Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

August 26, 2010
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

Company notes

Alexion Pharmaceuticals (Cheshire, CT) received approval from the US Food and Drug Administration for the company’s Rhode Island manufacturingfacility in Smithfield, Rhode Island, as a second source of commercial supply for Soliris (eculizumab). Earlier this year, Alexion reported thatthe European Medicines Agency had approved the facility as a second source of supply for Soliris in the European Union.

Aspen Pharmacare Holdings (Durban, South Africa) agreed to acquire the pharmaceutical business unit of Sigma Pharmaceuticals (Melbourne,Australia) for A$900 million ($796 million) in cash. The Sigma pharmaceutical unit includes the manufacture and sale of presripction, generic,and over-the-counter products.

Biogen Idec (Weston, MA) and Knopp Neurosciences (Pittsburgh, PA) formed a drug-development deal under which Biogen Idec will develop andcommercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, andpotentially other indications. Biogen Idec will purchase $60 million of Knopp stock, provide an up-front payment of $20 million and up to $265million in milestone payments. Biogen Idec will also pay royalties to Knopp on worldwide sales.

The governing board of California Institute for Regenerative Medicine (Palo Alto, CA), the state stem-cell agency, approved the conceptfor up to $243 million round of funding to move stem cell-based therapies to clinical trial. The funding will support multidisciplinary teams ofresearchers working toward filing a request with the US Food and Drug Administration to begin clinical trials, or completing an early stagetrial, within four years.

CSL Behring (King of Prussia, PA) received approval from the US Food and Drug Administration of a supplemental biologics license application(sBLA) to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% liquid, from 18 months to 24 months. Hizentra is the only20% subcutaneous immunoglobulin (SCIg) approved by FDA, and the only SCIg in the US that may be stored at room temperature.

DePuy Orthopaedics, a Johnson & Johnson (New Brunswick, NJ) business unit that makes joint replacements, received a Warning Letter from the US Food and Drug Administration for the marketing of two of its products. FDA says it never approved DePuy's TruMatch Personalized Solution System and that the company is marketing its Corail Hip System for two uses that FDA did not approve. The agency asked DePuy to stop selling the products and correct the violations detailed in the letter.

The Institute for Systems Biology (ISB, Seattle) will move its global headquarters to Seattle's South Lake Union neighborhood. ISB has signeda lease for approximately 140,000 ft2 of office and laboratory space at 401 Terry Avenue N., which will be home to more than 330 ISB employeesstarting in spring 2011, according to a company press release.

Oxford BioMedica (Oxford, UK), a gene-therapy company, signed a licensing agreement with Emergent Product Development Germany GmbH, asubsidiary of the biopharmaceutical company Emergent BioSolutions Inc (Rockville, MD). Emergent gains rights to Oxford BioMedica’s Hi-8 PrimeBoost technology patents and asub-license under poxvirus patents licensed to Oxford for the development and commercialization of vaccines and therapeutics targeting eightinfectious diseases, including tuberculosis. Emergent will pay an upfront licensing fee of $1 million, potential milestone payments of up to$20.4 million, and undisclosed royalties on sales.

Parexel International (Boston, MA), a global biopharmaceutical services organization, introduced an integrated temperature-recording solutionfor study drug transportation as part of its expanded Clinical Logistics Services. Parexel’s temperature-control process is designed to save 24to 48 hours of time compared with traditional cold-chain methods, according to a company press release.

Quark Pharmaceuticals (Fremont, CA), a developer of RNAi-based therapeutics, formed an agreement with Novartis (Basel). Novartis obtained anexclusive worldwide license to develop and commercialize Quark’s p53 temporary inhibitor siRNA drug QPI-1002, currently the subject of a Phase IIclinical trial. Quark will receive an upfront fee of $10 million, up to $670 million in milestone and other payments, and royalties on potentialproduct sales.

Roche (Basel) formed a collaboration with Aileron Therapeutics (Cambridge, MA) to develop a new class of drugs called stapled peptidetherapeutics, which are based on Aileron’s peptide stabilization technology. Roche will work with Aileron to develop drug candidates against upto five undisclosed targets. Roche will pay Aileron $25 million upfront and up to $1.1 billion in milestone payments. In addition, Aileron willreceive royalties on sales of potential products.

SAFC, a member of the Sigma-Aldrich Group (St. Louis, MO), and Novozymes Biopharma (Copenhagen) agreed to a 10-year extension of their jointagreement under which SAFC retains exclusive marketing and distribution rights for Novozymes Biopharma's LONG R³IGF-I (LONG R³) growth factorused for industrial cell-culture applications. The highly potent growth factor is manufactured specifically for customers in the cell-culturemarket.

Shire (Philadelphia, PA) plans to withdraw its hypotension drug ProAmatine (midodrine hydrochloride) effective September 30, 2010. The companynotified the FDA in November 2009 and healthcare professionals earlier this year of this decision. Shire's withdrawal was not related to anyconcerns regarding the safety of ProAmatine, the company said in a press release, but because FDA requested additional post marketing trials tobe conducted for the drug.

Thermo Fisher Scientific (Waltham, MA) opened a technology center in Shanghai. The center houses engineers and support staff focused ondeveloping a product pipeline to serve China-based customers across a range of industries.

TraceLink (Woburn, MA), a provider of supply-chain management software, and Patheon (Research Triangle Park, NC), a provider of contractdevelopment and manufacturing services, announced a partnership to provide a suite of visibility and collaboration softwaresolutions, advanced integration capabilities, and customized professional services.

People notes

Larry Kranking was named the new president and CEO of Coldstream Laboratories (Lexington, KY), a provider of sterile pharmaceuticalmanufacturing services. Kranking previously served at Aveta Lifesciences (Valparaiso, IN).

Discovery Laboratories (Warrington, PA), a biotechnology company, realigned its executive management by appointing Thomas F. Milleras COO, Charles F. Katzer as chief technical officer, and John G. Cooper as president and chief financial officer. These officers will reportdirectly to W. Thomas Amick, chairman of the board and interim CEO. The company hopes to fill the CEO position in 2011, according to a pressrelease.

Christopher B. Begley, chairman and CEO of Hospira (Lake Forest, IL), announced his intent to retire from the CEO position. He willremain executive chairman of the Hospira board, and will serve as CEO until his successor is named.

Icon (Dublin), a global provider of outsourced development services, appointed Alan Morgan group president of clinical-research services.Morgan is currently group president of Icon’s early-phase and laboratory services, and previously was COO of Icon's clinical researchdivision. He joined the company in 2006.

Torbjorn Bjerke was appointed CEO of Karolinska Development (Stockholm), a life-sciences company. Bjerke succeeds Conny Bogentoft, who willassume the position of chief scientific officer for Karolinska Development.

MPI Research (Mattawan, MI), a contract research organization, named Alan P. Breau vice-president of its bioanalytical and analytical services(B/AS) division. B/AS is one of the company's three core research divisions, along with drug-safety evaluation and discovery services.

Sigma-Aldrich (St. Louis) appointed Magnus Borg vice-president and chief information officer. Borg will report to Rakesh Sachdev, seniorvice-president, chief financial officer, and chief administrative officer.