• Advanced Viral Research Corp., of Yonkers, N.Y., received the third of four $3 million payments from James Dicke II and his son James Dicke III. On Feb. 3, ADVR entered an agreement with the Dickes in which ADVR agreed to sell an aggregate of 120 million shares of its stock and warrants to purchase 15 million shares at 20 cents per share, in four equal installments of 30 million shares. The Dickes have delivered an aggregate of $3 million to ADVR at each of the closings. (See BioWorld Today, Feb. 5, 2004.)

• Advanced Vision Therapies Inc., of Rockville, Md., received $687,000 through three separate Small Business Innovative Research grants from the National Institutes of Health in Bethesda, Md. The funds will support the advancement of its gene-transfer technology toward clinical applications for treating prevalent eye diseases, including age-related macular degeneration, diabetic retinopathy and retinitis pigmentosa.

• Amicus Therapeutics Inc., of New Brunswick, N.J., initiated a Phase I trial with its first clinical candidate, AT1001, for the treatment of Fabry's disease. AT1001 is designed to be an orally active, small-molecule drug for enhancing alpha-galactosidase-A activity in patients with Fabry's disease. Amicus received orphan drug designation from the FDA for AT1001 in March.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner, Boston Scientific Corp., of Natick, Mass., is expanding its nationwide recall reported last month, to include about 3,000 additional Taxus stent systems. The company first announced the voluntary recall of certain of the coronary stent systems due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown. Angiotech supplies the paclitaxel used in the product's coating.

• Astralis Ltd., of Fairfield, N.J., said Phase I results reported at the National Psoriasis Foundation's conference in San Diego showed Psoraxine to be generally well tolerated in patients with active but stable plaque psoriasis, with similar safety profiles among patients who received single doses of a placebo or 50 mg, 150 mg or 300 mg of Psoraxine. No patients were observed to have developed skin anergy to standard recall antigens, as the study provided preliminary evidence of a specific response to the Psoraxine antigen, without the suppression of normal immunologic response to other common antigens. The company said it submitted the findings to the FDA.

• BioSurface Engineering Technologies Inc., of College Park, Md., completed its second round of equity financings, led by EDF Ventures in Ann Arbor, Mich. The company president and CEO said BioSurface exceeded its funding target by more than 25 percent. BioSurface is focused on bringing therapeutic combinations, including synthetic peptides for tissue regeneration, to medical devices.

• CompuCyte Corp., of Cambridge, Mass., and the National University of Singapore entered a collaborative program to study the cell death-inducing activity of compounds for their application in treating cancer and other diseases. The school will provide compounds to CompuCyte, which will develop assays and perform high-content cell-based analysis of their effect on cells using its iCyte and iCys Imaging Cytometers.

• Cytogen Corp., of Princeton, N.J., expects to initiate a clinical trial to investigate the use of Quadramet (samarium Sm-153 lexidronam injection) in combination with docetaxel for the treatment of hormone-refractory prostate cancer. The study, which has completed regulatory and contractual review, will be conducted by researchers at the University of Texas M.D. Anderson Cancer Center in Houston under Cytogen's investigational new drug application. Quadramet now is on the market for pain palliation.

• Enterprise Technologies Inc., of Vancouver, British Columbia, said its wholly owned subsidiary, Phytomedical Technologies Corp., gained exclusive worldwide rights to pharmacologically active elements of a muira puama plant extract and ion channel modulators from natural sources discovered at New York University. Phytomedical said the first plant-derived compound, BDC 03, has pharmacologically active elements that have been successful in reducing body-fat percentage, increasing lean muscle mass and lowering cholesterol in animal studies. In exchange for the license, Phytomedical agreed to pay to the school a royalty on net sales of all licensed products, and also granted an option to acquire Phytomedical stock.

• EPIX Medical Inc., of Cambridge, Mass., filed a registration statement with the SEC relating to the resale of $100 million worth of its 3 percent convertible senior notes due 2024 and the common shares issuable upon their conversion. The notes were issued in a June private placement. When declared effective by the SEC, the registration statement would allow holders to publicly resell the notes and stock issuable upon their conversion.

• Genencor International Inc., of Palo Alto, Calif., and collaborators from the neighboring Stanford Linear Accelerator Center said they achieved a breakthrough in the ability to compute all possible metabolic behaviors open to a microorganism. The parallel algorithm can calculate the full spectrum of possible phenotypes in seconds, as opposed to hours or days, as was previously the case. The work was supported, in part, by the Department of Energy.

