Year: 2016

Progenics Receives $50 Million Milestone Payment Following FDA Approval of RELISTOR® Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-cancer Pain

On July 26, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported that it has received a $50 million milestone payment from its worldwide collaboration partner, Valeant Pharmaceuticals International, Inc. (NYSE:VRX), resulting from the US Food and Drug Administration’s marketing approval last week of RELISTOR Tablets for the treatment of opioid-induced constipation in adults with chronic non-cancer pain (Press release, Progenics Pharmaceuticals, JUL 26, 2016, View Source [SID:1234514031]).

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"We are pleased that our partner Valeant can now offer RELISTOR in a more convenient tablet form to patients in need," said Mark Baker, Chief Executive Officer of Progenics. "This and other sales milestone payments that we may receive from sales of RELISTOR provide an important source of non-dilutive financing for our Company as we approach topline, registrational data on AZEDRA and advance our diverse pipeline of prostate cancer imaging agents and therapeutics."

Under a 2011 collaboration with Salix Pharmaceuticals, Inc. (acquired by Valeant in April 2015), Progenics is also entitled to receive up to $200 million of sales milestone payments based on specified U.S. sales targets. The sales milestone payments range from $10 million when calendar-year U.S. net sales first exceed $100 million, to $75 million when such sales first exceed $1 billion. Each sales milestone payment is payable one time only, and one or more, or all, sales milestones could become payable within the same calendar year if the specified sales levels are met. Progenics also earns tiered royalties on total RELISTOR U.S. net sales, as follows: 15% on U.S. net sales up to $100 million, 17% on the next $400 million in U.S. net sales, and 19% on U.S. net sales over $500 million. Outside of the U.S. Progenics is entitled to receive 60% of any up-front milestone, royalty and other revenue, net of certain costs, as specified in our license agreement with Valeant.

About RELISTOR

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant. RELISTOR Tablets (450 mg once daily) is approved in the United States for the treatment of OIC in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for opioid-induced constipation approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.

Important Safety Information about RELISTOR

RELISTOR (methylnaltrexone bromide) Tablets is contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

Cases of gastrointestinal perforation have been reported in adult patients with OIC and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR.

Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia. Take into account the overall risk-benefit profile when using RELISTOR in such patients. Monitor for adequacy of analgesia and symptoms of opioid withdrawal in such patients.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The most common adverse reactions (≥ 12%) in adult patients with opioid-induced constipation and chronic non-cancer pain receiving RELISTOR tablets were abdominal pain, diarrhea, headaches, abdominal distention, hyperhidrosis, anxiety, muscle spasms, rhinorrhea, and chills. Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal.

Please see complete Prescribing Information for RELISTOR at valeant.com. For more information about RELISTOR, please visit www.relistor.com.

BIND Therapeutics Determines Pfizer’s $40 Million Bid Is Highest and Best in 363 Auction for Substantially All of BIND’s Assets

On July 26, 2016 BIND Therapeutics, Inc. (NASDAQ: BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS, reported that Pfizer Inc. (NYSE: PFE) prevailed at a Section 363 auction to purchase substantially all of BIND’s assets (Press release, BIND Therapeutics, JUL 26, 2016, View Source [SID:1234514067]). The winning bid of $40 million, subject to U.S. Bankruptcy Court approval for which a hearing is scheduled to take place on July 27, 2016, was selected as the highest and best bid. NanoCarrier Co., Ltd. has been selected as the back-up bidder. The Company plans to disclose additional terms of its agreement with Pfizer upon Court approval.

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BIND initiated voluntary Chapter 11 bankruptcy protection on May 1, 2016 and conducted a sale of assets, pursuant to Section 363 of the Bankruptcy Code, during an auction held on July 25 and 26, 2016.

CANbridge’s CAN-008 Approved for Phase I/II Trial in Newly-Diagnosed Glioblastoma Multiforme in Taiwan

On July 25, 2016 CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that the Taiwan Food and Drug Administration (TFDA) has approved the Investigational New Drug (IND) application for a Phase I/II clinical study of CAN-008, plus temozolomide (TMZ), during and after radiation therapy, in patients with newly-diagnosed glioblastoma multiforme (GBM) (Press release, CANbridge Life Sciences, JUL 26, 2016, View Source [SID:1234514049]).

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The study design consists of an open-label, dose-escalation Phase I trial, and a multi-center, double-blind, randomized, placebo-controlled Phase II trial. The Phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The Phase II trial will evaluate efficacy and safety. The combined Phase I/II trial will enroll a total of approximately 55 patients. The Phase I portion of the trial will commence in August 2016.
"The approval of our first human clinical trial marks CANbridge’s transition to a clinical stage company, validating our business strategy and regulatory approach to develop promising Western drug candidates for underserved conditions in the Asian market, " said James Xue PhD, CANbridge Chairman and CEO. "That we will be moving forward in a front-line setting is also good news for glioblastoma patients in Taiwan, and the rest of Asia, who have very few treatment options."
"This approval by the TFDA is a very important step in the development of CAN008 for patients with glioblastoma multiforme (GBM) brain tumors," said Mark Goldberg, MD, CANbridge Acting Chief Medical Officer. "Glioblastoma multiforme is a devastating type of brain tumor. Better therapies are desperately needed. We are pleased to be able to move the clinical program forward and hope that CAN008 will prove to be an important advance, improving outcomes for patients with GBM. "

About CAN-008
CAN-008 is a fully human fusion protein consisting of the extracellular domain of CD95 fused to the Fc region of human IgG that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan.

