On August 6, 2018 amcure, a biopharmaceutical company developing first-in-class cancer therapeutics, reported the dosing of the first patient in the extension cohort of its ongoing phase I/Ib study evaluating AMC303, amcure’s lead compound (Press release, amcure, AUG 6, 2018, View Source [SID1234528453]). The decision to move into the second part of the clinical trial protocol was based on positive safety and pharmacokinetic data obtained in the dose escalation part and a recommendation by the data safety monitoring board. amcure will present top-line data from the dose-escalation part of the trial in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, October 19-23 in Munich/Germany.

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AMC303 targets CD44v6, a key cell membrane molecule in pathways of several receptor-tyrosine-kinases, such as c-MET, VEGFR-2 and RON, which are involved in tumor growth and metastases. This approach provides a potential novel mechanism for the treatment of patients with advanced and solid tumors that have already begun to spread throughout the body.

The current study, which is being conducted in Belgium and Spain, is designed to assess the safety, tolerability and pharmacokinetics of multiple and increasing doses of AMC303 as monotherapy in patients with advanced metastatic malignant solid tumors of epithelial origin. The study also includes a comprehensive biomarker program. With the extension cohort, amcure is focusing its patient selection on patients with a moderate to high expression of the target molecule CD44v6 in four specific tumor types of squamous tumors: head and neck squamous cell carcinoma (HNSCC), squamous non-small-cell lung carcinoma (NSCLC), esophageal and cervical tumors.

"Our Phase I/Ib study with AMC303 is progressing as planned, demonstrating the safety and linear pharmacokinetic properties in a heavily pre-treated patient population. As drug combinations become increasingly the standard in today’s oncology practice, having a safe therapeutic option with a unique and additive mechanism of action would be an attractive asset. We look forward to continuing the development of AMC303 towards this goal with more preclinical data on the drug’s potential and on CD44v6’s disease biology and first clinical data being presented at the upcoming ESMO (Free ESMO Whitepaper) congress," said Klaus Dembowsky, CEO of amcure GmbH.

For more information on the trial please visit View Source

About AMC303

amcure’s lead compound, AMC303, is being developed as a potential treatment for patients with advanced and metastatic epithelial tumors, e.g. pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer. AMC303 has a high specificity for inhibiting CD44v6, a co-receptor required for signaling through multiple cellular pathways (c-Met, VEGFR-2, RON) involved in tumor growth, angiogenesis and the development and regression of metastases. AMC303 has demonstrated strong effects in various in vitro and in vivo assays.

On August 6, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that Jeff Baxter, President and CEO, will present at the Canaccord Genuity 38th Annual Growth Conference in Boston, MA, on Wednesday, August 8, 2018, at 9:30 AM ET (Press release, VBI Vaccines, AUG 6, 2018, View Source [SID1234528474]).

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A live webcast of the presentation and a subsequent replay may be accessed by visiting the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the company’s website for 90 days following the presentation.

Event: Canaccord Genuity 38th Annual Growth Conference
Date: Wednesday, August 8, 2018
Time: 9:30 – 9:55 AM ET
Event Website: View Source

On August 6, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it has signed a License, Collaboration and Distribution Agreement with CMS Medical Venture Investment Limited ("CMS Medical") for the commercialization of Can-Fite’s Piclidenoson for the treatment of rheumatoid arthritis and psoriasis and Namodenoson for the treatment of advanced liver cancer and NAFLD/NASH in China (including Hong Kong, Macao and Taiwan) (Press release, Can-Fite BioPharma, AUG 6, 2018, View Source [SID1234528454]).

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Under the terms of the agreement, CMS Medical is making an upfront payment of $2,000,000 to Can-Fite and is required to pay to Can-Fite milestone payments of up to $14,000,000 upon the achievement of certain regulatory milestones and payments of up to $58,500,000 upon the achievement of certain sales milestones. In addition, the agreement provides for double-digit royalty payments on net sales.

CMS Medical is a wholly-owned subsidiary of China Medical System Holdings Limited ("CMS"; SEHK: 867), a specialty pharmaceutical company based in China, focusing on marketing, promotion and sales of prescription drugs and other medicinal products to therapeutic departments in hospitals. CMS builds up its product portfolio for its target markets by asset acquisition, equity investment, licensing and distribution as well as in-house R&D. CMS is listed on the Hong Kong Stock Exchange with a current market capitalization of approximately HK$34 billion as at August 1, 2018.

According to the agreement, CMS will be responsible for the development of Piclidenoson and Namodenoson to obtain regulatory approval in China and shall be further responsible for obtaining and maintaining regulatory approval in China for the indications described above. Can-Fite may, at the option of CMS, supply finished product to CMS.

