ObsEva Hosts KOL Meeting on IVF Trends, Unmet Need and Market Potential of Nolasiban
Company remains on track to submit Nolasiban MAA in the fourth quarter of 2019
GENEVA, Switzerland and BOSTON, MA - July 17, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today hosted a key opinion leader (KOL) meeting in New York City on in-vitro fertilization (IVF).
At the event, three KOLs in women’s reproductive health along with company executives discussed trends in IVF, including current practice trends toward Day 5 embryo transfer, and the merits of single-embryo transfer (SET) vs. double embryo transfer (DET). Further, event participants discussed the potential clinical importance of nolasiban, ObsEva’s oral oxytocin receptor antagonist, to significantly improve the live birth rate (LBR) resulting from ET, and address the high physical, emotional and financial pain associated with failed cycles. ObsEva also provided perspectives on commercializing nolasiban in both the U.S. and Europe.
"We were honored to be joined today by three esteemed physicians from across the U.S. to discuss the IVF practice landscape and were delighted to have the opportunity to speak about nolasiban, our lead clinical candidate. Nolasiban is currently being evaluated in a Phase 3 trial in Europe, IMPLANT 4, and we are in discussion with the U.S. Food and Drug Administration (FDA) regarding a planned Phase 3 study in the U.S., IMPLANT 3, which we expect to begin late this year or early next year,” said Ernest Loumaye, M.D., Ph.D., co-founder and Chief Executive Officer of ObsEva.
“ART and IVF are growing in importance at the global level, and with that growth is an evolving standard-of-care that aims to improve outcomes for women who are looking to conceive,” he added. “Approximately 9% of women age 20-44 are affected by infertility, and despite good-quality embryos and best practice transfer techniques, IVF success rates are not optimal. Indeed, according to the 2016 Assisted Reproductive Technology Report from the CDC, a majority of embryo transfers still involve multiple embryos (mainly double), which too frequently result in multiple births. Despite that, women who have an embryo transfer still have less than 50% chance to take home a baby.”
Senior executives from ObsEva’s management team were joined at today’s event by KOLs:
- Samuel Pauli, M.D., Reproductive Endocrinologist and Surgical Director at Boston IVF;
- Vicki Schnell, M.D, Founder & Medical Director at the Center of Reproductive Medicine in Houston, TX; and
- Fady I. Sharara, M.D, Medical Director at the Virginia Center of Reproductive Medicine in Reston, VA.
“The number of IVF cycles continues to rapidly increase in the U.S. and worldwide. In addition, while practice trends have evolved in recent years, we must strive to do even better, as overall success rates below 50% and are even lower with increasing age. This is not acceptable, and we must keep working to do better through innovation and new approaches,” said Dr. Schnell.
Dr. Pauli commented, “Despite CDC and SART guidelines supporting SET, a significant number of embryo transfers are still DET to improve the chance of IVF success. A treatment like nolasiban that could meaningfully improve the success of SET would further encourage SET utilization. This would reduce the negative consequences of DET-associated multiple births and related medical risks and healthcare costs.”
Dr. Sharara added “It is very difficult for most people to comprehend the downside of cycle failure unless they have direct experience. In addition to the significant financial hurdles that patients face during their long journey to pregnancy and delivery of a baby, the emotional impact of failure is devastating and life altering.”
An archived webcast of the event including slides is available here.
About Assisted Reproductive Technology
Infertility affects about 10% of reproductive-aged couples, with more than 2 million ART treatments (including IVF and ICSI) performed worldwide each year. Currently 62% of fresh embryo transfers are performed on Day 5 and 30% on Day 3 in the United States (CDC report, 2016 data).
While the success of ART depends on multiple factors including ovarian response, fertilization, embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and insufficient blood flow to the uterus, may impair the implantation of the embryo.
Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live birth among women undergoing ART. ObsEva licensed nolasiban from Merck KGaA in 2013 and retains worldwide, exclusive commercial rights.
About IMPLANT 4
Begun in November 2018, the IMPLANT 4 trial is a placebo-controlled, double blind Phase 3 trial to be conducted in 49 clinical sites in 10 countries primarily in Europe, as well as in Canada and Russia. Planned enrollment is approximately 800 patients who are undergoing an IVF cycle with a Day 5 SET. Eligible women will be randomized in a 1:1 ratio to receive either a single oral 900 mg dose of nolasiban or placebo four hours prior to ET.
The primary endpoint of the IMPLANT 4 trial is the proportion of patients successfully achieving ongoing pregnancy 10 weeks post ET. Live birth rate is a secondary endpoint of the trial, and follow-up will include 28-day neonatal assessment, as well as infant development assessment at 6 and 12 months post-birth. A successful IMPLANT 4 study will support a Marketing Authorization Application (MAA) in Europe, Canada, Russia and other countries such as Switzerland.
ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.obseva.com.
