Shares of Puma Biotechnology, Inc. (PBYI) soared significantly after the company reported positive top-line results from the phase III trial on pipeline candidate, neratinib (PB272).
Puma Biotech is evaluating neratinib for the extended adjuvant treatment of breast cancer.
The phase III trial, ExteNET, (n=2821) is a double blind trial, which is evaluating neratinib versus placebo after adjuvant treatment with Roche’s (RHHBY) Herceptin in women suffering from early stage HER2-positive breast cancer.
The patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year after completion of adjuvant treatment with Herceptin.
The primary endpoint of the trial was disease free survival (DFS). The results of the trial showed that treatment with neratinib resulted in a 33% improvement in DFS versus placebo.
Based on positive results from the ExteNET trial, Puma Biotech plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015.
We note that Puma Biotech is also evaluating neratinib for the treatment of patients suffering from non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation.
Concurrent with the trial results, Puma Biotech also announced that it amended its existing licensing agreement with Pfizer (PFE) for neratinib. As per the new agreement, Puma Biotech will now be solely responsible for the expenses associated with the ongoing legacy clinical trials on neratinib.
The amendment will result in an approximate increase of $30 million of research and development expenses for Puma Biotech. A significant portion of the expected $30 million of expenses will occur in 2014.
Puma Biotech had cash, cash equivalents, and marketable securities, of approximately $196.1 million at the end of the first quarter with a burn rate of $14.6 million. Hence, the company expects that the available cash balance should suffice for the additional expenses associated with the amended agreement.
As per the original license agreement, there was a set a limit on the amount of external expenses that Puma Biotech would incur in completing these legacy clinical trials. The limit was reached in the fourth quarter of 2012. The original agreement also stated that Pfizer would be responsible for all expenses related to these ongoing legacy trials that were above the pre-determined limit until the trials were completed.
Upon commercialization of neratinib, Puma Biotech will now be required to pay Pfizer annual royalties on net sales of neratinib at a fixed rate in the low- to mid- teens as compared to the initial agreement of incremental annual royalties ranging around 10% to 20% of net sales.
The positive results from the ExteNET trial will be a boost for Puma Biotech, which does not have any approved drug in its portfolio.
We expect shares to gain in pre-market trading post the trial results.
We remind investors that Roche is a leader in the breast cancer market with its HER2 franchise with strong demand for drugs like Herceptin, Perjeta and Kadcyla.
Puma Biotech carries a Zacks Rank #4 (Sell). Right now, Allergan (AGN) is better-ranked stock in the healthcare sector with a Zacks Rank #1 (Strong Buy).