Dendreon NASDAQ: DNDN www.dendreon.com

Market position

PROVENGE was the first FDA-approved personalized cellular immunotherapy for cancer and is described as the only autologous immunotherapy in the world approved for human use. At the time of the 2017 Sanpower transaction the company had treated more than 20,000 metastatic prostate cancer patients since approval, against a stated addressable population of more than 40,000 men diagnosed each year in the U.S.; the company's website later cited nearly 40,000 men treated.

Provenge is an autologous, patient-specific immunotherapy built on a fusion-protein cassette platform rather than on electroporation-based dendritic cell vaccine methods, and it holds first-mover regulatory status as the first FDA-approved cell-based immune therapy for cancer with a demonstrated overall survival benefit in Phase III testing (an average of 4.1 months longer survival than control).

Technology

Dendreon's approach uses "Dendreon Cassette Technology" to insert a disease-specific target protein into a general platform, with the aim of breaking immune tolerance to disease-specific proteins. The company hypothesizes that receptor-mediated uptake of antigen by dendritic cells occurs when the cells are exposed to a fusion protein linking a disease-specific protein to a recognition protein — in Provenge's case, prostatic acid phosphatase (PAP) linked to GM-CSF. This contrasts with other dendritic cell vaccines that use methods such as electroporation to induce antigen presentation. Dendreon states the process can be generalized to other diseases by exchanging the PAP component for targets specific to other diseased cells, and has explored tumour-specific antigen selection. The company also acquired the nematode anticoagulant Nuvelo and selected Corvas patents covering peptide analog synthesis and drugs targeting coagulation and immune processes.

Go-to-market

PROVENGE is delivered through a commercial and sales organization supported by in-house manufacturing, operations and logistics infrastructure required for patient-specific autologous cell processing. Following the 2017 Sanpower acquisition, management stated intentions to expand access to PROVENGE internationally, particularly in China and Southeast Asia, and to work with relevant authorities on approvals in those markets.

Men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer and their treating physicians, plus biotechnology and pharmaceutical companies seeking development and manufacturing support for cellular therapies.

Geography

Headquartered in Seal Beach, California, with historical operations in Mountain View, California; Seattle, Washington; and a manufacturing facility in Morris Plains, New Jersey. Provenge was beginning to enter the European market as of 2015, and after the Sanpower acquisition the company targeted expansion into China and Southeast Asia. Its parent, Sanpower Group, is headquartered in Nanjing, China.

History

The company was established by Drs. William A. Haseltine, Edgar Engleman and Samuel Strober as Activated Cell Therapy in Mountain View, California, after securing funding from Health Care Ventures of Edison, New Jersey. It later changed its name to Dendreon — a reference to the dendritic cell central to its product candidates — and relocated to Seattle, Washington, under Christopher Henney. In 2006 it built a manufacturing facility in Morris Plains, New Jersey to support Phase III production and a possible FDA approval. The FDA accepted the Provenge Biologic License Application in January 2007, and in March 2007 an FDA advisory committee voted 17-0 that Provenge was reasonably safe and 13-4 that the data showed substantial evidence of efficacy; in May 2007 the FDA requested additional data before approval. Positive Phase III results were announced in April 2009 and full approval followed on April 29, 2010. Dendreon's stock fell 66% on August 4, 2011 after the company abandoned its forecast for Provenge. It filed for Chapter 11 bankruptcy protection in November 2014 and reached restructuring agreements with certain bondholders; Valeant Pharmaceuticals received approval to purchase all Dendreon assets on February 20, 2015. In January 2017 Sanpower Group agreed to acquire Dendreon from Valeant, closing the transaction in June 2017, at which point James Caggiano was promoted to Chief Executive Officer.

Risks & controversies

Sales of Provenge fell short of its development costs, and the company filed for Chapter 11 bankruptcy protection in November 2014, with its assets subsequently sold. Its stock fell 66% on August 4, 2011 after it abandoned its Provenge forecast, and fell 10% in June 2010 amid reports that Medicare's Coverage and Analysis Group was considering a cap on coverage of the treatment. Product labeling notes risks including acute infusion reactions, thromboembolic events such as deep venous thrombosis and pulmonary embolism, and reported cerebrovascular and cardiovascular events; PROVENGE is not tested for transmissible infectious diseases, and concurrent chemotherapy or immunosuppressive therapy has not been studied. Following the 2015 bankruptcy auction, Valeant's acquisition was characterized by some observers as opportunistic distressed-asset buying.