Company and People Notes: ImClone, BMS, and Merck Form Agreement; CRI Worldwide Names New CEO; More

Company Notes

Needham, MA (Oct. 22)-AVANT Immunotherapeutics and Celldex Therapeutics (Phillipsburg, New Jersey) signed a definitive merger agreement. The merger creates a NASDAQ-listed, fully integrated and diversified biopharmaceutical company with a large pipeline of product candidates. The all-stock transaction, approved by the boards of directors of both companies, will combine the two companies under the name AVANT. Celldex and AVANT shareholders will own 58% and 42% of the combined company on a fully diluted basis, respectively. The deal is expected to close in the first quarter of 2008. It is contingent upon a vote of approval by AVANT’s current shareholders at a special meeting scheduled for the first quarter of next year.

Exeter, NH (Oct. 23)-The board of directors of Bentley Pharmaceuticals unanimously approved a plan to separate its drug delivery business from Bentley in a transaction that will result in two independent and highly focused public companies. Bentley's independent, publicly traded drug delivery company will be known as CPEX Pharmaceuticals. Bentley’s drug delivery business segment reported revenues of $8.4 million in 2006. Upon completion of the plan, Bentley will focus on the generics pharmaceutical business. Completion of the proposal is subject to numerous conditions, including final approval by Bentley’s board of directors and the Securities and Exchange Commission.

Indianapolis (Oct. 18)-Eli Lilly and MacroGenics (Rockville, Maryland) will collaborate to develop and commercialize teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next-generation anti-CD3 molecules to treat autoimmune diseases. As part of the agreement, Lilly will acquire the exclusive rights to the molecule. Teplizumab is currently being studied in the PROTEGE trial, a global pivotal Phase II–III clinical trial for individuals with recent-onset type 1 diabetes. MacroGenics will continue to oversee the PROTEGE trial.

London (Oct. 23)-GlaxoSmithKline (GSK) and Tolerx (Cambridge, Massachusetts) formed an alliance to develop and commercialize otelixizumab (TRX4), a novel, humanized, anti-CD3 monoclonal antibody that could potentially treat various autoimmune and immune-mediated inflammatory diseases, including type 1 diabetes. Under the terms of the agreement, Tolerx will have responsibility for the Phase III clinical program for type 1 diabetes in the US, up to and including regulatory submission of the biologics license application. Tolerx has the option to copromote otelixizumab in type 1 diabetes in the US with GSK, while GSK will have exclusive rights to develop and commercialize otelixizumab in all other indications in the rest of the world. GSK also has the exclusive right to develop the pediatric indication for type 1 diabetes in the US.

New York (Oct. 17)-ImClone Systems and Bristol-Myers Squibb (BMS) made an agreement with Merck KGaA for the codevelopment and cocommercialization of “ERBITUX” (cetuximab) in Japan. Under the terms of the agreement, ImClone Systems, BMS and Merck KGaA will work together to develop and, following regulatory approval, market ERBITUX in Japan for the treatment of epidermal growth factor receptor-expressing metastatic colorectal cancer. The companies may agree to market ERBITUX to treat other cancers as well. The three companies will share profits and losses realized as a result of the agreement, and BMS and Merck KGaA will use their respective sales forces in Japan. Merck Serono Japan will distribute the product and record the sales for the collaboration.

Bristol, TN (Oct. 18)-King Pharmaceuticals plans to reduce its workforce by approximately 20% as part of a planned strategic shift, which includes emphasizing its focus in neuroscience, and hospital and acute care to maximize its long-term growth. King expects to realize the benefit of this plan in 2008 and estimates that next year’s cost savings will range from $75 million to $90 million. The company is taking these actions in light of recent challenges to its “ALTACE” (ramipril) patent. In September 2007, the US Court of Appeals ruled against the continued validity of the patent covering ALTACE. The company has filed a petition with the court seeking reconsideration of the decision, asserting it involves significant errors.

People Notes

Clementon, NJ (Oct. 23)-CRI Worldwide, a provider of clinical research services to the global pharmaceutical industry, named Kenneth S. King chief executive officer. Prior to joining CRI Worldwide, King held several executive positions at PerkinElmer in Waltham, Massachussetts.

La Jolla, CA (Oct. 23)-Immunosyn appointed Stephen D. Ferrone as the company’s chief executive officer, president and board member.

Raleigh, NC (Oct. 22)-INC Research, a therapeutically focused contract research organization, named David Provost vice-president of the Late Phase Services team. Provost will be responsible for managing the operational unit, as well as for providing strategic consulting to customers regarding the design and implementation of their global late phase programs. The group will initially focus on Phase IV trials, patient registries, observational outcomes studies and safety surveillance studies.

Vancouver (Oct. 22)-Protox Therapeutics named Dr. Samuel Denmeade chief scientific officer, effective immediately.

Bethesda, MD (Oct. 24)-Sucampo Pharmaceuticals appointed Mariam E. Morris chief financial officer, effective January 2, 2008. Morris currently serves as chief accounting officer and treasurer. Ronald W. Kaiser, the current CFO, will shift to an advisory role with Sucampo Pharmaceuticals following the transition.