• aaiPharma Inc., of Wilmington, N.C., completed its sale of its M.V.I. (Multi-Vitamin Infusion) and Aquasol product business for $105 million to Mayne Pharma (USA) Inc., of Paramus, N.J. At the same time, the specialty pharmaceutical company closed its previously reported two-year, $140 million credit facility provided by Silver Point Finance LLC, replacing its existing senior revolving and term debt facilities.

• Anadys Pharmaceuticals Inc., of San Diego, said the underwriters of its initial public offering exercised their overallotment option to purchase 743,950 shares, raising $4.8 million in additional proceeds. That brings the total proceeds of the IPO to about $48.6 million gross. SG Cowen Securities Corp. and Piper Jaffray & Co. acted as lead managers, while Legg Mason Wood Walker Inc. and Needham & Co. Inc. acted as co-managers for the offering. (See BioWorld Today, March 29, 2004.)

• Aptamera Inc., of Louisville, Ky., appointed Mark Rogers chairman. Rogers formerly held the position of CEO of Duke University Hospital and Health Network, as well as professor and associate dean of Johns Hopkins School of Medicine. He has served as chairman for a number of biotechnology firms in the oncology drug development field, including Genta Inc., Adherex Technologies Inc. and PolaRx Biopharmaceuticals Inc. Aptamera was formed in 2001 to discover, develop and commercialize drugs for the treatment of cancer.

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, said its in-licensed product CellCept showed the ability to reduce the risk to heart transplant patients of developing cancer by 27 percent, compared to patients receiving non-CellCept-based treatment regimens. CellCept is a marketed product in-licensed from F. Hoffmann-La Roche Ltd., of Basel Switzerland. CellCept is used in combination with other immunosuppressants to prevent rejection in patients receiving heart, kidney and liver transplants. It was first approved in 1995.

• Bone Care International Inc., of Middleton, Wis., said the FDA approved a new indication and strength for Bone Care's Hectorol (doxercalciferol) capsules. Hectorol, a pro-hormone vitamin D analogue, approved for the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients in the U.S., was approved for the treatment of SHPT that develops in the earlier stages (Stages III and IV) of chronic kidney disease prior to dialysis.

• Celmed BioSciences, a subsidiary of Theratechnologies Inc., of Montreal, sold Celmed USA and its neurology assets and technology platform to Michel Levesque. The agreement includes payments of royalties on sales upon the eventual commercialization of the technology. The transaction, which increases Theratechnologies' ownership from 58.5 percent to 59.7 percent, is in line with Celmed's new business plan to focus on its oncology program. Financial terms were not disclosed.

• Corixa Corp., of Seattle, began a Phase I trial of CRX-675 in seasonal allergic rhinitis. CRX-675 is a member of Corixa's family of compounds that interact with Toll-like receptor 4. In preclinical studies, Corixa's TLR4 agonists have been shown to reduce allergic reactions and to protect against infections. The Phase I study will evaluate CRX-675 given as a single intranasal dose in 64 adults allergic to ragweed pollen.

• Crystalplex Corp., of Pittsburgh, and the Pittsburgh Life Sciences Greenhouse (PLSG) said that PLSG, through its affiliate, the Pittsburgh Biomedical Development Corp., intends to invest $100,000 in pre-seed funds to Crystalplex, an early stage company that is developing a technology that aids in drug discovery and clinical diagnostics. The investment will be used to help the company develop its technology, which uses non-sized plastic beads that label, or "bar code," different molecules within a solution.

• CytRx Corp., of Los Angeles, received a letter indicating the company's stock is subject to delisting from the Nasdaq Small Cap Market due to its failure to file its annual report for the year ended Dec. 31. The company plans to request a hearing on the matter to keep its stock from being delisted by Wednesday. CytRx said the filing is delayed as a result of the company changing its independent auditors and certain pending accounting issues.

• Entercel Ltd., of Austin, Texas, said it licensed a technology that could improve the effectiveness of agrichemicals and drugs from the University of Texas at Austin. The chemical-based platform technology adjusts a cell's ability to resist foreign compounds it encounters in its environment. The university's partner is WesTech Ventures I LP, a venture capital fund of Emergent Technologies Inc., also of Austin. WesTech will provide capital for Entercel.

