Business Wire

Rhizen Pharmaceuticals AG Announces That Its Partnered Asset, Umbralisib (UKONIQ™), Has Received US FDA Accelerated Approval for Adult Patients With Relapsed or Refractory MZL & FL

Share

Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, today announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ:TGTX), has secured US FDA accelerated approval for the treatment of:

  • adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and
  • adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

Accelerated approval was granted for these indications, under a priority review (MZL), based on the results of the Phase 2 UNITY-NHL Trial (NCT02793583); in MZL, an ORR of 49% with 16% complete responses and in FL an ORR of 43% with 3% complete responses were achieved, respectively. Umbralisib was earlier granted Breakthrough Therapy Designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL.

Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon and was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics (NASDAQ:TGTX) at an IND stage (TGR 1202) in 2012. In 2014, both parties entered into a licensing agreement as a part of which TGTX obtained worldwide rights and Rhizen has retained commercialization rights for India while also being the manufacturing and supply partner for Umbralisib.

Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals said: “Umbralisib’s approval offers MZL & FL patients a new treatment option and is a huge validation of Rhizen’s drug discovery & development capabilities. This is a momentous occasion in Rhizen’s journey as a successful biotech that speaks of the true ability of our team to discover & develop safe and effective therapies that can last the rigors of drug development. Further, we are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.”

Pranav Amin, Chairman, Rhizen Pharmaceuticals & Managing Director of Alembic Pharmaceuticals Ltd said: “We are extremely proud of this historic milestone for Rhizen, and of the fact that Umbralisib is the first NCE discovered by Indian scientists to secure a US FDA approval. We are committed to working together with TG Therapeutics and Rhizen Pharma to ensure uninterrupted supply of UKONIQ™. Umbralisib is the first discovery asset to come out of Rhizen’s R&D efforts and this approval heralds the promise of the rest of Rhizen’s deep pipeline and continuing efforts.”

About Umbralisib:

Umbralisib is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies. Umbralisib is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. These indications are approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information on Umbralisib or UKONIQ™ can be found at https://www.tgtherapeutics.com/prescribing-information/uspi-ukon.pdf.

About Alembic Pharmaceuticals Ltd:

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s products that are marketed through a marketing team of over 5000 are well recognized by doctors and patients.

Information about Alembic can be found at http://www.alembicpharmaceuticals.com/.

(Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573)

About Rhizen Pharmaceuticals A.G.:

Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel onco-therapeutics. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in Basel, Switzerland. For additional information, please visit www.rhizen.com.

Contact information

Samyukta Bhagwati
Manager, Corporate Affairs & Communications
Rhizen Pharmaceuticals AG
+41 32 580 0113
corpcomm@rhizen.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

MyHeritage lanserer en banebrytende funksjon for å animere ansiktene i stillbilder25.2.2021 16:49:00 CETPressemelding

MyHeritage er verdens største globale tjenesten for å oppdage din fortid og styrke din fremtid. I dag annonserer selskapet Deep Nostalgia™, det en ny fotofunksjon som animerer ansikter i stillbilder. Deep Nostalgia™ gir slektshistorie et nytt perspektiv ved å produsere realistiske skildringer av hvordan mennesker kunne ha beveget seg og sett ut, hvis de hadde blitt videofilmet. MyHeritage er det eneste selskapet som tilbyr en komplett pakke med funksjoner for å fargelegge, gjenopprette, forbedre og nå animere historiske bilder. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20210225005805/no/ Introducing Deep Nostalgia™ (Photo: Business Wire) Denne teknologien som animerer ansikter i bilder ble lisensiert av MyHeritage fra D-ID, som er et selskap som har spesialisert seg på videorekonstruksjon ved hjelp av dyp læringteknologi. Deep Nostalgia™ bruker flere forhåndsdefinerte beveglsesvideoer som er utarbeidet av MyHeritage

CMT’s New Report Confirms Increasing Appetite for Connected Insurance in Europe25.2.2021 16:25:00 CETPress release

A large shift in driving habits due to the COVID-19 pandemic has changed how people think about motor insurance across Europe, according to a new study by Cambridge Mobile Telematics (CMT), the world’s leading mobile telematics and analytics provider. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005773/en/ (Graphic: Business Wire) Based on the surveys of 4,000 drivers in France, Germany, Italy and the U.K., the new report shows shifting attitudes towards quoting channels, claims services, pricing models and value-added services, broken down and analysed by location, age and driving behaviour. The two surveys - taken in January 2020, before the pandemic, and then nine months later in September 2020 - reveal up to 81 percent of the drivers in Europe have changed how they drive because of COVID-19. Now 65 percent are interested in connected insurance, a 32% jump in nine months. The pandemic has modified commuting patter