"We are very excited to enter into this agreement with CMS, with their broad and professional experience in development, registration and marketing of diverse drugs in the Chinese market and believe that they are the right partner for us to penetrate this big market," stated Dr. Sari Fishman, VP Business Development of Can-Fite. "We believe that CMS’s commitment to us is strong validation of our development efforts to date."

Can-Fite is currently enrolling patients for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis and plans to shortly initiate patient enrollment for its Phase III Comfort trial of Piclidenoson for the treatment of psoriasis. The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018.

Phase II studies with Namodenoson for the treatment of advanced liver cancer (hepatocellular carcinoma, Child Pugh B) and NAFLD/NASH are currently ongoing. The last patient for the advanced liver cancer trial was enrolled in August 2017, and treatment of remaining patients is still ongoing.

On August 6, 2018 bluebird bio, Inc. (NASDAQ: BLUE) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported a collaboration to apply their respective technology platforms to the discovery, development and commercialization of novel immune cell therapies for cancer (Press release, bluebird bio, AUG 6, 2018, View Source [SID1234528455]). The collaborators will specifically leverage Regeneron’s VelociSuite platform technologies for the discovery and characterization of fully human antibodies, as well as T cell receptors (TCRs) directed against tumor-specific proteins and peptides, and bluebird bio will contribute its field-leading expertise in gene transfer and cell therapy.

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"The collaboration with Regeneron complements bluebird bio’s growing immuno-oncology development portfolio, which includes clinical and pre-clinical CAR T and T cell receptor programs," said Philip Gregory, D.Phil., Chief Scientific Officer of bluebird bio. "With Regeneron’s proven targeting technologies, in combination with our deep expertise in cell biology and vector technology, as well as clinical experience with leading CAR T cell drug products, we hope to rapidly advance novel cellular therapies with the potential to transform the lives of people with cancer."

"Like Regeneron, bluebird is a science-focused company looking to push the limits of what novel technologies can do in drug discovery and development," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "We believe that the tremendous synergies between Regeneron’s proven technologies and bluebird’s toolbox of advanced cell and gene therapy technologies create a promising opportunity to help people with cancer by developing innovative new treatments. This collaboration adds yet another dimension to our rapidly advancing portfolio of immuno-oncology candidates and combination approaches."

The collaborators have jointly selected six initial targets and will equally share the costs of research and development up to the point of submitting an Investigational New Drug (IND) application. Additional targets may be selected over the five-year research collaboration term. When an IND is submitted for a potential cell therapy product, Regeneron will have the right to opt-in to a co-development/co-commercialization arrangement for certain collaboration targets, with 50/50 cost and profit sharing. If Regeneron does not opt-in, the company is eligible to receive milestone payments and royalties from bluebird bio on any potential resulting products.

Regeneron will also make a $100 million investment in bluebird bio common stock at a price of $238.10 per share, which represents a premium of 59 percent over the $150 closing price on August 3, 2018. This approximately $37 million premium will be credited against Regeneron’s initial 50 percent funding obligation for basic collaboration research, after which the collaborators will fund ongoing research equally. The transaction is subject to preclearance by the Federal Trade Commission under applicable antitrust laws.

Cell-based immunotherapies such as chimeric antigen receptor T cells (CAR Ts) use human immune cells (typically T cells derived from the patient with cancer) that are modified and returned to the patient to serve as therapeutic agents that specifically target and kill cancer cells. In advanced clinical studies, researchers have shown that modified T cells are highly active therapies in patients with a variety of blood cancers even after other treatment approaches have failed, and there are existing FDA-approved medicines that utilize this approach.

bluebird bio’s technologies use a customized lentiviral vector to modify T cells so that they can recognize tumor-specific proteins expressed by cancer cells and kill them upon engagement. Regeneron’s VelociSuite technologies, including VelocImmune and Veloci-T, enable the creation of fully-human antibodies and T cell receptors. These complementary technologies have the potential to expand the types of tumors that modified T cells can safely and effectively target by enabling the T cells to reach both extracellular and intracellular tumor antigens.

On August 6, 2018 Cardinal Health (NYSE: CAH) reported fourth-quarter fiscal year 2018 revenues of $35 billion, an increase of 7 percent from the fourth quarter last year, and fiscal year 2018 revenues of $137 billion, an increase of 5 percent from fiscal 2017 (Press release, Cardinal Health, AUG 6, 2018, View Source [SID1234528478]).

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Fourth-quarter GAAP operating earnings were a loss of $1.1 billion due to a Medical segment non-cash, goodwill impairment of $1.4 billion, which was primarily due to the performance of the Cordis business. Non-GAAP operating earnings were $465 million for the quarter. The company reported GAAP operating earnings of $126 million for fiscal year 2018 and non-GAAP operating earnings of $2.6 billion.

