• Amersham plc, of Buckinghamshire, UK, reported the in-licensing of a class of molecules from the University of Pittsburgh in Pennsylvania targeting amyloid plaque in the brain. Amersham's strategy is to identify a lead candidate for clinical evaluation as a positron emission tomography diagnostic and monitoring agent for Alzheimer's disease. Financial terms of the agreement have not been disclosed. Other molecules in the class also will be used by Amersham's pharmaceutical partners through its Imanet network of imaging research centers to accelerate and facilitate the development of therapeutic drugs that target Alzheimer's disease.

• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, said Phase III results showed that exenatide (synthetic exendin-4) produced statistically significant, dose-dependent reductions in the glucose control endpoint of a seven-month pivotal study in Type II diabetics who fail to achieve target blood glucose levels with sulfonylurea alone. The study is the second of three pivotal trials for the product. At the end of the study, 41 percent of subjects completing the trial on the highest dose of exenatide reduced their hemoglobin A1c levels to less than or equal to 7 percent. Reductions in average blood glucose were similar to reductions observed in the first exenatide pivotal study, which were announced three months ago, and the partners said they remain on track to report the remaining trial's results before the end of the year. (See BioWorld Today, Aug. 8, 2003.)

• Atrix Laboratories Inc., of Fort Collins, Colo., completed its pivotal Phase III study of Eligard 45 mg (leuprolide acetate for injectable suspension) for advanced prostate cancer and reported interim results from the trial at the CaP CURE Scientific Retreat. The company said it expects to submit a new drug application for the sustained-release, leutenizing hormone-releasing hormone product to the FDA next year. Eligard 7.5-mg, 22.5-mg and 30-mg products for advanced prostate cancer are marketed in the U.S. by Sanofi-Synthelabo Inc., of New York. The 7.5-mg dose was approved early last year. Separately, Atrix and Sanofi-Synthelabo were named in a suit filed by Wako Pure Chemical Industries Ltd., of Osaka, Japan, and Takeda Abbott Pharmaceuticals Products Inc., a joint venture between Takeda Chemical Industries Ltd., also of Osaka, and Abbott Laboratories, of Abbott Park, Ill., which claim Atrix's Eligard delivery system infringes their patent. Atrix called the suit baseless and "motivated by Takeda Abbott's concern over losing Lupron market share," and does not expect the event to disrupt Eligard sales. (See BioWorld Today, Jan. 25, 2002.)

• Biotique Systems Inc., of Emeryville, Calif., reported that Affymetrix Inc., of Santa Clara, Calif., licensed the Biotique Local Integration System for use in its research activities. The system is a customizable framework for biological data integration that helps scientists bridge "data islands" to promote knowledge sharing and the application of information assets to discovery and development.

• BTG plc, of West Conshohocken, Pa., said it is seeking partners to develop and commercialize its PDE-4 inhibitor portfolio for specific inflammatory indications outside of respiratory disease. The company noted that such products are candidates for non-respiratory indications such as cognitive disorders, multiple sclerosis, osteoporosis, contact dermatitis and rheumatoid arthritis.

• ChemBridge Research Laboratories LLC, of San Diego, entered a collaborative agreement to provide collections of small molecules, including its PharmaCophore, GPCR and Kinase Targeted Libraries, to support cancer drug research at the Experimental Therapeutics Center at Memorial Sloan-Kettering Cancer Center in New York. In turn, Memorial Sloan-Kettering will profile the biological activity of the libraries against multiple existing and new molecular targets in its newly established high-throughput screening core facility, which interacts with multiple research groups throughout the center. Financial terms of the five-year agreement were not disclosed.

• Chiron Corp., of Emeryville, Calif., is selling the Swedish vaccine unit of Powderject plc, of Oxford, UK, according to a report published by The Financial Times. The report said the decision was motivated by Chiron's decision to focus on influenza and meningitis vaccines - the facility produces travel vaccines. Chiron purchased Powderject earlier this year. (See BioWorld Today, May 20, 2003.)

