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Pharma news roundup and Larvol updates

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Month: July 2019

Weekly Top News – IBD – July 22, 2019

July 22, 2019

Halaven (eribulin mesylate) / Eisai
Anticancer agent Halaven approved for treatment of locally advanced or metastatic breast cancer in China (Eisai Press Release) – Jul 17, 2019 – “Eisai Co., Ltd….announced today that Eisai received New Drug Approval for Eisai’s in-house developed anticancer agent Halaven® (eribulin mesylate) for use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including an anthracycline and a taxane, from the China National Medical Products Administration (NMPA). This approval is based on the results of Study 304…Halaven demonstrated a statistically significant extension in the study’s primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine according to independent imaging review (Hazard Ratio: 0.80; 95% Confidence Interval: 0.65-0.98; p = 0.036).”

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Primary completion of P3 KEYNOTE-522 trial (NCT03036488) for TNBC in September 2025 and interim data from the trial in Q4 2019 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 437; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Piqray (alpelisib) / Novartis
Piqray: Regulatory submissions in US for HER2+ breast cancer, TNBC, 2L/3L HNSCC and ovarian cancer in 2023 or later (Novartis) – Jul 18, 2019 – Q2 2019 Results: CHMP opinion in EU for breast cancer in H2 2019   
[Screenshot]

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio clinical trial estimate: Data from P3 monarchE trial (NCT03155997) in HR+/HER2- breast cancer in 2021 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 333; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Kisqali (ribociclib) / Novartis
NICE U-turn for Kisqali in breast cancer (PharmaTimes) – Jul 17, 2019 – “The National Institute of Health and Care Excellence (NICE) has recommended Novartis’ Kisqali (ribociclib) for use on the NHS in combination with fulvestrant, where exemestane plus everolimus is the most appropriate alternative…The recommendation is based on the second line subpopulation of the MONALEESA-3 trial…There will be immediate access to the combination treatment in England through the Cancer Drugs Fund (CDF) and in Wales through the Welsh New Treatment Fund, whilst Novartis await the NICE Technology Appraisal.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology’s licensing partner Knight Therapeutics receives regulatory approval from Health Canada to commercialize Nerlynx (neratinib) for extended adjuvant treatment of hormone receptor positive, HER2-positive early stage breast cancer (Businesswire) – Jul 16, 2019 – “Puma Biotechnology…announced that its licensing partner Knight Therapeutics Inc. (Knight) has received marketing authorization from Health Canada to commercialize NERLYNX® (neratinib) in Canada for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy…Health Canada approval was based on the Phase III ExteNET trial…Treatment with neratinib in the approved Health Canada indication resulted in a 51% reduction in the risk of invasive disease recurrence or death at 2 years versus placebo after patients completed one year of therapy following a trastuzumab-based regimen.”

 

Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, Allergan; Kanjinti (trastuzumab biosimilar) / Amgen, Daiichi Sankyo, Allergan
Amgen and Allergan’s Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) now available in the United States (Amgen Press Release) – Jul 18, 2019 – “Amgen…announced that MVASI (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTI (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), are now available in the United States (U.S.). MVASI…is approved for the treatment of five types of cancer: mCRC, NSCLC, recurrent glioblastoma, metastatic renal cell carcinoma and metastatic cervical cancer. KANJINTI is FDA approved for all approved indications of Herceptin: for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.”

 

Piqray (alpelisib) / Novartis
Novartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increased (Novartis Press Release) – Jul 18, 2019 – “Piqray (alpelisib, formerly BYL719) was approved and launched in the US as the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.”

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Weekly Top News – IBD – July 22, 2019

July 22, 2019

Stelara (ustekinumab) / J&J
Stelara: Regulatory approval in US for ulcerative colitis in 2019 (J&J) – Jul 16, 2019 – Key 2019 Events  
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab clinical trial estimate: First data from P3 trials LUCENT 1 (NCT03518086), LUCENT 2 (NCT03524092) and LUCENT 3 (NCT03519945) for ulcerative colitis in 2021(Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 318; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Stelara (ustekinumab) / J&J
Stelara regulatory estimate: Approval for ulcerative colitis in H2 2019 (Wells Fargo) – Jul 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 67590167; Page no: 6; REPORT TITLE: “Johnson & Johnson – JNJ: 2Q19 preview & US pharma tracker”; AUTHOR: Biegelsen, Lawrence, et al; DATE: 07/07/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi clinical trial estimate: Primary completion of P3 trial (NCT03104413) for Crohn’s disease in June 2020 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 67; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Entyvio SC (vedolizumab SC) / Takeda
Investigational subcutaneous formulation of vedolizumab meets primary endpoint in achieving clinical remission at week 52 in patients with moderately to severely active Crohn’s disease(Businesswire) – Jul 22, 2019 – P3, N=644; VISIBLE 2 (NCT02611817); Sponsor: Takeda; “In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50. Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.”

