• Acorda Therapeutics Inc., of Hawthorne, N.Y., partnered with a subsidiary of Watson Pharmaceuticals Inc., of Parsippany, N.J., to launch an authorized generic version of Zanaflex (tizanidine hydrochloride) capsules for spasticity. Acorda will receive a royalty, but specific terms were not disclosed.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., completed its acquisition of Montreal-based Enobia Pharma Corp., gaining midstage enzyme therapy candidate asfotase alfa for ultra-orphan disease hypophosphatasia. The deal, disclosed in late December, calls for Alexion to pay $610 million up front, and up to $470 million in sales and regulatory milestones. (See BioWorld Today, Jan. 3, 2012.)

• Almirall SA, of Barcelona, Spain, made regulatory submissions for Sativex to a number of European countries including Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia. The submission was made to health authorities by GW Pharmaceuticals plc, of Salisbury, UK, under a mutual recognition procedure. A response is expected within the first half of 2012, and the approval processes will continue in each country according to local regulations.

• Amicus Therapeutics Inc., of Cranbury, N.J., received a two-year, $186,000 grant from the Muscular Dystrophy Association (MDA) to evaluate the effect of the pharmacological chaperone AT2220 (duvoglustat HCl) on immunogenicity related to the enzyme replacement therapy (ERT) alglucosidase alfa, the only approved treatment for Pompe disease. As part of the MDA grant, Amicus will investigate the ability of AT2220 to mitigate ERT-specific immunogenicity from blood samples obtained in the ongoing open-label Phase II drug-drug interaction study of AT2220 co-administered with ERT in individuals with Pompe disease and from normal donors.

• Cadence Pharmaceuticals Inc., of San Diego, voluntarily recalled a single lot of Ofirmev (acetaminophen injection), lot number V005710, due to the presence of an unidentified, visible particle in one vial of that lot during routine stability testing. Cadence contended that fewer than 1,000 vials remain in the market, and it has not received any reports of adverse patient events associated with particulate matter in the product.

• EpiCept Corp., of Tarrytown, N.Y., filed for fast-track designation of AmiKet (amitriptyline 4 percent, ketamine 2 percent cream) in chemotherapy-induced peripheral neuropathy. The firm is seeking a special protocol assessment from the FDA on a Phase III trial.

• Genentech Inc., of South San Francisco, a unit of the Roche Group, said the FDA accepted its biologics license application and granted priority review for pertuzumab in combination with Herceptin (trastuzumab) and docetaxel chemotherapy in HER2-positive metastatic or locally recurrent, unresectable breast cancer patients who have not received previous treatment or whose disease has relapsed after adjuvant therapy. The FDA confirmed the action date of June 8.

• Jennerex Inc., of San Francisco, published data in Molecular Therapy that validated mechanisms by which its product, JX-594, targets and kills cancer cells. The study showed multiple mechanisms that were dependent on biological traits of the cells. Replication of JX-594 was activated by epidermal growth factor receptor/Ras pathway signaling, cellular thymidine kinase levels and cancer cell resistance to Type I interferons.

• NeurogesX Inc., of San Mateo, Calif., saw its shares plummet 24 percent after the FDA's Center for Drug Evaluation and Research (CDER) released briefing documents for the Anesthetic and Analgesic Drug Products Advisory Committee meeting, scheduled for Feb. 9, to discuss Qutenza for the management of neuropathic pain associated with HIV-PN. The CDER document cited "statistical concerns regarding multiplicity" and said the absence of replicated statistically significant results "have raised the question of whether evidence of substantial efficacy has been demonstrated for this proposed treatment regimen." Although CDER acknowledged the unmet need to control the "often severe and disabling" neuropathic pain in HIV, "it would not be in the best interest of these patients for us to approve a product for which substantial evidence of efficacy has not been demonstrated, or one for which the benefits do not clearly outweigh the risks," according to the briefing document. The stock (NASDAQ:NGSX) lost 27 cents, or 23.6 percent, closing Tuesday at 88 cents, on 10 times its average trading volume.

• Pieris AG, of Freising, Germany, received a €1 million (US$1 .325 million) grant for development of PRS-110 in cancer. The funding will specifically fund work on a biomarker strategy. Pieris will present preclinical results for PRS-110 at the upcoming American Association for Cancer Research annual meeting.

• Pluristem Therapeutics Inc., of Haifa, Israel, said it plans to expand its R&D efforts in acute radiation exposure. Pluristem's PLX cells previously were shown to mitigate acute radiation syndrome and increase survival in animal models.

• Prismic Pharmaceuticals Inc., of Scottsdale, Ariz., acquired the assets of UK-based Scarista Ltd., including an exclusive license to London-based Amarin Corp. plc's intellectual property portfolio covering highly purified forms of omega-3 fatty acids for central nervous system disorders. Terms were not disclosed. Prismic said it is now looking to partner those assets with one or more pharmaceutical companies.

• Rib-X Pharmaceuticals Inc., of New Haven, Conn., received a $3 million milestone payment from Paris-based Sanofi SA under a collaboration signed in July 2011 relating to the RX-04 antibiotic program. That is the fourth payment thus far, for a total of $22 million. Sanofi has the right to license an unlimited number of product candidates from Rib-X that target a discrete binding site in the ribosome. (See BioWorld Today, July 7, 2011.)

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA granted priority review to a new drug application for crofelemer 125-mg tablets. The proposed indication is diarrhea in patients with HIV who are on antiretroviral therapy. Salix said crofelemer may inhibit chloride secretion by gut cystic fibrosis transmembrane conductance regulator protein and gut calcium-activated chloride channel.

• Thrasos Inc., of Montreal, said Nature Medicine published results of a collaborative research program detailing the role of the bone morphogenic protein (BMP) pathway in the development of kidney disease. The research described the potential for Thrasos' compounds to target receptors in that pathway, potentially leading to the control of fibrosis and induction of kidney regeneration. The preclinical studies detailed in the report demonstrated that the activin-like kinase 3 (Alk3) receptor is elevated early in diseased kidneys following injury and suggested Alk3-mediated signaling can protect kidneys by inhibiting fibrosis. A representative small peptide agonist from Thrasos' portfolio, THR-123, designed to bind selectively to the BMP receptors, was shown to control and reverse fibrosis and to induce kidney regeneration in preclinical models of chronic renal injury. THR-123 was delivered orally in the studies and achieved its effects without inducing bone formation. (See BioWorld Today, Sept. 14, 2011.)

• Tocagen Inc., of San Diego, inked a companion diagnostics partnership with Siemens Healthcare Diagnostics, which initially will support clinical trials related to Tocagen's viral gene therapy (Toca 511 and Toca FC) in primary brain cancer. That could be followed by potential commercialization of diagnostic tests for therapy monitoring, subject to FDA approval. Financial terms were not disclosed. Siemens also signed a deal with ViiV Healthcare Co., a joint venture between London-based GlaxoSmithKline plc and New York-based Pfizer Inc., for diagnostic tests related to Celsentri/Selzentry (maraviroc), a CCR5 co-receptor antagonist for CCR5-tropic HIV.

• ViroPharma Inc., of Exton, Pa., said the FDA issued a complete response letter regarding manufacturing expansion activities for Cinryze (C1 esterase inhibitor). The FDA made three comments related to cleaning validation. ViroPharma said it plans to complete needed additional activities quickly. The FDA has not yet completed review of ViroPharma's updated responses to the FDA's observations from a September 2011 inspection of the Amsterdam facility.