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."