May 4, 2006: Company and People News

May 4, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Cobra Biomanufacturing, Avecia, Dynavax Technologies, BASF, Codexis

CompanyNews

CobraBiomanufacturing (Keele, UK, www.cobrabio.com) announced an agreementwith  the International AIDSVaccine Initiative (New York, NY, www.iavi.org) and GlaxoSmithKlineBiologicals S.A.(Rixensart, Belgium, www.gsk-bio.com)to develop and manufacture two HIV vaccine candidates in clinicaltrials. The vaccines incorporate nonhuman primate adenovirus vectors,an area for which Cobra has manufacturing and process developmentexpertise.

Specialtychemical company Avecia (Milford, MA, www.aveciabiotechnology.com)has partnered with DynavaxTechnologies (Berkeley, CA, www.dynavax.com)on the production of an oligonucleotide intermediate to be used inDynavax's "Heplisav" hepatitis B. vaccine. Avecia will manufacture theintermediate,validate the production process, and provide support for clinicaltrials as well as potential regulatory and commercial activities forDynavax.

The University of Kentucky (Lexington,KY, www.uky.edu)unveiled a new $17-million Center forPharmaceutical Science andTechnology facility. The 20,000-ft2 building is the largest sterilepharmaceutical manufacturing facility in Kentucky. The center willprovide analysis, formulation, and manufacturing of sterile drugproducts for early-phase clinical trials. The plant will featurecustom-made mobile isolators so that the staff can manufactureconventional and highly potent compounds in the same room. The facilityalso will be able to manufacture sterileliquids for injection and tofreeze dry injectables.

Privatelyheld Codexis (Redwood City,CA, www.codexis.com)purchased the assets and technologies of Enzis BV, which will be used todevelop chemical processes. The acquisition will strengthen Codexis'sEnzymes and Intermediates business unit and will be used to developimproved manufacturing processes for small-molecule therapeutics.

BASF Aktiengesellschaft (Ludwigshefan,Germany, www.basf.com)extended the expiration date and increased its cash offer to $38 pershare forall of Englehard's (Iselin, NJ) outstanding shares. 

The UK Medicines and Healthcare ProductsRegulatory Agency approved SkyePharma's(London, UK, www.skyepharma.com)"DepoDur" single-dose, sustained-release injectable formulation ofmorphine.

NovartisPharma AG (East Hanover, NJ, www.novartis.com) will initiate the development ofan oral human growth hormone product using Emisphere's (Tarrytown, NY, www.emisphere.com)"eligen" delivery technology. According to the terms of the agreement,Emisphere is entitled to a $5-million development commencementmilestone payment.

SAFC Supply Solutions (St. Louis,MO, www.sigmaaldrich.com/SAFC)launched a cluster of proligo reagent products, including a line of"Pharmadite" admidites for oligo-based drugs, a TFA C6 linker, andadditions to its line of RNA amidites.

The Committee for Medicinal Products for HumanUse issued a positive opinion regarding the approvals of Abbott Laboratories's (Abbott Park, IL, www.abbott.com)reformulation of its "Kaletra"  (lopinavir/ritonavor) proteaseinhibitor. The anti-HIV drug is said to be a more convenient tabletformulation than the currently marketed capsule version and wasdevelopedusing melt-extrusion technology. 

PeopleNews

West Pharmaceutical Services (Lionville,PA, www.westpharma.com)announced the death of George W.Ebright, a company director

.Ebright, who served on West's board for more than fourteen years, diedon April 24 following a battle with amyotrophic lateral sclerosis, alsoknown as Lou Gehrig's disease.

Tunnell Consulting (King ofPrussia, PA, www.tunnellconsulting.com)announced the retirement of its chairman, Robert P. Hill, on April 28.After joining Tunnell in 1989, Hill established the firm'spharmaceutical practice, increased its consulting staff by 65%, andachieved a 35% compound annual growth rate.

