ObsEva Publicizes Relationship with Syneos Well being to Commercialize Linzagolix

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ObsEva Announce s
Relationship
with Syneos Well being to Commercialize Linzagolix

-Linzagolix, an oral GnRH antagonist, is pending regulatory approval within the U.S. and Europe for the therapy of uterine fibroids-

Financing settlement with JGB Administration
to fund the deliberate launch of linzagolix in addition to different growth and operational expense s


Modification of Kissei unique license and provide settlement

Advert hoc announcement pursuant to Artwork. 53 LR of the SIX Swiss Trade

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GENEVA, Switzerland , October 1 3 , 2021 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical firm devoted to bettering girls’s reproductive well being right this moment introduced a strategic relationship with Syneos Well being® (Nasdaq:SYHN), the one totally built-in biopharmaceutical options group, to commercialize linzagolix.

Linzagolix has the potential to be a best-in-class GnRH receptor antagonist for the therapy of uterine fibroids because of its efficacy and favorable tolerability profile. 1,2,3 If accepted, it will be the one GnRH antagonist for uterine fibroids with distinctive and versatile dosing choices, in addition to the primary to supply a low dose choice to deal with the wants of ladies who can not or don’t need to take hormones. 1,4 Linzagolix can also be being evaluated in an ongoing Part 3 (EDELWEISS 3) examine as a possible therapy for endometriosis-associated ache.

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Brian O’Callaghan, CEO of ObsEva, commented, “We’re thrilled to work with Syneos Well being on the commercialization of linzagolix. With a number one girls’s well being gross sales pressure, Syneos Well being is uniquely suited to assist our objective of providing aid to girls affected by uterine fibroids. Whereas conventional partnering preparations with massive pharma firms had been thought-about, we imagine that Syneos Well being affords ObsEva the best choice to maximise and preserve management, worth and optionality for this essential product.   This Syneos Well being relationship, along with the newly introduced financing facility and revised Kissei license phrases, gives ObsEva with a robust basis to execute on its commercialization plans.”

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“We’re proud to work with ObsEva on the event of a important therapy that has the potential to alter the lives of ladies affected by uterine fibroids,” stated Michelle Keefe, President, Business Options at Syneos Well being. “We’re excited to assist ObsEva of their launch using our full-service industrial mannequin together with company, area staff, and operations assist for linzagolix in each the U.S. and Europe.”

JGB Financing Settlement
ObsEva has additionally entered right into a convertible observe financing settlement with sure funds and accounts managed by JGB Administration, Inc. which is structured to offer as much as $135 million in borrowing capability, out there in 9 tranches. The primary tranche, for an preliminary $30 million, was funded at closing and used to retire the present debt facility with Oxford Finance LLC. Notes issued in reference to every tranche may have a three-year time period. All principal and curiosity can be convertible into ObsEva’s widespread shares at a worth of $3.20 per share.   In reference to every tranche, ObsEva may also concern warrants to buy its widespread shares, together with a warrant to buy 1,634,877 widespread shares that was issued on the preliminary closing. The warrants may have an train worth of $3.67 per share and a 4 yr time period from the date of issuance. Additional info with respect to the debt facility can be offered in a Type 6-Okay filed by ObsEva with the Securities and Trade Fee on October 13, 2021. Canaccord Genuity LLC acted as unique placement agent and monetary advisor to ObsEva.

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Kissei License and Provide Settlement
Lastly, ObsEva’s unique license and provide settlement with Kissei for linzagolix has been amended in order that first industrial gross sales milestones for the EU and the US will now be prolonged over a 5-year interval. As well as, North American royalty funds have been lowered to tiered single digit royalties on internet gross sales plus a provide worth for the lively pharmaceutical ingredient (API).

About Linzagolix
Linzagolix is a novel, as soon as day by day, oral GnRH receptor antagonist with a doubtlessly best-in-class profile 1,2,3 . Linzagolix has accomplished scientific trial growth for the therapy of heavy menstrual bleeding related to uterine fibroids and is at the moment in late-stage scientific growth for the therapy of ache related to endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide industrial rights, excluding Asia, for the product. Linzagolix will not be at the moment accepted wherever on this planet.

