The Digest

Pharma news roundup and Larvol updates

Contact Us

The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – Breast Cancer – July 8, 2019

July 8, 2019

Nerlynx (neratinib) / Puma
Puma Biotechnology submits a Supplemental New Drug Application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer (Businesswire) – Jul 1, 2019 – “Puma Biotechnology, Inc….has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease)….The sNDA is supported by the results of the Phase III NALA trial…”

 

Verzenio (abemaciclib) / Eli Lilly
Lilly aims to reshape Korea’s breast cancer treatment market (Korea Biomedical Review) – Jul 5, 2019 – “Lilly Korea is seeking to reshape Korea’s breast cancer treatment market on the occasion of its winning the sales approval for its Verzenio, a cyclin-dependent kinase (CDK) 4/6 inhibitor, from the Ministry of Food and Drug Safety, the company said Friday. The ministry approved the drug in combination with an aromatase inhibitor or as a combination therapy with fulvestrant in treating HR+/HER2-progressive or metastatic breast cancer with advanced disease after endocrine therapy in May.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Topline data from P2 MARIO-3 trial (NCT03961698) in combination with IPI-549 and Abraxane for 1L TNBC or 1L RCC in 2020 (Oppenheimer) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67540721; Page no: 2; REPORT TITLE: “Infinity Pharmaceuticals-Initiating coverage- 1st-in-class PI3K-γ inhibitor offers proxy for MDSCs in I-O; Initiating with outperform and $3 PT”; AUTHOR: Degeeter, Kevin, et al; DATE: 06/26/2019

 

Taclantis (paclitaxel injection concentrate for nanodispersion) / Sun Pharma
SPARC gains on acceptance of NDA by USFDA (Dalal Street Investment Journal) – Jul 1, 2019 – “Sun Pharma Advanced Research Company (SPARC) informed the bourses that USFDA has accepted the company’s New Drug Application (NDA) for Taclanti (Paclitaxel Injection Concentrate for Suspension)….Paclitaxel is one of the most widely used cytotoxic agents and is approved for the treatment of Breast cancer, Ovarian cancer, Non-Small Cell Lung cancer and Pancreatic cancer.”

 

Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi US sales projection: $1,217M (guidance: $1,057M) in FY2019; Imfinzi WW sales projection: $1,624M (guidance: $1,350M) in FY2019 (Barclays) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67531192; Page no: 1; REPORT TITLE: “AZN/NOVN/ROG: US oncology tracker: May edition (watch out for the tortoise…)”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 06/24/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda sales projection: $19.5B (previously $18.4B) in 2023 (Morgan Stanley) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67521900; Page no: 1; REPORT TITLE: “Merck & Co. Inc – Merck: Bumping PT on higher LT growth prospects”; AUTHOR: Risinger, David, et al; DATE: 06/21/2019

 

ALT02 (trastzumab biosimilar) / Alteogen, Qilu Pharma
China OKs Alteogen’s Herceptin biosimilar for clinical trials (Korea Biomedical Review) – Jul 4, 2019 – “Alteogen said that Qilu Pharmaceutical, its Chinese partner, has received investigational new drug (IND) approval for ALT-02, a Herceptin biosimilar, from the China Food and Drug Administration.”

 

Avastin (bevacizumab) / Roche; Kisqali (ribociclib) / Novartis
RIBBIT: Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line (clinicaltrials.gov) – Jul 5, 2019 – P3; N=158; Recruiting; Sponsor: iOMEDICO AG; Trial completion date: Jun 2025 –> Jun 2026; Trial primary completion date: Jun 2024 –> Jun 2025

Read More …

Weekly Top News – IBD – July 8, 2019

July 8, 2019

etrasimod (APD334) / Arena
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis (clinicaltrialsregister.eu) – Jul 3, 2019 – P3; N=330; Sponsor: Arena Pharmaceuticals, Inc.

 

filgotinib (GLPG0634) / Gilead
Gilead announces intent to submit New Drug Application for filgotinib to U.S. Food and Drug Administration this year (GlobeNewswire) – Jul 2, 2019 – “Gilead Sciences, Inc….today announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about…filgotinib. The company discussed with the agency the Phase 3 FINCH studies, as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result…a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019.”

