• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix group has made available to researchers a new CustomArray Human Drug Metabolism Array. The array is designed to enable researchers to screen a panel of genes and splice variants known to be critical for the pharmokinetics and metabolism for both established and new drugs.

• Adventrx Pharmaceuticals Inc., of San Diego, began patient recruitment at European sites as an extension of its Phase II trial of CoFactor for metastatic colorectal cancer. The open-label, single-arm study, which is under way at four U.S. sites, is designed to assess CoFactor in patients with metastatic colorectal cancer not previously treated or in those who have relapsed from previous 5-FU/leucovorin therapy. CoFactor is a biomodulator of 5-FU.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, completed its purchase of about 5.7 million common shares of specialty orthopedics company Orthovita Inc., of Malvern, Pa., for $25 million. The equity investment was originally announced in June. Orthovita develops and markets synthetic biomaterials for use in fracture repair and orthopedic trauma, spine surgery including spinal fusion, repair of osteoporosis-related fractures of the spine and other orthopedic applications.

• Aqua Bounty Technologies Inc., of Waltham, Mass., and Recalcine Farmaceutica SA, of Santiago, Chile, entered an agreement to develop, manufacture and market a range of aquatic veterinary vaccines, antimicrobial agents and diagnostic products targeted to infective species and strains specific to South America. In the process, the companies will create several regional diagnostic centers in shrimp and salmon farming areas to target shrimp and salmon diseases characteristic of the Southern hemisphere.

• Ascend Therapeutics Inc., of Herndon, Va., secured exclusive North American development, marketing and commercialization rights to a developmental hypogonadism product called Andrin (transdermal dihydrotestosterone gel), from Besins International Holdings. The company incorporated dihydrotestosterone into its Enhanced Hydroalcoholic Gel (EHG) technology to create Andrin, which is being evaluated in clinical trials for symptoms associated with low testosterone levels in older men.

• Astralis Ltd., of Fairfield, N.J., said the SEC declared effective its registration statement covering about 47.1 million shares of common stock (of which about 11.4 million are issuable upon exercise of warrants) for the resale of such shares from time to time by selling stockholders. The company will not receive any proceeds from the sale of shares by the selling stockholders. However, if the warrants are exercised for cash, the company would receive the exercise proceeds. Astralis focuses on treatments for immune system disorders and skin diseases.

• Biogen Idec Inc., of Cambridge, Mass., opened its new international headquarters in Zug, Switzerland, where the company will have access to a cluster of biotechnology expertise. The Zug offices will be staffed with 50 employees by the end of the year and will oversee operations in 16 countries, as well as a worldwide distribution network covering 79 markets. The headquarters will play a role in ongoing efforts to grow and expand the company's global operations, including the development of Antegren (natlizumab). Biogen Idec also is restarting construction of its large-scale biologic manufacturing facility in Hillerod, Denmark, investing $340 million. It should be available for commercial production in 2008, Biogen said.

• Bionomics Ltd., of Adelaide, Australia, entered a research collaboration focused on its animal model of epilepsy with the University of Wisconsin Medical School. The mouse model exhibits epileptic seizures similar to those found in humans. The Wisconsin research collaboration is funded by a five-year, $1.7 million grant from the National Institutes of Health. Bionomics will provide the university with the animal model, and gain access to new data and other intellectual property that result from the research.

• BioTime Inc., of Berkeley, Calif., said its South Korean licensing partner CJ Corp. received regulatory approval from the Korea Food and Drug Administration for Hextend, BioTime's blood plasma volume expander. BioTime received a $300,000 license fee from CJ, which now will seek Korean National Health Insurance pricing. Following that six-month process, it can begin marketing Hextend. BioTime will receive a royalty on Hextend sales.

• Biovitrum AB, of Stockholm, Sweden, and Artemis Pharmaceuticals GmbH, of Cologne, Germany, signed a research services agreement concerning the generation of RNAi-modified transgenic mice for the in vivo functional analysis of selected disease-related genes. Artemis will generate shRNAi knock-down transgenic mice that Biovitrum will use in certain pharmaceutical research programs. Biovitrum will provide selected shRNA sequences that correspond to genes that may play a central role in human diseases. Artemis will use its technologies to functionally down-regulate expression of targeted proteins.

