On May 14, 2018 Eli Lilly and Company (NYSE: LLY) reported an agreement to acquire AurKa Pharma, Inc., a company established by TVM Capital Life Science to develop oncology compound AK-01, an Aurora kinase A inhibitor that was originally discovered at Lilly (Press release, Eli Lilly, MAY 14, 2018, View Source [SID1234526591]). The compound is a potential first-in-class asset that AurKa Pharma is studying in Phase 1 clinical trials in multiple types of solid tumors.

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Aurora kinases are believed to play a crucial role in cellular division by controlling chromosomal segregation. Defects in segregation can cause genetic instability, a condition highly associated with the formation of tumors. Aurora kinases, consisting of Aurora A, Aurora B and Aurora C, are key mitotic regulators required for genome stability and are frequently overexpressed in cancerous tumors. AurKa Pharma’s asset, AK-01, has been shown to be highly selective for Aurora A, with potential clinical benefit observed in Phase 1 studies. Future studies will seek to determine if the selectivity profile of AK-01 can improve efficacy while limiting toxicity risks to a manageable level.

After a review of its clinical pipeline priorities in 2016, Lilly sold the compound to TVM Capital Life Science, which then established AurKa as part of the TVM Life Science Ventures VII fund. The fund is a novel investment model that seeks to develop early-stage pharmaceutical assets in a capital-efficient manner. As part of its innovation strategy, Lilly actively participates with venture capital firms to source early stage opportunities.

"The acquisition of AurKa Pharma supports Lilly’s external innovation strategy, in which we seek to partner with leading life science venture capital firms in order to identify, support and access promising innovation in areas of unmet medical need," said Darren Carroll, senior vice president of corporate business development at Lilly. "We are excited with the value TVM created for this compound through its early-Phase studies, and we look forward to more opportunities in the future."

"Lilly Oncology is focused on the development of innovative cancer therapies that can make a meaningful difference for patients," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "The acquisition of AurKa Pharma expands our pipeline with a promising oncology compound targeting a distinct cell cycle pathway. The work done by AurKa will allow Lilly to leverage emerging data about cancers in which this molecule might be effective, and determine if it can be beneficial to people living with various forms of cancer."

"Through the unique healthcare venture capital model pioneered by TVM Capital Life Science, companies such as AurKa have been established to more quickly and efficiently bring promising compounds to clinical proof-of-concept," said Luc Marengere, Ph.D., Managing Partner at TVM Capital Life Science. "We are pleased that the scientific advances made by AurKa could contribute to the development of AK-01 and hopefully help deliver a potential new medicine for cancer patients."

Under the terms of the agreement, Lilly will acquire all shares of AurKa Pharma. In return, AurKa Pharma shareholders will receive an upfront payment of $110 million. AurKa Pharma shareholders are also eligible to receive up to $465 million in regulatory and sales milestones should AK-01 gain approval in the U.S. and other markets, and achieve certain sales levels.

This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP), and is subject to customary closing conditions. There will be no change to Lilly’s 2018 non-GAAP earnings per share guidance as a result of this transaction.

Baird is acting as financial advisor to AurKa in this transaction.

On May 14, 2018 GT Biopharma Inc. (OTCQB: GTBP)(Euronext Paris GTBP.PA) reported the promotion of Dr. Raymond W Urbanski MD, PhD to the position of President and Chief Medical Officer effective immediately. Dr. Urbanski will report to Shawn Cross, the Company’s Chief Executive Officer (Press release, GT Biopharma , MAY 14, 2018, View Source [SID1234539531]).

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"I am pleased to announce the promotion of Dr. Urbanski to President and Chief Medical Officer. The combination of Ray’s experience as a practicing physician and subsequently experience in industry, where he has served in key leadership positions including serving as the Chief Medical Officer of one of Pfizer’s business units and as the Chief Medical Officer of Mylan. His training, depth of knowledge and experience as well as his organizational acumen has been invaluable as we prepare GT Biopharma for our next stage of growth," said Shawn M. Cross, Chairman and Chief Executive Officer of GT Biopharma. "In addition to pushing forward our pre-clinical and clinical product candidates, Ray has played a critical role in advancing other company initiatives including recruiting experienced members to our scientific advisory board and board of directors, implementing internal processes and procedures, which are less visible but very important, as progress towards certain goals including a NASDAQ up-listing, among others. In short, I am delighted to have Ray as a senior member of our leadership team."

