Alexion Pharmaceuticals Inc., of Cheshire, Conn., and Procter & Gamble Pharmaceuticals, a division of Cincinnati-based Procter & Gamble Co., completed enrollment for the pivotal Phase III efficacy trial of pexelizumab. The agent is being investigated for reducing mortality and myocardial infarction following coronary artery bypass graft (CABG) surgery. The study enrolled about 4,250 patients undergoing CABG surgery in six countries in Europe and North America.
Anadys Pharmaceuticals Inc., of San Diego, said the underwriters exercised in full their overallotment option to purchase 750,000 shares of common stock at $12.40 apiece. The exercise brings the total shares offered to 5.75 million, and the total gross proceeds to $71.3 million. Credit Suisse First Boston LLC and SG Cowen & Co. LLC are acting as joint book runners, while Piper Jaffray and Needham & Co. LLC are co-managers. (See BioWorld Today, Aug. 8, 2005.)
BioCryst Pharmaceuticals Inc., of Birmingham, Ala., started a Phase I pharmacokinetic study of Fodosine (forodesine hydrochloride) to evaluate the bioavailability and effect of food on oral vs. intravenous formulations in healthy volunteers. Fodosine, a transition state purine nucleoside phosphorylase inhibitor that functions by blocking the DNA synthesis machinery of the body's T-cells, is in development for T-cell mediated cancers and has orphan drug status. BioCryst also started a Phase Ib trial of BCX-4208, its second-generation, transition-state analogue inhibitor of purine nucleoside phosphorylase.
Bone Medical Ltd., of Bentley, Western Australia, said its level one American depository receipt (ADR) program is effective with receipts tradable on the Over-the-Counter Bulletin Board under the symbol "BMEDY." The Bank of New York was chosen to serve as the depositary bank for Bone Medical's ADR program.
Cenix BioScience GmbH, of Dresden, Germany, delivered a collection of potential therapeutic targets to one of its partners, Bayer HealthCare AG, of Leverkusen, Germany, as part of an RNAi-based collaboration. The deal involved using cell-based assays that were developed at Bayer and optimized to run as high-throughput RNAi screens at Cenix. Bayer has the first option to secure all rights to target-related intellectual property generated by this project, in exchange for milestone payments.
Cubist Pharmaceuticals Inc., of Lexington, Mass., and XTL Biopharmaceuticals Ltd., of Rehovot, Israel, ended patient dosing in the second of two Phase II hepatitis B clinical trials of HepeX-B. Cubist plans to review data with the FDA in order to design a Phase III trial. A data safety monitoring board recently reviewed data from the Phase II and no concerns were raised.
CytoGenix Inc., of Houston, entered an agreement with Imperial College London for research studies using the company's antimicrobial nucleic acid compound. The program aims at further elucidating the activity of CytoGenix's RBL-1 for potential therapeutic purposes. Financial terms were not disclosed.
DOV Pharmaceutical Inc., of Hackensack, N.J., said it amended its 2004 agreement with Whitehouse Station, N.J.-based Merck & Co. Inc. for clinical development activities of DOV 21,947 and DOV 216,303 for the treatment of depression. Under the amended terms, certain development initially will be handled by DOV for DOV 21,947, which is in Phase II studies. If those studies yield positive results, the company will be reimbursed by Merck for pre-agreed expenses and will receive a success premium. The amendment also provides an option for the companies to expand the collaboration to include an additional triple reuptake inhibitor from DOV's preclinical pipeline following testing by Merck.
Encore Pharmaceuticals Inc., of Riverside, Calif., received a Phase II Small Business Innovation Research grant from the National Institute of Aging of the National Institutes of Health in the field of neuroinflammation. The $750,000 award will support the continued collaborative research development between Encore and researchers at the Oklahoma Medical Research Foundation in Oklahoma City for a lead drug candidate in amyotrophic lateral sclerosis and Huntington's disease.
Genomatix Corp., of Roanoke, Va., said it changed its name to Intrexon Corp. for strategic purposes. Derived from the terms "intron" and "exon," the new name is intended to encompass the key components of a primary gene transcript. Intrexon provides genetic tools for characterization and modulation of the bio-molecular interactions.
Gentium SpA, of Villa Guardia, Italy, said data showed that its two DNA-based drugs, Defibrotide and Oligotide, appear to protect human endothelial cells from chemotherapy-induced activation, transendothelial migration and apoptotic damage. The drugs also might eliminate the increased allogenicity of cytotoxic T cells. Defibrotide received fast-track and orphan drug status in the U.S., and is being evaluated as a treatment for veno-occlusive disease with multiple organ failure. Study results were presented at the annual Congress of the International Society on Thrombosis and Hemostasis in Sydney, Australia.
