Merck to acquire Sigma-Aldrich for $17 billion

Merck KGaA, a leading company in the pharmaceutical, chemical and life science sectors, has set to acquire Sigma-Aldrich for $17 billion (€13.1 billion) and establishing one of the leading players in the $130 billion global life science industry.

Merck will acquire all of the outstanding shares of Sigma-Aldrich for $140 per share in cash. The agreed price represents a 37 per cent premium to the latest closing price of $102.37 on September 19, 2014, and a 36 per cent premium to the one-month average closing price. The transaction is expected to be immediately accretive to Merck’s EPS pre and EBITDA margin. Merck expects to achieve annual synergies of approximately €260 million (approximately $340 million), which should be fully realized within three years after closing.

Guggenheim Securities and J.P. Morgan are acting as financial advisers to Merck. Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal adviser to Merck. Morgan Stanley & Co. LLC is acting as financial adviser to Sigma-Aldrich and Sidley Austin LLP is acting as legal adviser.

Sagent Pharma launches oxaliplatin

Sagent Pharmaceuticals, Inc. has introduced oxaliplatin injection, USP, an antineoplastic agent, now in two liquid presentations. According to IMS, for the 12 months ending July 2014, the US market for oxaliplatin approximated $102 million. As with all products in Sagent's portfolio, oxaliplatin features Sagent's PreventIV MeasuresSM packaging and labeling, designed to help reduce the risk of medication errors.

Oxaliplatin injection, USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and for treatment of advanced colorectal cancer.

Sagent Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables.  

Telormedix's lead product Vesimune gets European patent

Telormedix, a clinical stage biopharmaceutical company focussed on TLR7 agonists in the treatment of cancer and infectious diseases, has been granted the European Patent No. 2393474 entitled "Pharmaceutical compositions comprising imidazoquinolin (amines) and derivatives thereof suitable for local administration" by the European Patent Office.

The European patent, which will expire in 2030, broadly covers Telormedix’s lead product Vesimune (TMX-101) and its use for the treatment of bladder cancer. Further patents for Telormedix’s Vesimune have also recently been granted in China and Australia.

,Vesimune is Telormedix’s lead product, a TLR-7 agonist currently has successfully completed a phase II trial in CIS (carcinoma in situ) of the bladder. The product is a unique sterile liquid formulation of a marketed immune modulatory compound, designed on innovative technology principles to carrier drug delivery systems in order to increase solubility, bio-adhesiveness and stability. These properties mean that the product can be used in therapeutic settings that the original product could not.

Sigma-Aldrich enters new gene editing partnership with University of Michigan

Sigma-Aldrich Corporation, a leading life science and high technology company, has entered into a new gene editing partnership with the University of Michigan (U-M) Medical School's Vector Core.

Under the partnership, Sigma-Aldrich will provide the Vector Core with Sigma CRISPR technology, experimental design consultation, and dedicated gene editing bioinformaticians.

The partnership is poised to accelerate gene editing-based research at the U-M Medical School. One initiative already underway, led by Assistant Professor Chad Brenner, involves constructing a large library of Sigma CRISPRs for precision studies of the 100 most common genes that have dysfunctions associated with cancer. Brenner's CRISPR library is expected to support the generation of an unprecedented dataset about oncogene functions and drug resistance, leading to improved decision-making for personalized medical treatment of cancer.

Eli Lilly's Trulicity receives US FDA approval to treat adults with type 2 diabetes

Eli Lilly and Company announced that the approval of Trulicity (dulaglutide) by the US Food and Drug Administration is the latest treatment option for adults with type 2 diabetes.

Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease.

Lilly plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. This marks the first approval for Trulicity anywhere in the world. It has also been submitted to the European Medicines Agency and other regulatory bodies

Biocon purchases GE Capital's stake in Syngene for Rs.215.38 crore

Drug maker Biocon has entered into an agreement with GE Equity International Mauritius, a subsidiary of GE Capital Corporation, to purchase the latter’s stake in Biocon research services subsidiary, Syngene International for Rs.215.38 crore.

GE Capital has 7.69 per cent stake in Syngene of Biocon according to the information shared with the stock exchange.

It was in November 2012, that Biocon signed an agreement with GE Equity International Mauritius, a subsidiary of GE Capital Corporation, to make a primary equity investment of Rs.125 crore in Syngene. GE received a 7.69 per cent equity share in Syngene. The investment from GE Capital saw Syngene’s Post Money Equity Valuation to be Rs.1,625 crore.

Syngene has been a pioneer in the contract research in India and is also recognised as the largest in Asia. It is engaged in integrated drug discovery and development services with a focus on medicinal chemistry, biology, in vivo pharmacology and toxicology. It has a total scientific strength of 1,500 to support the research and development programmes of global pharma, biotech and nutrition companies.

