|Email Newsletters from Pharmaceutical Technology and Pharmaceutical Technology Europe|
Providing the latest business, scientific, and regulatory news for the pharmaceutical and biotech industries.
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Week of May 26, 2011: Company and People Notes: Almac opens new North American headquarters; Sanofi Pasteur appoints Damian Braga as senior vice-president of global commercial operations; and More.
Almac, a contract development and manufacturing organization, officially opened its new $120-million, 240,000-ft2 North American headquarters in Souderton, Pennsylvania. The company’s global headquarters is located in Craigavon, United Kingdom.
Eli Lilly has formed BioCritica, a new biotechnology company, with private-equity investors Care Capital and NovaQuest Capital, which will focus on hospital-based critical-care drugs. The initial focus of the company will be on the US development and commercialization of Xigris (drotrecogin alfa [activated]), a drug to treat sepsis.
Johnson & Johnson (J&J) subsidiary Cilag GmbH International agreed to acquire the over-the-counter brands of JB Chemicals and Pharmaceuticals for approximately $260 million in cash. The brands included in the acquisition are Rinza, a Russian multisymptom cough-and-cold brand, and Doktor Mom, Russia’s number-two selling cough medicine brand, in addition to several other brands. J&J subsidiary Johnson & Johnson LLC and its affiliates will market these products in Russia, the Commonwealth of Independent States, and other countries.
In other news, FDA approved Tibotec Therapeutics’ Edurant (rilpivirine) tablets for use in combination with other antiretroviral agents in the treatment of HIV Type I in treatment‑naïve adults.
Merck & Co. and Roche have agreed to explore new combinations of investigational and marketed medicines used to treat chronic hepatitis C. Under the terms of the nonexclusive agreements in the United States, Genentech, a part of Roche, will include Victrelis (boceprevir) as part of its promotion to healthcare professionals on the use of Pegasys (peginterferon alfa-2a) in a triple-combination therapy regimen.
Par Pharmaceutical, a specialty pharmaceutical company, has agreed to acquire Edict Pharmaceuticals, a generic-drug company based in Chennai, India, for $37.5 million. The acquisition, which is subject to customary closing conditions and approvals, is expected to close by the end of 2011.
Rafagen, a biotechnology company, has partnered with the contract manufacturing organization Goodwin Biotechnology, for cell-line development and biological contract manufacturing.
The private-equity firm Ridgemont Equity Partners has acquired a majority stake in Gallus Biopharmaceuticals, a contract biologics manufacturer based in St. Louis, Missouri. The investment by Ridgemont allows Gallus to acquire a 200,000-ft2 biologics manufacturing facility in Berkeley, Missouri, from Centocor Biologics, part of J&J. The plant currently manufactures two Centocor Biologics’ products, Remicade (infliximab) and Stelara (ustekinumab). Ridgemont’s investment also will be used to expand the facility’s manufacturing capabilities, including building a clinical-services suite and expanding the existing development laboratory. Gallus plans to make an initial capital investment of $20 million to expand the facility, according to a release by the governor’s office in Missouri.
In other news, Gallus and the biomanufacutring company Xcellerex have entered into a biomanufacturing collaboration. Under the terms of the agreement, Gallus will acquire several Xcellerex bioproduction systems for new suites and laboratories at its existing manufacturing facility. Along with single-use XDR bioreactors to quickly expand capabilities in an existing commercial manufacturing suite, Gallus is acquiring small-scale 10-L bioreactors for its expanded development laboratory and a turnkey FlexFactory cGMP manufacturing line with XDR single-use bioreactors up to 2000-L scale for clinical supply.
Ropack, a provider of contract manufacturing and packaging services, has begun stickpack production in its new 15,000-ft2 manufacturing suite. The nearly $9-million facility provides unidose packaging of solid oral dosage in four Class 100000 cleanrooms at low relative humidity (20%), controlled temperature, and controlled residual oxygen to 4%. The new production suite is part of Ropack’s 210,000-ft2 manufacturing, packaging, warehouse, and distribution space. In addition to stickpacks, Ropack is equipped to perform standard and cold-form blistering, encapsulation, bottling, sachet filling, syringe assembly, clinical trials, and blending.
SAFC, the custom manufacturing and business services arm of Sigma-Aldrich, has formed a licensing agreement with Agilent Technologies, which makes SAFC a preferred partner in the sale of Agilent’s nucleic acids synthesis products and technologies. The product–line addition builds on a previous licensing agreement and covers Agilent’s proprietary TC-RNA phosphoramidites, which are chemistries that can enable the production of RNA-based oligos.
Shire, a specialty biopharmaceutical company, has agreed to acquire the regenerative medicine company Advanced BioHealing, for $750 million. The deal provides Shire a strategic platform for tissue regeneration using cell-based therapies and adds Dermagraft, a medication to treat diabetic foot ulcers, to its portfolio. The deal is subject to customary closing conditions and regulatory approval.
Thermo Fisher Scientific, a life-sciences services and product firm, has acquired Sterilin, a provider of single-use plastic products serving the microbiology, life-sciences, and clinical markets. Sterlin recorded 2010 sales of $35 million. Thermo Fisher also has agreed to acquire Phadia, a provider of allergy and autoimmunity diagnostics, from the European private-equity firm Cinven, for €2.47 billion ($3.5 billion) to build its specialty diagnostics business. The deal is expected to close in the fourth quarter of 2011, subject to customary closing conditions and regulatory approval.
Vetter Pharma, a contract development and manufacturing organization, has completed the structural work on its new center for visual inspection and logistics in Ravensburg, Germany. This high-bay warehouse will be used to house cold-storage and room-temperature products and will be powered by photovoltaics, biogas, and geothermal sources of energy. The €31 million ($44 million) project is scheduled to be completed in late 2011.
Fereydoun Firouz has resigned from his position as president and CEO of EMD Serono, an affiliate of Merck KGaA, following two decades of service. James Hoyes, who is currently chief commercial officer, will serve as acting head of the organization on an interim basis.
Sanofi Pasteur, the vaccines division of Sanofi, has appointed Damian Braga as senior vice-president of global commercial operations. Previously, Braga was president of Sanofi Pasteur US and vice-president of Sanofi Pasteur Americas.