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Friday, January 18, 2019

Novartis and Oxford University Tie up a Big Data Agreement


Prior to taking over the reins of Novartis, Vasant Narasimhan stressed the importance of harnessing of digital technology as a key method of saving a significant percentage of clinical trial costs. It was an idea where Narasimhan saw a significant opportunity for growth.
Narasimhan said he viewed the future of Novartis as both a medicines and data science company. To bolster that, he forged a partnership with Medidata Solutions to support clinical trials and commercialization programs. Then, in 2018, he struck a deal with Shyft Analytics, a company acquired by Medidata, to harness that company’s Intelligent Platform for Life Sciences to “aggregate and manage” third-party and proprietary commercial data sources.

Narasimhan isn’t done with digital technology. This morning, the Swiss pharma giant announced a five-year collaboration with Oxford University and that august institution’s Big Data Institute. The goal of the partnership is to establish a world-leading research alliance that will improve drug development by making it more efficient and more targeted. Novartis and Oxford University will use artificial intelligence and advanced analytics to “transform how ultra large and multiple datasets are analyzed, combined and interpreted to identify early predictors of patient responses to treatments for inflammatory diseases, such as multiple sclerosis (MS) and psoriasis.”
Oxford and Novartis will use anonymous data from about 5 million patients from the United Kingdom and partner organizations from across the globe. They will combine that data with other anonymized data captured from relevant Novartis clinical trials. Then, using statistical machine learning technology from Oxford’s Big Data Institute, Oxford and Novartis expect to predict how patients will respond to existing and new medicines.
Initially, the partnership between the two will focus on gaining scientific insights in multiple sclerosis (MS), dermatology and rheumatology.
Additionally, the company and academic institution believe that the development of an innovative IT environment and AI technology will help in the identification of patterns in data, particularly those across multiple data sources and types (imaging, genomics, clinical and biological), which cannot be detected by humans alone. Novartis and the BDI will also identify unprecedented insights into the characteristics of specific, complex diseases to understand what drives disease progression, and understand any commonalities between diseases.
John Tsai, head of Global Drug Development and Chief Medical Officer at Novartis, said the work with Oxford’s Big Data Institute will change how they look at disease and discover new insights. He said the partnership has the potential to transform the future design of clinical development programs in the future.
“This partnership with the BDI is aligned with the UK’s Life Sciences Industrial Strategy and offers the opportunity to expand our understanding and capabilities in data science at scale. As a leading medicines company driven by data and digital, Novartis expects the collaboration with the BDI to enhance its capabilities in data science and analytics.” Mark Toms, chief scientific officer of Novartis UK, said in a statement.
Gil McVean, director of Oxford’s Big Data Institute, said the collaboration will enable both groups to transform the scale and efficiency of clinical research at an unprecedented rate through the sharing of data, technology, and advanced analytics expertise.

Behind the Scenes at Lilly and Loxo’s Whirlwind Wedding


Eli Lilly and Company announced it was acquiring Loxo Oncology for $8 billion on January 5, 2019, just days ahead of the JP Morgan Healthcare Conference. Now, regulatory filings give a glimpse of the behind-the-scenes action for what was a whirlwind marriage.
The two companies inked a non-disclosure agreement on December 22, 2018, and amended it a day later. One of the things apparent is that the companies wanted to make a splash at the JPM conference. In an unusual note, the deal came together in a surprisingly short two weeks. The filing indicates Lilly’s team wanted to “expeditiously” perform due diligence and then make a big splash at the JPM.
In that regard, they were successful, with other companies working on targeted oncology therapies like Agios Pharmaceuticals, Blueprint Medicines and Clovis Oncology, showing a stock pop at the news.

