May 25, 2006: Company and People News

May 25, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Abraxis BioScience Inc., Bristol-Myers Squibb Company, Cambrex Corporation, Sigma-Aldrich Corporation, SkyePharma

CompanyNews

AbraxisBioScience Inc. (Los Angeles, CA, www.abraxisbio.com)added a 50,750-ft2 research facility to its site in Marinadel Rey,California. The facility houses a 20,000-ft2 space dedicatedtothe CGMP-compliant production of clinical trial materials forcell-based biotechnology products, including whole-cell vaccines andstem-cell therapies. The company  also purchased a 3.5-acre areainCulver City, California, on which it plans to develop abiopharmaceutical campus. Set for completion in 2008, the campus willbring together the company's research, development, and clinical trialcapabilities.

AlbanyMolecular Research, Inc. (Albany,NY, www.albmolecular.com)broke ground on a new 50,000 ft2research and development center in Hyderabad,India. The center will be completed in late 2007 and will be used toconduct contract projects, including custom-chemical synthesis andmedicinalchemistry. In addition, the new facility will house a scale-uplaboratory, which will be used to develop efficient methods forproducing larger quantities of active pharmaceutical ingredients andintermediates.

BioxelPharma Inc. (Sainte-Foy, Quebec, Canada, www.bioxelpharma.com)signed a two-year, renewable paclitaxel manufacturing and supplyagreement with a generic manufacturer in Europe. Bioxel manufacturesand sells CGMP paclitaxel to specialty pharmaceutical companies andgeneric formulation manufacturers. Its paclitaxel facility has 120 kgof annual manufacturing capacity.

Bristol-MyersSquibb Company (New York, NY, www.bms.com) discontinued the development of its"Muraglitazar" product, a dual alpha-gamma peroxisomeproliferator-activated receptor agonist for type 2 diabetes. In October2005, the US Food and Drug Administration issued an approvable letterfor muraglitazar requesting additional information on the drug'scardiovascular safety profile. The company concluded that to achieveregulatory approval and commercial success for the product, a long-termtrial would be needed. On the basis of this assessment and the marketfor upcoming diabetes alternatives, the development of the product wasdiscontinued.

CambrexCorporation's (East Rutherford, NJ, www.cambrex.com)subsidiary, Cambrex Bio ScienceHopkinton, Inc., entered a contract for the production ofclinical trial quantities of MerrimackPharmaceuticals Inc.'s (Cambridge, MA, www.merrimackpharma.com)lead product, MM-093, a recombinant version of human alpha-fetoprotein.Cambrex completed several batches of MM-093 and is in the processof finishing the production run.

CrucellN.V. (Leiden, Netherlands, www.crucell.com)signed two licensing agreements with biopharmaceutical company BIOA&D Co. Ltd. (Korea). Thefirst involves using Crucell's "PER.C6" technology to produceadenoviral vectors expressing ceNOS (constituted endothelial nitricoxide synthase) for the treatment of cardiovascular disease. Inaddition, BIOA&D will be allowed to use Crucell's patented "ceNOS"gene therapy technology, an enzyme that produces nitric oxide forvarious applications in the treatment of cardiovascular disease.

Gedeon RichterLtd. (Budapest, Hungary, www.richter.hu) and Repros Therapeutics, Inc. (TheWoodlands, TX, www.reprosrx.com)entered into a development and supply agreement for Repros's"Proellex," a progesterone receptor modulator currently in Phase IIclinical trials. According to the agreement, Richter will develop andsupply the active pharmaceutical ingredient for the drug.


The Lubrizol Corporation(Wickliffe, OH, www.lubrizol.com)completed the sale of its active pharmaceutical ingredient (API) andintermediate compounds business to AuctusManagement GmbH(Munich, Germany) and former managers of the API business. Thefacilities in Raubling, Germany, and Chennai, India, developed productsmarketed to proprietary and generic drug manufacturers worldwide.

Pliva (Zagreb, Croatia, www.pliva.com) enteredinto a product development, manufacturing, and supply agreement with Unichem Laboratories Limited (Jogeshwari,Mumbai, India, www.unichemindia.com

CRO PRA International (Reson, VA, www.prainternational.com)closed on its previously announced acquisition of Sterling Synergy Systems PrivateLimited (Mumbai, India).

