PharmaShots' Key Highlights of First Quarter 2022
- The first quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include Biocon acquired Viatris’ biosimilars assets for ~$3.335B, Stryker signed a definitive agreement to acquire Vocera Communications for ~$3.09B, Biohaven acquire Channel Biosciences for ~$3B
- The first quarter of the year also showcases regulatory events which includes AbbVie’s Rinvoq (upadacitinib) US FDA’s approval for AD, Amgen’s Lumykras (sotorasib) NICE recommendation for NSCLC
- Our team at PharmaShots has summarized and complied with the insights of Q1'22
Date: Jan 31, 2022
Product- Byooviz (biosimilar, ranibizumab)
- Biogen is eligible to receive ~ $2.3B for its stake in the joint venture which includes $1B in cash at closing, $812.5M at 1st anniversary & $437.5M at 2nd anniversary of the transaction close & is also eligible to receive $50M upon achievement of commercial milestones
- Biogen will also obtain commercial rights for Byooviz (biosimilar, ranibizumab) along with SB15 (aflibercept), a proposed biosimilar referencing Eylea
- Additionally, both companies have built the industry-leading anti-TNF portfolio in the EU including marketed products Benepali (biosimilar, etanercept), Imraldi (biosimilar, adalimumab), and Flixabi (biosimilar, infliximab)
Date: Jan 27, 2022
Product- Magrolimab + Azacitidine
- The US FDA has issued a partial clinical hold in 5 clinical P-Ib, P-II & III (ENHANCE 1/2/3) studies evaluating the combination of magrolimab + azacitidine due to an apparent imbalance in investigator-reported SUSARs b/w study arms
- Additionally, no clear trend in the adverse reactions or new safety signal was observed while enrolled patients will continue to receive magrolimab, azacitidine, or PBO and closely monitored based on the current study protocol
- The company is working closely with regulatory authorities to determine the next steps to resolve the partial clinical hold for new patient enrollment for the affected studies
Eleusis Going Public via Silver Spike SPAC Merger for ~$446M
Date: Jan 21, 2022
Product- ELE-Psilo
- Eleusis signs a SPAC merger with Silver Spike for an enterprise value of ~$446M, $287.5M in gross proceeds from SPKB’s trust account, Eleusis shareholders & other investors will receive ~14% as an enterprise value of the combined company. The transaction is expected to close in Q2 or Q3’22
- Eleusis’s ELE-Psilo is a psilocybin-based drug, formulated for IV infusion to treat depression & is expected to enter the P-I trial in 2022. Eleusis will secure funds to expand its psychedelic drug therapy globally through its Andala subsidiary
- The current owners of Eleusis will obtain ~49% ownership of the combined company. The new company will trade on NASDAQ under the ticker “ELEU”
UCB Signs a Definitive Agreement to Acquire Zogenix for ~$1.9B
Date: Jan 19, 2022
Product- Fintepla
- UCB will acquire all outstanding shares of Zogenix for $26.00/share in cash & milestone-based CVR of $2.00/share upon achievement of EU approval of Fintepla for LGS by Dec 31, 2023 making a total value of $1.9B representing a premium of 72% to avg. closing stock price of Zogenix. The transaction is expected to close at the end of Q2’22
- The acquisition will expands & builds upon UCB's role & adds Fintepla to UCB's existing product line to addres unmet needs of people living with specific or rare forms of epilepsy
- Fintepla has been approved in the US & EU and is under regulatory review in Japan for the treatment of seizures associated with Dravet syndrome in patients aged ≥2yrs.
Date: Jan 19, 2022
Product- Keytruda (pembrolizumab)
- The P-III (KEYNOTE-394) trial evaluates Keytruda (IV, q3w, for 35 cycles) +BSC vs PBO + BSC in 453 patients in Asia with advanced HCC prior treated with sorafenib or oxaliplatin-based CT
- The results showed an improvement in 1EPs of OS; 21% reduction in risk of death; m-OS (14.6mos. vs 13.0mos.); patients were alive @2yrs. (34.3% vs 24.9%) while an efficacy EPs showed a 26% reduction in risk of disease progression or death; m-PFS (2.6mos. vs 2.3mos.); ORR (12.7% vs 1.3%); m-DOR (23.9mos. vs 5.6mos.)
