PharmaShots' Key Highlights of Third Quarter 2022
- The third quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include CVS Health acquired Signify Health for ~$8B, Amgen acquired Chemocentryx for ~$4B
- The third quarter of the year also showcases multiple approvals of the therapies which include Incyte's Opzelura US FDA's approval for Vitiligo, Daiichi Sankyo, and AstraZeneca’s Enhertu US FDA’s approval for HER2 mutant metastatic non-small cell lung cancer
- Our team at PharmaShots has summarized and complied with the insights of Q3'22
NeuroSense Collaborated with NeuraLight to Advance ALS Oculometric Biomarkers Using AI and ML
Date- July 29, 2022
Product- N/A
- The companies collaborated to advance digital biomarkers for the detection & monitoring of neurological diseases incl. ALS
- NeuraLight's platform uses computer vision, AI, deep learning algorithms & ML to identify oculometric digital biomarkers to transform clinical development, diagnostics & precision medicine in neurology. The collaboration entails sharing & tracking patient data to advance the use of ALS digital biomarkers in a parallel study
- NeuroSense is conducting a P-IIb (PARADIGM) trial to evaluate the efficacy of NeuroSense's PrimeC for ALS. The effectiveness of NeuraLight's system will be validated by assuring objectivity, reliability & repeatability in trials as well as reducing costs and friction
NewAmsterdam Pharma to Go Public via FLAC SPAC Merger for ~$326M
Date- July 26, 2022
Product- N/A
- NewAmsterdam has entered into a definitive business combination agreement with FLAC at a pro forma cash balance of $470M with a total enterprise value of $326M while NewAmsterdam will receive ~$235M from upsized PIPE at $10.00/ share & funds held in FLAC’s trust account. The transaction is expected to close in H2'22 & will fund NewAmsterdam until 2026, allowing it to launch a product
- NewAmsterdam & FLAC shareholders and PIPE investors will hold ordinary shares in a newly formed NewAmsterdam company which is expected to list its ordinary shares on Nasdaq under the ticker symbol “NAMS”
- NewAmsterdam’s obicetrapib showed a promising safety & >50% LDL-lowering efficacy on top of high-intensity statins for dyslipidemia through a P-IIb trial for CV disease
Incyte's Opzelura (ruxolitinib) Receives the US FDA's Approval for the Treatment of Vitiligo
Date- July 19, 2022
Product- Opzelura
- The approval was based on the P-III (TRuE-V1 & V2) trial evaluating the safety and efficacy of Opzelura vs vehicle in 600+ patients aged ≥12yrs. with nonsegmental vitiligo
- The results showed a significant improvement in VASI scores representing improvements in facial and total body repigmentation @24 & 52wk. The results were consistent across both studies @24wk., ~30% vs 8% and 13% in (TRuE-V1 & V2) trial & ≥15% vs 2% of patients achieved ≥75% & ≥90% improvement from baseline in F-VASI75 & F-VASI90 @24wk.; ~50% & ~30% @52wk.
