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Pharma news roundup and Larvol updates

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Month: August 2019

Weekly Top News – Breast Cancer – August 19, 2019

August 19, 2019

Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer
A Multicentre, International Neoadjuvant (NA), Randomized, Double-blind Phase III Trial comparing FULVESTRANT to a combination of FULVESTRANT and PALBOCICLIB in patients with operable Luminal Breast Cancer (SAFIA Trial) (ESMO 2019) – Aug 18, 2019 – Abstract #198P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
Interim Results From CompLEEment-1 (A Phase 3b Study of Ribociclib and Letrozole as First-Line Therapy for Advanced Breast Cancer in an Expanded Population): Spanish cohort results (ESMO 2019) – Aug 18, 2019 – Abstract #336P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
First Canadian Interim Analysis from the Phase IIIb CompLEEment-1 Ribociclib + Letrozole HR+ HER2- Advanced Breast Cancer Trial (ESMO 2019) – Aug 18, 2019 – Abstract #337P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Final OS data from P3 SOPHIA trial (NCT02492711) in HER2 positive metastatic breast cancer in 2020 (Wedbush PacGrow Healthcare Conference, Macrogenics) – Aug 16, 2019  
[Screenshot]

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Roche wins additional indication for breast cancer treatment Kadcyla (Korea Biomedical Review) – Aug 12, 2019 – “Roche Korea said that it has received additional indication approval for Kadcyla, its HER2+ breast cancer drug, from the Ministry of Food and Drug Safety…hospitals can now use Kadcyla as postoperative adjuvant therapy in patients with HER2-positive early breast cancer with invasive residual lesions after receiving taxane and trastuzumab-based preoperative adjuvant therapy…The ministry approved the expanded indication after Roche confirmed the treatment’s efficacy through a global phase 3 KATHERINE clinical trial…”

 

LiPlaCis (liposomal cisplatin) / Oncology Venture
FDA grants IDE approval to use Oncology Venture’s LiPlaCis DRP for patient selection in a pivotal phase 3 study (GlobeNewswire) – Aug 15, 2019 – “Oncology Venture A/S…informs that the US Food & Drug administration (FDA) has approved an IDE (Investigational Device Exemption) application for use of the company’s drug response predictor LiPlaCis DRP® in a planned pivotal Phase 3 study. In parallel, the FDA is evaluating Oncology Venture’s IND (Investigational New Drug) application for the drug substance LiPlaCis®, which is primarily being developed as a potential new treatment of metastatic breast cancer in heavily pre-treated patients.”

 

Onconova Therapeutics, Inc. reports business highlights and second quarter 2019 financial results (GlobeNewswire) – Aug 14, 2019 – “‘Enrollment in our global Phase 3 INSPIRE Trial with IV rigosertib in second-line, higher-risk MDS patients is progressing. Our goal is to complete enrollment by the end of 2019 and we anticipate reporting top-line data in the first half of 2020…our Special Protocol Assessment (SPA) request to the FDA for a Phase 3 combination trial of oral rigosertib plus azacitidine in first-line higher-risk MDS patients is being pursued. We also have plans to target cancers driven by mutated Ras genes…and a Phase 1 study of rigosertib in combination with a PD-1 inhibitor for patients with progressive K-Ras mutated non-small cell lung cancer is expected to commence in 2019….We are also working toward filing an IND for a Phase 1 trial of ON 123300, our investigational, first-in-class, dual inhibitor of CDK4/6 + ARK5, which we believe has the potential to treat various cancers including refractory metastatic breast cancer.'”

