• AEterna Zentaris Inc., of Quebec City, reported positive results from a Phase II trial designed to evaluate dosage regimens of a depot formulation of cetrorelix, a luteinizing hormone-releasing hormone antagonist, in 250 patients with symptomatic benign prostatic hyperplasia. Data demonstrated a dose-dependent, durable and statistically significant (p<0.001) improvement of clinical symptoms characteristic of the disorder, including the International Prostate Symptom Score, at all dosages except the lowest, as well as a positive safety and tolerability profile.

• Akorn Inc., of Buffalo Grove, Ill., received notice that a default event occurred on its outstanding promissory note with NeoPharm Inc., of Lake Forest, Ill. The default was triggered when a processing agreement between the companies, which was to go into effect on or before Oct. 1, failed to occur. Akorn said it is working to resolve the issue and that pursuant to a subordination agreement, it cannot make payments to NeoPharm and NeoPharm cannot enforce any remedies against Akorn until Akorn's senior debt is paid and commitment for the senior debt is terminated.

• Amarin Corp. plc, of London, raised gross proceeds of $12.75 million after completing a private placement of about 13.4 million ordinary shares at about 95 cents apiece to a group of new and existing accredited investors and management. Amarin said the financing allows it to drive forward with plans for Phase III trials of Miraxion, its lead compound for Huntington's disease, and would facilitate in-licensing discussions for new late-stage compounds and out-licensing discussions with prospective partners for indications outside neurology.

• Amgen Inc., of Thousand Oaks, Calif., said data reported at the American Society of Bone and Mineral Research meeting show that Sensipar (cinacalcet HCl) effectively controlled calcium levels (hypercalcemia) in patients with parathyroid carcinoma and might reduce calcium levels across a range of patients with primary hyperparathyroidism (HPT). In the study, 122 patients were divided into three categories: 30 patients with recurrent primary HPT post-parathyroid surgery, 66 who met criteria for surgical intervention but had not undergone surgery and the 26 remaining.

• Antisense Therapeutics Ltd., of Melbourne, Australia, accepted a proposal from the Bank of New York to establish a Level 1 American depository receipt program. The company, which expects the stock listing to provide exposure to its programs, is developing antisense pharmaceuticals. Its two most advanced projects target multiple sclerosis and psoriasis.

• Applied Biosystems Group, of Foster City, Calif., said a U.S. district court dismissed a case filed against it and F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The suit was filed by Promega Corp., of Madison, Wis., but the court ruled that Promega failed to state a valid claim against Applied Biosystems and Roche. Additionally, the court rejected Promega's statements that Applied Biosystems and Roche made false claims to the U.S. government in connection with sales of Taq DNA polymerase, which is used to perform the polymerase chain reaction technology.

• Australian Cancer Technology Ltd., of Sydney, Australia, said it received A$1.9 million (US$1.4 million) through a share placement with Bioaccelerate Inc., of New York. Terms call for the sale of about 4.9 million AustCancer shares at about A38 cents apiece. Included in the agreement is a commitment to a wider collaboration, focused in particular on a new prostate cancer compound introduced by Bioaccelerate. The collaboration also will include work on AustCancer's pancreatic drug, RP101, which is targeted at preventing cells from developing resistance to chemotherapy.

• Biofrontera AG, of Leverkusen, Germany, acquired a Phase II compound for various cancerous and precancerous skin lesions, and some gynecological indications, from ASAT AG, of Zug, Switzerland. The product applies aminolevulinic acid in a nanocolloid formulation, which is suited for photodynamic therapy. Biofrontera said the formulation provides effective permeation, specifically into the malignant tissue, and enhances the formation of protoporphyrine in those cells, ultimately causing cell degeneration. Its efficacy and safety have been investigated, with positive results in pilot Phase II and III studies. Financial terms were not disclosed.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said Phase II findings to be reported at the North American Menopause Society meeting in Washington showed that all doses of Bio-E-Gel studied showed significant decreases in the frequency and severity of hot flashes vs. baseline (p<0.0001). The company added that a Phase III trial is on track to enroll all subjects by the end of this year, with completion planned by the end of the first quarter of next year. The product employs estradiol Advanced Transdermal Delivery gel technology from Antares Pharma Inc., of Exton, Pa.

• Bioxel Pharma Inc., of Sainte-Foy, Quebec, obtained a nonrefundable contribution of $500,000 from Investissement Quebec Immigrant Investors as part of the Immigrant Investor Program for Assistance to Business. The company also reached an agreement with the remaining holders of its convertible debentures worth an aggregate $1.5 million in principal amount of debentures.

