On April 11, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release first-quarter 2019 financial results before the market opens on Thursday, April 25, 2019, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, APR 11, 2019, View Source [SID1234535101]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 7794502.

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A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the West website three hours after the live call and will be available through Thursday, May 2, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 7794502.

On April 11, 2019 Incyte Corporation (Nasdaq:INCY) reported that it has scheduled its first quarter 2019 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, April 30, 2019 (Press release, Incyte, APR 11, 2019, View Source [SID1234535102]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The schedule for the press release and conference call/webcast is as follows:

Q1 2019 Press Release: April 30, 2019 at 7:00 a.m. ET

Q1 2019 Conference Call: April 30, 2019 at 8:00 a.m. ET

Domestic Dial-In Number: 877-407-3042

International Dial-In Number: 201-389-0864

Conference ID Number: 13689554

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13689554.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

On April 11, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) ("Aurinia" or the "Company"), a late clinical-stage biopharmaceutical company focused on the global immunology market, reported the appointment of Mr. Peter Greenleaf as Chief Executive Officer and as a Director on the Aurinia Board (Press release, Aurinia Pharmaceuticals, APR 11, 2019, View Source [SID1234535103]). The Company also announced the elevation of George M. Milne, Jr., Ph.D. to Chairman of the Board of Directors. Dr. Richard M. Glickman, who previously announced his plans to retire on November 6, 2018, will step down from his role as Chairman and CEO concurrent with Mr. Greenleaf’s appointment on April 29, 2019, and will remain an advisor to the Company for a period of 12 months.

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With more than twenty years of experience leading pharmaceutical and biotech firms, Mr. Greenleaf most recently served as the CEO of Cerecor, a leading U.S. pediatric orphan and rare disease pharmaceutical company. Prior to that, Mr. Greenleaf was the Chairman and CEO of Sucampo Pharmaceuticals which he led through the successful sale to Mallinckrodt Pharmaceuticals, PLC for $1.2B. Previously, Mr. Greenleaf served as the CEO and Board member of Histogenics, a regenerative medicine company. Prior to that he was the President of MedImmune, Inc, the global biologics arm of AstraZeneca, and President of MedImmune Ventures, a wholly owned venture capital fund within the AstraZeneca Group, where he led investment in emerging biopharmaceutical, medical device, and diagnostic companies.

"It is a pleasure to welcome Peter as the next Chief Executive Officer of Aurinia. As a seasoned leader in the pharmaceutical industry, Peter’s extensive knowledge of clinical and overall operations, along with business development and commercialization expertise, are ideally aligned with the next stages of growth for voclosporin and Aurinia," stated Dr. George Milne, incoming Chairman of the Board of Aurinia Pharmaceuticals.

"The Aurinia team has made extraordinary progress with voclosporin, which I believe to be a truly transformative drug for the potential treatment of proteinuric kidney diseases, such as lupus nephritis ("LN"), as well as a unique opportunity for the treatment of dry eye syndrome ("DES")," commented Mr. Greenleaf. "To that end, I am very excited to lead the Company at this pivotal time and through several critical datapoints over the next year including Phase 3 trial results by the end of 2019, followed by the planned regulatory submission and preparations for the potential commercialization of voclosporin during 2020."

Dr. Milne further commented, "I am also humbled to be assuming the Chairman role from Dr. Glickman. On behalf of the entire board and organization, I would like to thank Dr. Glickman for all of his efforts and contributions that have brought Aurinia to where it is today. As we wish him all the best on his retirement, we are also gratified to have his insight as an advisor for the next year."

Dr. Glickman stated, "Consistent with the succession planning set into motion last November, I am confident that Peter is the correct individual to lead Aurinia through the next set of value inflection points including the upcoming AURORA Phase 3 results, preparing for the potential launch of voclosporin, and expansion of the VOS dry eye syndrome program."