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Weekly Top News – IBD – August 19, 2019

August 19, 2019

Stelara (ustekinumab) / J&J
USTEKINUMAB IMPROVED WORK PRODUCTIVITY IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3 UNIFI INDUCTION AND MAINTENANCE STUDIES (UEGW 2019) – Aug 18, 2019 – Abstract #P1115; Pres time: Oct 22, 2019; 09:00 AM – 05:00 PM; Location: Poster Exhibition – Hall 7; “This abstract will be published on September 27, 2019”

 

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Data from P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in H2 2021 (Wells Fargo) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67741783; Page no: 2; REPORT TITLE: “Update from San Francisco biotech access day”; AUTHOR: Research Department; DATE: 08/02/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 clinical trial estimate: Initiation of P3 trial for Crohn’s disease in Q1 2020(Ladenburg, Thalmann) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67673924; Page no: 1; REPORT TITLE: “Redhill Biopharma Ltd 2Q19 results; Talica PDUFA November 2, 2019; Buy and $24 PT”; AUTHOR: Kaplan, Matthew, et al; DATE: 07/24/2019

 

mirikizumab (LY3074828) / Eli Lilly
EFFICACY AND IMPROVED HEALTH-RELATED QUALITY OF LIFE AFTER 52-WEEKS OF MIRIKIZUMAB TREATMENT IN PATIENTS WITH ULCERATIVE COLITIS: AN UPDATE FROM A RANDOMISED, DOUBLE-BLIND, CONTROLLED, PHASE 2 STUDY (UEGW 2019) – Aug 18, 2019 – Abstract #P1102; Pres time: Oct 22, 2019; 09:00 AM – 05:00 PM; Location: Poster Exhibition – Hall 7; “This abstract will be published on September 27, 2019”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
LONG-TERM EFFECT OF RISANKIZUMAB ON IMPROVED AND SUSTAINED HEALTH-RELATED QUALITY OF LIFE OVER 3 YEARS IN PATIENTS WITH MODERATE TO SEVERE CROHN’S DISEASE: INTERIM ANALYSIS OF A PHASE 2 OPEN-LABEL EXTENSION STUDY(UEGW 2019) – Aug 18, 2019 – Abstract #P0399; Pres time: Oct 21, 2019; 10:30 AM – 05:00 PM; Location: Poster Exhibition – Hall 7; “This abstract will be published on September 27, 2019”

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in H1 2020 (UBS) – Aug 15, 2019 – A subscription to Thomson ONE is required to gain full access to report 67716086; Page no: 4; REPORT TITLE: “Galapagos NV “More on offer; upgrade to Buy” (Buy) Sutcliffe”; AUTHOR: Sutcliffe, Laura, et al; DATE: 07/31/2019

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Weekly Top News – Psoriasis – August 19, 2019

August 19, 2019

BMS-986165 / BMS
BMS-986165 clinical trial estimate: Data from P3 trials POETYK-PSO-1 (NCT03624127) and POETYK-PSO-2 (NCT03611751) for moderate-to-severe plaque psoriasis in late 2020 (William Blair) – Aug 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67531579; Page no: 22; REPORT TITLE: “Bristol-Myers Squibb Co.: BMY: CheckMate-459 failure and deal closing delay for Otezla divestiture a double hit to sentiment”; AUTHOR: Phipps, Matt, et al; DATE: 06/24/2019

 

Taltz (ixekizumab) / Eli Lilly; Tremfya (guselkumab) / J&J
Lilly announces superiority of Taltz (ixekizumab) versus Tremfya (guselkumab) in delivering total skin clearance at week 12 in topline results from head-to-head (IXORA-R) trial in people living with moderate to severe plaque psoriasis (Eli Lilly Press Release) – Aug 13, 2019 – P4, N=1,027; IXORA-R (NCT03573323); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today Taltz® (ixekizumab) met the primary and all major secondary endpoints up to week 12 in the Phase 4 IXORA-R study, which evaluated the efficacy and safety of Taltz versus TREMFYA® (guselkumab) in people living with moderate to severe plaque psoriasis (PsO)….At 12 weeks, Taltz met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to TREMFYA as measured by PASI 100….Lilly plans to share results on the remaining key secondary endpoint of proportion of patients achieving PASI 100 at 24 weeks in 2020….Lilly plans to submit detailed data from the IXORA-R study for disclosure at scientific meetings and in peer-reviewed journals.”

 

Cosentyx (secukinumab) / Novartis; Tremfya (guselkumab) / J&J
Tremfya tops Cosentyx in late-stage study (PharmaTimes) – Aug 12, 2019 – P3, N=1,048; ECLIPSE (NCT03090100); Sponsor: Janssen Research & Development, LLC; “Johnson & Johnson’s Janssen has announced results from a Phase III ECLIPSE study, demonstrating superior long-term efficacy of Tremfya (guselkumab) compared with Cosentyx (secukinumab) in adults with moderate to severe plaque psoriasis.”