 

upadacitinib (ABT-494) / AbbVie
Upadacitinib clinical trial estimate: Primary completion of P3 SELECT-GCA trial (NCT03725202) for giant cell arteritis in March 2022 (Cowen & Co) – Jul 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 55; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

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Weekly Top News – Psoriasis – July 22, 2019

July 22, 2019

Cosentyx (secukinumab) / Novartis
Secukinumab Treatment Led to Normalization of Quality of Life and Disease Symptoms in Psoriasis Patients with or without Prior Systemic Psoriasis Therapy: PROSE Study Results (EADV 2019) – Jul 16, 2019 – Abstract #P1632; Pres time: Oct 9, 2019; Location: e-Poster Hall; No abstract available.

 

BMS-986165 / BMS
An oral, selective tyrosine kinase 2 inhibitor, BMS-986165, improves quality of life in psoriasis: results from a Phase 2 study (EADV 2019) – Jul 16, 2019 – Abstract #P1621; Pres time: Oct 9, 2019; Location: e-Poster Hall; No abstract available.

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab clinical trial estimate: First data from P3 trials OASIS-1 (NCT03482011) and OASIS-2 (NCT03535194) for psoriasis in 2021 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 318; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Otezla (apremilast) / Celgene
Efficacy and Safety of Apremilast in Patients With Moderate to Severe Plaque Psoriasis of the Scalp: 32-Week Results From the Phase 3, STYLE Study (EADV 2019) – Jul 16, 2019 – Abstract #P1705; Pres time: Oct 9, 2019; Location: e-Poster Hall; No abstract available.

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Tildrakizumab Efficacy by Metabolic Syndrome Status in Psoriasis: Post Hoc Analysis of 3-Year Data from the Phase 3 reSURFACE 1 Study (EADV 2019) – Jul 16, 2019 – Abstract #P1653; Pres time: Oct 9, 2019; Location: e-Poster Hall; No abstract available.

 

Cosentyx (secukinumab) / Novartis
Cosentyx clinical trial estimate: Primary completion of P3 EXCEED trial (NCT02745080) for psoriatic arthritis in March 2020 and data in late 2019/2020 (Cowen & Co) – Jul 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 524, 587; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019

 

Otezla (apremilast) / Celgene
FDA tentatively OKs Amneal’s generic Otezla (SeekingAlpha) – Jul 19, 2019 – “The FDA tentatively approves Amneal Pharmaceuticals’ (AMRX -3.5%) marketing application for a generic version of Celgene’s (CELG -0.5%) psoriasis med Otezla (apremilast).”

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory submission for nrAxSpA in 2019 (Novartis) – Jul 18, 2019 – Q2 2019 Results: Regulatory submission for psoriatic arthritis in 2020  
[Screenshot]

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Nomad On-the-Go

July 17, 2019

By Linh NguyenAssociate Marketing Manager


Why work remote?

 

There are various reasons as to why an individual would want to be a digital nomad. A lot of people see it as the perfect way to be location independent – the ability to travel the world with little more than a laptop, and an internet connection, all while earning money!
 
The traditional job that requires you to clock in at 9:00am-5:00pm is becoming a thing of the past. The allure of working remote is that it provides not only a benefit to you, but also your employer. Being a digital nomad allows you to be more productive and gives you the freedom to design a work schedule that suits both yourself and your employer.
 
These factors (along with my manager’s guidance) really pushed me to get out of my comfort zone and travel while working online. Prior to this, I was working remote for one and a half years at Larvol in the comfort of my own home. Travel was something I was definitely always interested in, but never something I was able to do for more than 2 weeks at a time. The fact that Larvol allows you to be location independent really pushed me to travel and work. So in February of this year, I bought a one-way ticket to Ho Chi Minh City, Vietnam with the intent of traveling Southeast Asia.
 

 

3-Month Journey

 
Although I got a one-way ticket, I had a rough timeline of the trip I was going to take: Ho Chi Minh City, Chiang Mai and Bali. Since this was going to be more of a test run for me, I knew that I only wanted to spend roughly 3 months working abroad – one month in each country. I didn’t want to move around every 2 weeks and travel to a new city because I really wanted to familiarize myself with the location and develop a routine.
 

