|Email Newsletters from Pharmaceutical Technology and Pharmaceutical Technology Europe|
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Week of Apr. 21, 2011: Company Notes: Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.
The biopharmaceutical company Access Pharmaceutical has formed an agreement with an undisclosed pharmaceutical company for its CobaCyte and CobOral technology for the targeted delivery of RNA interference (RNAi) therapeutics. Access will provide the pharmaceutical company with CobOral and CobaCyte siRNA formulations for evaluation of gene knockdown following oral and intravenous administration. Any successful formulation developed will be jointly owned by the parties and subject to a subsequent full licensing agreement.
Axcan, a specialty pharmaceutical company, has agreed to acquire the biopharmaceutical company Mpex Pharmaceuticals. Mpex’s lead product candidate is Aeroquin, a proprietary aerosol formulation of levofloxacin that is currently in Phase III clinical trials for treating pulmonary infections in patients with cystic fibrosis. Financial terms were not disclosed. The deal is expected to close in the second half of 2011, subject to customary closing conditions.
Bend Research, a contract development and manufacturing organization, has received a US patent for improving bioavailability of low-solubility drugs. The patent, “Pharmaceutical Compositions Comprising Drug and Concentration-Enhancing Polymers” (US patent 7887840), was issued by the US Patent and Trademark Office in February. The technology covered by this patent does not require spray-drying or hot-melt extrusion formulation to improve bioavailability, but rather involves conventional blending of the drug form with a polymer additive. Drug forms covered by the patent are nanoparticles, absorbed drugs, drugs in nanosuspensions, supercooled drug melts, cyclodextrin/drug forms, gelatin dosage forms, and softgel dosage forms.
The custom manufacturing arm of Dr. Reddy’s Laboratories has expanded its Chirotech Technology Center at Cambridge Science Park, United Kingdom. The new 33,000-ft2 facility is designed for laboratories and offices and has been fitted to Dr. Reddy’s requirements for chemistry, biology, and analytics.
The specialty glass and materials company Gerresheimer has begun commercial production of ClikSTAR insulin pens for sanofi-aventis. The individual components of the ClikSTAR pens are manufactured at Gerresheimer’s Pfreimd, Germany, plant.
Johnson & Johnson (J&J) and Merck & Co. have agreed to amend the distribution rights to Remicade (infliximab) and Simponi (golimumab), which treat chronic inflammatory diseases such as rheumatoid arthritis. Under the agreement, Merck's subsidiary, Schering-Plough (Ireland) will relinquish exclusive marketing rights for Remicade and Simponi to J&J’s Janssen pharmaceutical companies in Canada, Central and South America, the Middle East, Africa and Asia Pacific, effective July 1, 2011. The retained territories by Merck include Europe, Russia, and Turkey.
In other news, the Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, announced this week that it is voluntarily recalling two lots of Topamax (topiramate) 100-mg tablets. These lots were shipped between Oct. 19, 2010 and Dec. 28, 2010 and distributed in the US and Puerto Rico. According to a company news release, there are probably fewer than 6000 bottles remaining in the marketplace. The recall is based on consumer reports of an uncharacteristic odor which may have been caused by TBA (2,4,6 tribromoanisole). This chemical has been associated with that used on the wooden pallets that are often used to store and transport packaging materials for medications.
Takeda Pharmaceutical has formed a two-year drug-discovery and development pact for G-protein coupled receptors (GPCR) with the biopharmaceutical company Heptares Therapeutics. Under the agreement, Takeda receives worldwide commercial rights to new drugs emerging from the collaboration. Takeda is making an upfront payment of £1.7 million ($2.8 million) to Heptares and is taking an equity stake of approximately £2.8 million ($4.6 million) in Heptares. Heptares is also eligible to receive future milestone payments of up to £60.5 million ($98.4 million) plus royalties on product sales.
The pharmaceutical company Vertex Pharmaceuticals and the Cystic Fibrosis Foundation Therapeutics have expanded their drug-development agreement in cystic fibrosis. The collaboration will support development activities for VX-661, Vertex's second corrector to enter clinical development, and the accelerated discovery and development of next-generation correctors. Vertex plans to begin the first study of VX-661 by the end of 2011 in people with cystic fibrosis who have the F508del mutation.
The generic-drug company Watson Pharmaceuticals has designated Parsippany, New Jersey, as the new site of its corporate headquarters (formerly located in Corona, California). The new 148,700-ft2 facility enables Watson to combine its operations, currently in separate facilities in the Morristown, New Jersey, area into a larger space.
West Pharmaceutical Services, a provider of systems, devices, and related services for injectable drugs, plans to increase capacity at its facility in Scottsdale, Arizona, for manufacturing the Daikyo Crystal Zenith 1-mL syringe system. The expansion will have the capacity of producing up to 20 million units annually. It will also handle the warehousing and release of other ready-to-use Crystal Zenith systems, such as vials and bulk drug containers. The expansion is scheduled to be completed in the fourth quarter of 2011.