Post by Uncle on Oct 27, 2015 1:30:52 GMT
OPKO Strategic Investment Pharmsynthez - Xenetic - RUSNANO - SciVac - Lockshin - Connection
Expenditures "Pharmsynthez" on research and development in the first half of 2015 increased by 8 times
Pharmaceutical Bulletin
Faomatsevtichesky Gazette
Russia
Sept 26, 2015
JSC "Pharmsynthez" presented the consolidated report for the 1st half of 2015, generated by the International Accounting Standards. The company's sales in the period increased by almost 50% to 206.85 million rubles. Gross profit increased by 81.24% and amounted to 147.55 million rubles. This operating loss was also higher - three times, up to 281 million rubles., A net loss also increased by 3.5 times and amounted to 282.98 million rubles.
At the same time the company received state grants for research and development in the amount of 40 million rubles., For the same purpose "Pharmsynthez" spent 234.2 million rubles. own resources that exceeds the amount of funding for scientific research in the first half of 2014 by 8 times.
Author: Elena Kalynovska, "Pharmaceutical Bulletin"
Note:
Xenetic Biosciences, Inc. is a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics. Xenetic's proprietary drug technology platforms include PolyXen®, designed to develop next generation biologic drugs by extending the efficacy, safety and half-life of biologic drugs, and OncoHist™ for the development of novel oncology drugs focused on orphan indications.
Xenetic's lead product candidates include ErepoXen®, a polysialylated form of erythropoietin (EPO) for the treatment of anemia in pre-dialysis patients with chronic kidney disease, and OncoHist™, a novel recombinant human histone H1.3 molecule for the treatment of refractory Acute Myeloid Leukemia (AML) with potential to treat numerous other cancer indications.
Xenetic is collaborating with Russian-based OJSC Pharmsynthez (who is an affiliate of a significant shareholder in Xenetic) and the Serum Institute of India to test additional drug candidates and to de-risk the development process with clinical data generated in Russia and India before Xenetic takes these candidates into the clinic in the Western markets.
Xenetic is also working together with Baxalta Incorporated (formerly Baxter Healthcare) to develop a novel series of polysialylated blood coagulation factors, including a next generation Factor VIII. This collaboration relies on the Xenetic's PolyXen® technology to conjugate PSA to therapeutic blood-clotting factors, with the goal of improving the pharmacokinetic profile and extending the active life of these
biologic molecules. Baxalta is one of the Company's largest shareholders having invested in a number of rounds with the most recent investment of $10M.
The agreement is an exclusive research, development and license agreement which grants Baxalta a worldwide, exclusive, royalty-bearing license to Xenetic's PSA patented and proprietary technology in combination with Baxalta's proprietary molecules designed for the treatment of blood and bleeding disorders. Under the agreement, Xenetic may receive regulatory and sales target payments for total potential milestone receipts of up to $100 million plus royalties on sales.
In April 2013, OPKO invested $9.6 million in exchange for approximately 13.6 million shares of Pharmsynthez common stock. Concurrent with their investment, Pharmsynthez also agreed, at its option, to issue approximately 12.0 million shares of its common stock or pay us Russian Rubles (“RUR”) 265.0 million (approximately $8.1 million as of December 31, 2013) on or before December 31, 2013. OPKO had a right to purchase additional shares in Pharmsynthez at a fixed price if Pharmsynthez paid us in cash rather than the 12.0 million shares of Pharmsynthez common stock. Pharmsynthez delivered approximately 12.0 million shares of its common stock to us in January 2014. Report Link
OPKO announced that the partnering with Pharmsynthez was to develop and market several OPKO products for sale in Russia and certain other Eastern European countries. Pharmsynthez would assist OPKO with sponsored research and product registration in Russia and neighboring Eastern European countries for CTAP101 Capsules, a vitamin D prohormone to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, for several diagnostic products utilizing OPKO's point of care platform, and for the 4Kscore™, its novel panel of kallikrein biomarkers and associated algorithm for the detection of prostate cancer.
The Russians on the MFD RU Stock Board talk about here. LINK
OPKO and Pharmsynthez have also entered into collaboration and funding agreements pursuant to which Pharmsynthez and OPKO will share costs for certain research and development activities.
Pharmsynthez manufactures and markets branded pharmaceutical products principally within Russia and the Baltic states, provides contract research and development services, and has four proprietary drug candidates targeting niche markets; Virexxa for the treatment of advanced endometrial cancer, MyeloXen for the treatment of multiple sclerosis, PulmoXen for the treatment of cystic fibrosis, and Hivirin for the treatment of HIV infection.
