• Barrier Therapeutics Inc., of Princeton, N.J., said Zimycan achieved statistical significance in a Phase III study of Candida-associated diaper dermatitis in infants. Results showed that more than twice the percent of patients treated with Zimycan reached the primary endpoint of overall cure at day 14, as compared to those treated with a vehicle consisting of zinc oxide plus petrolatum. The study will form the basis of the filing of an amendment by the end of this year to Barrier's pending new drug application. The double-blind study, which was conducted at 20 sites in the U.S. and Latin America, included 236 children younger than 3 who were diagnosed with diaper dermatitis that was complicated by the presence of the yeast Candida. They were treated for seven days. At the end of treatment, the average reduction in the signs and symptoms score was 72 percent with Zimycan vs. 25 percent with the vehicle ointment. Zimycan consists of 0.25 percent miconazole nitrate in the zinc oxide petrolatum base. It was well tolerated with no serious adverse events.

• Beckman Coulter Inc., of Fullerton, Calif., entered an exclusive licensing and development agreement with NPE Systems Inc., of Pembroke Pines, Fla., for NPE's flow-based cellular analysis systems. Beckman Coulter plans to integrate NPE's Quanta family of products into its Cell Lab suite of cellular analysis solutions.

• Benitec Ltd., of Queensland, Australia, said it settled a U.S.-based patent-infringement case with Ambion Inc., of Austin, Texas. As part of the settlement, it issued Ambion a worldwide nonexclusive license to make and sell DNA-directed RNAi-based products. Benitec said it expects to grant more such licenses down the road.

• BioDelivery Sciences International Inc., of Newark, N.J., entered a definitive agreement to pay about $7.2 million to acquire all the stock of Arius Pharmaceuticals Inc., of Research Triangle Park, N.C. BioDelivery will issue Arius stockholders about 1.6 million shares of a newly designated, non-voting and non-interest-bearing series of convertible preferred stock. The value of the transaction was based on the $4.25-per-share price of BioDelivery's initial public offering. The stock will be convertible into BioDelivery common shares on a 1-for-1 basis, upon the satisfaction of certain conditions, and is eligible for conversion upon the earlier of the FDA's approval of Arius' first product or five years from the acquisition's closing date. Arius, a specialty pharmaceutical company focused on acute treatment opportunities for surgical and oncology patients, will remain based in North Carolina. BioDelivery is developing a delivery technology called the Bioral nanocochleate technology.

• Biopure Corp., of Cambridge, Mass., filed a preliminary prospectus to its shelf registration statement for a public offering of up to 15 million shares of its common stock, a transaction that could raise about $10 million based on Wednesday's closing price. The company said in the prospectus that it may sell substantially less than 15 million shares, as there is no minimum amount required to complete the offering. Biopure appointed New York-based C.E. Unterberg, Towbin LLC as agent to the offering. The company's stock (NASDAQ:BPUR) lost 12 cents Monday, or 15 percent, to close at 68 cents.

• ChondroGene Ltd., of Toronto, said it intends to raise up to $4.5 million by way of a brokered private placement of up to about 4.7 million common shares at 95 cents apiece. ChondroGene agreed to compensate its adviser with a 6 percent fee on gross proceeds, plus a broker warrant entitling the adviser to purchase that number of common shares equal to 6 percent of the number of shares sold for 24 months from completion of the placement. It is expected to close on or about Aug. 20 and remains subject to regulatory approval.

• DiagnoCure Inc., of Quebec City, said findings published in the current issue of Urology show that its uPM3 molecular test gave a correct positive or negative result for the presence of prostate cancer 81 percent of the time. The test detects the presence of a new prostate cancer gene marker, called PCA3, in urine. In contrast, traditional prostate cancer detection, measuring total prostate-specific antigen levels, had an overall accuracy of 43 percent or 47 percent in the multicenter study.

• Diagnostic Hybrids Inc., of Athens, Ohio, received a $10 million minority investment. The cell culture provider said it would use the funding for new research and development initiatives, to expand its facilities and pursue technology and company acquisitions. The investment was led by Summit Partners and also included Kenson Ventures LLC. Both placed representatives on the company's board in the process - Summit's Harrison Miller and Kenson's Kenneth Fong.

• Evotec OAI AG, of Hamburg, Germany, and Seikagaku Corp., of Tokyo, entered a collaboration to identify small-molecule therapeutics for inflammatory diseases. Evotec will apply its assay development and high-throughput screening technologies to identify biologically active compounds from its library that interact with Seikagaku's disease targets.

• Genmab A/S, of Copenhagen, Denmark, said Phase II data detailing the duration of patients' responses to HuMax-CD4 showed that 42 percent of cutaneous T-cell lymphoma patients achieved at least a partial response. The data stem from a study of 38 patients - 50 percent had at least a partial response at 560 mg, and 75 percent at 980 mg.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., and Odyssey Pharmaceuticals, of East Hanover, N.J., a subsidiary of Pliva d.d., of Zagreb, Croatia, began U.S. distribution of Sanctura (trospium chloride tablets) as they prepare to launch the product later this month. Indevus received FDA approval for Sanctura in May as a treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. Indevus and Odyssey, which have a co-promotion and licensing agreement, hired and trained a 480-person sales force that will launch the product to primary-care physicians, urology specialists, obstetricians and gynecologists. The average daily wholesale price of Sanctura would be $2.98. (See BioWorld Today, June 1, 2004.)

