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Aptevo Therapeutics Receives $20 Million Payment From Emergent BioSolutions

On January 13, 2017 Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, reported that it has received a $20 million cash payment from Emergent BioSolutions pursuant to a promissory note granted as a result of the spin-off of Aptevo from Emergent, effective August 1, 2016 (Press release, Aptevo Therapeutics, JAN 13, 2017, View Source;p=irol-newsArticle&ID=2237367 [SID1234517410]).

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With the additional $20 million cash payment announced today, Emergent has provided a total of $65 million in cash contributions to fund Aptevo’s operations as a newly-launched oncology and hematology-focused company with a broad pipeline of commercial, clinical and preclinical assets and a proprietary bispecific technology platform, ADAPTIR, focused on the development of immuno-oncology therapeutics.

"The achievement of this final payment from Emergent marks another important milestone in Aptevo’s progress," said Marvin L. White, President and Chief Executive Officer. "With the generous funding provided by Emergent, and a strong portfolio of revenue-generating commercial assets, Aptevo is solidly positioned to achieve our near-term goals. Specifically, these include: capturing increased market share for our newly-launched Hemophilia B therapeutic, IXINITY; generating additional data from our two clinical-stage programs, otlertuzumab and MOR209/ES414; and rapidly advancing new ADAPTIR immuno-oncology candidates into clinical development."

About Aptevo Therapeutics Inc.

Aptevo Therapeutics Inc. is a biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Our core technology is the ADAPTIR (modular protein technology) platform. Aptevo has four commercial products in the areas of hematology and infectious diseases, as well as various investigational stage product candidates in immuno-oncology.

RedHill Biopharma Provides 2017 Semi-Annual Business Update

On January 12, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported update on key programs, potential milestones and estimated timelines (Press release, RedHill Biopharma, JAN 12, 2017, View Source [SID1234517389]).

Micha Ben Chorin, RedHill’s CFO, said: "We are heading into 2017 with important potential catalysts in the coming months and with several ongoing Phase III and Phase II programs for gastrointestinal indications. Following the recently announced U.S. co-promotion agreement for Donnatal1, RedHill is advancing its strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with commercial presence in the U.S. This transition is planned to support potential future commercialization of RedHill’s Phase III-stage gastrointestinal drugs, if approved by the FDA. We are backed by strong institutional investors and maintain a debt-free balance sheet with approximately $70 million in cash, allowing us to continue to diligently execute our plans."

RHB-105 – H. pylori bacterial infection (confirmatory Phase III)

The confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to enroll 440 patients in up to 55 U.S. sites, is planned to be initiated by April 2017 following completion of an ongoing supportive pharmacokinetic (PK) program.
RHB-104 – Crohn’s disease (Phase III)

254 of the planned total of 410 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled first Phase III study in the U.S. and additional countries with RHB-104 for Crohn’s disease (the MAP US study).
A second independent data and safety monitoring board (DSMB) meeting of the MAP US study is expected in the second quarter of 2017, with an interim efficacy analysis and an option for early stop for success for overwhelming efficacy.
BEKINDA (RHB-102) – acute gastroenteritis (Phase III) and IBS-D (Phase II)

291 of the planned total of 320 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study). Top-line results are expected by mid-2017.
83 of the planned total of 120 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase II clinical study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line results are expected in mid-2017.
YELIVA – Phase I/II studies for multiple oncology and inflammatory indications

RedHill is currently pursuing several Phase I/II clinical studies with YELIVA in the U.S., targeting oncology indications, with support from National Cancer Institute (NCI) grants awarded to Apogee Biotechnology and U.S. universities, including ongoing studies for advanced hepatocellular carcinoma (Medical University of South Carolina), refractory or relapsed multiple myeloma (Duke University Medical Center ) and refractory/relapsed diffuse large B-cell lymphoma and Kaposi sarcoma (Louisiana State University Health Sciences Center).
Additional Phase I/II studies with YELIVA are in various stages of preparation, including a Phase Ib study to evaluate YELIVA as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy, planned to be initiated in the first half of 2017.
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)

As part of RedHill’s strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with a commercial presence in the U.S., the Company entered earlier this month into an exclusive co-promotion agreement with a subsidiary2 of Concordia International Corp. (NASDAQ:CXRX) (TSX:CXR), granting RedHill certain U.S. promotion rights for Donnatal, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel)3. RedHill expects to initiate promotion of Donnatal in the coming months.
RIZAPORT (RHB-103) – acute migraines (approved for marketing in Germany)

Re-submission of the RIZAPORT NDA to the FDA is expected in the first half of 2017. RIZAPORT was approved for marketing in Germany under the European Decentralized Procedure (DCP) in October 2015 and a first commercialization agreement was signed with Grupo JUSTE S.A.Q.F for Spain and a second commercialization agreement was signed with Pharmatronic Co. for South Korea. RedHill continues discussions with additional potential commercialization partners for RIZAPORT in the U.S., Europe and other territories.
About Donnatal:

Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal comes in two formulations: immediate release Donnatal Tablets and immediate release Donnatal Elixir, a fast acting liquid.