Cautionary Note Regarding Forward Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates, the timing of enrollment in and data from clinical trials, the results of interactions with regulatory authorities, and the potential efficacy and commercialization of our product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, risks and uncertainties regarding challenges in launching or commercializing our product candidates, including issues related to market acceptance and reimbursement, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2018, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information, please contact
Media Contact Switzerland and Europe:
+41 22 308 6220 Office
+41 79 476 26 87 Mobile
Media Contact U.S.
+1 212 223 4047 Office
+1 646 537 5649 Mobile
CEO Office Contact
+41 22 552 1550
Senior Director, Investor Relations
+1 857 972 9347 Office
+1 781 366 5726 Mobile
# # #
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality16.8.2019 17:17:00 CEST | Press release
Expanded TAVR Indication to Younger, More Active Patients Signals Groundbreaking Shift in the Future Treatment of Heart Valve Disease DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR) system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is the final surgical risk category to be approved for this minimally invasive alternative to open-heart surgical valve replacement (SAVR) and includes patients who may be younger and more active than higher-risk patients. The expanded indication approval is based on randomized clinical data from the global, prospective, multi-center Evolut Low Risk Trial, which evaluated three valve generations (CoreValve™, Evolut™ R, and Evolut™ PRO valves) in more than 1,400 patients. The data showed TAVR to have an excellent safety prof
Banks net position in the Riksbank16.8.2019 16:40:00 CEST | Press release
Aug 16, 2019 SEK MILLION LENDING BORROWING 261
Acacia Pharma Group plc - Issue of Equity on Exercise of Options16.8.2019 16:39:00 CEST | Press release
Cambridge, UK and Indianapolis, US – 16 August 2019: Acacia Pharma Group plc (the "Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialisation of new nausea and vomiting treatments for surgical and cancer patients, announces that application has been made to Euronext Brussels for the admission of the 106,997 Ordinary Shares of £0.02 each (the “New Ordinary Shares”) to trading on Euronext Brussels ("Admission") to satisfy the exercise of options granted under the Company’s [Enterprise Management Incentive Share Option Plan]. The New Ordinary Shares will rank pari passu in all respects with the Company's existing Ordinary Shares in issue. Following issue of the New Ordinary Shares, the Company's total issued share capital will consist of 53,442,417 Ordinary Shares with one voting right per share. The Company does not hold any Ordinary Shares in Treasury. Therefore, following the issue of the New Ordinary Shares, the total number of votin
Conditions for Riksbank Bid Procedures Sek Bonds16.8.2019 16:20:00 CEST | Press release
Sveriges Riksbank Bid procedure details Government Bonds, 2019-08-22 Maturity date Loan ISIN code Coupon Volume, SEK million 2025-05-12 1058 SE0005676608 2.50 % 500 +/- 250 2029-11-12 1061 SE0011281922 0.75 % 500 +/ -250 Settlement date 2019-08-26 Bids have to be entered by 10.00 on AUG 22, 2019 Highest permitted bid volume: 500 SEK million in issue SGB 1058 and 500 SEK million in issue SGB 1061 Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.10 (CEST) ON AUG 22, 2019 For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved at http://www.riksbank.se
Correction: Prosafe SE: Publication of Information Memorandum16.8.2019 15:05:00 CEST | Press release
Correction: the Information Memorandum was not attached to the previous announcement, and has now been attached. Not for release, publication or distribution, in whole or in part, in or into any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction. Reference is made to announcement of 3 June 2019 concerning the merger agreement between Prosafe SE ("Prosafe", OSE ticker PRS) and Floatel International Ltd ("Floatel"). Pursuant to section 3.5 of the Oslo Stock Exchange Continuing Obligations for listed companies, Prosafe has today published an information memorandum in respect of the merger. A copy of the information memorandum is available on www.newsweb.no and on Prosafe's website along with relevant financial reports at the following link: https://www.prosafe.com/information-memorandum/category1096.html Stavanger, 16 August 2019 Prosafe SE For further questions, please contact: Glen Ole Rødland, Chairman of Prosafe: + 47 907 41 662 Jesper K
Avance Gas Holding Ltd - Invitation to Earnings Release Audio Webcast for the Second Quarter of 201916.8.2019 14:38:00 CEST | Press release
Bermuda, 16 August 2019 - Avance Gas Holding Ltd (OSE: "AVANCE"), will on Thursday 22 August 2019 release its unaudited results for the second quarter of 2019. In connection with the earnings release, an audio webcast and conference call will be held at 15:00 (CET). The webcast can be accessed at Avance Gas' website www.avancegas.com. Dial in details are +44 (0) 2071 928 000 (UK and International), +1 631 510 7495 (US) or +47 23 96 02 64 (Norway). Please quote the passcode: 3835678. Phone lines will open 10 minutes before the conference call. For further queries, please contact: Peder C. G. Simonsen CFO Tel: +47 22 00 48 15 Email: firstname.lastname@example.org ABOUT AVANCE GAS Avance Gas Holding Ltd operates in the global market for transportation of liquefied petroleum gas (LPG). The Company is one of the world's leading owners and operators of very large gas carriers (VLGCs), operating a fleet of 14 modern VLGC. For more information about Avance Gas, please visit: www.avancegas.com This i