Top 20 World Pharma News of 2016 ! PA...
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Top 20 World Pharma News of 2016 ! PART 2
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Daiichi Sankyo announces commencement of clinical trials in Japan for Duchenne muscular dystrophy treatment

Daiichi Sankyo

Daiichi Sankyo

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that administration of the Duchenne muscular dystrophy (hereafter, DMD) treatment drug DS-5141b (hereafter, the Drug), which is jointly developing with the Orphan Disease Treatment Institute Co., Ltd. (hereafter, ODTI), to the first subject has begun in the first clinical trial in Japan.DMD is known as a disease that affects one in 3,500 new-born males regardless of ethnicity. It is known that DMD occurs because muscle cells do not produce dystrophin, but there is no fundamental therapy available.

Because the Drug induces exon 45 skipping of a dystrophin mRNA to promote incomplete but functional dystrophin production, it is expected to be an effective treatment for DMD. The Drug contains the active ingredient ENA® oligonucleotide, a modified nucleic acid made using proprietary technology owned by Daiichi Sankyo. Daiichi Sankyo expects to obtain manufacturing and marketing approval by the end of 2020.

Daiichi Sankyo remains committed to meeting the needs of more patients and medical professionals through drug development and contributing to medical care by providing new treatment options.

About ODTI
Daiichi Sankyo jointly established the ODTI with the Innovation Network Corporation of Japan and a fund managed by Mitsubishi UFJ Capital Co., Ltd. – see Daiichi Sankyo press release dated February 14, 2013 entitled, Daiichi Sankyo Announces Development of Nucleic Acid Treatment for Duchenne Muscular Dystrophy Utilizing Proprietary Technology.

About ENA® oligonucleotides
ENA® is an ethylene-bridged nucleic acid in which ethylene is bridged at the furanose sugar ring at 2′-O and 4′-C ends. Short-chain nucleic acids and ENA® oligonucleotides found in ENA® demonstrate high binding force with complementary DNA and RNA as well as superior thermal stability and nuclease resistance. ENA® is a registered trademark of Daiichi Sankyo.

About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group’s research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics.

 

7.Type 2 diabetes drug can exhaust insulin-producing cells

Long-term use of liraglutide, a substance that helps to lower blood sugar levels in patients with type 2 diabetes, can have a deteriorating effect on insulin-producing beta cells, leading to an increase in blood sugar levels. This according to a study on mice implanted with human insulin-producing cells conducted by a team of scientists from Karolinska Institutet, Sweden, and the University of Miami, USA. The researchers flag the possible consequences of this popular form of therapy in the next issue of the journal ‘Cell Metabolism’.Blood-sugar suppressors in the form of analogues of the incretin hormone GLP-1 are commonly used in the treatment of type 2 diabetes, since they stimulate the glucose response of the pancreatic beta cells to make them secrete more insulin. There is now compelling evidence that liraglutide therapy is efficacious at least in the short term, since it produces an initial reduction in blood sugar. However, many patients do not respond to the treatment and some even display adverse reactions such as nausea, vomiting and diarrhoea.

To study the long-term effects of incretin therapy, which has never previously been assayed, researchers at Karolinska Institutet and the University of Miami worked with humanised mice, generated by transplanting human insulin-producing cells into the anterior chamber of the eye. The mice were given daily doses of liraglutide for more than 250 days, during which time the researchers were able to monitor how the pancreatic beta cells were affected. The results showed an initial improvement in the insulin-producing cells, followed by a gradual exhaustion, with reduced secretion of insulin as a response to glucose. This, they say, was unexpected.

“Given the lack of clinical studies on the long-term effect of these drugs in diabetes patients, this is a very important discovery,” says Midhat Abdulreda, researcher at the Diabetes Research Institute, University of Miami Miller School of Medicine.

“We also need to take these results into account before prescribing blood-sugar suppressing GLP-1 analogues when planning long-term treatment regimens for patients,” says Per-Olof Berggren, PhD, Professor at the Rolf Luft Research Centre for Diabetes and Endocrinology at Karolinska Institutet’s Department of Molecular Medicine and Surgery. “Our study also shows in general how to carry out in vivo studies of the long-term effects of drugs on human insulin-producing cells, which should be extremely important to the drug industry.”

The study was financed by grants from several bodies, including the Diabetes Research Institute Foundation (DRIF), the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases, the Swedish Research Council, the Knut and Alice Wallenberg Foundation, the Family Erling-Persson Foundation, the Stichting af Jochnick Foundation, the European Research Council (ERC) and the Novo Nordisk Foundation. Corporate interests: Per-Olof Berggren is co-founder and CEO of Biocrine, an unlisted biotech company that uses the anterior chamber of the eye as a research tool. Midhat Abdulreda is a consultant for the same company.

