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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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TMC310911, Ascletis In-Licenses China Rights to HIV Drug from Janssen
TMC310911, credit pubchem
see structure http://aac.asm.org/content/55/12/5723/F1.expansion.html
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232804/ structure available
TMC310911, Ascletis In-Licenses China Rights to HIV Drug from Janssen
Apr 30, 2013
Ascletis, a China-US drug developer, has in-licensed China rights to a next-generation HIV protease inhibitor from Janssen R&D Ireland, a subsidiary of Johnson & Johnson. Janssen believes the drug, known as TMC310911, is likely to prove more effective against drug-resistant strains of HIV than currently available PIs. The molecule is the third drug candidate in-licensed by Ascletis, which is also developing its own siRNA anti-cancer drug candidate.
CHINA MARKET-Takeda and Sanofi Sign Co-promotion Agreement to Expand Reach of Diabetes Treatment Alogliptin in China
ALOGLIPTIN
22.04.2013
• Alogliptin is a DPP-4 inhibitor that is designed to slow the inactivation of incretin hormones GLP-1 and GIP
• Agreement is part of Takeda’s strategy to complement capabilities through partnerships
• Agreement complements Sanofi’s diabetes portfolio and expand its offer of innovative diabetes treatment to Chinese patients
• The regulatory approval of alogliptin in China is expected in 2013
Shanghai, China, April 22, 2013 – Takeda and Sanofi today announced that they have entered into an agreement for the co-promotion of alogliptin in China for the treatment of type 2 diabetes. Alogliptin is Takeda’s new type 2 diabetes therapy, which has been filed for marketing authorization in China. It is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).
Under the terms of the agreement, Takeda will grant Sanofi the exclusive right to co-promote alogliptin in China. Sanofi will utilize its commercial capabilities and experience to promote the product in defined territories in China. The commercial terms of the agreement were not disclosed.
“Diabetes has become a major public health problem in China with a rapid increase in the prevalence over recent years. China is now the country with the largest number of people with diabetes,” said Haruhiko Hirate, Corporate Officer and Head of North Asia of Takeda. “The collaboration will expand our reach to Chinese physicians treating patients with type 2 diabetes. Both Takeda and Sanofi have a long history and significant experience in diabetes and this makes for a win-win partnership, as we work together to advance patient care and help to meet the needs of this growing patient population.”
“We are pleased to announce the collaboration with Takeda,” said Fabrice Baschiera, General Manager, Pharmaceutical Operations, Sanofi China. “Alogliptin reinforces the strategic focus of Sanofi in the diabetes field. The new addition of alogliptin strengthens our offer of innovative diabetes treatment to Chinese patients, which includes best-in-class oral and insulin drugs. We look forward to working with Takeda to make alogliptin more widely available to patients with type 2 diabetes in China,” added Mr. Baschiera.
Alogliptin was approved and marketed in Japan in 2010 under the brand name of Nesina®, where it is currently the best-selling DPP-4i for type 2 diabetes. It was approved by the U.S. FDA as a monotherapy and also in fixed-dose combination with pioglitazone (Oseni®) and metformin (Kazano®) in January 2013 for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
In China, the rapid economic development has brought mass urbanization, changing diets and increasingly sedentary lifestyles. These factors greatly increase the risk of developing type 2 diabetes. China has the largest number of people with diabetes1, with approximately 92.4 million adults suffering from the disease, 60.7% of which are undiagnosed2. Over the next 20 years, an additional 40 million Chinese adults are expected to develop type 2 diabetes, surpassing the overall prevalence rate of the United States3.
Alogliptin is under registration review in China. Takeda is expecting to obtain the regulatory approval in 2013.