Donnatal is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.

Further information, including prescribing information, can be found on www.donnatal.com.

Please see the following website for important safety information about Donnatal: View Source

Kitov Enters Immuno-Oncology Field Through Acquisition of TyrNovo

On January 12, 2017 Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported the expansion of its pipeline through the acquisition of a majority stake in TyrNovo Ltd., a privately held developer of novel small molecules in the immuno-oncology therapeutic field (Press release, Kitov Pharmaceuticals , JAN 12, 2017, View Source [SID1234517379]).

The expansion into developing immuno-oncology drugs comes as Kitov plans to file its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its flagship combination drug, KIT-302, which is intended to treat osteoarthritis pain and hypertension simultaneously, in Q1 2017, with commercial launch anticipated for the first half of 2018. Kitov plans to harness its development and regulatory capabilities in proceeding towards submitting an investigational new drug (IND) application with the U.S. FDA and initiate clinical trials for its newly acquired drug, NT219.

The market for immuno-oncology treatments is believed to become worth $14 billion by 2019 and to grow to $34 billion by 2024, driven by long-term and durable tumor responses to immuno-oncology drugs, according to Global Data.

Kitov will initially acquire an approximately 56% equity stake in TyrNovo from its majority shareholder, for consideration of $2 million in cash and $1.8 million equivalent ordinary shares of Kitov based on the closing price of Kitov’s shares on the TASE on January 11, 2017. Following the closing of this initial acquisition, which is expected to take place on January 13, 2017, Kitov anticipates that it may acquire additional equity stakes in TyrNovo from all or part of TyrNovo’s additional minority shareholders for consideration consisting of ordinary shares of Kitov in such amounts as to be agreed with the shareholders.

"The TyrNovo acquisition represents a major milestone in Kitov’s strategic vision of establishing a diverse pipeline that we believe will secure long term value creation for its shareholders. We are excited about NT219 and its prospects in the oncology field. NT219 can be developed as a platform combination drug for overcoming multi-drug resistance often observed in various tumors. It has the potential to be developed as a combination therapy with several approved oncology drugs for multiple types of tumors," stated Dr. Paul Waymack, Kitov’s Chairman and Chief Medical Officer.

"The Kitov regulatory team has a proven track record in the development and approval of drugs for oncology as well as other indications required to develop NT219 towards submission of an IND and initiation of clinical trials," Waymack added.

TyrNovo is led by its CEO, Dr. Hadas Reuveni, a co-inventor of the TyrNovo technology, who received her Ph.D., Summa Cum Laude, for anti-cancer drug discovery from the Hebrew University of Jerusalem and has nearly two decades of R&D experience in Biotechnology. Dr. Reuveni commented, "I am excited to join Kitov and its team to expedite the development of NT219, which addresses a true unmet medical need for numerous oncology indications. Cancer drug resistance is the major reason for failure in anti-cancer drug treatment. Preventing resistance to the drugs is critical for improving effective cancer treatment."

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and 2 as well as the inhibition of signal transducer and activator of transcription 3 (STAT3). While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers by preventing the tumors from developing multi-drug resistance and ameliorating multi-drug resistance after resistance is acquired. NT219, in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers, through the prevention of acquired resistance and regression of resistant tumors.

Heron Announces Submission of CINVANTI™ NDA for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)

On January 12, 2017 Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on developing novel best-in-class treatment solutions to address some of the biggest unmet patient needs, reported submission of the New Drug Application (NDA) for CINVANTI (HTX-019), the first polysorbate 80-free, intravenous formulation of aprepitant for the prevention of CINV, to the U.S. Food and Drug Administration (FDA) (Press release, Heron Therapeutics, JAN 12, 2017, View Source;p=RssLanding&cat=news&id=2237084 [SID1234517367]). Aprepitant belongs to a class of agents known as NK1 receptor antagonists, which are often used in combination with 5-HT3 receptor antagonists for the prevention of CINV.

