• Bruker Daltonics, of Billerica, Mass., said it has formed a collaboration with Boston University School of Medicine focusing on the application of high performance ion trap mass spectrometry and fourier transform mass spectrometry to glycomics and proteomics applications. The university already is using Bruker's amaZon ion trap mass spectrometer for detailed and high-throughput analyses of glycan structures, and has just ordered a solariX FTMS with a 12 Tesla magnet for high performance bottom-up and top-down proteomics and glycomics with ETD and ECD capabilities.

• Caraco Pharmaceutical Laboratories Ltd., of Detroit, said it has executed a settlement agreement with MedImmune Inc., of Gaithersburg, Md., for the dismissal of federal lawsuits filed regarding the submission of an abbreviated new drug application for a generic version of Ethyol. Under the settlement agreement, MedImmune grants Caraco a license to certain patents, permitting Caraco to continue marketing a generic version of Ethyol in the U.S. Financial terms were not disclosed.

• The FDA said Monday that Botox, Botox Cosmetic, Myobloc and Dysport now carry black-box warnings on their labeling cautioning that the effects of the products may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including potentially life-threatening swallowing and breathing difficulties and even death. The symptoms were mostly reported in children with cerebral palsy being treated for muscle spasticity, an unapproved indication. To help reduce the potential for dosing errors, Botox and Botox Cosmetic, marketed by Allergan Inc., of Irvine, Calif., have changed their established drug names, also referred to as the generic name, from botulinum toxin type A to onabotulinumtoxinA, and Myobloc, marketed by Solstice Neurosciences Inc., of Malvern, Pa., has changed from botulinum toxin type B to rimabotulinumtoxinB. Dysport (abobotulinumtoxinA), marketed by Medicis Pharmaceutical Corp., of Scottsdale, Ariz., and Ipsen SA, of Paris, which was approved in April with the boxed warning, did not require a new name change. (See BioWorld Today, May 4, 2009.)

• Genentech Inc., of South San Francisco, a subsidiary of Roche Holdings AG, said the FDA expanded the approval of Avastin (bevacizumab) for use in combination with interferon-alfa in untreated metastatic renal-cell carcinoma. The application was based on data from a Phase III study showing that patients who received the combination therapy had a 67 percent increase in progression-free survival (10.2 months) compared to those receiving interferon-alfa alone (5.4 months). Avastin previously gained approval in colorectal, lung and breast cancers.

• Janssen Pharmaceutica NV, of Titusville, N.J., said the FDA approved Invega Sustenna (paliperidone) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults. The drug is the first once-monthly, long-acting, injectable atypical antipsychotic approved in the U.S. for that use.

• MDRNA Inc., of Bothell, Wash., said its UsiRNA technology demonstrated highly potent activity against metabolic disease and cancer targets in rodent models. The data established that the knockdown of those targets is achieved via an RNAi-mediated process. Of particular importance is that the data demonstrated that strategic placement of UNA (unlocked nucleobase analogues) results in the ability to manipulate, either increasing or decreasing, strand-specific activity thus minimizing off-target activity and providing the ability to impart improved drug-like characteristics to the UsiRNAs, the company said. The data were presented at the IBC Drug Discovery & Development Week conference in Boston.

• Medivir AB, of Stockholm, Sweden, said that the FDA has approved Lipsovir for early treatment of cold sores. Lipsovir, a combination of hydrocortisone and acyclovir, will be the first product marketed for the treatment of cold sores that has a corresponding label or has been shown to prevent an outbreak with early treatment.

• Micromet Inc., of Bethesda, Md., has received orphan drug designation from the European Medicines Agency for BiTE antibody blinatumomab (MT103) for acute lymphoblastic leukemia. Blinatumomab is an antibody that activates T cells to seek out and destroy cancer cells. In June, Micromet said it achieved its primary endpoint in an ongoing Phase II study of ALL patients.

• Neurotez Inc., of Bridgewater, N.J., said the National Institutes of Health, through the Small Business Innovation and Research program, awarded a $2.73 million dollar, three-year grant to initiate the clinical development of a leptin product as a novel therapy for Alzheimer's disease.

• URL Pharma, of Philadelphia, said it has acquired an FDA-inspected 19,000-sq-ft. facility from PharmPro Inc., of Upland, Pa., which the firm said would expand its capacity and capabilities for product development and manufacturing operations. The acquisition also includes DuraGran, a proprietary platform technology that enables the efficient production of uniform, small granules in the development and manufacture of modified-release dosage forms.

• Vical Inc., of San Diego, has entered an exclusive agreement with Abic Marketing Ltd., a subsidiary of Teva Pharmaceutical Industries Ltd., of Jerusalem, for sales and marketing of the company's Allovectin-7(r) immunotherapeutic product candidate in Israel. Teva has agreed to pay Vical up-front and milestone payments in exchange for the rights to an exclusive license for Israel.

• XenoPort Inc., of Santa Clara, Calif., said its partner Astellas Pharma Inc., of Tokyo, plans to file a marketing application in Japan for XP13512 (also known as ASP8825) as a potential treatment for moderate-to-severe primary restless legs syndrome by the end of next March. The filing will be based on data from a successful Phase II study in RLS patients conducted in Japan conducted by Astellas and XenoPort's clinical program conducted in the U.S. The company said Astellas has concluded that Phase III studies in Japan will not be required for the application filing. XenoPort also said that Astellas does not intend to continue the development of XP13512 in Japan as a potential treatment for painful diabetic neuropathy under the current circumstances. A Phase II trial of XP13512 in Japanese patients with painful diabetic neuropathy indicated that continuation of the study was not likely to demonstrate a statistically significant advantage of the drug over placebo on the primary endpoint of the study. The FDA currently is reviewing an application for XP13512, known in the U.S. as Solzira, submitted by GlaxoSmithKline plc, of London, for the potential treatment for moderate-to-severe primary RLS. (See BioWorld Today, Nov. 7, 2008.)

• Zogenix Inc., of San Diego, and Astellas Pharma US Inc., of Deerfield, Ill., have entered into a co-promotion agreement for Sumavel DosePro (sumatriptan injection) needle-free delivery system, which received FDA approval in July for subcutaneous sumatriptan, a migraine treatment. Under the terms of the agreement, the companies will collaborate on the promotion and marketing with Zogenix focusing its sales activities primarily on the neurology market and Astellas mostly on primary care physicians. Zogenix will have responsibility for manufacturing and distribution, and product sales will be booked by Zogenix. Astellas will be compensated based on sales performance within their prescriber audience. Financial details were not disclosed.