American drugmakers Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer, Inc. (NYSE:PFE) fired off a series of nine lawsuits to prevent generic versions of Eliquis, a treatment that helps reduce the risk of stroke in patients with atrial fibrillation. The lawsuits stem from abbreviated new drug applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) to market generic versions of apixaban, the anticoagulant agent used in Eliquis. The suits have all been filed in the U.S. District Court for the District of Delaware (D. Del.).
On January 20th, NYC-based drugmaker Bristol-Myers Squibb Co. (NYSE:BMY) and Kenilworth, NJ-based pharmaceutical firm Merck & Co. (NYSE:MRK) announced that the two companies had entered into a settlement and licensing agreement resolving worldwide patent litigation over a cancer treatment. As per the announced terms of the settlement, Merck will make a one-time payment of $625 million to Bristol-Myers Squibb and will also pay future royalties through 2026 on sales of Merck’s Keytruda.
Bristol-Myers Squibb was able to move on in clinical trials of its cancer drug Opvido more quickly than anticipated after kidney cancer patients who were administered the medication showed superior overall survival compared to those patients who were not on an Opvido regimen. Opvido, which has already been approved by the U.S. Food and Drug Administration for the treatment of advanced melanomas and lung cancers, is an inhibitor of the protein known as programmed cell death protein 1, or PD-1. PD-1 inhibits the response of T cell lymphocytes, making it more difficult for an immune system to target a tumor.
There’s been a lot of positive activity in recent months for Bristol-Myers Squibb of New York City. In early March, the U.S. Food and Drug Administration approved the use of BMS’s immunotherapy drug Opvido for the treatment of lung cancer. The approval came ahead of schedule after a clinical trial of the drug was ended due to a significant improval in survival rates. In the early days of April, the company announced a partnership with Dutch-based pharmaceutical developer uniQure that will see BMS pay uniQure $254 million for the successful development of a genetic therapy for congestive heart failure. Also in early April, BMS finalized the acquisition of Flexus Biosciences, a California firm focused on developing anti-cancer therapeutics.
There are certainly some signs for hope. One of them came recently from Princeton University, where graduate students worked on a project which identified a treatment for blocking an enzyme which is important for metastasis, or the spread of cancer through a patient’s body. Many methods of treating cancers can be incredibly damaging to a patient’s body. Today there are many cancer treatments that are developed with an eye towards minimizing the difficult side effects caused by a regimen of chemotherapy or radiation.
Kava Plant May Prevent Cigarette Smoke-induced Lung Cancer *** Conditional Approval for Treatment of T-cell Lymphoma in Dogs *** All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1 *** Favorable Markman Ruling for Dopomed in GRALISE® Patent Litigation *** More FDA Woes for Ranbaxy *** Inovio Develops DNA-based Immune Booster to Enhance T-cell Responses *** Fish & Richardson Wins Hatch-Waxman Litigation for Allergan *** FDA approves Mekinist with Tafinlar for Advanced Melanoma
What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of December 2013. Fitch Puts Negative Outlook on Bristol-Myers. AstraZeneca Loses at the Federal Circuit on Omeprazole. Merck and GlaxoSmithKline Collaborate on Regimen for Advanced Renal Cell Carcinoma. Teva and Pfizer Settle Viagra® Patent Dispute. FTC Settles with Mylan over Agila Acquisition. FDA Fast Tracks Savara Pharmaceuticals Antibiotic AeroVanc to treat MRSA. Fitch Gives Johnson & Johnson AAA Rating. Sales of Antiretroviral Drugs for HIV Predicted to Decrease.