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On September 2009, Molecular Insights Pharmaceuticals (MIP) and BioMedica Life Sciences S.A. reached to an agreement that provides BioMedica Life Sciences s.a an exclusive sub-license to OnaltaTM (90Y-DOTATOC) trademark in Europe, the Middle East, North Africa, Russia and Turkey. Under this agreement, BioMedica Life Sciences S.A. is expected to perform Clinical Studies and market, distribute and commercialize OnaltaTM (90Y-DOTATOC) in the specified territories and secure all regulatory approvals.
 


Introduction R&D

The process of a new drug development from the time it is discovered until it is registered can take from 10 to 12 years and it typically costs about €700 million. Only in specific cases (e.g. orphan drugs) can EMEA or FDA authorize the acceleration of the whole process. The endmost of this time-consuming procedure is that all pharmaceutical products that finally get registration meet all the necessary effectiveness and safety requirements.

BioMedica Life Sciences shows great interest in the research and development of novel products in a variety of fields such as the molecular diagnostic imaging and molecular therapy via radiolabeled biomelecules, the development of substances for pharmaceutical and cosmetic use and the peptide chemistry. The result of those efforts is that there is already one compound in a clinical evaluation stage and two pharmaceutical products (both “orphan drug” designated) which are entering Phase II and Phase III clinical trials.


Research fields
  • Radiolabeled biomolecules for molecular diagnosis & therapy
    • Onalta®
    • Demogastrin®
    • Demobesin®
  • Retinoids for pharmaceutical & cosmetic application
  • Resins for peptide synthesis
    • APSAM resins
    • TFMT resins
  • Clinical trials
  • R & D collaborations

Research fields

Radiolabeled biomolecules for molecular diagnosis & therapy

The research efforts of BioMedica Life Sciences mainly focus in Molecular Radiopharmacology and expand in Nuclear Medicine. Nuclear medicine is a specialty that uses radionuclides and relies on the process of radioactive decay for the diagnosis and/or treatment of a disease. When radionuclides are bound to certain chemical compounds or biomolecules they form Radiopharmaceuticals which are the main tool for Nuclear Medicine. Radiopharmaceuticals once administered to the patient, can localize to specific organs or cellular receptors and allow the diagnosis or treatment of a disease based on the cellular function and physiology rather than relying on the anatomy.

In Nuclear Medicine Imaging, radiopharmaceuticals are administered internally and afterwards external detectors (gamma camera, PET camera, etc) capture and form images from the emitted radiation. In Nuclear Medicine Therapy, the radiation treatment dose is also administered internally rather from an external radiation source. The difference of diagnosis and therapy lies mainly on the radionuclide used: gamma or positron emitters for imaging, e.g. 99mTc and 18F – beta- or auger e- emmiters for therapy, e.g. 90Y and 111In.

In the future, Nuclear Medicine may be known as Molecular Medicine. As our understanding of biological processes in the cells of living organism expands, specific probes can be developed to allow visualization, characterization, and quantification of biologic processes at the cellular and subcellular level. Nuclear Medicine is an ideal specialty to adapt to the new discipline of Molecular Medicine, because of its emphasis on function and its utilization of imaging agents that are specific for a particular disease process.

Onalta®

BioMedica Life Scienses has recently reached to an agreement with Molecular Insights Pharmaceuticals (MIP) that provides BioMedica an exclusive sub-license to intellectual property rights and know-how of MIP with respect to Onalta®, originally developed by Novartis Pharmaceuticals. Under the agreement, BioMedica is expected to perform clinical studies and market, distribute and commercialize Onalta® in Europe, Russia, Turkey, North Africa and Middle East and secure all regulatory approvals.

Onalta® (90Y-DOTATOC) is a novel radiotherapeutic product under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy. It comprises from the synthetic peptide DOTATOC (edotreotide) which has high affinity for the somatostatin receptor subtypes 2 and 5 and it is labeled with the beta emitting radionuclide 90Y. The compound has shown the potential to selectively deliver lethal radiation to cancer cells. Onalta® has received “Orphan Drug” Designation in the EU and the European Medicines Agency (EMEA) has approved MIP’s Phase III protocol design and plan for EU development.


For the patients who will not enter clinical trial phase III (limited number of patients) Onalta® will be available in the specified territories through a Named Patient Program (NPP), meaning that every patient should get an individual approval from the Country’s Authorities. The Onalta® kit is a cold GMP kit, pharmaceutical grade (containing all the excipients) and ready to be labeled with 90Y according to a defined labeling protocol. This procedure is the only one that is compliant with European Regulatory Authorities. This Program will be run in Europe by IDIS (www.idispharma.com), a UK based company, which specializes in providing access to medications via NPP and which will give all necessary support to the Authorities in every Country and will supply the Onalta® kit. 90Y can be obtained from any of the certified suppliers (currently Eckert & Ziegler and Perkin Elmer).

Demogastrin®

Demogastrin® (99mTc-Demogastrin 2) is a diagnostic radiopharmaceutical which has been developed as the result of the ongoing collaboration of BioMedica Life Sciences with the Molecular Radiopharmacy Group at the Institute of Radioisotope and Radiodiagnostic Products of the N.C.S.R. “Demokritos”. It is a novel minigastrin analogue for diagnosis, staging and follow-up of Human Medullary Thyroid Carcinoma (MTC) which will also provide a tool to detect micrometastasis. This compound has a strong affinity to tumors that overexpress cholecystokin-2/gastrin receptors (CCK-2/gastrin-R) which are present at MTC. Demogastrin® has already acquired the “Orphan Drug” status designation by EMEA and has successfully passed through Phase I clinical trials in Erasmus MC, University of Rotterdam in Holland. A GMP-kit formulation has already been developed and the radiopharmaceutical has acquired clearance for Phase II multi-center clinical trials aiming toward eventual registration of the product by EMEA.

