Pharma/fine chemicals roundup—21 January 2014
12:25 AM MST | January 21, 2014 | By DEEPTI RAMESH
Antibody-drug conjugates: A developing market with substantial growth potential
The antibody-drug conjugates (ADCs) market, which is in its early stages of development, offers growth opportunities for several contract-manufacturing organizations (CMOs). With the success of two ADC drug products in the worldwide market, and with several others in different stages of development, CMOs are looking to ride the growth wave, experts and industry players say. ADCs are a mix of synthetic chemistry and biopharmaceuticals, says Enrico Polastro, v.p. and senior industry specialist at Arthur D. Little (Brussels). ADCs offer a new treatment method for cancer under which cancer cells are destroyed in a more targeted way and healthy cells are less damaged, reducing the toxic effects of chemotherapy, Polastro says.
EFCG appoints new president
The European Fine Chemicals Group (EFCG; Brussels), an industry association that is part of Cefic, the Brussels-based European chemical industry council, says that the EFCG board has appointed Heinz Sieger as president, Roger LaForce as v.p., and Hubert Stueckler as sector group manager all with effect from 1 January 2014. EFCG was formed in 2004 to be the focus, the forum and the voice of European fine chemical manufacturers.
Sieger is chairman of CU Chemie Uetikon (Lahr, Germany) and he has been a member of the EFCG board since its inception in 2004. He replaces Brian Murphy of Robinson Brothers (West Bromwich, UK) as president. LaForce is CEO of Zach System (Bresso, Italy) and is a former chairman of the EFCG pharmaceuticals business committee. Stueckler, until recently, has been the president of the actives division and head of global operations of Siegfried (Zofingen, Switzerland) and was formerly a senior executive of DSM.
AMRI appoints new head of India operations to bolster API business
Albany Molecular Research Inc. (AMRI; Albany, NY) says it has appointed Vijay Kumar Batra, to the position of managing director, AMRI India, effective 2 January. Batra will report to Steve Hagen, senior v.p./manufacturing and pharmaceuticals at AMRI. Batra brings a “wealth of experience in the active pharmaceutical ingredients [API] and intermediates business and he also brings a leadership acumen that helps AMRI continue our plan for growth in the Indian and world markets,” Hagen says. Before joining AMRI, Batra held a number of executive roles with Teva Pharmaceutical Industries (Petaḥ Tiqwa, Israel) since 2003. Most recently, he was vice chairman and managing director, Teva API India, responsible for research and development and manufacturing of APIs and advanced intermediates for the global market. Batra also served as chairman of Teva API China during his most recent tenure.
Socma membership rises
Socma announced that 12 firms, including makers of specialty chemicals, distributors, and service providers, have joined the lobbying group. The new members were approved by Socma’s board last month at its meeting at New York, the group says. The new members include Codexis (Redwood City, CA). They also include several makers of a variety of chemicals, from active pharmaceutical ingredients to polymers, a law firm, a consulting firm, an equipment maker, and a research center. Socma has over 200 member companies.
Bayer launches takeover offer for Norwegian pharmaceutical firm Algeta
Bayer says that it has commenced the previously announced public takeover offer for all the shares of Norwegian pharmaceutical company Algeta (Oslo) for 362 Norwegian kroner ($59) in cash per Algeta share. The offer values the total share capital of Algeta at about 17.6 billion Norwegian kroner ($2.85 billion). Bayer raised its offer for Algeta, after initially offering to pay 336 Norwegian kroner per Algeta share. Bayer has today ssued the takeover offer on the basis of the agreement signed with Algeta on 19 December 2013. The offer period starts on 20 January and expires on 24 February. The board of directors of Algeta has unanimously recommended that its shareholders accept the offer.
Air Liquide unit gets Excipact certification as pharmaceutical excipient supplier
The Excipact Association, a project of the IPEC Federation (Brussels), says that Sepiprod (Castres, France) has received an Excipact certification from mdc medical device certification, one of Excipact's certification bodies. Sepiprod is a production site of Seppic (Paris), a subsidiary of Air Liquide within its healthcare business. Excipact certification demonstrates that this Sepiprod site manufactures pharmaceutical excipients according to the Excipact GMP certification standard. This is the first French site to receive such certification. The other certified sites are in Germany — BASF site at Ludwigshafen; Merck KGaA site at Darmstadt; and Aug. Hedinger site at Stuttgart, Excipact says.
The US and European Union pharmaceutical excipient regulations now require drug manufacturers to do either their own or third party physical audits of all their starting material suppliers to demonstrate GMP and/or good distribution practice (GDP) compliance. The audit burden is huge, Excipact says. Using GMP and GDP standards designed for excipients, the new third party Excipact certification scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and ensure quality, Excipact says.
Actavis to sell operations in seven European countries to Aurobindo
Aurobindo Pharma (Hyderabad, India) says it will acquire the commercial operations of Actavis (Dublin) in seven Western European countries. Aurobindo will acquire Actavis' pharmaceutical commercial infrastructure in Belgium, France, Germany, Italy, the Netherlands, Portugal, and Spain, including products, marketing authorizations and dossier license rights. The two companies will also enter into a long-term strategic supply arrangement. Financial details of the deal were not disclosed. Management estimates the net sales for the acquired businesses would be about €320 million ($432 million) in 2013 with a growth rate of over 10%/year, Aurobindo says. Actavis is a specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Aurobindo manufactures generic pharmaceuticals and active pharmaceutical ingredients (APIs).
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