Month: May 2016

Sandoz’ biosimilar rituximab regulatory submission accepted by European Medicines Agency

On May 24, 2016 Sandoz, a Novartis division and the global leader in biosimilars, reported that the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche’s EU-licensed MabThera (rituximab) (Press release, Novartis, MAY 24, 2016, View Source [SID:1234512719]). Rituximab is a monoclonal antibody that is used to treat non-Hodgkin’s lymphoma, which includes follicular lymphoma and diffuse large B-cell lymphoma, chronic lymphocytic leukemia and autoimmune diseases such as rheumatoid arthritis. Sandoz is seeking approval for the same indications as the reference product.

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"Patients with hematologic or blood cancers and rheumatoid arthritis, as well as their doctors, often have few treatment options and have long relied on rituximab as a vital part of their treatment," said Richard Francis, Division Head and CEO of Sandoz. "If approved, we believe our biosimilar rituximab will help broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines."

Sandoz believes that the totality of data in its submission will demonstrate that our biosimilar rituximab has essentially the same biological substance as, and the final drug product is highly similar to, the reference product. In addition to analytical, functional and pre-clinical data, the submission includes data from two pivotal confirmatory safety, PK/PD and efficacy studies that involved 629 follicular lymphoma and 173 rheumatoid arthritis patients.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars. Biosimilar rituximab is part of Sandoz’ growing oncology and immunology portfolios. The oncology portfolio includes two marketed products (filgrastim and epoetin-alfa) and biosimilar candidate pegfilgrastim, which is under regulatory review in the US and EU. Today’s announcement marks the sixth of 10 regulatory filings that the company plans to submit over a three-year period (2015-2017). As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

Lilly Details Robust R&D Pipeline to Investment Community

On May 24, 2016 In a presentation to the investment community today, Eli Lilly and Company (NYSE: LLY) reported it has the potential to launch 20 new products in the 10 years beginning in 2014 and extending through 2023 (Press release, Eli Lilly, MAY 24, 2016, View Source [SID:1234512717]). In addition, Lilly could launch an average of two new indications or line extensions for already-approved products per year during that same time period.

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"We’re pleased to share with investors the breadth and depth of the Lilly pipeline, which showcases our progress across our key therapeutic areas. This includes recent launches as well as a robust lineup of assets in late-stage development or already under regulatory review," said John C. Lechleiter, Ph.D., Lilly’s chairman, president and chief executive officer. "There are no guarantees given the nature of science and of our business; however, in looking at our recent launches and current pipeline, we believe we are in the midst of the most prolific period of new launches in our company’s 140-year history."

Lilly’s R&D efforts focus on five therapeutic areas where the company has assets and capabilities that enable it to compete successfully. These include four core areas—diabetes, oncology, immunology and neurodegeneration—and one emerging area—pain. Building upon a similar investment community meeting in December 2015 focused on neurodegeneration – specifically Alzheimer’s disease – as well as animal health, today’s presentation highlighted the company’s R&D strategy and progress in diabetes, oncology, immunology and pain.

"We have improved the productivity and success of our pipeline through discrete actions aimed at enhancing focus, quality and speed, and by positioning ourselves as an attractive partner for external innovation opportunities," said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories. "These improvements have led to the potential for unprecedented R&D output."

Diabetes
Lilly’s long-standing commitment to diabetes care dates to 1923, when it was the first company to bring insulin to patients. Today, the company has the broadest range of diabetes therapies in the industry. Lilly’s R&D efforts in diabetes focus on differentiated therapeutics and delivery devices within three key areas of unmet need: glucose control, metabolic control and end-organ protection. The company aims to combine its strong in-house diabetes R&D capabilities with a comprehensive external network to deliver continued innovation in this important area of therapy.

Oncology
Lilly has a long history of leadership in oncology. The company has a balanced R&D approach across three key areas of disease modification: tumor cell signaling, tumor microenvironment and immuno-oncology. This approach allows for testing of combinations of internally-derived agents to address tumor heterogeneity and drug resistance. Lilly has a portfolio of differentiated assets across these approaches, including Cyramza (ramucirumab), Portrazza (necitumumab), olaratumab and abemaciclib. Lilly’s immuno-oncology portfolio will have five differentiated molecules in clinical testing by the end of 2016, and as many as 11 by the end of 2018.