Since joining the company in October 2017 Dr. Urbanski has been instrumental in driving key milestones and initiatives including the transitioning the first TriKE IND from the University of Minnesota to GT Biopharma while engaging the FDA in preparation for human clinical testing to begin in 2H 2018; implementing processes to expedite the identification and development of future tumor antigen targets; driving forward our Bi-specific Antibody Drug Conjugate platform which included the formation of our Antibody-Drug Conjugate Clinical Advisory Board. Dr. Urbanski has also been a major factor in developing a strong working relationship with the University of Minnesota, Masonic Cancer Center, the epicenter of innovation for the TriKE and TetraKE platforms.

Dr. Urbanski also represents the company at key international meetings such as ASH (Free ASH Whitepaper) and the upcoming ASCO (Free ASCO Whitepaper) conferences, attending investor conferences and recruiting top tier Scientific Advisory Board members and consultants.

On May 14, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the UBS Global Healthcare Conference on Monday, May 21, 2018 at 2:00 p.m. ET (7:00 p.m. BST) from New York the UBS Global Healthcare Conference on Monday, May 21, 2018. The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Contact:
Jennifer Zibuda
Investor Relations
+1 781 609 6129

On May 14, 2018 FY2017 performance reflects superior execution (Press release, Takeda, May 14, 2018, View Source [SID1234526592])
– Underlying results: Revenue +5.5%, Core Earnings +40.2%, Core EPS +44.8%
– Takeda will maintain its underlying growth momentum in FY2018

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Underlying Revenue growth +5.5% led by Takeda’s Growth Drivers
• Underlying Revenue grew +5.5%, with Takeda’s Growth Drivers (Gastroenterology, Oncology, Neuroscience and Emerging Markets) posting strong underlying revenue growth of +12.8%.
• Broad based revenue performance was led by double digit growth in the U.S. (U.S. +13.5%, Japan -0.2%, Europe & Canada +6.7%, Emerging Markets +2.0%; Japan growth was +7.0% excluding returned portfolio)
• Reported revenue grew +2.2%, with underlying growth (+5.5%) and positive currency impact (+2.5pp), partly offset by the impact of divestitures (-5.8pp).

Stellar EPS growth reflects strong revenue growth and progress of Global Opex Initiative
• Underlying Core Earnings grew +40.2%, with the Core Earnings margin increasing by 420bps due to product mix improvement and strong cost discipline (+280bps gross margin; +160bps from OPEX margin). Reported operating profit was up +55.1%, mainly driven by Core Earnings growth. In FY2017, Takeda booked a large one-time gain of 106.3 billion yen from the sale of Wako; however, higher one-time expenses resulted in total other income/expenses being less favorable than prior year by-27.8 billion yen.
• Underlying Core EPS was up +44.8%, in-line with underlying Core Earnings growth. Reported EPS was 239 yen, an increase of +62.7% from 147 yen in the prior year, benefitting also from a lower tax rate due to re-measurement of deferred tax liabilities as a result of the U.S. tax reform.

Significant pipeline progress leveraging therapeutic area expertise
• 17 New Molecular Entity clinical stage-ups in FY2017, compared with 5 in the same period of the previous year. Important events included European Commission approval of ALOFISEL (darvadstrocel) in the area of GI, a label update for TRINTELLIX in neuroscience, and the initiation of Phase 3 for pevonedistat in oncology.
• Further strengthened innovation network with 56 new collaborations with academia and bio-tech/bio-ventures.

Net leverage improved due to continued strong progress on cash flow
• Operating Free Cash Flow was up +52.9% to 242.9 billion yen, higher than the dividend payment for the third consecutive year. Non-core asset sales generated an additional 164.4 billion yen of cash.
• Strong cash generation allowed rapid de-leveraging with the net debt/EBITDA ratio improving from 2.7x in March 2017 to 1.8x in March 2018.

Christophe Weber, President and Chief Executive Officer of Takeda, commented:

"Takeda’s transformation is delivering superior results as we execute against our key mid-term priorities of growing the portfolio, strengthening the pipeline, and boosting profitability. In FY2017, our Growth Drivers maintained their strong momentum, which together with disciplined cost management under the Global Opex Initiative resulted in industry-leading revenue and earnings growth. We also made significant progress in R&D, with 17 New Molecular Entity clinical trial stage-ups, and 56 new collaborations to strengthen our innovation network.
The strength of the underlying business means we expect to maintain revenue and earnings growth momentum in FY2018, and I am confident that through strategic focus and superior execution, Takeda will continue to deliver long-term value to patients and shareholders."