• Evotec OAI AG, of Hamburg, Germany, and Oxford Bioscience Partners, of Boston, a venture capital firm, expanded their 2002 agreement by integrating Evotec's newly established rational drug design platform, EVOrationale. EVOrationale consists of protein engineering and production, X-ray crystallography and computational chemistry to assist customers in delivering de novo structure determination, validation of screening hits and structure-guided lead optimization programs.

• FEI Co., of Eindhoven, the Netherlands, said it will join the European Union-funded Interaction Proteome project, which was coordinated by the Max Planck Institute for Biochemistry in Martinsried, Germany. The project, which is receiving €12 million over five years, brings together the science of 11 European research institutions and companies to develop technologies for proteomics research. FEI will collaborate to develop instruments with improved sensitivity to the analysis of protein complexes within the cell.

• Genmab A/S, of Copenhagen, Denmark, agreed to license a cancer target called GT43 from privately held Ganymed Pharmaceuticals AG, of Mainz, Germany. The target is expressed in a range of tumors, including melanoma, breast cancer, lung cancer and hepatocellular carcinoma. Ganymed will be entitled to license fees, milestones and royalties on the sale of commercialized products.

• Genzyme Corp., of Cambridge, Mass., and ILEX Oncology Inc., of San Antonio, received a request from the Federal Trade Commission for more information related to the previously reported acquisition of ILEX by Genzyme. The companies intend to respond promptly to the information request, Genzyme said. That second request extends the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, during which the FTC is permitted to review the transaction. The companies continue to anticipate that the merger, which was announced in late February and estimated at $1 billion at the time, will close mid-year. (See BioWorld Today, March 1, 2004.)

• Halozyme Therapeutics Inc., of San Diego, signed nonexclusive, global distribution agreements with three in vitro fertilization suppliers to market Cumulase, the first and only synthetic alternative to impure slaughterhouse-derived enzymes currently used for the treatment of eggs prior to certain IVF procedures. Halozyme signed agreements with Cook Ob/Gyn Inc., of Spencer, Ind.; MediCult A/S, of Jyllinge, Denmark; and MidAtlantic Diagnostics Inc., of Marlton, N.J., to distribute Cumulase worldwide.

• Hard To Treat Diseases Inc., of Delray Beach, Fla., signed a letter of intent to sell the assets of its recycling division, International Foam Solutions. HTDS will sell the recycling assets of that division for $250,000 and 20 percent of the stock of the purchasing company. The purchasing company is controlled by Harvey Katz, a former officer of that division, and a current consultant to HTDS. The sale should be finalized within 30 days, in accordance with the letter of intent. The purchasing company has patent technology that is more encompassing than the patent technology being sold by HTDS, it said.

• Immtech International Inc., of Vernon Hills, Ill., said the FDA granted its first oral drug, DB289, fast-track designation to treat human African sleeping sickness (Trypanosomiasis). DB289 is a dicationic pharmaceutical compound. No other oral treatment exists for the disease, the company said, noting that there are serious side effects associated with non-oral drug alternatives.

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said preclinical results of its catalytic antioxidant compound, AEOL 10150, in amyotrophic lateral sclerosis showed three times the survival period, compared to an untreated group. In another arm, AEOL 10150 in addition to creatine and rofecoxib showed a doubling in survival time compared with those treated with creatine and rofecoxib alone. Incara is preparing to file an investigational new drug application and could enter a Phase II/III trial as early as the first half of 2005.

• The Institute for Systems Biology in Seattle established a partnership with the Pacific Northwest National Laboratory to expand their technical capabilities in systems biology and related areas. They will work to build an infrastructure to solve complex biological problems faster, refine technological and computational abilities to measure and predict complex cell behavior, and strengthen existing collaborative research and development projects in systems biology.

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical results published in Molecular Therapy point to the mechanisms by which mda-7/IL-24, the active component of the company's INGN 241, kills non-small-cell lung cancer cells. Data from the studies, which were conducted in collaboration with the University of Texas M.D. Anderson Cancer Center, Baylor College of Medicine and the University of Texas Medical Branch at Galveston, identify a new intracellular pathway through which mda-7/IL-24 causes lung cancer cells to undergo apoptosis. They highlight the ability of mda-7/IL-24 to exert its anticancer effects through a variety of pathways, depending on the gene-expression patterns of various types of cancer cells, potentially making it a candidate for cancers resistant to conventional therapies.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., filed a shelf registration statement to offer, from time to time, up to $75 million of its common stock, preferred stock, warrants or debt securities. The shelf registration statement also includes up to 3.6 million shares of ISTA common stock to be offered by certain selling stockholders. ISTA plans to use proceeds for general corporate purposes, including financing potential acquisitions, funding development and growth of its products, and general working capital. ISTA focuses on products to treat serious diseases and conditions of the eye.