Mylan to buy Arixtra's US rights from Aspen

Mylan Inc's subsidiary Mylan Ireland Limited has entered into an agreement to acquire the US commercialization, marketing and intellectual property rights relating to Arixtra (fondaparinux sodium) injection and the authorized generic (AG) of Arixtra from Aspen Global Incorporated.

Arixtra is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip fracture surgery, including extended prophylaxis, hip replacement surgery, knee replacement surgery or abdominal surgery who are at risk for thromboembolic complications. Mylan already is selling Arixtra in the US through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.

Mylan CEO Heather Bresch commented, "DVT/PE is a serious health concern that is estimated to affect up to 600,000 people in the U.S.1 The addition of Arixtra is an attractive opportunity to broaden the range of therapeutic categories we market in the US, in both the hospital and retail settings, and bolster our growing portfolio of complex injectables to better meet our customers' needs."

GSK joins with UK &South African Medical Research Councils

GSK recently announced a £5m collaboration with the UK and South African Medical Research Councils, to support much-needed research into non-communicable diseases (NCDs) in Africa, as part of GSK’s Africa NCD Open Lab initiative.



The funding was pledged today by the UK Foreign Office Minister responsible for Africa, James Duddridge, and South Africa’s Minister for Science and Technology, Naledi Pandor, at an event in Cape Town, South Africa, as part of a broader collaboration between the two countries on scientific research. It will be used to support researchers from South African institutions conducting research projects in NCDs, aligned with the objectives of GSK’s Africa NCD Open Lab.

£2.5m will be provided by the UK MRC, via the UK Newton Fund a government fund established in 2013 to develop science and innovation partnerships that promote the economic development and welfare of developing countries and approximately £1.5m will come from the South African Medical Research Council. GSK will provide an additional £1m, together with a commitment of internal R&D expertise, to support projects within South Africa.  As the first initiative to receive support from the UK / South Africa Newton Fund, this is significant external endorsement for GSK’s open approach to NCD research in Africa.

Navidea inks agreement with Hainan Sinotau Pharma

Navidea Biopharmaceuticals has entered an exclusive agreement with a wholly-owned subsidiary of Hainan Sinotau Pharmaceutical Co., Ltd., a pharmaceutical organisation with a broad China focus in oncology and other therapeutic areas, who will develop and commercialise Lymphoseek (technetium Tc 99m tilmanocept) injection in China.

In exchange, Navidea will earn revenue based on unit sales to Sinotau, a royalty based on Sinotau’s sales of Lymphoseek and up to $2.5 million in milestones from Sinotau, including a $300,000 upfront payment. Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical approved in the US for use in lymphatic mapping to assist in the detection of lymph nodes in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in certain oral cancer patients.

As part of the agreement, Sinotau is responsible for costs and conduct of clinical studies and regulatory applications to obtain Lymphoseek approval by the China Food and Drug Administration (CFDA). Upon approval, Sinotau will be responsible for all Lymphoseek sales, marketing, market access and medical affairs activities in  China and excluding Hong Kong, Macau and Taiwan. Navidea and Sinotau will jointly support certain pre-market planning activities with a joint commitment on clinical and market development programmes pending CFDA approval. In addition to the $300,000 upfront, Navidea is eligible for $700,000 in milestones up to and through product approval, and an additional $1.5 million in sales milestones.

BIOCRATES Life Sciences introduces -Metabolomics-based bile acids kit

BIOCRATES Life Sciences AG, developer of cutting-edge mass-spectrometry-based kit products, has launched the first-ever bile acids kit based on targeted metabolite quantitation.

Bile acids are essential for regulating cholesterol metabolism and the intestinal digestion and absorption of fat. Their signaling functions play an important role in chronic disorders, sepsis, or drug metabolism.

BIOCRATES Life Sciences has now developed an assay for the standardized analysis of 16 human specific and 19 mouse specific bile acids from sample sizes as small as 10 µL designed for research use.

The BIOCRATES Bile Acids Kit is based on (ultra) high performance liquid chromatography coupled with electrospray tandem mass spectrometry (UHPLC-MS/MS) and is characterized by quick and highly effective sample extraction on a 96-well patented filter plate. To ensure accuracy and precision, the kit comes with a set of calibration standards, isotope-labeled internal standards, and quality control samples. The assay has been rigorously validated to European Medicines Agency (EMA) guidelines.

Novartis to present data from three clinical trials

Novartis announced that a wealth of new data from its respiratory portfolio will be presented at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany. In total, 44 abstracts (including four late-breakers) will be presented by Novartis, representing more than any other company at the congress.

"Novartis is committed to making a difference to the lives of millions of people worldwide living with debilitating conditions, such as COPD and severe asthma," said Vasant Narasimhan, global head of development, Novartis Pharmaceuticals. "We hear from patients how their lives have improved because of our respiratory medicines, and this motivates us to continue to advance respiratory treatments in our portfolio."