- The company also launched a patient support program i.e., IncyteCARES that provide access to eligible patients to use Opzelura & also offers financial assistance, ongoing education, and resources
Polpharma Biologics Report EMA's Acceptance of MAA for Biosimilar Natalizumab, a Proposed Biosimilar to Tysabr for Relapsing-Remitting Multiple Sclerosis
Date- July 15, 2022
Product- biosimilar natalizumab
- The EMA has accepted the MAA for biosimilar natalizumab, a proposed biosimilar to Tysabr for highly active RRMS. Biosimilar natalizumab was developed by scientists at Polpharma Biologics
- The MAA submission was based on analytical, preclinical & clinical data incl. P-III (Antelope) study to evaluate biosimilar natalizumab in patients with RRMS. The P-III (Antelope) & P- I trial met their 1EPs & shown that the effectiveness and safety of the biosimilar matched those of the reference drug
- Under the 2019 agreement with Sandoz, Polpharma will be responsible for the manufacturing & supply of the product while Sandoz gets the rights to commercialize & distribute the proposed biosimilar
Royalty Pharma to Acquire Royalty Rights from Theravance and Innoviva for ~$1.5B
Date- July 15, 2022
Product- N/A
- Theravance to receive ~$1.5B (based on the disclosed value of Theravance) incl. ~$1.1B up front & ~$250M in sales-based milestones and ~$200M in NPV of Trelegy Ellipta’s rights along with 85% of the Trelegy royalties for Ex-US net sales after Jul 2029 & 85% in the US after Jan 1, 2031. The transaction is expected to close within 10 business days
- Theravance also receives $25M up front & $15M in regulatory milestones for the clinical development of ampreloxetine for symptomatic nOH in MSA patients. In return, Royalty Pharma to receive 2.5% & 4.5% royalties on net sales of ~$500M & over $500M, respectively
- The acquisition will diversify RPRX's portfolio with the addition of GSK's Trelegy Ellipta & add $200M to non-GAAP in 2025. Theravance plans to initiate the P-III trial of ampreloxetine in early 2023 & share additional details in 2022
Date- Date- July 14, 2022
Product- Dupixent
- The P-III trial evaluates Dupixent (high/low dose) vs PBO in 102 children aged 1 to 11yrs. with EoE
- The trial met its 1EPs of histological disease remission @16wks., 68% & 58% of children in a high & low dose. In high dose, 86% vs 21% reduction in peak esophageal intraepithelial eosinophil count from baseline; 0.88 & 0.84 vs 0.02 & 0.05 in disease severity & extent; 3.5 vs 0.3 point in abnormal endoscopic, improvement in the proportion of days & children experienced symptoms of EoE but not statistically significant
- The lower dose group's 2EPs were equivalent to the higher dose. The safety results were consistent with the safety profile of Dupixent in children & adults aged ≥12yrs., AEs (79% vs 91%) & treatment discontinuation due to AEs (0% vs 6%) @16wk.
Labcorp Launched Neurofilament Light Chain Blood Test to Identify Neurodegenerative Disease
Date- Date- July 13, 2022
Product- N/A
- The company launched the new NfL blood test that allows doctors to identify and verify signs of neurodegenerative disease along with diagnosing and treating patients more quickly & effectively
- The test measures key biomarkers associated with neuronal damage; assists in the diagnosis of diseases incl. MS, AD Parkinson’s, or brain injury. It is anticipated that having a wide range of diagnostic tools available to doctors will have a positive impact on the ability to diagnose & treat numerous conditions more successfully
- The test's launch and availability showed Labcorp's dedication to neurology and to enhancing the health and lives of people suffering from neurodegenerative and related disorders
Medtronic to Acquire CathWorks for ~$585M and Entered into a Co-Promotion for FFRangio System
Date- Date- July 13, 2022
Product- N/A
- Medtronic will invest ~$75M in CathWorks & begin marketing CathWork’s FFRangio catheter system in the US, EU & Japan. The collaboration highlights Medtronic's dedication to providing new, innovative technologies and solutions from diagnosis to treatment
- Under the separate agreement, Medtronic gets an option to acquire CathWorks if undisclosed milestones are met. CathWorks get the rights to compel Medtronic to acquire the company, if Medtronic does not exercise the option which expires in July 2027 with an estimated value of $585M & earn-out payments post-acquisition
