First-quarter 2018 Business EPS(1) up 1.4% at CER

On April 27, 2018 Sanofi reported financial results for the first quarter ended March 31, 2018 (Press release, Sanofi, APR 27, 2018, View Source [SID1234525827]).

First-quarter 2018 reflected strong Specialty Care sales offset by U.S. Lantus and sevelamer exclusivity losses

Net sales were €7,898 million, down 8.7% on a reported basis, down 0.4%(3) at CER and down 1.1% at CS/CER(4).
Sanofi Genzyme sales grew strongly, up 16.2%(5), driven by contribution from the new immunology franchise.
Vaccines sales (-0.9%) reflected strong performance in EU, offset by expected Pentaxim supply constraint in China.
CHC sales grew 2.0% supported by double-digit growth in Emerging Markets(6).
Diabetes and Cardiovascular GBU sales down 15.7%; global Diabetes franchise sales declined 10.0%.
Emerging Markets sales(6) increased 8.3%, driven by double-digit growth in China and Latin America.
2018 guidance confirmed

First-quarter 2018 business EPS(1) increased 1.4% at CER to €1.28.
First-quarter 2018 IFRS EPS was €0.81 (-82.0%) due to a gain on disposal of the Animal Health business in 2017.
Sanofi continues to expect 2018 Business EPS to grow between 2% and 5% at CER(7) barring unforeseen major adverse events. Applying the average April 2018 exchange rates, the currency impact on 2018 Business EPS is estimated to be around -7%.
Announcement of a €1.5bn share buyback program(8) expected to be completed in mid-2019

Sanofi strengthens leadership in Specialty Care through the addition of a Rare Blood Disorder franchise

Sanofi completed the acquisition of Bioverativ and consolidated its financial results from March 9.
First patient dosed with fitusiran, a novel RNAi therapeutic for hemophilia, in phase 3 ATLAS program.
Ablynx acquisition(9) will add caplacizumab for aTTP(10) (submitted in EU) and innovative Nanobody platform.
Sustaining innovation in R&D

Praluent significantly reduced the risk of cardiovascular events in high risk patients in the ODYSSEY OUTCOMES study and was associated with a lower death rate.
Dupixent supplemental BLA filed in the U.S., Japan and EU for moderate-to-severe asthma in adults and adolescents.
Cemiplimab filed in EU for metastatic cutaneous squamous cell carcinoma.
Sotagliflozin submitted in the U.S. and EU for type 1 diabetes.

Compugen Reports on Status of Investigational New Drug Application for COM701, a First-in-Class Immuno-Oncology Therapeutic Antibody

On April 27, 2018 Compugen Ltd. (Nasdaq: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) requested that the Company provide additional CMC information in support of its IND application for COM701, initially submitted in late March 2018 (Press release, Compugen, APR 27, 2018, View Source [SID1234525798]). COM701 is a first-in-class immuno-oncology therapeutic antibody targeting PVRIG. FDA recommended a lower starting dose of COM701 for the trial, which now requires a more sensitive COM701 assay detection method for this dose. The FDA informed the Company that the IND application review can be completed and the application can be taken off clinical hold once the requested information is provided by Compugen. The IND is intended to support initiation of a planned Phase 1 clinical trial of COM701 in patients with advanced solid tumors. This trial is not yet active at any investigational sites and has not recruited any patients.

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"We are working closely with the FDA to provide the additional information requested as quickly as possible. In anticipation for FDA clearance, site selection activities in multiple centers in the United States are currently ongoing to allow future patient enrollment, and we look forward to evaluating COM701 in a clinical setting," stated Anat Cohen-Dayag, PhD, President and CEO of Compugen. "We continue to be encouraged by the preclinical data for COM701, which suggest that targeting PVRIG may be a primary means of stimulating an anti-tumor immune response in certain cancers that may be unresponsive to available treatments."

The Company will continue to provide updates on this matter as appropriate.

Medpace Holdings, Inc. to Report First Quarter 2018 Financial Results on April 30, 2018

On April 27, 2018 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its first quarter 2018 financial results after the market close on Monday, April 30, 2018 (Press release, Medpace, APR 27, 2018, View Source [SID1234525797]). The Company will host a conference call the following morning, Tuesday, May 1, 2018, at 9:00 a.m. ET to discuss these results.

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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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To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 5992038.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Tuesday, May 1, 2018 until 12:00 p.m. ET on Tuesday, May 15, 2018. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 5992038.

