• Alimera Sciences Inc., of Atlanta, entered an exclusive worldwide agreement with Emory University in Atlanta to explore oxidative stress management - specifically the reduction of reactive oxygen species - as a treatment for ophthalmic diseases. Alimera gained an option to license a class of compounds, nicotinamide adenine dinucleotide phosphate reduced form oxidase inhibitors. Also included in the agreement is an exclusive right to sublicense in ophthalmology and the exclusive option for nonophthalmic uses. Emory is eligible to receive milestone payments and sales royalties.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., has reached agreement with the FDA on a special protocol assessment for its global Phase III trial of oral deforolimus, its small-molecule inhibitor, in patients with metastatic sarcomas. Progression-free survival will be the primary endpoint and overall survival will be a secondary endpoint. The company expects to begin patient enrollment later this month. The double-blind trial is designed to evaluate about 650 patients who will be randomized (1:1) to oral deforolimus or placebo at approximately 125 sites. The trial is 90 percent powered to detect a 33 percent increase in median progression-free survival (corresponding to a hazard ratio of 0.75) comparing the oral deforolimus arm with the placebo arm. Two interim analyses are included. Complete patient enrollment and the second interim analysis are expected within approximately two years of the first patient being enrolled.

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, have decided not to proceed with a regulatory submission for CellCept as an induction therapy for lupus nephritis. In June, Aspreva disclosed that the induction portion of a Phase III clinical trial of CellCept (oral mycophenolate mofetil) in lupus nephritis missed its primary endpoint. The 24-week study failed to prove that CellCept was superior to intravenous cyclophosphamide (IVC), a cancer drug used off-label in lupus nephritis and widely considered to be the current standard of care. Instead, the two drugs showed similar response rates. (See BioWorld Today, June 28, 2007). The maintenance phase of the trial continues for patients who successfully completed the induction phase. The study will continue until a predetermined number of patients have left the study or for a maximum of 36 months. Full clinical data from the induction phase will be presented later, the company said. Shares of Aspreva (NASDAQ:ASPV), which fell 5.2 percent, or $1.04, to close at $19.04.

• BioDelivery Sciences International Inc., of Morrisville, N.C., exercised its option to acquire U.S. rights to the BEMA drug-delivery technology it licensed from QLT USA Inc., a Fort Collins, Colo., subsidiary of QLT Inc. The acquisition gives BDSI full ownership of the BEMA technology and eliminates any payment of royalties to or the sharing of milestone payments with QLT going forward. Also, BDSI said it is not required to share the $30 million up-front payment, or any future financial benefit it expects to receive from the partnership agreement signed last week with Meda AB, of Solno, Sweden, involving BEMA Fentanyl. BDSI paid QLT $3 million at closing and issued a $4 million promissory note.

• Biogen Idec, of Cambridge, Mass., and Elan Corp. plc., of Dublin, Ireland, said that the Scottish Medicines Consortium has advised the use of Tysabri (natalizumab) in people with highly active relapsing remitting multiple sclerosis (RRMS). All Scottish health boards are obliged to consider the SMC's advice and ensure that Tysabri is made available to meet patient's clinical needs, the firms stated. Similar positive guidance on Tysabri was issued last month by Great Britain's National Institute for Health and Clinical Excellence. Tysabri is the first treatment to be licensed for highly active RRMS. Tysasbri is approved in Switzerland, Canada, Australia and Israel.

• Biomoda Inc., of Albuquerque, N.M., entered an agreement with Quintiles Consulting, of Rockville, Md., for regulatory consulting and design of clinical studies of Biomoda's test for detection of early lung cancer. The technology is based on a porphyrin application that preferentially binds to cancerous or aberrant cells extracted from lung sputum samples.

• Bioniche Life Sciences Inc., of Bellville, Ontario, has reached agreement with the FDA under the special protocol assessment for a pivotal Phase III study using its Mycobacterial Cell Wall-DNA Complex (MCC) in non-muscle-invasive bladder cancer at high risk of recurrence or progression. Bioniche will begin recruiting 800 patients in the U.S., Australia and Europe for the second pivotal study in the first quarter of 2008. The double-blind, randomized study will compare MCC to the standard treatment for non-muscle-invasive bladder cancer at high risk of recurrence or progression - Bacillus Calmette-Guerin (BCG). The primary efficacy endpoint will be the duration of disease-free survival of patients after two years. In addition, safety will be evaluated based on two criteria: the percentage of patients who experience two consecutive delays of one week in treatment administration due to drug-related adverse events; and through a comparative tabulation of drug-related adverse events. The goal will be to demonstrate noninferior efficacy and improved safety of Urocidin over BCG. The company continues to enroll patients in its first Phase III clinical trial of the efficacy of MCC as therapy in superficial bladder cancer refractory (unresponsive) to BCG. This first pivotal trial was granted fast-track status by the FDA in May, 2006.