 

bimekizumab (UCB4940) / UCB
Bimekizumab launch estimate: For psoriatic arthritis in 2022 (Kepler Cheuvreux) – Aug 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67604813; Page no: 19; REPORT TITLE: “UCB SA – Q&A report | UCB | Buy | What can really get UCB shares moving?”; AUTHOR: Evans, David, et al; DATE: 07/21/2019

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun, CSIR-IICT ink global licensing pact for patents (The Economic Times) – Aug 15, 2019 – “…the company is preparing to launch it in Japan. Sun in its analyst presentation said these launches reflect its global aspirations for speciality business.”

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
LEO Pharma A/S acquires rights to develop and market brodalumab for moderate-to-severe psoriasis outside of Europe (Businesswire) – Aug 13, 2019 – “LEO Pharma…today announced it has acquired the exclusive rights to develop and market brodalumab (marketed as Kyntheum® in the European Union) for the treatment of moderate-to-severe psoriasis outside of Europe through a new sub-licencing agreement with Bausch Health Ireland Limited. The new agreement includes countries with significantly high unmet need, such as Australia, Brazil, Egypt, Mexico, Russia and Saudi Arabia….Under the new arrangement terms, Bausch Health has granted LEO Pharma A/S an exclusive license to its global rights to brodalumab but continues to hold the rights for the US and Canada.”

 

M923 (adalimumab biosimilar) / Baxter Healthcare, Momenta
Momenta drops Humira biosimilar, pays GSK $43m in manufacturing hit (BioProcess International)- Aug 12, 2019 – “Momenta says planned runs at manufacturing partner GSK could be reattributed to another product as it ends development of M923, a biosimilar candidate to Humira (adalimumab)….the firm has now made the decision to drop the adalimumab program M923.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
SMC rejects Orkambi, accepts four medicines (PharmaTimes) – Aug 13, 2019 – “The Scottish Medicines Consortium (SMC) has published advice accepting four new medicines…Illumetri (tildrakizumab), an Almirall drug for moderate to severe plaque psoriasis in adults….’Our decision on tildrakizumab for plaque psoriasis means another treatment option is available for patients who have failed to respond to previous therapies.'”

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: 2023 in US and 2024 in EU (BTIG) – Aug 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67737390; Page no: 5; REPORT TITLE: “Protagonist Therapeutics, Inc. – Additional results from phase 1 study with pn-943 provide support; details to be presented at ACG Conference in October”; AUTHOR: Chiang, Timothy, et al; DATE: 08/02/2019

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Weekly Top News – Breast Cancer – August 12, 2019

August 12, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio (abemaciclib) available in Canada for metastatic breast cancer (Canada Newswire) – Aug 8, 2019 – “Eli Lilly Canada Inc…is pleased to announce the availability of VERZENIO™ (abemaciclib). VERZENIO is indicated for the treatment of estrogen and/or progesterone hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (mBC)….The approval of VERZENIO is based on the efficacy and safety demonstrated in the pivotal MONARCH 3, MONARCH 2 and MONARCH 1 clinical trials.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 clinical trial estimate: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive breast cancer patients previously treated with Kadcyla at SABCS (December 10-14, 2019) (J.P. Morgan) – Aug 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67723679; Page no: 2; REPORT TITLE: “Daiichi Sankyo Company Limited – Daiichi Sankyo (4568): Strong start; Next catalyst is WCLC (in September)”; AUTHOR: Kumagai, Naomi, et al; DATE: 07/31/2019

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Roche wins additional indication for breast cancer treatment Kadcyla (Korea Biomedical Review) – Aug 12, 2019 – “Roche Korea said that it has received additional indication approval for Kadcyla, its HER2+ breast cancer drug, from the Ministry of Food and Drug Safety…hospitals can now use Kadcyla as postoperative adjuvant therapy in patients with HER2-positive early breast cancer with invasive residual lesions after receiving taxane and trastuzumab-based preoperative adjuvant therapy…The ministry approved the expanded indication after Roche confirmed the treatment’s efficacy through a global phase 3 KATHERINE clinical trial…”

