Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA (ADR) (NYSE:SNY) announced that the Phase 3 ODYSSEY JAPAN trial of the investigational therapy Praluent® (alirocumab) Injection met its primary endpoint. At week 24, patients in the Praluent group experienced an average 64 percent greater reduction from baseline in their bad cholesterol, known as low-density lipoprotein cholesterol (LDL-C), when added to current standard of care including statins, compared to standard of care alone (p less than 0.0001). Patients were started on the lower dose of 75 mg, with the option to adjust their dose to 150 mg if they had not achieved their LDL-C goal (as defined by the Japan Atherosclerosis Society guidelines) at week 8. At week 24, 97 percent of patients in the Praluent group reached their LDL-C treatment goal, compared to 10 percent for placebo (p less than 0.0001). Ninety-nine percent of patients treated with Praluent remained on the lower dose; two patients required adjustment to the higher dose.
The trial involved 216 Japanese patients with hypercholesterolemia at high cardiovascular (CV) risk and/or with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH). Results were presented today for the first time at the Annual Scientific Meeting of theJapan Atherosclerosis Society (JAS) in Sendai, Japan. Praluent is an investigational fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).
“These results demonstrate the significant cholesterol-lowering ability of Praluent among patients with some of the greatest unmet needs in Japan. This includes those with an inherited form of high cholesterol or pre-existing cardiovascular disease, such as a history of heart attack,” said lead investigatorTamio Teramoto, MD, PhD, Director of Teikyo Academic Research Center. “Despite current treatment options, many Japanese patients with hypercholesterolemia are still unable to reach their LDL-C goals, highlighting the need for additional treatment options. Notably, almost all patients reached their LDL-C target levels while remaining on the 75 mg dose, avoiding the need for overtreatment.”
ODYSSEY JAPAN evaluated Praluent (n=144) compared to placebo (n=72), both on top of standard care, in Japanese patients with hypercholesterolemia, with either HeFH or at high CV risk, and who could not reach their LDL-C treatment goal as defined by the JAS guidelines despite lipid-lowering treatments that included statins. The mean LDL-C value at baseline was 141.2 mg/dL. Patients were initially randomized to receive either Praluent 75 mg every two weeks administered as a single 1 milliliter (mL) injection, or placebo. Patients in both groups received statins, with or without other lipid-lowering therapies.
Ninety-nine percent of patients who received Praluent at week 8 remained on the initial 75 mg dose, while one percent of patients had their dose adjusted to receive 150 mg every two weeks, also as a single 1 mL injection. The most common adverse events (occurring in at least 5 percent of patients in the Praluent group) were nasopharyngitis, injection site reaction, and back pain.
On June 9, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of Praluent. The FDA has a target action date of July 24; and while the FDA takes the Committee’s advice into consideration, the FDA is not bound by its recommendation. In addition, the Marketing Authorization Application for Praluent in the European Union is currently under review by theEuropean Medicines Agency (EMA). The safety and efficacy of Praluent have not been fully evaluated by any regulatory authority. (Original Source)
Shares of Regeneron Pharmaceuticals closed yesterday at $509.30. REGN has a 1-year high of $544 and a 1-year low of $295.76. The stock’s 50-day moving average is $514.01 and its 200-day moving average is $456.21.
On the ratings front, Regeneron has been the subject of a number of recent research reports. In a report issued on June 16, Piper Jaffray analyst Edward Tenthoff reiterated a Hold rating on REGN, with a price target of $484, which represents a slight downside potential from current levels. Separately, on June 15, RBC’s Adnan Butt reiterated a Buy rating on the stock and has a price target of $550.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward Tenthoff and Adnan Butt have a total average return of 25.4% and -1.8% respectively. Tenthoff has a success rate of 57.4% and is ranked #195 out of 3694 analysts, while Butt has a success rate of 47.2% and is ranked #3005.
Overall, 3 research analysts have assigned a Hold rating and 7 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $532.00 which is 4.5% above where the stock closed yesterday.
Regeneron Pharmaceuticals Inc is a fully integrated biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.