BioInItaly Newsletter

La vetrina del biotech italiano all’estero

BioInItaly nr. 7 - 2012

03 lug, 2012

The European Patent Office grants MolMed a new patent on its anticancer drug NGR-hTNF

MolMed S.p.A. (MLM.MI) announced that it received the official notification from the European Patent Office of the decision to grant a patent covering the therapeutic use of its investigational anticancer drug NGR-hTNF for the treatment of mesothelioma, a pleural cancer caused by exposure to asbestos. The grant will take effect on 4 July 2012, when it will be published in the European Patent Bulletin. NGR-hTNF is currently being investigated in the only ongoing Phase III trial for relapsed mesothelioma, as well as in a randomised Phase II trial as first line maintenance therapy for mesothelioma patients who completed the standard chemotherapy.
This new European patent on NGR-hTNF (EP2285416) becomes part of a large proprietary patent family which comprises 11 additional patent applications filed in the most important pharmaceutical markets, including the United States, Japan, Canada, Australia and China. The patent will afford protection until 2029 with the possibility of term extension, and will give right to market exclusivity in 38 European countries, including the European Union member states, Eastern Europe countries, Switzerland and Turkey.
This patent will further strengthen the intellectual property position on NGR-hTNF, consisting of seven patent families, which, with the grant of this patent, will include 116 granted patents and 28 pending applications. The patent portfolio relevant to NGR-hTNF covers in particular the following elements: product, targeting technology, synergistic combinations with other anticancer drugs, effective compositions, therapeutic uses and the specific treatment of mesothelioma.
The pivotal Phase III trial (NGR015) for the treatment of relapsed malignant pleural mesothelioma is ongoing in 35 participating centres in Europe (Italy, the UK, Ireland, Poland and Belgium), the US, Canada and Egypt. To date, more than 200 patients have been enrolled on a planned trial population of 390 patients. The trial is expected to include more than 40 centres worldwide, with primary data analysis expected in 2013. MolMed presented at ASCO 2012 long-term follow up data of a completed Phase II trial in mesothelioma: the 3-year follow-up results on 57 patients in relapse, receiving NGR-hTNF given either every three weeks or once a week, show that the survival rates for patients receiving the dose-dense schedule are five-fold higher. These results provide an important indication for the optimal treatment schedule together with a clear signal of antitumor activity.

Cell Therapeutics Completes Acquisition of Pacritinib a Highly Selective JAK2 Inhibitor

Cell Therapeutics, Inc. (“CTI”) (NASDAQ and MTA: CTIC), announced that it has completed its acquisition gaining world-wide rights to S*BIO Pte Ltd.’s (“S*BIO”) pacritinib. Pacritinib is a highly selective oral JAK2 (Janus Associated Kinase 2) inhibitor that demonstrated encouraging clinical activity in phase 1 and 2 clinical studies of patients with primary myelofibrosis (“MF”) and MF secondary to other myeloproliferative neoplasms (“MPN”). Pacritinib has orphan drug designation in the United States and Europe for myelofibrosis.
S*BIO is a privately held biotechnology company focused on the research and clinical development of novel targeted small molecule drugs for the treatment of cancer.
Under the terms of the asset purchase agreement between CTI and S*BIO, CTI made an upfront payment of $2 million in cash at signing. At closing, CTI made a final payment of $13 million in cash, along with 15,000 unregistered shares of preferred stock convertible into common stock of CTI. The asset purchase agreement also includes regulatory success- and sales-based milestone payments, as well as single digit royalties on net sales. CTI will be solely responsible for development and commercialization activities of pacritinib worldwide.