Ho Chi Minh City – Vietnam

 
I chose to travel to Vietnam first because it is my motherland. I’ve only been to Vietnam once before when I was 10, so I didn’t get the chance to appreciate everything the country has to offer. Ho Chi Minh City’s low cost of living, delicious food and fast hi-speed internet made it an amazing city to start my digital nomad journey. The only downside would be the lack of a digital nomad community (compared to the other countries I’ve visited), and pollution (public transport is really non-existent and people rely heavily on their motorbikes).
 

 

Chiang Mai – Thailand

 
Next on the itinerary was Chiang Mai, Thailand! I’ve heard so many great things about this city and how it’s supposedly one of the top destinations for digital nomads, so it’s no surprise why I chose Chiang Mai as my next location. The food in Chiang Mai was simply delicious and cheap – you can get street food for as low as $1 a dish. One of the best things about the city is that its immense popularity with expats means there’s a thriving digital nomad community that you can immerse yourself in. With so many location-independent workers, there are plenty of coworking spaces and cafes in Chiang Mai. As far as internet speed goes, Thailand has one of the fastest internet speeds in Southeast Asia, and can be found everywhere!
 

 

Bali – Indonesia

 
Last but not least was Bali, Indonesia (one of my favorite places on this entire journey). Prior to arriving in Bali, it was difficult to decide between Canggu – the chill surf beachtown, and Ubud – the spiritual oasis. Ultimately, I ended up going with Canggu because it’s the #1 hotspot for digital nomads from around the world. The community here is amazing and everywhere you go, you meet friendly expats. Bali is home to the most instagrammable places, whether you’re visiting a coffee shop, waterfall or catching the scenic sunsets. Canggu has some unique cafes perfect to get your work done and also snap that brunch shot for the ‘gram. The downsides to Canggu would be its traffic and spotty wifi connections (I relied heavily on data usage). Other than that, Bali is definitely the number one place I would recommend for a digital nomad!
 

 

Challenges

 
Despite the amazing experience I had working remote in Southeast Asia over the course of 3 months, it wasn’t all rainbows and unicorns. The biggest challenges for myself were juggling different time zones and achieving a suitable work-life balance. Working in Eastern Standard Time had me accustomed to working in the mornings and afternoons, while my evenings were generally free. While I was in Southeast Asia, it was difficult not being in the same time zone as the majority of my colleagues. Therefore, it’s really important to create a routine – the major factor contributing to success when working remote.To juggle time zones, I mainly did my work in the afternoons, evenings and night. Even though it does take some time to adjust, finding a schedule that works best for you actually forces you to work more efficiently. For me, I was able to do all of my “touristy” things in the morning and then start work after. It really allows you to take advantage of time! Surprisingly, I found that I was more focused on my work when I was travelling compared to when I was at home. This was probably because I was motivated to get my work done so I could enjoy the exciting and new environments!
 

Would I travel and work again?

 
Some digital nomads keep on traveling, some slow it down while others stop altogether. For me, working while traveling Southeast Asia was an amazing experience. I was able to immerse myself in different cultures, try local foods I’ve never had the opportunity to taste, and meet wonderful people from all over the world. It really expanded my perspective allowing me to develop a wider world view. So would I do this again? Definitely!
 

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Weekly Top News – Breast Cancer – July 15, 2019

July 15, 2019

Tecentriq (atezolizumab) / Roche
Brazil issues new indication nod for Roche’s Tecentriq in triple-negative breast cancer (GBI Health) – Jul 11, 2019 – “Brazil’s National Health Surveillance Agency (ANVISA) recently issued a new indication approval for Swiss major Roche’s programmed death-ligand 1 (PD-L1) immunotherapy Tecentriq (atezolizumab). The approved indication is for use in triple-negative breast cancer (TNBC), and adds to earlier approvals for urothelial carcinoma (UC) and non-small cell lung cancer (NSCLC) issued in October 2017, as reported by GBI.”

 

Ibrance (palbociclib) / Pfizer
New treatment approved for patients with breast cancer in Scotland (The Scotsman) – Jul 8, 2019 – “A new drug for patients with advanced breast cancer has been approved for use by the NHS in Scotland. The Scottish Medicines Consortium (SMC) said palbociclib (Ibrance) can increase the time before the condition progresses and delay the need for chemotherapy.”