Immunology
With the recent launch of Taltz (ixekizumab) and the submission of baricitinib for regulatory review, Lilly has designated immunology as the company’s newest core therapeutic area. While these assets represent the foundational first wave of innovation, Lilly has built a robust emerging pipeline of both internal assets and partnered molecules focusing on key pathways and interventions in multiple autoimmune diseases.

Neurodegeneration
Lilly’s commitment to Alzheimer’s disease is demonstrated by its more than 25 years of research and development in the field. As a result of this sustained effort and deep understanding of the disease, Lilly today has one of the industry’s most comprehensive Alzheimer’s portfolios, with seven molecules already in human testing. The company’s Alzheimer’s research includes disease prevention, detection and treatment.

Pain
Pain is an emerging research area for Lilly, focusing on non-opioid treatment for chronic pain. The two late-stage innovative medicines currently in development are galcanezumab (CGRP Ab), being studied for cluster headache and migraine, and tanezumab, being studied for osteoarthritis pain, chronic lower back pain and cancer pain in partnership with Pfizer.

A live audio webcast of today’s presentation is available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay will be available for approximately 90 days.

EISAI TO PRESENT NEW RESEARCH ON ONCOLOGY PRODUCTS AND PIPELINE AT 52ND ASCO ANNUAL MEETING

On May 24, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a series of abstracts highlighting new study results on Halaven (eribulin mesylate; halichondrin class microtubule dynamics inhibitor, "eribulin") and Lenvima (lenvatinib mesylate; selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, "lenvatinib") will be presented during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place in Chicago, the United States, from June 3 to 7, 2016 (Press release, Eisai, MAY 24, 2016, View Source [SID:1234512716]).

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Poster presentations for this year’s ASCO (Free ASCO Whitepaper) meeting include a presentation highlighting the results of a Phase I clinical study of eribulin liposomal formulation in solid tumors. Presentations for lenvatinib include updated results from the SELECT study regarding response to lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer as well as final analysis results of a Phase II study of lenvatinib in patients with differentiated, medullary, and anaplastic thyroid cancer.

Eisai positions oncology as a key franchise area. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and in doing so seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families as well as healthcare providers.

Major Poster Presentations:
Product Abstract title and scheduled presentation date and time (local time)
Eribulin
(Halaven)

Abstract No: 2524 Phase 1 multicenter, open-label study to establish the maximum tolerated dose (MTD) of two administration schedules of E7389 (eribulin) liposomal formulation in patients (pts) with solid tumors.

Poster Presentation | June 5 (Sun), 08:00-11:30
Eribulin
(Halaven)

Abstract No: 11015 Evaluation of quality of life at progression in patients with soft tissue sarcoma.

Poster Presentation | June 6 (Mon), 08:00-11:30
Eribulin
(Halaven)

Abstract No: 11037 Subtype-specific activity in liposarcoma (LPS) patients (pts) from a phase 3, open-label, randomized study of eribulin (ERI) versus dacarbazine (DTIC) in pts with advanced LPS and leiomyosarcoma (LMS).

Poster Presentation | June 6 (Mon), 08:00-11:30
Lenvatinib
(Lenvima)

Abstract No: 4553 Subgroup analyses and updated overall survival from the phase II trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in metastatic renal cell carcinoma (mRCC).

Poster Presentation | June 6 (Mon), 13:00-16:30
Lenvatinib
(Lenvima)

Abstract No: 6088 Phase II study of lenvatinib in patients with differentiated, medullary, and anaplastic thyroid cancer: Final analysis results.

Poster Presentation | June 4 (Sat), 13:00-16:30
Lenvatinib
(Lenvima)

Abstract No: 6089 Response to lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC): Updated results from SELECT.