• KV Pharmaceutical Co., of St. Louis, said a federal court denied a motion for a preliminary injunction filed by CIMA Labs Inc., of Eden Prairie, Minn., and Schwarz Pharma AG, of Monheim, Germany, in a patent infringement action brought against KV and its Ethex Corp. subsidiary. The denial of the motion allows Ethex to continue marketing the product in question. CIMA and Schwarz allege that KV and Ethex infringe on CIMA's DuraSolv orally dissolving drug delivery technology.

• Medarex Inc., of Princeton, N.J., plans to offer $125 million of convertible senior notes expected to be due in 2011 to qualified institutional buyers. The notes would be convertible into Medarex common stock at a price to be determined. The company intends to use proceeds to purchase or redeem all or a portion of its outstanding 4.5 percent convertible subordinated notes due 2006, as well as for general corporate purposes. In other news, Medarex shipped to Sinova Biotech Co. Ltd. in Beijing a sample of the fully human antibody to severe acute respiratory syndrome developed by the company and the Massachusetts Biologic Laboratories of the University of Massachusetts Medical School. Sinovac will study it in the preclinical setting as a vaccine against strains of SARS.

• Metabolon Inc., of Durham, N.C., moved to its new office location at Alexandria Technology Center-Alston, and its metabolomic technology platform is up and functioning, it said. Based on the new facilities and new equipment, Metabolon is moving to further its research in Lou Gehrig's disease, Alzheimer's disease and Parkinson's disease. In addition, Metabolon is working with various academic centers and pharmaceutical companies to assist them in metabolomics research.

• Neurochem Inc., of Montreal, said its independent Data Safety Monitoring Board issued a fourth unanimous recommendation to continue the company's Phase II/III clinical trial of Fibrillex to treat amyloid A amyloidosis. No specific treatment exists for AA amyloidosis, a consequence of chronic infection and inflammatory diseases that has a five-year survival rate of about 50 percent. Neurochem expects to complete its trial by January. Fibrillex has orphan drug status and fast-track product designation in the U.S. for that indication. A total of 144 patients out of 183 enrolled have completed at least 12 months of the Phase II/III study. Fibrillex belongs to the class of glycosaminoglycan mimetics.

• Northwest Biotherapeutics Inc., of Bothell, Wash., entered a recapitalization agreement with Toucan Capital Fund II LP. At Toucan's option, and if successfully implemented, the recapitalization would provide the company with up to $40 million through the issuance of new securities to Toucan and a syndicate of investors. Following the recapitalization, Toucan and the syndicate would potentially own, on a combined basis, over 90 percent of the outstanding stock. The proposed recapitalization would occur in two stages, a bridge period which expires July 23, unless extended by Toucan, followed by a potential equity financing.

• Novozymes A/S, of Bagsvaerd, Denmark, received a one-year extension to its collaborative subcontract with the National Renewable Energy Laboratory and will receive $2.3 million in research funding to further reduce the costs of fuel ethanol to about 10 cents per gallon. The parties found that by combining their technology, the enzyme costs of converting cellulosic biomass into sugars for fuel ethanol product have been reduced about 20-fold. NREL and Novozymes entered into a $14.8 million, three-year subcontract agreement in January 2001.

• Proligo LLC, of Boulder, Colo., signed an agreement under which RNAx GmbH, of Berlin, will provide access to RNA interference functional validation technology. Proligo, a unit of Degussa AG, of Dusseldorf, Germany, which will employ the technology for the functional validation of internal siRNA technologies, will own the derived results. Financial terms were not disclosed.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said at the Association of Research in Vision and Ophthalmology annual meeting that began Sunday and continues through Thursday in Ft. Lauderdale, Fla., that the expression of TB4 after corneal wounding was "markedly blunted" in aged animals compared to younger animals. TB4, which the company said is known to promote corneal wound healing, is a naturally occurring molecule being developed for dermal, ocular and other wound-healing indications by RegeneRx. It is a naturally occurring 43-amino-acid peptide presented in virtually all human cells, the company said. Other data showed that TB4-treated corneas of laboratory animals demonstrated decreased inflammation and hyphema (bleeding in the anterior chamber of the eye) seven days after injury when compared to placebo, as well as modulation of certain other proteins associated with wound healing.

