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 Nanoparticle mills provide efficiency and control
The DeltaVita line of ultrafine nanoparticle mills from NETZSCH Premier Technologies (Exton, PA) includes devices appropriate for the wet grinding of batch sizes from 0.05 to 2000 L. The mills’ high-energy input and high flow rates in a recirculation process enable them to complete 10 cycles in the time it takes other mills to complete one. Continuous high-flow throughput ensures that the entire batch passes the mill several times before the process is completed while the batch tank is continuously agitated. The milling process is continuously monitored, which helps control the end point of the process and yield the desired product quality. The DeltaVita mills incorporate NETZSCH’s Zeta grinding system, which uses small grinding media to produce fine end products in the nanometer range. The machines are designed for easy cleaning, repeatability, and easy validation. The units are isolated for operator safety, and their wetted parts are manufactured according to good manufacturing practice standards.
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Contract manufacturing organization Aesica Pharmaceuticals will purchase three manufacturing sites in Germany and Italy from the biopharmaceutical company UCB. Aesica will acquire the German sites in Monheim and Zwickau, as well as UCB’s Pianezza, Italy site. The companies also formed a long-term supply agreement.
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Contract Manufacturing and Packaging for Solid Oral Dosage
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Biogen Idec (Weston, MA) acquired a subsidiary of Neurimmune Holding (Zurich), which includes the worldwide rights to three preclinical immunotherapy programs focused on human antibodies. Biogen Idec will make an initial payment of $32.5 million and up to $395 million in contingent payments. The programs address three central nervous system targets, alpha-synuclein, tau, and TDP-43, which are believed to be relevant for the treatment of neurodegenerative diseases such as Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS). This acquisition builds on a 2007 agreement between the two companies to explore human antibodies.
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Interphex
Thousands of pharmaceutical, biologic, generic, and contract services professionals gather annually at INTERPHEX (March 29-31, 2011, Javits Convention Center, New York City) to see new products, network, and learn about emerging trends surrounding drug manufacturing. At INTERPHEX 2011, you’ll find the solutions and education you need to ensure quality, improve efficiency, and solve your manufacturing and supply chain problems. Register for a free exhibit hall pass at
 www.INTERPHEX.com |
bluebird bio (formerly Genetix Pharmaceuticals, Cambridge, MA), a company focused on gene therapies for severe genetic disorders, and Généthon, a not-for-profit research center focused on gene-therapy treatments for rare diseases, will collaborate on process development and scale-up efforts for the manufacturing of lentiviral vectors. Specific terms of the agreement were not disclosed.
Bristol-Myers Squibb (New York) formed a drug-development pact with biotechnology company Oncolys BioPharma (Tokyo) for festinavir, a once-a-day nucleoside reverse transcriptase inhibitor (NRTI) in Phase II development for HIV. Oncolys may receive up to $286 million in milestone payments and is also eligible to receive tiered royalties on product sales.
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Enercon
On-Demand Webinar & Whitepaper: Achieve a Perfect Seal
Get exclusive access to this on-demand webinar and whitepaper to learn the basic principles of the induction sealing process. Enercon Industries and Selig Sealing Products team up to discuss the three critical elements required to achieve a perfect seal, remedies for common application issues and techniques used to maximize line efficiencies.
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DSM Pharmaceutical Products (Parsippany, NJ), the custom manufacturing organization of Royal DSM (Heerlen, The Netherlands), formed a license agreement with the biotechnology company c-LEcta GmbH (Leipzig, Germany), an industrial biotechnology, for proprietary screening technology.The agreement grants DSM rights to c-LEcta’s proprietary alcohol dehydrogenases for enzyme screening programs and development of sustainable manufacturing routes for manufacturing of pharmaceutical active ingredients and intermediates.
Eli Lilly and Company (Indianapolis) completed the acquisition of Avid Radiopharmaceuticals (Philadelphia), a company developing molecular imaging compounds for the detection of chronic human diseases. Lilly acquired all outstanding shares of Avid for an upfront payment of $300 million, subject to adjustment based on existing cash on hand at closing. Avid stockholders will also be eligible for up to $500 million in additional payments contingent on regulatory and commercial milestones for florbetapir, a molecular imaging agent under investigation for detecting the presence of amyloid plaque in the brain. The transaction, first announced on November 8, 2010, met all closing conditions. The impact of the acquisition will be reflected in Lilly's fourth quarter 2010 financial statements, but is not expected to be material.
Emisphere Technologies (Cedar Knolls, NJ), a biopharmaceutical company, formed a drug-delivery pact with the healthcare company Novo Nordisk (Bagsværd, Denmark). The companies will work to develop and commercialize oral formulations of Novo Nordisk's insulins, which have the potential of treating diabetes, using Emisphere's Eligen Technology. The agreement includes $57.5 million in potential milestone payments to Emisphere, of which $5 million will be payable upon signing, as well as royalties on sales. This is the second license agreement between the two companies.
Gilead Sciences (Foster City, CA) agreed to acquire the biotechnology company Arresto Biosciences (Palo Alto, CA) for $225 million and potential future sales-based milestone payments. Gilead expects the deal to close in the first quarter of 2011, pending regulatory approval.
GlaxoSmithKline (London) and Impax Pharmaceuticals, the brand products division of the specialty pharmaceutical company Impax Laboratories (Hayward, CA), will collaborate to develop and commercialize IPX066, Impax’s extended release carbidopa-levodopa product designed to treat Parkinson’s Disease currently in Phase III clinical trials. GSK will pay Impax an $11.5-million upfront payment, milestone payments of up to $175 million, and royalties on product sales for an exclusive license to commercialize IPX066 throughout the world except in the US and Taiwan.
