August 12, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Waltham, Mass.-based Tesaro , in anticipation of its first drug approval in September, indicated today it has started hiring up to 100 additional staff.
“We’re in the process of expanding our commercial organization,” said Mary Lynne Hedley, Tesaro co-founder and president in an interview with the Boston Business Journal. “We probably have 95 percent of our commercial organization in place and we’re preparing our pre-launch activity, so if rolapitant is approved on Sept. 5, we’ll be prepared to launch the drug in the fourth quarter.”
Rolapitant is an anti-nausea medication for treatment of cancer patients responding to chemotherapy. It is a long-acting NK-1 receptor antagonist and is being developed for both oral and IV formulations. The drug acts by interacting with the receptors in the brain that control vomiting.
On July 30, Tesaro announced it had signed an exclusive license agreement for the development, registration, manufacture and commercialization of rolapitant in China with Jiangsu Hengrui Medicine Co. Ltd. Although details were not disclosed, Hengrui will make an upfront payment and milestone payments, as well as royalty payments on net sales.
“Tesaro is committed to advancing new therapeutic options for patients with cancer, and we are pleased to be working with Hengrui to develop and commercialize rolapitant for patients in China,” said Lonnie Moulder, co-founder and chief executive officer of Tesaro in a statement. “Hengrui is a leading innovative pharmaceutical company in China, with a substantial portfolio of marketed oncology products, deep regulatory expertise, and a robust pipeline of product candidates. With a strong commitment to quality and a significant level of expertise in clinical development, regulatory affairs, and commercialization, we believed Hengrui is the optimal partner to develop rolapitant in China.”
To date, rolapitant has not been approved for use by any regulatory agency. The New Drug Application (NDA) for oral rolapitant is under review by the U.S. Food and Drug Administration (FDA) and a decision is expected by Sept. 5.
In addition to the two formulations of rolapitant, Tesaro has several different products in its pipeline, including Niraparib in Phase III trials for ovarian cancer maintenance and Phase II for ovarian cancer treatment, and Phase III for BRCA+ breast cancer treatment. The same compound is being studied in Phase I trials in conjunction with other drugs for ovarian cancer and Ewing’s sarcoma. It also has several other compounds in various preclinical stages of development for a variety of cancers.
has been, for the most part, on a climb until recently. Shares traded for $25.93 on Nov. 6, 2014, rose to $42.85 on Jan. 26, 2015, and again to $60.63 on Mar. 18, 2015. Shares spiked on April 23 to $64.65, dropped to $50.84 on May 5, then jumped again to a high of $65.80 on July 17. Shares are currently trading for $48.92.
Zacks Research gave Tesaro a top momentum style rating and a consensus rating of one. On a scale of one to five, one is a “Strong Buy” rating and five is a “Sell” rating. Not a lot of analysts are covering Tesaro, but the Enterprise Leader indicates sell-side research firms gave Tesaro stock a one-year price target of $69, based on four analysts. The high was $70 and the low was $67.
In an interview with Boston Business Journal, Moulder said, “We’re just getting started with our product launching in the fourth quarter followed by the product launch next year. We’re enthusiastic, but not predicting any specific stock price.”