Positive new results from the phase III head-to-head LANTERN study showed the superiority of once-daily, dual bronchodilator, Ultibro Breezhaler (indacaterol/glycopyrronium bromide) in improving lung function compared to twice-daily Seretide Accuhaler (salmeterol/fluticasone combination: LABA/ICS), in patients with moderate-to-severe COPD.

TaNeDS collaborative drug discovery programme in Europe

Daiichi Sankyo Company, Limited, a global pharmaceutical company, announced details of the application for its Take a New Challenge for Drug Discovery (TaNeDS) Global Programme 2014, a collaborative drug discovery initiative for universities and research institutes in Europe.

The TaNeDS programme was launched in Japan in 2011 to help discover new lines of research through open innovation. From 2013, it expanded abroad, opening up to researchers in Germany, Switzerland and Austria, and becoming known as the TaNeDS Global Programme. Now, in 2014, it has expanded further across Europe to include all EU member countries. The program is conducted with the aim of realizing Daiichi Sankyo’s corporate slogan of “Passion for Innovation. Compassion for Patients.” Through increasing collaborative opportunities with researchers in Europe. U3 Pharma GmbH, a wholly owned subsidiary of Daiichi Sankyo, is also participating in the programme in order to nurture the seeds of drug discovery for the next generation.

The TaNeDS Global Programme 2014:  Countries where research could be conducted: All EU member countries plus Norway and Switzerland.

Overview of research programmes: Daiichi Sankyo seeks innovative technological research collaborators for novel drug discovery and testing projects that could result in novel drug discovery and novel new drugs.

Research themes: 1) Cancer - New targeted and investigative research for small-molecule and biologic treatments (antibody drugs, etc.). 2) Cardiovascular and metabolic disorders - New mechanisms and drug treatments for obesity, kidney and renovascular-related disorders. 3) Other disorders - New mechanisms and drug treatments for genetic disorders, new drug treatments for pain, genetic analysis and new drug research for rare diseases. 4) Revolutionary drug discovery technology - New biologic technology, target molecules and delivery systems for nucleic acid treatments, new technology for drug development based on protein structural analysis.

US FDA grants fast track status to Pfizer’s clostridium

The US Food and Drug Administration (FDA) has granted Fast Track designation to the Pfizer’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhoea and pseudomembranous colitis.




“C. difficile is a growing, difficult-to-treat healthcare-associated infection,” said Dr. Emilio Emini, senior vice president of vaccine research and development for Pfizer. “No vaccine is currently available to prevent the infection-associated disease. In the United States alone, there are approximately 250,000 cases of C. difficile-associated disease, resulting in approximately 14,000 deaths each year.”

Clostridium difficile (klos-TRID-e-um dif-uh-SEEL), often called C. difficile, is the most frequent cause of healthcare-associated infections. C. difficile is a spore-forming, Gram-positive anaerobic bacillus that produces two exotoxins: toxin A and toxin B. It is a common cause of antibiotic-associated diarrhoea (AAD) and accounts for 15-25 per cent of all episodes of AAD.
FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.

Activity of brain cell networks

Learning is easier when it only requires nerve cells to rearrange existing patterns of activity than when the nerve cells have to generate new patterns, a study of monkeys has found. The scientists explored the brain’s capacity to learn through recordings of electrical activity of brain cell networks. The study was partly funded by the National Institutes of Health.

“We looked into the brain and may have seen why it’s so hard to think outside the box,” said Aaron Batista, Ph.D., an assistant professor at the University of Pittsburgh and a senior author of the study published in Nature, with Byron Yu, Ph.D., assistant professor at Carnegie Mellon University, Pittsburgh.

The human brain contains nearly 86 billion neurons, which communicate through intricate networks of connections. Understanding how they work together during learning can be challenging. Dr. Batista and his colleagues combined two innovative technologies, brain-computer interfaces and machine learning, to study patterns of activity among neurons in monkey brains as the animals learned to use their thoughts to move a computer cursor.

“This is a fundamental advance in understanding the neurobiological patterns that underlie the learning process,” said Theresa Cruz, Ph.D., a programme official at the National Center for Medical Rehabilitations Research at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). “The findings may eventually lead to new treatments for stroke as well as other neurological disorders.”

Brain-computer interfaces seek to turn thoughts into action. With small surgically implanted electrodes, researchers can simultaneously monitor the electrical activity of hundreds of neurons. A computer converts the signals into commands to move an external device, such as a robotic arm or a computer cursor. Brain-computer interfaces are being developed to help paralysed patients as well as to study the function of healthy brains.

“This evolving technology is a powerful tool for brain research,” said Daofen Chen, Ph.D., a programme director at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “It helps scientists study the dynamics of brain circuits that may explain the neural basis of learning.”