• Cellectricon AB, of Gothenburg, Sweden, named Ulf Jonsson CEO effective Jan. 1. He has served as CEO of Biacore and worked for London-based Amersham Pharmacia Biotech (now Amersham plc) as marketing manager for molecular biological systems.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, and Ex Vivo Technologies Inc., of Houston, entered a nonexclusive research license agreement to use Chromos' ACE System to genetically modify adult-derived stem cells for research purposes. Ex Vivo will use the system to engineer adult-derived stem cells for research related to optimizing proliferation and controlled differentiation of those cells. Chromos will receive an up-front payment and annual maintenance fees. Further terms were not disclosed.

• Crucell NV, of Leiden, the Netherlands, began patent-infringement proceedings in the District Court of Dusseldorf against Cevec Pharmaceuticals GmbH. Crucell alleges that Cevec is planning to create a company based on a human cell line that mirrors features of Crucell's patented PER.C6 technology. Crucell said on Oct. 6 the European Patent Office granted a patent covering cell lines marketed by Crucell as part of its PER.C6 technology.

• Delex Therapeutics Inc., of Mississauga, Ontario, presented a preview of its Phase IIa trial results with its lead product, AeroLEF (aerosolized liposome-encapsulated fentanyl), in post-surgical patients at the BioContact 2004 Conference. The study saw 95 percent of patients being able to safely self-titrate AeroLEF and achieve analgesia without the standard trial-and-error approach of bolus dosing of intravenous opioids. The study used AeroLEF as the primary analgesic treatment in adult patients experiencing moderate to severe pain following elective knee surgery.

• Dimethaid Research Inc., of Markham, Ontario, released initial plans for restructuring its financial state. Its directors will no longer receive cash as an annual retainer or for attending meetings, and instead will receive 50,000 options to acquire common shares at the prior day's closing price. The options vested on the date they were granted. The company also received a short-term loan to fund operations, and expects to complete studies of Pennsaid by the end of next year and submit an amended new drug application by mid-2006. The company develops and commercializes targeted therapeutic drugs based on two technology platforms that focus on transcellular drug delivery and immune system regulation.

• Endovasc Inc., of Montgomery, Texas, which is reorganizing its corporate structure, filed with the SEC to be regulated as a Business Development Company (BDC), which provides access to public funds to promote developing businesses. Endovasc's chief financial officer said the company already is designed as a holding company and the recent action would benefit its subsidiaries by opening access to capital investment funds. Also, Southern Securities Inc. agreed to an investment banking deal, committing $5 million over the next 12 months. Endovasc will devote the funds to its pipeline and acquisitions. The financing will commence upon Endovasc's conversion to a BDC.

• GenoMed Inc., of St. Louis, said it would offer its broad-spectrum viral antidote to the nation during this coming flu season. The company said it would meet this month with the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., to discuss further testing of its approach against viral diseases, including influenza. GenoMed noted that it has had 100 percent success in treating a small number of normal, immunocompetent patients suffering from West Nile virus encephalitis during the past two summers, including the elderly.

• Gen-Probe Inc., of San Diego, signed licensing agreements with Paris-based bioMerieux and its affiliates granting access to Gen-Probe's ribosomal RNA technologies and, in turn, providing Gen-Probe admittance to bioMerieux's intellectual property related to genetic mutation detection, specifically in blood clotting disorders. Terms include a payment to Gen-Probe of up to $250,000 for a limited nonexclusive research license and options to develop diagnostic products for certain targets using its technology. Options if exercised could be worth an aggregate $4.5 million. BioMerieux also could acquire development rights for extra targets, paying up to $3 million by the end of 2006, and Gen-Probe is entitled to sales-based royalties. Gen-Probe will pay bioMerieux $1 million plus potential royalties for a nonexclusive worldwide license to its intellectual property to develop mutation detection kits focusing on genes coding for Factor V and prothrombin. The French company ended agreements to develop assays for its VIDAS instrument with Gen-Probe, which expects to record the remaining $500,000 in the third quarter. The companies agreed that Gen-Probe could negotiate rights to develop certain transcription-mediated amplification assays to run on bioMerieux's Easy Q platform.

• Helsinn Healthcare SA, of Lugano, Switzerland, granted exclusive Israeli rights to palonosetron (Aloxi) to Rafa Ltd., of Jerusalem. The 5-HT3 receptor antagonist was approved by the FDA to prevent acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. U.S. rights belong to MGI Pharma Inc., of Minneapolis.