 

Herceptin (trastuzumab) / Roche; Nerlynx (neratinib) / Puma
New early breast cancer option recommended by NICE (PharmaTimes) – Aug 7, 2019 – “The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Pierre Fabre’s Nerlynx (neratinib) as an additional treatment for some people with early hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer….The governing body announced that the drug is only recommended provided that Herceptin (trastuzumab) is the only HER2-directed adjuvant treatment people have had.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: NDA submission in combination with exemestane for HR+ metastatic breast cancer in 2020 (Syndax) – Aug 8, 2019 – Q2 2019 Results  
[Screenshot]

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports second quarter 2019 financial results and provides clinical and business update (PRNewswire) – Aug 7, 2019 – “…’We look forward to the near-term completion of E2112, the Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we anticipate will occur either in the fourth quarter of 2019 or the first half of 2020. A positive survival benefit at either assessment will enable us to file an NDA with the FDA and take us one step closer to improving outcomes for patients with this difficult to treat disease’.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports second quarter 2019 financial results (Businesswire) – Aug 8, 2019 – P2, N=650; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “…’We anticipate the following key milestones during the remainder of 2019: (i) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the third quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries’.”

 

Nerlynx (neratinib) / Puma
Knight Therapeutics Reports Second Quarter 2019 Results (GlobeNewswire, Knight Therapeutics)- Aug 8, 2019 – Received regulatory approval from Health Canada for NERLYNX® for the treatment of HER2-positive breast cancer. Reached an agreement with the pan-Canadian Pharmaceutical Alliance (“pCPA”) regarding Probuphine® and to date have obtained reimbursement through public insurance plans administered by Alberta, Saskatchewan and the Non-insured Health Benefit Program (“NIHB”). We have advanced our commercial presence and product pipeline with the regulatory approval of NERLYNX® and the submission of Ibsrela™…Knight plans to launch NERLYNX® in late 2019.

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Primary completion of P3 IMpassion030 trial (NCT03498716) for TNBC on January 15, 2022 (Barclays) – Aug 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67703402; Page no: 1; REPORT TITLE: “Roche Holding Ltd: ROG: (neo)adjuvant TNBC: Beaten to the punch…”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 07/29/2019

 

EDP1503 / Evelo Biosci; Keytruda (pembrolizumab) / Merck (MSD)
Evelo Biosciences announces positive interim phase 1b clinical data and provides second quarter 2019 financial results (GlobeNewswire) – Aug 6, 2019 – “Oncology: Clinical Studies and Anticipated Milestones – EDP1503 – Phase 1/2; Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data is expected in the first half of 2020.”

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Weekly Top News – IBD – August 12, 2019

August 12, 2019

Stelara (ustekinumab) / J&J
Ustekinumab Improved Work Productivity in Patients With Moderate to Severe Ulcerative Colitis: Results From the Phase 3 UNIFI Induction and Maintenance Studies (ACG 2019) – Aug 8, 2019 – Abstract #P1393; Pres time: Oct 28, 2019; 10:30 AM – 04:15 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline, patients had a mean percent work time missed ranging from 17.7% to 19.3%, impairment while working from 39.1% to 45.3%, overall work impairment from 43.7% to 49.1%, and activity impairment from 51.8% to 52.8%. At Wk8, patients who received UST IV had significantly greater improvement in WPAI domains and daily productivity VAS compared with PBO (Table). In the maintenance study, UST-treated patients generally maintained or numerically improved WPAI scores, while scores for patients in the PBO group worsened.”

 

Stelara (ustekinumab) / J&J
Effects of Ustekinumab Maintenance Therapy on Endoscopic Improvement and Histologic Improvement in the UNIFI Phase 3 Study in Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #56; Pres time: Oct 30, 2019; 08:40 AM – 08:50 AM; Location: Stars at Night Ballroom – B2; “At maintenance Week 44, EI was achieved in 28.6%, 43.6%, and 51.1% of pts treated with placebo, UST q12w (p=0.002 vs placebo), and UST q8w (p< 0.001), respectively. HI was achieved at Week 44 in 32.9%, 54.0%, and 59.3% of pts treated with placebo, UST q12w, and UST q8w, respectively (p< 0.001 for both q12w and q8w). MH was achieved at Week 44 in 24.1%, 38.8%, and 45.9% of pts treated with placebo, UST q12w (p=0.002), and UST q8w (p,0.001), respectively.”

