• Acrongenomics Inc., of Athens, Greece, closed a private placement of 1 million shares at $4 per share, raising gross proceeds of $4 million. Funds will be used to support ongoing development of its Nano-JETA platform and for general corporate purposes.

• Affymetrix Inc., of Santa Clara, Calif., and Applied Biosystems Group, of Foster City, Calif., said Applied Biosystems' parent, Applera Corp., has taken a nonexclusive, worldwide license to a number of Affymetrix patents related to the manufacture, sale and use of microarrays for gene expression analysis. The license will be applied to the continued expansion of the Applied Biosystems Expression Array System for high-density microarray analysis and will enable customers to use that system for gene expression, research and development purposes.

• Amarin Corp. plc, of London, completed a private placement of 26.1 million American depository shares at $1.01 per share to raise $26.4 million. The company also issued 9.1 million five-year warrants to investors at an exercise price of $1.43 per share. Amarin develops drugs for treating central nervous system disorders. Its lead compound, Miraxion, is in Phase III testing for Huntington's disease and in Phase II development for depressive disorders. Investors in the private round included Southpoint Capital Advisors LP, Biotechnology Value Fund LP, Fort Mason Capital LLC and Domain Public Equity Partners LP.

• Avalon Pharmaceuticals Inc., of Germantown, Md., said its agreement established in December 2003 with Sanofi Aventis Group, of Paris, expired. The collaboration focused on using molecular cytogenetics to identify and validate oncology targets. The agreement expired as a result of Sanofi's decision not to advance targets for further validation. Avalon plans to continue validation studies on its own.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said the FDA gave verbal approval for the company to begin human studies with peramivir, its intravenous influenza neuraminidase inhibitor, which has shown in preclinical studies an activity against multiple strains of flu, including the H5N1 virus. The news caused BioCryst's stock (NASDAQ:BCRX) to jump 15.7 percent, gaining $2.38 to close at $17.59. In a separate item, the company initiated a Phase I/II trial of Fodosine (forodesine hydrochloride) to determine the safety of repeat doses of an intravenous formulation of the drug in patients with B-cell acute lymphoblastic leukemia. Fodosine is a purine nucleoside phosphorylase inhibitor. BioCryst also reported that it received early termination of the required waiting period under the Hart-Scott-Rodino Act, regarding its licensing agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, announced a month ago. Under that agreement, BioCryst granted Roche exclusive, worldwide rights to its Phase I compound, BCX-4208, for the prevention of acute rejection in transplantation and for autoimmune diseases in a deal worth up to $560 million. (See BioWorld Today, Dec. 1, 2005.)

• Callisto Pharmaceuticals Inc., of New York, established Guanilib as the developmental name for its drug candidate previously identified as SP304. The company's scientists developed the first-in-class compound for serious inflammatory gastro-intestinal diseases. Guanilib is designed to mimic a naturally occurring hormone called uroguanylin normally produced in the body's intestinal tract.

• Cephalon Inc., of Frazer, Pa., settled its patent infringement dispute relating to Provigil (modafinil) with Princeton, N.J.-based Ranbaxy Laboratories Ltd., and agreed to grant Ranbaxy a nonexclusive royalty-bearing right to market and sell a generic version of the drug in the U.S. Ranbaxy's license will become effective in October 2011. The companies also agreed to a series of business arrangements related to modafinil, including allowing Cephalon license to certain of Ranbaxy's intellectual property rights related to modafinil in exchange for milestone payments.

• Crucell NV, of Leiden, the Netherlands, signed a PER.C6 contract manufacturing license agreement with the Saskatchewan Research Council of Saskatoon in Canada. SRC will pay an initial license fee, along with annual maintenance fees and royalties. Crucell also signed a cooperative research and development agreement with the Walter Reed Army Institute of Research to evaluate its PER.C6 technology to develop vaccines against the flaviviruses dengue fever and Japanese encephalitis. And the company signed a PER.C6 research license agreement allowing Merial Ltd., of Duluth, Ga., to use the cell line to develop gene therapy in a specific field of companion animal medicine. The nonexclusive agreement includes an option for a commercial license.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., reported Phase II data showing that HepeX-B prevented viral reinfection in hepatitis B patients. The product, which last year was licensed to Cubist by XTL Biopharmaceuticals Ltd., of Rehovot, Israel, was studied as maintenance therapy to prevent reinfection with the virus in liver transplant patients. They were treated with monthly infusions of 20 mg or 40 mg HepeX-B vs. 5,000 IU of HBIg, and the data also showed fewer and less serious adverse experiences reported in both HepeX-B groups compared to the HBIg group. Cubist will review the results with the FDA early next year.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., said it filed what it believes to be a complete response to the FDA's approvable letter for its investigational products oxymorphone extended-release (oxymorphone ER) and immediate-release (oxymorphone IR) tablets. The FDA issued approvable letters for both products in October, requesting additional clarification and information, including data from additional clinical trials to further confirm safety and efficacy. Oxymorphone ER is partnered with Penwest Pharmaceuticals Co., of Danbury, Conn.

• Flamel Technologies SA, of Lyon, France, said its collaborator, London-based GlaxoSmithKline plc, submitted a new drug application for the controlled-release formulation of a marketed drug using Flamel's Micropump technology. The filing will result in a $2 million milestone payment under an agreement formed in March of 2003.

