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June 29, 2015 By Alex Keown , BioSpace.com Breaking News Staff STAMFORD, Conn. – Swiss-based Novartis AG will acquire Spinifex Pharmaceuticals , a maker of drugs for neuropathic pain, for an upfront payment of $200 million, the company announced this morning. With the acquisition, Novartis will see to add Spinifex ’ lead candidate EMA401, a angiotensin II type 2 (AT2) receptor antagonist. The drug is being developed as a potential first-in-class oral treatment for chronic pain, particularly neuropathic pain, without central nervous system (CNS) side effects, Spinifex said this morning after announcing the deal. Novartis said there are about 7 to 8 percent of adults dealing with neuropathic, which is defined as pain “caused by a lesion or disease of the somatosensory nervous system.” The causes can include pain associated with diabetes, cancer or its treatment with therapeutic agents including chemotherapy, some viruses and nerve trauma. Current treatments for neuropathic pain do not relieve pain in all individuals or are not well tolerated, so drugs targeting a new treatment modality are needed urgently, Spinifex said. David Epstein , head of Novartis Pharmaceuticals , said EMA401 could “provide a novel, differentiated treatment approach to provide relief for patients and healthcare providers worldwide.” Novartis expects the Spinifex drug to reach a large audience. The company said neuropathic pain is a chronic condition with high unmet medical need, with approximately 40 percent of patients not responding to current first line treatments. Additionally, 25 percent of patients do not respond to second-line treatments, Novartis said. In announcing the acquisition, Novartis said including an AT2R antagonist in its pipeline is an important piece of the puzzle in treating pain. “Leveraging peripheral targets, such as an AT2R antagonist, is an emerging and promising approach to neuropathic pain treatment because peripheral targets act outside the blood-brain barrier and therefore are expected to be devoid of common side effects in the central nervous system, such as dizziness or confusion,” the company said . According to terms of the deal, Spinifex will receive the upfront payment as well as undisclosed clinical development and regulatory milestone payments. Spinifex shareholders are eligible to receive payments contingent on future clinical development and regulatory milestones. The deal is expected to close in the second half of 2015, per regulatory approval. Following the acquisition, Novartis will continue to develop EMA401, and launch Phase IIb trials, following successful Phase II trials conducted by Spinifex . Novartis intends to pursue a broad peripheral neuropathic pain label for EMA401. The Spinifex deal comes on the heels of Novartis backing out of a deal to acquire Israeli drugmaker Gamida Cell a year after the plan was initially floated. As part of the termination agreement, Novartis will pay $142 million to Elbit Medical , Gamida ’s largest shareholder. This was the second time Novartis got cold feet in acquiring Gamida Cell . In May 2014 , Novartis decided to back out of a $600 million plan to acquire Gamida . Gamida Cell Ltd. , located in Jerusalem, makes stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. Novartis has had its share of up and down news over the past few months. The company has been working with a number of startups in hopes of forging new paths in therapies. In May Novartis partnered with the Bay Area’s Rani Therapeutics on a method to deliver large molecule drugs, which are typically administered as an injectable, in a “robot pill” form through the use of smart technology. Additionally, Novartis and Indiana-based Eli Lilly were part of a group that backed startup Aeglea BioTherapeutics in $44 million in Series B. Financing. The $44 million investment will be used to support the continued development of Aeglea ’s pipeline of engineered human enzymes that target diseases at the extremes of abnormal metabolism. But, the company has also seen its recent share of controversy. In February Japan’s health ministry ordered the Japanese unit of Novartis AG to halt sales and manufacturing of prescription drugs for 15 days for failing to report the side effects of some medications. In December The Japan Times reported Novartis failed to report a total of 3,264 cases of patient health problems possibly caused by adverse effects of 26 types of drugs sold by the company. The company conducted an internal probe of its practices after issues arose over data collected in trials its blood pressure drug Diovan and two leukemia drugs. Also in March two former employees filed a $110 million gender discrimination suit against Alcon Laboratories, Inc. , a division of Novartis AG , alleging the company fosters a “boys club” attitude that is hostile to women. As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be? Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo. Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo , a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK) . So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "as-rumors-swirl-about-glaxo-bid-who-could-suitors-be", placeholder: "pd_1434950261" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));

