Amgen and Takeda Pharmaceutical Co. Ltd. entered an agreement under which Takeda will develop and commercialize as many as 13 molecules from Amgen’s pipeline for the Japanese market. The collaboration includes early to mid-clinical-stage candidates across a range of therapeutic areas, including oncology, inflammation, and pain.     
    
Under the terms of the agreement, Amgen will receive an upfront cash payment of $200 million. Takeda will also pay to Amgen as much as $340 million in expected worldwide development costs for these molecules during the next few years, $362 million in success-based milestone payments, and royalties on sales in Japan. Also, Takeda plans to acquire all the shares of Amgen’s Japanese subsidiary, Amgen KK. The share transaction is expected to close in the first quarter.
   
Takeda will become Amgen’s worldwide partner for motesanib diphosphate (AMG 706), and will pay Amgen $100 million upfront, $175 million in success-based milestones for the first two indications, and royalties on sales in Japan. Takeda will also pay 60% of ongoing clinical development expenses outside Japan and the two companies will share profits outside Japan.
   
“We are excited about the agreements with Amgen, and also to welcome Amgen KK into Takeda Group,” said Takeda president Yasuchika Hasegawa. “The target indications of the molecules we licensed from Amgen, such as cancer and bone/joint diseases, are in our core therapeutic areas. We believe they will enhance our R&D pipeline and we are looking forward to offering novel treatment options to the patients with such diseases and to physicians as early as possible, through conducting development activities in close collaboration with Amgen.”
   
“The development programs included in this collaboration represent the growth engine for Amgen in the next decade,” said Amgen chairman and chief executive officer, Kevin Sharer. “Takeda’s confidence in these programs validates their potential to become innovative therapies for patients in Japan and worldwide. We value and respect Takeda’s strong development and marketing capabilities and look forward to working with the leading pharmaceutical company in Japan.”
   
The partnership includes Amgen’s Vectibix (panitumumab), motesanib diphosphate and additional molecules in oncology, inflammation and neurology/pain. With the exception of oncology candidate motesanib diphosphate, all molecules included in the partnership are biologics. Amgen retains certain co-promotion rights in Japan on all programs.

Althea Technologies, Inc. has entered a manufacturing supply agreement with Quintessence Biosciences to produce the firm's first drug candidate, QBI-139. The drug is effective in cancer models against a broad range of solid tumors. Quintessence plans to file an IND with the FDA for QBI-139 in 1Q2008. Althea will provide protein production, purification, and aseptic filling services to produce the clinical trial materials.
   
"Althea is an outstanding company with significant experience in the contract manufacture of protein therapeutics," said Ralph Kauten, Quintessence Biosciences chief executive officer. "We are confident in their ability to produce the quality of drug we need for our upcoming clinical trials."
   
"We are very pleased to begin work on Quintessence's leading drug candidate," stated president and Co-CEO of Althea, Dr. Magda Marquet. "The Quintessence QBI-139 therapeutic program is exciting as it represents a new and potentially safer approach to combat a broad array of devastating cancer types."

A recent study by the Tufts Center for the Study of Drug Development found that how drug developers organize their companies affects operational and financial performance. The research, developed by Tufts CSDD and PRTM, an operations management consulting firm, found that: globally positioned operations correlate with higher sales per product, annual number of approvals, and levels of operating efficiency; operations with diverse product portfolios correlate with higher levels of operating efficiency and commercial and innovation effectiveness; organizations with centralized decision-making structures correlate with higher levels of innovation efficiency; and organizations with more integrated business units correlate with higher levels of revenue growth.
   
"Moving forward, no company—big, medium, or small pharma, or biotech—will develop new drugs entirely alone," said Tufts CSDD Director Kenneth I Kaitin, who co-chaired the panel. "Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organizations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company's core competencies."
   
He added, "While traditional responses to boost R&D productivity, such as full or partial vertical integration strategies, still carry validity, they are not the wave of the future, since they tend to divert attention away from what a company does best."
   
Panelists in the study agreed that to speed the pace of new drug development, pharma and biopharma companies will partner with each other and also form strong alliances with organizations outside the drug development industry, such as overnight shipping companies. The panel, part of the Tufts CSDD Management R&D Roundtable Series, was organized to identify operating models that can improve R&D productivity.  

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