• Amarin Corp. plc, of London, said it received a Nasdaq deficiency letter indicating it was not in compliance with the minimum bid price requirement for continued listing. Amarin will be provided with 180 calendar days, until Dec. 3, to regain compliance, which would be achieved by its American depositary shares closing at $1 or more for at least 10 consecutive business days.
• Antisoma plc, of London, said it received the first scheduled payment of $75 million from Novartis AG, of Basel, Switzerland, under the licensing agreement for ASA404, announced in April. The payment was triggered by completion of the licensing agreement following notification of compliance with the provisions of the Hart-Scott-Rodino Antitrust Improvements Act of 1976. ASA404 is a small-molecule vascular disrupting agent discovered at the University of Auckland, New Zealand. It has shown a survival benefit in patients with non-small-cell lung cancer when added to paclitaxel-based chemotherapy in a randomised phase II study.
• Archimedes Pharma Ltd., of Reading, UK, released new data from a Phase II study of Nasalfent, a fentanyl citrate nasal spray aimed at providing fast relief for breakthrough cancer pain, showing it gives significant, clinically meaningful levels of pain relief and a reduction in pain intensity within five minutes of dosing. A Phase III trial of the product is under way.
• Ardana plc, of Edinburgh, UK, said the Scottish Medicines Consortium gave a positive opinion on Emselex (darifenacin hydrobromide), a once-per-day oral treatment for the symptoms of overactive bladder. The product was launched in October of last year and is marketed in collaboration with Novartis Pharmaceuticals UK Ltd., a division of Novartis AG, of Basel, Switzerland. Emselex works by selectively inhibiting the muscarinic M3 receptor, the primary mediator of detrusor muscle contraction.
• BioLineRx Ltd., of Jerusalem, launched a new initiative to provide funding for early stage research and development of innovative therapeutics that have not yet achieved in vivo proof of concept. Called the Early Development Program (EDP), it is funded by a $6 million grant from Pan Atlantic Bank and Trust Ltd. and BioLineRx. The Pan Atlantic grant for the EDP is in addition to $9 million it invested in BioLineRx earlier this year.
• Blue Blood Biotech Corp., of Taiwan, and ProMetic BioTherapeutics Inc., of Montreal, have formed an alliance to develop drugs derived from human plasma using ProMetic's proprietary manufacturing process. The partnership initially will target hyperimmune Cytomegalovirus, as well as two other high value therapeutics, with Taiwan and Southeast Asia as the primary markets, creating what the companies say is an opportunity exceeding C$50 million in annual sales. Financial terms were not disclosed. ProMetic's manufacturing process enables the extraction of key therapeutic proteins from plasma. Each protein is removed from plasma by a specific ProMetic Mimetic Ligand adsorbent and subsequently purified in a side stream. The removal sequence has been optimized to give exceptionally high protein recoveries at unprecedented activity levels.
• Cardio3 BioSciences, of Braine l'Alleud, Belgium, and the Mayo Clinic in Rochester, Minn., entered a collaboration related to the licensing of Mayo Clinic research, know-how and intellectual property in the field of cardiac commitment of stem cells. That research has focused on the guided commitment of adult as well as embryonic stem cells. The scope of the license covers heart failure of ischemic and non-ischemic origin. Cardio3 plans to enter immediately into the last phase of preclinical work and move the program into human testing as early as the second quarter of 2008.
• Cellectis SA, of Paris, was granted a European patent covering the use of homologous recombination processes in eukaryotes. The patent covers a "method for activating expression, or improving the level of expression, of a gene," and it brings to 65 the total number of Cellectis' patents and patent applications. Cellectis has an exclusive license for the technology concerned from the Institut Pasteur in Paris.
• Crucell NV, of Leiden, the Netherlands, and Royal DSM NV, of Sittard, the Netherlands, entered a nonexclusive PER.C6 research licensing deal with Sartorius Biotech GmbH, of Goettingen, Germany. Sartorius will use Crucell's technology to evaluate monoclonal antibodies produced using PER.C6 cells for calibrating and testing equipment products useful in the manufacture and/or purification of recombinant monoclonal antibodies. Crucell and Sartorius further agreed to expand their PER.C6 collaboration by sharing technology and data on antibody production. Financial terms were not disclosed.
• Eurand NV, of Milan, Italy, is receiving a $1 million milestone payment from partner GlaxoSmithKline plc, of London, which started a registration bioequivalence study for a new orally disintegrating tablet formulation of an undisclosed compound. It dissolves in the mouth in about 30 seconds without water and without leaving a bitter or sour taste. GSK plans to file for FDA approval by the end of this year.
