• Aeterna Zentaris Inc., of Quebec City, said it entered a deal with Ventana Medical Systems Inc., a member of the Roche Group, of Basel, Switzerland, to develop a companion diagnostic for the immunohistochemical determination of luteinizing hormone-releasing hormone (LHRH) receptor expression to go along with the company's doxorubicin LHRH-targeted conjugate compound, AEZS-108. LHRH receptors are expressed in a significant proportion of endometrial, ovarian, breast, bladder, prostate and pancreatic tumors.

• AiCuris GmbH & Co., of Wuppertal, Germany, said the FDA granted orphan drug status for AIC246 (letermovir), an inhibitor of human cytomegalovirus (HCMV), for the prevention of HCMV viremia and disease in at-risk populations. Letermovir recently completed a Phase IIb trial, and results are expected shortly.

• AlloCure Inc., of Burlington, Mass., said the FDA granted fast-track designation to AC607 in acute kidney injury (AKI). A therapy comprising allogeneic bone marrow-derived mesenchymal stem cells harvested from healthy adult donors, AC607 recently completed a Phase I trial, in which it demonstrated a good safety profile and suggested an ability to reduce both the incidence of AKI and length of hospital stay in cardiac surgery patients.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and Arrowhead Research Corp., of Pasadena, Calif., said they inked a collaboration and joint licensing deal, under which Alnylam grants Arrowhead rights to its intellectual property enabling the discovery, development and commercialization of an RNAi therapeutic targeting hepatitis B virus. Under the terms, Alnylam is eligible for milestone payments and royalties. In addition, Alnylam received a license to use Arrowhead's Dynamic Polyconjugate delivery technology for an RNAi therapeutic product against an undisclosed target in its Alnylam 5x15 pipeline in exchange for milestones payments and royalties to Arrowhead. Specific financial terms were not disclosed.

• Celtaxsys Inc., of San Francisco, acquired CTX-4430 (formerly EP-501) from Estrellita Pharmaceuticals Inc., also of San Francisco. The clinical-stage drug candidate inhibits the pro-inflammatory enzyme Leukotriene A4 Hydrolase (LTA4H), which is a key enzyme in the production of the major pro-inflammatory mediator Leukotriene B4 (LTB4). LTA4H and receptors to LTB4 are known to be elevated in a number of human lung diseases, including cystic fibrosis, asthma and chronic obstructive pulmonary disease. In preclinical studies, CTX-4430 demonstrated the ability to reduce the progression of chronic inflammation in several animal models.

• ChemoCentryx Inc., of Mountain View, Calif., said that GlaxoSmithKline plc, of London, exercised its option for an exclusive license to develop and commercialize CCX354, a selective inhibitor of CCR1, a chemokine receptor that drives the recruitment of inflammatory cells into the joints of patients with rheumatoid arthritis. ChemoCentryx recently reported positive results from a Phase II study of CCX354 that investigated the safety, tolerability, clinical and biological activity of the compound in patients with RA. Under terms of the collaboration, ChemoCentryx will receive an option exercise fee of $25 million and will be eligible for additional regulatory and sales milestone payments. Subject to successful commercialization of the compound, ChemoCentryx also will receive double-digit royalties on net sales. (See BioWorld Today, Oct. 18, 2011, and Aug. 25, 2006.)

• DFH Pharma Inc., of Gaithersburg, Md., is collaborating with CiVentiChem LLC, of Research Triangle Park, N.C., to develop the next generation of HIV maturation inhibitor drugs. DFH will work with CiVentiChem to extend its recent efforts to discover new drug candidates with potent activity against all HIV strains, including those that proved resistant to the first-in-class maturation inhibitor, bevirimat. In addition to new triterpene analogs, which form the basis for the second-generation program, the companies plan to explore new chemical space in hopes of identifying additional classes of compounds with maturation inhibition activity. No terms were disclosed.

• Ensemble Therapeutics Inc., of Cambridge, Mass., said it identified a series of small-molecule antagonists of interleukin-17, a pro-inflammatory cytokine implicated in inflammatory and autoimmune diseases such as psoriasis, rheumatoid arthritis, Crohn's and intestinal bowel disease. The company expects the program to produce a development candidate by the end of this year. In separate news, Ensemble said it extended its 2009 alliance with New York-based Bristol-Myers Squibb Co. involving Ensemble's drug discovery platforms and Ensemblin compound libraries to discover drug candidates against up to eight targets. In April, Ensemble delivered Ensemblins against one of the designated targets in exchange for a milestone payment. Under the agreement extension, Ensemble will continue to pursue all collaboration targets. (See BioWorld Today, April 15, 2009.)

• Insys Therapeutics Inc., of Phoenix, said the FDA approved Subsys fentanyl sublingual spray, a formulation of fentanyl using a delivery device intended to offer benefits to patients experiencing episodes of breakthrough cancer pain. The company aims to launch the product under the recently approved TIRF REMS Access Program, expected to be launched later this quarter. Shares of Insys (PINKSHEETS:NEOL) gained $1, or 9 percent, to close Thursday at $12.

• OctoPlus NV, of Leiden, the Netherlands, said it expanded its drug delivery technology evaluation contract with an existing undisclosed global pharmaceutical company. Financial terms were not disclosed.