Demogastrin® application was the first application that has ever been submitted by Greece to the EMEA. The “Orphan Drug” designation given in 2006 will speed up the necessary procedures for the development and official licensing of the drug.


Demobesin®

The cooperation of BioMedica Life Sciences with the Molecular Radiopharmacy Group of N.C.S.R. “Demokritos” is currently focused on the development of 99mTc-labeled bombesin-like antagonists for prostate cancer imaging. Demobesin® is a 99mTc-labeled compound with high affinity for the gastrin releasing peptide receptors (GRP-R) which are overexpressed in prostate adenocarcinoma. This diagnostic radiopharmaceutical has already passed through preclinical evaluation and has entered Phase I clinical trials at the Institute of Pathology, University of Bern in Switzerland.

Retinoids for pharmaceutical & cosmetic application

BioMedica Life Sciences collaborate with Scientific Researchers from the Medical School and the Chemistry Department of the University of Patras, in order to develop a new series of retinoids. These compounds are prototype conjugates of polyamine derivatives of vitamin A, which inhibit rivonuclease RNase-P and present remarkable counterirritant and antibacterial effect. Concerning these properties of the new retinoid compounds it is strongly considered that in the near future new pharmaceutical products will arise for the treatment of a variety of diverse diseases such as:
  • Dermatological conditions e.g. Acne, Ichthyosis
  • Auto-immune diseases e.g. Psoriasis, Lupus Erythematosus
  • Skin cancers e.g. Squamous Cell Carcinomas (SCC), Basal Cell Carcinomas (BCC)

RASP® retinoid molecule is now under preclinical evaluation.

Development of resins for solid phase peptide synthesis (S.P.P.S.)

The most widely used synthetic method for the production of peptides for pharmaceutical and not only application is solid phase peptide synthesis. BioMedica Life Sciences participates and actively contributes in the continuing progress that is taking place in Greece as far as the evolvement of techniques and protocols that comprise S.P.P.S. More specifically in collaboration with the Immunopeptidic Chemistry Laboratory of N.C.S.R. “Demokritos”, novel resins as solid polymeric substrates are being developed.

APSAM resins

The majority of the widely applied and commercially available resins for S.P.P.S. are polystyrene resins which are durable, show good expansion and have low cost. On the other hand they are quite lipophilic and allow incorporation of peptide chains. New modified resins of cross co-polymer polystyrene-divinylbenzoil (APSAM – Aminomethyl Polystyrene resins with Altered Microenviroment of the developing peptide) have been discovered by the Immonochemistry Lab Group of “Demokritos”. These novel resins show improvement in the synthesis yield while the purity of the peptides synthesized in these resins is higher than when using conventional resins. APSAM resins can be easily and repeatably produced while their cost is not particularly high. There has been a patent application to the Greek Industrial Property Organisation for this product (Patent Application No 20080100173).

TFMT resins
The use of trityl-type resins is very popular because of the low rate of adverse byproducts (rakemic products). Their industrial production nevertheless is deterrent due to their high cost. There is a way that these resins can be produced cost effectively but they may have quite many disadvantages (low expansion, byproduct formation, etc). For the optimization of these products there has been a production/development of a novel trityl-type resin (TFMT) with cross co-polymer polystyrene-divinylbenzoil, which carries at least one tri-fluoro group at an appropriate position of the trityl-system rings. The new resin has been studied as far as its expansion ability and effectiveness for S.P.P.S. and has been compared with commercially available resins of the same type. In conclusion the new TFMT resin has a low production cost, presents excellent expansion ability in the common solvents used in peptide synthesis and generally in organic synthesis and is suitable for application as activated solid substrates in S.P.P.S. Additionally, on a TFMT resin peptides are synthesized quicker and also show purity which is significantly higher compared to the ones which are synthesized on commercially available resins of the same type. There has already been granted a patent certificate for these (GR1005656).



R&D collaborations

A long-existing cooperation between BioMedica Life Sciences, SA and the Institute of Radioisotope and Radiodiagnostic Products at N.C.S.R. “Demokritos”, continues successfully to work on the design, evaluation and commercial exploitation of 99mTc-based diagnostic radiopeptides with oncological application as well as in the production of novel resins for peptide synthesis. Another collaboration with the Pharmaceutical and Medicine Department of University of Patras lies on the design, synthesis and evaluation of peptides and chemicals as useful compounds for pharmaceutical and/or cosmetic applications. BioMedica Life Sciences with respest to produce research results in the fields of its interest also collaborates with major Universities, Research Centres and Institutes in Greece and throughout Europe with encouraging outcome.
 

Biomedica Life Sciences S.A. in order to optimize its efficiency in exploiting the results of the R&D activities, has established two Spin-off Companies in which is the controlling shareholder.
The companies are :
 

Biomedica Life Sciences S.A
4 Papanikoli Street, 152 32 ,
Halandri,Athens, GR
T:+30 210 6899801
F:+30 210 6899809
E:info@biomedica.gr
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