Isis Pharmaceuticals Inc., of Carlsbad, Calif., said the Committee for Orphan Medicinal Products in Europe has adopted a positive opinion recommending ISIS-TTRRx for designation as an orphan medicinal product for the treatment of ATTR-amyloidosis to the European Commission (EC). The opinion will be subject to review by the EC, which ultimately grants the decision on orphan drug designation. ISIS-TTRRx is an antisense drug in development with Glaxosmithkline plc, of London.
Mylan Inc., of Pittsburgh, said its subsidiary Agila Specialties Private Ltd. is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of etomidate for injection 2 mg/mL – 10 mL and 20 mL. The 10 lots were manufactured by Agila Specialties Polska sp.zo.o in Warsaw, Poland. All of the products bear a label from Pfizer Inc., of New York. The recall is due to the potential for small black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiry date on the outer carton, and the potential for illegible/missing lot number and expiry on individual vials.
Nicox S.A., of Sophia Antipolis, France, said it is re-focusing its naproxcinod development efforts. As a result it has granted an undisclosed financial partner the right to enter a period of exclusive evaluation to assess the potential development of the product and of next generation nitric oxide (NO)-donors outside the ophthalmology area. The evaluation will be entirely funded by the partner and will be focused initially on Duchenne muscular dystrophy (DMD). The partner has the exclusive right, should the results of the evaluation be satisfactory, to invest in naproxcinod through an independent structure. In October 2013, the European Commission granted orphan drug designation for naproxcinod for the treatment of DMD.
Prothelia Inc., of Milford, Mass., and the University of Nevada, Reno, inked strategic agreements with Alexion Pharmaceuticals Inc., of Cheshire Conn., to develop Laminin-111, a protein replacement therapy candidate for merosin-deficient congenital muscular dystrophy (MDC1A), an ultra-rare disease caused by a genetic deficiency of the laminin-211 protein. As part of the binding agreement, Alexion has an exclusive option to acquire privately held Prothelia and to license Laminin-111 directly from the university upon the achievement of undisclosed R&D milestones. In addition, the three organizations entered a sponsored research agreement to accelerate research on Prothelia’s investigational therapy, conditioned on the outcome of certain development activities that Alexion will perform. Additional terms were not disclosed. Laminin-111 is a form of laminin found in embryonic skeletal muscle that has been shown in early animal studies to substitute for the loss of laminin-211.
Soligenix Inc., of Princeton, N.J., said it was awarded a Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases to support additional preclinical development of SGX943 to treat melioidosis. The award will provide Soligenix with approximately $300,000 over one year to conduct the studies in collaboration with Tulane University. In bacterial infection models, SGX943 showed preclinical efficacy with gram-positive methicillin resistant Staphylococcus aureus and gram-negative pathogens. SGX943 stimulates the immune system to combat infection while simultaneously suppressing inflammation.
Sunshine Biopharma Inc., of Montreal, said it initiated the construction of mouse xenograft models for pancreatic cancer as part of the plans of positioning lead drug candidate Adva-27a for clinical development for pancreatic cancer in parallel with multidrug-resistant breast cancer. The work is being conducted in collaboration with parent company, Advanomics Corp., the co-recipient of $1.45 million in research grants in Canada. To date Adva-27a, a topoisomerase II inhibitor, has been found to be effective at destroying cells of the very aggressive pancreatic cancer cell line, Panc-1.
Theratechnologies Inc., of Montreal, said it expects current inventory of Egrifta (tesamorelin for injection) to be depleted in the coming weeks due to a combination of manufacturing delays and issues observed during the production of new batches of the drug. These issues will eventually result in a stock-out. The company said EMD Serono Inc. has notified the FDA about the situation. Theratechnologies also revealed that it has decided to temporarily cease the manufacture of Egrifta and is unable to provide a timeline on the resumption in the manufacture and its delivery. Despite this setback, the company confirmed it is still on track to close the agreement in the second quarter with EMD Serono, a subsidiary of Merck KGaA, of Darmstadt, Germany, to regain U.S. rights to Egrifta, including commercialization rights, under a collaboration and licensing agreement inked in 2008. The therapy was approved by the FDA in 2010 for HIV-associated lipodystrophy, a metabolic complication that affects patients taking antiretroviral therapies long term. EMD Serono will receive an early termination fee of $20 million, payable over five years. (See BioWorld Today, Dec. 17, 2013.)
Xenetic Biosciences Inc., of Lexington, Mass., said its common stock began trading under the new ticker “XBIO” on the OTC Bulletin Board (OTCBB), following a reverse merger and name change in January. The company previously traded on the OTCBB as “GAIFD.” Xenetic reported 146.7 million common shares outstanding, following a direct equity investment of $10 million last month from Baxter International Inc., of Deerfield, Ill., which resulted in Xenetic issuing an additional 10.7 million shares.