Company and People Notes: Synta and GSK End Agreement; WuXi Appoints US VP; More...

Company notes

Adimab (Lebanon, NH), a company focused on the discovery of fully human antibodies, launched a human antibody discovery platform based on the first fully synthetic human pre-immune IgG repertoire, according to a company release. The company also announced two research collaborations. In two separate deals, Adimab will use its proprietary yeast-based antibody discovery platform to identify fully human antibodies against targets selected by Merck (Whitehouse Station, NJ) and Roche (Basel, Switzerland). Under the respective agreements, Merck and Roche will have the right to commercialize antibodies generated from the collaboration.

AMRI (Albany, NY) finished the construction of a new 32,300-ft² chemistry research and development facility in Budapest, Hungary. The facility, which includes a scale-up laboratory for non-GMP synthesis for batch sizes up to 25 L, will support AMRI’s offerings in parallel synthesis and medicinal chemistry and the establishment of fragment-based drug discovery.

Crucell (Leiden, The Netherlands) purchased a FlexFactory bioproduction line and multiple XDR single-use bioreactors from Xcellerex (Marlborough, MA) for its manufacturing operations in Leiden, The Netherlands. Financial terms were not disclosed.

The biotechnology company Dendreon  (Seattle, WA) will expand its Morris Plains, New Jersey facility, according to an SEC filing. Phase II, which consists of additional quality-control laboratories, a data center, training areas, infrastructure and offices, should be completed in December 2009. Phase III, which consists of additional manufacturing cleanroom work stations, production support areas, warehouse, infrastructure and offices, should be completed in April 2010.

The US District Court for the District of New Jersey granted summary judgment of noninfringement in Hospira’s (Lake Forest, IL) favor with regard to a suit involving Sanofi-Aventis' chemotherapy medication Eloxatin (oxaliplatin). US sales of Eloxatin last year were approximately $1.4 billion. Hospira, a provider of generic injectable pharmaceuticals, has tentative approval from the US Food and Drug Administration for its generic version of the product, and expects full FDA approval shortly, according to a company press release. Sanofi-aventis (Paris) released a statement saying it intends to appeal this decision.

Precision Stability Storage (Wilson, NC), a provider of sample storage, management, and logistics, will expand its Wilson, North Carolina facility. The company plans to double the size of its existing operation and will include an additional 8500 ft³ of stability storage space, 2500 ft³ of retain sample storage, and a controlled-environment room for bulk powder and liquid sampling and dispensing. The expansion will maintain compliance with US Food and Drug Administration standards and current good manufacturing practices.

Protein Sciences (Meriden, CT) initiated manufacture of its vaccine PanBlok, its H1N1 influenza vaccine made using the company's baculovirus and insect-cell manufacturing technology. Following bulk production, the vaccine will undergo routine quality tests, but the company expects that the vaccine should be ready to use by mid-July in clinical trials and/or vaccinations. In a related story, the AP reported that sanofi-aventis will donate 100 million doses of H1N1 influenza vaccine to the World Health Organization (WHO). Once the company begins production of the vaccine, it will reserve 10% of its output for the WHO to help address the pandemic in developing countries. According to Bloomberg, a spokesman for GlaxoSmithKline has said that it will also donate vaccine doses. Novartis, however, has said that it won't, according to the Bloomberg report. A spokesman told Bloomberg that donations would not address the current pandemic or create sustainable access.

Synta Pharmaceuticals (Lexington, MA), a biopharmaceutical company, and GlaxoSmithKline (GSK, London) will end their collaborative agreement for the clinical development and commercialization of elesclomol effective no later than Sept. 10, 2009. Worldwide rights to elesclomol will revert to Synta, and Synta may pay GSK a low single-digit royalty on any potential future sales of elesclomol, according to a Synta press release.

The Global Alliance for TB Drug Development (TB Alliance), a not-for-profit, product development partnership, and the pharmaceutical company Tibotec (Yardley, PA) will collaborate to accelerate the discovery and development of new drugs to fight tuberculosis (TB). The organizations will share resources in the development of TMC207, which could become the first TB drug with a new mechanism of action in 40 years, says a TB Alliance press release. TMC207 is currently in a Phase II study.

The Global Alliance for Vaccines and Immunization (GAVI) partners, the World Bank, the World Health Organization, UNICEF, five national governments and the Bill & Melinda Gates Foundation formalized the first Advance Market Commitment (AMC), which is designed to accelerate access to vaccines against pneumococcal disease. The AMC is a financing mechanism with the mission of ensuring that children in the world’s poorest countries receive life-saving vaccines 15-20 years before they might otherwise have been available and at prices their governments can afford, according to a GAVI press release. In the AMC pneumococcal pilot, the governments of Italy, the United Kingdom, Canada, Russia, and Norway and the Bill & Melinda Gates Foundation committed $1.5 billion and the GAVI Alliance committed $1.3 billion through 2015. GAVI hopes to assist up to 60 of the world’s poorest countries to introduce these vaccines by 2015.

