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Oct 3, 2013

Lilly Peers Into Future, Sees Three Drug Launches in 2014

  • Eli Lilly told investors today it expects to launch several new medicines for unmet patient needs starting next year. The launches, the company said, will get it on track to grow its revenues and profit margins after 2014. The launches may also help Lilly bounce back from several clinical-stage disappointments and recent patent-cliff losses that prompted the company to lay off 1,000 employees earlier this year.

    Lilly said it believes at least three of its late-stage compounds can be launched in 2014, having made regulatory submissions in the United States and the European Union for empagliflozin for type 2 diabetes, a drug being co-developed with Boehringer Ingelheim; dulaglutide (LY2189265), a once-weekly treatment for type 2 diabetes; and ramucirumab.

    The company said its pipeline is the deepest in company’s 137-year history, with 13 potential medicines in Phase III, and 26 more in Phase II.

    However, ramucirumab is now seeking marketing approval for one of three potential indications, as a single-agent treatment for patients with advanced gastric cancer who have had disease progression after initial chemotherapy. Just over a week ago, on Sept. 26, Lilly disclosed that ramucirumab failed one Phase III trial for another indication by failing to hit its primary endpoint, progression-free survival among women with locally recurrent or metastatic breast cancer.

    In that trial—dubbed ROSE or TRIO-012, conducted with the international cancer research group Translational Research in Oncology (TRIO)—ramucirumab and docetaxel were compared to placebo and docetaxel as a first-line treatment in patients with unresectable, locally recurrent, or metastatic HER2-negative breast cancer. While the primary endpoint of progression-free survival in this study favored ramucirumab, it was not statistically significant. Worse, an interim analysis for overall survival showed no benefit for ramucirumab.

    Ramucirumab joins several Lilly compounds to disappoint in late stage trials. In June, the company voluntarily terminated a Phase II study of its drug candidate LY2886721, a beta secretase (BACE) inhibitor being evaluated as a once-daily treatment for Alzheimer’s disease. In May, Lilly halted development of enzastaurin (LY317615 HCl) after it failed the Phase III PRELUDE study, which assessed the drug candidate as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma.

    Ramucirumab fared better in two Phase III trials. One was RAINBOW, where ramucirumab in combination with paclitaxel met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival in patients with advanced gastric cancer. And in the REGARD trial, ramucirumab alone improved overall survival and progression-free survival in patients with advanced gastric cancer who have had disease progression after initial chemotherapy.

    Lilly and Boehringer Ingelheim went ahead with submissions on empagliflozin in part after the sodium glucose co-transporter-2 (SGLT2) inhibitor generated topline Phase III results earlier this year showing that once-daily 10 and 25 mg dosages of the drug candidate met its primary efficacy endpoint, namely significant change in HbA1c from baseline compared to placebo in patients with type 2 diabetes.

    Diabetes is one of several disease areas where Lilly expects its drugs to generate continuing revenue growth beyond 2014, based on now-marketed insulins and Trajenta®, as well as the launches of empagliflozin, dulaglutide, an insulin glargine product, and a new basal insulin. Diabetes should also drive Lilly growth in emerging markets, the company added.

    Lilly is also looking to growth beyond 2014 in animal health, citing strong global demand for animal-based protein and a growing companion animal market, as well as in oncology, where the company cited patents that could provide exclusivity for Alimta® into the early 2020s in the United States and Europe. Lilly is also anticipating the launches of ramucirumab and necitumumab, which showed promising Phase III results in patients with metastatic squamous non-small cell lung cancer. These drugs, according to Lilly, "could form the basis for a regulatory submission as early as 2014.” In January, Lilly revealed it lost Bristol-Myers Squibb as a partner in developing necitumumab for North America and Japan.

    Also expected by the end of 2014, Lilly said, are regulatory submissions for the new insulin glargine product and new data readouts for four other late-stage assets. The company anticipates seeing clinical readouts for the vast majority of its Phase II assets during this period, Jan M. Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories, said in a statement.

    Lilly also reaffirmed its near-term goals of generating at least $20 billion in revenue, $3 billion in net income, and $4 billion in operating cash flow through next year, despite the pending losses of U.S. marketing exclusivity on Cymbalta in 2013 and Evista in 2014. Those losses sparked Lilly’s layoff of 1,000 U.S. sales representatives, announced in April. After 2014, the company said, it expects to provide a large, stable, and profitable revenue base moving ahead.



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