VARUBI® (rolapitant) was originally developed by Schering-Plough, which was taken over by Merck & Co. in November 2009. Currently, it has been licensed by Tesaro Inc., a relatively new biopharmaceutical company specializing in the development and marketing of cancer medications. It is primarily indicated for chemotherapy patients experiencing nausea and vomiting as a result of their treatment.
Tesaro recently issued a warning letter to health care providers about serious side effects that can include anaphylaxis and other serious allergic reactions. Several law firms across the country are now announcing the filing of a class action lawsuit against Tesaro on behalf of shareholders, alleging that the company provided false or misleading information about its product in order to inflate its stock price.
VARUBI® is a neurokinin 1 (NK1) antagonist. Medications of this class work by inhibiting the action of a particular protein receptor in the nervous system, preventing signals from getting through to certain cells. In the case of NK1 antagonists, the result is suppression of gastrointestinal reflexes that result in vomiting (emesis).
The history of these medications go back to the early 1930s, when two biologists discovered a chemical produced in the bodies of mammals, known as “Substance P” (SP). This biochemical is a “first responder” when the body detects the presence of toxic substances or external stimuli that threaten health and safety; it is, therefore, an integral part of the body's defenses, playing an important role in survival.
Among other functions, SP causes intestinal contractions, which can lead to nausea and vomiting. This occurs when NK1 receptors detect the presence of SP; the purpose of medications such as VARUBI® is to prevent these receptors from transmitting biochemical messages to the intestinal tract.
Pharmaceutical companies began research into NK1 antagonists in 1991. Pfizer was among the first to begin development on such a medication for the treatment of depression and inflammatory diseases as well as emesis, but the product failed to get beyond Phase II clinical studies.
Two years later, Merck began studies on the relationship between the molecular structure of NK1 antagonists and how they operate on the target receptors (SAR studies). The studies led to the development of new compounds, one of which greatly improved the efficacy of such medications. The end result of these studies was the first NK1 receptor, known as aprepitant. Although investigations into aprepitant as a treatment for depression failed to yield results, it was approved by the FDA in 2003 for the treatment of nausea and vomiting associated with chemotherapy and postoperative recovery. Today, the medication is still sold in both oral and injectable form under the brand name Emend.
VARUBI® was granted U.S. approval as an orally-administered medication in September 2015 after clinical trials demonstrated its safety and efficacy as being similar or better than existing drugs used for treating chemotherapy-induced nausea and vomiting (CINV). It is used on adult patients as an adjunct treatment in combination with other anti-vomiting drugs (antiemetics).
Tesaro Fails to Provide Full Disclosure to Investors
At the time of its initial FDA approval, known side effects of VARUBI® were listed as decreased appetite, reduction in the concentration of white blood cells (neutropenia), dizziness, indigestion and inflammation gums, lips and mouth (stomatitis). On March 14th 2016, Tesaro announced to investors that it had submitted a New Drug Application (NDA) for an injectable version of VARUBI® The intravenous formulation of VARUBI® received FDA approval in October 2017. In the months following Tesaro's announcement of the NDA, company stocks traded at “artificially inflated prices,” reaching over $190 per share one year earlier.
On January 12th 2018, Tesaro announced updates for its U.S. labeling for the new intravenous formula. The changes came as a result of adverse event reports of “anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions.” By January 17th, Tesaro shares had fallen by nearly 64 percent, trading at under $62 per share.
It is worth noting that although the company was founded in 2010, it took five years for Tesaro to produce its first commercially viable product. Yet during its initial public offering, it was able to raise $86 million on nothing more than promises in what the website FierceBiotech called “a rare IPO success story.”
In the majority of cases, the serious side effects associated with VARUBI® have occurred within minutes of administering the drug. The reactions associated with anaphylaxis can include respiratory distress, swelling, itching and skin rashes, pain in the chest and/or back, and dangerously low blood pressure, all of which can require hospitalization. Tesaro is now advising healthcare providers to be aware of any patient allergies, particularly to legumes such as peanuts and soybeans (the oil of which is an ingredient in intravenous VARUBI®). The medication is now contraindicated in patients with such allergies. In a recently-issued letter to physicians, Tesaro warns that “cross-reactions to other allergens is possible,” recommending that physicians monitor their patients closely and be aware of any allergies.
Current Legal Action Against Tesaro
The current class action lawsuit brought on behalf of investors alleges that Tesaro made “materially false and misleading statements,” failing to disclose the danger of serious, life-threatening allergic reactions for patients with hypersensitivity disorders. Shareholders seek recovery of losses sustained as a result of Tesaro's failure under Sections 10(b) and 20(a) of the 1934 Securities Exchange Act as well as SEC Rule 10b-5, which makes it illegal for any person or entity to “make any untrue statement of a material fact or to omit to state a material fact...in connection with the purchase or sale of any security.”
Although the lawsuit has been filed, the class has not yet been certified; therefore, any investors wishing to file suit or deciding not to join the class will need to retain their own counsel.
This said, current investigations of Tesaro and the pending class action lawsuit over securities fraud has revealed that Tesaro not only concealed vital information from its shareholders, but from physicians and their patients as well. It should be noted that in January 2017, the FDA contacted Tesaro, expressing some concerns about the contractors that were responsible for actually producing the drug; these concerns involved chemistry, manufacturing and control (CMC) issues. Such a communication from the FDA, known as a “Complete Response Letter” (CRL) is usually issued when there are questions about product quality and compliance with current Good Manufacturing Practices It is, therefore, possible that additional information about VARUBI® will be revealed in coming months. Depending on what is discovered, such information may open the door for people who have been affected by taking VARUBI® and will be coming forward to file injury claims against Tesaro.