- FFRangio system provides diagnostic & physiologic inf. through AI to disrupt traditional FFR & revolutionize the management of CAD. The system showed diagnostic accuracy (93%), sensitivity (91%) & specificity (94%)
EarlySign Collaborated with Roche to Develop AI Solution for Early Detection of Lung Cancer
Date- July 8, 2022
Product- N/A
- The companies collaborated to enable innovative, evidence-based solutions & provide validated clinical machine learning models to identify lung cancer leading to earlier diagnosis & treatment
- The agreement is based on the 2021 agreement b/w Roche & EarlySign which originally focused on a personalized health solution for early detection of gastric cancer
- EarlySign's LungFlag, a highly accurate model is intended to assist providers in concentrating additional effort on enriched sub-populations & determining care pathways so that follow-up screenings can be more precisely prescribed in a cost-effective manner
AstraZeneca to Acquire TeneoTwo for ~$1.27B
Date- July 6, 2022
Product- TNB-486
- AstraZeneca to acquire all outstanding equity of TeneoTwo in exchange for $100M up front. TeneoTwo’s equity holders will receive ~$805M in R&D-related milestones, and ~$360M in commercial-related milestones. The transaction is expected to close in Q3’22
- The acquisition will advance the development of TNB-486 (bispecific CD19 & CD3 T-cell engager, currently in P-I study) for B-cell hematologic malignancies. TNB-486 broadens AstraZeneca's hematology pipeline & includes multiple therapy modalities & mechanisms to target blood cancer that builds on the success of Calquence
- TNB-486 as monothx. or in combination with CD20-targeted therapy can deepen clinical responses & enhance patient outcomes by refocusing the body's natural immune response to target B-cell malignancies
Date- July 6, 2022
Product- Imfinzi
- The P-III (HIMALAYA) trial evaluates Imfinzi (1500mg, q4w) + tremelimumab (300mg) vs sorafenib in 1324 patients with HCC regardless of baseline liver functional reserve. The P-III (TOPAZ-1) trial evaluates Imfinzi + CT vs PBO + CT in 685 patients with unresectable advanced or m-BTC irrespective of primary tumor location
- The exploratory subgroup analysis showed consistent OS benefits in both trials. In (HIMALAYA) trial, ORR, DoR & tolerability profiles for STRIDE were consistent regardless of ALBI score & liver function was stable over time & the outcomes illustrate the effects of treatment discontinuation & QoL benefits for maintaining patients on treatment with the STRIDE regimen
- In (TOPAZ-1) trial, the incidence of grade 3 or 4 AEs & TRAEs were comparable b/w treatment groups
Date- July 6, 2022
Product- Ayvakit, Ayvakyt & Gavreto
- The collaboration stated that the financings help to advance innovative precision therapy pipeline through internal R&D & strategic business development along with the launch of Ayvakit/Ayvakyt & Gavreto
- Blueprint will receive $250M up front from Sixth Street for future royalties from Ayvakit & BLU-263 at a rate of 9.75% with an annual cap of $900M in net sales & cumulative cap of 1.45 times the invested capital; $150M of a $400M senior secured credit facility will be drawn by Blueprint initially with the remaining $250M in delayed draw tranches at Blueprint's election; $260M credit facility for buy-side business development opportunities
- Royalty pharma has acquired an Ex-US royalty on Roche's sales of Gavreto (Ex- greater China) & Blueprint to receive $575M incl. $175M up front & $165M in milestones on future sales. Gavreto has been submitted for marketing approval for thyroid cancers in the EU with an expected decision in H2’22
PathAI Extends its Multi-Year Collaboration with BMS to Develop Therapies Using AI
Date- Aug 26, 2022
Product- N/A
- The companies focus to expand the use of AI for the development of therapies through translational research, clinical trials & diagnostic across the areas of oncology, fibrosis, and immunology
- The companies also use AI pathology models to advance patient segmentation in clinical trials across multiple disease indications & will also develop AI-powered diagnostics measuring CD8 T-cell infiltration across oncology disease areas
- The extended collaboration was based on the 2016 collaboration & has recently presented the results in the Journal of Modern Pathology that compares the use of AI-powered algorithms against manual IHC scoring PD-L1 expression related to outcomes across multiple cancer types in multiple trials