Notes
1 International Diabetes Federation. New diabetes figures in China: IDF press statement
2 Diabetes: Wenying Yang et al, N ENGL J MED, March 25, 2010;
3 Kantar Health. The Burden of the Complicated Type 2 Diabetes Patient in China.
About Alogliptin
Alogliptin is a DPP-4i for the treatment of type 2 diabetes as an adjunct to diet and exercise. DPP-4 is designed to slow the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. A New Drug Application (NDA) for NESINA (alogliptin) was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is available under the same brand name in Japan. NESINA (alogliptin) was approved by the U.S. FDA as a monotherapy and also in fixed-dose combination with pioglitazone (OSENI) and metformin (KAZANO) in January 2013 for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes affecting millions of people globally. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help them manage their blood glucose levels. According to the International Diabetes Federation, the global health care expenditures for diabetes (both type 1 and 2) were estimated at $471.6 billion in 2012. By 2030, this number is projected to exceed $595 billion. China is now the country with the largest number of people with diabetes and 92.4 million adults are suffering from the disease.
About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website,www.takeda.com.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
From a structural point has uracil (Uracil) structure, synthesis of these compounds are usually replaced with urea or urea and 1,3 – parents Electric reagent directly related ring, and substituted ureas from amines and isocyanate obtained. Compound 1 and methyl isocyanate urea derivatives obtained by reacting 2 , 2 and 1,3 – diethyl reaction 3 , 3 chlorination with phosphorus oxychloride to obtain 4 , 4 with a secondary amine 5 reaction of 6 , 6 de-Boc protected with acid reaction and generate benzoate Alogliptin benzoate.
CHINA – Shenzhen Chipscreen Biosciences announced that Chidamide (Epidaza®) met its primary endpoint in a Phase II trial
Chidamide
(CAS 743420-02-2)
N-(2-amino-5-fluorophenyl)-4-[[[1-oxo-3-(3-pyridinyl)-2-propen-1-yl]amino]methyl]-benzamide
Chidamide is a histone deacetylase inhibitor that increases histone H3 acetylation levels in LoVo and HT29 colon cancer cells at concentrations as low as 4 µM. Additionally, chidamide affects the activation of oncogenic signaling kinases by dose-dependently reducing phosphorylated Akt, mTOR, p70S6k, Raf, and Erk1/2 protein expression in colon cancer cells. Furthermore, chidamide treatment dose-dependently upregulates p21 protein expression, downregulates CDK4, and induces cell cycle arrest at the G0/G1 phase.
Apr 16, 2013
Shenzhen Chipscreen Biosciences announced that Chidamide (Epidaza®) met its primary endpoint in a Phase II trial, which was conducted in China patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The objective response rate was at least 27%, the agreed-upon goal. Chipscreen is developing the drug under an SFDA-approved accelerated review. The company will release more data at the ASCO conference in June
GSK licenses out Tykerb in China, signs Singapore pact with A*Star
LAPATINIB
Lapatinib (INN), used in the form of lapatinib ditosylate, (USAN) (Tykerb/Tyverb, GSK) is an orally active drug for breast cancer and other solid tumours.It is a dual tyrosine kinase inhibitor which interrupts the HER2/neu and epidermal growth factor receptor (EGFR) pathways. It is used in combination therapy for HER2-positive breast cancer. It is used for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 (ErbB2)
Expanding its Asia focus, GlaxoSmithKline has signed up Hong Kong-based Eddingpharm to sell its breast cancer drug Tykerb in China, having just entered into an alliance with Singapore’s A*Star to develop new medicines for emerging markets.
First up, Eddingpharm is to acquire exclusive rights in mainland China to import, market and promote Tykerb (lapatinib), which has recently been given the green light by the country’s state Food and Drug Administration. Specifically the drug is approved for use in combination with Roche’s Xeloda (capecitabine) for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who have received prior therapy with an anthracycline, a taxane and another Roche drug, Herceptin (trastuzumab).
Xin Ni, chief executive at Eddingpharm, said the deal, the financials for which have not been disclosed, is an important milestone, not least because “this is the first time a Chinese pharmaceutical company will participate in the launch of a proprietary global oncology drug”. He added that the partnership with GSK “helps us fully leverage our rich market experience and mature marketing platforms to open a fast track for Tykerb’s China launch”.
Tykerb has been approved in the aforementioned indication in more than 100 countries and Eddingpharm noted that in China there are 170,000 new cases of breast cancer diagnosed each year.