• Depomed Inc., of Menlo Park, Calif., completed patient dosing in a pair of pivotal trials - a second Phase III study of once-daily Metformin GR for Type II diabetes and a Phase III study of once-daily Ciprofloxacin GR for urinary tract infections. The former began two years ago and the latter began this summer. Depomed said it would complete data analyses and report results from both trials in the first quarter of next year, with plans to file new drug applications for both products during the first half of next year. At the same time, the company said it received an additional patent on its controlled-release Gastric Retention drug delivery system on which both products are based. (See BioWorld Today, June 22, 2001, and June 4, 2003.)

• Dharmacon Inc., of Lafayette, Colo., entered an agreement to supply small interfering RNA reagents to Bayer Pharmaceuticals Corp., a unit of Bayer AG, of Leverkusen, Germany. The reagents will be designed using Dharmacon's SmartSelection and SmartPool technologies, and will be among the siRNAs used in Bayer's target validation research. Financial terms were not disclosed.

• Elan Corp. plc, of Dublin, Ireland, said it completed the offering and sale of $460 million in aggregate principal amount of 6.5 percent convertible guaranteed notes due in 2008, issued by Elan Capital Corp. Ltd., a wholly-owned subsidiary of Elan and guaranteed by Elan. The offering and sale of the notes was made outside the U.S. to non-U.S. persons.

• Elixir Pharmaceuticals, of Cambridge, Mass., reported the identification of a single gene, microsomal transfer protein (MTP), which is a marker of lifespan in a group of centenarians from the U.S. The findings will be published this week in the online version of the Proceedings of the National Academy of Sciences. MTP is well characterized in an extension of previously reported results from centenarian studies conducted by company scientists and co-founders that established the heritability of average life expectancy and honed in on a region on chromosome 4 as the likely location of a gene or genes associated with longevity.

• EpiTan Ltd., of Melbourne, Australia, said that, following a successful meeting with the FDA, the company expects to submit an investigational new drug application in mid-2004 and begin clinical trials shortly thereafter. An acceptable indication for Melanotan is expected to be for prevention or reduction of UV-induced skin damage in subjects at high risk (genetic or occupational). The IND will be for Melanotan in a sustained-release implant formulation.

• Galapagos Genomics NV, of Mechelen, Belgium, entered an antiviral discovery research collaboration with Boehringer Ingelheim GmbH, of Ingelheim, Germany, which will use the former's SilenceSelect gene knockdown platform to perform a genome-wide screen for all druggable genes that influence viral replication in human cells. In return, Galapagos gained up-front technology access fees and will be eligible for further option and license fees during the program. Further financial terms were not disclosed.

• Genaera Corp., of Plymouth Meeting, Pa., raised gross proceeds of about $8.5 million after accepting subscriptions from unaffiliated institutional investors to purchase about 2.1 million common shares at $4.15 apiece through a registered direct offering. The share price represents the stock's Nov. 10 closing price. Fortis Securities Inc. acted as placement agent for the transaction, which is expected to close on or prior to Nov. 14.

• Genentech Inc., of South San Francisco, entered an agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to test Genentech's TNKase/Metalyse (tenecteplase) in combination with percutaneous coronary intervention (PCI) for acute myocardial infarction. The 4,000-patient trial, ASSENT 4 PCI, has two arms: half the patients will receive a full-dose, single bolus of TNKase/Metalyse plus unfractionated heparin followed by immediate PCI. The other half will receive immediate PCI alone.

• GlycoFi Inc., of Lebanon, N.H., and Biogen Inc., of Cambridge, Mass., initiated a joint research study to evaluate GlycoFi's humanized yeast platform for the production of an undisclosed Biogen protein. The study, supported by Biogen, will combine GlycoFi's expression technology to produce uniform human glycoproteins with Biogen's expertise in the area of therapeutic protein discovery and manufacturing.

• Hard to Treat Diseases Inc., of Delray Beach, Fla., said the testing of Tubercin has begun by a U.S. medical group. The testing is the continuation of the required FDA process. Tubercin is a substance that is derived from Mycobacterium Tuberculosis. It is purified until it is a safe, nontoxic and a non-addictive substance, the company said, and it is a combative substance against cancer. An immunostimulant, Tubercin is designed to increase the strength of the immune system so that it is capable of destroying cancer cells.