Mediapharma established in Chieti

MediaPharma is an Italian Biopharmaceutical Company focussed on the discovery, development and marketing of Monoclonal Antibodies for cancer treatment.
In particular, MediaPharma’s mission is to develop drugs along with a companion diagnostic test, thus offering the unique advantages of a faster development of personalized treatments.
Established as a “spin-off” of the “G. d'Annunzio“ University of Chieti-Pescara, Italy has as industrial partner Abiogen Pharma, Pisa, Italy and operates in a highly translational research environment (5 employees  of which 4 in R&D), including Phase I facilities. The Management Team includes an international board of investigators with long standing experience and successful collaboration with industry, company start-up and generation of profit.                              
Starting its activities in April 2009, has raised financing of 2.0 million euro both from public and privates investors. It owns the intellectual property of two monoclonal antibodies of potential clinical relevance for the treatment of several types of malignancies. Recently, have been chimerized ad humanized. The reagents have a limited number (2) of competitors on the pharmaceutical market. One of the antibodies, MP-RM-1, which is directed against the ErbB3 receptor, is likely to be in Phase I testing by Q3 2014, pending the cash flow which may become available soon.

NicOx signs worldwide licensing agreement with Rapid Pathogen Screening, Inc. for ophthalmic diagnostics

NicOx S.A. (NYSE Euronext Paris: COX) and Rapid Pathogen Screening, Inc (RPS®) announced that they have entered into a licensing agreement giving NicOx access to RPS®'s innovative diagnostic tests. The agreement grants NicOx worldwide rights to unique point-of-care tests in the ocular field. The first of these tests is AdenoPlus(TM), which is already authorized for marketing in the United States (US) and in Europe. These tests are based on RPS®'s proprietary technology and enable rapid and accurate in-office diagnosis of specific ocular diseases and conditions.
AdenoPlus(TM) is an easy-to-use point-of-care diagnostic test that identifies patients with Adenoviral conjunctivitis using a small tear sample. It provides a definitive result in only ten minutes, making the correct diagnosis available at the time of the doctor visit rather than relying on only signs and symptoms or waiting for results from a laboratory. AdenoPlus(TM), in addition to the US and Europe, is also authorized for marketing in other countries throughout the world. The agreement grants NicOx exclusive rights to commercialize AdenoPlus(TM) to eye care professionals in the US, as well as full exclusive rights to market AdenoPlus(TM) in the rest of the world. RPS® maintains rights to commercialize these ocular tests to primary and urgent care professionals in the US.
The worldwide licensing agreement also covers two additional diagnostic tests currently in development, one for the combined detection of Adenoviral and allergic conjunctivitis and the other to diagnose ocular herpes. In addition, the agreement grants NicOx an exclusive worldwide option to negotiate an agreement for an additional promising product, based on RPS® meeting certain milestones which include on-going external discussions.
NicOx has begun building its own commercial organization in the US and Europe to market AdenoPlus(TM) and potentially other ophthalmology products, both diagnostic and therapeutic, that it plans to acquire or in-license in the future. The Company expects to launch AdenoPlus(TM) in the US and in key European markets by the end of 2012.
Under the agreement, NicOx will pay RPS® a total of $4 million in license and option fees. The financial terms also include single-digit royalties and potential additional milestone payments of up to $2 million. NicOx will also pay half of the development costs for the two development-stage products, subject to an agreed budget.

Medi Service: signal detection

From July 2012 a new legislation for pharmacovigilance will apply in the European Union and will replace the current set in Volume 9A of the Rules Governing medicinal product in the EU, EMA/827661/2011, 20 February 2012.  This new guidance is organized into Modules (now available first seven Modules, I, II, V, VI, VII, VIII, IX ).  The Module IX is dedicated to Signal management, a process defined as  “the set of activities performed to determine whether there are new risks associated with an active substance or a medicinal product or whether risks have changed. The dataset is based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, literature information or other data sources”. The signal management process shall cover all steps from detecting signals (Signal Detection) through their validation, analysis and assessment to recommending action. Medi Service, an Italian CRO, developed a process by which identification of new safety signals for medicinal products is conducted periodically in the Pharmacovigilance and Risk Management Unit. This process is based on Reaction Monitoring Reports (RMRs) generated from a Global Safety Database. The aim of this statistical analysis methodology is to produce Periodical Reports where it is possible to observe and predict excess in the Adverse Event Drug Related Incidence Rates.  The Periodical Reports included a series of graphic evaluations (Statistical Signal Detection Graph) that allow to have an immediate perception of the real situation of the ADRs frequency for each geographical region and/or temporal function. The purpose of the Statistical Signal Detection Graph is to investigate retrospectively and to predict in the future if there will be relevant and significative increment in the trend of the ADRs Incidence Rates.

