Eagle Pharmaceuticals gets a 505(b)(2) approval for docetaxel

In the past month, Eagle Pharmaceuticals (Woodcliff Lake, NJ) has won a pair of approvals that showcase its ability to do reformulations of generic drugs and to navigate the 5050(b)(2) pathway. FDA’s 505(b)(2) pathway, which has been called “the third sector” between branded and generic drugs, creates, among other things, the ability to design a drug and delivery mechanism that can fit better with commercial market needs: In the case of docetaxel, Eagle’s formulation is alcohol-free, thus sidestepping a safety warning issued by FDA in 2014 of alcohol intoxication for some patients taking current formulations (including the original version of the drug, Sanofi’s Taxere). Docetaxel is a therapy for a variety of cancers.

A few weeks earlier, Eagle also won FDA approval for Bendeka (bendamustine hydrochloride); it is partnering with Teva Pharma to market that product, and earned a $15-million milestone payment. In the case of Bendeka, Eagle devised a tenfold reduction in the infusion volume (from 500 to 50 mL), which equates with a 10-minute infusion duration for patients, as opposed to the 30-60 minutes needed for the original formulation, which was originally marketed as Treanda by Cephalon Pharma. Bendeka is targeted for chronic lymphocytic leukemia (CLL) and for a type of non-Hodgkin lymphoma.

Notwithstanding the claimed benefits of the Eagle formuations, Scott Tarriff, Eagle CEO, says that the two drugs will be marketed at prices comparable to existing formulations on the market.

In between the two FDA approvals, Eagle announced positive results from a safety and efficacy study of Ryanodex (dantrolene) for exertional heat stroke (EHS), a life-threatening condition for, among others, the military and young athletes. Ryanodex is already being marketed by Eagle for malignant hyperthermia, a life-threatening condition sometimes experienced by patients under general anesthesia. With EHS, Eagle is hoping to address emergency care needs outside the hospital setting. Key to the product’s utility is that Eagle reformulated the drug so that its dosage volume is reduced from 720 mL (which can necessitate administering multiple vials of product) to 5 mL—a much easier quantity to store, transport and administer.

The study Eagle conducted was, in a word, unusual: creating an on-the-spot, randomized test of patients experiencing hyperthermia during 2015’s Hajj pilgrimage in Saudi Arabia. Thirty-four patients received either the standard of care (SOC)—cold water immersion and other treatments—or SOC plus Ryanodex. Outcomes were measured by a protocol known as the Glasgow Coma Scale, which measures neurological impairment, at set times following treatment. Patients given Ryanodex showed significant improvement as compared to SOC, says Eagle, which will present detailed results to FDA in the near future.

Tarriff says that Eagle’s business model is to use the 5050(b)(2) pathway generally for injectable products, where “commercial gaps” are found in how drugs are dispensed or administered. “Big Pharma walked away from these disease states because they are usually not blockbuster opportunities,” he says. “With our in-house formulation expertise, and by licensing appropriate technologies (such as the NanoCrystal fine-particle process, originated by Elan and now owned by Alkermes, which is being used in the Ryanodex reformulation), we can satisfy unmet medical needs.” Wall Street seems to agree: since the beginning of 2015, the company’s stock has risen nearly sevenfold.