![]() ![]() What's the DFS difference between the two groups after two years? Four years? Eight years? The Kaplan-Meier curves would tell you. These are used to identify trends in DFS rates over time-here, for example, between the neratinib group and the placebo group. Second, there are the Kaplan-Meier curves. Norfolk County Council says Puma lied to or misled investors and others about the absolute DFS rates coming out of the ExteNET trial and the improvement in DFS between the neratinib group and the placebo group. The success of the ExteNET neratinib trial was primarily measured by the percentage of disease free survival ("DFS") among patients taking neratinib versus those taking a placebo. The alleged misstatements are basically about two things. In short, Norfolk County Council and other investors accuse Puma and its executives of making false or misleading statements about the ExteNET trial results, and accordingly filed this putative class action. This case concerns Puma's statements about the results of that trial. There was a clinical trial of neratinib called the ExteNET trial. Neratinib is supposed to irreversibly bind to the HER2 receptor, and eventually slow down or stop out-of-control cell growth. "Adjuvant therapy" means that neratinib is a therapy given after an initial treatment (such as surgery) to help suppress further formation of cancerous tumors. Neratinib is an "extended adjuvant treatment." "Extended" refers to neratinib's viability as a long-term treatment beyond the year window that existing drugs cover. Puma has focused its efforts almost entirely on drug PB272, also called neratinib. It's a pharmaceutical company that acquires and develops new drugs. ![]() So up until now, there generally haven't been any drugs that patients with HER2-positive breast cancer can use after a year on the existing drugs. There are drugs that combat overexpression of the HER2 gene, but most patients develop resistance to them after a year. These HER2 receptors promote cell division and proliferation, which results in HER2-positive breast cancer spreading more aggressively than other types of breast cancer. A fourth or fifth of breast cancer patients are HER2-positive: they have cells that make too many copies of a cell surface receptor called human epidermal growth factor receptor 2, or HER2 for short. In particular, this case revolves around statements about a potential treatment for a subset of breast cancers that are called HER2-positive breast cancers. Some of the science behind this sickness is relevant here. The disease's impact far too often includes (but never ends with) the loss of those who we love most. Breast cancer radically reshapes the lives of our mothers and daughters, sons and fathers, brothers and sisters, husbands and wives, friends and family, every day of every year, in every corner of every country. And as they often do, statistics fail to give us the right measure of heartbreak. The disease is the most common cancer among women in our country. That year, 41,324 people in the United States died from breast cancer. Breast Cancer Statistics, Centers for Disease Control and Prevention, (last visited September 30, 2016). In 2013-the most recent year numbers are available-232,924 people in the United States were diagnosed with breast cancer. Lead Plaintiff Norfolk County Council, as administering authority of the Norfolk Eyler (collectively, "Puma") filed a motion to dismiss the case ("Motion to Dismiss") under Federal Rule of Civil Procedure 9(b) (" Rule 9(b)"), Federal Rule of Civil Procedure 12(b)(6) (" Rule 12(b)(6)"), and the Private Securities Litigation Reform Act ("PSLRA"). Defendants Puma Biotechnology, Inc., Alan H. Pension Fund, and others filed this lawsuit under the Securities Exchange Act of 1934 ("Exchange Act") and Securities and Exchange Commission Rule 10b-5.
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