Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Adeline Siew, PhD

 that it is developing the first nanodrug combination of Merck’s temozolomide and Celgene’s thalidomide (in a 50:50 ratio) for the treatment of gliomas and other cancers. PKC will collaborate with the University of California, San Diego’s department of nano-engineering at the Moores cancer centre to develop the nanodroplet formulation. 

According to PKC, 2000 to 20000 molecules of each type of drug can be packaged in one nanodroplet. Preliminary studies have indicated that the ratio of these different drugs can be precisely controlled. PKC’s goal is to produce nanodroplets that have special affinities for cancer cells with enhanced efficacy in destroying such cells compared with conventional chemotherapy. 

 testing of the temozolomide–thalidomide nanodroplets. Preliminary findings show that the combination is significantly more effective than the current commercially available formulations of these drugs that are being used in the clinic.  

It is thought that direct local delivery is necessary to achieve the potentially high efficacy of the nanodrugs. PKC is developing a microminiaturized metronomic biofeedback pump nano (MBPn) version, a fully implantable infusion pump that enables programmable, metronomic, local delivery and sampling via a multichannel catheter that has the potential to avoid elimination by the liver. The company hopes that the MBPn will enhance anticancer activity of the drugs at the target site while reducing adverse effects on healthy cells.  

 "We are conducting ongoing development and testing in order to prove the efficacy of delivering proprietary nanodroplet formulations of anticancer medications using our MBP," said Frank Adell, CEO of PKC in a 

. "If these tests are successful, we believe PKC will produce a major advance in treating gliomas and potentially other types of cancer as well." 

Articles

Pharmaco-Kinesis Corporation (PKC) announced that it is developing the first nanodrug combination of Merck's temozolomide and Celgene's thalidomide (in a 50:50 ratio) for the treatment of gliomas and other cancers. PKC will collaborate with the University of California, San Diego's department of nano-engineering at the Moores cancer centre to develop the nanodroplet formulation.

Pharmaco-Kinesis Corporation Develops First Nanodrug Combination for Glioma

Bayer announced that it has signed a merger agreement with US-based birth-control specialist Conceptus. This acquisition will expand Bayer’s position in women’s health, enabling the company to offer a broad range of short-term, long-term and permanent contraceptive choices. 

Bayer is offering to acquire all shares in Conceptus for US$31.00 per share in cash with the transaction of Conceptus being valued at approximately US$1.1 billion (approximately EUR 852 million). Closing of the deal is expected by mid 2013, subject to customary conditions, particularly anti-trust approval in the US. 

 "Bayer is committed to augmenting its organic growth with strategic bolt-on acquisitions. The acquisition of Conceptus represents an excellent fit for our healthcare business," said Marijn Dekkers, CEO of Bayer AG, in a 

 "Both Bayer and Conceptus are focusing on innovative solutions to advance women's healthcare. Essure completes Bayer’s portfolio of long-acting intrauterine systems and short-acting oral contraceptives. Our experience in the field of gynecology combined with our sales and distribution expertise will help to further develop Conceptus’ business," said Andreas Fibig, member of the Bayer healthcare executive committee and president of Bayer healthcare pharmaceuticals. 

Conceptus developed the Essure procedure, which is a non-surgical, hormone-free, permanent birth control method marketed in the United States and other countries. Essure was approved by FDA in 2002. The procedure can be performed by a physician in less than 10 minutes without the risks associated with general anesthesia or tubal ligation. Clinical trials have demonstrated that Essure is 99.8% effective with zero pregnancies based on five-year follow up. More than 700,000 women worldwide have undergone the procedure. 

Conceptus generated net sales of US$141 million (approximately EUR 110 million) in 2012. Adjusted EBITDA for 2012 was $28.2 million (approximately EUR 22.0 million). 

Bayer announced that it has signed a merger agreement with US-based birth-control specialist Conceptus.