For the quarter, GAAP diluted earnings per share (EPS) were a loss of $3.76, while non-GAAP diluted EPS were $1.01. GAAP diluted EPS for fiscal year 2018 were $0.81, and non-GAAP diluted EPS were $5.00.

"Fiscal ’18 was a challenging year, but we are making significant progress by taking decisive actions to drive growth, reduce costs and enhance profitability," said Mike Kaufmann, CEO of Cardinal Health. "We are on track, and Cardinal Health’s best-in-class products and services continue to distinguish us with our customers and their patients."

Tax rates
During the fourth quarter of 2018 and 2017, GAAP effective tax rates were 1.8 percent and 25.8 percent, respectively. During fiscal years 2018 and 2017, GAAP effective tax rates were 213.8 percent and 32.7 percent, respectively. The fiscal year 2018 effective tax rates were adversely affected by the non-deductible Medical segment goodwill impairment. This unfavorable impact was partially offset in both the fourth quarter and fiscal year 2018 by net discrete tax benefits. Also, as previously disclosed, the fiscal year 2018 GAAP effective tax rate benefitted from transitional tax benefits of $2.97 per share due to the enactment of the U.S. Tax Cuts and Jobs Act ("U.S. tax reform") and a lower U.S. federal income tax rate.

During the fourth quarter of 2018 and 2017, the non-GAAP effective tax rates were 11.8 percent and 27.0 percent respectively. During fiscal years 2018 and 2017, the non-GAAP effective tax rates were 29.3 percent and 32.6 percent. The non-GAAP effective tax rates for the fourth quarter and fiscal year 2018 benefitted from net favorable discrete items and the lower U.S. federal income tax rate due to U.S. tax reform.

Segment results
Pharmaceutical segment
Fourth-quarter revenue for the Pharmaceutical segment increased 6 percent to $31 billion due to sales growth from Pharmaceutical and Specialty Distribution customers. This was partially offset by the divestiture of the company’s China distribution business and expiration of a large, mail-order customer contract, both of which were previously announced.

Segment profit for the quarter decreased 18 percent to $416 million primarily due to the negative impact from the company’s generic program performance.

Medical segment
Fourth-quarter revenue for the Medical segment increased 14 percent to $4 billion, which was driven primarily by the acquisition of the Patient Recovery business.

Medical segment profit decreased by 17 percent, or $24 million, to $114 million in the fourth quarter driven by the performance of Cardinal Health Branded products, primarily Cordis, and compensation-related items. This was mostly offset by contributions from acquisitions.

Outlook
The company does not provide GAAP EPS outlook because it is unable to reliably forecast most of the items that are excluded from GAAP EPS to calculate non-GAAP EPS. These items could cause EPS to differ materially from non-GAAP EPS. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company’s fiscal year 2019 guidance range for non-GAAP diluted EPS from continuing operations is $4.90 to $5.15.

Recent highlights

Closed on partnership with Clayton, Dubilier & Rice to accelerate the growth of naviHealth, a market leader in post-acute care management. Cardinal Health retains approximately a 45 percent interest in naviHealth and, at closing, received net cash proceeds of $736 million and expects to record a pre-tax gain of more than $500 million in the first quarter of FY19.

The company exited its transition services agreements (TSA) with Medtronic for North America, Latin America and the Global Supply Chain during the last week of July and is on track for TSA exits in other regions in late calendar year 2018 and early 2019.

Awarded more than $3 million in grants to more than 70 nonprofit organizations to support local efforts to combat the opioid epidemic across Ohio, West Virginia, Kentucky and Tennessee. The grants were made through the Cardinal Health Foundation’s Generation Rx program and are funded by Cardinal Health’s Opioid Action Program.

FY18 awards and recognition highlights

Named as one of 2018 World’s Most Admired Companies by Fortune for the fourth consecutive year

Earned distinction as a 2018 "Top 70 Companies for Executive Women" by the National Association for Female Executives for the seventh consecutive year

Recognized by Becker’s Healthcare as one of the 150 Top Places to Work in Healthcare in 2018 for the fifth consecutive year

Named to the Human Rights Campaign (HRC) Best Places to Work for LGBT Equality for the tenth consecutive year based on ratings in HRC’s 2018 Corporate Equality Index

Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth-quarter and year-end results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available on the Cardinal Health website at ir.cardinalhealth.com until August 5, 2019.

Upcoming webcasted investor events

Morgan Stanley 16th Annual Global Healthcare Conference on Friday, Sept. 14 at 8:45 a.m. Eastern in New York City