Novartis and Nordic Biosciences have begun a Phase III clinical program of oral salmon calcitonin (SMC021) for the treatment of osteoarthritis, a chronic, irreversible and degenerative condition. SMC021 is a new drug candidate with potential to be the first disease-modifying drug for osteoarthritis.

The salmon calcitonin is formulated in tablet form using a novel eligen delivery technology Emisphere Technologies. The delivery system creates the potential for salmon calcitonin to be available as a convenient oral medication for the first time.

"We are pleased to announce the initiation of Phase III trials for oral calcitonin, which may represent the first disease-modifying drug for the treatment of osteoarthritis," said Michael V. Novinski, president and chief executive officer of Emisphere. "Currently, there are no available treatment options for osteoarthritis that actually help prevent disease progression or joint damage, and we are excited to be at the leading edge of research in this area. An unmet need facing osteoarthritis patients and physicians today is the lack of any proven disease-modifying drug for osteoarthritis. Oral Calcitonin would help prevent structural damage in at-risk joints, or the progression of structural damage in joints already affected. Current treatment options for osteoarthritis provide only symptomatic relief."

The Phase III clinical program is being conducted by Nordic Bioscience both in the European Union and in the U.S., and is planned to include more than 2000 patients. In 2000, Emisphere and Novartis entered into a license agreement for the development of oral salmon calcitonin for the treatment of osteoarthritis and osteoporosis. A Phase III clinical trial of oral calcitonin for the treatment in osteoporosis started also early this year.

Exelixis has submitted an IND application to the FDA for XL019. In preclinical studies, the compound has shown to be a potent, selective and orally available small molecule inhibitor of the cytoplasmic tyrosine kinase JAK2, according to the company. Activating mutations in JAK2 are frequently observed in patients with myeloproliferative disorders such as myelofibrosis, polycythemia vera and essential thrombocythemia. JAK2 activity is also upregulated via multiple mechanisms in many lymphomas and solid tumors.

"This is our fourth IND filing this year, reflecting the integration and productivity of our discovery and development processes," said Gisela M. Schwab, M.D., senior vice president and chief medical officer at Exelixis. "XL019 is a potent inhibitor of the JAK/STAT signaling pathway, which plays a critical role in cell growth and survival in a number of diseases where few clinical options currently exist. We believe that evaluation of XL019 in such indications may allow us to early on in clinical development observe biologic activity and potentially affect clinical outcome."

Nektar Therapeutics has announced plans to restructure, reducing its annual spending by $65 million. As part of this initiative, the company will fire 200 full-time workers, comprising nearly one-quarter of its workforce. In its press announcement, reducing costs and reworking its organizational structure will "allow the company to accelerate the development of its proprietary pipeline, and improve innovation, focus, and accountability across the enterprise." Nektar develops PEGylated and pulmonary technology-based therapeutics.

"During the past several months, we have enacted change at Nektar that prioritizes strong management, timely decision-making, and efficient use of resources," said Howard W. Robin, chief executive officer and president of the company. "These actions greatly strengthen our ability to build a world-class therapeutics company."

Hoyoung Huh M.D., Ph.D. has been promoted to chief operating officer and head of the PEGylation Business Unit. Nevan Elam was promoted earlier to serve as the head of the company's Pulmonary Business Unit. In addition, Michael Simms was named senior vice president of operations, replacing Truc Le, who is leaving the company. Chief financial officer Louis Drapeau is retiring and will leave the company in the coming months.

Overall, the restructuring and layoffs will reduce spending by $65 million. This amount includes reductions of $21 million from general and administrative costs, $23 million from non-cost-of-goods operations, $16 million from R&D, and $5 million from capital spending. Approximately $27 million of this annual spending reduction will be realized in 2007, according to the company.

Nektar reports that it is "making excellent progress" developing its proprietary pipeline. The company plans to complete a Phase IIb trial of NKTR-061 (inhaled amikacin) to treat hospital-acquired gram-negative pneumonia by the end of 2007. Nektar also plans to initiate Phase II trials by the end of the year in its two leading PEGylated small molecule programs, NKTR-102 (PEGylated-irinotecan) for solid tumors and NKTR-118 (PEGylated-naloxol) for opioid-induced constipation.