 

Stelara (ustekinumab) / J&J
Molecular Response to Ustekinumab in Moderate-to-Severe Ulcerative Colitis by Serum Protein and Colon Transcriptomic Analysis: Results From the UNIFI Phase 3 Maintenance Study (ACG 2019) – Aug 8, 2019 – Abstract #P0454; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At Wk44 after the start of maintenance therapy, expression of colonic genes dysregulated in UC was altered towards normal levels in all treatment groups, with the greatest improvements among those receiving UST and those in clinical remission (p< 0.05 for Wk44 versus start of maintenance). No dose effect was observed between q8w and q12w UST doses, and no significant improvements in disease signature occurred in non-responders to placebo or UST. UST maintenance therapy magnified the normalization of serum proteins following UST induction; among pts receiving q8w UST who were in remission at Wk44, the proteins IFNγ, IL-17A, MMP3, and SAA reached concentrations comparable to those seen in healthy controls.”

 

Stelara (ustekinumab) / J&J
Safety of Ustekinumab in Inflammatory Bowel Diseases: Integrated Safety Analysis of Results From Phase 2 and 3 Studies in Crohn’s Disease and Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #P0505; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline (2370 pts in pooled phase 3 IBD studies), median age was 38.0 years, 46.9% were receiving corticosteroids, 30.8% were receiving IMM, 53.0% had failed biologics, and 37.1% were naïve to biologics. In phase 3 IBD studies, through Wk8 of PBO-controlled induction, the frequency of key safety events was similar between UST and PBO (Table 1). In addition, through 1 year across phase 2/3 IBD studies (Table 2), numbers of pts per 100 PY with key safety events were similar between treatment groups.”

 

Entyvio SC (vedolizumab SC) / Takeda
Takeda submits New Drug Application for a subcutaneous formulation of vedolizumab for patients with moderately to severely active ulcerative colitis in Japan (Takeda Press Release) – Aug 8, 2019 – “Takeda…announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both syringe and pen options.”

 

PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics reports second quarter 2019 financial results (PRNewswire) – Aug 7, 2019 – “Protagonist and Janssen are jointly conducting the development of PTG-200 through completion of a Phase 2 proof-of-concept study in Crohn’s disease. Protagonist and Janssen Biotech completed the filing of a U.S. Investigational New Drug (IND) application to support the global Phase 2 clinical study with initiation expected in the fourth quarter of 2019.”

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Weekly Top News – Psoriasis – August 12, 2019

August 12, 2019

BMS-986165 / BMS
BMS-986165 clinical trial estimate: Data from P3 trials POETYK-PSO-1 (NCT03624127) and POETYK-PSO-2 (NCT03611751) for moderate-to-severe plaque psoriasis in late 2020 (William Blair) – Aug 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67531579; Page no: 22; REPORT TITLE: “Bristol-Myers Squibb Co.: BMY: CheckMate-459 failure and deal closing delay for Otezla divestiture a double hit to sentiment”; AUTHOR: Phipps, Matt, et al; DATE: 06/24/2019

 

Stelara (ustekinumab) / J&J
Safety of Ustekinumab in Inflammatory Bowel Diseases: Integrated Safety Analysis of Results From Phase 2 and 3 Studies in Crohn’s Disease and Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #P0505; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline (2370 pts in pooled phase 3 IBD studies), median age was 38.0 years, 46.9% were receiving corticosteroids, 30.8% were receiving IMM, 53.0% had failed biologics, and 37.1% were naïve to biologics. In phase 3 IBD studies, through Wk8 of PBO-controlled induction, the frequency of key safety events was similar between UST and PBO (Table 1). In addition, through 1 year across phase 2/3 IBD studies (Table 2), numbers of pts per 100 PY with key safety events were similar between treatment groups.”

