• Acura Pharmaceuticals Inc., of Palatine, Ill., said it reached agreement with the FDA on a special protocol assessment for a pivotal Phase III trial of OxyADF tablets. The FDA previously communicated to the company that only one successful Phase III pivotal study would be required prior to NDA submission. The pivotal trial, AP-ADF-105, will evaluate OxyADF (oxycodone HCl and niacin) in the treatment of pain following bunionectomy surgery in adults. The 405-patient study will compare two drug doses to placebo. Enrollment remains dependent upon the company's ability to secure near-term funding, as its current cash will fund operations only through mid-July, Acura said.

• Althea Technologies Inc., of San Diego, has been engaged by GeoVax Labs Inc., of Atlanta, to manufacturer its HIV-1 DNA AIDS vaccine. The vaccine will be used in GeoVax's advanced Phase II human trials planned to start in early 2008. Trial participants will be administered the GeoVax HIV-1 DNA vaccine which "primes" the immune system followed by the GeoVax HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines deliver more than 50 percent of the AIDS virus components but cannot cause AIDS.

• Anadys Pharmaceuticals Inc., of San Diego, nominated ANA598 as a candidate for clinical development as an orally administered direct antiviral for the treatment of chronic hepatitis C virus. The compound is a small-molecule, non-nucleoside inhibitor of the NS5b polymerase. It anticipates submitting an investigational new drug application in the second quarter of 2008.

• AngioGenex Inc., of New York, said its shares were approved for trading on the Frankfurt Stock Exchange under the symbol "TLE." The goal is to enhance trading liquidity and improve its access to European capital markets, the company said. AngioGenex is developing anticancer drugs designed to work through an anti-angiogenesis mechanism.

• Applied Biosystems, of Foster City, Calif., said scientists at its company and at the Cold Spring Harbor Laboratory and Howard Hughes Medical Institute have discovered that a family of small RNA molecules known as microRNAs (miRNAs) are components in a well-studied tumor suppressor network, the p53 pathway, that stops the growth of tumor cells in mice. That tumor suppressor capability represents a newly discovered function for miRNAs and may suggest new approaches for treating cancers. The study results will be published in the June 28 issue of the journal Nature.

• Auriga Laboratories Inc., of Los Angeles, said it has formed Advanced Topical Solutions, a new division with a 46-person national sales team targeting primarily dermatologists with a secondary focus on gastroenterologists and colon-rectal specialists. The sales force is expected to be launched later this week. The dermatology sector will focus on its Akurza Cream & Lotion (salicylic acid 6%). The company expects to add two additional products next month, with other products to follow later this year and in 2008.

• F. Hoffmann-La Roche Ltd., of Basel, Switzerland, signed a definitive agreement to acquire NimbleGen Systems Inc., of Madison, Wis., for $272.5 million. NimbleGen has a high-density DNA microarray business and technologies focused on targeted DNA sequencing. Roche said the move would strengthen its position in the genomics research market. NimbleGen will become part of Roche Applied Science, a business area of the Diagnostic Division of Roche, which intends to maintain current NimbleGen facilities in Wisconsin, Iceland and Germany, as well as its 140 employees. NimbleGen expects to expand its product portfolio in the near term to include higher-density arrays, integrated instrument systems and related reagents and consumables for advanced genome analysis. The deal is expected to close in the third quarter.

• Gene Network Sciences, of Cambridge, Mass., entered a cancer-treatment collaboration with the Weill Cornell Medical College. They will use GNS's REFS (reverse engineering and forward simulation) software platform to characterize the synergies between two commonly used classes of cancer drugs, farnesyl transferase inhibitors and taxanes. Financial terms of the agreement were not disclosed.

• Genocea Biosciences, of Cambridge, Mass., hired George Siber as executive chairman. Genocea was founded in 2006 to commercialize vaccine technology. It said it can rapidly identify antigens that result in the in vivo stimulation of protective CD8+ and CD4+ T cells, targets that can be incorporated immediately into existing antigen delivery systems to produce multivalent vaccine formulations. Siber previously was executive vice president and chief scientific officer of Wyeth Vaccines, and before that he had worked on vaccines extensively at academic institutions.