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About ObsEva
ObsEva is a biopharmaceutical firm growing and commercializing novel therapies to enhance girls’s reproductive well being and being pregnant. Via strategic in-licensing and disciplined drug growth, ObsEva has established a late-stage scientific pipeline with growth applications centered on new therapies for the therapy of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq International Choose Market and is traded beneath the ticker image “OBSV” and on the SIX Swiss Trade the place it’s traded beneath the ticker image “OBSN”. For extra info, please go to  www.ObsEva.com .

About Syneos Well being
Syneos Well being ®  (Nasdaq:SYNH) is the one totally built-in biopharmaceutical options group. The Firm, together with a Contract Analysis Group (CRO) and Contract Business Group (CCO), is purpose-built to speed up buyer efficiency to deal with trendy market realities. We deliver collectively roughly 27,000 scientific and industrial minds with the power to assist clients in additional than 110 nations. Collectively we share insights, use the newest applied sciences and apply superior enterprise practices to hurry our clients’ supply of essential therapies to sufferers. To study extra about how we’re  Shortening the gap from lab to life ® , go to  syneoshealth.com  or  subscribe to our podcast .

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Cautionary Be aware Concerning Ahead Wanting Statements of ObsEva SA
Any statements contained on this press launch that don’t describe historic info might represent forward-looking statements as that time period is outlined within the Non-public Securities Litigation Reform Act of 1995. These statements could also be recognized by phrases equivalent to “imagine”, “anticipate”, “might”, “plan”, “potential”, “will”, and comparable expressions, and are primarily based on ObsEva’s present beliefs and expectations. These forward-looking statements embrace expectations concerning the scientific growth of and commercialization plans for ObsEva’s product candidates, together with linzagolix, expectations concerning regulatory and growth milestones, together with the potential timing of regulatory submissions to the EMA and FDA and ObsEva’s capacity to acquire and preserve regulatory approvals for its product candidates, and the outcomes of interactions with regulatory authorities, and expectations concerning the usage of funds from the financing settlement with JGB Administration. These statements contain dangers and uncertainties that would trigger precise outcomes to vary materially from these mirrored in such statements. Dangers and uncertainties which will trigger precise outcomes to vary materially embrace uncertainties inherent within the conduct of scientific trials and scientific growth, together with the chance that the outcomes of earlier scientific trials might not be predictive of the outcomes of later stage scientific trials, associated interactions with regulators, ObsEva’s reliance on third events over which it could not all the time have full management, the affect of the continuing novel coronavirus outbreak, and different dangers and uncertainties which are described within the Danger Elements part of ObsEva’s Annual Report on Type 20-F for the yr ended December 31, 2020 filed with Securities and Trade Fee (SEC) on March 5, 2021 and different filings ObsEva makes with the SEC. These paperwork can be found on the Buyers web page of ObsEva’s web site at http://www.ObsEva.com. Any forward-looking statements communicate solely as of the date of this press launch and are primarily based on info out there to ObsEva as of the date of this launch, and ObsEva assumes no obligation to, and doesn’t intend to, replace any forward-looking statements, whether or not because of new info, future occasions or in any other case.

For additional info, please contact:
CEO Workplace contact
Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

Investor Contact
Joyce Allaire
jallaire@lifesciadvisors.com
+1 (617) 435-6602

1. Stewart E, ASRM 2020; Late-breaker summary P-930
2. Al-Hendy A, NEJM 2021; 384:630-42
3. Schlaff W, NEJM 2020; 382:328-40
4. Bradley L, ASRM 2020; Late-breaker summary P-931

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ObsEva Publicizes Relationship with Syneos Well being to Commercialize Linzagolix ObsEva Publicizes Relationship with Syneos Well being to Commercialize Linzagolix

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