On February 17, 2015 Teva Pharmaceutical Industries and Eagle Pharmaceuticals reported that the companies have entered into an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride (HCl) rapid infusion product for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) (Press release Teva, FEB 17, 2015, View Source [SID:1234501639]). Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.

Eagle has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle has requested Priority Review of the NDA; this product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from Eagle’s recently-completed clinical trials demonstrating that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture.

“Since 2008, Teva’s bendamustine HCl product, TREANDA, has played a valuable role in the treatment of patients with CLL or indolent B-cell NHL that has progressed,” stated Paul Rittman, Vice President and General Manager, Teva Oncology. “With a substantially shorter infusion time, Eagle’s rapid infusion bendamustine HCl represents an important and improved benefit to both patients and healthcare providers. By adding this product to Teva’s Oncology portfolio, we are furthering our commitment to enhancing treatment options for patients affected by cancer and executing on a business development strategy to pursue opportunities in therapeutic areas where we can apply our expertise, commercial infrastructure and experience.”

“We are very pleased to partner with Teva for the commercialization of our rapid infusion bendamustine product,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “Given their strong presence and unsurpassed knowledge of this market, we believe there is no better company than Teva to optimize the market potential of this product.”

As part of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which should allow the product to come to market more quickly. Under the terms of the exclusive license agreement, Eagle will receive an upfront cash payment of $30 million and is eligible to receive up to $90 million in additional milestone payments. In addition, Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval.

The companies will also settle the pending patent infringement action between them in the United States District Court for the District of Delaware involving Teva’s U.S. Patent No. 8,791,270.

On February 17, 2015 Seattle Genetics reported of the initiation of a phase 1 clinical trial of SEA-CD40 for multiple types of advanced solid tumors (Press release Seattle Genetics, FEB 17, 2015, View Source [SID:1234501637]). SEA-CD40 is a novel investigational immuno-oncology agent targeted to CD40, a widely expressed stimulatory receptor found on antigen-presenting cells (APCs) which play a role in immune cell activation. SEA-CD40 utilizes Seattle Genetics’ proprietary sugar-engineered antibody (SEA) technology to produce a non-fucosylated antibody targeting CD40. Preclinical data show that SEA-CD40 stimulates the immune system to fight cancer.

“We are pleased to advance our SEA-CD40 immuno-oncology program into the clinic to evaluate it broadly in multiple types of solid tumors,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our proprietary SEA technology builds on our expertise in empowered, targeted approaches for the treatment of cancer and represents a novel technology designed to increase the potency of monoclonal antibodies through glycoengineering which may lead to an improved antitumor immune response. We look forward to data from the phase 1 trial.”

The study is a phase 1, open-label, multi-center, dose-escalation clinical trial of SEA-CD40 in patients with advanced solid tumors who have failed current standard of care treatments. Expansion cohorts are planned to evaluate SEA-CD40 across up to three cancer indications that will be determined based on data from the dose escalation portion of the study. The primary endpoints are determination of the maximum tolerated dose (MTD) and safety profile of SEA-CD40. In addition, the trial will evaluate antitumor activity, pharmacokinetics and immunological pharmacodynamic effects. The phase 1 trial will enroll approximately 50 patients during dose escalation and up to 90 patients in the expansion cohorts at multiple centers in the United States.

On February 17, 2015 Ignyta, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Ignyta’s lead product candidate entrectinib for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer (Press release Ignyta, FEB 17, 2015, View Source [SID:1234501634]).

“We are pleased to receive from the FDA this orphan drug designation for colorectal cancer, our third orphan designation in addition to neuroblastoma and non-small cell lung cancer,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “Entrectinib has the potential to address unmet needs of patients with rare cancers, and we will continue to aggressively pursue our clinical development program for entrectinib in solid tumors for the benefit of these patients and to create value for our stockholders.”

On February 17, 2015 Takeda Pharmaceutical reported that the primary endpoint of progression-free survival (PFS) was not met in the Phase 3 MONET-A study of patients with stage IV non-squamous non-small cell lung cancer (NSCLC) who were randomized to treatment with investigational motesanib in combination with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and carboplatin (Press release Takeda, FEB 16, 2015, View Source [SID:1234501638]). As a result,Takeda has elected to terminate the MONET-A trial, and will report on the full trial results once available. Motesanib is an investigational, orally administered small molecule antagonist of vascular endothelial growth factor receptors 1, 2 and 3, platelet driven growth factor receptors and stem cell factor receptor.

Takeda is working with trial investigators to ensure patients who participated in the study
will receive appropriate therapies.

About the MONET-A Study
MONET-A is a multinational Phase 3, randomized, placebo-controlled, double-blind study examining the efficacy and safety of motesanib when administered with paclitaxel and carboplatin. Patients (n=401) with stage IV or recurrent non-squamous NSCLC were randomized in a 1:1 ratio to either motesanib in combination with paclitaxel and carboplatin or placebo in combination with paclitaxel and carboplatin.
Patients included in the study had a confirmed diagnosis of stage IV non-squamous NSCLC, no prior chemotherapy, molecularly-targeted therapy or immunotherapy (for metastatic disease) and other outlined eligibility criteria.

The primary efficacy endpoint was PFS. Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response, safety and pharmacokinetics of motesanib and its metabolites when the compound was administered in combination with paclitaxel and carboplatin.
The MONET-A study was initiated among patients in Japan, South Korea, Taiwan and Hong Kong, following the completion of a previous Phase 3 trial, MONET1, which compared motesanib combined with paclitaxel and carboplatin to chemotherapy alone in patients with non-squamous NSCLC. Although the MONET1 trial did not meet its primary objective of demonstrating a statistically significant improvement in OS, a pre-planned analysis revealed significant and consistent findings in the Asian population for ORR, PFS and OS, providing rationale for further investigation.