Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  Swiss Exchange  >  Santhera Pharmaceuticals Holding AG    SANN   CH0027148649

SANTHERA PHARMACEUTICALS HOLDING AG

(SANN)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

Santhera Pharmaceuticals : ReveraGen Receives $3.3 Million NIH Commercialization Readiness Pilot Grant for NDA Preparations for Vamorolone in Duchenne Muscular Dystrophy

11/17/2020 | 12:57pm EST

ReveraGen Receives $3.3 Million NIH Commercialization Readiness Pilot Grant for NDA Preparations for Vamorolone in Duchenne Muscular Dystrophy

-- Funds will support NDA preparatory activities for anticipated filing in 2021 --

November 17, 2020, 08:30 AM Eastern Time

Rockville, Maryland-ReveraGen, Inc., a privately held company developing vamorolone (VBP15) as a potential safer alternative for corticosteroid treatment in Duchenne muscular dystrophy and other disorders, today announced an award of a $3.3 million grant from the National Institute of Neurological Disorders and Stroke (NINDS) at National Institutes of Health (NIH). The two-year SBIR/STTR Commercialization Readiness Pilot (CRP) Program award will provide additional funding towards the new drug application (NDA) preparation, enabling timely filing after the read-out of the fully-enrolled registration study (VBP15-004;NCT03439670) anticipated in Q2 2021.

The Commercialization Readiness Pilot (CRP) program is designed to aid companies with previously funded SBIR/STTR Phase II/IIB projects as they advance to commercialization. ReveraGen has held a NINDS SBIR Phase II grant that enabled completion of Phase 2a clinical trials that showed dose- responsive improvement of vamorolone-treated DMD participants at both 24-weeksand 18-monthstreatment. A subsequent NIH SBIR Phase IIB award has supported the ongoing pivotal trial in 121 DMD boys recruited at 30 sites in 11 countries.

"This generous support from NIH is enabling the execution of the global regulatory and global intellectual property strategy of vamorolone, which we are developing jointly with Santhera," said Dr. Eric Hoffman, VP Research and principal investigator at ReveraGen on the award.

"Upfront of the CRP application, ReveraGen had carried out a formal gap analysis to identify pending items required for the upcoming NDA submission, and the CRP award will be beneficial in addressing these," noted Dr. Jesse Damsker, VP Operations at ReveraGen.

"We congratulate our partner ReveraGen to this grant which not only provides support in advancing vamorolone towards FDA submission and commercialization but also stands for recognition of the drug's promising potential," added Dario Eklund, Chief Executive Officer of Santhera.

ReveraGen has open INDs for development of vamorolone in both Duchenne muscular dystrophy and Becker muscular dystrophy. Studies of vamorolone in animal models of multiple chronic inflammatory diseases (multiple sclerosis, asthma, inflammatory bowel disease, arthritis and others) have shown efficacy similar to corticosteroids, and an improved safety profile. Studies of vamorolone in DMD boys have shown loss of the stunting of growth seen with treatment with corticosteroid standard of care (deflazacort, prednisone), with less physician-reported safety concerns.

Structure/activity studiescomparing the active metabolites of glucocorticoid receptor ligands (vamorolone, deflazacort, prednisone) have shown differential activity in binding co-activators and co-repressors, leading to vamorolone showing unique mechanisms of action. Specifically, vamorolone binding leads to less positive gene transcription activity associated with safety concerns, while retaining potent anti-inflammatory activity.

Recently, Santhera Pharmaceuticals has acquired a world-wide license to vamorolone in all indications. ReveraGen continues to manage the clinical programs and carry out NDA preparations.