• Igeneon AG, of Vienna, Austria, intends to start two pivotal trials for its cancer vaccine IGN101. The first, in metastatic colorectal cancer, will be a 700-patient, placebo-controlled Phase III conducted in 24 European centers. The other is a Phase III in adjuvant breast cancer, scheduled to be conducted in cooperation with the Austrian Breast & Colorectal Cancer Study Group. A Phase II/III trial in adjuvant non-small-cell lung cancer is ongoing. IGN101 is designed to trigger an immune response to EpCAM (epithelial cell adhesion molecule), a membrane protein that is almost always expressed - and often overexpressed - on epithelial cancer cells. It aims at the selective destruction of disseminated tumor cells and might prevent or delay the formation of metastases.

• Kemin Pharma, of Herentals, Belgium, reported the identification of carbohydrate-based molecules with highly effective and selective activity against human cytomegalovirus (CMT). The molecules are part of a new class being screened by Kemin Pharma that exhibit positive activity, selectivity and toxicity profiles, the company said. The company was able to chemically modify and optimize the lead molecule, creating molecule KPE1015, which Kemin said delivered improved in vitro activity, superior to ganciclovir, against both the Davis and AD-169 strains of CMV.

• Lexicon Genetics Inc., of The Woodlands, Texas, reached the first performance milestone in its drug discovery alliance with Genentech Inc., of South San Francisco. Lexicon established the alliance with Genentech in December 2002 to discover therapeutic proteins and antibody targets and was expected to potentially bring Lexicon more than $39 million. Lexicon is using its target validation technologies to discover the functions of secreted proteins and potential antibody targets identified through Genentech's drug discovery research. (See BioWorld Today, Dec. 19, 2002.)

• Life Sciences Partners, a European venture capital firm located in Amsterdam, the Netherlands, and Munich, Germany, made an initial commitment to NeuroNova AG, of Munich, as part of a 14 million round of equity financing. NeuroNova is a biopharmaceutical company in the field of affective disorders. The company said the funding will enable it to pursue product acquisition and outlicensing options as well as to start its first collaborations with the pharmaceutical industry.

• Lynx Therapeutics Inc., of Hayward, Calif., signed a multiyear, multimillion dollar services agreement with Pioneer Hi-Bred International Inc., a subsidiary of DuPont, of Wilmington, Del., which will continue to use Lynx's technology in its discovery and development efforts related to agricultural traits and products. The pact extends a five-year agreement that dates to 1998, which also includes the use of Lynx's Massively Parallel Signature Sequencing technology.

• Metaphore Pharmaceuticals Inc., of St. Louis, presented two abstracts at the Society for Neuroscience 33rd annual meeting in New Orleans, demonstrating that excessive formation of superoxide is crucial in the development and maintenance of hyperalgesia, clinically defined as an increased sensitivity to painful stimuli. Metaphore's lead compound, M40403, a synthetic low-molecular weight superoxide dismutase mimetic, currently in Phase II trials, has been shown to reduce inflammation and hyperalgesia in in-vivo models both peripherally and centrally.

• Norwood Abbey Ltd., of Melbourne, Australia, signed an exclusive license arrangement for its immunology intellectual property with TAP Pharmaceutical Products Inc., of Lake Forest, Ill. Norwood's immunology intellectual property will be studied for use in the enhancement of an existing class of sex steroid drugs called GnRH analogues, of which TAP's Lupron is a member. TAP made a $2 million investment in Norwood Abbey's stock. Norwood will receive a milestone payment and royalty payments based on incremental sales in the immunology arena.

• NuGEN Technologies Inc., of San Carlos, Calif., presented data at the Society for Neuroscience 33rd annual meeting in New Orleans demonstrating the use of its Ovation Nanosample RNA Amplification System to investigate the molecular mechanisms of Parkinson's disease. The data showed that scientists were able to generate microgram amounts of single-stranded DNA from samples as small as 1ng total RNA, among other things.