New Study Finds that 24 Percent of Women Seen in the Obstetrics-Gynecology Setting Met NCCN Guidelines for Hereditary Cancer Genetic Testing

On April 27, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that results from a large prospective process-intervention study that evaluated genetic testing practices in the obstetrics-gynecology setting will be presented at the 2018 ACOG annual meeting in Austin, Texas (Press release, Myriad Genetics, APR 27, 2018, View Source [SID1234525795]). The key findings are that 23.8 percent of patients qualified for genetic testing based on National Comprehensive Cancer Network (NCCN) guidelines and 5.5 percent of patients who underwent testing were found to carry a pathogenic mutation.

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"Myriad is committed to helping obstetricians and gynecologists incorporate genetic testing into their practices and help expand patients’ access to personalized medicine," said Royce (Terry) Adkins, M.D., FACOG, board certified ob-gyn physician and vice president of Medical Affairs, Myriad Genetic Laboratories. "Importantly, this study found that process-intervention strategies and the myRisk Hereditary Cancer test can help doctors find women at increased risk of hereditary breast and ovarian cancers so that steps can be taken to lower their risk."

The study data are summarized below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about ACOG annual meeting news and updates by using the hashtag #ACOG18.

Title: Hereditary Cancer Genetic Testing in Community-Based Obstetrics and Gynecology Settings.
Presenters: Mark S. DeFrancesco, M.D., FACOG, Women’s Health Connecticut and
Richard N. Waldman, M.D., FACOG, Associates for Women’s Medicine.
Date: Saturday, April 28, 2018, 3:30 to 4:30 p.m. CST.
Poster Location: Session K, #3K.

The study evaluated the impact of incorporating routine hereditary cancer risk assessment, counseling and follow-up genetic testing in the community obstetrics-gynecology practice setting. The trial included two large obstetrics-gynecology practice groups in two states with five practice sites. The process intervention included baseline process assessment, refinement of clinic-specific patient screening workflows and tools and training in hereditary cancer risk screening and follow-up. Outcomes related to hereditary cancer screening and testing were measured during an eight-week post-intervention period. Patients and providers also were surveyed about satisfaction with the process.

The results show that 3,811 women were screened for hereditary cancer risk. Among those screened, 23.8 percent met NCCN guidelines for genetic testing. Of those screened, 39 percent agreed to undergo genetic testing with the myRisk Hereditary Cancer test. Importantly, the myRisk Hereditary Cancer test found pathogenic mutations in more than five percent of women tested. All healthcare providers in this study said they would continue to use the established hereditary cancer risk assessment process. Additionally, 98.8 percent of patients referred for genetic testing were able to understand the information provided and 97.6 percent were satisfied with the overall process.

"This study demonstrates that it is feasible and beneficial to incorporate hereditary cancer screening, education and testing into community obstetrics-gynecology practices," said Mark DeFrancesco, M.D., study investigator and managing partner at Westwood Women’s Health in Waterbury, Connecticut, a division of Women’s Health Connecticut. "Patients and providers were satisfied, and integrating multigene panel testing in this setting identified patients with significant cancer risks who would not otherwise have been identified."

The findings from this study also support an ACOG position statement called Access to Genetic Testing, which was released in January 2018.

"Importantly, this study supports the ACOG position that obstetrician-gynecologists are qualified to counsel and order genetic tests by incorporating hereditary cancer screening into routine practice," said Richard N. Waldman, M.D., study investigator and president of Associates for Women’s Medicine. "Understanding a woman’s hereditary cancer risk can dramatically impact medical management to prevent or delay cancer occurrence and to inform cancer care."

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms in an 850 step laboratory process to evaluate 28 clinically-significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source

Myriad Genetics to Present at Two Upcoming Healthcare Conferences

On April 27, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine reported that Mark C. Capone, president and CEO, is scheduled to present at two upcoming investor conferences (Press release, Myriad Genetics, APR 27, 2018, View Source [SID1234525794]). On May 8, 2018, Mr. Capone will present at the 43rd annual Deutsche Bank Healthcare Conference in Boston at 12:50 p.m. ET. On May 16, 2018, Mr. Capone will present at the Bank of America Healthcare Conference in Las Vegas, Nevada at 6:40 p.m. ET.

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The presentations will be available to interested parties through a live audio webcast accessible through a link in the investor information section of Myriad’s website at www.myriad.com.