Pharmsynthez has some Innovative projects.
OAO Pharmsynthez (MICEX:LIFE), a growing, 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 million) two-stage financing in Pharmsynthez alongside the Russian Corporation of Nanotechnologies, a Russian state owned company (RUSNANO). RUSNANO invested approximately RUR 820 million (US$26.1 million) in the first step of the transaction. RUSNANO was established in 2007 to foster development of nanotechnology and to encourage the growth of this field in Russia.
RUSNANO was founded as an open joint stock company in March 2011, through reorganization of state corporation Russian Corporation of Nanotechnologies.
RUSNANO USA, Inc. also facilitates the marketing of Russian nano-enabled products in North American and global markets. Rusnano Link
SynBio Nanopharmaceuticals (Shareholders in Portfolio Company RUSNANO, IceGen LLC) (Which includes PolyXen® platform) offers the Sustained-release drugs containing polysialic acid—biobetters for treatment of diabetes mellitus, Alzheimer’s disease, chronic kidney disease, and other illnesses under the (PolyXen® platform).
Back to Xenetic
Xenetic Curtis Lockshin Ph.D.VP, Research & Operations joined Xenetic in March 2014. In the past, Curtis Lockshin held a R&D management position at OPKO Health, Inc. On top of being head of Research & Operations for Xenetic, Dr. Lockshin serves as Chief Executive Officer of SciVac since September 2014. SciVac Therapeutics Inc. announced that they have entered into an agreement and plan of merger under
which SciVac has agreed to acquire VBI to form a commercial-stage company with a licensed hepatitis B (“HBV”) vaccine and a pipeline of preventative and therapeutic vaccine candidates.
Sci-B-Vac is a commercial HBV vaccine that mimics all three viral surface antigens of the hepatitis B virus.
VBI’s lead eVLP asset is a prophylactic Cytomegalovirus (“CMV”) vaccine.
The acquisition of VBI provides SciVac with access to an impressive portfolio of vaccine candidates that may address large unmet needs in both infectious diseases and oncology,” said Dr. Lockshin.
OPKO Health, Inc. (NYSE:OPK) will be the largest shareholder of the combined company, with approximately 14% of the issued and outstanding shares of the combined company.
Expenditures "Pharmsynthez" on research and development in the first half of 2015 increased by 8 times
Pharmaceutical Bulletin
Faomatsevtichesky Gazette
Russia
Sept 26, 2015
JSC "Pharmsynthez" presented the consolidated report for the 1st half of 2015, generated by the International Accounting Standards. The company's sales in the period increased by almost 50% to 206.85 million rubles. Gross profit increased by 81.24% and amounted to 147.55 million rubles. This operating loss was also higher - three times, up to 281 million rubles., A net loss also increased by 3.5 times and amounted to 282.98 million rubles.
At the same time the company received state grants for research and development in the amount of 40 million rubles., For the same purpose "Pharmsynthez" spent 234.2 million rubles. own resources that exceeds the amount of funding for scientific research in the first half of 2014 by 8 times.
Author: Elena Kalynovska, "Pharmaceutical Bulletin"
Note:
Xenetic Biosciences, Inc. is a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics. Xenetic's proprietary drug technology platforms include PolyXen®, designed to develop next generation biologic drugs by extending the efficacy, safety and half-life of biologic drugs, and OncoHist™ for the development of novel oncology drugs focused on orphan indications.
Xenetic's lead product candidates include ErepoXen®, a polysialylated form of erythropoietin (EPO) for the treatment of anemia in pre-dialysis patients with chronic kidney disease, and OncoHist™, a novel recombinant human histone H1.3 molecule for the treatment of refractory Acute Myeloid Leukemia (AML) with potential to treat numerous other cancer indications.
Xenetic is collaborating with Russian-based OJSC Pharmsynthez (who is an affiliate of a significant shareholder in Xenetic) and the Serum Institute of India to test additional drug candidates and to de-risk the development process with clinical data generated in Russia and India before Xenetic takes these candidates into the clinic in the Western markets.
Xenetic is also working together with Baxalta Incorporated (formerly Baxter Healthcare) to develop a novel series of polysialylated blood coagulation factors, including a next generation Factor VIII. This collaboration relies on the Xenetic's PolyXen® technology to conjugate PSA to therapeutic blood-clotting factors, with the goal of improving the pharmacokinetic profile and extending the active life of these
biologic molecules. Baxalta is one of the Company's largest shareholders having invested in a number of rounds with the most recent investment of $10M.