• Cell Therapeutics Inc., of Seattle, said the Gynecologic Oncology Group (GOG) submitted an investigational new drug application to the FDA, including a special protocol assessment package, for a pivotal trial examining the ability of Xyotax to maintain remission and prolong the survival of ovarian cancer patients. In March, the GOG, which is a National Cancer Institute-sponsored research group of more than 250 institutions, entered a clinical trials agreement with the company to sponsor and conduct the study. The GOG plans to begin the trial later this year, and expects to enroll about 1,550 patients over 18 to 24 months.

• Cellegy Pharmaceuticals Inc., of South San Francisco, said a UK regulatory committee would recommend approval for Cellegesic (branded Rectogesic outside the U.S.) upon receipt of satisfactory responses to minor patient information and packaging specification issues. The company expects formal approval within the next several months, and upon approval, Rectogesic (nitroglycerin ointment) will be indicated for pain associated with chronic anal fissures. The UK's regulatory agency also agreed to act as a reference member state for regulatory filings of the product in other European Community member states, a process that generally takes about six to nine months from the time formal approval is granted. Last week, Cellegy resubmitted its new drug application for Cellegesic to the FDA. (See BioWorld Today, July 1, 2004.)

• Chiron Corp., of Emeryville, Calif., received a license for its new meningococcal B vaccine for New Zealand, MeNZB. Chiron developed the vaccine in collaboration with the New Zealand Ministry of Health and the Norwegian Institute of Public Health to protect against the specific meningococcal B strain responsible for a 13-year epidemic in the country. The parties signed the agreement in 2001, and Chiron has supplied vaccine for clinical studies conducted by the Ministry of Health and the University of Auckland.

• Corautus Genetics Inc., of Atlanta, raised about $9.8 million in a private placement of common stock. The first tranche of about $4.9 million has closed, while the second tranche of the same amount was placed in escrow. It will close upon treatment of the first patient in an upcoming Phase IIb trial for severe cardiovascular disease. The common shares in both tranches priced at $5.22 apiece, which equates to 90 percent of the average closing price during the 13 trading days prior to executing the definitive agreement. At the closing of each tranche, purchasers also will obtain warrants to purchase 235,869 additional shares with an exercise price equal to 120 percent of the closing price on the day prior to closing that tranche.

• CoTherix Inc., of South San Francisco, said Scott Harkonen resigned as CEO and as a member of the board to pursue other interests. The cardiopulmonary drug development firm, which is using an executive search firm to recruit a new CEO, will be led in the interim by Donald Santel, its president and chief operating officer.

• Crucell NV, of Leiden, the Netherlands, and contract manufacturer DSM Biologics, of Groningen, the Netherlands, achieved the first development milestone in their protein production collaboration. The alliance signed in December 2002 combines DSM's manufacturing capacity and production expertise with Crucell's PER.C6 cell line technology. The companies have secured 10 licensees to date and have been working on a development program that has demonstrated industry-high yields in Fed-batch and perfusion. DSM made an undisclosed milestone payment to Crucell.

• DOV Pharmaceutical Inc., of Hackensack, N.J., reached an agreement with the FDA's Cardio-Renal Division on the scope and design of clinical trials required for submission of a new drug application for DOV diltiazem, a calcium channel blocker to treat angina and hypertension. The FDA agreed that no additional preclinical or toxicology studies would be required for the NDA submission. DOV believes it can complete clinical studies necessary for filing the NDA in 2005.

• Elan Corp. plc, of Dublin, Ireland, completed the sale of its worldwide rights to Myobloc/Neurobloc (botulinum toxin Type B) injectable solution to the new company Solstice Neurosciences Inc. The sale includes related intellectual property, product inventory and the manufacturing facility. Employees will be offered the opportunity to continue work with Solstice. Financial terms were not disclosed. Myobloc was developed by Elan and is approved in the U.S., Canada and Europe for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain.

• Geron Corp., of Menlo Park, Calif., granted a nonexclusive license to Procter & Gamble Co., of Cincinnati, relating to Geron's human telomerase reverse transcriptase technology for research applications. Procter & Gamble will use hTERT to create immortalized cell lines from specified types of skin cells. It plans to use the immortalized cells to study the regulation of cell function and develop biological assays for screening purposes. Financial terms were not disclosed.