• Exact Sciences Corp., of Marlborough, Mass., and NorDiag ASA, of Oslo, Norway, entered an agreement to advance the development and commercialization of colorectal cancer screening technologies outside the U.S. and Canada. Exact extended a nonexclusive license to its DIA (long-DNA) technology and related know-how to NorDiag for commercializing such tests in Europe, Japan and Australia. The collaboration and license also include the right to develop an in vitro diagnostic test kit for those markets. In exchange, NorDiag will pay a licensing fee and royalties, though specific financial terms were not disclosed.
• Geneart AG, of Regensburg, Germany, said its board of directors and advisory board plan to suggest a 1:1 stock increase from company funds at the shareholders' meeting July 24. Each Geneart shareholder would receive one additional share for each share held. The capital increase from company funds doubles the company's share capital without an infusion of new shareholders' equity, and also doubles the number of company shares. After the increase, each ordinary share will retain its value of €1. The company said the goal is to boost market liquidity of the shares and make them more attractive to a broader circle of investors. If approved, the new shares are expected to be issued in September.
• Ipsen SA, of Paris, announced that preliminary data from the phase III study for its investigational four-month formulation of triptorelin do not support the expected sustainable blood levels of triptorelin in all patients, and the company has decided not to perform the second administration in the protocol. No safety concerns have been observed throughout the trial. At the end of their respective monitoring period, patients will be switched to appropriate approved treatment. The investigational product, one of Ipsen's new sustained-release formulation candidates of triptorelin, has shown an adequate efficacy and safety profile in phase II allowing a move to phase III. Ipsen said its goal remains to have a new formulation of triptorelin available when the current patents of the three-month formulation of Decapeptyl expire.
• Medical Solutions plc, of Nottingham, UK, conditionally agreed to acquire all of Geneservice Ltd., of Cambridge, UK, for £3.86 million (US$5.2 million) payable in cash and loan notes. Geneservice, which was formed through a management buyout of the UK Medical Research Council's sequencing facility, has about 35 employees and provides genomics products and services. Medical Solutions specializes in histopathology and cytology products and services. The deal is contingent on Medical Solutions stockholder approval.
• Movetis, of Turhhout, Belgian, which was spun out from Janssen Pharmaceutica, of Titusville, N.J., last December, and which specializes in treatments for gastrointestinal disorders, has started a Phase IIa multidose trial with M0002, an orally active selective vasopressin antagonist that inhibits water reabsorption from the kidneys. Its clinical pipeline also includes Resolor, which has completed phase III for the treatment of chronic constipation.
• Mymetics Corp., of Nyon, Switzerland, reported its HIV vaccine elicited neutralizing IgA mucosal antibodies in a non-human primate model. Findings showed that more than 90 percent of primates vaccinated with virosomes expressing the HIV-1 gp41 peptide produced mucosal IgA antibodies in the genital and intestinal compartments, and those mucosal antibodies were capable of preventing HIV transcytosis, a process by which HIV crosses the membrane epithelium of the mucosa, by 60 to 90 percent. Mucosal IgA produced against the HIV gp41 protein after vaccination was determined to be as good or better than the best anti-HIV neutralizing monoclonal antibodies on the market, when comparing the amount of antibodies required for neutralizing 50 percent of the viruses.
• Pacific Edge Biotechnology Ltd., of Dunedin, New Zealand, is working with the Ludwig Institute's Centre for Clinical Sciences in Melbourne, Australia, to complete the development of a prognostic tool for the segregation of patients with invasive melanoma. The collaboration aims to overcome the difficulty in identifying patients with aggressive disease by developing a gene expression profile that is able to distinguish between patients with good and bad outcomes. So far, the team has determined a 15-gene expression signature that has a predictive accuracy of about 90 percent, and it has filed a provisional patent. Further validation studies on independent samples are expected to be completed in the third quarter.
• Polyplus-transfection, of Strasbourg, France, which specializes in the development and marketing of reagents for drug delivery, gene therapy and transfection, has set up a user group called the "Polyplus in vivo consortium." Polyplus-transfection hopes that creating this international network of research scientists and clinicians who use its synthetic gene transfer reagents will boost the number of clinical trials in which its reagents are used and thus accelerate their development. Polyplus-transfection has developed a compound called jetPEI that allows intracellular delivery of nucleic acids and is widely used for in vivo experiments. In vivo-jetPEI is derived from the synthetic molecule polyethylenimine (PEI), for which the company holds an exclusive worldwide license for the transfection of nucleic acids.