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Oct. 7 — Clarus Therapeutics Inc. failed in its bid to get a ruling blocking Lipocine Inc. from marketing an oral testosterone product until 2026 ( Clarus Therapeutics, Inc. v. Lipocine, Inc. , 2016 BL 334603, D. Del., Civil Action No. 15-1004-RGA-MPT, 10/6/16 ).
Judge Richard G. Andrews of the U.S. District Court for the District of Delaware Oct. 6 granted Lipocine's request to toss the suit for lack of jurisdiction. The court found that Clarus's complaint was too speculative to go forward.
Clarus had sought a ruling blocking Lipocine's product from entering the market until April 2026 when a Clarus patent expires.
Clarus's declaratory judgment complaint “is based on speculative future events that lack immediacy,” Andrews said, noting that the Food and Drug Administration hadn't completed its review of Lipocine's new drug application (NDA).
“[O]n the facts alleged, there is no potential for actionable infringement until after Defendant both achieves FDA approval and enters the market,” the judge wrote.
The impetus behind the suit is Clarus's goal to be first to market with its own oral testosterone medicine, Jatenzo (previously called Rextoro). It filed its NDA seeking Food and Drug Administration approval of the product and its application is still under review.
Although Clarus wasn't able to secure a court ruling to block Lipocine's product, who gets to market first with a new oral therapy for hypogonadism has potentially huge financial repercussions. The current U.S. market for testosterone replacement products in the U.S. is worth $1.8 billion, according to Dr. Robert Dudley, Clarus's president and chief executive officer. Clarus is based in Northbrook, Ill.
Testosterone therapy is approved in the U.S. for men with medical conditions leading to testosterone deficiencies, such as testicular damage due to chemotherapy.
Because earlier oral treatments were associated with liver injury, their use has declined in favor of gel-based treatments like Eli Lilly's Axiron and AbbVie Inc's Androgel, which now dominate the market, Dudley said.
If approved by the FDA, Jatenzo (oral testosterone undecanoate) would be the first oral testosterone medicine approved to treat hypogonadism (low testosterone or “low-T”) in more than 40 years, Dudley told Bloomberg BNA in an Oct. 7 telephone call. “The market potential is huge,” he said.
If Jatenzo is approved, “We expect that there will be switches to the oral therapy and we'll pick up newly diagnosed men with hypogonadism,” Dudley said.
“None of the currently approved therapies are particularly user-friendly,” he said, and patient compliance can be an issue. Because taking a pill by mouth is an easier delivery system than applying a gel, compliance is likely to improve, too, Dudley said.
“One of the advantages oral therapy offers is an opportunity for men to stay on their medicines as they should.”
The FDA hasn't finished its review of either Clarus's NDA or Lipocine's application. The FDA accepted Clarus's NDA for its oral testosterone undecanoate product in early 2014. Lipocine submitted its oral testosterone NDA in August 2015.
Dudley said Clarus is putting together its response to the FDA's complete response letter on the Jatenzo application. The FDA issues a complete response letter to companies to specific deficiencies in their application and outline recommended actions to get the application ready for approval.
He expects that “on the next go-round, we'll be able to address all the issues the FDA has raised and we'll get approval.”
Dudley added that Lipocine's NDA may not be as far along in the review process as Clarus's application. According to Dudley, “It is our understanding and our view that they received a complete response letter and they're going to have to do another Phase III study.”
Phase III studies are clinical trials in which the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Meanwhile, Lipocine issued a statement Oct. 7 saying it's pleased the court dismissed the case. “Going forward, we will continue to aggressively defend our intellectual property,” Dr. Mahesh Patel, the Lipocine president and CEO, said. “We believe that LPCN 1021 [its product] has the potential to improve the ease of use compared to the available formulations, including topical gels and injections, and to overcome inadvertent testosterone transference risk to children and partners that exist with topical gels.”
Meanwhile, Dudley said Clarus stands ready to refile its lawsuit “if and when” Lipocine's NDA is approved.
Dudley said Clarus wasn't surprised by the judge's dismissal of the lawsuit given that the Lipocine application has yet to receive final approval, nearly a year after the suit was filed.
Lipocine, based in Salt Lake City, is a specialty pharmaceutical company focused on developing innovative oral treatment alternatives for use in men’s and women’s health using its proprietary drug delivery technologies.
Clarus's suit, filed in November 2015, seeking a court ruling that Lipocine's NDA infringed Clarus's U.S. Patent No. 8,828,428. The '428 patent, which is titled “Pharmaceutical Delivery Systems For Hydrophobic Drugs And Compositions Comprising Same,” claims oral formulations containing testosterone undecanoate. It sought a a court ruling that would bar Lipocine from commercially marketing its product before April 14, 2026, the expiration date of the '428 patent.
Green, Griffith & Borg-Breen LLP in Chicago, and Morris, Nichols, Arsht & Tunnell LLP in Wilmington, Del., represented Clarus. Fish & Richardson, P.C. in Wilmington, Del., represented Lipocine.
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