• Hemispherx Biopharma Inc., of Philadelphia, said its partner, Laboratories Del Dr. Esteve SA, of Barcelona, Spain, received import authorization for Ampligen to conduct a clinical trial in patients co-infected with hepatitis C and HIV viruses. Hemispherx shipped the total amount of vials of Ampligen required for the trial to Esteve, which agreed to conduct, at its expense, clinical trials using Ampligen in that patient population as part of a 2002 agreement. In exchange, Esteve gained exclusive rights to market Ampligen in Spain, Portugal and Andorra for chronic fatigue syndrome.

• Immunomedics Inc., of Morris Plains, N.J., said it settled a patent with CIS bio international, a French unit of Schering AG, of Berlin. The issues arose from past sales of in vitro products in relation to Immunomedics' carcinoembryonic antigen patents, which cover antibodies that specifically recognize carcinoembryonic antigen. Terms of the settlement call for CIS bio to pay an undisclosed sum for its past sales of the products.

• Isotechnika Inc., of Edmonton, Alberta, received permission from the FDA to commence a Phase Ib trial for TAFA-93. TAFA-93 is a novel prodrug of the mTOR inhibitor rapamycin, designed to reduce the unfavorable pharmacokinetics and side effects of rapamycin. TAFA-93 has the potential to be administered as a complementary therapy along with ISA247 in the prevention of organ rejection after transplantation, Isotechnika said. A Canadian Phase Ia trial for TAFA-93 is ongoing in Montreal.

• Jerini AG, of Berlin, said the FDA granted orphan drug status to Icatibant, the company's bradykinin receptor antagonist for the treatment of edema in severe burn patients. Edema is a complication in burn patients with more than 20 percent of skin having second- and third-degree burns. Jerini plans to initiate Phase II trials for Icatibant in patients with severe burn injuries in 2005.

• KetoCytonyx Inc., of West Conshohocken, Pa., said a Phase I study began on KTX 0101 in preventing cognitive impairment in patients undergoing coronary artery bypass graft surgery. The study will enroll up to 20 volunteers who will receive an intravenous infusion of KTX 0101 in a dose-escalation design up to the maximum dose of 300 mg/kg, to be infused intravenously over 24 hours. KTX 0101 (sodium beta-hydroxybutyrate) is one of a series of ketone bodies, which are components of normal metabolic pathways.

The Mayo Clinic in Rochester, Minn., said preclinical findings published in the July 2004 issue of Nature Genetics point to its researchers' discovery of a gene responsible for the onset of aging, including age-related disorders such as infertility, reproductive problems and cataracts. Specifically, they found that a gene called BubR1 governs production of a protein that modulates physical aging. Mice in the study lacked normal levels of that protein and began to age prematurely.

• MWG Biotech AG, of Ebersberg, Germany, said it will engage in the worldwide distribution of the ExpressArt product line of mRNA amplification kits (excluding Great Britain, Japan and Switzerland), starting in September. Kits for the amplification of bacterial mRNA, for severely degraded RNAs from difficult samples, and from paraffin-embedded tissues will be launched before the end of 2004. The ExpressArt product line is based on a technology by artus GmbH, of Hamburg, Germany.

The National Institute of Genetics, also known as Idenken, and Fujitsu Ltd., of Tokyo, agreed to collaborate on developing a next-generation database system. Idenken and Fujitsu plan to develop the world's fastest database system and position it as the de-facto standard for the field. The system will be based on Fujitsu's Interstage Shunsaku Data Manager Enterprise Edition XML database engine. The prototype is to be installed at Idenken's Center for Information Biology and DNA Data Bank of Japan, and is expected to be unveiled by the end of the year.

• Neurochem Inc., of Montreal, said Fibrillex was selected by the Cardio-Renal Drug Product Division of the FDA to be part of the Continuous Marketing Applications Pilot 2 program aimed at accelerating the development and eventual marketing of the product. Fibrillex is a fast-track product to treat amyloid A amyloidosis. It is currently in an ongoing Phase II/III trial, which should be completed by January 2005.

• Neuromed Technologies Inc., of Vancouver, British Columbia, appointed Christopher Gallen president and CEO and a member of the company's board. Gallen was most recently vice president and chief of operations, clinical research and development at Wyeth Research. Neuromed is developing chronic pain drugs with pipeline programs in anxiety, epilepsy and cardiovascular disease.