MELBOURNE, Australia, February 5, 2014 /PRNewswire/ -- Phase 2 trial met its primary endpoint, reduced pain in postherpetic neuralgia (PHN) versus placebo Significant patient response to EMA401 treatment and drop in pain intensity compared with placebo, meeting a key secondary endpoint First published demonstration of the therapeutic potential of angiotensin II type 2 (AT2)receptor antagonists EMA401 identified as a possible new treatment for neuropathic pain with a novel mechanism of action Spinifex Pharmaceuticals, an Australian pain drug development company, today announces that The Lancet has published the results of its Phase 2 clinical trial of its lead candidate, EMA401, in postherpetic neuralgia (PHN)[1]. EMA401 is a novel angiotensin II type 2 (AT2) receptor antagonist under development as a potential first-in-class oral treatment for chronic pain without CNS side effects. PHN is a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals. The Phase 2 trial met its primary endpoint by showing that patients randomised to EMA401 achieved a greater reduction in pain from baseline to the last week of 28 days of treatment than patients randomised to placebo. Analysing all patients randomised (intent to treat population), the mean pain intensity reduction from baseline after 4 weeks treatment was as follows: EMA401: -2.29; Placebo: -1.60; p = 0.007. A significantly greater proportion of patients on active treatment reported a more than 30% reduction in mean pain intensity score compared to baseline (i.e. responder rate) (EMA401: 57.6%; Placebo: 35.2%; p = 0.0023), meeting a key secondary endpoint. A subgroup of patients who had moderate or severe pain at study entry continued to take a single existing medicine for their PHN during the study (45% of patients in the EMA401 group and 40% of patients in the placebo group). In this subgroup, patients randomised to EMA401 achieved significantly greater pain reduction when compared to patients randomised to placebo. In addition, pain relief was also observed in those patients that were not taking a single existing medicine for their PHN. These results indicate that EMA401 may have the potential to provide relief for patients with PHN who don't achieve optimal pain relief with current treatments or who don't wish to continue with these medicines due to their side effects. EMA401 was generally safe and well tolerated with no serious treatment related adverse events reported. In a commentary also published in the Lancet[2], Dr Nanna Finnerup, of the Danish Pain Research Center, Aarhus University, described this first clinical study to evaluate the efficacy of an AT2 receptor antagonist in neuropathic pain as encouraging adding: "Most importantly, their work identifies a possible new drug for the treatment of neuropathic pain with a novel mechanism of action, and thus offers hope for patients who have insufficient pain relief with presently available drugs." 1. EMA401, an orally administered highly selective angiotensin II type 2 receptor antagonist, as a novel treatment for postherpetic neuralgia: a randomised, double-blind, placebo-controlled phase 2 clinical trial, Rice, A.S.C. et al., The Lancet, Published Online, February 5, 2014; (13)62337 2. Angiotensin II: from blood pressure to pain control, Finnerup, N. B. et al., The Lancet, Published Online, February 5, 2014; (13)62638-0 Andrew Rice, a Professor of Pain Research at Imperial College, Hon. Consultant in Pain Medicine at Chelsea and Westminster Hospital, and lead author of The Lancet paper said: "These results demonstrated EMA401 was able to significantly reduce pain in patients with postherpetic neuralgia and was well tolerated. This paper is the first publication of the clinical effects of any AT2 receptor antagonist and contributes to our understanding of the potentially important role of this new drug class in relieving chronic pain. These results are an exciting step in the development of a novel approach to the treatment of neuropathic pain and chronic pain more generally." Spinifex Pharmaceuticals' CEO Tom McCarthy said: "There is a clear need for new treatments that bring patients pain relief with fewer CNS side effects. The publication of the Phase 2 data with EMA401 in such a prestigious publication is an endorsement of the quality of our scientific development capabilities. We are pleased The Lancet, in the associated commentary, recognises the significant milestone we have achieved in translating basic science on a new pain pathway into clinical efficacy in patients. As stated in the commentary, in addition to PHN, we see broad potential for EMA401 to treat a range of chronic painful conditions such as pain due to osteoarthritis and diabetes. We look forward to delivering on the further development of EMA401." The paper is available via the following link: (13)62337/abstract. EMA401 EMA401 is an angiotensin II type 2 (AT2) receptor antagonist. The discovery that AT2 receptor antagonists offer an innovative approach to the treatment of neuropathic and inflammatory pain was originally made by Professor Maree Smith at The University of Queensland. Having acquired the technology, Spinifex has conducted a comprehensive pre-clinical and early clinical development program on EMA401. In addition to positive Phase 2 results, EMA401 has shown efficacy in a number of relevant pre-clinical models and good human safety and pharmacokinetics in Phase 1 studies. Spinifex's clinical program for EMA401 includes an ongoing Phase 2 study in the treatment of pain in patients with cancer chemotherapy. Spinifex continues to conduct research into the role of the AT2 receptor in nociceptive, inflammatory and neuropathic pain states and these fundamental studies support not only the EMA401 clinical program but also Spinifex's ongoing AT2 receptor antagonist drug discovery program. Spinifex Pharmaceuticals Spinifex Pharmaceuticals is an Australian biotechnology company developing new drug candidates for the treatment and management of pain. Established in 2005 and based in Melbourne, Spinifex has applied its world-class drug development capabilities to advance product candidates. Its lead product EMA401 is under development as a potential first-in-class oral treatment for chronic pain and related symptoms without CNS side effects. Spinifex's Phase 2 program for EMA401 includes clinical trials in a number of chronic pain conditions. Spinifex investors are GBS Venture Partners, Brandon Capital Partners, Uniseed and UniQuest. For more information please contact: Company Dr Tom McCarthy CEO Spinifex Pharmaceuticals Tel: +1-203-321-7130 Email: tom.mccarthy@spinifexpharma.com.au Media Chris Gardner/Sita Shah Citigate Dewe Rogerson Tel: +44(0)20-7638-9571 Email: sita.shah@citigatedr.co.uk SOURCE Spinifex Pharmaceuticals Help employers find you! Check out all the jobs and post your resume.