OPKO Strategic Investments >OAO Pharmsynthez (MICE: LIFE) (~11% right interest)
April 18, 2013 09:43 AM Eastern Daylight Time
MIAMI–(BUSINESS WIRE)–OPKO Health, Inc. (NYSE:OPK) announced that it has acquired one approximate ten percent stake in OAO Pharmsynthez (MICEX:LIFE), a augmenting, fully-integrated Russian pharmaceutical company and the only life science company listed on the Moscow Stock Exchange. OPKO’s investment is part of an approximate RUR 1.9 billion (US$60 very great number) two-stage financing in Pharmsynthez by the side of the Russian Corporation of Nanotechnologies, a Russian express owned company (RUSNANO). RUSNANO invested nearly RUR 820 million (US$26.1 million) in the first step of the doing. RUSNANO was established in 2007 to rear development of nanotechnology and to reassure the growth of this field in Russia.
OAO Pharmsynthez
Virexxa ~Orphan Drug Designation Expedites Virexxa Clinical Trial Program in US~
HIVirin
Myeloxen
Virexxa
Virexxa is a unique preparation being in clinical trials in quest of treatment of advanced and relapsing forms of endometrial cancer, what one. action is based on increase of endometrial cancer sensitivity to hormonotherapy ~ means of means of induction of progesterone receptors in progesterone-forbearing endometrial cancer.
The OJSC “Pharmsynthez” fulfills the program of Virexxa clinical increase investigating efficiency of combined application of Virexxa and progestins in patients by advanced and relapsing endometrial cancer who developed endurance to progestins monotherapy. At the jiffy the phase II clinical trials of the condition have been running in several clinical centers in the Russian Federation. Phase II clinical trials in the European Union countries command be started in 2011 after fabrication end of cGMP preparation series in the place of clinical trials at the enterprise KeveltAS. OJSC “Pharmsynthez” has freshly reported on the purchase of 100 % shares of this undertaking. The start of Virexxa clinical trials in the USA was of old planned for 2012.
Published 21.05.2013 at 17:13
Cancer deaden with narcotics candidate Virexxa to be manufactured in Estonia
The cancer medicine candidate Virexxa, a part of the outcome portfolio of the Competence Center according to Cancer Research (CCCR), is going to have existence produced at the AS Kevelt collection in Estonia the owners of which will upgrade the drug manufacturing unit for eight million euros.
Riin Ehin, comptroller of CCCR, said the international biological drugs and diagnostics group OPKO Health at the end of April invested 46 very great number euros in Pharmsynthez, parent company of the CCCR participant AS Kevelt. The owners invested additionally 20 the masses euros. Eight million euros will have ~ing spent for the upgrade of the mix with ~s manufacturing unit of AS Kevelt to what drugs will start to be manufactured conducive to the European and US market.
“The cooperation between Pharmsynthez and CCCR can be compared to Skype, as development operations and in the futurity also production will take place in Estonia. Estonia was chosen as location because of the strong cooperation between the public and private sector in this place in cancer research and drug disclosure,” Ehin said.
She said investors esteem voiced recognition of CCCR’s adequate and well structured functioning, good comprehension of new paradigms in drug exhibition, and the capability to bring a scientific invention to the point of introduction of novelty. AS Kevelt and CCCR are moving together also on the development of a different drug candidate, Oncohist, meant for the handling of acute myeloid leucemia.
Virexxa is aspirant for approval for the treatment of endometrial cancer, or malignancies that arise from the endometrium, or lining, of the uterus. There is not at all specific treatment now for the sickness that is estimated to affect 25,000 patients in Europe annually. Trials of Virexxa be delivered of been very successful and the physic is seen to have a in posse market of 600 million to human being billion euros. Virexxa also has comprehensive potential in the US market.
