• Acorda Therapeutics Inc., of Hawthorne, N.Y., reached agreement with the FDA on a special protocol assessment for a second Phase III trial of Fampridine-SR in multiple sclerosis. The primary objective of the study is to show consistent improvements in walking for drug-treated patients. The design of MS-F204 is similar to Acorda's first Phase III trial of Fampridine-SR in MS, the successful MS-F203 study. However, the current study protocol will require 14 weeks of patient participation compared to 21 weeks in MS-F203. The FDA agreed the two trials would be adequate to support a new drug application filing. The new study is being planned. Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine, or 4-AP), which is believed to improve communication between damaged nerves and increase neurological function.

• Advancis Pharmaceutical Corp., of Germantown, Md., said the FDA accepted for filing its new drug application for Amoxicillin Pulsys for the treatment of adolescents and adults with acute pharyngitis/tonsillitis via the 505(b)(2) regulatory pathway. The company resubmitted the NDA in March after the agency rejected the first filing because it failed to include a proposed commercial batch record or a detailed commercial process description. The FDA set a PDUFA date of Jan. 23, 2008, to determine approval of Amoxicillin Pulsys, a once-a-day presentation of amoxicillin intended to offer a more convenient alternative to existing penicillin and amoxicillin regimens for patients with strep throat. Upon approval, Advancis anticipates launching the product as early as the start of the 2008/2009 cough and cold season. Shares of Advancis (NASDAQ:AVNC) gained 37 cents, or 13.6 percent, to close at $3.10.

• Axxam SpA, of Milan, Italy, and PerkinElmer Inc., of Boston, entered a deal under which PE will become the exclusive provider of Axxam's Photina photoprotein technology to the drug discovery market. The technology is a luminescent cell-based assay platform optimized for screening drug discovery targets, including G protein- coupled receptors and ion channels. Terms also provide for a formal research and development program for additional Photina GPCR and ion channel cell lines for use in high-throughput screening and compound profiling. Axxam retains rights to use the technology for its discovery services to third parties. Terms of the deal were not disclosed.

• Dyadic International Inc., of Jupiter, Fla., said it is abandoning its Asian operations following a number of alleged improprieties that came to light after the death of the managing director for the Asian subsidiaries. Dyadic is conducting an investigation into those allegations and has, thus far, discovered that the Asian subsidiaries' largest customer secretly was controlled by the Asian subsidiaries' management. That customer, which represented about 25 percent of the Asian subsidiaries' reported $6.1 million 2006 net sales and about 33 percent of their $1.7 million in net accounts receivable as of December 31, reportedly purchased products from the Asian subsidiaries which it subsequently re-sold on a cash basis to businesses in mainland China, apparently allowing the businesses to avoid Chinese reporting and sales tax requirements. Dyadic is working with the public accounting firm Ernst & Young LLP to determine proper accounting treatment to abandon those operations. As of Dec. 31, the Asian subsidiaries' assets totaled about $4.7 million.

• Dyax Corp., of Cambridge, Mass., said partner Trubion Pharmaceuticals Inc., of Seattle, opted to expand its existing research agreement, which covers protein therapeutics and diagnostics discovery. In addition to the ongoing multiple-target funded research project, Dyax will transfer its phage library to Trubion's facility for use in identifying therapeutic leads to additional targets, further enabling Trubion's ability to design and develop candidates against a range of disease targets. Financial terms were not disclosed.

• EpiStem plc, of Manchester, UK, entered feasibility studies with London-based AstraZeneca plc to use its plucked hair biomarker technology to help guide preclinical and clinical development of cancer drugs. EpiStem's biomarker technology is designed to enable the measurement of effects of cancer treatments over time in a minimally invasive manner and might help inform the early stage assessment of drugs in preclinical development to reduce the risk of expensive drug failures in later clinical trials. The biomarker program evolved from EpiStem's discovery of the link between the stem cells in the small intestine and the hair follicle. Terms of the deal were not disclosed.

• GangaGen Life Sciences Inc., of Ottawa, Canada, and the University of Nottingham in Nottingham, UK, agreed to engage in a research project aimed at developing a bacteriophage-based treatment for the control of Campylobacter bacteria in poultry. Work is expected to complement GangaGen's food safety product portfolio, which also includes phage products against Salmonella and E. coli 0157:H7. Terms of the agreement were not disclosed.