Novartis (Basel) agreed to a merger agreement under which Novartis will acquire the remaining part of the eye-care company Alcon (Hünenberg, Switzerland) for $12.9 billion, or $168 per share. The new Alcon division of Novartis will be led by Kevin Buehler, current president and CEO of Alcon.
Novavax (Rockville, MD) received clearance from FDA for its Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection; the program is no longer on clinical hold. In November, the company reported that it had received a question from FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.
Pfizer (New York) recalled one lot—approximately 19,000 bottles—of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the US. The product was recalled because of complaints of an “uncharacteristic odor” attributed to contamination by 2,4,6 tribromoanisole (TBA), which can stem from the use of the chemical 2,4,6-tribromonophenol (TBP) as a preservative on wooden pallets that are used to transport and store products. Pfizer said it prohibits the use of TBP-treated wood in the shipment of its medicines.
Phylogica (Perth, Australia), a drug-discovery company, signed a drug-discovery agreement with Pfizer (New York) for peptide-based vaccines. Phylogica will use its proprietary Phylomer drug-discovery platform to identify Phylomer peptides suitable for further evaluation. Phylogica will receive an upfront payment of $500,000 and will be eligible for milestone payments of up to $134 million, as well as royalties on worldwide sales. Phylogica grants Pfizer licensing and commercialization rights.
Royal DSM (Heerlen, The Netherlands) will form a 50/50 global joint venture (JV) for its business group DSM Anti-Infectives with the Chinese chemical company Sinochem Group (Beijing). As part of the JV agreement, Sinochem will take a 50% equity interest in DSM Anti-Infectives for €210 million ($275.7 million) on a cash and debt-free basis. The JV will be headquartered in Hong Kong, and all 2000 DSM Anti-Infectives employees will be part of the new entity. The parties anticipate closing to take place in the second quarter of 2011.
Sanofi-aventis (Paris) and Ascendis Pharma (Palo Alto, CA) formed a global licensing and patent-transfer agreement on Ascendis’ proprietary drug-delivery technology TransCon Linker and Hydrogel carrier. The technologies are designed to allow controlled release of a drug, and TransCon Linker has shown encouraging results in preclinical studies in delivering insulin, according to a company press release.
Sanofi-aventis (Paris) signed a drug-development pact with Avila Therapeutics (Waltham, MA) to discover targeted covalent drugs for the treatment of cancers. sanofi-aventis obtains a worldwide exclusive license to develop and commercialize the compounds resulting from the discovery collaboration. Avila will receive up to $40 million in upfront and research support payments, and is eligible to receive uup to $154 million in milestone payments if the product is approved in the US, Europe, and Japan. Avila may also receive staged royalties on product sales.
Sanofi-aventis (Paris) signed a research and development deal with Merck KGaA (Darmstadt, Germany) to investigate experimental combinations of agents that could block specific pathways in cancer cells. The combinations involve Merck Serono’s MEK inhibitor MSC1936369B (also known as AS703026), sanofi-aventis’s PI3K/mTOR inhibitor SAR245409 (also known as XL765) and class I PI3K inhibitor SAR245408 (also known as XL147), respectively.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Cephalon’s (Frazer, PA) founder, chairman, and CEO Frank Baldino, Jr. passed away last Thursday evening. The company mourns his passing and extends its sympathies to the entire Baldino family.
Johnson & Johnson (New Brunswick, NJ) appointed Alex Gorsky, currently worldwide chairman of medical devices and diagnostics, and Sheri McCoy, currently worldwide chairman of pharmaceuticals, to the positions of vice-chairmen of the executive committee, effective Jan. 3, 2011. Gorsky and McCoy will join William C. Weldon, chairman of the board and CEO, in an expanded Office of the Chairman.
Pier Pharmaceuticals (Louisville, CO), a clinical-stage biopharmaceutical company focused on the treatment of sleep-related breathing disorders, appointed Peter W. Letendre as its CEO, president, and member of the board of directors. The company was formerly known as Steady Sleep Rx.
Sanofi-aventis (Paris) appointed Elias Zerhouni president of global research and development, covering medicines and vaccines, effective January 1, 2011. Zerhouni will report directly to Christopher A. Viehbacher, the company's CEO.
The Procter & Gamble Company (Cincinnati) appointed Susan Desmond-Hellmann, chancellor of the University of California, San Francisco, to its board of directors.
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The International Conference on Harmonization has launched a redesigned website. Located at the same URL address, www.ich.org, the new look offers easier navigation of resources, meetings, and guidelines. Also new is a redesigned logo and tagline "ICH: harmonisation for better health." The refreshed designs are part of the organization's 20th anniversary
celebration.
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Take the 8th Annual Global BioManufacturing Survey |
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Budget trends, new technologies, capacity, outsourcing and hiring issues, downstream processing, disposables, cost cutting, and quality initiatives, are just a few of the important topics covered in this year's 8th Annual Biopharmaceutical Manufacturing Report and Survey held by BioPlan Associates, Inc. Last year, more than 400 biomanufacturers and suppliers participated globally, and this year we're expecting even more. You will receive a free summary of the results from the study. In addition, for each completed survey, BioPlan Associates will donate $10 (up to $10,000) to the Global Alliance for Vaccine Initiative, or American Cancer Society.
Coming Soon: A special report focuses on best practices for manufacturing deviations in the January issue of Pharmaceutical Technology. |
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Pharma Forecast 2011
What area of the pharmaceutical industry do you think will experience the most change in 2011?
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View the poll archive. |
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