Transgenomic Launches First Commercially Available CLIA Test for Detection of EGFR C797S Mutations That Predict Resistance to 3rd Generation Kinase Therapies for Lung Cancer

On July 25, 2016 Transgenomic, Inc. (TBIO), (NASDAQ: TBIO) reported the launch of its new CLIA assays that detect the presence of the EGFR C797S mutation, a novel mechanism of acquired resistance to third-generation tyrosine kinase inhibitor (TKI) drugs for non-small cell lung cancer (NSCLC) (Press release, Transgenomic, JUL 26, 2016, http://www.transgenomic.com/2016/07/25/transgenomic-launches-first-commercially-available-clia-test-for-detection-of-egfr-c797s-mutations-that-predict-resistance-to-3rd-generation-kinase-therapies-for-lung-cancer/ [SID:1234514048]). The C797S detection test is available as a solo assay and in three panels–TBIO’s EGFR-TKI resistance panel that also tests for the EGFR T790M mutation, its MX-ICP EGFR NSCLC panel and its MX-ICP EGFR Analysis panel, which also test for other actionable EGFR mutations relevant to the treatment of lung cancer.

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These ultra-high sensitivity assays use TBIO’s Multiplexed ICE COLD-PCR (MX-ICP) enrichment technology to generate accurate results from tissue, blood or serum samples, making it feasible to test patients for resistance as treatment proceeds. The EGFR tests are currently available for clinical use through the company’s Oncology CLIA laboratory in Omaha, Nebraska.

TBIO President and CEO Paul Kinnon commented, "We are proud to be the first to offer testing for the EGFR C797S mutation and to do so in flexible formats designed to maximize their utility. This is our 10th CLIA-certified ICP assay for the detection of actionable cancer mutations, with many more slated for commercial release in the coming months. Our ICP technology is an ideal solution for the repeat DNA testing needed to capitalize on new cancer treatments–it has high sensitivity and requires very small amounts of sample, thereby enabling the liquid biopsies needed for ongoing patient monitoring. These unique ICP CLIA assays provide potentially lifesaving information by enabling the ongoing testing and optimal treatment of lung cancer patients."

The EGFR C797S assay is intended for NSCLC patients potentially eligible for treatment with third generation EGFR-TKI drugs. The combination of EGFR C797S and T790M markers comprise an acquired resistance panel for EGFR-TKI therapy. EGFR C797S has also been added to the MX-ICP NSCLC (EGFR exons 18 – 21, EGFR C797S, KRAS exons 2 and 3, BRAF exon 15, PIK3CA exons 9 and 20) and the MX-ICP EGFR Analysis (EGFR exons 18 – 21, EGFR C797S) panels to provide comprehensive testing of genetic markers that are key actionable mutations relevant to the treatment of NSCLC. NSCLC is one of the most common types of cancer in the US and is the leading cause of cancer deaths.

ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available. ICP was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

AstraZeneca files first clinical trial application in Moderna messenger RNA collaboration

On July 26, 2016 AstraZeneca reported that it has filed a Clinical Trial Application (CTA) with the Paul Ehrlich Institute and the German Federal Ministry of Health to initiate a Phase I clinical trial of AZD8601 (Press release, AstraZeneca, JUL 26, 2016, View Source [SID:1234514046]). The programme is part of a collaboration between AstraZeneca and Moderna to discover, develop and commercialise messenger mRNA (mRNA) TherapeuticsTM to treat serious cardiovascular, metabolic and renal diseases as well as cancer. It marks the first programme resulting from the collaboration to progress towards clinical trials.

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AZD8601 is an investigational mRNA-based therapy that encodes for vascular endothelial growth factor-A (VEGF-A). It was discovered and developed in collaboration with Kenneth Chien, M.D., Ph.D., Professor of Cellular and Molecular Biology and Medicine and his team at the Integrated Cardio-Metabolic Centre at Karolinska Institutet in Stockholm, Sweden.

Marcus Schindler, Vice President, Innovative Medicines & Early Development at AstraZeneca said, "Development of regenerative therapies for the treatment of cardiometabolic disease is a hugely exciting and innovative area. We believe that using modified mRNA to initiate a strong, local and transient surge of VEGF-A expression could help us overcome challenges associated with previous approaches to regulate this protein in tissues. AZD8601 could one day provide a unique regenerative treatment option for patients with heart failure, diabetic wound healing and other ischemic vascular diseases."

Stéphane Bancel, Chief Executive Officer, Moderna said, "This marks a significant milestone for both Moderna and AstraZeneca as our first partnered mRNA programme reaches the clinic. It is a validation of our shared vision to harness the potential of mRNA Therapeutics to address serious unmet needs with the goal of improving patients’ lives." This has been a highly collaborative partnership since its inception, and I want to recognise the tremendous work of all involved, including the AstraZeneca team, my Moderna colleagues and Dr. Chien and his team. Together, I believe we will continue to make significant strides that will push new boundaries in the treatment of cardiovascular and metabolic diseases."

Dr. Chien said, "It has been rewarding working as an integrated academic partner with AstraZeneca and Moderna to generate a complete package of strong pre-clinical data over the past three years since our initial publication in mouse studies and we are thrilled that the clinical trial application has been filed."

About AZD8601
mRNA is responsible for carrying genetic instructions transcribed from DNA, which cells then translate to produce proteins. Proteins are responsible for directing the body’s biological functions. Moderna’s pioneering mRNA Therapeutics are designed to trigger the cellular machinery to produce specific proteins. In this application, AZD-8601 may enable the delivery of genetic instructions to spur the production of VEGF-A.

The AZD8601 program is built upon a decade of pioneering research on heart stem cells in cardiovascular development conducted by Dr. Chien, including the finding that VEGF-A can act as a cell fate switch for cardiac progenitors.[i]