• Genome Canada, Genome Quebec and the Universite de Montreal said the Canadian government is providing C$34.5 million (US$31.8 million) in funding for an international consortium known as the Public Population Project in Genomics, or P3G. Counting all contributions to the program, the total budget could reach C$64.5 million. P3G is a Montreal-based nonprofit consortium founded in 2003 that attempts to foster collaboration between researchers and projects in the field of population genomics.

• Genzyme Corp., of Cambridge, Mass., said a study demonstrated that administering gene therapy both systemically and directly into the brain helped to preserve motor and cognitive functions and significantly extend the lifespan in a mouse model of Niemann-Pick disease. The study tested the combination of brain and systemic injections of adeno-associated viral vectors encoding human acid sphingomyelinase, the enzyme that is deficient in Niemann-Pick disease patients. After 54 weeks of observations, Genzyme researchers found that combination therapy led to a preservation of motor and cognitive functions at near normal levels. Data were published in The Proceedings of the National Academy of Sciences.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., signed a commercial supply agreement with Baxter Healthcare Corp., of Deerfield, Ill., to provide additional manufacturing capacity for Javelin's injectable diclofenac, Dyloject, which will supplement its existing supply and manufacturing agreement. During the three-year, renewable term agreement, Baxter will serve as a secondary manufacturer of Dyloject pending regulatory approval. The agreement sets forth minimum purchase and production requirements. Financial terms were not disclosed. Dyloject is pending marketing approval in the UK and is in Phase III trials in the U.S. in acute moderate to severe pain.

• Lpath Inc., of San Diego, presented proof-of-concept data from Sphingomab in an animal model of human age-related macular degeneration. Sphingomab (in its humanized form) was shown to mitigate almost completely the choroidal neovascularization formation in mice with laser-induced choroidal damage, which mimics the pathologic neovascularization experienced by patients with AMD. Sphingomab, generated by Lpath's ImmuneY2 platform technology, is a monoclonal antibody against the bioactive lipid S1P (sphingosine-1-phosphate). Lpath plans to initiate clinical trials for wet AMD in early 2008.

• Lux Biosciences Inc., of Jersey City, N.J., expanded its existing technology licensing agreement with Rutgers University to add exclusive access for ophthalmic use to some of the university's polycarbonate intellectual property estate. That adds to the polyarylate patent portfolio Lux licensed from Rutgers in September 2006, and it gives Lux access to a broader range of polymers that are bioerodible and based on long-term delivery of medications to the eye. The license includes several patents that specifically disclose methods of generating drug release formulations for peptides using polymers as the drug delivery matrix. Financial terms were not disclosed.

• Mpex Pharmaceuticals Inc., of San Diego, named Daniel Burgess as CEO. He previously served as chief operating officer and chief financial officer of Hollis-Eden Pharmaceuticals Inc., also of San Diego. Mpex, which discovers and develops antibacterial drugs, is in Phase I testing with its lead product, an aerosol antibiotic.

• Pediatric Bioscience LLC, of Sacramento, Calif., entered a deal to sponsor research at the University of California. The state will provide matching funds. The focus is to gain insight into whether certain gene expression traits are being passed on from parent to child, leading to susceptibility to autism in those children. Pediatric Bioscience was formed in 2006 by a group of researchers, parents and business people to develop products to predict, diagnose and treat children with autism.

• Samaritan Pharmaceuticals Inc., of Las Vegas, signed a second exclusive marketing and distribution agreement with Shire Human Genetic Therapies AB, of Basingstoke, UK, to launch and sell Replagal (agalsidase alfa), a European approved drug for Fabry's disease, in Greece and Cyprus. Replagal is a long-term enzyme replacement therapy. Terms of the deal were not disclosed.

• Synosia Therapeutics, of South San Francisco, acquired a license from Syngenta AG, of Basel, Switzerland, to develop a potential treatment of Parkinson's disease. The compound, SYN-118, is a hydroxyphenylpyruvate dioxygenase inhibitor, which already is approved in the U.S. and Europe for the metabolic disorder hereditary tyrosinemia Type I. Synosia intends to develop the compound in central nervous system disorders. Under the terms, Synosia will be responsible for ongoing clinical development and commercialization of SYN-118, while Syngenta is eligible for milestones and royalties.

• TMO Renewables Ltd., of Surrey, UK, licensed the ERGO bioinformatics software developed and maintained by Chicago-based Integrated Genomics Inc. for gene annotation, metabolic reconstruction and enzyme data mining, as well as for comparative genomics. The ERGO platform is expected to allow TMO to further understand and exploit its thermophilic strains to deliver green biofuels. Terms of the deal were not disclosed.