Core Earnings is calculated by deducting SG&A expenses and R&D expenses from reported Gross Profit. In addition, certain other items that are non-core in nature and significant in value may also be adjusted.

2 Underlying growth compares two periods of financial results on a common basis, showing the ongoing performance of the business excluding the impact of foreign exchange and divestitures.
3 Attributable to the owners of the company.

FY2018 Management Guidance: Maintaining underlying growth momentum
• Underlying revenue continues to grow despite negative headwinds of -4.4pp that include Velcade decline due to competitor entry (-3.5pp) and portfolio changes (-0.9pp).
• Continued product mix improvement and execution of the Global Opex Initiative will underpin margin improvement. Underlying Core Earnings margin to expand at lower end of the +100-200bps range bringing the 2-year margin expansion to more than 500 basis points.
• Underlying Core Earnings will grow high single digit, despite Velcade decline which negatively impacts Core Earnings growth by over 18 percentage points.
• Annual dividend of 180 yen per share, in-line with Takeda’s well-established dividend policy of being strongly committed to shareholder returns with the dividend as a key component.

FY2018 Reported Forecast: Underlying strength lessens impact of significant decline in one-time items
• Underlying revenue growth momentum offset by Forex and divestitures.
• Excluding the negative impact of Forex and divestitures, Core Earnings growth is forecast to be high single digit.
• Reported operating profit is impacted by lower other income (-40.9pp, especially the 106.3 billion yen gain on the sale of Wako in FY2017) and the impact of divestitures (-9.6pp).

Takeda is currently in an offer period (as defined in the City Code on Takeovers and Mergers (the "Code")) with respect to Shire plc. Pursuant to Rule 28 of the Code, statements made regarding Takeda’s guidance for FY2018 (including statements regarding forecasts for FY2018 revenue, Core Earnings, Operating profit, Profit before income taxes, Net profit attributable to owners of the Company, Basic earnings per share, R&D expenses, Amortisation and impairment and other income/expense, Underlying Revenue, Underlying Core Earnings and Underlying Core EPS) constitute a profit forecast for the year ending March 31, 2019 (the "Takeda Profit Forecast"). For additional information regarding the Takeda Profit Forecast and the required statement by its Directors that such profit forecast is valid and has been properly compiled on the basis of the assumptions stated and that the basis of accounting used in consistent with Takeda’s accounting policies, please see page 21 of Takeda’s Financial Results (Tanshin) for the Fiscal Year Ended March 31, 2018, dated May 14, 2018.

Raising our objectives for non-core asset disposals by the end of FY2018
• Revised objective is to unlock 190 billion yen of cash by the end of FY2018 from real estate disposals and the sale of securities, increased from 130 billion yen guidance given in May 2017.

On May 14, 2018 Immunicom, Inc., a medical technology company developing revolutionary non-pharmaceutical approaches for treating cancer and autoimmune diseases, reported the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Immunopheresis therapy, which is based on a proprietary technology that selectively removes immune inhibitors from a patient’s bloodstream potentially enabling their natural immune system to more-effectively attack cancer tumors (Press release, Immunicom, MAY 14, 2018, View Source [SID1234637423]).

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To achieve Breakthrough Device designation, a technology must demonstrate compelling potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
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The FDA’s intent in granting this specific designation to qualified devices is to collaboratively facilitate expediting the device’s assessment and review processes through more interactive communication and planning with the FDA; ensuring proper data collection, efficient clinical study design, senior management engagement of Agency personnel, and priority review of applicable filings.

In contrast to immunotherapy pharmaceuticals and biologicals that introduce foreign compounds and material into a patient’s body, and which are often accompanied by negative side effects, Immunicom’s patented technology is based on a "subtractive" approach that is intended to potentially limit treatment-associated adverse effects. By removing immune system inhibitors from the blood without introducing new substances, Immunicom’s therapeutic approach has been shown in preliminary preclinical studies to enhance anti-cancer immune system response without causing unwanted side effects.
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Immunicom’s blood-filtering device technology is the first step in execution of a broader corporate strategic vision. "We are very pleased with FDA’s granting of Breakthrough Device designation for Immunopheresis, our initial immunotherapy product for treating late/end stage IV cancer patients with metastatic solid tumors," said Amir Jafri, CEO of Immunicom, "This significant milestone will enable us to more efficiently pursue device regulatory approval and address critical unmet patient needs sooner, while also continuing our commitment to invest in other exciting treatment options in our product pipeline."