evaluate lomitapide as a treatment for FC in the second half of 2011.
Apricus Biosciences, Inc., (Nasdaq:APRI) today announced the formation of a Male and Female Sexual Dysfunction Clinical Advisory Board as a first step to further the development of its product Femprox(R), for female sexual arousal disorder. The Sexual Dysfunction Clinical Advisory Board consists of key opinion leaders, Irwin Goldstein, M.D., Jed Kaminetsky, M.D. and Ajay Nehra, M.D.
Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, today announced the signing of a global settlement agreement among Alnylam, Max Planck Society, the Whitehead Institute for Biomedical Research and the University of Massachusetts resolving their ongoing litigation regarding the Tuschl patents. The Massachusetts Institute of Technology, formerly a party to the litigation, has also agreed to the terms of the settlement.
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has signed an agreement with OncoSec Medical Inc. (OTC Bulletin Board:ONCSD.OB) providing for the sale to OncoSec of certain non-DNA vaccine technology and intellectual property relating to electroporation technology useful for electrochemical and cytokine based immune therapies for treating solid tumors. OncoSec will pay Inovio an undisclosed purchase price for the assigned assets and cash fees and a royalty on commercial product sales.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced that it has received 510(k) clearance from the FDA for its ASAP(TM) thrombus aspiration catheter. "We are pleased that the ASAP(TM), which we have been selling successfully in Europe, will now be available in the United States," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer.
Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR) and New York University (NYU) Medical Center today announced the formation of a partnership to study the use of Pluristem's proprietary placenta-derived PLX cells for the treatment of Diabetic Foot Ulcers (DFU). "We are very proud to be working with a world-renowned expert such as Dr. Chen and partnering with the NYU Medical Center in using PLX cells for the potential treatment of Diabetic Foot Ulcers," said Zami Aberman, Chairman and Chief Executive Officer of Pluristem. "Our PLX-PAD cells have been shown to be safe and potentially effective and to improve the quality of life in patients with Peripheral Artery Disease (PAD), some of whom had suffered from ulcers. We are, therefore, excited about testing the PLX cells' effectiveness in treating DFU."
AdCare Health Systems, Inc. (NYSE Amex: ADK) , a nursing home and assisted living company, has signed a definitive agreement with a private seller for the asset purchase of four skilled nursing facilities in Arkansas and the acquisition of a 10-year lease for one skilled nursing facility in Missouri for an aggregate consideration of $20 million.