• Genzyme Corp., of Cambridge, Mass., filed with the FDA for approval of Synvisc-One, a single treatment of Synvisc (hylan G-F 20) that is designed to provide up to six months of pain relief from osteoarthritis of the knee. If approved, Synvisc-One would be the only viscosupplementation product available worldwide proven to provide that duration of pain relief from a single injection, Genzyme said. The company expects the FDA to take action on the submission by the end of the year. Synvisc currently is delivered through three intra-articular administrations of 2 mL each given at one-week intervals. Synvisc-One is delivered as three combined doses in one single 6-mL administration.

• Insmed Inc., of Richmond, Va., said it received a deficiency letter from Nasdaq relating to a 30-day trading period in which its stock traded below the $1 minimum price requirement for continued listing. Insmed has 180 calendar days to regain compliance by maintaining a closing bid price per share of $1 or higher for a minimum of 10 consecutive business days.

• Inspire Pharmaceuticals Inc., of Durham, N.C., and FAES Farma SA, of Madrid, Spain, have amended their licensing agreement for the U.S. and Canadian development and commercialization of oral bilastine for the treatment of allergic rhinitis after talks with the FDA. FAES has agreed to conduct additional clinical work and an expanded QT/QTc comparative trial, which likely will include an FDA-approved antihistamine. Inspire will have no financial obligations for the oral program while FAES is conducting the additional clinical work. As a result, Inspire said it expects to decrease estimated cash expenditures by approximately $14 million in 2007, including an $8 million milestone payment that had been anticipated this year. Inspire will continue to hold the new drug application for oral bilastine and will work with FAES over the next year to evaluate the additional clinical data with an eye on a new drug application filing. Beginning in December 2007, FAES has the option to discontinue the additional clinical work, and Inspire has the option to terminate the agreement, in whole or in part, with no further expense. Shares of Inspire (NASDAQ:ISPH) rose 12 cents to close at $5.87.

• Materia Inc., of Pasadena, Calif., granted Eisai Co. Ltd., of Tokyo, a nonexclusive license to its metathesis platform. Eisai gained rights to discover, develop and patent pharmaceutical compounds and related processes using Materia's catalysts and associated intellectual property. Metathesis catalysts enable the formation and manipulation of carbon-carbon bonds for use in the synthesis of new pharmaceutical products, and in the development of production processes for existing products.

• NexMed Inc., of East Windsor, N.J., has appointed Vivian Liu as CEO, succeeding Richard J. Berman, who was elected by the board to serve as its nonexecutive chairman. Liu has been with NexMed since 1994.

• Noven Pharmaceuticals Inc., of Miami, said Shire plc, of Basingstoke, UK, has exercised its option under agreements with Noven to acquire exclusive development rights to a new transdermal patch for ADHD to be formulated by Noven. In connection with that, Noven received a $5.9 million milestone payment from Shire. Noven successfully completed a Phase I study of an amphetamine transdermal system (ATS) for the treatment of ADHD. Shire has requested modifications to the original patch formulation to align ATS with its future direction in ADHD. In addition to the milestone payment, Noven will receive an unspecified amount from Shire for continuing development efforts.

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., said its application for a listing on the American Stock Exchange has been approved. Pipex expects that its shares will begin trading on or before June 26 under the new ticker symbol "PP."

• President Bush, citing moral grounds, vetoed the Stem Cell Research Enhancement Act, which would have lifted restraints on federal government support for research on embryonic stem cells. The veto was expected. Bush did issue an executive order designed to promote research on other cell types. Based on previous votes, it did not appear Democrats and other supporters in Congress had enough votes to override the veto.

• Proteros Biostructures GmbH, of Martinsried, Germany, said it is due a milestone payment following progress in its collaboration with Bayer HealthCare AG, of Berlin, in the field of fragment-based protein crystallography. Under the deal from June 2006, Proteros is applying technologies to deliver protein-ligand structures of active fragments from Bayer's discovery programs. Proteros also gets a copy of the jointly selected fragment library for its own use. Specifics on the milestone were not disclosed.

• Vasogen Inc., of Mississauga, Ontario, has appointed Chris Waddick as president and CEO, succeeding Terrance Gregg, who will remain as chairman of the board of directors. Waddick, who previously served as chief operating officer and CFO, has been with Vasogen over the past 12 years.

• VASTox plc, of Oxford, UK, has been awarded a grant of £400,000 (US$797,000) by the Welsh Development Agency under the SMARTCymru program. The 12-month grant will support the research and development work undertaken at VASTox's Aberystwyth facility, which works to identify naturally occurring biologically-active carbohydrate compounds.

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