On September 19, 2016 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that EORTC, the European Organisation for Research and Treatment of Cancer, is expanding its collaborative agreement with Ignyta (Press release, Ignyta, SEP 19, 2016, View Source [SID:SID1234515203]). Under this collaboration, Ignyta will serve as a diagnostic laboratory performing fusion testing for EORTC’s SPECTA (Screening Patients for Efficient Clinical Trial Access) initiative.

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Part of the testing will include identifying patients who harbor a gene fusion for the NTRK, ROS1 or ALK genes for potential inclusion of these patients in Ignyta’s global STARTRK-2 Phase 2 clinical study of entrectinib. The genetic data obtained from this screening will also be available for potential future academic research as part of EORTC’s SPECTA initiative.

"EORTC’s SPECTA network includes a broad pool of clinical trial sites, tissue samples and patient data, which is helping us identify patients with a variety of tumor histologies across Europe who could potentially be enrolled in our STARTRK-2 clinical trial, and may benefit from entrectinib, our CNS-penetrant, targeted Trk, ROS1 and ALK inhibitor," said Zachary Hornby, COO at Ignyta. "We are happy to work with EORTC to demonstrate the value of biomarker-driven clinical trials to bring forward innovative, targeted cancer medicines."

EORTC’s SPECTA program is a pan-European biobank and molecular profiling platform for patients in colorectal, brain, lung, melanoma and rare cancers, which aims to optimize drug access, help advance the development of targeted treatments and accelerate new healthcare delivery. Built as a collaborative network, SPECTA provides access to large sets of patient-level clinical and biological data for international, multidisciplinary clinical research.

"Identification of specific genetic mutations provides opportunities for improving treatment efficacy in cancer patients," said Vassilis Golfinopoulos, Medical Director at EORTC. "This is at the heart of our SPECTA program, which helps oncologists find trials that are adapted to their patients’ needs. The collaboration with Ignyta is allowing more patients to be screened, and providing more data to advance the development of precision medicine in cancer."

The Ignyta STARTRK-2 Phase 2 study is evaluating the effectiveness of entrectinib, a selective tyrosine kinase inhibitor targeting tumors that harbor NTRK, ROS1 or ALK gene fusions. The STARTRK-2 trial is actively enrolling and working with leading cancer centers worldwide, including nine countries throughout Europe.

About EORTC

The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 4,600 collaborators from all disciplines involved in cancer treatment and research in more than 640 hospitals in over 37 countries. A unique pan-European clinical research infrastructure, EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices through translational and clinical research.

On September 16, 2016 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it has expanded its strategic collaboration with Amgen, one of the world’s leading independent biotechnology companies, to market and distribute three of Amgen’s medicines in India in the therapy areas of oncology and osteoporosis. (Press release, Dr Reddy’s, SEP 16, 2016, View Source [SID:SID1234515193]). Under the terms of the collaboration, Dr. Reddy’s will commercialise XGEVA (denosumab), Vectibix (panitumumab) and Prolia (denosumab) in India.

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"We are delighted to continue our relationship with Amgen as it strengthens our constant endeavor to enhance patients’ access to novel treatment options across therapy areas. These medicines provide unique treatment options to physicians to address unmet medical need in the area of oncology and osteoporosis."
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In 2015, Dr. Reddy’s announced an initial strategic collaboration with Amgen to execute a full range of regulatory and commercial services to seek approval of and launch Amgen’s Kyprolis (carfilzomib), BLINCYTO (blinatumomab) and Repatha (evolocumab) in India. The collaboration leverages the capabilities of both companies, combining Amgen’s innovative therapies with Dr. Reddy’s deep understanding of patient and physician needs in India.

M.V. Ramana, Executive Vice President and Head of Emerging markets and India Business, Dr. Reddy’s Laboratories Limited, said, "We are delighted to continue our relationship with Amgen as it strengthens our constant endeavor to enhance patients’ access to novel treatment options across therapy areas. These medicines provide unique treatment options to physicians to address unmet medical need in the area of oncology and osteoporosis."

Penny Wan, Amgen Vice President and General Manager, Japan Asia Pacific Region, said, "We are happy to strengthen our relationship with Dr. Reddy’s. Amgen is committed to addressing unmet medical needs of patients in India, and we are pleased with the commitment Dr. Reddy’s has demonstrated toward making our medicines available in India as quickly as possible."