Alpega Group Showed Impressive Results In 202025.2.2021 16:00:00 CETPress release

Alpega Group, a leading provider of end-to-end transportation and logistics management software, has positioned itself to meet logistics challenges with impressive results in 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005665/en/ Alpega Group, a leading provider of end-to-end transportation and logistics management software, has positioned itself to meet logistics challenges with impressive results in 2020. (Photo: Alpega Group) Alpega’s business units had an outstanding performance last year. On one hand, their freight exchanges’ customer acquisitions strongly grew by 20% compared to the previous year and existing clients had a higher renewal rate. On the other hand Alpega TMS added 83 new customers and had a tremendous increase in usage of their smart booking solution. Alpega’s CEO, Todd DeLaughter, commented on these results: “I’m very excited with Alpega’s excellent performance proving the value of our sol

MyHeritage Releases Groundbreaking Feature to Animate the Faces in Still Photos25.2.2021 15:54:00 CETPress release

MyHeritage, the leading global service for discovering your past and empowering your future, announced today the release of Deep Nostalgia™, a new feature that animates the faces in still photos. Deep Nostalgia™ gives family history a fresh new perspective by producing a realistic depiction of how a person could have moved and looked if they were captured on video. MyHeritage is the only company to offer a complete suite of features for colorizing, restoring, enhancing, and now animating historical photos. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005747/en/ Introducing Deep Nostalgia™ (Photo: Business Wire) The technology for animating the faces in photos was licensed by MyHeritage from D-ID, a company that specializes in video reenactment using deep learning. Deep Nostalgia™ uses several pre-recorded driver videos prepared by MyHeritage, which direct the movements in the animation and consist of sequences of rea

Andersen Global Enhances Caribbean Platform with Baptiste & Co. Law Firm25.2.2021 15:30:00 CETPress release

Further strengthening its Caribbean platform and adding additional coverage in the southern edge of the region, Andersen Global expands into St. Vincent and the Grenadines with collaborating firm Baptiste & Co. Law Firm. Established in 1986, Baptiste & Co. Law Firm, was founded by Managing Partner René M. Baptiste, who possesses more than 40 years of experience. In addition to founding the firm, René’s accomplishments include admission to the Bar in St. Vincent and the Grenadines, Antigua and Barbuda, Saint Kitts and Nevis; published articles in the International Finance journal; two terms of service as an elected member of Parliament and Cabinet Minister in St. Vincent and the Grenadines; and the role of Speaker of the Organization of Eastern Caribbean States’ Assembly. Additionally, she possesses well over 50 years of public service, which has resulted in recognition from Her Majesty Queen Elizabeth II in the form of elevation to Commander of Saint Michael and Saint George (CMG) for

C3 AI Awarded Robust Omnibus U.S. Patent for End-to-End Enterprise AI Platform25.2.2021 15:00:00 CETPress release

C3 AI today announced that it was awarded a broad-ranging omnibus patent for the company’s end-to-end enterprise AI solution, C3 AI® Suite, further solidifying the company’s position as a leading enterprise AI software provider for accelerating digital transformation, as well as strengthening C3 AI’s intellectual property and competitive advantage. The newly issued U.S. patent (No.10,817,530) was granted for “systems, methods, and devices for an enterprise AI application development platform.” The patent encompasses not only advanced data processing and AI application development, but also the extensive array of techniques necessary to build an end-to-end enterprise AI platform, including C3 AI’s unique model-driven architecture. “This patent is the most significant and substantial we have been awarded to date,” said Thomas M. Siebel, CEO of C3 AI. "When we filed years ago, no one else conceived of a comprehensive, end-to-end solution with a model-driven architecture that accelerates t

Lenovo to Be Main Sponsor of Red Bull Illume Image Quest 202125.2.2021 15:00:00 CETPress release

The world’s greatest adventure and action sports imagery contest, Red Bull Illume® returns in 2021 with global technology leader, Lenovo™, as its Exclusive Computing Sponsor. A showcase for the best of adventure and action sports imagery, the competition is expected once again to receive tens of thousands of entries from around the world including some of the most creative and extreme images ever captured. As part of this two-year partnership, Lenovo will be involved through brand, product placement and logo incorporation for both online and in-person content, prizes for finalists and winners, as well as having promotional access to the incredible contest imagery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005071/en/ Austrian photographer Philip Platzer gets the perfect in-air shot of Red Bull Skydive teammate, Marco Fürst, participating in The Megaswing Project. (Photo: Philip Platzer/ Red Bull Illume) Lenovo enab