Bayer to Acquire Conceptus for US$1.1 Billion

Catalent Pharma Solutions, a provider of drug and biologic development services, delivery technologies and supply solutions, has officially opened a new biomanufacturing center of excellence in Madison. The facility, which was constructed in response to customer demand, is expected to quadruple Catalent's current biologics manufacturing capacity and extensively utilise single-use technology for greater flexibility and efficiency. It will allow the company to extend its offerings in the biologics sector while enhancing the efficiency and output of its proprietary GPEx cell line engineering technology as well as other mammalian cell lines. 

Catalent recently acquired an exclusive license to market Redwood Bioscience’s proprietary SMARTag precision protein-chemical engineering technology for developing advanced antibody drug conjugates (ADCs) with enhanced potency, safety and stability. The technology adds to Catalent’s broad range of analytical and fill-finish services, including the company’s proprietary GPEx cell line expression system, which provides a platform for rapid development of stable, high yielding cell lines. 

The Madison site marks a further expansion of Catalent’s capabilities to help its customers develop better biologic treatments. This 100 000-square-feet facility has been designed for flexible cGMP production, from 10 L up to 1000 L, and nonGMP production of up to 250 L. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development laboratories as well as separate microbiology and quality-control functions. 

Catalent has moved all its 89 employees from its current 43 000-square-feet facility in Middleton to the Madison site. The company also plans on eventually employing more than 100 people at the new facility. 

 "Our new biomanufacturing center of excellence has been specifically designed to meet our customers’ needs through improved delivery of integrated services in the areas of biologic development and manufacturing, and we will be pleased to welcome many of them on site at the official opening," Barry Littlejohns, president of Catalent’s Biologics business said in a 

. "The extensive application of single-use technology greatly reduces the risk of cross contamination and gives us huge flexibility and scale, while our on-site capabilities enable us to provide our customers with solutions for even the most difficult to express proteins." 

Catalent Pharma Solutions, a provider of drug and biologic development services, delivery technologies and supply solutions, has officially opened a new biomanufacturing center of excellence in Madison. The facility, which was constructed in response to customer demand, is expected to quadruple Catalent's current biologics manufacturing capacity and extensively utilise single-use technology for greater flexibility and efficiency. It will allow the company to extend its offerings in the biologics sector while enhancing the efficiency and output of its proprietary GPEx cell line engineering technology as well as other mammalian cell lines.

Catalent Biologics Opens New Single-Use Biomanufacturing Facility in Madison

Lundbeck has launched Selincro in Norway, Finland, Poland and the Baltic countries of Latvia, Lithuania and Estonia for the treatment of alcohol dependence in patients with high-risk drinking levels. According to Lundbeck, the launch marks the first introduction of a new treatment for alcohol dependence in Europe for more than a decade. Additional launches in other countries are expected to follow later in 2013 and 2014. 

Selincro (nalmefene) was granted marketing approval by the European Commission in March 2013 for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high risk drinking level (>60g/day for men, >40g/day for women) without physical withdrawal symptoms and who do not require immediate detoxification. Clinical trials demonstrated that Selincro reduced alcohol consumption by approximately 60% after six months treatment. 

 in its press release that this is the first and only medicine approved for the reduction of alcohol consumption in patients with alcohol dependence. "We are proud to make Selincro available to patients suffering from alcohol dependence. This is an area with significant unmet medical needs, and we are excited about introducing an innovative treatment concept that provides a new and different option for patients who may otherwise not seek treatment," said Ole Chrintz, the company’s senior vice president of international markets and Europe. 

Lundbeck has launched Selincro in Norway, Finland, Poland and the Baltic countries of Latvia, Lithuania and Estonia for the treatment of alcohol dependence in patients with high-risk drinking levels. According to Lundbeck, the launch marks the first introduction of a new treatment for alcohol dependence in Europe for more than a decade.