 

bimekizumab (UCB4940) / UCB
Bimekizumab launch estimate: For psoriatic arthritis in 2022 (Kepler Cheuvreux) – Aug 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67604813; Page no: 19; REPORT TITLE: “UCB SA – Q&A report | UCB | Buy | What can really get UCB shares moving?”; AUTHOR: Evans, David, et al; DATE: 07/21/2019

 

Efleira (netakimab) / Biocad
Efleira clinical trial estimate: Initiation of pivotal trial in Europe for psoriasis in Q4 2019(GlobalData) – Aug 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 66555904; Page no: 22; REPORT TITLE: “Biocad”; AUTHOR: GlobalData; DATE: 07/22/2019

 

Tremfya (guselkumab) / J&J
Tremfya pricing: Wholesale acquisition cost of $10,859/Injection (J.P. Morgan) – Aug 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67760273; Page no: 21; REPORT TITLE: “European Pharmaceuticals: Weekly chartbook: trx for week ending July 26th “; AUTHOR: Vosser, Richard, et al; DATE: 08/05/2019

 

Tremfya (guselkumab) / J&J
MorphoSys AG reports second quarter 2019 financial results (Market Watch) – Aug 6, 2019 – “An increasing royalty stream from Tremfya further strengthens our cash position and we are confident that there will be other compounds that follow Tremfya’s market entry in the future….Revenues also included an estimate of royalties on net sales of Tremfya amounting to EUR 7.1 million (estimate only since royalties for Q2 2019 had not been reported by Janssen as of the balance date)….Further phase 3 trials of Tremfya conducted by Janssen in psoriatic arthritis and a potential submission of a BLA planned for later this year as communicated by Janssen.”

 

Otezla (apremilast) / Celgene
Otezla sales projection: $2.7B in 2022 (Cowen & Co) – Aug 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 67713313; Page no: 2; REPORT TITLE: “Celgene Corp – Solid Q2 – bb2121 filing likely early ’20, not clear if KarMMa data at ASH”; AUTHOR: Werber, Yaron, et al; DATE: 07/30/2019

 

ANB019 / AnaptysBio
AnaptysBio announces second quarter 2019 financial results and provides pipeline updates(AnaptysBio Press Release) – Aug 8, 2019 – “The Company is conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with top-line data anticipated in the first half of 2020….Research and development expenses were $27.4 million and $48.0 million for the three and six months ended June 30, 2019, compared to $10.6 million and $22.4 million for the three and six months ended June 30, 2018. The increase was due primarily to continued advancement of the Company’s…ANB019 clinical programs…”

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Weekly Top News – Breast Cancer – August 5, 2019

August 5, 2019

Kisqali (ribociclib) / Novartis
Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct phase III trials (GlobeNewswire) – Jul 31, 2019 – P3, N=726; MONALEESA-3 (NCT02422615); Sponsor: Novartis Pharmaceuticals; “Novartis today announced Kisqali®(ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial. MONALEESA-3 evaluated efficacy and safety of Kisqali plus fulvestrant in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in both the first-line and second-line settings….No new safety signals were observed; adverse events were consistent with previously reported Phase III trial results.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Regulatory submission in EU for HER2 positive breast cancer in Q1 FY 2020 (Daiichi Sankyo) – Aug 1, 2019 – Q1 FY 2019 Results: Regulatory submission in Japan for HER2 positive gastric cancer in Q1 FY 2020

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 clinical trial estimate: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive breast cancer patients previously treated with Kadcyla at SABCS (December 10-14, 2019) (J.P. Morgan) – Aug 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67723679; Page no: 2; REPORT TITLE: “Daiichi Sankyo Company Limited – Daiichi Sankyo (4568): Strong start; Next catalyst is WCLC (in September)”; AUTHOR: Kumagai, Naomi, et al; DATE: 07/31/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Merck’s Keytruda (pembrolizumab) in combination with chemotherapy met primary endpoint of pathological complete response (pCR) in pivotal phase 3 KEYNOTE-522 trial in patients with triple-negative breast cancer (TNBC) (Merck (MSD) Press Release) – Jul 29, 2019 – P3, N=1,174; KEYNOTE-522 (NCT03036488); Sponsor: Merck; “Merck…announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status.”