The deal came a day after GSK linked up with the Institute of Chemical and Engineering Sciences (ICES), owned by the Agency for Science, Technology and Research (A*Star) in Singapore.
A five-year strategic agreement has been signed to develop new evidence-based formulations (EBFs) specifically for emerging markets. The latter are medicines which are reformulated to provide additional patient benefit.
Keith Carpenter, executive director at ICES, which has been working with GSK since 2003, said that this latest deal “provides an opportunity for us to further our research and deepen our capabilities in formulation science with skilled scientists and technical expertise”. He added that the venture “will enable us to develop future scientists and laboratory analysts with the right skills to grow this industry in Singapore”.
Duncan McKay, head of emerging markets and Asia Pacific R&D at GSK, said that within the firm’s portfolio of off-patent products, “EBFs are an important part of our growth strategy”. He went on to say that “our hope is that together with ICES, we will create a sustainable, scalable model to meet both specific market conditions and patient requirements”.
Tapping into Singapore scientific talent
Commenting on the agreement, Kevin Lai, director of biomedical sciences at the Singapore Economic Development Board, said the deal is a strong endorsement of the country’s “scientific talent and capabilities”. He added that it also “further reinforces Singapore’s offering as the base for companies to generate insights and develop new solutions and market access strategies for the fast-growing emerging markets”.
GSK is a major player in Singapore, which is home to the drug giant’s headquarters for the emerging markets and Asia Pacific. It also has an R&D facility in Biopolis, two global manufacturing and supply sites (Jurong and Quality Road), a manufacturing facility for its Stiefel unit and a state-of-the-art vaccines plant in Tuas.
A*Star oversees 14 biomedical sciences and physical sciences and engineering research institutes, plus six consortia and centres and says it supports Singapore’s “key economic clusters by providing intellectual, human and industrial capital to its partners in industry”.
Links
TLC388 (Lipotecan®) Taiwan Liposome Company Hepatic cancer drug candidate gets fast track approval status from SFDA
TLC388 (Lipotecan®) structure can be figured out from a link below of a poster
http://www.tlcbio.com/files/news/2011111701580783.pdf
IT IS A CAMPOTHECIN ANALOGUE
The str can be concluded from above picture from a poster by TLC BIO
TLC388 (Lipotecan) is a potent Topoisomerase-1 inhibitor and it can disrupt both Sonic Hedgehog and HIF1-α pathways to overcome cancer drug resistance and inhibit angiogenesis induced by tumor hypoxia. This phase I first-in-human study of Lipotecan examined the MTD, safety, anti-tumor activity and pharmacokinetic profiles of TLC388 in patients with advanced incurable solid tumors.
Methods: Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle. Patients underwent safety assessments regularly and tumor assessments every other cycle. Pharmacokinetic samples were drawn on days 1, 8 and 15 of cycles 1 and 2 for all treated patients.
http://mct.aacrjournals.org/cgi/content/meeting_abstract/10/11_MeetingAbstracts/A89
http://clinicaltrials.gov/show/NCT00747474
MAR19 2013
China SFDA has granted fast track approval status to Taiwan Liposome company hepatic cancer drug Lipotecan, shortening the review period. The drug will enter Phase 2 clinical trials in China in the second half of this year. Lipotecan has been granted orphan drug status by US FDA and EU EMEA for the treatment of hepatocellular carcinoma (HCC)
Nexavar is the standard of care in first line advanced liver cancer patients. Lipotecan as a second-line treatment allows patients who have failed prior treatment with Nexavar to maintain a six month course of the disease without progressing
Sinovac Reports Preliminary Top-Line Results from Phase III Clinical Trial for EV71 Vaccine Candidate Against Hand, Foot and Mouth Disease
BEIJING, March 14, 2013
Sinovac Biotech Ltd. a leading provider of vaccines in China, announced today preliminary top-line data from its Phase III clinical trial assessing the efficacy, immunogenicity and safety of the Company’s proprietary Enterovirus 71 (“EV71”) vaccine against hand, foot and mouth disease (“HFMD”).
