• AMDL Inc., of Tustin, Calif., said AMDL Australia Pty. Ltd., its Down Under distributor, began selling its DR-70 cancer detection test in Australia and New Zealand. The non-intrusive blood test is designed to detect and monitor 13 types of cancer from a single blood serum sample.

• Amylin Pharmaceuticals Inc., of San Diego, said it repaid early its outstanding loans to Johnson & Johnson, of New Brunswick, N.J. Amylin paid J&J $62.5 million, representing a 7 percent discount to the total loan obligation as of the repayment date. The loans were made before 1998 through an earlier collaboration on Amylin's Symlin (pramlintide acetate) and they collectively accrued interest at about 8 percent. Most of the debt was due in June 2005. A portion of Amylin's completed convertible notes private placement in June was used to repay the loans. (See BioWorld Today, June 18, 2003.)

• Caliper Technologies Corp., of Hopkinton, Mass., said Serono SA, of Geneva, Switzerland, bought the Caliper 250 drug discovery system to develop kinase assays. The Caliper 250 system is an automated drug discovery platform based on Caliper's microfluidic LabChip technology that is designed to reduce hit-to-lead drug development timelines. Financial terms were not disclosed.

• Connetics Corp., of Palo Alto, Calif., received a $100,000 up-front assignment fee after selling its rights to recombinant human relaxin to privately held BAS Medical. Connetics, which in May 2001 discontinued the product's development seven months after disclosing poor results from a Phase III study in scleroderma, said it also would receive up to $1 million in licensing and milestone fees, as well as royalties on future product sales. BAS assumed rights to develop and commercialize relaxin for all indications. In addition to the assignment fee this quarter, Connetics said it would recognize $661,000 in deferred revenue relating to previous relaxin license agreements. (See BioWorld Today, Oct. 10, 2000.)

• Crimson Pharmaceutical (Hong Kong) Ltd., the parent company of Crimson Pharmatech USA, of Fort Lee, N.J., reported an agreement to license three drug candidates from Octamer Inc., of Tiburon, Calif. The compounds are being investigated to treat a variety of diseases including cancer, AIDS and acute inflammatory conditions such as stroke. Crimson obtained exclusive rights to develop and market the licensed compounds in China, Korea, Hong Kong, Taiwan, Singapore and other areas in Southeast Asia. Financial terms were not disclosed.

• CuraGen Corp., of New Haven, Conn., said findings published in the online early edition of the Proceedings of the National Academy of Sciences describe the development of a new cell-based assay system for drugs that affect central nervous system disorders. The data demonstrated the highly predictive nature of a small set of genes changing in cells treated with psychoactive agents correlated to what their effects are in humans, identifying a pattern of biomarkers that specify whether cells are responding to a particular drug as though it were an antidepressant, antipsychotic or opiate.

• DiaDexus Inc., of South San Francisco, said the FDA granted marketing clearance for the PLAC test. The test is cleared as an aid in predicting an individual's risk for coronary heart disease in conjunction with clinical evaluation and patient risk assessment. The PLAC test measures the level of lipoprotein-associated phospholipase A2 (Lp-PLA2) in human blood. Lp-PLA2 is an enzyme that has been identified as a risk factor for coronary events.

• DOR BioPharma Inc., of Lake Forest, Ill., entered definitive agreements to sell about $5.4 million in securities in a private placement to institutional and accredited investors. The financing was led by OrbiMed Advisors LLC and included Perceptive Life Sciences Fund, Wexford Capital, Height Capital, Eagle Advisors and A.M. Pappas & Co. Acting as placement agent was Paramount Capital Inc. DOR sold about 6.8 million shares and warrants to purchase about 6.8 shares of common stock. The warrants are exercisable at 87.56 cents per share for a period of five years, subject to accelerated expiration if the common stock is at or above $2.62 per share for 20 consecutive trading days. The exercised warrants would bring the company an additional $5.9 million. It plans to use the proceeds for continuation of work on its drug and vaccine development programs, technology license fees and general corporate purposes. It is working on vaccines against ricin toxin and botulinum toxin.

• Enanta Pharmaceuticals Inc., of Watertown, Mass., presented data on its macrolide discovery program at the 4th International Symposium on Antimicrobial Agents and Resistance in Seoul, South Korea. The research was on a class of antibacterial agents, discovered at Enanta, that are effective against antibiotic-resistant Streptococcus pneumoniae and are being developed for the treatment of upper and lower respiratory tract infections. The presentation highlighted Enanta's work with erythromycin derivatives known as ketolides, which have demonstrated potency against specific resistant organisms, the company said.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., said development partner SkyePharma plc, of London, submitted a new drug application to the FDA for DepoMorphine (morphine sulfate sustained-release liposome injection), an epidural injectable analgesic for pain relief after surgery. DepoMorphine is an injectable formulation of morphine sulfate encapsulated with SkyePharma's sustained-release DepoFoam lipid vesicular delivery technology. Separately, SkyePharma said it licensed exclusive marketing and distribution rights for DepoCyte, a treatment for lymphomatous meningitis, to Mundipharma International Holdings Ltd., of Cambridge, UK, for most European and Eastern European countries. Mundipharma will pay SkyePharma 14.25 million plus additional milestone payments that could total 110.75 million. SkyePharma will manufacture the drug at its San Diego facility. Mundipharma also will pay SkyePharma a royalty on sales.