Abbott's New Spinal Cord Stimulation Device Receives the US FDA’s Approval for Chronic Pain
Date- Aug 23, 2022
Product- N/A
- The US FDA has approved Abbott's Proclaim Plus SCS system to deliver FlexBurst360 therapy & superior pain relief along with adding more treatment options for evolving pain conditions
- Abbot's FlexBurst360 therapy & Burst DR stimulation that works by mimicking natural patterns in the brain, provides pain relief in ~6 different locations of the trunk or limbs, allowing programming that may be changed as a person's therapeutic needs
- Proclaim Plus has a recharge-free battery lasting up to 10yrs. and can be used with the NeuroSphere virtual clinic which facilitates secure in-app video chat with a physician, ensure proper functionality & remote adjustments to their therapeutic settings as needed
Date- Aug 22, 2022
Product- Sparsentan
- The EMA has accepted the CMA application for sparsentan’s review to treat IgAN. The EMA’s decision is expected on H2’23
- The EMA submission was based on an ongoing P-III (PROTECT) study to evaluate sparsentan vs irbesartan in 404 patients aged 18yrs. with IgAN along with additional clinical studies. The (PROTECT) study met its pre-specified interim primary efficacy EPs i.e., patients achieved a mean reduction in proteinuria from baseline (49.8% vs 15.1%) @36wks. & the therapy was well-tolerated & consistent with its overall observed safety profile, based on the preliminary results
- The results from the confirmatory EPs analysis are expected in H2’23. If sparsentan is approved, it will be the first treatment for patients with IgAN in the EU
Date- Aug 18, 2022
Product- Tavneos
- NICE has recommended Tavneos for sev., active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA) in combination with a rituximab or cyclophosphamide regimen in England, Wales & Northern Ireland
- The recommendation was based on P-III (ADVOCATE) trial to evaluate Tavneos (30mg, BID) vs prednisolone in 331 patients with ANCA-associated vasculitis (GPA/MPA) across 20 countries. Tavneos is expected to be available in the UK in the next week
- The study met its 1EPs of disease remission @26wk., sustained remission @26 & 52wk. & not using glucocorticoids within 4wks. before 52wk. The therapy also showed non-inferiority in terms of remission @26wks., and superiority in sustained remission @52wks., SAEs (37.3% vs 39%)
Date- Aug 17, 2022
Product- Amcenestrant
- The company discontinued the P-III (AMEERA-5) trial evaluating the efficacy and safety of amcenestrant + palbociclib vs letrozole + palbociclib in a ratio (1:1) in 1068 patients with ER+/HER2- advanced breast cancer
- The decision was based on the prespecified interim analysis which showed that P-III (AMEERA-5) trial failed to meet the prespecified boundary over the control arm while no new safety signals were observed
- The company will continue to review the data and intends to eventually inform the scientific community of its findings. All additional amcenestrant studies will discontinue, incl. the (AMEERA-6) study in early-stage breast cancer
Date- Aug 17, 2022
Product- JMKX002992
- Jemincare to receive $60M up front & is also eligible to receive ~$590M in additional fees upon achievement of development, regulatory and sales-based milestones along with royalties on net sales. The collaboration focuses to develop new treatment options for patients with advanced prostate cancer
- Jemincare to get an exclusive license to develop and commercialize JMKX002992 globally Genentech will be fully responsible for the development and commercialization costs
- JMKX002992 is a novel oral degrader of the androgen receptor & is indicated to treat patients with prostate cancer who have developed resistance to current therapies
Date- Aug 12, 2022
Product- Enhertu
- The approval was based on the results from the P-II (DESTINY-Lung02) trial evaluating the safety & efficacy of Enhertu (5.4mg/kg & 6.4mg/kg) in patients (n=101) with HER2 mutant mNSCLC. The US FDA has also approved companion diagnostic tests to detect HER2 mutation in lung tumor tissue & plasma
- The results demonstrated an ORR of 57.7% in patients who previously received a systemic therapy as assessed by BICR along with a CR of 1.9%, PR of 55.8% & a mDoR of 8.7mos.