• Borean Pharma ApS, of Aarhus, Denmark, and Eden Biodesign Ltd., of Liverpool, UK, signed an agreement under which Eden will manufacture MBP-DC-SIGN, a therapeutic candidate in cancer, for Borean's preclinical studies. The project is expected to be completed early in 2008. MBP-DC-SIGN is one of Borean's products based on the mannose-binding protein platform. Financial terms of the deal were not disclosed.

• BrainStorm Cell Therapeutics Inc., of New York, completed a preliminary meeting with representatives of the FDA to discuss BrainStorm's preclinical research program in Parkinson's disease. The meeting was a prelude to an investigational new drug application filing, and the FDA suggested confirmatory studies in a second species of experimental animals to provide more data on safety and efficacy of Brainstorm's procedure. The firm is developing adult stem cell therapeutic products, derived from autologous bone marrow cells, for the treatment of neurodegenerative diseases.

• Crucell NV, of Leiden, the Netherlands, said Merck & Co. Inc., of Whitehouse Station, N.J. has exercised an option for the exclusive use of Crucell's PER.C6 technology and an option for access to Crucell's AdVac vaccine technology in two infectious disease areas. Under the terms, Crucell acquires rights to certain cell-line technology developed by Merck for the manufacturing of recombinant proteins. The option and the related rights to certain technology developed by Merck originate from the cross-license agreement executed in 2006 between the two firms, and further terms remain undisclosed.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., and Winnersh, UK-based Vernalis plc said the FDA is targeting Sept. 30, 2007, as the PDUFA date for the companies' supplemental new drug application for Frova (frovatriptan succinate) 2.5 mg tablets. The agency previously requested an extension of the Aug. 19, 2007, PDUFA date to have more time to review the application for the additional indication as short-term (six days) prevention of menstrual migraine. Endo and Vernalis intend to continue with their existing commercial plan, which includes the commercial launch of Frova in January 2008, upon approval.

• GenVec Inc., of Gaithersburg, Md., said it has entered into a collaborative research and development agreement with the Department of Defense (DOD) Military Malaria Vaccine Program at the Walter Reed Army Institute of Research and the Naval Medical Research Center for the development and preclinical testing of a malaria vaccine candidate against Plasmodium vivax (P. vivax). More than 50 percent of malaria cases in U.S. military personnel are caused by P. vivax, which is debilitating upon primary infection and can cause recurrent illness years after infection occurs. GenVec also has signed a one-year contract with the DOD to construct and test the adenovector-based vaccine, which carries a novel proprietary antigen against P. vivax developed by Walter Reed scientists. GenVec and its collaborators will jointly design preclinical studies to evaluate the immunogenicity of the adenovector and Walter Reed's recombinant subunit vaccine in various combination prime/boost vaccination strategies.

• High Throughput Genomics Inc., of Tucson, Ariz., is collaborating with the University of California in San Diego, specifically the Department of Medicine's Division of Endocrinology and Metabolism to generate arrays using tissue samples from mice as well as various cell lysates to evaluate genes responsible for inflammation and insulin production using HTG's gNPA quantitative Nuclease Protection Assay technology. The research program aims at studying the mechanisms of insulin resistance and how inflammation is involved in the pathogenesis of diabetes.

• Innovive Pharmaceuticals Inc., of New York, acquired exclusive European rights from Tokyo-based TMRC Co. Ltd. to develop and commercialize tamibarotene, a synthetic retinoid drug candidate. Innovive previously gained North American rights to tamibarotene and is preparing to start a pivotal Phase II trial, under a special protocol assessment, in patients with relapsed or refractory acute promyelocytic leukemia following treatment with all-trans retinoic acid and arsenic trioxide. Under the terms of the new agreement, Innovive has a license to develop the drug in Europe for APL, with an option to include other oncology disease areas, such as multiple myeloma, myelodysplastic syndromes and solid tumors, except for hepatocellular carcinoma. TMRC received an up-front fee and will be eligible for undisclosed development, regulatory and sales milestones and royalties.

• MedImmune Inc., of Gaithersburg, Md., resolved the observations made by the FDA during an annual inspection of the company's influenza vaccine manufacturing facility in Speke, UK. The agency's observations led to the issuance of a warning letter on May 24, 2007. The UK facility is the bulk manufacturing site for FluMist influenza vaccine.

• Metabasis Therapeutics Inc., of San Diego, said MB07133, its product candidate for hepatocellular carcinoma, or primary liver cancer, has been granted orphan designation by the FDA. MB07133 is a HepDirect prodrug of cytarabine monophosphate (araCMP) designed to produce the oncolytically active form, cytarabine triphosphate, in the liver tumor, where it acts to inhibit cell proliferation and induce apoptosis. It has reported encouraging preliminary results from a Phase I/II trial of MB07133.