• Gen-Probe Inc., of San Diego, said bioMerieux SA, of Marcy L'Etoile, France, exercised a second option to develop diagnostic products for certain undisclosed disease targets using Gen-Probe's ribosomal RNA technologies, pursuant to a year-old agreement. In exchange, bioMerieux will pay Gen-Probe a $2.1 million license fee. BioMerieux also retains an option to develop products for other disease targets by paying Gen-Probe up to an additional $900,000 by the end of 2006. Gen-Probe also would receive royalties.

• Icagen Inc., of Research Triangle Park, N.C., said its partner, New-York-based Bristol-Myers Squibb Co., discontinued a Phase I proof-of-concept study initiated in 2004 as part of the companies' atrial fibrillation program due to slow enrollment. BMS is considering alternative trial designs. The compound is designed to target a potassium ion channel that is selectively expressed in human atrial myocytes.

• ImClone Systems Inc., of New York, said Swissmedic, the Swiss agency for therapeutic products, approved Erbitux (cetuximab), an IgG1 monoclonal antibody, in combination with radiation in patients with previously untreated, advanced squamous-cell carcinoma of the head and neck. Merck KGaA, of Darmstadt, Germany, received the approval based on a Phase III trial that included 424 patients with advanced squamous-cell carcinoma of the oropharynx, larynx or hypopharynx that had spread through the head and neck region.

• Introgen Therapeutics Inc., of Austin, Texas, asked the FDA for permission to accelerate an interim analysis of its Phase III Advexin trial data ahead of schedule, before the protocol-specified number of survival events has occurred. The trial is investigating Advexin monotherapy in the control of recurrent squamous-cell carcinoma of the head and neck.

• Invitrogen Corp., of Carlsbad, Calif., and Families of Spinal Muscular Atrophy, of Libertyville, Ill., formed a collaboration to identify biological targets that are linked to the causes and symptoms of spinal muscular atrophy. Financial terms were not disclosed. The initial stages of the collaboration will be performed using Invitrogen's ProtoArray protein microarray technology.

• La Jolla Pharmaceutical Co., of San Diego, said Nasdaq has granted an extension for the company to comply with the minimum bid price rule of at least $1. If the closing price is at least $1 for a minimum of 10 consecutive trading days on or before Jan. 6, 2006, La Jolla Pharmaceutical will regain compliance and maintain its Nasdaq National Market listing. The company has completed its 1-for-5 reverse stock split, which should help in achieving compliance, it said.

• Large Scale Biology Corp., of Vacaville, Calif., said it is ceasing operations, effective today, and is notifying its staff that their employment will terminate since the company is no longer able to fund payroll. President and CEO Kevin Ryan said efforts to be acquired or license out property were not effective in time to provide cash for operations, or to meet Nasdaq listing requirements. He said the company continues to explore alternatives.

• Medivir AB, of Stockholm, Sweden, said the FDA approved its proposal for configuring the pivotal trials for its labial herpes product, ME-609. The trials are expected to begin during the fall of 2006, and the company estimates Phase III costs to run about SEK40 million (US$5 million.)

• Novavax Inc., of Malvern, Pa., filed a $100 million universal shelf registration statement to issue securities such as common and preferred stock, warrants, or any combination thereof, in one or more future offerings. The drug delivery company said it has no current plans to access either the public or private equity markets.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said its UK subsidiary focused on the discovery and development of diabetes and obesity therapeutics granted a worldwide nonexclusive license under its DPIV patent portfolio to an undisclosed major British pharmaceutical company. The portfolio covers the use of DPIV inhibitors for the treatment of Type II diabetes and related indications. OSI will receive up-front, milestone and royalty payments.

• Osiris Therapeutics Inc., of Baltimore, closed a $19 million private equity round to fund the company's five ongoing clinical programs using its adult stem cell technology platform. The programs include Prochymal for graft-vs.-host disease, Provacel for repairing damaged tissue in heart attack patients, and Chondrogen for treating knee injuries and preventing arthritis. The round was arranged by Swiss investment firm Friedli Corporate Finance Inc. To date, Osiris has raised $70 million.

• PTC Therapeutics Inc., of South Plainfield, N.J., initiated a Phase II study of PTC124 at Hadassah University Hospital in Israel in patients with cystic fibrosis due to a nonsense mutation. The study is being conducted in parallel with a similar U.S.-based Phase II trial in CF, which recently began recruiting patients. PTC124 also is being investigated in Duchenne's muscular dystrophy and has the potential to treat other genetic disorders, PTC said.

• Vasogen Inc., of Toronto, filed a $100 million mixed shelf registration statement with the SEC and regulatory authorities in Canada to offer up to that amount worth of common shares, debt securities and warrants from time to time in one or more offerings over the next 25 months. The move is intended to give the cardiovascular and neurological disease drug development firm flexibility to take advantage of financing opportunities when available.

• Voyager Pharmaceutical Corp., of Raleigh, N.C., said it is enrolling subjects into the ALADDIN studies, a Phase III double-blind, placebo-controlled trial investigating the safety and efficacy of VP4896 in mild to moderate Alzheimer's disease. A total of 64 sites now are enrolling. Fifty-three of the sites are located in the U.S. and Canada, and 11 are in Australia.