About Mr. Peter Greenleaf

Peter Greenleaf previously served as CEO of Cerecor, Inc., since March 2018. Prior to that he served as Chairman and CEO of Sucampo Pharmaceuticals, Inc. from March 2014 to February 2018, when Sucampo was sold to Mallinckrodt PLC. Previously, Mr. Greenleaf served as CEO of Histogenics Corporation from June 2013 to March 2014, as President of MedImmune, Inc., and MedImmune Ventures from 2010 to June 2013, and Senior Vice President, Commercial Operations of MedImmune from 2006 to 2010. Mr. Greenleaf also held senior commercial roles at Centocor Biotech, Inc. (now Janssen Biotechnology, Johnson & Johnson), from 1998 to 2006, and at Boehringer Mannheim G.m.b.H. (now Roche Holdings) from 1996 to 1998. Mr. Greenleaf is a member of the Board of Directors of Cerecor since May 2017, is the Chairman of the Board of Bio-delivery Sciences since May 2018, EyeGate Pharmaceuticals since August 2018, and Antares Pharma since December 2018. Mr. Greenleaf chairs the Maryland Venture Fund Authority, and previously served on the boards of BIO, PhARMA, the Tech Council of Maryland and the University of Maryland Baltimore Foundation, Inc. Mr. Greenleaf earned an MBA degree from St. Joseph’s University and a BS degree from Western Connecticut State University.

About George M. Milne, Jr., Ph.D.

Dr. Milne was appointed to the Aurinia Board of Directors in May 2017 and serves as Chair of the Company’s Governance & Nomination Committee. Dr. Milne has over 30 years of experience in pharmaceutical research and product development. He joined Pfizer in 1970 and held a variety of positions conducting both chemistry and pharmacology research. Dr. Milne became director of the department of immunology and infectious diseases at Pfizer in 1981, was its executive director from 1984 to 1985, and was vice president of research and development from 1985 to 1988. He was appointed senior vice president in 1988. In 1993 he was appointed President of Pfizer Central Research and a senior vice president of Pfizer with global responsibility for human and veterinary medicine research and development. Dr. Milne has served on multiple corporate boards including Mettler-Toledo, Inc., MedImmune, Athersys, Biostorage Technologies, Aspreva, and Conor Medsystems. Dr. Milne received his B.Sc. in Chemistry from Yale University and his Ph.D. in Organic Chemistry from MIT.

On April 11, 2019 Qualigen, Inc., and the University of Louisville (UofL) reported that Qualigen has entered into a Sponsored Research Agreement (SRA) with UofL for development of several small-molecule RAS Inhibitor drug candidates (Press release, Qualigen, APR 11, 2019, View Source [SID1234535120]). Under the terms of this Sponsored Research Agreement, Qualigen assumed funding responsibility for this program from April 1, 2019 through September 30, 2020.

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RAS is the most common oncogene in human cancer. Activating mutations in one of the three human RAS gene isoforms (KRAS, HRAS, or NRAS) are present in about one-fourth of all cancers. As an example, mutant KRAS is found in 98% of all pancreatic ductal adenocarcinomas, 52% of all colon cancers, and 32% of all lung adenocarcinoma. Every year in the U.S., these three mutant KRAS associated cancers are diagnosed in more than 170,000 people, resulting in more than 120,000 deaths. There are no FDA-approved direct RAS protein inhibitors currently available. Drugs that target downstream signaling of RAS are available but have shown disappointing clinical activity, most likely because RAS is a "hub" that activates multiple effectors and blocking any single pathway (or even two) will be ineffective. RAS is a G-protein that works as a switch, toggling between "on" and "off" when bound to guanosine nucleotides, GTP or GDP. The RAS mutations found in cancer cause this protein to be turned on (i.e. bound to GTP) most of the time. Most drug targets are proteins that have a well-defined "pocket" that can be targeted by small molecules, as with enzymes (substrate binding site) or kinases (ATP binding site). However, RAS lacks such pockets and thus is more difficult to target directly, but the UofL team has been able to develop small molecules that are protein-protein interaction (PPI) inhibitors that block the binding of RAS to its effector proteins.

