On January 21, 2020 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported Q4 2019 operational highlights, revenue and cash position for Nicox SA and its subsidiaries (the "Nicox Group"), as well as key expected milestones in 2020 (Press release, NicOx, JAN 21, 2020, View Source [SID1234553353]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Key Expected Upcoming Milestones
NCX 470 Phase 3 clinical trial preparation: End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) is scheduled in Q1 2020. Initiation of the first of the two U.S. Phase 3 clinical trials ("Mont Blanc") is expected by the end of Q2 2020, comparing NCX 470 ophthalmic solution 0.065% and 0.1% vs. latanoprost ophthalmic solution 0.005% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
NCX: 4251: Meeting with the U.S. FDA is scheduled in Q1 2020 to discuss the next steps of the development plan.
ZERVIATETM U.S. launch: Commercial launch of ZERVIATETM (cetirizine ophthalmic solution), 0.24% in the U.S. is planned in H1 2020 by Nicox’s partner Eyevance Pharmaceuticals, LLC.
Fourth Quarter 2019 and Recent Operational Highlights
The total number of prescriptions1 for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, in the U.S. in the fourth quarter of 2019 increased by 12% compared to the third quarter 2019 and by 72% compared to the fourth quarter of 2018.
Positive results were reported from the U.S., multicenter, Phase 2 safety and efficacy clinical trial ("Dolomites") which evaluated NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. NCX 470 0.065% demonstrated non-inferiority and statistical superiority to latanoprost 0.005%, the U.S. market leader in prostaglandin analog prescriptions.
Positive top-line results were reported from the Phase 2 clinical trial ("Danube") of NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, which met the primary objective of the U.S. multicenter, dose escalating, first-in-human clinical trial which evaluated its safety and tolerability in patients with acute exacerbations of blepharitis. NCX 4251 0.1% once daily (QD) treatment was selected to advance into a larger Phase 2b clinical trial, subject to the outcome of a meeting with the U.S. FDA scheduled in Q1 2020, and the necessary financial resources being secured. Selected dose also demonstrated promising efficacy in reducing signs and symptoms of dry eye disease.
An exclusive license agreement was entered into with Samil Pharmaceutical Co., Ltd for the development and commercialization of ZERVIATE (cetirizine ophthalmic solution), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis in South Korea.
Global partner Bausch + Lomb, announced that VYZULTA, indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension, will be listed as a limited use product under the Ontario Drug Benefit Formulary, one of the principle drug benefit programs in Canada. VYZULTA is currently covered by most private insurance plans in Canada, and was launched in this market earlier this year.
Global partner Bausch + Lomb also received approval of VYZULTA in Mexico, Hong Kong and Argentina.
Future Nicox research activities will be focused on NO-donating phosphodiesterase-5 (PDE5) inhibitors projects for glaucoma, for which Nicox expects to be able to announce an Investigational New Drug (IND)-track candidate in 2020.
Changes in Management
Dr. Tomas Navratil, PhD, has been promoted to Executive Vice President, Head of R&D of the Nicox Group and General Manager of Nicox Ophthalmics Inc. as of January 1, 2020. In this expanded role, Dr. Navratil will be responsible for all research, non-clinical and clinical development, CMC and regulatory affairs activities for Nicox and general management of Nicox U.S. operations in Durham, North Carolina.

Fourth Quarter 2019 Financial Highlights
As of December 31, 2019, the Nicox Group had cash and cash equivalents of €28.0 million as compared with €17.4 million at September 30, 2019 and €22.1 million at December 31, 2018. The December 31, 2019 cash position does not include the last €8 million drawn down under the bond financing agreement with Kreos Capital. Net revenue2 for the fourth quarter of 2019 was €0.6 million, compared to €3.3 million for the fourth quarter of 2018. Net revenue2 for the full year 2019 was €6.9 million (€2.1 million in net royalties, €4.8 million in license payments), compared to €4.0 million (€1 million in net royalties and €3 million in license payments) for the full year 2018.

In November 2019, Nicox raised €12.5 million in gross proceeds through a private placement via the issuance of 3,315,650 new ordinary shares.

As of December 31, 2019, the Nicox Group had financial debt of €11.1 million in the form of a bond financing agreement with Kreos Capital signed in January 2019. Nicox has drawn down a total of €20 million under this bond financing agreement, as €8 million in January 2019, €4 million in October 2019 and €8 million in December 2019 received in January 2020. No further amounts can be drawn down under this bond financing agreement.

