Company and People Notes: CSL and Talecris Terminate Merger Agreement; Eli Lilly Hires Former Indianapolis Mayor; More...

Company Notes

3M Drug Delivery Systems (St. Paul, MN) introduced two enhancements to its inhalation drug delivery with pressurized metered dose inhalers (pMDIs)-3M Plasma Coating Technology and the 3M Face Seal Valve. Both technologies improve the performance and capabilities of pMDI systems. 3M also announced its Taper Dry Powder Inhaler and the Conix Dry Powder Inhaler, new technologies that expand its inhalation platform. The Taper Dry Powder Inhaler stores active pharmaceutical ingredients on a microstructured carrier tape, enabling it to provide up to 120 premetered doses.

Acceleration (Lee, MO), a contract research organization, launched its new GMP manufacturing service and facility. The services focus on clinical supplies, primary and secondary packaging, labeling, and global distribution. An autodose provides vial and capsule filling.

AstraZeneca (London) and Abbott (Abbott Park, IL) submitted a new drug application (NDA) to the US Food and Drug Administration for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL cholesterol, high triglycerides, and low HDL-cholesterol. The investigational compound contains the active ingredients of AstraZeneca's Crestor (rosuvastatin calcium) and Abbott's Trilipix (fenofibric acid), and pending approval of the NDA, the treatment will be marketed as Certriad.

CoreRx (Tampa, FL) a pharmaceutical company, launched an expansion of its pharmaceutical formulation-development headquarters. Over the next several months, the company will increase from its current 10,000-ft² facility to approximately 80,000 ft². The new facility will be equipped with more than 15,000 ft² of laboratory space, eight formulation-development suites and 11 CGMP-manufacturing suites, including cytotoxicity suites.

CSL (Melbourne, Australia) and Talecris Biotherapeutics (Research Triangle Park, NC) mutually agreed to terminate their merger agreement, announced on Aug. 12, 2008, under which CSL agreed to acquire Talecris for $3.1 billion in cash. The transaction was blocked by the US Federal Trade Commission. Both parties will fulfill their obligations for termination contained in the merger agreement. CSL will pay Talecris a $75-million break fee, and the plasma supply contract formed in connection with the merger agreement will remain in effect.

Eastar Chemical (Sacramento, CA) expanded its custom manufacturing and product development offerings to include custom quality assurance and quality control services. The company offers custom manufacturing and analytical services in the United States and China.

Genzyme (Cambridge, MA) acquired the worldwide rights to Campath/MabCampath (alemtuzumab) from Bayer HealthCare (Leverkusen, Germany). This gives Genzyme primary responsibility for the development and commercialization of the drug, which is a multiple sclerosis (MS) therapeutic candidate. Genzyme is conducting two Phase III studies of alemtuzumab in relapsing-remitting MS patients.

GlaxoSmithKline (London) and Concert Pharmaceuticals (Lexington, MA) formed a pact to develop and commercialize deuterium-containing medicines. The deal includes three of Concert's research and development programs; namely, CTP-518, a protease inhibitor for the treatment of HIV expected to enter Phase I clinical trials in the second half of 2009, a preclinical compound for chronic renal disease, and a third research product in Concert's pipeline. Concert will also provide GSK with deuterium-modified versions of three GSK pipeline compounds for GSK to develop.

The contract sterile manufacturer IDT Biologika (Dessau, Germany) opened new offices in Herndon, Virgina, to meet customer demand in the United States. The company’s expansion in the US coincides with the opening of new filling and packaging facilities in Germany this past January.

Microsoft (Redmond, WA) signed an agreement with Merck & Co. (Whitehouse Station, NJ) to acquire certain assets of Rosetta Biosoftware, a business unit of Rosetta Inpharmatics, a wholly owned subsidiary of Merck. The deal allows Microsoft to incorporate genetic, genomic, metabolomic, and proteomics data-management software into its Amalga Life Sciences platform, the company’s data-aggregation and management software.

Novartis (Basel) announced that the Novartis Vaccines Institute for Global Health (NVGH) was awarded a grant from the Wellcome Trust to develop a bivalent vaccine for typhoid fever. The EUR 5.15-million ($7.1 million) grant will fund preclinical development and Phase I and II studies for a vaccine that protects against both S. Typhi and S. Paratyphi A, two very similar illnesses which, if left untreated, can result in complications and death. The currently available vaccines for S. Typhi do not protect infants and young children.

OctoPlus (Leiden, The Netherlands) signed a new drug-delivery technology evaluation contract for two compounds with a European biotechnology company. This is the eighth client for which OctoPlus will work on a controlled-release formulation.

Patheon (Research Triangle Park, NC), a provider of drug-development and manufacturing services, announced that its Swindon, UK, facility extended its aseptic vial-filling capabilities to include the commercial supply of small-scale specialty products. This new capability includes vial sizes ranging from 2mL–30mL and allows for the use of disposable components.