 

Ibrance (palbociclib) / Pfizer
Ibrance pricing: Wholesale acquisition cost of $11,856.54/package (Cantor Fitzgerald) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67546938; Page no: 83; REPORT TITLE: “Don’t hibernate this summer; Take the good with the bad into 2H19”; AUTHOR: Research Department; DATE: 06/27/2019

 

Halaven (eribulin mesylate) / Eisai
Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer (clinicaltrials.gov) – Jul 8, 2019 – P2; N=118; Completed; Sponsor: Asan Medical Center; Active, not recruiting –> Completed; Trial completion date: Dec 2019 –> Jun 2019

 

Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: $3-12B (analyst projection: $5B) peak (Trefis) – Jul 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67553223; Page no: 5; REPORT TITLE: “Roche Holding Ltd- Trefis report: Roche Holdings – $37.70 Trefis price estimate”; AUTHOR: Research Department, et al; DATE: 06/30/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda sales projection: $10B+ peak (Trefis) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67553248; Page no: 9; REPORT TITLE: “Merck & Co., Inc. Trefis report: Merck – $88.45 Trefis price estimate”; AUTHOR: Research Department; DATE: 07/01/2019

 

Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: >$2B by 2021 (Trefis) – Jul 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67545638; Page no: 2; REPORT TITLE: “Roche Holding Ltd- Can Roche’s #1 therapeutic area with $28 billion in revenue grow further?”; AUTHOR: Research Department, et al; DATE: 06/27/2019

 

Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi WW sales projection: $3.7B+ (consensus: $3.8B) in 2024 (Guggenheim) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67545132; Page no: 1; REPORT TITLE: “AZN.LN – Imfinzi sailing into new waters with positive CASPIAN results”; AUTHOR: Fernandez, Seamus, et al; DATE: 06/27/2019

 

Piqray (alpelisib) / Novartis
NCCN updates clinical practice guideline for breast cancer (Journal of Clinical Pathways) – Jul 9, 2019 – “The National Comprehensive Cancer Network (NCCN) updated their Clinical Practice Guideline for the treatment of breast cancer. In the workup for recurrent stage IV (M1) disease, an option was added to assess for PIK3CA mutation with tumor or liquid biopsy if the tumor is HR-positive and HER2-negative and if considering therapy with alpelisib…In the section for systemic therapy for ER-negative and/or PR-positive recurrent or stage IV (M1) disease, fulvestrant plus alpelisib was added as a category 1 option for PIK3CA-mutated tumors.”

 

Kisqali (ribociclib) / Novartis
An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.(clinicaltrials.gov) – Jul 8, 2019 – P1/2; N=26; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Recruiting –> Active, not recruiting; N=86 –> 26

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Weekly Top News – IBD – July 15, 2019

July 15, 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 9, 2019 – P3; N=372; Sponsor: Arena Pharmaceuticals Inc.

 

filgotinib (GLPG0634) / Gilead
Filgotinib US launch estimate: 2022+ for moderate-to-severe IBD (Credit Suisse) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67561676; Page no: 9; REPORT TITLE: “First edition – US alert: Tuesday, July 2, 2019”; AUTHOR: Product Marketing, Credit Suisse G, et al; DATE: 07/02/19

 

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

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J; Tremfya (guselkumab) / J&J
Celsius Therapeutics signs collaboration agreement with Janssen to identify response biomarkers for ulcerative colitis (Businesswire) – Jul 9, 2019 – “Celsius Therapeutics…announced a collaboration with Janssen Biotech, Inc. Under the terms of the agreement, Celsius will apply its proprietary single-cell genomics and machine learning platform to identify predictive biomarkers of response from Janssen’s VEGA study, a Phase 2a clinical trial evaluating the efficacy and safety of combination therapy with guselkumab and golimumab in patients with ulcerative colitis.”

 

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $1.7B peak (Wells Fargo) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67559640; Page no: 1; REPORT TITLE: “Gilead Sciences Inc- GILD: Path forward for Filgotinib in RA”; AUTHOR: Research Department; DATE: 07/01/2019

 

Otezla (apremilast) / Celgene
Otezla patent expiry: Between 2023-2034 and 2023 for drug substance patent (Guggenheim) – Jul 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67532791; Page no: 2; 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

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz sales projection: $3B peak (Trefis) – Jul 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67553289; Page no: 16; REPORT TITLE: “Pfizer Inc. Trefis Report: Pfizer – $51.64 Trefis price estimate”; AUTHOR: Research Department; DATE: 07/01/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib WW sales projection: $6B ($3B in rheumatoid arthritis, $600M for Crohn’s disease, $400M for ulcerative colitis) peak (Jefferies) – Jul 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67561267; Page no: 1; REPORT TITLE: “Galapagos NV- Ball’s in FDA’s court with US Filgotinib filing now confirmed for 2019”; AUTHOR: Welford, Peter, et al; DATE: 07/02/19

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Weekly Top News – Psoriasis – July 15, 2019

July 15, 2019

Humira (adalimumab) / Eisai, AbbVie; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Comparing patient populations of the risankizumabphase III clinical trial programme to the U.K.general population: results from a British Association of Dermatologists Biologics and Immunomodulators Register analysis (BAD 2019) – Jul 11, 2019 – Abstract #P069; “The BADBIR cohort included 5657 patients aged ≥ 18 years, enrolled during 2007 to September 2017, receiving adalimumab for the first time, and from the U.K. and Republic of Ireland. AbbVie participated in the interpretation of data and review and approval of the publication. No authors were paid for writing this publication.”