• Oncodesign SA, of Dijon, France, and Ipsen SA, of Paris, entered a research collaboration to discover and develop LRRK2 kinase inhibitors as potential treatments for Parkinson's and other diseases, using Oncodesign's Nanocyclix technology. Under the agreement, Ipsen will have two options to exclusively license Oncodesign's LRRK2 inhibitor program, with worldwide development, manufacturing and commercialization rights. Oncodesign is entitled to a technology access fee, funding of the research and early development activities, tiered royalties, and up to about $147 million in license options, opt-in fees and additional development, regulatory and commercial milestone payments for the development of molecules in two or more indications. Nanocyclix is a chemistry technology based on a macrocyclization process of small molecules.

• Sanofi SA, of Paris, said the U.S. District Court in Massachusetts granted it a preliminary injunction against a Synvisc-One (hylan G-F 20) competitor product developed by Seikagaku Corp., of Tokyo, which allows for a restricted launch of Seikagaku's product prior to a scheduled date in April and prohibits Seikagaku from selling its product below the current average sales price of Synvisc-One. A single-injection viscosupplement to treat osteoarthritis knee pain, Synvisc-One was launched in 2009 by developer Cambridge, Mass.-based Genzyme Corp., which was acquired by Sanofi last year.

• Senesco Technologies Inc., of Bridgewater, N.J., said it restructured its 1999 R&D agreement with Rahan Meristem Ltd., of Western Galilee, Israel, from a cost- and profit-sharing arrangement to a license agreement, which provides Senesco with a mid- to upper-single-digit royalty on incremental revenue from the sale of Rahan's banana seedling products containing Senesco's eIF5A technology. Senesco said the move is intended to allow it to benefit from agricultural applications of its technology without shifting focus from its own work in human therapeutics. A clinical study testing lead candidate SNS01-T in multiple myeloma is ongoing.

• Shire plc, of Dublin, Ireland, reported that the UK's Medicines Healthcare products Regulatory Agency accepted its Venvanse for review and will act as the reference member state for the decentralized procedure, which will initially include eight European countries. The application follows the completion of the European Phase III study of once-daily Venvanse (lisdexamfetamine dimesylate) in children and adolescents with attention-deficit hyperactivity disorder (ADHD) last year. Venvanse is available in Brazil to treat children with ADHD, and marketed as Vyvanse; it's approved in Canada and the U.S. to treat ADHD in children, adolescents and adults. (See BioWorld Today, Feb. 27, 2007, and April 24, 2008.)

• Targacept Inc., of Winston-Salem, N.C., said London-based AstraZeneca plc informed the biotech that it plans to progress the development of AZD1446 in Alzheimer's disease. The drug, a selective modulator of the alpha4beta2 neuronal nicotinic receptor, stems from the companies' 2005 collaboration. Under the terms, AstraZeneca is responsible for conducting and funding the development and commercialization of AZD1446. The next trial is expected to be a Phase II study testing the drug as an adjunct treatment to donepezil in patients with mild to moderate Alzheimer's disease. (See BioWorld Today, Dec. 29, 2005.)

• Tengion Inc., of Winston-Salem, N.C., relocated its corporate headquarters from East Norriton, Pa. to the firm's existing facility in Winston-Salem, part of a restructuring designed to fund the company's lead development programs through key milestones in 2012 while reducing anticipated cash use.

• Tetragenetics Inc., of Cambridge, Mass., reported preclinical study results showing that an investigational nanoparticle-based influenza vaccine protects against a highly pathogenic H5N1 avian influenza strain. The study was conducted at the Institute for Antiviral Research of Utah State University in Logan, Utah and Tetragenetics under a contract sponsored by the National Institute of Allergy and Infectious Diseases.

• Tivorsan Pharmaceuticals Inc., of Providence, R.I., said the Muscular Dystrophy Association awarded it $1 million to help speed preclinical work needed before filing an investigational new drug application for a recombinant humanized form of biglycan in Duchenne's muscular dystrophy (DMD). Tivorsan's approach looks to treat DMD by up-regulating the utrophin protein and its candidate, TVN-102, previously demonstrated a reduction in muscle damage, muscle degeneration and improved muscle function in a mouse model.

• Ultragenyx Pharmaceutical Inc., of Novato, Calif., said it in-licensed an enzyme replacement therapy program from St. Louis University to treat mucopolysaccharidosis Type 7, an ultra-rare genetic, metabolic disorder that results from the deficiency of the beta-glucuronidase enzyme. Terms were not disclosed.

• ValiRx plc, of London, said its wholly owned subsidiary, ValiFinn Oy, acquired from Pharmatest Services Oy, of Oulu, Finland, its biomarkers business unit, together with five families of patents, patent applications and related intellectual property (IP). Under the terms, Pharmatest gets a payment of €75,000 (US$95,921) and the allotment of 15 million shares in ValiRx, plus royalties from future revenues relating to the IP and for the life of the patents.

• Yaupon Therapeutics Inc., of Malvern, Pa., changed its name to Ceptaris Therapeutics Inc. to reflect the recent changes in management and the company's ongoing transformation into a commercial operation. Ceptaris' lead drug candidate, mechlorethamine gel, is under FDA review in early stage mycosis fungoides, a type of cutaneous T-cell lymphoma.