RobertEssner, chairman and CEO of Wyeth (Madison,NJ, www.wyeth.com),announced the election of BernardPoussot to the position of presidentand vice-chairman ofthe company. Poussot assumes leadership of Wyeth's Consumer Healthcareand Fort Dodge Animal Health divisions in addition to his previousresponsibilities as executive vice-president of Wyeth R&D.

MichaelD. Ironside, PhD, was promoted to vice-president of chemicaldevelopment and small-scale CGMP manufacturing at Albany Molecular Research (AMRI,Albany, NY, www.albmolecular.com).Ironside worked at companies such as Sterling Organics, Glaxo Wellcome, andHovionebefore joining AMRI in 1998.

The US Food and Drug Administration (Rockville,MD, www.fda.gov)selected Steven Kozlowski asdirector of the Office ofBiotechnology Products (OBP) withinthe Office of Pharmaceutical Science. Kozlowski has served asacting director of OBP for the past year and has overseen theregulatoryprocess from preinvestigational new drug application productdevelopment through inspections, licensing, and postapprovalsupplements.

ZymoGenetics (Seattle, WA, www.zymogenetics.com)announced this week the appointment of VaughnB. Himes, PhD, to thepost of senior vice-president of technical operations at the company.Himes joined ZymoGenetics as vice-president of commercialmanufacturing operations in November 2005 after working asvice-president for worldwide manufacturing operations for CorixaCorporation.

Biovail (Mississauga, ON, Canada, www.biovail.com)hired Gilbert Godin as itssenior vice-president of technicaloperations and drug delivery. Godin will be responsiblefor Biovail's product-development capability, manufacturing, andcontract-development services.

HyNguyen has been appointed research and development engineeringmanagerfor the Polymer Products Division of Saint-GobainPerformance Plastics (Aurora, OH, www.plastics.saint-gobain.com).Nguyen, a fluoropolymer expert with more than 25 years of engineeringexperience, will be based at the company's Garden Grove,California facility.



HighlightedEvents

May 8: The USFood and Drug Administration (FDA, Rockville, MD, www.fda.gov) hasscheduled a publicmeeting, ?Preparation for International Conference on Harmonization(ICH) Meetings in Yokohama, Japan.? FDA will hold its preparatorymeeting on Monday, May 8 at 9:30 a.m at the agency?s Rockville officesto provide information and solicit public input about the topics fordiscussion in Yokohama on June 5?8. Participants should register withSema Hashemi, [email protected].

June 12?15: The Institute of ValidationTechnology (Duluth,MN, www.ivthome.com) will host the PharmTechAnnual Event inSomerset, NJ. The main conference offers six distinct tracks:ingredients, formulation and development, analytical technology,manufacturing, information systems and technology, and outsourcing.The event will feature keynote industry speakers, interactiveworkshops, technology  demonstrations, a group networkingexcursion, anda plant tour of Cardinal Health.

June 19?23: A CleaningValidation & Best Practicesfor Cleaning Processes event will be offered by Instituteof Validation Technology (Duluth, MN, www.ivthome.com) inLas Vegas, Nevada. The conference features five separate workshops onestablishing residue limits; improving pharmaceutical cleaningprograms; cleaning validation of APIs; required documentation forcleaning validation; and cleaning monitoring after validation. The mainconference offers more than 50 sessions as well as a demonstration dayoffering hands-on tutorials with live demonstrations of cleaningtechnologies.

June 27?30: Interphex(Norwalk, CT, www.interphex.com)has introduced its Interphex Mexico (Norwalk, CT, www.interphexmexico.com)conference to give pharmaceutical manufacturing professionals theopportunity to access new equipment, technologies, and services fromtop suppliers. The conference will cover the latest developments andapplications to increase productivity and will give attendees theopportunity to network with colleagues. High-level general sessionswill feature industry leaders. Additional suppliers and solutions canbe found at colocated EXPO PACK Mexico and PROCESA. Interphex Mexico isscheduled for June 27?30 in Mexico City, Mexico.


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