Week of Nov. 21, 2011: Pfizer, MIT Break Ground on New Research Units in Massachusetts; PhRMA Names Richard I. Smith Executive Vice-President of Policy and Research; and More

Company Notes

Aileron Therapeutics announced that Roche will initiate a new program to expand its collaboration with Aileron to discover, develop, and commercialize stapled-peptide drugs. The potential $1.1-billion drug-development collaboration, launched in August 2010, encompassed up to five programs of strategic importance to Roche. Pursuant to the expanding relationship, Aileron and Roche will now begin work on a third program focused on inflammatory diseases. Aileron also announced that it achieved a key milestone under the collaboration agreement triggering a substantial milestone payment related to in vivo proof-of-concept against one of the programs of importance to Roche.

Boehringer Ingelheim Pharmaceuticals announced that it has made more than $350 million worth of capital investments throughout its United States (US) operations in 2011, to further bolster its drug-discovery, development, and manufacturing capabilities. The latest investment is a 72,000-ft² R&D facility at the company’s US headquarters in Ridgefield, Connecticut. When complete, the $65-million facility will handle production of APIs used in early-development activities. Products developed here, if approved, move on to Boehringer Ingelheim’s full-scale R&D facilities in Ohio and Virginia, as well as Germany and Italy. Other investments by Boehringer Ingelheim in 2011 include: a new $42-million drug-safety assessment building in Ridgefield, scheduled to be completed in 2013, and which will provide space for nonclinical safety studies; a new $50-million high-containment operations facility in Columbus, Ohio, for developing and manufacturing high-potency tablets and capsules; and the acquisition of the former Amgen biologics facility in Fremont, California, which provided 300,000 ft² for laboratories, manufacturing, and process development of clinical and market supplies.

CureVac, an mRNA-based vaccination technologies company, has signed several agreements with Sanofi Pasteur, the vaccines division of Sanofi. Under these agreements, CureVac and Sanofi Pasteur will further develop and apply CureVac’s proprietary RNActive technology platform for developing vaccines against several infectious diseases. A research proposal with total funding of $33.1 million involving a collaboration among CureVac, Sanofi Pasteur (including Sanofi Pasteur VaxDesign Corp.), and In-Cell-Art, a French biotechnology company contributing its nanoparticle technology, has been selected by the Defense Advanced Research Projects Agency, an agency within the Department of Defense. In this four-year project, CureVac and the other parties to the collaboration will further advance key aspects of CureVac’s RNActive technology platform and will evaluate several vaccine candidates in several disease models. Under the terms of the license agreements, CureVac may receive an upfront payment from Sanofi Pasteur for each pathogen, research funding and payments for achieving several clinical, regulatory and commercial milestones. For each pathogen subject to Sanofi Pasteur’s option, the agreements could encompass up to EUR 101.5 million ($136.6 million) for CureVac in upfront and milestone payments in addition to tiered royalties on sales of RNActive vaccines if Sanofi Pasteur develops a prophylactic or a therapeutic vaccine against such pathogen and up to EUR 150.5 million ($202.5 million) if Sanofi Pasteur develops both a prophylactic and a therapeutic vaccine. Under the license agreements, Sanofi Pasteur will fund all research and development activities and will have exclusive marketing rights worldwide for RNActive vaccines against the pathogens for which Sanofi Pasteur has exercised the option.

Daiichi Sankyo has established its 100% owned Chinese subsidiary, Daiichi Sankyo China, in Shanghai. Daiichi Sankyo China will manage the operations of Daiichi Sankyo Pharmaceutical (Beijing) and Daiichi Sankyo Pharmaceutical (Shanghai).

Eisai has entered into a Japan copromotion agreement with Novartis Pharma for three Novartis Pharma therapies for chronic obstructive pulmonary disease (COPD). These include Onbrez inhalation capsules 150 mcg (indacaterol maleate), which were launched in Japan on Sept. 20, 2011, and, if approved, the investigational drugs NVA237 (glycopyrronium bromide) and QVA149 (fixed-dose combination of indacaterol maleate and glycopyrronium bromide), both of which are currently in Phase III development. The manufacture and sale of Onbrez will be handled by Novartis Pharma in the same way as before, with the two companies commencing copromotion of NVA237 and QVA149 following their launch.

Eli Lilly will provide more than $4 million in additional funding to the Infectious Disease Research Institute (IDRI) to allow IDRI to continue its early-phase drug-discovery efforts focused on identifying new and better therapies against tuberculosis (TB), including multidrug-resistant strains known as MDR-TB. In addition, Lilly will provide more than $1 million in-kind for volunteer time from Lilly scientists and access to the company's drug-discovery expertise, chemical libraries, and research tools. These additional commitments bring Lilly’s total support of early-stage TB drug-discovery efforts through IDRI to more than $20 million-and Lilly’s total funding of TB and MDR-TB efforts to more than $170 million.

Geron, a biopharmaceutical company, has announced that it will focus on its oncology programs and the company will discontinue further development of its stem-cell programs and is seeking partners for these assets.

Gilead Sciences has agreed to acquire Pharmasset, a clinical-stage pharmaceutical company, have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share or approximately $11 billion. The deal is expected to close in the first quarter of 2012. Pharmasset currently has three clinical-stage product candidates to treat chronic hepatitis C virus.

GlaxoSmithKline has issued its support for the decision of the GAVI Board to provide funding to facilitate the provision of cervical cancer immunization programs and the rubella vaccination across the world’s poorest countries. GAVI has confirmed that it will open a new funding window for vaccines that target the human papillomavirus, which can cause cervical cancer, as well as a second funding window for rubella vaccines.

Incyte announced that FDA has granted marketing approval for Jakafi (ruxolitinib) for treating patients with intermediate or high-risk myelofibrosis (MF), including primary MF, postpolycythemia vera MF and postessential thrombocythemia MF. Jakafi is the first and only product to be approved by the FDA for MF, and the first in a new class of drugs, known as Janus associated kinase (JAK) inhibitors, to be approved for any indication. Jakafi is an oral JAK1 and JAK2 inhibitor.

PCI Synthesis, a contract API manufacturing company, has successfully completed its eighth FDA inspection of the company’s commercial manufacturing site in Newburyport, Massachusetts. Additionally, PCI received its sixth product preapproval. With that preapproval, PCI’s partner expects to launch a new drug in the first or second quarter of 2012.

Pfizer and the Massachusetts Institute of Technology held the official groundbreaking of the new location of Pfizer’s Cardiovascular, Metabolic and Endocrine Diseases and Neuroscience research units in Cambridge, Massachusetts, on Nov. 21, 2011. In September, Pfizer announced it had entered into a 10-year lease agreement with MIT for more than 180,000-ft² of work space.

FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept) for treating wet (neovascular) age-related macular degeneration.

Shire, a specialty biopharmaceutical company, has entered into an agreement with the Japanese pharmaceutical company Shionogi & Co. to codevelop and cocommercialize several of Shire’s attention-deficit hyperactivity disorder medicines in Japan. Shionogi will pay a one-time fee and share costs with Shire in exchange for rights to jointly codevelop and cocommercialize the products upon approval for the Japanese market.

The CRO WuXi PharmaTech has formed a corporate venture fund, capitalized at up to $50 million. The fund will invest in technologies and life-science companies to enhance its platform capabilities.

People Notes

The Pharmaceutical Research and Manufacturers of America has appointed Richard I. Smith as executive vice-president of policy and research. Smith will report to President and CEO John J. Castellani.