The agreement is an exclusive research, development and license agreement which grants Baxalta a worldwide, exclusive, royalty-bearing license to Xenetic's PSA patented and proprietary technology in combination with Baxalta's proprietary molecules designed for the treatment of blood and bleeding disorders. Under the agreement, Xenetic may receive regulatory and sales target payments for total potential milestone receipts of up to $100 million plus royalties on sales.
In April 2013, OPKO invested $9.6 million in exchange for approximately 13.6 million shares of Pharmsynthez common stock. Concurrent with their investment, Pharmsynthez also agreed, at its option, to issue approximately 12.0 million shares of its common stock or pay us Russian Rubles (“RUR”) 265.0 million (approximately $8.1 million as of December 31, 2013) on or before December 31, 2013. OPKO had a right to purchase additional shares in Pharmsynthez at a fixed price if Pharmsynthez paid us in cash rather than the 12.0 million shares of Pharmsynthez common stock. Pharmsynthez delivered approximately 12.0 million shares of its common stock to us in January 2014. Report Link
OPKO announced that the partnering with Pharmsynthez was to develop and market several OPKO products for sale in Russia and certain other Eastern European countries. Pharmsynthez would assist OPKO with sponsored research and product registration in Russia and neighboring Eastern European countries for CTAP101 Capsules, a vitamin D prohormone to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, for several diagnostic products utilizing OPKO's point of care platform, and for the 4Kscore™, its novel panel of kallikrein biomarkers and associated algorithm for the detection of prostate cancer.
The Russians on the MFD RU Stock Board talk about here. LINK
OPKO and Pharmsynthez have also entered into collaboration and funding agreements pursuant to which Pharmsynthez and OPKO will share costs for certain research and development activities.
Pharmsynthez manufactures and markets branded pharmaceutical products principally within Russia and the Baltic states, provides contract research and development services, and has four proprietary drug candidates targeting niche markets; Virexxa for the treatment of advanced endometrial cancer, MyeloXen for the treatment of multiple sclerosis, PulmoXen for the treatment of cystic fibrosis, and Hivirin for the treatment of HIV infection.
Pharmsynthez has some Innovative projects.
OAO Pharmsynthez (MICEX:LIFE), a growing, 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 million) two-stage financing in Pharmsynthez alongside the Russian Corporation of Nanotechnologies, a Russian state owned company (RUSNANO). RUSNANO invested approximately RUR 820 million (US$26.1 million) in the first step of the transaction. RUSNANO was established in 2007 to foster development of nanotechnology and to encourage the growth of this field in Russia.
RUSNANO was founded as an open joint stock company in March 2011, through reorganization of state corporation Russian Corporation of Nanotechnologies.
RUSNANO USA, Inc. also facilitates the marketing of Russian nano-enabled products in North American and global markets. Rusnano Link
SynBio Nanopharmaceuticals (Shareholders in Portfolio Company RUSNANO, IceGen LLC) (Which includes PolyXen® platform) offers the Sustained-release drugs containing polysialic acid—biobetters for treatment of diabetes mellitus, Alzheimer’s disease, chronic kidney disease, and other illnesses under the (PolyXen® platform).
Back to Xenetic
Xenetic Curtis Lockshin Ph.D.VP, Research & Operations joined Xenetic in March 2014. In the past, Curtis Lockshin held a R&D management position at OPKO Health, Inc. On top of being head of Research & Operations for Xenetic, Dr. Lockshin serves as Chief Executive Officer of SciVac since September 2014. SciVac Therapeutics Inc. announced that they have entered into an agreement and plan of merger under
which SciVac has agreed to acquire VBI to form a commercial-stage company with a licensed hepatitis B (“HBV”) vaccine and a pipeline of preventative and therapeutic vaccine candidates.
Sci-B-Vac is a commercial HBV vaccine that mimics all three viral surface antigens of the hepatitis B virus.
VBI’s lead eVLP asset is a prophylactic Cytomegalovirus (“CMV”) vaccine.
The acquisition of VBI provides SciVac with access to an impressive portfolio of vaccine candidates that may address large unmet needs in both infectious diseases and oncology,” said Dr. Lockshin.
OPKO Health, Inc. (NYSE:OPK) will be the largest shareholder of the combined company, with approximately 14% of the issued and outstanding shares of the combined company.