XGEVA is a RANK ligand (RANKL) inhibitor and is approved in India for the prevention of skeletal related events in patients with advanced malignancies involving bone.

Vectibix is an epidermal growth factor receptor (EGFR) antagonist approved in India for the treatment of adult patients with wild-type KRAS metastatic colorectal cancer (m-CRC) as first line treatment as monotherapy following disease progression, in wild type RAS m-CRC as first-line combination with FOLFOX and in second line in combination with FOLFIRI after prior treatment with fluoropyrimidine-based chemotherapy (excluding irinotecan).

Prolia is a RANK ligand (RANKL) inhibitor approved in India for treatment of post-menopausal women with osteoporosis at high risk for fracture and also for treatment of increased bone mass in men with osteoporosis. Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.

On September 16, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for a new Lymphoseek 50 microgram kit for radiopharmaceutical preparation (Press release, Navidea Biopharmaceuticals, SEP 16, 2016, View Source [SID:SID1234515192]). Lymphoseek is a medicinal product for diagnostic use only and is indicated in the EU for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity.1 This new Lymphoseek "dose packaging" enables a single injection per patient and is appropriate for the radiopharmaceutical distribution model in Europe.

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"This is an important milestone achieved by both Navidea and our partner SpePharm AG and was achieved through great collaboration by both companies," said William J. Regan, Navidea Senior Vice President and Director Navidea UK, Ltd. "We are excited that Lymphoseek, with proven clinical benefits and performance characteristics which may improve the clinical outcomes of oncology patients, will shortly be available throughout Europe. The impact of this new dose packaging will also be important to Lymphoseek distribution as we register in markets throughout the rest of the world."

Peter Stein, Chief Executive Officer, Norgine commented, "As a European specialist pharma company, Norgine is looking forward to making this specialist product available to patients in Europe. The EMA positive opinion on the Lymphoseek reduced mass dose vial will ensure that patients can have their cancer accurately staged with the minimum of potentially disfiguring and disabling surgical intervention."

Lymphoseek is approved in the U.S. by the U.S. Food and Drug Administration (FDA) for use in lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management and for guiding Sentinel Lymph Node Biopsy (SLNB) using a handheld gamma counter in patients with node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA- and EMA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by FDA for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek also received EMA European approval in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

EU Lymphoseek Indication

Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.

External imaging and intraoperative evaluation may be performed using a gamma detection device.

Important Safety Information about Lymphoseek for EU patients

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

Prescribing information and more information about Lymphoseek for EU patients is available on the EMA website.

For full prescribing information and more information about Lymphoseek for U.S. patients, please visit: www.lymphoseek.com.

About Norgine

Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2015, Norgine’s total revenue was EUR 320 million and the company employs over 1,000 people.

Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.

Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales and one in Dreux, France.

For more information, please visit www.norgine.com.

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the U.S. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

On September 16, 2016 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it has entered into a worldwide license agreement with Menlo Park, CA-based TeneoBio, Inc (Press release, Ligand, SEP 16, 2016, View Source [SID:SID1234515191]). Under the license, TeneoBio will be able to use the OmniFlic technology from the OmniAb platform to discover fully human bispecific antibodies to be developed for the treatment of various diseases, with an initial focus on therapeutics for cancer, autoimmunity, and infectious diseases. Ligand is eligible to receive annual platform access payments, sublicensing fees, milestone payments and royalties for products incorporating an OmniFlic antibody. TeneoBio will be responsible for all costs related to the programs.

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"Ligand continues to increase its portfolio of partners and fully funded drug research programs. Similar to our Captisol acquisition years ago, our OmniAb business is proving to be a valuable platform for new deal making," said John Higgins, Chief Executive Officer of Ligand. "These follow-on licensing deals post acquisition are important as we are able to expand our programs from which we are entitled to receive potential future economics without increasing our operating costs or diluting our capital structure."

"We are delighted with our partnership with Ligand," said Wim van Schooten, Chief Scientific Officer of TeneoBio. "OmniFlic platform access will enable TeneoBio to discover novel antibody sequences that perfectly complement our UniAb technology. We are familiar with the range of technology offerings in the field, and believe OmniAb is an industry-leading platform for the efficient generation of fully-human antibodies. We look forward to further leveraging our unique discovery engine to develop therapeutic antibodies at unprecedented speeds."