Poster Presentation | June 4 (Sat), 13:00-16:30
(Note) SELECT Study: Study of E7080 "LEnvatinib" in Differentiated Cancer of the Thyroid

PharmaCyte Biotech to Engage Principal Investigator for Clinical Trial in Pancreatic Cancer

On May 24, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that PharmaCyte has commenced its search for a Principal Investigator for its Phase 2b clinical trial in advanced pancreatic cancer (Press release, PharmaCyte Biotech, MAY 24, 2016, View Source [SID:1234512742]).

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PharmaCyte will be meeting with potential candidates at this year’s annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago, Illinois, June 3-7, 2016.

PharmaCyte’s Chief Operating Officer, Dr Gerald W. Crabtree, commented, "It is crucial that the person selected for this important position be a recognized expert in the treatment of pancreatic cancer and someone who has had experience in multi-site clinical trials for this devastating disease. It is also an advantage if the person selected is familiar with the oncologists who will lead the efforts at the specific study sites. Therefore, it is imperative that PharmaCyte appoint the best available pancreatic cancer authority possible to the post of Principal Investigator to oversee the entire clinical trial."

PharmaCyte plans to commence a Phase 2b clinical trial in the United States, with study sites in Europe, to meet a critical unmet medical need for patients who no longer benefit from the combination chemotherapies of Abraxane + gemcitabine or FOLFIRINOX after 4-6 months of treatment and whose tumors are inoperable and non-metastatic. Currently, chemotherapy + radiation is used for such patients, but this treatment is only marginally effective and carries with it significant side effects. The goal of the trial is to show that PharmaCyte’s pancreatic cancer therapy can serve as a consolidation therapy that is better than the currently used therapy by exhibiting increased antitumor effectiveness and reduced side effects.

The Principal Investigator is a recognized expert in the area of oncology addressed in the clinical trial. This person serves as the general supervisor for the entire trial and acts as a mentor for the site investigators, protecting the rights, safety and welfare of the patients. The Principal Investigator also ensures that the trial is conducted at all study sites in compliance with the clinical trial protocol, procedures and regulations. In addition, the Principal Investigator plays a major role in developing the final study report of the results of the trial.

There is also an individual "site investigator" at each study site. That is usually the oncologist on site responsible for how the trial is conducted at that site. If a trial is conducted by a team of oncologists at a trial site, the site investigator is the responsible leader of the team that administers the treatments described in the clinical trial protocol and conducts treatment-related tests, protecting the rights, safety and welfare of the patients under the site investigator’s care. When tasks are delegated by a site investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated.

Chugai announcement: Avastin approved for additional indication of advanced or recurrent cervical cancer

On May 23, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it gained approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) on May 23, 2016, for "advanced or recurrent cervical cancer," as new additional indication for the anti-cancer agent / anti-VEGF humanized monoclonal antibody, "AVASTIN I.V. Infusion 100 mg/4 mL and 400 mg/16 mL" [generic name: bevacizumab (genetic recombinant) for Infusion] (Avastin) (Press release, Hoffmann-La Roche , MAY 24, 2016, View Source [SID:1234512741]).

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In Japan, Avastin is currently marketed for the indications of "unresectable advanced or recurrent colorectal cancer," "unresectable advanced or recurrent non-squamous non-small cell lung cancer," "inoperable or recurrent breast cancer," "malignant glioma" and "ovarian cancer." On September 14, 2015, Avastin for advanced or recurrent cervical cancer has been designated as orphan drug and priority review product.
This approval was obtained based on the results of overseas phase III studies (The GOG-0240 study) and Japanese phase II study (The JO29569 study).

The GOG-0240 study evaluated the efficacy and safety profile of standard chemotherapies (paclitaxel and cisplatin or paclitaxel and nogitecan) with or without Avastin in 452 patients with persistent, recurrent or metastatic cervical cancer.

– The study met its primary endpoint of improving overall survival (OS) with a statistically significant 26 percent reduction in the risk of death, representing a median gain in survival of 3.9 months, compared with those who received chemotherapy alone [16.8 months vs. 12.9 months; HR=0.74, stratified log-rank test, one-sided p=0.0066 (significance level: 0.0140)]

– The study showed that patients who received Avastin plus chemotherapy had a significant improvement of progression free survival (PFS) compared with those who received chemotherapy alone ［8.3 months vs. 6.0 months; HR=0.66, stratified log-rank test, p<0.0001.