Abdulreda et al., Liraglutide Compromises Pancreatic b Cell Function in a Humanized Mouse Model, Cell Metabolism (2016), http://dx.doi.org/10.1016/j.cmet.2016.01.00

AstraZeneca completes acquisition of Takeda’s respiratory business

AstraZeneca

AstraZeneca

AstraZeneca has completed the acquisition of the core respiratory business of Takeda Pharmaceutical Company Limited (“Takeda”). The agreement, announced in December 2015, includes the expansion of rights to roflumilast (marketed as Daliresp in the US and Daxas in other countries), the only approved oral PDE4 inhibitor for the treatment of chronic obstructive pulmonary disease. AstraZeneca has marketed Daliresp in the US since the acquisition of the rights from Actavis in the first quarter of 2015.About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Amgen builds its digital health capabilities through investment in leading digital health incubator

Amgen

Amgen

Amgen (Europe) GmbH, an affiliate of Amgen Inc. (NASDAQ:AMGN) (collectively, “Amgen”) today announced an investment in eHealth Ventures, an Israel-based digital health incubator. The investment reflects Amgen’s commitment to serving patients by driving innovation and sustainable healthcare through technology discovery, and recognizes the importance of Israel as a source of innovation in eHealth and digital technologies. Additional investors include Israeli HMO Maccabi Healthcare Services and Amgen’s Israeli distributor Medison Pharma Ltd. Amgen will be the lead biopharmaceutical investor.”Engaging in multi-stakeholder partnerships will drive innovation and enable us to deliver additional value to patients and the healthcare community, beyond our life-saving medicines,” said Corinne Le Goff, senior vice president, Amgen Europe. “This collaboration with eHealth Ventures is a natural fit for Amgen and will help us expand our digital health pipeline and support the growth of valuable health technology to improve the lives of patients across the world.”

“We are proud to have Amgen, a global market leader, join the eHealth Ventures unique consortium together with Maccabi Healthcare Services, Cleveland Clinic and Medison Pharma. This addition will provide a new strategic element to our screening process and build significant value to our portfolio companies. Having Amgen on board will deliver invaluable assets and know-how in many of the digital health innovation aspects, including market input, commercialization of R&D, business modeling, go-to-market strategies and more,” said Talor Sax, eHealth Ventures Incubator chief executive officer. “We are grateful to our partner Medison Pharma, for realizing this vision and making this partnership a reality.”

About eHealth Ventures
eHealth Ventures, a consortium of world-class organizations and investors active in the field of digital health, was launched in March of 2016 with Israeli government backing. The consortium, which comprises Cleveland Clinic, a leading US hospital, Maccabi Healthcare Services, Israel’s leading and most advanced health provider, and Medison Pharma, Israel’s largest independent specialty pharmaceutical company and Amgen’s distributor in Israel, aims to invest in 40 new companies over an eight year period.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

10. A Faster and cheaper way to produce new antibiotics

A novel way of synthesising a promising new antibiotic has been identified by scientists at the University of Bristol. By expressing the genes involved in the production of pleuromutilin in a different type of fungus, the researchers were able to increase production by more than 2,000 per cent.With resistance growing to existing antibiotics, there is a vital and urgent need for the discovery and development of new antibiotics that are cost effective. Promising developments are derivatives of the antibiotic pleuromutilin, which are isolated from the mushroom Clitopilus passeckerianus.

These new compounds are some of the only new class of antibiotics to join the market recently as human therapeutics. Furthermore, with their novel mode of action and lack of cross-resistance, pleuromutilins and their derivatives represent a class with further great potential, particularly for treating resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA) and extensively drug resistant tuberculosis (XTB).

However, mushrooms are basidiomycete fungi which are not generally amenable to strain improvement and fermentation.

Therefore, in collaboration with pharmaceutical company GSK, Bristol scientists carried out research to identify the genes involved in the production of pleuromutilin. They discovered that a seven-gene cluster is required to produce the antibiotic in C. passeckerianus.

The seven-gene pleuromutilin cluster was then reconstructed within a more industrial fungus, Aspergillus oryzae which belongs to a different group of fungi, the ascomycetes. This resulted in a significant increase (2,106 per cent) in production.

This is the first gene cluster from a basidiomycete to be successfully expressed in an ascomycete, and paves the way for the exploitation of a metabolically rich but traditionally overlooked group of fungi.

Co-author of the research, Professor Gary Foster said: “This was a massive team effort over many years to achieve this major breakthrough. It involved, in the School of Biological Sciences, the drug discovery team led by myself and Dr Andy Bailey, with Dr Colin Lazarus on alternative expression platforms. In addition, significant effort came from chemists at the University of Bristol led by Professor Chris Willis and Professor Russell Cox, and collaborative scientists in GSK.

“With this development, we are now ideally placed to develop novel derivatives and new antibiotics and produce them rapidly and cost effectively – something which is desperately needed globally.”

A novel semisynthetic pleuromutilin, retapamulin, was launched by GSK as the drug Altabax.

‘Identification and manipulation of the pleuromutilin gene cluster from Clitopilus passeckerianus for increased rapid antibiotic production’ by Andy Bailey, Fabrizio Alberti, Sreedhar Kilaru, Catherine Collins, Kate de Mattos-Shipley, Amanda Hartley, Patrick Hayes, Alison Griffin, Colin Lazarus, Russell Cox, Christine L Willis, Karen O’Dwyer, David Spence, Gary Foster in Scientific Reports

COURTESY –  WORLD PHARMA NEWS



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