Human Genome Sciences Inc., of Rockville, Md., closed its private placement of $230 million principal amount of 2.25 percent convertible subordinated notes due 2012. The company intends to use all of the net proceeds to repurchase, from time to time, its 5 percent convertible subordinated notes due 2007.
McGill University Health Center in Montreal said its scientists, in a collaboration with the Institut de Recherches Cliniques, also in Montreal, identified 153 genes that respond to estrogen, and one gene in particular that can be used to halt the growth of breast cancer cells. The study was published in Tuesday's Proceedings of the National Academy of Sciences.
Memory Pharmaceuticals Corp., of Montvale, N.J., saw its stock fall 20 percent following the release of its second-quarter earnings Tuesday. The company posted a net loss of $8.4 million, or 40 cents per share, for the three months ending June 30, compared to a loss of $5.9 million, or 29 cents per share, for the same period in 2004. Its cash, cash equivalents and marketable securities totaled $25.2 million. Shares of Memory (NASDAQ:MEMY) closed at $2.65 Tuesday, down 72 cents.
Millipore Corp., of Billerica, Mass., completed the acquisition of more than 90 percent of the shares of NovAseptic AB, of Gothenburg, Sweden, from the company's majority shareholders. Millipore said it is in the process of acquiring the remaining shares from the minority stockholders. NovAseptic provides a range of solutions for aseptic processing applications in manufacturing operations.
New Leaf Venture Partners (NLV Partners), of New York and Menlo Park, Calif., closed a $310 million venture capital fund dedicated to health care technologies. The company will invest primarily in firms focused on clinical stage biopharmaceutical products, early stage medical devices and molecular diagnostics. NLV Partners initiated operations in July under the former managers of Sprout Group's Healthcare Technology venture team. In addition, the NLV Partners team will continue to manage the existing $800 million health care technology portfolio of Sprout Group.
New River Pharmaceuticals Inc., of Radford, Va., said it reprioritized its lead preclinical candidates to position NRP369 as a backup to NRP290 for the acute pain market, placing its recently in-licensed drug NRP388 at the front of its preclinical line-up. Data suggested that NRP388 could reduce the opioid tolerance effect on patients who are administered opioids over long periods, and New River expects to file an investigational new drug application on an intravenous formulation late this year or early next year. The company has recently started clinical trials of NRP290.
Novavax Inc., of Malvern, Pa., said Rahul Singhvi was appointed president and CEO, effective Tuesday. He also was elected a director. Singhvi's appointment follows the decision of Nelson Sims to retire immediately from his position as president, CEO and director. Novavax is a specialty biopharmaceutical company focused on products using drug delivery and biological technologies for large and growing markets. It markets Estrasorb, its topical emulsion estrogen therapy.
OncoGenex Technologies Inc., of Vancouver, British Columbia, said the first patients have been treated in a Phase II trial evaluating OGX-011 in combination with gemcitabine and cisplatin in chemotherapy-na ve patients with advanced non-small-cell lung cancer. OGX-011 is a second-generation antisense drug designed to specifically inhibit the production of clusterin, a cell-survival protein that is up-regulated in response to standard cancer treatments and has been found to induce drug resistance. OncoGenex is developing this compound in collaboration with Carlsbad, Calif.-based Isis Pharmaceuticals Inc.
Orion Genomics LLC, of St. Louis, initiated several collaborations with researchers at Washington University in St. Louis to discover biomarkers for the development of tests that screen for cancer at an early stage and provide information about how tumors should be treated. Scientists will focus on the most common cancers and will look for "Second Code" biomarkers that indicate the presence of cancer and how it will respond to certain therapies.
Osteotech Inc., of Eatontown, N.J., completed a $16.5 million sale and leaseback transaction on the land and building in Eatontown that serves as the company's processing facility for allograft tissue. Osteotech used a portion of the proceeds to pay off its outstanding debt of about $11 million, and plans to use the rest for general working capital purposes.
Power3 Medical Products Inc., of The Woodlands, Texas, obtained the exclusive worldwide license to patents and technologies for early detection screening tests, identified protein biomarkers and drug targets for cancer patients' resistance to drug therapy. The technology was developed through joint collaboration between the scientific team of Power3 Medical and The University of Texas M.D. Anderson Cancer Center.