- Enhertu is a HER2-directed ADC developed using Daiichi Sankyo’s proprietary DXd ADC technology. Daiichi Sankyo & AstraZeneca will ensure access to medication and necessary financial support to the US patients who are prescribed Enhertu
Amgen to Acquire Chemocentryx for ~$4B
Date- Aug 12, 2022
Product- N/A
- Amgen will acquire ChemoCentryx for $52/share in cash at a total enterprise value of ~$3.7B representing a premium of ~116% to the last close date. The transaction is expected to close in Q4’22
- The acquisition will enable Amgen to add its decades-long leadership in inflammation & nephrology with Tavneos which focused on developing treatments for autoimmune diseases, inflammatory disorders & cancer. ChemoCentryx has 3 early-stage drug products targeting chemoattractant receptors in other inflammatory diseases & oral checkpoint inhibitor for cancer
- Tavneos was approved in the US for sev. active ANCA-associated vasculitis in combination with standard therapy & was also approved outside of the US incl. the EU & Japan. Amgen’s portfolio includes Otezla, Enbrel, Tezspire, Amgevita, Riabni & Avsola
Date- Aug 3, 2022
Product- Keytruda
- The P-III (LEAP-002) trial evaluating Keytruda + Lenvima vs Lenvima monothx. in a ratio (1:1) in 794 patients with uHCC
- The trial failed to meet its dual 1EPs of OS & PFS in patients with uHCC, trends toward improvement in OS & PFS but these results did not meet statistical significance per the pre-specified statistical plan, m-OS of the Lenvima monothx. was longer than that observed in prior reported clinical trials. The safety profile of Keytruda + Lenvima was consistent with prior reported data on the combination
- The results are expected to be presented at an upcoming medical conference. Keytruda is currently approved as monothx. in the US, EU, China, Japan & other countries globally for the same indication
Date- Aug 2, 2022
Product- Stelara
- The approval was based on the PK data from the P-III (PSTELLAR/CADMUS/CADMUS Jr) trial in adult & pediatric patients with plaque PsO & (PSUMMIT I & II) trial in adult patients with active PsA for Stelara
- The results showed that ustekinumab's PK exposure in pediatric PsO patients with active PsA was consistent with P-III trials in pediatric PsO patients without active PsA along with adult patients with PsO or with active PsA. The pediatric PsO patients with active PsA had similar data on similar effectiveness EPs
- The company launched STELARA withMe support program that offers access to patients to use Stelara & provides information on insurance coverage, out-of-pocket costs, treatment support & identifies options for affordable treatment for patients
Date- Sept 26, 2022
Product- Stelara
- The EC has approved Ultomiris as an add-on to standard therapy for gMG in adult patients who are AChR Ab+
- The EC’s decision was based on the P-III (CHAMPION-MG) trial evaluating Ultomiris in a ratio (1:1) in 175 adult patients with gMG across North America, EU, Asia-Pacific & Japan for 26wks. The results showed that the therapy was superior to PBO in the 1EPs of change from baseline in MG-ADL total score @26wk. clinical benefits were seen @60wks. in prolonged follow-up results from OLE
- Reduction in treatment burden with dosing q8w & the results were published in NEJM Evidence, improvement in daily activities in patients with milder symptoms. The safety profiles were consistent with P-III trials in PNH & aHUS
Merck Animal Health Signed a Definitive Agreement to Acquire Vence
Date- Sept 23, 2022
Product- N/A
- Merck Animal Health to acquire Vence from its founders and shareholders & the transaction is expected to be completed in Q3’22
- Vence provides virtual fencing technology for rotational grazing and livestock management. The technology also allows the cattle producers and ranchers to manage natural resources more effectively
- The acquisition will broaden Merck Animal Health’s portfolio of veterinary pharmaceuticals, vaccines, and animal intelligence solutions to advance animal health and well-being along with customers’ outcomes. Additionally, the technology is currently available in the US and parts of Australia
Carisma Therapeutic to Go Public through Reverse Merger with Sesen Bio for CAR-M Therapies
Date- Sept 22, 2022
Product- N/A
- The combined company will have ~$180M in cash, cash equivalents & marketable securities, and $30M from concurrent financing by Carisma to fund the research pipeline through 2024. The merger is expected to close in the next 3 to 4 months
- The companies will use engineered macrophages & monocytes to advance Carisma's cell therapy platform in cancer & other serious disorders. Sesen Bio stockholders will own ~41.7% of the combined company while Carisma stockholders will own ~58.3%