 

Humira (adalimumab) / Eisai, AbbVie
Humira pricing: $40,415/year (Infinata) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67557275; Page no: 8; REPORT TITLE: “UCB S.A. – Company Report”; AUTHOR: Infinata, et al; DATE: 07/01/2019

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J
Remicade pricing: $28,906/year (Infinata) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67557275; Page no: 8; REPORT TITLE: “UCB S.A. – Company Report”; AUTHOR: Infinata, et al; DATE: 07/01/2019

 

PF-06700841 / Pfizer; PF-06651600 / Pfizer
PF-06651600 + PF‑06700841 clinical trial estimate: Primary completion of P2a trial (NCT03395184) for Crohn’s disease in February 2020 (Morgan Stanley) – Jul 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 18; REPORT TITLE: “Pfizer Inc – Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi revenue projection: Guidance of $150M in H2 2019 (CrispIdea) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67508148; Page no: 3; REPORT TITLE: “Abbvie Inc – Initiating Coverage – Abbvie showing progress in its pipeline by approval of Skyrizi”; AUTHOR: Agarwal, Akansha, et al; DATE: 06/18/2019

 

ABP 710 (infliximab biosimilar) / Amgen
Amgen pulls European application for its biosimilar infliximab ABP 710 (Center for Biosimilars) – Jul 1, 2019 – “Amgen has informed the European Medicines Agency (EMA) it is withdrawing its application for ABP 710, its biosimilar infliximab (Remicade). According to the letter sent to the EMA, Amgen said the decision was due to a change in product strategy.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales estimate: $26M (consensus: $10M) in Q2 2019; Skyrizi sales projection: $221M (consensus: $147M) for FY2019 (UBS) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67522126; Page no: 1; REPORT TITLE: “Abbvie Inc First Read: Abbvie “weekly Skyrizi tracker” (Neutral) Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 06/21/2019

 

BMS-986165 / BMS
Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis (clinicaltrialsregister.eu) – Jul 3, 2019 – P2; N=120; Ongoing; Sponsor: Bristol-Myers Squibb International Corporation

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan: Newly added patent in Orange Book (Orange Book) – Jul 2, 2019 – Patent expiry on October 2, 2029  
[Screenshot]

Read More …

Weekly Top News – Psoriasis – July 8, 2019

July 8, 2019

bimekizumab (UCB4940) / UCB
BE VITAL: A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 5, 2019 – P3; N=1045; Not yet recruiting; Sponsor: UCB Biopharma S.P.R.L.

 

Enstilar (calcipotriene/betamethasone dipropionate) / Leo Pharma
LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris (clinicaltrials.gov) – Jul 5, 2019 – P3; N=722; Completed; Sponsor: LEO Pharma; Active, not recruiting –> Completed

 

mirikizumab (LY3074828) / Eli Lilly
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2) (clinicaltrials.gov) – Jul 5, 2019 – P3; N=1443; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting –> Active, not recruiting

 

Taltz (ixekizumab) / Eli Lilly
Taltz pricing: Wholesale acquisition cost of $5,162/Injection (J.P. Morgan) – Jul 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67530491; Page no: 20; REPORT TITLE: “European Pharmaceuticals: Weekly chartbook: TRx for week ending June 14th”; AUTHOR: Vosser, Richard, et al; DATE: 06/24/2019

 

BMS-986165 / BMS
BMS-986165 clinical trial estimate: Completition of P3 trials POETYK-PSO-1 (NCT03624127) and POETYK-PSO-2 (NCT03611751) for moderate-to-severe plaque psoriasis by late-2020 (RBC Capital Markets (Canada)) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67512769; Page no: 22; REPORT TITLE: “Game Changers: Disruptive forces in biotech: 2H19 edition (v3.0)”; AUTHOR: Abrahams, Brian, et al; DATE: 06/19/2019

 

ABP 710 (infliximab biosimilar) / Amgen
Amgen pulls European application for its biosimilar infliximab ABP 710 (Center for Biosimilars) – Jul 1, 2019 – “Amgen has informed the European Medicines Agency (EMA) it is withdrawing its application for ABP 710, its biosimilar infliximab (Remicade). According to the letter sent to the EMA, Amgen said the decision was due to a change in product strategy.”

 

Otezla (apremilast) / Celgene
Otezla sales projection: $2.3B (consensus: $2.5B) in 2024 (Guggenheim) – Jul 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67532791; Page no: 1; REPORT TITLE: “Bristol-Myers Squibb Co. – BMY – They’re not gonna give Otezla away…but need to sell adds uncertainty & impacts timing”; AUTHOR: Fernandez, Seamus, et al; DATE: 06/25/2019

 

Taltz (ixekizumab) / Eli Lilly
Eli Lilly Korea gains further reimbursement for psoriasis treatment Taltz (Korea Biomedical Review) – Jul 1, 2019 – “The Korean branch of Eli Lilly said that it had gained additional reimbursement for its psoriasis treatment Taltz (Ingredient: ixekizumab) for treating active and progressive psoriatic arthritis from the Ministry of Health and Welfare.”