Only the figure related to the cash position of the Nicox Group as of December 31, 2018 is audited; all other figures of this press release are non-audited.
Notes
1. Bloomberg data, comparing the period of the weeks ending October 4, 2019 to December 27, 2019 with the period of the weeks ending July 5, 2019 to September 27, 2019 and October 5, 2018 to December 28, 2018
2. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss.

On January 21, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has granted conditional marketing authorisation for Polivy (polatuzumab vedotin), in combination with bendamustine plus MabThera (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a haematopoietic stem cell transplant (Press release, Hoffmann-La Roche, JAN 21, 2020, View Source [SID1234553352]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"With this approval, people in the EU with relapsed or refractory diffuse large B-cell lymphoma will have the opportunity to benefit from this new Polivy combination," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "For patients battling this aggressive disease, the prognosis is poor and few treatments are available. We are proud to bring this first-in-class treatment option to those who need it most."

The conditional approval is based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival (OS) compared to BR, a commonly used regimen, in people with R/R DLBCL who are not candidates for a haematopoietic stem cell transplant. Results of the study showed that 40% of people treated with Polivy plus BR achieved a complete response (n=16/40), meaning no cancer could be detected at the time of assessment, compared to 17.5% (n=7/40) with BR alone. Complete response rates were assessed by an independent review committee. The study also showed that OS more than doubled, with a median of 12.4 months in the Polivy arm vs. 4.7 months in the BR alone arm (HR=0.42). Furthermore, patients treated with Polivy plus BR showed a longer time between first response to treatment and disease worsening than those receiving BR alone (investigator assessed median duration of response: 10.3 months vs. 4.1 months; HR=0.44). The most commonly reported adverse events in people treated with Polivy in combination with BR included anaemia, thrombocytopenia, neutropenia, fatigue, diarrhoea, nausea, and pyrexia.

Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.

Today’s conditional EU approval follows the US Food and Drug Administration’s (FDA) accelerated approval of Polivy in combination with BR for the treatment of people with R/R DLBCL who have received at least two prior therapies, in June 2019. Polivy was granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of people with R/R DLBCL in 2017, the first PRIME designation for a Roche medicine. Additional submissions of the GO29365 data to health authorities around the world are ongoing with the goal of bringing this new treatment option to more patients as soon as possible.

About the GO29365 study
GO29365 is a global, phase Ib/II study evaluating the safety, tolerability and activity of Polivy (polatuzumab vedotin) in combination with bendamustine and MabThera (rituximab) (BR) or Gazyvaro (obinutuzumab) in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). Eligible patients were not candidates for a haematopoietic stem cell transplant at study entry. The phase II part of the study randomised 80 patients with heavily pre-treated R/R DLBCL to receive either BR, or BR in combination with Polivy for a fixed duration of six 21-day cycles. Of the patients enrolled, 80% had refractory disease. The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography and assessed by an independent review committee (IRC). Secondary endpoints included overall response rate (ORR; CR and partial response) by investigator assessment and best ORR at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response, progression-free survival, event-free survival and overall survival.

About Polivy (polatuzumab vedotin)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells (an immune cell impacted in some types of non-Hodgkin lymphoma (NHL)), making it a promising target for the development of new therapies.1,2 Polivy binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells.3,4 Polivy is being developed by Roche using Seattle Genetics ADC technology and is currently being investigated for the treatment of NHL. Polivy is marketed in the US by Genentech as Polivy (polatuzumab vedotin-piiq), with piiq as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the US Food and Drug Administration.

About diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.5 DLBCL is an aggressive (fast-growing) type of NHL, which is generally responsive to treatment in the frontline.6 However, as many as 40% of patients will relapse, at which time salvage therapy options are limited and survival is short.6 Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.7

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3, Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.ounced that

On January 21, 2020 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported is proud to be named in the Corporate Knights Global 100 Most Sustainable Corporations in the World (Global 100) for the fifth consecutive year (Press release, Takeda, JAN 21, 2020, View Source [SID1234553347]). Corporate Knights assesses more than 7,300 companies against 21 key performance indicators. It uses these indicators to determine the top 1% most sustainable companies in the world, which are announced annually at the World Economic Forum in Davos, Switzerland.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Building sustainable value is a fundamental part of the way we do business at Takeda, and we are proud to be recognized as a global leader in sustainability," said Christophe Weber, President and CEO. "This recognition by Corporate Knights is a testament to the strong foundation Takeda has laid and the progress we have already achieved. We remain steadfast in our commitment to realizing Better Health and a Brighter Future for all."