About Vamorolone

Vamorolone is a first-in-class drug candidate that binds to the same receptor as corticosteroids but modifies its downstream activity and as such is a dissociative partial agonist. This mechanism has the potential to 'dissociate' efficacy from typical steroid safety concerns and therefore vamorolone could emerge as a promising alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD. There is substantial unmet medical need in this patient group as high-dose corticosteroids have significant systemic side effects that diminish patient quality of life. The fully enrolled, pivotal Phase 2b VISION-DMD trial (VBP15-004,https://vision-dmd.info/2b-trialinformation) is currently being conducted at study sites across North America, Europe, Israel and Australia and topline 6-month data are expected in Q2-2021, paving the way for a US NDA submission in Q4-2021. Vamorolone has been granted Orphan Drug status in the US and in Europe, and has received Fast Track and Rare Pediatric Disease designations by the US FDA and Promising Innovative Medicine (PIM) status from the UK MHRA. Vamorolone was discovered by US- based ReveraGen BioPharma, Inc. and is being developed in collaboration with Santhera, which owns worldwide rights to the drug candidate in all indications. The vamorolone development program has received funding from several international non-profit foundations and patient organizations, the US National Institutes of Health, the US Department of Defense and the European Commission's Horizon 2020 program. See www.reveragen.com; https://vision-dmd.info.

About ReveraGen BioPharma

ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders. The development of ReveraGen's lead compound, vamorolone, has been supported through partnerships with foundations worldwide, including Muscular Dystrophy Association USA, Parent Project Muscular Dystrophy, Foundation to Eradicate Duchenne, Save Our Sons, JoiningJack, Action Duchenne, CureDuchenne, Ryan's Quest, Alex's Wish, DuchenneUK, Pietro's Fight, Michael's Cause, and Duchenne Research Fund. ReveraGen has also received generous support from the US Department of Defense CDMRP, National Institutes of Health (NCATS, NINDS, NIAMS), and European Commission (Horizons 2020). www.reveragen.com.

Contact

ReveraGen BioPharma

Eric Hoffman, PhD, Vice President of Research Phone: + 1 240-672-0295 eric.hoffman@reveragen.com

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Santhera Pharmaceuticals Holding AG published this content on 17 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 November 2020 17:56:01 UTC


© Publicnow 2020
All news about SANTHERA PHARMACEUTICALS HOLDING AG
2020SANTHERA PHARMACEUTICALS : Completes Capital Increase for Financing Arrangements
AQ
2020Santhera Pharmaceuticals Closes Issuance of Treasury Shares
MT
2020SANTHERA PHARMACEUTICALS : Completes Capital Increase for Financing Arrangements
PU
2020SANTHERA PHARMACEUTICALS : Completes Capital Increase for Financing Arrangements
AQ
2020PRESS RELEASE : Santhera Completes Capital Increase for Financing Arrangements
DJ
2020SANTHERA PHARMACEUTICALS : Completes Capital Increase for Financing Arrangements
AQ
2020SANTHERA PHARMACEUTICALS : Completes Capital Increase for Financing Arrangements
DJ
2020Santhera Completes Capital Increase for Financing Arrangements
GL
2020Santhera Pharmaceuticals Partner ReveraGen Gets $3 Million Funding to Advance..
MT
2020SANTHERA PHARMACEUTICALS : ReveraGen Receives $3.3 Million NIH Commercialization..
PU
More news
Financials
Sales 2020 14,6 M 16,5 M 16,5 M
Net income 2020 -55,3 M -62,4 M -62,4 M
Net Debt 2020 - - -
P/E ratio 2020 -0,94x
Yield 2020 -
Capitalization 60,3 M 68,1 M 68,1 M
Capi. / Sales 2020 4,13x
EV / Sales 2021 2,41x
Nbr of Employees 113
Free-Float 85,3%
Chart SANTHERA PHARMACEUTICALS HOLDING AG
Duration : Period :
Santhera Pharmaceuticals Holding AG Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends SANTHERA PHARMACEUTICALS HOLDING AG
Short TermMid-TermLong Term
TrendsBullishBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus UNDERPERFORM
Number of Analysts 2
Average target price 5,35 CHF
Last Close Price 2,97 CHF
Spread / Highest target 159%
Spread / Average Target 80,1%
Spread / Lowest Target 1,01%
EPS Revisions
Managers and Directors
NameTitle
Dario Eklund Chief Executive Officer
Elmar J. Schnee Chairman
Andrew P. Smith Chief Financial Officer
Thomas Meier Director
Martin Gertsch Vice Chairman
Sector and Competitors