Toscana Biomarkers Coordinator of GAPAID project, ranked 12th in "Research for SMEs" call of the 7° Framework Programme

The "Genes And Proteins for Autoimmunity Diagnostics" (GAPAID) project, coordinated by Toscana Biomarkers Srl, achieved an outstanding recognition by the European Commission within the "Research for SMEs" 2012 call of the 7° Framework Programme, which received more than 830 submissions in last December: GAPAID was ranked 12th and therefore is included in the first group of the 150 projects which will be funded by the Commission, after appropriate negotiation, already in progress.
The project covers a period of two years and will be implemented through the collaboration of four companies (Progenika Biopharma SA, Spain, Diagnosticum, Hungary, Pharma Quality Europe Srl, Italy, and Toscana Biomarkers Srl, Italy) and six research institutions of the same three Countries that have already established valuable partnerships in the past.
GAPAID target is the development of a novel diagnostic / prognostic platform for Rheumatoid Arthritis and Systemic Lupus Erythematosus, two complex multifactorial autoimmune diseases with a high social impact, caused by the interplay of genetic and environmental factors.
In particular, GAPAID scientific activities will be focused on the discovery of the diagnostic and prognostic value of the genetic and serological profiles associated to Rheumatoid Arthritis and Systemic Lupus Erythematosus. The technological activities will contribute to develop multiplex arrays for the detection of relevant biomarkers and to set up a software for the Rheumatoid Arthritis and Systemic Lupus Erythematosus diagnosis / prognosis by matching the clinical, genetic, and serological data. The exploitation of the scientific and technological results will allow the participant SMEs to develop and to commercialize highly innovative in vitro diagnostic products composed by a genetic array, a serological array, and a software.

New initiatives from Fondazione Filarete

Fondazione Filarete for Biosciences and Innovation is a research and technology transfer center in life science and a business incubator for startups in this field. With its state-of-the-art laboratories and researchers in many areas (genomics and bioinformatics, biomaterials, plant model systems, cell model systems, mouse and animal pathology, molecular and cellular imaging, proteomics)  Fondazione Filarete works with companies to support their innovation processes.
Fondazione Filarete also works with entrepreneurs and startups to validate their projects, to help them developing their products and services and to facilitate their access to capital and market. Two new initiatives are now available for startups.
The first is Filarete Healthy Startups, the monthly appointment to present and discuss innovative entrepreneurial ideas in Health.
Business development managers, investors, researchers and entrepreneurs take part in Filarete Healthy Startups in order to give feedbacks and comments about the projects presented.
The second iniziative is Filarete Soft Incubation and it’s addressed to all those startups and companies which need a  desk in Milan but don’t want to open an Italian branch. The basic option is a "5 days per month" rent at a very interesting rate and gives the opportunity to get in touch with the most important business community in Italy.

The Distretto Toscano Scienze della Vita/Tuscany Life Science Cluster is looking for a Temporary Manager

The Distretto Toscano Scienze della Vita/Tuscany Life Science Cluster has opened a selection for a Temporary Manager job position (until the 30th of June, 2014).
The Temporary Manager will be asked to be involved in the activities and challenges of the Distretto/Cluster providing expertise in the processes of innovation.
Required skills: Master Degree (Laurea Specialistica/Magistrale/Vecchio Ordinamento) with at least 5 years of work experience with similar functions in the Life Sciences Sector (Pharma or Biotech or Medical Devices).
To apply for this position, please send your CV through the website by 13th July 2012  (1:00 PM).