Corporate Knights highlighted Takeda’s performance in the following areas:

Significant year-on-year improvement in energy, water and greenhouse gas productivity scores.
High marks for clean revenue, which measures revenue earned by providing access to medicine for top priority diseases in low- and middle-income countries through equitable pricing strategies.
Three times the average score for female representation among senior executives.
In addition to the Global 100 index, Takeda is recognized by many other environmental, social and governance (ESG) investment valuations. As a long-standing member of the United Nations Global Compact, Takeda’s sustainability efforts are guided by key international targets, such as the Sustainable Development Goals (SDGs).

Name of
Index or Rating

Company/
Organization

Country

History of
Inclusion

Dow Jones Sustainability World Index

Dow Jones

U.S.

1st year

Dow Jones Sustainability Asia Pacific Index

Dow Jones

U.S.

10th year

FTSE4Good Developed Index

FTSE Russell

U.K.

15th consecutive year

MSCI ESG Leaders Index

MSCI

U.S.

10th consecutive year

Ethibel EXCELLENCE Investment Register

Forum Ethibel

BEL

Since July 2017

Prime Status

ISS-Oekom

GER

2nd consecutive year

Industry Mover Sustainability Yearbook Award 2019

RobecoSAM

CHE

Since February 2019

On January 21, 2020 OncoTherapy Science, Inc. (President & CEO: Jae-Hyun Park; hereinafter "OncoTherapy") reported that the first patient has been enrolled for Phase I study of OTSA101 and the treatment initiated (Press release, OncoTherapy Science, JAN 21, 2020, View Source [SID1234553342]). This is a Phase I study to assess the safety of OTSA101 in Japanese patients with refractory, relapsed and/or advanced synovial sarcoma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In this study, the safety and pharmacokinetic profiles of radioisotope-conjugated OTSA101 will be evaluated in the synovial sarcoma patients.

OTSA101 is an anti-FZD10 chimeric monoclonal antibody. Frizzled homolog 10 (FZD10) was identified through genome-wide gene expression analysis by Yusuke Nakamura, a former professor in the University of Tokyo. FZD10 is a transmembrane protein which is highly expressed in synovial sarcoma but not in human normal vital organs. Radioisotope-conjugated OTSA101 was specifically accumulated in tumor tissue and showed strong anti-tumor effect in preclinical study, and it is being developed as a radioimmunotherapy (RIT) for synovial sarcoma. The investigatorinitiated Phase I study in France was completed with the favorable results about the primary objectives of this study, safety and bio-distribution profile. OTSA101 has been designated as an orphan drug against synovial sarcoma by European Medicines Agency (EMA) and Food and Drug Administration (FDA).

On January 20, 2020 Oasmia Pharmaceutical AB reported is launching its product, Apealea 60 mg, in Sweden, Denmark and Finland (Press release, Oasmia, JAN 20, 2020, View Source [SID1234556565]). The first batch of the drug has been shipped to distributors in these countries.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Apealea is a patented, water-soluble, intravenously injectable formulation of paclitaxel, developed using Oasmia’s proprietary technology platform – XR17 – which facilitates the solubility of paclitaxel. Paclitaxel is a chemotherapy medication used to treat a number of types of cancers. Apealea has been authorized for marketing by the European Commission. Apealea in combination with Carboplatin is approved for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

"The launch of Apealea in the Nordic countries enables therapeutic potential for patients in need of innovative cancer treatment. This is an important milestone for Oasmia in its transition towards becoming a fully integrated pharmaceutical company. As a second step, we intend to continue our efforts of engaging strategic partners for Apealea in other territories", comments Sven Rohmann, acting CEO of Oasmia.

"Oasmia has fulfilled all the regulatory requirements required for launch of the drug in the EU. The next intended step for us is to prepare for the submission for a regulatory approval from the United States Food and Drug Administration to obtain access to the U.S. market", says Nina Heldring, Chief Medical Officer at Oasmia.

Oasmia will participate as official sponsor of the 41st EORTC-PAMM Winter Meeting in Stockholm between February 13th – 15th 2020. The Winter Meeting is organized under the umbrella of the European Organization for Treatment of Cancer (EORTC) intended to provide opportunities for interdisciplinary and international exchange of knowledge on optimizing cancer treatment.