rights to market Pertzye (pancrelipase) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis...The board is recommending that shareholders approve the arrangement resolution, which is intended, among other goals, to improve Mirati's ability to attract funding in the larger U.S

Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer...In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients

In separate news, Hyperion said it exercised its option to acquire Buphenyl (sodium phenylbutyrate) tablets and powder, an FDA-approved therapy for the chronic management of the most prevalent UCDs, and Ammonul (sodium phenylacetate and sodium benzoate) injection, a hospital-based product used to treat UCD patients in hyperammonemic crisis, from Valeant Pharmaceuticals International Inc., of Montreal...According to a March 2012 agreement between Hyperion and Medicis Pharmaceutical Corp. (later

The agreement is subject to customary regulatory and legal approvals, including the approval of at least 66.67 percent of the votes cast by Resverlogix shareholders at a special meeting called for May 28...Resverlogix also will transfer $5 million to $10 million of cash to provide for the initial capitalization of Spinco. (See BioWorld Insight, April 15, 2013, and BioWorld Today, April 30, 2013...On Tuesday, the FDA also approved Raptor Pharmaceutical Corp.'s orphan drug Procysbi (RP103, cysteamine

for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments...Xenon Pharmaceuticals Inc., of Burnaby, British Columbia, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA has granted orphan drug designation to XEN402 to treat pain associated with erythromelalgia, a rare autosomal dominant condition characterized by burning pain in the

In other news, Prana reported that it received a A$2.5 million (US$2.6 million) cash refund under the R&D Tax Incentive Program...The refund was received to support research and clinical development of PBT2 for Huntington's and Alzheimer's diseases, as well as for other Prana research activities into Parkinson's disease and other neurological indications

ImmunoGen Inc., of Waltham, Mass., and Novartis AG, of Basel, Switzerland, amended their multitarget agreement inked in October 2010, allowing Novartis to take a license to develop and commercialize products directed at two pre-defined and related undisclosed targets – one licensed on an exclusive basis and the other on a nonexclusive basis...The refund was received to support research and clinical development of PBT2 for Huntington's and Alzheimer's diseases, as well as for other Prana research

Omeros said it plans to submit an application in Europe to start clinical trials in the second quarter...In other news, SCT closed its previously announced private placement for gross proceeds of C$3.2 million (US$3.1 million

Other candidates currently undergoing tests required for investigational new drug applications with the FDA include an undisclosed iBioLaunch-produced monoclonal antibody and vaccines for anthrax, malaria and yellow fever...Plasma-derived C1 esterase inhibitor is an orphan drug approved by the FDA to treat or prevent the symptoms of hereditary angioedema...The agreement aims to identify inhibitors of a kinase that plays a key role in tissue protection and repair

The product is designed to neutralize IL20 and IL22, which are involved in proliferation and differentiation of keratinocytes and are implicated in autoimmune diseases of the skin such as atopic dermatitis and psoriasis...Cangene Corp., of Winnipeg, Manitoba, said the FDA approved its Botulism Antitoxin (equine), heptavalent (A, B, C, D, E, F, G) (BAT) product for treating suspected or documented exposure to the botulinum neurotoxin A, B, C, D, E, F or G. Cangene's BAT received orphan drug

Another $13 million to $15 million in equipment, integration service and testing will be provided by Agila...The compounds are thought to have relevance for Parkinson's disease...Proteo Inc., of Irvine, Calif., said the FDA granted orphan drug designation to Elafin for the prevention of inflammatory complications of transthoracic esophagectomy

GenSpera Inc., of San Antonio, said the FDA granted orphan drug designation to G-202 for the treatment of hepatocellular carcinoma...In other news, law firm Bronstein, Gewirtz & Grossman LLC, of New York, said it is investigating claims on behalf of purchasers of Spectrum securities, after shares (NASDAQ:SPPI) fell as much as 38 percent on March 13 on news that the company slashed its revenue projections for colon cancer drug Fusilev (levoleucovorin

After nearly shuttering in 2009 following the failure of its initial program, in 2011 Adventrx acquired privately held SynthRx Inc., of Houston, and its rheologic and antithrombotic agent, poloxamer (ANX-188), to treat sickle cell crisis in a pediatric population, for which the compound has orphan drug designation...Allergan intends to effect a short-form merger of Groundhog into MAP under Delaware law, with MAP becoming a wholly owned subsidiary of Allergan

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...The goal is to modulate the half-life of the therapy to increase efficacy of treatment...The FDA previously granted orphan drug designation to Pluristem's PLX cells in Buerger's disease

Defibrotide will continue to be available to patients under a named patient program...The goal is to modulate the half-life of the therapy to increase efficacy of treatment...The FDA previously granted orphan drug designation to Pluristem's PLX cells in Buerger's disease

18 to close at $1.94, with more than 31 million shares changing hands. (See BioWorld Today, Dec. 6, 2012...Proteologics Ltd., of Rehovot, Israel, and Newcastle Innovation Ltd., the technology transfer company of the University of Newcastle, Australia, entered an exclusive license agreement to develop and commercialize therapeutics for respiratory and other diseases based on the target Midline-1, an E3 ubiquitin ligase...SOV Therapeutics Inc., of Morrisville, N.C., said the FDA granted orphan drug

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

NeurOp is working with Emory to accelerated N-methyl D-aspartate, or NMDA, receptor research in the three-year collaboration...Osiris Therapeutics Inc., of Columbia, Md., reported that the European Medicines Agency granted orphan drug status to Prochymal (remestemcel-L) as a treatment of acute graft-vs.-host disease (GvHD...and six other countries under an expanded access program

OSE Pharma SA, of Paris, said the FDA granted orphan drug status to its lead candidate, OSE 2101, to treat non-small-cell lung cancer (NSCLC) in patients expressing HLA-A2...for the treatment of active, mild-to-moderate ulcerative colitis