Sartorius Stedim Biotech (Goettingen, Germany), a supplier for the pharmaceutical and biotechnology industries, received several large orders for disposables used in biopharmaceutical production from global vaccine manufacturers. They primarily ordered specialty filters, aseptic single-use bags, and other disposables for sterile filtration of pharmaceutical liquids and for storage and transport of intermediate serum products. The orders from major vaccine producers are linked to current A (H1N1) influenza vaccine testing and the expected startup of production operations, according to a company press release.

Sanofi-aventis (Paris) announced that Sanofi-Aventis Deutschland GmbH has purchased Pfizer's Diabel insulin-manufacturing plant in Frankfurt-Höchst, Germany. Sanofi-aventis will gain buildings, equipment, machinery, and some existing contracts. The acquistion is valued at EUR 30 million ($42.1 million).

The biopharmaceutical company TorreyPines Therapeutics’ (La Jolla, CA) board of directors decided to liquidate the company’s assets and dissolve the company. The board’s plan of liquidation and dissolution is subject to stockholder approval.

The World Health Organization has recommended that rotavirus vaccination be included in all national immunization programs to provide protection against a virus that is responsible for more than 500,000 diarrhoeal deaths and 2 million hospitalizations every year among children. WHO awarded global prequalification to GlaxoSmithKline Biologicals’ vaccine against rotavirus, Rotarix. The prequalification is necessary for United Nations' agencies and the Global Alliance for Vaccines and Immunization to purchase rotavirus vaccines on behalf of developing countries, and will accelerate access of the vaccine in Asia and Africa.

Regulatory Roundup

The European Union’s competition services is examining Pfizer’s takeover of Wyeth to determine whether the deal breaches competition rules. The EU will announce its decision July 6, and at that time could approve of the merger, possibly with conditions, or it could further investigate the deal.

The Senate is reviewing the Family Smoking Prevention and Tobacco Control Act, H.R. 1256, and could vote on the measure this week. The bill would allow the US Food and Drug Administration to regulate the manufacture, marketing, and sales of tobacco products. An amendment to the bill, sponsored by Sen. Byron Dorgan (D–ND), would have allowed the reimportation of prescription drugs from Australia, Canada and other countries. The Senate held a cloture vote that ended debate on the amendment.

This week, the International Conference on Harmonization steering committee and expert working groups are meeting in Yokohama, Japan. These groups generally meet twice a year in different regions of the world to discuss pending guidelines and other relevant issues. ICH is also holding a public symposium in Tokyo on Friday, June 12. The symposium will cover recent ICH developments, electronic exchange of information, clinical research safety guidelines, the Q4B guideline on “Evaluation and Recommendation of Pharmacopoeial Texts,” and quality implementation. There will also be a special session on implementing ICH guidelines in Asian countries, including Thailand, Singapore, and Korea.  See the full program. In related ICH news, the quality implementation working group has published a list of questions and answers regarding the Q8, Q9, and Q10 quality guidelines.

The US Food and Drug Administration has redesigned its website in efforts to make it easier to use. Some new features, designed to ease site navigation, include the categorization of information by topic for easier retrieval, consistent page design and navigation throughout the site, and the removal of redundant and outdated content from the site. The agency welcomes feedback on the new design.

The US Food and Drug Administration announced last week the launch of its Transparency Task Force, which is aimed at providing the public with information about the agency’s operations and decision-making processes. Efforts include the launch of the FDA Transparency Blog and a public meeting on June 24, 2009, where comments about how to improve transparency are welcome. Read more on PharmTech’s blog.

People Notes

Akorn (Lake Forest, IL) appointed Raj Rai interim CEO while the search continues for a permanent replacement. Rai replaces Jeffery A. Whitnell, who is leaving the company to pursue other interests. The company also appointed Timothy A. Dick chief financial officer and Joseph Bonaccorsi  senior vice-president, general counsel and secretary.

AssureRx (Cincinnati, OH), a personalized medicine company, appointed James S. Burns president and CEO. Burns comes to AssureRx with more than 30 years of executive experience in the management of science and technology for pharmaceutical, diagnostic, and biotechnology companies.

Biopartners (Baar, Switzerland) appointed Conrad Savoy CEO and president of the board. The appointment is the result of a planned succession strategy following the purchase of the company by the Bioton Group in 2007. The company’s former CEO, Jean-Noël Treilles, will remain closely involved with the company in advisory consultancy role.

Covance (Princeton, NJ) appointed Monte Jarvis vice-president of global data management and biostatistics for periapproval services. Jarvis will oversee data management and biostatistics for Phase IIIb/IV clinical studies, patient registries, and observational studies.

Eli Lilly (Indianapolis, IN) appointed former Indianapolis mayor Bart Peterson senior vice-president of corporate affairs and communications. Peterson will be a member of the company's executive and the operations committees and will report directly to Chairman, President, and CEO John C. Lechleiter.

Five Prime Therapeutics (San Francisco, CA), a biotechnology company focused on protein therapeutics, appointed Julia P. Gregory president, CEO, and a member of the company’s board of directors, effective June 18, 2009. Gregory was previously executive vice-president and chief financial officer of Lexicon Pharmaceuticals (The Woodlands, TX).