• Pain Therapeutics Inc., of South San Francisco, said three poster presentations at this week's Society for Neuroscience conference in New Orleans pointed to the anti-addictive and anti-tolerance properties of ultra-low-dose opioid antagonists, which play an integral part in its painkiller, Oxytrex. Among the findings, one study showed that rats that previously self-administered opiates plus ultra-low-dose opioid antagonists showed significantly reduced drug-seeking behavior compared to rats that self-administered the same amount of the opiate drug.

• Plexxikon Inc., of Berkeley, Calif., reported that a lead compound for an oncology target was accepted by Genentech Inc., of South San Francisco, thereby triggering a milestone payment to Plexxikon. The compound is a kinase inhibitor developed by Plexxikon under a drug discovery collaboration established with Genentech in May 2003. The companies are collaborating to develop a series of small-molecule therapeutics for the treatment of cancer and other diseases, for which Genentech has an option to further develop, commercialize and market under a worldwide license. (See BioWorld Today, May 21, 2003.)

• Prima Biomed Ltd., of Melbourne, Australia, reported new data from its preclinical drug development program for rheumatoid arthritis indicating that a short course of treatment with its compounds can result in sustained suppression of the debilitating autoimmune disease. The company said those findings validate past results in which scientists at Melbourne's Austin Research Institute identified the Fc receptor on human white blood cells as a key source of the chemicals that cause inflammation.

• Progen Industries Ltd., of Brisbane, Australia, reported the divestiture of their non-core life sciences business unit with the agreement signed with Global Science and Technology Ltd., a subsidiary of New Zealand EBOS Ltd., of Christchurch, New Zealand. The transaction, valued at $1.2 million along with recent capital raising, leaves Progen with about $16 million in cash to focus on its cancer drug development.

• StemCells Inc., of Palo Alto, Calif., said The Riverview Group LLC converted the $2 million face value of 3 percent cumulative redeemable convertible preferred stock remaining from its $5 million purchase in December 2001, at the original conversion price of $2 per share. Riverview received 1 million shares of StemCells' common stock plus 10,833 accumulated dividend shares in the redemption. Riverview also exercised part of the warrant received in connection with its purchase of 4 million shares of StemCells' common stock in May, acquiring about another 1.1 million shares at $1.50 per share.

• Synthetic Blood International Inc., of Costa Mesa, Calif., completed testing of the first of three dose levels in a Phase I study of Oxycyte, the company's perfluorocarbon-based blood substitute. Nine subjects were given intravenous infusions of either Oxycyte or a control fluid and then evaluated extensively for adverse effects. One reaction, a transient fever, was seen in one subject. It is not known whether this was a test or control subject, since the study is double blinded.

• Tanox Inc., of Houston, reported data that showed continuing evidence of the tolerability and antiretroviral activity of TNX-355 from preliminary analysis of its multi-dose Phase Ib trial in HIV-1-infected patients. TNX-355 therapy was well tolerated and associated with initial, clinically meaningful reductions in viral load, while a recovery in viral load was associated with decreased in vitro sensitivity to TNX-355. Tanox plans to report more detailed results within the next several months and is planning a Phase II study for next year.

• Targacept Inc., of Winston-Salem, N.C., said in vitro data reported at the Society for Neuroscience conference in New Orleans demonstrated the role of nicotinic ligands in promoting neuroprotection, as well as in inhibiting the activity of pro-inflammatory cytokines. Another study showed that ligand interaction with the alpha-7 neuronal nicotinic receptor may override the effects of beta-amyloid, a protein present in the plaque of Alzheimer's disease patients' brain cells. Additional data indicated that alpha-6 may be an important target for drugs to treat Parkinson's disease.

• Zivena Inc., of Columbus, Ohio, is part of a group awarded $8 million from the state of Ohio to research lung cancer therapies. Others include Ohio State University's Comprehensive Cancer Center and the Battelle Memorial Institute, both in Columbus, as well as Siemens Medical Solutions. The award also drew a commitment of an additional $13.5 million in commercial investment from the partners. The research will focus on improving prevention, detection and treatment for lung cancer. The lead product at Zivena, which is developing inhaled drugs for lung cancer, is Resmycin (doxorubicin HCl inhalation solution). The product is in Phase II testing.

No Comments