 

PF-06700841 / Pfizer
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 1, 2019 – P2b; N=196; Recruiting; Sponsor: Pfizer; Not yet recruiting –> Recruiting

Read More …

Weekly Top News – Breast Cancer – July 1, 2019

July 2, 2019

Nerlynx (neratinib) / Puma
Puma Biotechnology submits a Supplemental New Drug Application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer (Businesswire) – Jul 1, 2019 – “Puma Biotechnology, Inc….has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease)….The sNDA is supported by the results of the Phase III NALA trial…”

 

capivasertib (AZD5363) / Otsuka, AstraZeneca
Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (clinicaltrialsregister.eu) – Jun 26, 2019 – P3; N=800; Ongoing; Sponsor: AstraZeneca AB

 

Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer (GlobeNewswire) – Jun 28, 2019 – “Roche…announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease.The CHMP recommendation is based on data from the Phase III IMpassion130 study…”

 

Talzenna (talazoparib) / Pfizer
Talzenna: “The Committee confirmed that all issues previously identified in this application had been addressed [treatment of adult patients with germline breast cancer susceptibility gene (BRCA) mutated human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer].” (EMEA) – Jun 26, 2019 – CHMP Final Minutes for the meeting on 23-26 April 2019: “The Committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201 regulatory estimate: Submission for approval in HER2+ breast cancer in June-September 2019 (J.P. Morgan) – Jun 28, 2019 – A subscription to Thomson ONE is required to gain full access to report 67534138; Page no: 1; REPORT TITLE: “Daiichi Sankyo (4568): Raise price target and reiterate overweight rating “; AUTHOR: Kumagai, Naomi, et al; DATE: 06/20/2019

 

epirubicin / generics
MYELOSUPPRESSION AND MONITORING OF ABSOLUTE NEUTROPHIL COUNTS IN EPIRUBICIN/CYCLOPHOSPHAMIDE-TREATED BREAST CANCER PATIENTS: RESULTS FROM A PHASE-2A COLLABORATIVE TRIAL OF THE AGO-B AND CESAR STUDY GROUPS (MASCC-ISOO 2019) – Jun 24, 2019 – Pres time: Jun 23, 2019; 02:16 PM – 02:19 PM; Location: Station 2; “ANC monitoring may be most informative if measured on day 11 or day 12 to assess the first occurrence (incidence) and on days 13 to 15 for the presence of grade 4 neutropenia (prevalence). A reliable and early detection system for grade 4 neutropenia offers an opportunity for the instigation of preventative measures to mitigate the infection risk for patients.”

 

Zirabev (bevacizumab biosimilar) / Pfizer
Pfizer receives U.S. FDA approval for its oncology biosimilar, Zirabev (bevacizumab-bvzr) (Businesswire)- Jun 28, 2019 – “Pfizer Inc…announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer…The FDA approval was based on review of a comprehensive data package which demonstrated biosimilarity of ZIRABEV to the reference product. This includes results from the REFLECTIONS B7391003 clinical comparative study…”

 

Talzenna (talazoparib) / Pfizer; ZEN-3694 / Zenith Capital Corp
Zenith Epigenetics announces dosing of first patient in triple negative breast cancer trial with Pfizer(GlobeNewswire) – Jun 27, 2019 – “Zenith Epigenetics Ltd….announced today that it has dosed the first patient in a Phase 1b/2 clinical trial undertaken in collaboration with Pfizer Inc….The trial will evaluate the combination, safety and efficacy of the Company’s ZEN-3694, a novel and differentiated bromodomain and extra-terminal domain inhibitor (‘BETi’), and Pfizer’s talazoparib, a poly ADP ribose polymerase inhibitor (‘PARPi’), in patients with locally advanced or metastatic triple negative breast cancer without germline BRCA1/2 mutations.”

 

Minerva Biotechnologies announces FDA acceptance of IND application for huMNC2-CAR44 T cells to treat metastatic breast cancer (Businesswire) – Jun 24, 2019 – “Minerva Biotechnologies…announced today that the U.S. FDA…has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR44, an autologous CAR T cell therapy for solid tumors. huMNC2-CAR44 targets MUC1* (muk one star), a cleaved form of MUC1 present on over 75% of solid tumor cancer cells. Unlike the normal full-length MUC1, MUC1* is a potent growth factor receptor that is rendered constitutively active when onco-embryonic growth factor NME7AB binds to and dimerizes its truncated extracellular domain. Minerva intends to commence clinical trials in breast cancer before the end of 2019.”