• Orion Genomics LLC, of St. Louis, and ViaLactia Biosciences Ltd., of Auckland, New Zealand, said they would provide sequence data to characterize the gene sequence of ryegrass to Cold Spring Harbor Laboratory researchers in New York. The data stem from a 2001 research alliance. Cold Spring Harbor researchers will use the data to annotate publicly available plant sequences with the aim of improving forage and cereal crops for greater nutritive value and higher yield. Results will be made available through the Gramene database.

• Osiris Therapeutics Inc., of Baltimore, appointed Randal Mills president and CEO, effective July 5. Mills also was elected to the board. He was a founding member of Regeneration Technologies Inc. and served in several leadership positions. Osiris Therapeutics is focused on stem cell therapy.

• Paratek Pharmaceuticals Inc., of Boston, initiated the next phase of the company's program to develop tetracycline-derived antimalarial therapeutics for treatment and prophylaxis of malaria. Under a Phase II Small Business Innovative Research grant, Paratek will receive about $1 million for each of two years to develop oral agents against Plasmodium falciparum.

• Penwest Pharmaceuticals Co., of Danbury, Conn., said Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., reached agreement with the FDA on the design of a new clinical trial for oxymorphone extended-release tablets to support a new drug application. Endo and Penwest jointly developed oxymorphone ER. Endo submitted the trial protocol under the special protocol assessment process and plans to soon initiate a 12-week, multicenter, double-blind, placebo-controlled trial. In October, the FDA issued an approvable letter for Endo's oxymorphone ER NDA, but it requested an additional trial to confirm the safety and efficacy. Oxymorphone ER is an oral opioid analgesic for treating moderate to severe pain in patients requiring continuous opioid therapy.

• Pharmos Corp., of Iselin, N.J., said it has been added to the Russell 2000 Index, a subset of the Russell 3000 Index. The Russell 3000 comprises 3,000 of the largest U.S. companies based primarily on market capitalization and style attributes. Pharmos discovers, develops and commercializes therapeutics to treat a range of indications, in particular neurological and inflammation-based disorders.

• Prometic Life Sciences Inc., of Montreal, said its subsidiary Prometic BioSciences Ltd. signed a contract with GlaxoSmithKline plc, of London, to provide access to Prometic's purification technology. Prometic will develop affinity materials and purification process steps for the isolation and purification of therapeutic proteins of interest to GSK. Financial terms were not disclosed.

• QRxPharma Pty. Ltd., of Winchester, Mass., said the Australian Research Council recently awarded QRx and the University of Queensland in Brisbane, Australia, a $3.2 million ARC Linkage Discovery grant. That total reflects all cash, direct and indirect contributions made by all parties. The new grant builds on the previously established collaboration between QRx and the University of Queensland for the identification of pharmaceutically active compounds through a systematic study of the venoms of Australian snakes.

• SurroMed Inc., of Menlo Park, Calif., extended and expanded the previously unannounced agreement for biological marker discovery with Merck & Co. Inc., of Whitehouse Station, N.J. SurroMed will analyze preclinical samples provided by Merck in SurroMed's biomarker discovery laboratory using its integrated platform for proteomic analysis. SurroMed will analyze and mine bioanalytic data using its suite of informatics tools to identify candidate biological markers. Financial terms were not disclosed.

• Theratechnologies Inc., of Montreal, said its minority-owned subsidiary Celmed BioSciences Inc. completed the acquisition of NewBiotics Inc., of San Diego. The all-share transaction resulted in a reduction of Theratechnologies' ownership in Celmed from 59.7 percent to 42 percent. Spun off by Theratechnologies in 2001, Celmed develops photodynamic-based therapies to treat hematological and immune diseases using its Theralux technology. The deal was reported last month as part of a restructuring at Theratechnologies. (See BioWorld Today, June 9, 2004.)

• Xenova Group plc, of Slough, UK, began patient dosing in a Phase III trial of TransMID to treat progressive or recurrent non-operable glioblastoma multiforme. The randomized, open-label, multicenter trial will enroll up to 323 patients who have failed conventional therapy. It will compare TransMID against a number of chemotherapeutic agents. In May, Xenova and the FDA reached agreement under the special protocol assessment procedure for the revised Phase III trial program for TransMID.

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