– The study showed that patients who received Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared with those who received chemotherapy alone [45.4% (95% CI: 38.8-52.1%) vs. 33.8% (95% CI 27.6-40.4%); Chi-squared test, p=0.0117].

– The safety profile in the study was consistent with previous reports of Avastin, except for an increase in gastrointestinal-vaginal fistulas observed in patients who received Avastin plus chemotherapy compared to those who received chemotherapy alone (8.3% vs. 0.9% respectively). All patients with gastrointestinal-vaginal fistulas had a history of prior pelvic radiation.

The JO29569 study evaluated the tolerability, safety and efficacy of Avastin plus paclitaxel and cisplatin. Within eight Japanese patients with advanced or recurrent cervical cancer enrolled in the study, seven patients were evaluated, and one patient was excluded before the start of the study. As a result, the tolerability of Avastin plus chemotherapy was confirmed, and the harmful phenomenon to become the problem was not accepted, and no new safety finding were observed.

"We are proud that Avastin received an approval for cervical cancer as the sixth indication in Japan, which will contribute to the treatment of many cancer patients," said Chugai’s Director and Executive Vice President, Dr. Yutaka Tanaka. "We believe that Avastin would bring great news for the treatment of advanced or recurrent cervical cancer, which has limited treatment options and has not seen any progress for the last ten years."

Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, renal cell cancer, ovarian cancer and cervical cancer, and is available in the US for the treatment of colorectal cancer, non-small cell lung cancer, renal cell cancer, recurrent glioblastoma, cervical cancer and recurrent ovarian cancer. Avastin is approved for cervical cancer in 67 countries (as of January, 2016).

The number of patients newly diagnosed as cervical cancer in Japan continues to rise each year and the annual average in 2015-2019 is estimated to be approximately 10,600.*

As the top pharmaceutical company in the field of oncology in Japan, Chugai is convinced that Avastin can contribute to the treatment of patients with "advanced or recurrent cervical cancer," a disease with high unmet medical need, by providing a new therapeutic option.

Drug Information
The underlined descriptions are newly added.
Brand name: Avastin for intravenous infusion 100 mg/4 mL
Avastin for intravenous infusion 400 mg/16 mL
Generic name: bevacizumab (genetic recombination)
Indications, dosage and administration:
Indications Dosage and Administration Unresectable advanced or recurrent colorectal cancer The usual adult dosage is 5 mg/kg (body weight) or 10 mg/kg (body weight) of bevacizumab (recombinant) per intravenous infusion in combination with other antineoplastic agents. The administration interval of AVASTIN should be 2 weeks or longer. The usual adult dosage is 7.5 mg/kg (body weight) of bevacizumab (recombinant) per intravenous infusion in combination with other antineoplastic agents. The administration interval of AVASTIN should be 3 weeks or longer. Unresectable advanced or recurrent non-squamous nonsmall cell lung cancer The usual adult dosage is 15 mg/kg (body weight) of bevacizumab (recombinant) per intravenous infusion in combination with other antineoplastic agents. The administration interval of AVASTIN should be 3 weeks or longer. Ovarian cancer Advanced or recurrent cervical cancer Inoperable or recurrent breast cancer The usual adult dosage is 10 mg/kg (body weight) of bevacizumab (recombinant) per intravenous infusion in combination with paclitaxel. The administration interval of AVASTIN should be 2 weeks or longer. Malignant glioma The usual adult dosage per intravenous infusion of bevacizumab (recombinant) is 10 mg/kg (body weight) every 2 weeks or 15 mg/kg (body weight) every 3 weeks. The administration interval of AVASTIN should be appropriately extended on the basis of patient condition. Drug prices: Avastin for intravenous infusion 100 mg/4 mL JPY 41,738/vial Avastin for intravenous infusion 400 mg/16 mL JPY 158,942/vial