• FeRx Inc., of San Diego, was awarded a $640,000 Phase II Small Business Innovation Research grant from the National Cancer Institute of the National Institutes of Health in Bethesda, Md. The grant supports research to continue the development of intratumoral radiation therapy of liver lesions using FeRx's MagneTarg drug delivery system. Receipt of the entire grant award is contingent upon the achievement of certain research and development milestones.

• FibroGen Inc., of South San Francisco, reported positive results from the first clinical safety study of recombinant human gelatin, finding the study material safe and well tolerated at all doses tested. The data support the use of FibroGen's 8.5 kD gelatin fragment as a safe and fully characterized alternative to animal- and plasma-derived proteins currently used as stabilizing components in formulations of vaccines and biological therapeutics. The safety was examined in human volunteers. No significant changes in antibody titers against recombinant gelatin or yeast-derived mannan and protein were seen.

• Galen Holdings plc, of Craigavon, Northern Ireland, said that the preliminary discussions announced last week that could have led to an offer being made to purchase Galen Holdings have been terminated. The company said Thursday it was in discussions with an undisclosed company concerning a potential buyout, and its stock had been trading higher. On Thursday, when it acknowledged its rising stock price and announced it was in discussions, its stock rose $6.77, or 16.6 percent, to close at $47.55. Its stock (NASDAQ:GALN) fell $8.63 Monday, or 18.7 percent, to close at $37.59.

• Helsinn Healthcare SA, of Lugano, Switzerland, acquired an exclusive license to the worldwide marketing and distribution rights for Gelclair from Sinclair Pharmaceuticals Ltd., of Godalming, UK. Gelclair is a bioadherent oral gel indicated for the management and relief of pain resulting from oral mucositis, oral surgery or traumatic ulcers caused by dental prostheses. Approved by the FDA in January 2002, Gelclair's exclusive North American distribution rights are held by OSI Pharmaceuticals Inc., of Melville, N.Y. Financial terms were not disclosed.

• Immune Network Ltd., of Vancouver, British Columbia, said it filed a lawsuit against PRA International Inc., of McLean, Va., in the Superior Court of California seeking damages due to PRA's alleged failure to meet contractual obligations to carry out a clinical trial program for Immune Network. The complaint charges PRA with breach of contract and damages, breach of contract and specific performance, and negligence. Immune estimated damages at $5 million. The case is related to clinical trials of dapsone in Alzheimer's disease, originally contracted to CroMedica Global Inc., which was acquired by PRA in 2002.

• Kinexis Inc., of Carlsbad, Calif., entered a drug discovery program involving biologic target validation and small-molecule screening of a prokineticin receptor in central nervous system indications with Merck & Co. Inc., of Whitehouse Station, N.J. Kinexis said the molecules have been shown to be important modifiers of circadian rhythm and gastrointestinal motility in animal models. Formed last summer, the privately held firm will receive research funding and may be entitled to future milestone payments and product royalty payments from Merck. Specific financial terms were not disclosed.

• Meridian Bioscience Inc., of Cincinnati, said it would begin production of a recombinant Trypanosoma cruzi (Chagas' disease) antigen under a license agreement with Corixa Corp., of Seattle, in its wholly owned life science production laboratories located at Viral Antigens Inc., of Memphis, Tenn. The recombinant polyvalent antigen, known as TcF, will be marketed to diagnostic test manufacturers for use in production of test kits for blood bank screening and other diagnostic applications. Financial terms were not disclosed.

• Plantigen Inc., of London, Ontario, entered a collaborative research agreement focused on plant-made antigens that prevent autoimmune disease in companion animals with Dow AgroSciences Canada Inc., of Calgary, Alberta. The collaboration will build on Plantigen's intellectual property and experience in immune modulation using mammalian proteins derived from plants.

• Ribapharm Inc., of Costa Mesa, Calif., said that after weighing the implications of the recent summary judgment related to its patent infringement suit involving ribavirin, the board reaffirmed its position rejecting a tender offer put forth by ICN Pharmaceuticals Inc., also of Costa Mesa. ICN proposed to acquire all of Ribapharm's outstanding common shares it does not already hold for $5.60 apiece. Ribapharm's board reiterated its previous recommendation that its stockholders reject ICN's unsolicited tender offer and urged stockholders not to tender their shares pursuant to ICN's offer.

• Rigel Pharmaceuticals Inc., of South San Francisco, completed its Phase I/II study of R112, a drug to treat allergic rhinitis. The study evaluated the efficacy and safety of a single intranasal administration of R112 in patients with asymptomatic seasonal allergic rhinitis. R112 demonstrated significant improvement or consistent positive trends in reducing the release of chemical mediators involved in mast cell activation, the company said. The study involved 20 patients with at least a two-year history of seasonal allergic rhinitis and confirmed reactivity to a specific allergen. The patients were randomized to receive either placebo or R112 in a nasal spray.

• Valentis Inc., of Burlingame, Calif., began a randomized, double-blinded, placebo-controlled Phase II trial of its Del-1 angiogenesis gene. The study's design randomizes 100 patients with peripheral arterial disease, specifically intermittent claudication, to receive either Del-1 or placebo. It is being conducted in 12 U.S. centers, with enrollment expected to be completed in the first quarter of next year and data to be released in the third quarter.

• Vectura Ltd., of Chippenham, UK, said Phase IIa results showed that VR004 (inhaled apomorphine HCl) improved erectile performance with a rapid onset of action and was tolerable at all doses tested. The company said it would begin additional studies in the near future as it pursues licensing discussions in an effort to partner the product by the end of this year.