Pressure BioSciences Inc., of West Bridgewater, Mass., said it sold an aggregate of 232,792 shares of VI Technologies Inc. (Vitex), also of Watertown, Mass., for which it received about $1.8 million in proceeds. Pressure BioSciences continues to hold about 627,199 shares of Vitex and could receive 152,938 additional shares that are being held in escrow until September 2006, per the terms of the March 2005 merger between Vitex and Panacos Pharmaceuticals Inc., of Gaithersburg, Md. (See BioWorld Today, March 11, 2005.)
Prima Biomed Ltd., of Melbourne, Australia, and the Austin Research Institute agreed in principle on a process enabling Prima to gain full ownership of its four subsidiary companies, Oncomab Pty. Ltd., Panvax Ltd., Cancer Vac Pty. Ltd., and Arthron Pty. Ltd. Prima is expected to acquire the holdings in exchange for about 15 million ordinary shares. The agreement also provides for ARI and Prima to continue their commercial collaborative relationship, and arrangements are being finalized for Prima to keep reviewing technologies arising from ARI, other than xenotransplantation, for possible commercial opportunities.
Progen Industries Ltd., of Brisbane, Australia, reported the expansion of the Phase II trial program of its lead anticancer product, PI-88, into prostate cancer. The first patients will begin treatment this week. The new trial, where PI-88 will be combined with the chemotherapy agent Taxotere, will assess the efficacy and safety of PI-88 in 82 patients with androgen-independent prostate cancer.
Reaction Biology Corp., of Malvern, Pa., received a Phase II Small Business Innovation Research grant from the National Institutes of Health to apply its DiscoveryDot High Throughput Screening technology for drug discovery. The $750,000 grant supports the use of the company's microarray technology for screening caspases and other proteases.
Rigel Pharmaceuticals Inc., of South San Francisco, enrolled the first patient in a comparative Phase II study of R112, an intranasal therapy to treat allergic rhinitis. R112 inhibits mast cell activation and blocks the major pathways triggered in an allergic attack. The trial, which will enroll about 375 patients, will compare R112 to placebo and Beconase AQ (beclomethasone) nasal spray over a seven-day period.
Sanguine Corp., of Pasadena, Calif., filed for additional patent coverage detailing the specific formulation for PHER-02. While the company's president and CEO, Thomas Drees, has received an approved patent for the use of a perfluorodecalin, a key component of PHER-02, for use as a blood substitute, the patent recently filed incorporates additional critical materials used to formulate the product, as well as language depicting PHER-02 as an oxygen carrier for use as a red blood cell enhancer and a transportation medium for diabetic islet cell transplantation.
Senetek plc, of Napa, Calif., which is focused on products for the anti-aging market worldwide, signed a new agreement with its marketing partner, Valeant Pharmaceuticals International. Valeant will receive expanded distribution rights for Kinetin, which it now markets under the brand Kinerase and exclusive worldwide manufacturing and marketing rights to Zeatin. In exchange for those grants, Senetek will receive minimum guaranteed annual royalty payments in the amounts of $6 million in 2006, $7 million in 2007 and $8 million each in 2008, 2009 and 2010 before existing credits plus the potential for additional royalties.
U.S. BioDefense Inc., of City of Industry, Calif., said its option agreement to license European and U.S. patents relating the use of liver cell progenitor to treat liver disease was terminated by UCL BioMedica plc, a subsidiary of University College of London, allegedly due to partial non-payment. U.S. BioDefense is disputing the allegation, claiming that no partial payment schedules have been set since negotiations for the full license have been ongoing for the past few months.
Velcura Therapeutics Inc., of Ann Arbor, Mich., entered an agreement with Japanese company Nippon Chemiphar Co. Ltd. to develop small-molecule therapies for osteoporosis and other bone diseases. The deal calls for Nippon Chemiphar's expertise in drug discovery to be used with Velcura's process for growing human bone in tissue culture. The companies also said they have discovered their first lead compound, which was shown to be effective in animal models. Velcura plans to start clinical trials on this drug in 2006.
Xenogen Corp., of Alameda, Calif., secured two lines of credit totaling up to $18 million, subject to borrowing base calculations and other terms and conditions. The credit facilities are being provided by Silicon Valley Bank and Partners for Growth. The new line of credit with the bank restructured Xenogen's original loan facility with Silicon, and all borrowings outstanding under the original loan facility were rolled into the new secured line of credit. Xenogen combines systems biology and low-light optical imaging to create new biophotonic imaging technology.