- The combined company will operate under the name Carisma Therapeutics Inc. and will list on Nasdaq under the ticker symbol, CARM. Carisma is also working to expand its oncology pipeline through the collaboration with Moderna for in vivo CAR-M therapies for ~12 targets
AmerisourceBergen to Acquire PharmaLex for ~$1.30B
Date- Sept 13, 2022
Product- N/A
- AmerisourceBergen to acquire PharmaLex for ~$1.30B in cash using funds advised by AUCTUS capital partners. The transaction is expected to close in March 2023
- The acquisition will accelerate AmerisourceBergen’s global biopharma services platform to support manufacturer partners across pharmaceutical development & commercialization. PharmaLex provides biopharma companies strategic guidance & regulatory support, incl. consulting during clinical development & marketing authorization
- AmerisourceBergen has a presence in the EU for pharmaceutical distribution and manufacturer services for biopharma products while AmerisourceBergen's imperatives will be advanced & will strengthen the company's position in the biopharma market
Date- Sept 7, 2022
Product- Fasenra
- The (XALOC) RWE program consists of (XALOC-1 & 2) study evaluating Fasenra in 750+ & 400+ patients along with the (ImPROve Asthma) study in Germany with SEA
- The (XALOC-1) study results showed an AAER reduction of 84% @48wk. over baseline in an overall patient population, reduction in AAER of 79–91% across patient subgroups regardless of atopic status, CRSwNP comorbidity, maintenance OCS use, FeNO & blood eosinophil cut-offs, improvements in asthma control
- The (ImPROve Asthma) study, part of the (XALOC-2) study showed improvements across PROs measures in the total SEA cohort & CRSwNP, 35% achieved clinical remission @6mos. in a real-world setting & 44% with SEA & comorbid CRSwNP, and no decrease of forced expiratory volume in FEV1 ≥200 mL vs baseline
CVS Health to Acquire Signify Health for ~$8B
Date- Sept 6, 2022
Product- N/A
- Under the agreement, CVS Health will acquire Signify Health’s stock for $30.50 per share in cash for a total transaction value of ~$8B which is expected to be closed in the H1’23
- Private equity funds affiliated with New Mountain Capital own ~60% of Signify Health’s common stock, and have agreed to vote the shares they own in favor of the transaction
- As part of CVS Health, Signify Health will help providers transition to value-based reimbursement and improve the quality of care through continue the advancement of its extensive primary care enablement capabilities incl. turnkey analytics, network, and practice improvement solutions
Novo Nordisk to Acquire Forma Therapeutics for ~$1.1B
Date- Sept 2, 2022
Product- N/A
- Novo Nordisk to acquire all outstanding shares of Forma Therapeutics’ common stock at $20/share in cash representing a total equity value of $1.1B and a premium of 92% to Forma Therapeutics’ volume-weighted avg. price/share over the past 30 days. The acquisition is expected to close in Q4’22
- The acquisition will strengthen Novo Nordisk’s strategy to advance the scientific presence and pipeline in haemoglobinopathies with the addition of etavopivat for patients with SCD and rare blood disorders
- Etavopivat is a selective PKR activator & is currently being studied in the P-II/III trial for SCD, and P-II trial for transfusion-dependent SCD and other inherited haemoglobinopathy insights to optimize patient outcomes
Date- Sept 1, 2022
Product- MiniMed 780G System
- The (ADAPT) study evaluating MiniMed 780G system vs SoC (MDI + CGM) in patients with T1D
- The study showed an improvement in glycemic targets who transit to MiniMed 780G system with a sustained HbA1C reduction (1.4%) @6mos. & 27.6% absolute increase in time in range over SoC without increase in time in hypoglycemia, 27.8% use MiniMed 780G system achieved an HbA1c ≤7% while none of the patients who continued taking MDI + isCGM got the intended outcome
- Patients experienced an increase in treatment satisfaction, and reduction in fear of hypoglycemia & had improvement across all glycemic metrics when transitioned to MiniMed 780G system. The system is available in ~60 countries globally and is currently under the US FDA’s review
Related Post: PharmaShots' Key Highlights of Second Quarter 2022
Tags
NeuroSense
NeuraLight
NewAmsterdam Pharma
Incyte
Polpharma Biologics
Royalty Pharma
Theravance
Innoviva
Regeneron
Sanofi
Labcorp
Medtronic
CathWorks
EarlySign
Roche
AstraZeneca
TeneoTwo
Blueprint Medicines
PathAI
BMS
Abbott
CSL Vifor
Travere
Genentech
Merck
Eisai
Daiichi Sankyo
Amgen
Chemocentryx
Janssen
Merck Animal Health
Carisma Therapeutic
AmerisourceBergen
PharmaLex
CVS Health
Novo Nordisk
Forma Therapeutics
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