On January 7, Andrew Berens, an analyst with Leerink, wrote in a note to investors, “Today’s acquisition marks the third deal for targeted oncology companies since the beginning of December, and we believe the resurgence in M&A is likely to benefit the other late development-stage and early-commercial stage companies in our coverage universe.”
The two companies had been in contact since April 2018, but acquisition talks only began in December. The deal was announced on December 20.
Loxo has one FDA-approved drug on the market, Vitrakvi (larotrectinib), which was only recently approved. It is an oral TRK inhibitor developed and commercialized in collaboration with Bayer.
Regulatory documents suggest that Lilly was most interested in one of Loxo’s pipeline products, LOXO-292, which has “positive interim data” in early-stage clinical trials and had been granted breakthrough status by the FDA in September. LOXO-292 is an oral RET inhibitor being evaluated across multiple cancer types. Investment bank Raymond James projects almost $500 million in annual revenue for the drug by 2023.
Loxo also has LOXO-305, an oral BTK inhibitor currently in Phase I/II, being evaluated in several B-cell leukemias and lymphomas. It also has LOXO-195, a follow-on TRK inhibitor being studied by Loxo and Bayer.
Loxo didn’t hunt for competing bids and Lilly apparently revised its offer only a single time, going from the initial $230 per share to $235 per share. This was a 68 percent premium on Loxo’s January 4 closing share price.
Loxo’s chief executive officer Josh Bilenker and his team are big winners as well. Bilenker’s stock options are worth $240 million, with an $86 million golden parachute, $2 million in salary and severance, for a total of $326 million.
Jacob Van Naarden, Loxo’s chief operating officer, raked in $92 million in stock and $41 million for the golden parachute. Jennifer Burstein, senior vice president of Finance gained $25 million in stock and $13 million for the golden parachute. And Nisha Nanda, Loxo’s chief development officer, received $37 million in stock.
Lilly has been trying to build its oncology presence. The Loxo acquisition will go a long ways toward that goal, even though the company took a hit today. Its ANNOUNCE Phase III clinical trial of Lartruvo (olaratumab) in advanced or metastatic soft tissue sarcoma (STS) failed to meet the primary endpoints of overall survival (OS).
Lartruvo, a platelet-derived growth factor receptor alpha blocking antibody, was being studied in combination with doxorubicin in patients with STS compared to doxorubicin alone, a standard of care. It didn’t meet OS in the full study population or in a sub-population of patients with leiomyosarcoma. There was no difference in survival between the study arms.
In a Phase II trial of 133 patients, the combination had shown an OS benefit, which resulted in the U.S. Food and Drug Administration (FDA) granting the drug accelerated approval and conditional marketing authorization by the European Medicines Agency (EMA).
Soft tissue sarcoma is a complex disease marked by multiple subtypes, which complicates diagnosis and treatment. Sarcomas are described as “relatively rare” and typically develop in connective tissue, which includes fat, blood vessels, nerves, bones, muscles, deep skin tissues and cartilage. The American Cancer Society estimated 13,040 newly diagnosed cases in 2018, with about 5,000 of those people likely to die from it.
“Lilly was surprised and disappointed that Lartruvo did not improve survival for patients with advanced soft tissue sarcoma in this study,” stated Anne White, president of Lilly Oncology. “Lilly is committed to helping people who have soft tissue sarcoma and we will carefully study the detailed data in an effort to better understand the different results between the two trials. We are thankful for the patients and physicians who have participated in the ANNOUNCE study.”

Kura Oncology shares remain ‘significantly undervalued’: Piper Jaffray


Kura Oncology today provided evidence that tipifarnib could be active in patients with no abdominal pain and/or nodal/liver met disease, both of which are associated with high CXCL12 expression, Piper Jaffray analyst Tyler Van Buren tells investors in a research note. The analyst estimates tipifarnib’s opportunity in the HRAS-driven head and neck squamous cell carcinomas opportunity alone is worth $500M-plus in peak sales. However, with the recent data in CXCL12-driven peripheral T-cell lymphomas presented and now potentially pancreatic cancer, these estimates “could be pushed significantly higher over time,” Van Buren adds. He continues to believe Kura Oncology shares are “significantly undervalued” and keeps an Overweight rating on the name with a $25 price target.
https://thefly.com/landingPageNews.php?id=2851131

GW Pharmaceuticals launch of Epidiolex is going well, says Piper Jaffray


After an update from management and consulting with two neurologists, Piper Jaffray analyst Danielle Brill believes the launch of GW Pharmaceuticals’ Epidiolex launch is going well. GW indicated demand is high but the majority of current prescriptions are from academic institutions, that payer coverage is expanding nicely, and that fill time is now less than two weeks, Brill tells investors in a research note titled “Expert Feedback on Epidiolex Instills Confidence in Strength of Launch.” The experts she spoke to mostly agreed. The analyst reiterates an Overweight rating on GW Pharmaceuticals with a $180 price target.

Clementia Pharmaceuticals initiated at Baird


Clementia Pharmaceuticals initiated with an Outperform at Baird. Baird initiated Clementia Pharmaceuticals with an Outperform and $24 price target.

CVS, Walmart in new PBM pharmacy network agreement, terms not disclosed


https://thefly.com/landingPageNews.php?id=2850732

Avrobio announces FDA acceptance of AVR-RD-04 IND application


Avrobio announced that its investigational gene therapy candidate for cystinosis, AVR-RD-04, is cleared to begin a Phase 1/2 clinical trial, following acceptance of the investigational new drug, or IND, application by the FDA. The Phase 1/2 clinical trial is a planned investigator-sponsored trial to be conducted by the University of California, San Diego. AVR-RD-04 is designed as one-time gene therapy and is being investigated for the treatment of cystinosis by inserting the functional gene for human cystinosin, or CTNS, and is designed to maximize the likelihood of sustained CTNS production in patients to correct for the single-gene defect in the CTNS gene that causes cystinosis.