• Ribonomics Inc., of Durham, N.C., was awarded $663,000 through two Small Business Innovation Research grants from the National Institutes of Health in Bethesda, Md. One is titled "RNA Binding Proteins and Beta-Cell Function" and involves the application of its RAS technology for understanding signaling processes important to beta-cell function. The second grant, titled "Ribonomic Dissection of LRb-expressing Cells and Neurons," is aimed at identifying signaling pathways involved in leptin receptor-regulated physiology.

• RNA-TEC NV, of Leuven, Belgium, and Lonza Group Ltd., of Basel, Switzerland, entered an agreement related to TBDMS-based oligonucleotides. The partners, which will make available RNA-synthesis knowledge to others, also are looking for additional synergies related to the field.

• Sanofi-Synthelabo SA, of Paris, entered an agreement to pay more than $63 billion to merge with Aventis SA, of Strasbourg, France, to create Sanofi-Aventis. Aventis' management and board recommended that the company's shareholders tender their shares into Sanofi-Synthelabo's offer, which values each Aventis share at €68.93, should holders choose to receive cash for their shares. They also could choose to receive five Sanofi-Synthelabo shares and €120 in cash for six Aventis shares or about 1.2 Sanofi-Synthelabo shares for each Aventis share. The offer is subject to the condition that shares representing more than 50 percent of the share capital and voting rights of Aventis are tendered, on a fully diluted basis. Prior to the agreement, another Aventis suitor, Novartis AG, of Basel, Switzerland, decided to discontinue negotiations and not submit a bid for a potential combination with Aventis.

• Third Wave Technologies Inc., of Madison, Wis., launched its Invader hepatitis C virus genotyping reagents. Invader offers faster and more accurate results when compared to other commercially available HCV-genotyping methods and technologies, according to data presented by the company at the 20th annual Clinical Virology Symposium in Clearwater Beach, Fla., it said. The product enables clinical laboratories to develop assays that identify all six genotypes of the hepatitis C virus.

• Transkaryotic Therapies Inc., of Cambridge, Mass., began a clinical trial to evaluate the safety and clinical activity of GA-GCB, an enzyme-replacement therapy to treat Gaucher's disease. The trial will involve 12 Type I Gaucher's disease patients, who will receive treatment for nine months. The trial should be completed in 2005. GA-GCB is a human glucocerebrosidase product developed using TKT's gene-activation technology.

• ViRexx Medical Corp., of Edmonton, Alberta, received a $500,000 Phase III Technology Commercialization Award from Alberta Heritage Foundation for Medical Research. The funds will be used to support costs of a Phase I liver cancer study of the Occlusin Injection product, anticipated to begin in the second half of this year. The agreement provides that the award will be repaid under certain terms based on sales of Occlusin. Occlusin consists of injectable particles for the treatment of solid tumors. Once injected into the blood vessels of a target tumor, the Occlusin particles become lodged in those vessels, impeding blood flow. Simultaneously, platelets flowing in the bloodstream are captured on the surface of the Occlusin particles leading to local clot formation, and ultimately tumor starvation, the company said.

• Wilex AG, of Munich, Germany, signed a co-development and marketing agreement for Rencarex in Southern Europe with Laboratorios del Dr. Esteve SA, of Barcelona, Spain. Esteve, which will receive exclusive marketing rights to Rencarex for Spain, Italy, Portugal, Greece and Andorra, will become a co-sponsor in Spain for Wilex's upcoming Phase III trial of Rencarex in renal-cell carcinoma patients. Patient enrollment in that pivotal trial of the chimeric antibody is expected to begin this quarter. Wilex, which will receive an undisclosed up-front payment and is entitled to milestone payments and royalties, will be responsible for Rencarex's clinical development and manufacturing, and for the global regulatory approval process.