• Hi-Tech Pharmacal Co. Inc., of Amityville, N.Y., and Blansett Pharmacal Co. Inc., of Little Rock, Ark., agreed to co-promote Naprelan in the U.S. Hi-Tech recently licensed extended-release Naprelan tablets from Elan Pharmaceuticals Inc., a unit of Elan Corp. plc, of Dublin, Ireland. Blansett will promote the non-steroidal, anti-inflammatory agent with its own sales force, targeting primary-care physicians in the U.S. The drug was formulated with Elan's Intestinal Protective Drug Absorption System and is administered once a day.

• Icoria Inc., of Research Triangle Park, N.C., said Agilent Technologies Inc., of Palo Alto, Calif., was approved by the National Institute of Standards and Technology's Advanced Technology Program to partner with Icoria in its continuing work on an $11.7 million grant. It originally was awarded in June 2002 to Icoria and its initial partner, LION bioscience AG, of Heidelberg, Germany, but LION since has withdrawn from participation and was replaced by Agilent. The goal is to support the development of a Target Assessment Technologies Suite for the improved discovery and validation of targets for product development in the pharmaceutical and life sciences areas.

• ImClone Systems Inc., of New York, and Bristol-Myers Squibb Co., also of New York, said they would begin a Phase III trial called IMCL-0452 to evaluate chemotherapy alone, with either docetaxel or pemetrexed, or chemotherapy in combination with Erbitux (cetuximab) in 800 patients with second-line non-small-cell lung cancer. Its primary endpoint is tumor response rate, defined as tumor regression greater than 50 percent. Secondary endpoints include progression-free and overall survival. Based on a special protocol assessment, the FDA agreed that the study, pending its outcome, could serve as the basis for an accelerated approval in the second-line treatment of non-small-cell lung cancer. Also, Merck KGaA, of Darmstadt, Germany, began a randomized Phase III trial in Europe, Latin America and Asia called EMR-046 to test a platinum-based chemotherapy and vinorelbine alone or in combination with Erbitux in 1,100 patients with first-line non-small-cell lung cancer.

• IntraBiotics Pharmaceuticals Inc., of Palo Alto, Calif., retained Lazard Freres & Co. in New York as adviser, as it considers strategic options. The company, which has no long-term debt or similar obligations, intends to maximize shareholder value via mergers, acquisitions, in-licensing and liquidation. It expects to have cash and investments of between about $46 million and $50 millions at year end.

• Inyx Inc., of New York, signed an agreement in principle to acquire the assets and certain business of Aventis Pharmaceuticals Puerto Rico from Aventis Pharmaceuticals Inc., a wholly owned subsidiary of Sanofi-Aventis Group, of Paris. The deal calls for execution of a definitive agreement by Dec. 15, closing by March 31, though its completion will be dependent upon factors such as Inyx completing customary due diligence and securing financing. Financial terms were not disclosed. Inyx focuses on niche drug delivery technologies and products.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its Ibis program was granted three government contracts valued at up to $10 million for the continued development of its TIGER biosensor technology. TIGER, which stands for Triangulation Identification Genetic Evaluation of Risks, is a research program initially sponsored by the Defense Advanced Research Projects Agency under a bioweapons defense subcontract from Science Applications International Corp., of San Diego. The TIGER program also is funded by the Centers for Disease Control and Prevention in Atlanta for epidemiological surveillance applications, the FBI in Washington for the development of a microbial agent database, and by the National Institute of Allergy and Infectious Diseases for biological products screening.

• Lynx Therapeutics Inc., of Hayward, Calif., entered a service agreement with the American Type Culture Collection (ATCC) to study gene expression in human embryonic stem cells. Lynx will be compensated for genomics discovery services using its Massively Parallel Signature Sequencing technology. ATCC will search for universal sets of genes and their expression to shed light on specific cell states.

• Nymox Pharmaceutical Corp., of Montreal, signed an agreement with Health Canada for the licensing of patent rights and technology for the treatment of E. coli O157:H7 bacteria in cattle. The company said the agreement is part of a collaboration with Roger Johnson and the Laboratory for Food-borne Zoonoses in Guelph, Ontario, for the research and development of new animal and related treatments for E. coli 0157:H7, a bacteria implicated in contamination of meat products and of drinking water supplies. Financial terms were not disclosed.