"We are excited about the possibility of adding a small molecule RAS Inhibitor to our portfolio of anticancer drug technologies. This technology is synergistic with our other cancer therapeutics platforms and will expand our future product pipeline," noted Michael S. Poirier, Chairman, CEO and President of Qualigen. "We are pleased to partner with UofL to continue the innovative work of Dr. Geoffrey Clark, Dr. John Trent and their colleagues at the University of Louisville. We believe that this research will result in a powerful new tool in the fight against cancer."

This technology was developed at UofL with key support from several robust programs, including UofL’s ExCITE program, a National Institutes of Health Research Evaluation and Commercialization Hub (REACH). These programs drive the translation of innovative research from UofL’s campus to the marketplace, leading to licensing through the university’s Commercialization EPI-Center.

"We are excited to work with Qualigen on the product development of our small molecule RAS Inhibitor drug to fight cancer," said Dr. Allen Morris, EPI-Center’s director. "This is the kind of outcome UofL seeks in its translational efforts – working closely with industry to get our cutting-edge research to market."

On April 11, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported publication of an independent, prospective study of 159 patients with cutaneous melanoma showing that the DecisionDx-Melanoma gene expression profile (GEP) test accurately identified risk of melanoma recurrence independent of other prognostic factors such as Breslow thickness and sentinel lymph node biopsy (SLNB) result (Press release, Castle Biosciences, APR 11, 2019, View Source [SID1234535104]). The study was published in the journal Cancer Medicine and is consistent with previously published prospective and retrospective studies demonstrating the high performance of DecisionDx-Melanoma to predict outcomes, supporting its clinical value to inform patient management decisions.

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"In this prospective study with 3.5 years of overall follow up, DecisionDx-Melanoma was shown to be an independent prognostic factor that is additive to traditional staging factors," commented lead study investigator Eddy C. Hsueh, M.D., Professor and Director, Division of General Surgery, St. Louis University Hospital. "Accurate risk assessment for cutaneous melanoma is increasingly important to inform patient management decisions including surveillance, follow-up and potential adjuvant therapy consideration."

Patients from this academic center who were diagnosed with cutaneous melanoma received both the DecisionDx-Melanoma test and SLNB as part of their initial work-up. The median tumor Breslow thickness was 1.4 mm and 24% of patients had ulcerated tumors. Sixty percent of patients had American Joint Committee on Cancer (AJCC) Stage I melanoma, 25% had Stage II melanoma and 15% had Stage III melanoma. Patients were followed at regular intervals with an overall median follow-up time of 3.7 years for patients who did not experience an event.

Key Results:

117 patients had a Class 1 (low risk) DecisionDx-Melanoma test result; 42 patients had a Class 2 (high risk) test result.
139 patients had a negative SLNB result; 20 patients had a positive SLNB result.
29 patients experienced a recurrence. Of those who experienced recurrence, 23 (79%) were classified as high risk (Class 2) by DecisionDx-Melanoma. Ten patients who experienced recurrence (34%) had a positive SLNB result and 19 (66%) had a negative SLNB result. Nine of 10 patients who were high risk by both assessments (positive SLNB result and Class 2 result) experienced recurrence.
The negative predictive value (NPV) of a Class 1 result was 95% for recurrence and 99% for distant metastasis. Sensitivity of a Class 2 result was 79% for recurrence and 94% for distant metastasis.
The 3-year recurrence-free survival (RFS) rate for patients with a Class 1 result was 96.6%, significantly higher than the RFS of 47.4% for those with a Class 2 result (p<0.0001).
The 3-year distant metastasis-free survival (DMFS) rate for patients with a Class 1 result was 99.1%, significantly higher than the DMFS of 64.1% for those with a Class 2 result (p<0.0001).
DecisionDx-Melanoma was the most significant predictor of recurrence (Class 2 hazard ratio=9.2, p=0.0001) and distant metastasis (Class 2 hazard ratio=19.0, p=0.009) risk in multivariate analysis comparing to age, Breslow thickness, ulceration and SLNB result.
The full published study results can be accessed at the journal’s website.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including over 780 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multicenter and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.