• Nektar Therapeutics, of San Carlos, Calif., lost more than a third of its stock value on news from research analysts that European regulatory authorities might not approve Exubera. The inhaled insulin product is being jointly developed with Pfizer Inc., of New York, and Aventis SA, of Strasbourg, France. Also, Nektar's stock was downgraded by Deutsche Bank. On Thursday, its shares (NASDAQ:NKTR) lost $6.14, or 37 percent, to close at $10.45.

• NeoPharm Inc., of Lake Forest, Ill., entered a nonexclusive worldwide distribution and marketing agreement for NeoPhectin and NeoPhectin-AT with Nippon Genetics Co. Ltd., of Tokyo. Nippon Genetics will market and promote the products to its genetic engineering customers. NeoPhectin is an in vitro transfection reagent that uses NeoPharm's cationic cardiolipin technology, while NeoPhectin-AT is an in vivo transfection reagent for nucleic acid delivery including siRNA.

• NeuroSearch A/S, of Ballerup, Denmark, and Abbott Laboratories, of Abbott Park, Ill., reported that Abbott initiated Phase I studies with the compound ABT-894 for the treatment of neuropathic pain. In preclinical models, ABT-894 demonstrated a pain-relieving effect similar to morphine without causing side effects associated with morphine and other opioids. NeuroSearch will receive an undisclosed milestone payment from Abbott.

• New River Pharmaceuticals Inc., of Radford, Va., raised $33.6 million through its initial public offering of 4.2 million common shares at $8 apiece. Its stock (NASDAQ:NRPH) fell 50 cents Thursday to close at $7.50. The specialty pharmaceutical company, which said it is developing pharmaceuticals that are safer and improved versions of prescription drugs such as amphetamines and opioids, also granted the underwriters a 630,000-share overallotment option. WR Hambrecht + Co is acting as lead underwriter, with co-management from First Albany Capital, Wells Fargo Securities LLC and Punk, Ziegel & Co. New River is offering all the shares.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., said it is moving next month into new headquarters in Waltham. The company, which is preparing to launch its lead product Factive (gemifloxacin mesylate) tablets for acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia, is leasing about 31,500 square feet at the site.

• Phares Drug Delivery AG, of Muttenz, Switzerland, signed a binding letter of intent to out-license an inhalation platform technology to Inyx Inc., of New York. Phares said the technology would enable its licensee to develop inhalation therapy drugs, including combination drugs, delivered in aerosol formats. Phares expects to complete the acquisition within 60 days. Financial terms were not disclosed.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said it would proceed with plans to bring its human growth hormone to the U.S. market later this year following a favorable court ruling. The company and its partner, Teva Pharmaceutical Industries Ltd., of Jerusalem, said a U.S. district court found invalid and unenforceable a patent relating to recombinant human growth hormone that belongs to Novo Nordisk A/S, of Bagsvaerd, Denmark. Approved by the FDA and already marketed in more than 30 countries, the product for growth hormone deficiency in children is licensed to Teva for U.S. distribution. Savient's stock (NASDAQ:SVNT) gained 34 cents Thursday, or 16.4 percent, to close at $2.41.

• Shamrock Structures LLC, of Woodridge, Ill., signed an agreement with Intra-Cellular Therapies Inc., of New York, to provide integrated structural proteomics services. Shamrock Structures will perform structure-activity relationship co-crystallization, synchroton-data collection and structure determination of an Intra-Cellular protein target to which inhibitors are bound. The agreement terms include an up-front fee and performance-based milestone payments. Additional terms of the agreement remain undisclosed. Intra-Cellular is developing drugs for depression, schizophrenia, Alzheimer's disease and Parkinson's disease.

• St. Jude Children's Research Hospital in Memphis, Tenn., and Erasmus University Medical Center/Sophia Children's Hospital in Rotterdam, the Netherlands, said their researchers published findings in the Aug. 4, 2004, issue of the New England Journal of Medicine showing that a relatively small number of genes are linked to either resistance or sensitivity to four major cancer drugs used to treat acute lymphoblastic leukemia. They identified four groups of genes, each of which had a characteristic pattern of expression in leukemia cells depending on whether they were sensitive or resistant to the four antileukemic agents, and found that the expression pattern of the genes was related to treatment outcome. Separate St. Jude research published the August 2004 issue of the Journal of Clinical Oncology showed that 75 percent of children treated for ependymoma with conformal radiation therapy did not experience progression of their cancer after three years, and their cognitive development was not significantly impaired by radiation therapy.

No Comments