Because Teva Pharmaceutical Industries Ltd. – having settled matters with Eagle Pharmaceuticals Inc. regarding a rapidly infused form of liquid Treanda (bendamustine) – likely "will look to effectuate a 'hard' switch" to Eagle's product, future abbreviated new drug applications (ANDA) likely won't get much traction, even if they can find a way around intellectual property (IP) held by Teva.

That's the view of Piper Jaffray analyst David Amsellem in the wake of the deal between Eagle, of Woodcliff Lake, N.J. and Teva, of Jerusalem, which signed an exclusive license agreement for Eagle's EP-3102 in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). Eagle's stock (NASDAQ:EGRX) closed Wednesday at $36.75, up $10.65, or 40.8 percent.

Teva is waiving its orphan-drug exclusivities for NHL and CLL with respect to EP-3102 so the compound can reach the market sooner, and Eagle collects an up-front cash payment of $30 million, with another $90 million in milestone payments possible, along with royalties. By the end of 2018, cumulative payments and royalties to Eagle as pre-tax income could exceed $300 million, Amsellem wrote in a research report.

Eagle CEO Scott Tarriff said during a conference call that the "transformational event" comes exactly one year from the closing of Eagle's IPO, which raised $50 million by selling 3.4 million shares at $15, the midpoint of the $14-$16 projected span, The deal "should make us a profitable company for 2015 and beyond," Tarriff said. Milestone payments are based on "approval timing, sales levels and reimbursement criteria," he added, declining to detail the royalty arrangement, which he called "very healthy" and in the "double-digit" range.

In November, Eagle disclosed positive results with EP-3102 in a trial that delivered a dose of Treanda's active ingredient in a 50 mL admixture in 10 minutes vs. a 500 mL admixture in the 60-minute infusion required for Teva's drug. EP-3102 was found bioequivalent to Treanda, which was the primary endpoint of the study. Eagle received tentative approval for this formulation in July 2014, and the positive data supported Eagle's thesis that the product can be delivered in this new low-volume infusion, for which the firm won orphan drug designation in the CLL and NHL indications.

"We would expect to see a number of ANDA filings on Teva's currently available liquid formulation of bendamustine," Amsellem wrote, though "how the litigation plays out is something of a wild card (with 30-month stay expiries not until 2017). Regarding ANDA filings on the lyophilized [powder] form of bendamustine, we believe these are even less of a concern, given that the market will have likely completely switched over to liquid formulations by the time" competitors arrive, and showing non-infringement against Teva's IP "is hardly a slam-dunk for this group of filers, in our view."

Tarriff acknowledged "a number of [ANDA] filers out there," but said their 30-month stays provide cushion and "the trials for those ANDAs aren't coming up until the end of 2015. Our expectation is that we'll have some pretty good separation, though you can't know 100 percent, from the time we launch to the time we see competition. This [agreement] really gives us the opportunity now to fully implement the strategy we've outlined to everybody over the past year or so."

Asked if the company would rely more on partnerships such as the one with Teva in the future, Tarriff said Eagle is "certainly not giving up our ability to be a commercial organization. We view oncology as being unique. We've always looked at that as being a different animal, if you will, with certain specific nuances to it," and the company did not relish the prospect of forming its own oncology sales force. "Who better than Teva, the innovator of bendamustine, to go with?" he said.

Teva brought aboard Treanda in its 2011 buyout of Frazer, Pa.-based Cephalon Inc. for $6.8 billion in cash, grabbing all of Cephalon's outstanding shares for $81.50 per share to create a combined company with more than 20 branded products and a then-pipeline of more than 30 developmental products, with three at the filing stage, and $7 billion in annual sales. Treanda sold $767 million last year, compared to $709 million the year before. (See BioWorld Today, May 3, 2011.)

During Teva's conference call on earnings this month, CEO Erez Vigodman pointed out that Treanda was facing a loss of market exclusivity in May 2016 and the company was "checking all the possibilities to extend it further." Teva has other worries with regard to pending generic versions of the multiple-sclerosis drug Copaxone (glatiramer acetate). Last month, in a 7-2 decision that will delay their launches, the Supreme Court took issue Tuesday with the way the Federal Circuit struck down the remaining patent for Copaxone. The high court sent Teva Pharmaceuticals USA Inc. v. Sandoz Inc. back to the U.S. Court of Appeals for the Federal Circuit for a do-over, with instructions that the appellate court "must apply a 'clear error,' not a de novo, standard" when reviewing how a lower court resolves subsidiary factual disputes while constructing a patent claim.

Following the decision, Momenta Pharmaceuticals Inc., of Cambridge, Mass., said the firm was "optimistic" an ANDA for M356, the generic Copaxone it created with Sandoz Inc., "could be approved by the FDA in the near term." (See BioWorld Today, Jan. 21, 2015.)