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said preliminary Phase I data reported at the Drug Discovery Technology World Congress in Boston demonstrated that ISIS 301012 produced dose-dependent, rapid and prolonged reduction of its target, apoB-100, by up to 55 percent. It also reduced low-density lipoprotein, very-low-density lipoprotein and total cholesterol levels in normal volunteers with borderline elevated cholesterol. The findings stem from 19 patients. The dose-escalation study is expected to enroll about 40 volunteers.

• Medicure Inc., of Winnipeg, Manitoba, began patient enrollment in its Phase II trial of MC-4232 for diabetic patients with hypertension. MC-4232 is a combination of MC-1 and an ACE inhibitor. The randomized, double-blind, placebo-controlled, double-crossover trial will involve 120 patients with co-existing diabetes and hypertension.

• MedImmune Inc., of Gaithersburg, Md., said results show that elevated levels of EphA2 often contribute to ovarian cancer progression, and high levels of the protein might relate to decreased patient survival. Data from the study, which was conducted at the University of Texas M.D. Anderson Cancer Center, were published in the Aug. 1, 2004, issue of Clinical Cancer Research. At least 76 percent of the invasive ovarian tumor samples in the study overexpressed EphA2, with the highest levels of the protein found on the most aggressive cancers. MedImmune's researchers are aiming to develop products that target EphA2, which also is overexpressed in melanoma and breast and prostate cancers.

• NanoString Technologies Inc., of Seattle, raised $4.3 million in early stage capital. The start-up nanotechnology company, which is developing bar coding systems for single molecules, said it would use the capital to accelerate its development program that began at the Institute for Systems Biology in Seattle. The investment was jointly led by OVP Venture Partners and Draper Fisher Jurvetson.

• Norak Biosciences Inc., of Research Triangle Park, N.C., entered a collaboration with BASF Pharma, of Ludwigshafen, Germany, for the discovery of active ingredients against selected G protein-coupled receptor (GPCR) targets. Norak will employ its Transfluor technology to screen a selected portion of its larger compound library against GPCR targets developed by BASF, which is interested in developing compounds for crop protection. Norak will receive technology access and screening fees, as well as milestones and royalties. Norak licensed the Transfluor technology in 1999 from Duke University Medical Center.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said it has selected most of the U.S. sites for a Phase II study of NX-1207, its investigational drug for benign prostatic hyperplasia. The trial is expected to begin later this year. Prior studies showed that NX-1207 produced a statistically significant improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia, and the drug also was shown to produce a statistically significant loss of prostate volume.

• SkyePharma plc, of London, received a $5 million payment from Quintiles Transnational Corp., of Research Triangle Park, N.C., for consenting to the transfer of the U.S., Canadian and Mexican marketing rights to SkyePharma's dermatology product Solaraze to Bradley Pharmaceuticals Inc., of Fairfield, N.J. Those rights had been licensed to Quintiles' wholly owned subsidiary, Bioglan Pharmaceutical Co., of Malvern, Pa, which also had marketed it in the U.S. But on Tuesday, Bioglan's assets were acquired by Bradley pursuant to an asset purchase deal between the companies. That deal originally was reported in June.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said preliminary Phase II data show that elsamitrucin demonstrated evidence of antitumor activity against relapsed or refractory non-Hodgkin's lymphoma. The product also was well tolerated in the vast majority of patients, with a favorable side effect profile. It is being tested as a single agent in the ongoing multicenter study, which is expected to complete enrollment before the end of next year.

• St. Jude Children's Research Hospital in Memphis, Tenn., said findings published in the Aug. 10, 2004, issue of the Proceedings of the National Academy of Sciences show that a single type of primitive stem cell transplanted from donor mice gave rise to both blood-forming and bone-forming cells in recipient mice. The study used a technique called retroviral integration-site analysis to prove that a single type of stem cell can give rise to two distinctly different bodily tissues.

• The Medicines Co., of Parsippany, N.J., said long-term findings of the REPLACE-2 angioplasty clinical trial were published in the Aug. 11, 2004, issue of the Journal of the American Medical Association. The article includes new analyses showing significantly lower mortality at one year among high-risk patients treated with the anticlotting agent Angiomax (bivalirudin). The trial, which enrolled more than 6,000 patients undergoing percutaneous coronary intervention, compared Angiomax to a combination of heparin and platelet blockers known as GP IIb/IIIa inhibitors. Angiomax is approved in the U.S. for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.

• TheraQuest Biosciences LLC, of Blue Bell, Pa., said it had a pre-investigational new drug application meeting with the FDA for its injectable non-narcotic analgesic, TQ-1011, for the management of moderate to severe acute pain. TheraQuest also completed consultations on TQ-1011 with UK and Canadian regulatory agencies. TheraQuest said it received FDA guidance on the next steps toward submitting the IND through to a pivotal Phase III program required for approval.

• TransForm Pharmaceuticals Inc., of Lexington, Mass., formed a collaboration with the University of South Florida in Tampa for the design and discovery of pharmaceutical co-crystal structures to enhance drug properties. The company also signed a license agreement with the university in which TransForm will gain access to new technology and product opportunities through exclusive rights to new co-crystal forms discovered at USF. The parties have consolidated their early intellectual property and will combine IP on their ongoing research. Financial terms were not disclosed.

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