Lundbeck Launches Selincro as First Alcohol Dependence Drug in Europe

BioOutsource, a contract testing services provider to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts. The facility marks the company's first North American offices, which were opened in response to increasing demand for the company's bioanalytical and biosafety services, particularly in the field of biologic and biosimilar characterisation. The announcement was made at the 2013 BIO International Convention, "the Global Event for Biotechnology," in Chicago, Illinois. 

 that it will draw on its experience in providing biosimilar characterisation assays to its European customers, in providing similar services throughout North America. The office will be located at the Cambridge Innovation Center on Kendall Square, which is adjacent to the Massachusetts Institute of Technology campus and home to a number of growing life sciences and venture capital firms. 

Gerry MacKay, CEO of BioOutsource said that the new facility "will facilitate engagement with North American customers for our off-the-shelf biosimilar biological characterisation assays, for example for Humira, Enbrel, Rituxan, Herceptin, Remicade, and Avastin." 

 "We are in the fortunate position to have been first-to-market in both Europe and the US with our assays, and count Big Pharma as well as leading biotechnology as valued customers," said Verna McErlane, BioOutsource director of sales and business development, bioanalytical division. “We look forward to being able to interact with them and provide our market-leading services, that much more readily, from our North American base of operations in Cambridge. Cambridge is, of course, part of greater Boston, which is now the number one cluster for early-stage biotechnology, and a growing center of operations for some of the world's leading pharmaceutical firms, as well." 

 "We see the North American market as an essential strategic element of our global expansion plans. We remain committed to not only growing our business in North America but in nurturing our relationships with our existing North American clients, as well. We invite all our customers and potential customers to stop by our new offices whenever you are in the Boston area," MacKay concluded. 

BioOutsource provides contract testing services to the biopharmaceutical industry. Core offerings include a range of services to support the testing of biologics, vaccines and biosimilars throughout their development. 

BioOutsource, a contract testing services provider to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts. The facility marks the company's first North American offices, which were opened in response to increasing demand for the company's bioanalytical and biosafety services, particularly in the field of biologic and biosimilar characterisation.

BioOutsource Opens New Facility in Cambridge, Massachusetts

 that it has upgraded its EudraGMP database to include information on GDP in addition to GMP. The new 

 (FMD) that came into effect in January 2013. The aim is to increase supply chain security in the EU by making supervision of manufacturing and distribution of medicines more robust to ensure supplier compliance. Those involved in the supply chain will be able to check information available on their suppliers. 

EudraGMDP is a modification of the EudraGMP database, which was first launched in April 2007 to facilitate the exchange of information on compliance and noncompliance with GMP among the regulatory authorities within the European medicines network. The database currently contains manufacturing and import authorisations; GMP certificates; statement of noncompliance with GMP; and GMP inspection plans in countries outside the EU. 

Over the next few months, medicines regulatory authorities in EU member states will upload distribution-related information as it becomes available. The additional information will include wholesale distribution authorisations; GDP certificates; statements of noncompliance with GDP; and registrations of manufacturers, importers (including information on their suppliers) and distributors of active substances. 

The new system follows the new GMP inspection planning module introduced in December 2012 for countries outside the EU. It was developed to make better use of inspection resources by sharing of information among EU regulators and avoiding redundant inspections. 

Most information in EudraGMDP is accessible by the public except for information of commercially or personally confidential nature. The decision on which information can be made public is made by the medicines regulatory authority in the member state that uploads the information to the database. 

About the FMD: The directive was adopted to protect patients and consumers from falsified medicines by strengthening supervision of the supply chain of medicinal products and active substances entering the EU.  New requirements of the FMD can be divided into four categories: safety features on medicines; supply chain and GDP; active substances and excipients; and Internet sales. 

EMA has upgraded its EudraGMP database to include information on GDP in addition to GMP. The new EudraGMDP database is a key deliverable of the Falsified Medicines Directive (FMD) that came into effect in January 2013. The aim is to increase supply chain security in the EU by making supervision of manufacturing and distribution of medicines more robust to ensure supplier compliance.