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Amgen Licenses AMG 714 for Refractory Celiac Disease

On March 2, 2015 Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing autoimmune diseases reported that it has licensed a Phase 2-stage, anti-IL-15 monoclonal antibody (AMG 714) from Amgen (NASDAQ:AMGN) (Press release, Celimmune, MAR 2, 2015, View Source [SID:1234511963]). Under the provisions of this exclusive license agreement, Celimmune has the rights to develop, manufacture and commercialize AMG 714 on a worldwide basis excluding Japan. Concurrently, Amgen has been granted an exclusive option to reacquire AMG 714, upon completion of additional clinical studies. Financial terms of the agreements are not being disclosed. Celimmune plans to initiate Phase 2 studies of AMG 714 for the treatment of diet non-responsive celiac disease and refractory celiac disease (RCD).

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Dr. Francisco Leon, Celimmune’s CEO and Chief Medical Officer,stated, "Celiac disease is the only common autoimmune disease without any approved medication. Published literature demonstrates that the gluten-free diet is not a solution for the vast majority of patients. As such, Celimmune is delighted to have an opportunity to license an experimental therapeutic that will test one of the main hypotheses in the pathophysiology of celiac disease, namely that IL-15 plays a central role in RCD and non-responsive celiac disease. IL-15 appears to be an essential, non-redundant, growth factor for the intraepithelial lymphocytes, which cause intestinal mucosal atrophy and the progression to lymphomain RCD. IL-15 has been shown to be one of the key factors in the loss of tolerance to food antigens in celiac disease, and also is believed to be involved in Crohn’s disease and other autoimmune diseases."

Ashleigh Palmer, Celimmune’s Executive Chairman, said, "Our agreement with Amgen underscores Celimmune’s distinctive core competence focused on the translational and clinical development of high-potential therapeutics for priority autoimmune and other immunological diseases with high levels of unmet medical and socioeconomic need, including cancer. Celimmune, in partnership with our enabling networks, has deep management experience, proven capabilities and industry leading expertise in developing clinical-stage assets for celiac and other autoimmune diseases. AMG 714 could be the first drug to market for a celiac indication, and there are currently no other drugs in clinical development targeting the IL-15 cytokine. In addition to celiac, AMG 714 could have longer-term expansion and life cycle management opportunities within adjacent gastrointestinal autoimmune diseases."

About Celiac Disease
Celiac disease is a chronic hereditary systemic autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing gastrointestinal dysfunction and debilitating symptoms. Nutritional malabsorption can lead to a failure to thrive in children and anemia and osteopenia in adults. Over the course of a life time, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Currently 1% of Western and 0.5% of Asian populations suffer from celiac disease and diagnosed prevalence is expected to increase dramatically with improved diagnostic tools and clinical awareness.

Genmab Announces That Agreement to Transfer Ofatumumab Collaboration to Novartis is Now Effective

On March 2, 2015 Genmab reported that GlaxoSmithKline (GSK) and Novartis Pharma AG (Novartis) have announced that the definitive agreement in which Novartis agreed to acquire GSK’s oncology products including ofatumumab has been completed (Press release, Genmab, MAR 2, 2015, View Source [SID:1234502137]). As a result, the agreement Genmab entered with GSK and Novartis to transfer the ofatumumab collaboration from GSK to Novartis in November 2014 is now effective. Novartis will develop and commercialize ofatumumab in cancer indications and GSK will continue to develop and commercialize ofatumumab for autoimmune indications.

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Under the terms of the transfer agreement, the parties agreed that Genmab would not be required to pay existing funding liabilities or to fund development costs for ofatumumab beyond December 31, 2014. For more information on the agreement between Genmab, GSK and Novartis, please refer to Genmab’s Company Announcement number 49 published on November 3, 2014.