 

mirikizumab (LY3074828) / Eli Lilly
Efficacy and safety of mirikizumab ( LY 3074828) in the treatment of moderate-to-severe plaque psoriasis: results from a randomized phase II study (BAD 2019) – Jul 11, 2019 – Abstract #88; No abstract available.

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NICE recommends funding for psoriasis and type 1 diabetes drugs (pharmaphorum) – Jul 12, 2019 – “Patients in England and Wales should soon be able to access AbbVie’s psoriasis drug Skyrizi after NICE recommended regular NHS funding….NICE reviewed Skyrizi (risankizumab) and made its recommendation meaning that NHS commissioners are committed to funding within 30 days of final guidance due at the end of August.”

 

Stelara (ustekinumab) / J&J
Retinal toxoplasmosis in psoriasis treated with ustekinumab: a case study (BAD 2019) – Jul 11, 2019 – Abstract #BI29; Pres time: Jul 2, 2019; 08:45 AM – 12:15 PM; Location: Hall 1B; “This has not yet been reported in the literature, and leads to the devastating outcome of permanent loss of vision, despite complete treatment with pyrimethamine, azithromycin, folinic acid and topical therapies. In conclusion, changing our practice depends on ongoing close surveillance of the side-effect profile of this drug to establish the risk better. Without awareness that presentations such as toxoplasma retinitis may be related to therapies such as ustekinumab, there may be under-reporting of these to the Medicines and Healthcare products Regulatory Agency, which will limit our ability to provide any evidence-based guidance.”

 

Stelara (ustekinumab) / J&J; Humira (adalimumab) / Eisai, AbbVie
Phenotypic switch from psoriasis to eczema onanti-interleukin-17 therapy: a case series (BAD 2019) – Jul 11, 2019 – Abstract #P038; “A woman in her late 20s presented with severe psoriasis vulgaris, who had failed to respond adequately to phototherapy, methotrexate, adalimumab and ustekinumab. We hypothesize that inhibition of the axis by secukinumab may be responsible for a shift towards the opposing Th2 cell axis, subsequent barrier disruption and eczema development. Ongoing postmarketing pharmacovigilance is important and further investigation is required to establish a causal link and understand the pathogenesis.”

 

Stelara (ustekinumab) / J&J; BMS-986165 / BMS
Efficacy and Safety of BMS-986165 Compared with Placebo in Subjects with Active Psoriatic Arthritis (PsA) A BMS-986165 placebóhoz viszonyított hatásossága és biztonságossága aktív artritisz pszoriatikában (PsA) szenvedő betegeknél (clinicaltrialsregister.eu) – Jul 9, 2019 – P2; N=180; Ongoing; Sponsor: Bristol-Myers Squibb International Corporation

 

Otezla (apremilast) / Celgene
Otezla patent expiry: Between 2023-2034 and 2023 for drug substance patent (Guggenheim) – Jul 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67532791; Page no: 2; 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

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ASCO 2019, Chicago, IL

July 9, 2019

by Sam Szentmiklosy, Digital Media Specialist

 


 

The American Society of Clinical Oncology (ASCO) Annual Meeting took place from May 31 – June 4, 2019 in Chicago, IL. “Great turnout at ASCO 2019! It was great connecting with our clients.“, said Larvol Senior Account Manager, Saera Jean. 1http://linkedin.com/in/saerajean

 

 

 

People from many walks of life attend the ASCO Annual Meeting every year. Though we do not have access to this year’s demographics at this time, we can still take a look at the demographics from 2018 as an example. In 2018, there was a total of 415 attendees. 275 of which were professionals and 113 were exhibitors. Of the 415, 98% were from the US while 2% were International guests. The top countries in attendance are the US and Canada. Guests’ primary professional roles range from medical oncologists, physicians, medical science liaisons, pharmacists, and more. 2https://meetings.asco.org/am/previous-meeting-demographics

 

 

 

Connecting with our clients is always a pleasure and these conferences give us the opportunity to say hello and touch base. We are always looking to attend conferences. Follow us on Twitter to stay up to date on our upcoming events or visit our website.

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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

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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  
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