The Michigan Technology & Research Institute (Ann Arbor, MI), and Detroit’s Wayne State University (WSU) will form a drug-development company focused on a potential new treatment for depression. The collaboration is expected to serve as a model for expediting and maturing university technologies into commercially attractive ventures at a faster and strategic pace of development, according to a WSU press release. "This collaboration is an example of a new model for growth in southeast Michigan by partnering with former Pfizer scientists," said Randy Ramharack, technology licensing manager at WSU.

Vetter (Ravensburg, Germany), a provider of aseptically prefilled injection systems, installed six automatic packaging lines at the company’s new packaging services facility, Vetter Secondary Packaging, located in Ravensburg, Germany. The new lines perform various packing operations, including hand-packing, pen assembly, auto-injectors, safety devices, automatic setting of plungers, labeling, and blistering.

Regulatory Roundup

President Obama devoted $1.1 billion to comparative effectiveness research in his 2009 economic stimulus bill (see back story, Stimulus Bill Opens Door to Comparative Effectiveness). This type of research is meant to provide healthcare providers with information about which medical therapies and devices are most effective for patients with a specific health problem. Now, Democratic leaders in the Senate are proposing, as part of healthcare reform legislation, a new Center for Comparative Effectiveness Research as well as an independent Comparative Effectiveness Research Commission to oversee the Center (see related coverage, Would Comparative Effectiveness Reduce Patients’ Options?).

The US Food and Drug Administration is proposing a study of the effectiveness of direct-to-consumer (DTC) television and print ads for prescription drugs, according to a notice in the June 22, 2009, Federal Register. The study is designed to communicate quantitative information about product benefits in DTC print and television ads. Comments on the proposed study are due by Aug. 21, 2009.

The European Medicines Agency (EMEA) is inviting public comments on its draft transparency policy, which focuses on three objectives: making the daily operations of the agency more transparent; strengthening the agency's interaction with its stakeholders (particularly patients and healthcare professionals); and promoting a harmonized approach to transparency across the European medicines network. The deadline for comments is Sept. 25, 2009, according to an EMEA release. As part of the consultation process, the agency will hold a second workshop on transparency in October 2009 to analyze and review feedback. The final adoption and publication of the policy is planned for the end of 2009. In related news, FDA recently established its own transparency task force and blog. FDA held a public meeting June 24 to discuss transparency issues).

The International Pharmaceutical Excipients Council (IPEC) of the Americas and of Europe issued a joint position paper on excipient pedigrees. The position paper provides guidance for all parties involved in the ingredient supply chain to use in establishing and verifying the identity and security provided to an excipient throughout its journey from point of manufacture to its ultimate acceptance and use. The paper also discusses how already-published IPEC guidance can help to establish an excipient’s pedigree. In related news, IPEC recently competed a new Excipient Stability Program Guide, which will be addressed in detail in Pharmaceutical Technology’s September issue.

SOCMA, a trade organization of custom and batch manufacturers, joined Rx-360, an international consortium that is working to enhance the security of the pharmaceutical supply chain. SOCMA has joined the consortium as a non-voting observer member to enhance its ongoing advocacy efforts on drug ingredient quality compliance.

People notes

Calcionics (Bellevue, WA), a biotechnology company focused on cardiovascular disease, appointed Daniel O. Wilds executive chairman of the company’s board of directors. Wilds recently retired as chief executive officer of SCOLR Pharma (Bothell, WA) and currently serves on the board of directors of Helix BioMedix (Bothell, WA).

The contract manufacturing organization Dishman Group (Ahmedabad, Gujarat, India) appointed Nick Green to the newly created position of president of Dishman Contract Research and Manufacturing Services (CRAMS). Green will report to Jay Vyas, managing director of the pharmaceutical services provider.

Hemispherx Biopharma (Philadelphia, PA), a specialty pharmaceutical company, appointed Robert Dickey IV senior vice-president. In his newly created role, Dickey will bring together various activities relating to fundraising, strategic partnering, and finance functions.

Manhattan Pharmaceuticals (New York) announced a management-restructuring plan that took effect June 16, 2009. Douglas Abel was appointed chairman of the board of directors and stepped down from his positions as CEO and president. Abel has been retained as a consultant to the company. Michael G. McGuinness, chief operating and financial officer, will assume day-to-day leadership responsibilities, and company consultant Mary Spellman will remain as head of dermatology and drug development.

The Noveon Consumer Specialties team of Lubrizol Advanced Materials (Wickliffe, OH) realigned its business management, sales, marketing, and technical organizations earlier this month. Tom Malafronte, senior vice-president and general manager for Noveon Consumer Specialties, will direct the new business teams. For details of the individual team leaders, see the company’s press release.

WuXi PharmaTech (Shanghai), a pharmaceutical, biotechnology, and medical-device research and development outsourcing company, appointed Felix Hsu senior vice-president of WuXi AppTec US. Hsu will be responsible for WuXi’s US business and will report to Edward Hu, chief operating officer, acting chief financial officer, and current head of US operations.