Sigma-AldrichCorporation (St. Louis, MO, www.sigmaaldrich.com)signed an exclusive arrangement with RosettaInpharmatics LLC, a subsidiary of Merck & Co., Inc. (WhitehouseStation, NJ, www.merck.com)to use Rosetta's design technology to launch human and model organismsiRNA whole genome libraries, to deliver siRNA panels targeted tospecific gene families, and to provide access to single-targetpredesigned siRNAs through an enhanced Web interface. Researchers willhave access to these products which will be manufactured bySigma-Aldrich's Sigma Genosys and Proligo operations.

SkyePharma (London, UK, www.skyepharma.com)and FirstHorizon Pharmaceutical Corporation (Alpharetta, GA, www.horizonpharm.com)will develop a controlled-release form of a Sular (nisoldipine)antihypertensive drug, FirstHorizon's largest product. The new version will be designed to improvethe drug's pharmacokinetic profile and is expected to replace thecurrent formulation.

Valeant Pharmaceuticals International (CostaMesa, CA, www.valeant.com)sold its manufacturing facility in Warsaw, Poland, to Strides Polska Sp.Transaction details have not been disclosed. Valeant develops,manufactures, and markets products primarily in neurology, infectiousdiseases, and dermatology.

Vectura Group plc (Chippenham, UK, www.vectura.com) andUnilever Ventures Ltd(London, UK, www.unileverventures.com)have jointly established a new speciality pharmaceutical company, PharmaKodex Ltd (Chippenham, UK, www.pharmakodex.com). The company will developpharmaceutical products using proprietary oral and transdermalenabling technologies from Vectura and Unilever.


PeopleNews

RobertBruce Merrifield, a biochemist who won the 1984 Nobel Prize inChemistry for his method of solid-phase peptide synthesis, died on May14. Merrifield's method reduced the time needed to synthesize peptidesfrom years to days by anchoring the first building block of the proteinto a polymer. The accelerated process spurred the development of drugssuch as blood pressure, insulin, and hormone medications. The synthesismethod also advanced research inbiochemistry, molecular biology, pharmacology, and medicine. Merrifielddied at his home in Cresskill, New Jersey, after a long illness. He was84.

BiotechnologyIndustry Organization(BIO, Washington,DC,www.bio.org)named Tom DiLengevice-president and general counsel. DiLenge joined BIO in November 2005as deputy general counsel and has served as acting general counselsince late February. He was previously chief counsel and policydirector for the House Homeland Security Committee and senior counselfor the House Energy and Commerce Committee.

CharlesRoss and Son Company(Hauppauge, NY, www.mixers.com)added RamiroMagboo, a new application engineer, to its corporatestaff. Magboo worked with Shell Petroleum before joining Ross and isresponsible for the company's technical-application engineeringprojects. Magboo graduated from De La Salle University in 2004 with adegree in chemical engineering.

GenerexBiotechnology Corporation(Toronto, ON, Canada, www.generex.com)hired GeorgeMarkus as its manager of regulatory affairs. He willassume responsibility for the preparation, review, and evaluation ofdocuments for submission to international regulatory authorities.Markus also will provide regulatory advice to other functional areasand interact with government regulators. Markus has heldregulatory affairs positions with Pasteur Merieux Connaught, BiovailCorporation International, Sanofi Winthrop, Genpharm Pharmaceuticals,and Sandoz Canada.

Theodore Miro joined specialtypharmaceutical company SynovicsPharmaceuticals (Phoenix, AZ, www.synovics.com) asvice-prseident responsible for technical operations. Miro  previously worked forForrestLabs, Barr Labs, and Pfizer.

Oncologydrug development company XanthusPharmaceuticals, Inc.,

(Cambridge,MA, www.xanthus.com)

appointed

JohnLister-James, PhD, vice-president of development. Lister-Jamesjoins Xanthus from theSchering AG group where he served as vice-president of corporate CMCdevelopment and radiopharmaceuticals at CIS-US, Inc.

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