 

Verzenio (abemaciclib) / Eli Lilly
Lilly’s Verzenio (abemaciclib) significantly extended life in women with HR+, HER2- advanced breast cancer in MONARCH 2 (Eli Lilly Press Release) – Jul 30, 2019 – P3, N=669; MONARCH 2 (NCT02107703); Sponsor: Eli Lilly and Company; “The analysis showed that treatment with Verzenio in combination with fulvestrant met its secondary endpoint of overall survival. The MONARCH 2 study previously demonstrated a statistically significant improvement in progression-free survival, the trial’s primary endpoint which served as the basis for its approval of this regimen in more than 50 countries around the world. No new safety signals were observed in this analysis of MONARCH 2, consistent with the established safety profile of Verzenio…. Lilly plans to submit these data to regulatory authorities and present the detailed data at an upcoming medical meeting later this year.”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: OS data from P3 MONARCH-2 trial (NCT02107703) in HER2- breast cancer in 2020 (Eli Lilly) – Jul 31, 2019 – Q2 2019 Results

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
KHK2375: Completion of P2 trial (NCT03291886) for advanced or recurrent hormone receptor-positive breast cancer in November 2021 (Kyowa Hakko Kirin Pharma) – Aug 2, 2019 – Q2 2019 Results

 

 

Tecentriq (atezolizumab) / Roche; Avastin (bevacizumab) / Roche; Opdivo (nivolumab) / Ono Pharma, BMS; IPI-549 / Infinity Pharma
Infinity Pharmaceuticals provides company update and second quarter 2019 financial results(PRNewswire) – Jul 30, 2019 – “Recent developments include: MARIO-3 Initiating in Q3 – This Phase 2 study in collaboration with Roche/Genentech will evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq® and Abraxane® in TNBC and with Tecentriq and Avastin® in RCC; Arcus Biosciences Collaboration Study Initiating in Q3 – This Phase 1 trial, to be conducted by Arcus, will evaluate a checkpoint-inhibitor free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil® in advanced TNBC patients; Completing MARIO-1 by year end – Infinity anticipates completing enrollment in the second half of 2019 in the expanded combination cohorts in MARIO-1, the company’s ongoing Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in approximately 225 patients with advanced solid tumors.”

 

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from early P1 trial (NCT03599453) in combination with Ampligen, Intron A and celecoxib for TNBC by 2020 (GlobalData) – Aug 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67689228; Page no: 176; REPORT TITLE: “Hemispherx Biopharma Inc (HEB) – Financial and strategic SWOT analysis Review”; AUTHOR: GlobalData; DATE: 08/01/2019

 

Ogivri (trastuzumab biosimilar) / Biocon, Mylan
Mylan, Biocon launch biosimilar of cancer drug Herceptin in Australia (Bloomberg Quint) – Aug 1, 2019 – “Biocon Ltd. and Mylan NV on Thursday launched Ogivri, used for treatment of certain breast and stomach cancers, in Australia. It is a biosimilar of Hoffmann-La Roche’s Herceptin.”

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Weekly Top News – IBD – August 5, 2019

August 5, 2019

Remsima SC (infliximab biosimilar SC) / Celltrion
Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn’s disease (clinicaltrialsregister.eu) – Aug 1, 2019 – P3; N=600; Ongoing; Sponsor: Celltrion, Inc

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P3 Diversity1 trial (NCT02914561) for Crohn’s disease in December 2019 (Oppenheimer) – Aug 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67660525; Page no: 2; REPORT TITLE: “Gilead Sciences Inc.: New CEO prepping for growth”; AUTHOR: Research Department; DATE: 07/22/2019

 

TD-1473 / J&J
Theravance Biopharma, Inc. reports second quarter 2019 financial results and provides business update (BioSpace) – Jul 31, 2019 – “Program Updates: TD-1473: Registrational Phase 2b/3 induction and maintenance study in ulcerative colitis (RHEA) and Phase 2 induction study in Crohn’s disease (DIONE) progressing. Data from the Phase 2b portion of the ulcerative colitis and Phase 2 Crohn’s disease studies planned late-2020.”