• Palatin Technologies Inc., of Cranbury, N.J., said it has reacquired full rights to bremelanotide, a first-in-class melanocortin agonist drug candidate for the treatment of male erectile dysfunction (ED) and female sexual dysfunction from King Pharmaceuticals Inc., of Bristol, Tenn. The firms mutually agreed to end their collaborative development and marketing agreement on bremelanotide, with King exercising its right to terminate. Under the termination, effective Dec. 6, Palatin has all rights to bremelanotide, without any obligation for future payments to King. King has no financial obligation for future payments to Palatin, other than for previously incurred costs not yet reimbursed and approved expense reimbursements related to the wind-down of the collaboration. The decision comes after the FDA raised serious concerns about the acceptable benefit-risk ratio to support the progression of bremelanotide into Phase III studies for ED as a first-line therapy in the general population. Palatin said it plans to talk to the agency to determine next steps related to the further development of bremelanotide for the treatment of ED.

• Resverlogix Corp., of Calgary, Alberta, said it achieved positive results from preliminary proof-of-concept studies of TGF-Beta Shield as a treatment for glaucoma. Data were seen in an animal model. Resverlogix is developing a therapeutic approach to modulate the deleterious effects of transforming growth factor-beta in glaucomatous eyes, as well as in other fibrotic and ophthalmic conditions.

• RXi Pharmaceuticals, of Worcester, Mass., said it has entered into an agreement with TriLink Biotechnologies Inc., of San Diego, to exclusively license three RNA interference (RNAi) chemistry technologies for all therapeutic RNAi applications. RXi is a subsidiary of Los Angeles-based CytRx Corp. The agreement includes rights to sublicense a patented RNA linker technology, a patent application on RNAi compositions and an undisclosed chemistry approach that has potential applications in improving existing RNAi compounds. Specific terms of the agreement were not disclosed, but include up-front and yearly minimum licensing payments, royalties of 1 percent or less from RXi to TriLink on sales of therapeutic products developed from technologies included in the license agreement and payments based on the achievement of certain clinical milestones. RNAi has been shown to effectively interfere with the expression of targeted disease-associated genes.

• Sepracor Inc., of Marlborough, Mass., was the subject of a decision by U.S. District Court judge granting final approval of a $52.5 million settlement in two separate but related securities class action suits against the company. Both cases stemmed from allegations that Sepracor concealed safety concerns surrounding Soltara, an antihistamine candidate that the FDA rejected as a treatment for allergic rhinitis in 2002. The company opted to discontinue development of the drug in late 2003.

• TapImmune Inc., of Vancouver, British Columbia, said AppTec Laboratory Services Inc., of St. Paul, Minn., began preclinical testing of its lead product, a TAP-based therapeutic cancer vaccine. The immunotherapy vaccine is designed to treat a variety of TAP-deficient carcinomas. After initial testing and certification, TapImmune would move forward with the production of commercial-grade vaccine for toxicology and Phase I trials. The TAP vaccine is designed to move antigens to the surfaces of cells.

• ValiRx plc, of London, said initial results from research conducted with Cancer Research Technology Ltd., a technology transfer and development company, also of London, showed that its GeneICE compound appears to arrest the development and terminate the existence of cancer cells. Those results confirmed earlier preclinical studies, and also suggested that GeneICE drug candidates targeted to Bcl-2 restored apoptosis in six cancer cell lines by penetrating the walls of cancer cells and targeting the nucleus. That GeneICE compound is being developed by ValiRx's subsidiary, Cronos Therapeutics Ltd., also of London.

• Vermillion Inc., of Fremont, Calif., said it received a notice of noncompliance from Nasdaq, indicating that the company fails to comply with the minimum bid price requirement for continued listing. The letter gives the company notice that the bid price of its common stock has closed under $1.00 for the last 30 business days, and Vermillion has 180 calendar days, or until March 4, 2008, to regain compliance.

• VGX Pharmaceuticals Inc., of Blue Bell, Pa., was awarded a $1.9 million, 12-month contract from the Defense Threat Reduction Agency (DARPA) to develop its constant current electroporation technology for intradermal delivery of DNA vaccines and therapeutics. Under the contract, VGX will demonstrate in vivo efficacy of vaccines derived from DNA plasmid-based pox virus antigens delivered using a skin micro-electroporation system.

• Xceleron Ltd., of York, UK, is collaborating with Organon A/S, of Oss, the Netherlands, on a three-compound human microdose study focusing on candidate selection for further clinical development. All three compounds emerged from Organon's gynecological research and development activities, and the microdose study aims to assess pharmacokinetic properties while confirming the scalability of the microdose to pharmacological dose. Xceleron will use its Accelerator Mass Spectrometry technology to determine human plasma concentrations after microgram administration of the drug candidates. Financial terms were not disclosed.