• Peninsula Pharmaceuticals Inc., of Alameda, Calif., said it completed a Phase I trial of PPI-0903 as a treatment for complicated skin and skin-structure infections, as well as community- and hospital-acquired pneumonias. The study evaluated intravenous escalating single doses and then escalating multiple doses for up to 14 days. Preliminary analyses showed the drug was well tolerated. The compound is a next-generation cephalosporin antibiotic and has shown in vitro potency against resistant strains of Gram-positive and Gram-negative bacteria. Takeda Chemical Industries Ltd., of Osaka, Japan, is responsible for development and commercialization in Japan, and will manufacture product for worldwide distribution. Peninsula has worldwide development and commercialization rights, outside Japan.

• PharmaMar SA, of Madrid, Spain, said the FDA designated Yondelis an orphan drug for soft-tissue sarcoma. The U.S. application was sponsored by Johnson & Johnson Pharmaceutical Research & Development Inc., a unit of Johnson & Johnson, of New Brunswick, N.J. European authorities already granted orphan status to the product, a marine-derived antitumor agent isolated from the colonial tunicate Ecteinascidia turbinata.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., reached target enrollment for its Phase II study of methylnaltrexone (MNTX) for postoperative ileus. It expects top-line results from the 60-patient proof-of-concept trial in patients at high risk of prolonged ileus by early next year. The trial was designed to assess MNTX's ability to restore gastrointestinal function and decrease the length of hospital stays.

• Resverlogix Corp., of Edmonton, Alberta, entered an agreement to raise up to C$9 million (US$7.1 million) with lead agent First Associates Investments Inc., together with a syndicate including Haywood Securities Inc., Sprott Securities Inc. and Jennings Capital Inc. with regards to a private equity placement at a price to be determined. Closing is expected on or about Nov. 9.

• Santarus Inc., of San Diego, entered a five-year, co-promotion alliance with Otsuka America Pharmaceutical Inc., of Rockville, Md., to co-promote Zegerid (omeprazole) Powder for Oral Suspension to U.S. physicians. Otsuka's 172 sales representatives are expected to begin promoting the product, which received FDA approval in June, early next month. In addition, Santarus granted options to Otsuka to extend the agreement to Zegerid capsule and chewable tablet formulations, subject to receipt of marketing approval of those products. To that end, Santarus began a pivotal pharmacokinetic and pharmacodynamic trial to evaluate a 20-mg chewable tablet formulation of the proton pump inhibitor. Santarus plans to begin a pivotal trial to evaluate the tablets in a 40-mg dose later this year.

• Santhera Pharmaceuticals AG, of Liestal, Switzerland, granted a nonexclusive license to its cellular screening system to Genzyme Corp., of Cambridge, Mass., for the discovery of therapies for a variety of muscle diseases, including Duchenne muscular dystrophy. Genzyme also gained an option to obtain an exclusive worldwide license to develop and commercialize a subset of Santhera's small-molecule compounds for Duchenne muscular dystrophy and related diseases. Terms of the agreement call for Santhera to receive a technology license fee, though more specific financial details were not disclosed.

• Serologicals Corp., of Atlanta, said that Serologicals Ltd., located in the UK, gained FDA approval for its expanded monoclonal antibody production facility in Livingston, Scotland. The unit supplies blood typing reagents and CE-marked products for the blood typing market.

• Sienabiotech SpA, of Rome, entered an agreement with Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J., to perform joint research and co-develop compounds targeted at neurodegenerative diseases, with a focus on Alzheimer's disease. Wyeth will have an option to select candidate molecules for further preclinical and clinical development in the field and will have worldwide marketing rights to resulting products. In return, Sienabiotech will receive a series of up-front payments and further milestone payments, as well as royalties. Sienabiotech also will have the option to develop compounds emerging from the collaboration for orphan disease indications. More specific financial terms were not disclosed.

• Xcyte Therapies Inc., of Seattle, filed a registration statement for a proposed public offering of 1.5 million shares of convertible exchangeable preferred stock. The company plans to grant the underwriters an option to purchase up to 225,000 additional shares to cover overallotments. All the shares will be offered by Xcyte, which is developing activated, patient-specific T cells designed to enhance a body's natural immune response to treat cancer, infectious diseases and other conditions associated with weakened immune systems. The offering's lead manager is Piper Jaffray & Co. JMP Securities LLC will act as a co-manager. On Thursday, Xcyte's stock (NASDAQ:XCYT) dropped 40 cents, or 11.8 percent, to close at $3.

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