The NDA filing includes data demonstrating the bioequivalence of CINVANTI to EMEND IV (fosaprepitant), supporting its efficacy for the prevention of both acute and delayed CINV with both moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Results also showed CINVANTI was better tolerated than EMEND IV, with significantly fewer adverse events reported with CINVANTI.

"The filing of the NDA for CINVANTI is an important milestone, bringing us one step closer to a new NK1 receptor antagonist treatment option for cancer patients suffering from the debilitating side effects of chemotherapy," said Kimberly J. Manhard, Executive Vice President, Drug Development at Heron Therapeutics. "We look forward to working closely with the FDA during the review of the NDA for CINVANTI in anticipation of FDA approval in late 2017."

"CINVANTI is based on the most widely used NK1 receptor antagonist, with almost 9 years of safety and efficacy experience," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "Since NK1 receptor antagonists are used in combination with 5-HT3 receptor antagonists, CINVANTI offers a strong strategic and operational fit with Heron’s existing commercial product, SUSTOL, our extended-release, injectable product that incorporates the 5-HT3 receptor antagonist granisetron and is also indicated for the prevention of CINV."

About CINVANTI (HTX-019) for CINV
CINVANTI is a proprietary intravenous formulation of aprepitant, a NK1 receptor antagonist for the prevention of CINV. NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists. Currently, the only injectable NK1 receptor antagonist approved in the U.S. contains polysorbate 80, a surfactant, which may cause hypersensitivity reactions, infusion site reactions or other adverse reactions in some patients. Heron’s formulation for CINVANTI does not contain polysorbate 80 and may have a lower incidence of certain types of adverse reactions than reported with the other commercially available injectable NK1 receptor antagonist.

About SUSTOL (granisetron) extended-release injection
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of MEC or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical trials that evaluated efficacy and safety in more than 2,000 patients with cancer. The efficacy of SUSTOL in preventing nausea and vomiting was evaluated in both the acute phase (day 1 following chemotherapy) and the delayed phase (days 2-5 following chemotherapy). Please see full prescribing information, including additional important safety information, available at www.SUSTOL.com.

Delcath Announces Ongoing Patient Treatment And Data Collection In Intrahepatic Cholangiocarcinoma Study Cohort

On January 12, 2017 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that patient treatment and data collection for the intrahepatic cholangiocarcinoma (ICC) cohort of its European Phase 2 HCC/ICC study is ongoing, and that the Company will announce interim results for the cohort once the data are fully mature (Press release, Delcath Systems, JAN 12, 2017, View Source;p=RssLanding&cat=news&id=2237085 [SID1234517366]). Additionally, the Company believes that the original goal to obtain an efficacy signal for the Phase 2 ICC cohort has been satisfied by the result of multicenter patient outcomes identified in the retrospective data collection of our commercial ICC cases conducted by our European investigators. These promising outcomes and observations were discussed with Key Opinion Leaders (KOL) at a Delcath-organized medical advisory panel meeting and led to the agreement that PHP therapy does, indeed, "demonstrate an efficacy signal in ICC and is worthy of full clinical investigation."

The Company also announces that it has accepted an invitation from The Cholangiocarcinoma Foundation (CCF) to present its initial research plans for use of PHP therapy in the treatment ICC. The CCF is the largest patient advocacy organization devoted to finding a cure and improving the quality of life for patients with cholangiocarcinoma, or bile duct cancers. Company representatives will present a summary of European investigator findings and its clinical development plans for ICC to the Foundation’s medical advisory board at the CCF’s 2017 Annual Meeting, to be held in Salt Lake City, UT from February 1-3, 2017. Delcath will also provide a sponsorship grant to support the work of the CCF as part of its participation in the CCF Annual Meeting.

"Though the interim data we expected for ICC cohort in our Phase 2 trial in HCC/ICC are not yet available, the objectives for this study have largely been satisfied by the independent retrospective analysis conducted by our European investigators" said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "The promising outcomes and observations identified at our global KOL forum last year provide us with considerable confidence in the potential of our therapy in the ICC tumor type and helped form our initial research plan. The future research in ICC is designed to be cost effective and pursued in a financially prudent manner."

Dr. Simpson continued, "the CCF is one of the most important organizations for patients diagnosed with bile duct cancers, and the organization has attracted the participation of some of the leading researchers working on this difficult to treat disease. We are delighted with the opportunity to present to KOLs in this space the potential that the European investigators have identified for our therapy in the treatment of ICC."

About ICC
ICC is the second most common primary liver tumor and represents approximately 15% of new hepatocellular carcinoma (primary liver cancer or HCC) cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.