 

Xeljanz (tofacitinib) / Pfizer
Pfizer reports second-quarter 2019 results (BioSpace) – Jul 29, 2019 – “Xeljanz globally, up 36% operationally, driven by: 103% operational growth in international markets…and 21% growth in the U.S., reflecting volume growth from the launches of the UC and psoriatic arthritis (PsA) indications as well as continued growth in the RA indication…partially offset primarily by lower revenues for: Enbrel internationally, down 16% operationally, primarily reflecting continued biosimilar competition in most developed Europe markets as well as the unfavorable impact of timing of government purchases in certain emerging markets…”

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: Guidance of $4-5B peak (Wells Fargo) – Aug 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67660211; Page no: 1; REPORT TITLE: “Morphic Holding- Initiating coverage – MORF: Initiating at Outperform on oral integrin platform”; AUTHOR: Research Department; DATE: 07/22/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib: Completion of enrollment in P3 DIVERSITY trial (NCT02914561) for Crohn’s disease in Q3 2020 (Gilead) – Jul 31, 2019 – Q2 2019 Results

 

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Weekly Top News – Psoriasis – August 5, 2019

August 5, 2019

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Brodalumab: Regulatory decision in Asia for psoriasis in 2020 (Kyowa Hakko Kirin Pharma) – Aug 2, 2019 – Q2 2019 Results  
[Screenshot]

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces regulatory filing of tildrakizumab in Japan; stock down 1.5% (IIFL) – Aug 1, 2019 – “The co. announced that one of its wholly owned subsidiaries has filed an application for Manufacturing and Marketing Authorization of Tildrakizumab for moderate-to-severe psoriasis and psoriatic arthritis with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.”

 

PF-06700841 / Pfizer
A PHASE 2B DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM IN PARTICIPANTS WITH CHRONIC PLAQUE PSORIASIS (clinicaltrialsregister.eu) – Aug 1, 2019 – P2; N=240; Ongoing; Sponsor: Pfizer Inc.

 

piclidenoson (CF101) / Can-Fite, China Medical System
Can-Fite signs agreement with Kyongbo Pharm for the distribution in South Korea of piclidenoson in the treatment of psoriasis (Can-Fite Biopharma Press Release) – Aug 1, 2019 – “Can-Fite BioPharma…today announced it has signed a distribution agreement with Kyongbo Pharm Co., Ltd., to distribute Can-Fite’s lead drug candidate, Piclidenoson (CF101), for the treatment of psoriasis in South Korea, upon receipt of regulatory approvals….Up to $4,000,000 in upfront and milestone payments, plus a transfer price for delivering finished product…”

 

ANB019 / AnaptysBio
ANB019 US pricing projection: $50,000/year (Credit Suisse) – Jul 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407578; Page no: 6; REPORT TITLE: “Anaptysbio Inc ANAB: Bull versus bear debate”; AUTHOR: Auster, Martin, et al; DATE: 05/29/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx sales projection: $4.9B in 2023 (Kepler Cheuvreux) – Aug 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67665572; Page no: 8; REPORT TITLE: “Novartis AG – Espresso note | Novartis | Hold | Great business, fair value: downgrade to Hold”; AUTHOR: Evans, David, et al; DATE: 07/23/2019

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall; Skilarence (dimethyl fumarate) / Almirall
Almirall H1 2019 – Continued strong business momentum while reinforcing pipeline (Almirall Press Release) – Jul 29, 2019 – “Research & Development costs were €43.9 MM in H1, representing 10.2% of Net Sales (vs. 9.7% of Net Sales in Q1 2019 and 10.4% in H1 2018) due to Phase IV studies for Skilarence® and Ilumetri….Rollout of Ilumetri is ongoing, achieving a solid unit sales growth (+63% unit growth) during Q2 2019 in Germany, the UK and some Nordic Countries….Rollout continues in H2 with The Netherlands, Austria, Spain, Ireland, Poland and additionally Switzerland, following positive recommendations by Swissmedic….Skilarence® has delivered €16 MM of sales, representing over 102% year-on-year Net Sales growth vs. H1 2018.”

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