Taiho Submits TAS-102 (brand name in Japan: “Lonsurf®”) Marketing Authorization Application to the European Medicines Agency for the Treatment of Refractory Metastatic Colorectal Cancer

Taiho Pharmaceutical reported that Taiho Pharma Europe Ltd., a subsidiary of Taiho Pharmaceutical, has submitted on February 27, 2015 a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer (mCRC) (Press release, Taiho, MAR 2, 2015, View Source [SID:1234502139]).

This MAA submission closely follows the TAS-102 New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which was accepted for review by the FDA on February 17, 2015. TAS-102 was approved initially in Japan in March 2014 and launched in May 2014 under the brand name “Lonsurf combination tablet T15, T20”.

This MAA submission is supported by the results of the randomized, double blind, placebo controlled, Phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies. The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.0001) and demonstrated a safety profile consistent with that observed in earlier clinical trials. About TAS-102 TAS-102 is an oral combination investigational anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase. TAS-102 was approved initially in Japan in March 2014 for the indications of "unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies)," based on the results of the Phase II clinical trial conducted in Japan, and launched in Japan in May 2014 under the brand name "Lonsurf combination tablet T15, T20".

ABRAXANE® Approved by European Commission for First-Line Treatment of Patients with Non-Small Cell Lung Cancer

On March 2, 2015 Celgene reported that the European Commission (EC) has approved ABRAXANE (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy (Press release, Celgene, MAR 2, 2015, View Source [SID:1234502133]).

The ABRAXANE Marketing Authorisation has been updated across 28 member states in the European Union to include this new indication in non-small cell lung cancer (NSCLC), adding to the existing indications for the treatment of metastatic pancreatic and breast cancers.

Lung cancer is the fourth most commonly diagnosed cancer in both men and women, however it is the leading cause of cancer-related mortality in Europe. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for 85 to 90% of all cases. The predominant cause of lung cancer is cigarette smoking, although environmental and occupational factors also can cause the cancer.

The EC decision follows the positive CHMP opinion received on 23 January and is based on the results of a multicenter, randomized, open-label study including 1,052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. The study compared ABRAXANE in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer. The primary efficacy endpoint, overall response rate, was significantly higher for patients in the ABRAXANE/carboplatin arm at 33%, compared with patients in the control arm, at 25%. The most common adverse reactions (≥ 20%) of ABRAXANE in combination with carboplatin for NSCLC were anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, nausea, and fatigue.

Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, “At Celgene, we are pleased that the EC’s approval of ABRAXANE in NSCLC allows patients in Europe who have been diagnosed with this devastating disease to access this innovative nanotechnology medicine. The expanded application of ABRAXANE across three difficult to treat tumors – breast, pancreatic and lung cancers – reinforces the value ABRAXANE provides and our commitment to advance transformational science, deliver life-enhancing medicines and serve patients with cancers the world over.”

U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Yervoy® (ipilimumab) as Adjuvant Treatment for Patients with Stage 3 Melanoma Who Are at High Risk of Recurrence

On March 2, 2015 Bristol-Myers Squibb Company reported that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Yervoy for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection (Press release, Bristol-Myers Squibb, MAR 2, 2015, View Source [SID:1234502132]). The projected FDA action date is October 28, 2015.

For many stage 3 melanoma patients, there is a high risk of disease recurrence and there has been a low overall survival rate. By five years, the majority of patients experience disease recurrence, with nearly 90 percent in those considered at the highest risk. Once the disease returns, survival rates have been been very low historically, ranging from 11 to 20 percent.

“Four years ago, Yervoy was approved for the treatment of unresectable or metastatic melanoma, the most advanced form of the disease,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Today’s announcement is a reflection of our commitment to investigate our immuno-oncology treatments for patients across lines of therapy and stages of the disease.”

This filing acceptance is based on clinical data from a randomized, double-blind Phase III trial, CA184-029 (EORTC 18071), assessing the efficacy of Yervoy, at the investigational dose of 10 mg/kg, in preventing or delaying recurrence after complete resection of high-risk stage 3 melanoma.