The primary objective of the study was to evaluate the efficacy of the EV71 vaccine in the prevention of HFMD caused by EV71 in infants of 6 to 35 months old. The preliminary Phase III data showed that Sinovac’s EV71 vaccine was 95.4% (95% CI: 87.5%, 98.3%) efficacious against HFMD caused by EV71.
The Phase III trial showed good immunogenicity and safety for Sinovac’s EV71 vaccine. The overall incidence of serious adverse events in this trial was 2.2% among the EV71 candidate vaccine recipients and 2.6% among those receiving a control vaccine during the fourteen months observation period. The difference in rates of serious adverse events (“SAEs”) is not statistically significant. Most of the SAEs were considered unlikely to be vaccine-related.
The double-blinded, randomized, placebo controlled Phase III clinical trial was conducted at three sites across China’s Jiangsu province. Approximately 10,000 healthy infants completed the two dose vaccination schedule (at 0 and 28 days) in the first quarter of 2012, prior to the HFMD epidemic season in China, followed by active monitoring period.
In parallel, Sinovac conducted another clinical study that was comprised of 1,400 volunteers and designed to evaluate the consistency of three consecutive lots of EV71 vaccine manufactured by the Company. The trial was conducted in children from 6 month to 5 years old. After receiving the vaccine, the ratios of neutralizing antibody GMTs on the 56th day of any two groups were calculated and the 95% confidence intervals of the ratios are all between 0.67 and1.5, which indicates the immunogenicity of the three vaccine lots is equivalent. The study results showed consistent immune response for all three lots and a good safety profile. With immunogenicity equivalent across the three consecutive lots, the results showed Sinovac’s vaccine production process and quality are stable.
In March 2008, an EV71 outbreak in Fuyang City of China’s Anhui Province caused 23 fatalities, and attracted significant attention from the government and medical communities. In May 2008, the PRC Ministry of Health identified EV71 as a Class C infectious disease according to prevention and control regulations. EV71 outbreaks have increased over the last five years, with over 1 million cases identified and 500 to 900 reported fatalities each year.
Dr. Weidong Yin , Chairman, President and CEO of Sinovac, commented, “We are excited to report an over 95% efficacy rate from the Phase III trial on our proprietary EV71 vaccine candidate. The conclusion of this trial marks an important milestone in the development of our proprietary vaccine. Hand, foot, and mouth disease continues to represent a significant unmet public health need and economic burden in China, as well as several other Asian countries. Our EV71 vaccine is poised to provide an effective solution to prevent hand, food and mouth disease caused by EV71, a much needed resource given the current limited prevention and EV71 specific treatment methods. At Sinovac, we are committed to our stated mission to develop and supply vaccines to eliminate human diseases.”
Professor Hua Wang, Lead Principal Investigator, stated, “The Phase III study for Sinovac’s EV71 vaccine candidate met its primary objective. The trial results demonstrated that the vaccine is not only safe, but shows significant efficacy in subjects.”
The Company’s next step is to finalize the clinical report, which will become an important part of documents to be filed with the PRC State Food and Drug Administration (“SFDA”) for the application of new drug certificate, GMP certification, and the production license in order to commence the commercial production of the vaccine. In parallel, Sinovac’s dedicated EV71 vaccine manufacturing facility has been completed and is ready for the GMP inspection by SFDA.
Sinovac obtained clinical research approval for its proprietary EV71 vaccine candidate from the SFDA in December 2010, and completed Phase I and II clinical trials in 2011. The preliminary results of the Phase I and Phase II studies confirmed that Sinovac’s vaccine candidate has good safety and immunogenicity profile.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza and mumps, as well as animal rabies vaccine. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac is developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot, and mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, varicella and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines.