 

Arvinas receives authorization to proceed for ARV-471, a PROTAC protein degrader to treat patients with locally advanced or metastatic ER+ / HER2- breast cancer (GlobeNewswire) – Jun 25, 2019 – “Arvinas, Inc….announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application (IND) for ARV-471, an oral estrogen receptor (ER) PROTAC® protein degrader, designed to selectively target ER for the treatment of patients with locally advanced or metastatic ER positive / HER2 negative breast cancer. Arvinas expects to initiate a Phase 1 clinical trial for ARV-471 in the third quarter of 2019.”

Read More …

Weekly Top News – IBD – July 1, 2019

July 2, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from induction part of P3 Diversity1 trial (NCT02914561) for crohn’s disease at end of 2020/early 2021 (Kepler Cheuvreux) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67505266; Page no: 16; REPORT TITLE: “Belgian Life Science Day”; AUTHOR: Landemaine, Thomas, et al; DATE: 06/17/2019

 

etrasimod (APD334) / Arena
ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Jun 24, 2019 – P3; N=330; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: 10-week induction part data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in H2 2019; 58-week maintenance part data from P2b/3 SELECTION1 trial for ulcerative colitis in H1 2020 (Kepler Cheuvreux) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67505266; Page no: 16; REPORT TITLE: “Belgian Life Science Day”; AUTHOR: Landemaine, Thomas, et al; DATE: 06/17/2019

 

Stelara (ustekinumab) / J&J
Stelara: “The Committee discussed the issues identified in this application, mainly relating to the wording of the indication and the target population [treatment of adult patients with moderately to severely active ulcerative colitis].” (EMEA) – Jun 26, 2019 – CHMP Final Minutes for the meeting on 23-26 April 2019: “The Committee adopted a request for supplementary information with a specific timetable.”

 

Entyvio (vedolizumab) / Takeda
Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn’s Disease] (clinicaltrials.gov) – Jun 28, 2019 – P; N=300; Not yet recruiting; Sponsor: Takeda

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan exclusivity expiry: 2028 (Zacks) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67412332; Page no: 3; REPORT TITLE: “Bausch Health Cos Inc.(BHC) Zacks company report”; AUTHOR: Research Department; DATE: 05/29/2019

 

vidofludimus (IMU-838) / Immunic
Immunic, Inc. to present previously unpublished data regarding lead program, IMU-838, at the GI Inflammatory Diseases Summit in Boston (PRNewswire) – Jun 24, 2019 – “Immunic…announced that Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present today previously unpublished data regarding the company’s lead program, IMU-838, at the GI Inflammatory Diseases Summit (GIIDS) in Boston….Preclinical data shows that IMU-838 appears selective towards those T cells producing high amounts of the pro-inflammatory cytokines, IFNγ and IL-17….In a phase 2a clinical study in steroid dependent UC and Crohn’s disease patients, the active moiety of IMU-838 (vidofludimus) has shown activity in the ability to wean off steroids, with a total response rate of 88.5%.”

 

Entyvio (vedolizumab) / Takeda
Entyvio: Expiry of patents in US in September 2021 and EU in August 2022 (Takeda) – Jun 29, 2019 – Annual Report 2018: Regulatory data protection in EU until May 2024 and US until May 2026; Re-examination period in Japan until July 2026  
[Screenshot]

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan pricing: $30,000/year in US (J.P. Morgan) – Jun 27, 2019 – A subscription to Thomson ONE is required to gain full access to report 67441460; Page no: 17; REPORT TITLE: “Axcella Health Inc- Initiating coverage- Axcella: No Axcella to grind; Initiating at overweight”; AUTHOR: FYE, Jessica, et al; DATE: 06/03/2019

 

Kappaproct (cobitolimod) / InDex
InDex Pharmaceuticals enrolls last patient in phase IIb study CONDUCT with cobitolimod (PRNewswire)- Jun 26, 2019 – P2b, N=215; CONDUCT (NCT03178669); Sponsor: InDex Pharmaceuticals; “InDex Pharmaceuticals…announced that patient enrolment was completed in the dose optimisation study CONDUCT, which is evaluating cobitolimod for the treatment of moderate to severe ulcerative colitis. Top line results are expected to be available in 8-10 weeks.”

Read More …
« Older Entries
Next Entries »