Established in 2005, CCCR is a investigation and development institution certified by the Estonian Ministry of Education and Research. Its portfolio includes 14 projects that are financed ~ dint of. Enterprise Estonia, the Archimedes foundation and CCCR’s 14 partners. The modern include the Tallinn University of Technology, the North Estonia Medical Center, the University of Tartu, since well as biotechnology, drug development and fundamental synthesis businesses from Estonia, Sweden, the United States and Latvia.
http://www.vm.ee/?q=swelling/17311
OAO Pharmsynthez
HIVirin
OJSC “Pharmsynthez” has started progression in a continuously ascending gradation of HIVirin, a preparation which should be a part of AIDS complex usage. This novel preparation blocks penetration of the poison into the cell.
At the value the main focus is obtaining of a non-glycolized recombinant chimeric protein based attached conservative immunodominant fragments of ENV proteins, plasmid DNA toward eukaryotic expression of this protein. Within the frames of these works genealogy, purification and study of properties of protein- and plasmid DNA-containing complex are performed.
The pilot lots of HIVirin state of being prepared for next studies are planned to occur in the current year. The next stage of the project is appointed as far as concerns 2012-2013 and shall constitute preclinical studies of the compounded containing non-glycolized recombinant chimeric polypeptide and DNA. There are more requirements specified for the development, including already settled prolonged action, purity of the compounded and nature of preparation ingredients. The works are performed according to general and international standards, including GMP, GLP and environmental safety assurance. The studies are based forward up-to date trends in biotechnology and pharmacology. In the coming events the results of specified developments can contribute to creation of a expanded range of therapeutic vaccines for management of social diseases.
OAO Pharmsynthez
Myeloxen
In 2010 the OJSC “Pharmsynthez” has completed preclinical studies of “Myeloxen”, a able drug for treatment of multiple sclerosis.
The traditionary therapy for this disease is limited to petition of only one agent – glatiramer acetate. So the very problem is to create a with reference to something else cheap and effective preparation in proper state to change the course of the disorder. Glatiramer acetate is known under the term “Copaxone” and is produced by the company Teva Ltd., Israel. There are not at all analogs of this preparation at the emporium.
Multiple sclerosis is an advanced proceeding disease of the central nervous system accompanied by various neurologic symptoms. The disease usually occurs in young and intervening age people under the influence of a line of internal and external factors. Multiple sclerosis leads to difficulties in instigating up to full paralysis, and difficulties in sensation, as well as to loss of dominion government over neuropsychological conditions. Hundreds of thousands of persons suffer from Multiple sclerosis. Therefore it is in a high degree. important to find the preparation of higher rank to Glatiramer acetate in ability to free from error the immune response to the myelin basic protein.
For this purpose the OJSC “Pharmsynthez” has used up-to-fix the ~ of knowledge in the field of MS pathogenesis for example well as modern immunology and nanotechnologies. The inference was creation of “Myeloxen”, busily engaged pharmaceutical ingredient and finished drug. «Myeloxen» is a lyophilizate because of injections, representing peptide vaccine. The ready ingredient of the preparation is a knot of peptides homologous to immunogenic sites of the myelin basic protein. According to preclinical in vivo studies, the treatment with this preparation is more forcible than with “Copaxone”. According to studies without ceasing experimental animals, “Myeloxen” has nay toxic, anaphylactogenic, allergic, immunotoxic, teratogenic and mutagenic properties and doesn’t authority the reproductive function. The quality of the elegant drug meets all the requirements of general and international standards and Pharmacopoeias. The clinical trials and process of state marketing authorization of “Myeloxen” plan are to begin in 2011.
RUSNANO Invests in Production of Advanced Pharmaceuticals
RUSNANO and Pharmsynthez accept announced that financing is underway in quest of a project to manufacture drugs to delight certain cancers and multiple sclerosis. The investment from RUSNANO is 820 million rubles. Current shareholders of the remedy company and American company OPKO Pharmaceuticals are co-investing in the shoot forward.
Rusnano Press Release:
2013-04-19_RUSNANO_Pharmsynthez
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