A sensor-adaptor mechanism for enterovirus uncoating from structures of EV71
Xiangxi Wang, Wei Peng, Jingshan Ren, Zhongyu Hu, Jiwei Xu, Zhiyong Lou, Xumei Li, Weidong Yin, Xinliang Shen, Claudine Porta, Thomas S Walter, Gwyndaf Evans, Danny Axford, Robin Owen, David J Rowlands, Junzhi Wang*, David I Stuart*, Elizabeth E Fry* & Zihe Rao*
Enterovirus 71 1 (EV71) is a major agent of hand, foot and mouth disease in children that can cause severe central nervous system disease and death. No vaccine or antiviral therapy is available. High-resolution structural analysis of the mature virus and natural empty particles shows that the mature virus is structurally similar to other enteroviruses. In contrast, the empty particles are markedly expanded and resemble elusive enterovirus-uncoating intermediates not previously characterized in atomic detail. Hydrophobic pockets in the EV71 1 capsid are collapsed in this expanded particle, providing a detailed explanation of the mechanism for receptor-binding triggered virus uncoating. These structures provide a model for enterovirus uncoating in which the VP1 1 GH loop acts as an adaptor-sensor for cellular receptor attachment, converting heterologous inputs to a generic uncoating mechanism, highlighting new opportunities for therapeutic intervention. [ Nat Struct Mol Biol. 2012 Mar 4. doi: 10.1038/nsmb.2255. Epub ahead of print. PMID: 22388738 ][ PDF ]
Phase 1-Lorus Therapeutics Announces Allowance of Chinese Patent for Anticancer Drug LOR-253
has a fluoro gp
WO-2004016086, feb2004
2,4,5-Trisubstituted imidazoles and their use as anti-microbial agents
WO-2006126177, nov 2006
WO-2010102393, sept 2010
Description of LOR-253, LT253: LOR-253 HCl is the hydrochloride salt of a small molecule inhibitor of human metal-regulatory transcription factor 1 (MTF-1) with potential antitumor activity. MTF-1 inhibitor LOR-253 inhibits MTF-1 activity and thereby induces the expression of MTF-1 dependent tumor suppressor factor Kruppel like factor 4 (KLF4). This subsequently leads to the downregulation of cyclin D1, blocking cell cycle progression and proliferation. This agent also causes decreased expression of genes involved in tumor hypoxia and angiogenesis.
http://clinicaltrials.gov/ct2/show/NCT01281592
ClinicalTrials.gov Identifier: NCT01281592
Lorus Therapeutics
This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
March 5, 2013) – Lorus Therapeutics Inc. (“Lorus”), a biopharmaceutical company specializing in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, today announced that Lorus’ patent for its lead small molecule anticancer drug LOR-253 has been allowed in China. The patent provides Lorus with exclusive rights to LOR-253 in China until 2026.
The Chinese patent provides composition of matter protection for LOR-253 and for use in the manufacture of therapies for the treatment of cancer. The patent covers a wide range of cancers, including leukemia, melanoma, as well as non-small cell lung, colon, prostate, and breast tumors. This patent extends the Company’s international patent portfolio which includes similar protection for LOR-253 in the United States, Canada, and Australia. Applications are pending in Europe and Japan.
“This increased patent protection for our anticancer therapies supports our business discussions with potential partners,” said Dr. Aiping Young, Lorus’ President and CEO. “This Chinese patent is an important addition to our global IP portfolio for LOR-253, and demonstrates our commitment to the development of innovative cancer therapies intended for significant markets.”
LOR-253 is currently in a clinical study at Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center evaluating tumor biomarkers in biopsy-suitable patients with advanced or metastatic solid tumors.
About LOR-253
LOR-253 represents a new class of anticancer agent, which we believe may offer a competitive advantage over conventional drugs. This drug candidate has shown selective and potent antitumor activity in preclinical investigations with a variety of human cancers, including colon cancer and non-small cell lung cancer, and has demonstrated an excellent therapeutic window due to its low toxicity. LOR-253 is a first-in-class small molecule that has been optimized to induce the novel tumor suppressor Krüppel-like factor 4 (KLF4), leading to cancer cell cycle arrest and apoptosis as well as inhibition of metastasis.
About Lorus
Lorus is a biopharmaceutical company focused on the discovery, research and development of novel therapeutics in cancer. Lorus’ goal is to capitalize on its research, preclinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination with other drugs, to successfully manage cancer. The Company also has expertise in antimicrobial drug discovery. Lorus Therapeutics Inc. is listed on the Toronto Stock Exchange under the symbol LOR.
New Drug Approvals 