- The therapy is being evaluated in multiple studies as monothx. & Combination with other treatments. The company has a global development program of 7 trials & expects to enroll ~3,000 patients
Date: Jan 17, 2022
Product- Rinvoq (upadacitinib)
- The approval is based on P-III (Measure Up 1/2/ AD Up) studies to evaluate Rinvoq (15/30 mg, qd) with TCS vs PBO in 2500+ patients aged ≥12yrs.with AD
- The trial met 1EPs & 2EPs i.e., @16wk., improvement in higher levels of skin clearance (53%/66% vs 8%)/(42%/58% vs 5%)/(43%/63% vs 13%) in EASI 90 & (17%/27% vs 2%)/(14%/19% vs 1%)/(12%/23% vs 1%) in EASI 100; skin clearance (70%/80% vs 16%)/(60%/73% vs 17%)/65%/77% vs 23%) in EASI 75 & (48%/62% vs 8%)/(39%/52% vs 5%)/(40%/59% vs 11%) in vIGA-AD 0/1
- The therapy showed (52%/60% vs 12%)/(42%/60% vs 9%)/(52%/62% vs 15%) improvement in itch @1wk. & safety profile was similar to patients with RA. The therapy is also approved in the EU for AD
Date: Jan 17, 2022
Product- Tapinarof
- The P-III (PSOARING 3) extension study evaluates tapinarof (qd) in adult patients with PsO. The results were presented at Winter Clinical Dermatology 2022
- The results demonstrated high rates of satisfaction across all evaluated parameters. Additionally, 78.5% (n=599) of patients who completed the survey showed that 81.7% considering more effective, 85.8% can manage psoriasis with tapinarof, 82.5% will continue to use tapinarof if available
- The US FDA has accepted an application for tapinarof to treat PsO in Aug 2021 & assigned a PDUFA date in Q2’22. Tapinarof is a steroid-free, cosmetically elegant topical cream & a therapeutic aryl hydrocarbon receptor modulating agent for PsO & AD
Date: Jan 13, 2022
Product- Edaravone (MT-1186)
- The NDA is based on the P-III (RADICAVA IV) trial evaluating the safety & tolerability of edaravone vs Radicava IV formulation in 185 patients with ALS along with 7 P-I clinical pharmacology studies to evaluate PK, safety, drug-drug interactions, dosing, bioavailability & bioequivalence in ALS patients with/out PEG/NGT
- Additionally, edaravone has been developed to have a similar clinical profile compared to the IV formulation of Radicava (edaravone)
- The US FDA has accepted the application for priority review with an anticipated PDUFA date of May 12, 2022. Edaravone is an investigational oral formulation & received the US FDA’s approval for the treatment of ALS in May 2017
Date: Jan 11, 2022
Product- Keytruda (pembrolizumab)
- The P-III (KEYNOTE-091) trial evaluates Keytruda (200mg, IV, q3w) vs PBO in a ratio (1:1) in 1,177 patients with stage IB-IIIA NSCLC following surgical resection with/out adjuvant CT
- The trial met its 1EPs of DFS for patients with stage IB-IIIA NSCLC regardless of PD-L1 expression. In an interim analysis, the therapy showed an improvement in DFS in the all-comer population & whose tumors express PD-L1. The safety profile was consistent with previously reported studies
- The company has an extensive clinical development program in lung cancer. Keytruda is being evaluated in multiple registration-enabling studies in combination with other treatments & as monothx. for lung cancer
Stryker Signs a Definitive Agreement to Acquire Vocera Communications for ~$3.09B
Date: Jan 07, 2022
Product- N/A
- Stryker to acquire all outstanding shares of common stock of Vocera for $79.25/share making a total equity value of ~$2.97B and a total enterprise value of ~$3.09B. The acquisition is expected to close in Q1’22
- The acquisition will add Stryker's medical division to address the increasing need for hospitals to connect caregivers along with providing various data-generating medical devices
- Vocera’s software and hardware solutions complement Stryker’s advanced digital healthcare offerings. Additionally, the combined business will bolster Stryker’s focus to prevent adverse events throughout the continuum of care
Date: Jan 07, 2022
Product- N/A
- Exscientia to receive $100M up front & is eligible to receive ~$5.2B upon achievement of research, translational, clinical development, regulatory & commercial milestones & also get an option for clinical co-investment to increase the royalty ~21% on net sales of co-funded products
- The agreement will use Exscientia’s AI-based capabilities & personalized medicine platform to identify & select target projects along with the development of 15 new small molecule therapies for cancer & immune-mediated diseases
- Exscientia will lead the small molecule drug design & optimization activities. Sanofi will lead the preclinical/ clinical development, manufacturing & commercialization of the product
Date: Jan 05, 2022
Product- Telisotuzumab Vedotin (Teliso-V)
- The designation is based on an ongoing P-II (LUMINOSITY/ M14-239) study evaluating Teliso-V monothx. in patients with advanced/m-EGFR WT, nonsq. NSCLC with high levels of c-Met overexpression whose disease has progressed on or after Pt-based therapy
- The 1EPs of the study is ORR per central review in patients with ≥ 12wks. follow-up. in patients with EGFR WT nonsq. NSCLC, ORR (53.8% & 25.0%) in c-Met high & intermediate group respectively at a previously reported interim analysis
- Teliso-V is being evaluated in the ongoing P-I (M14-237) study in combination with osimertinib for NSCLC. The therapy is also evaluated as monothx. in the P-III (TeliMET NSCLC-01/ M18-868) for the same indication
Amylyx Reports Submission of MAA to EMA for AMX0035 to Treat ALS
Date: Jan 05, 2022
Product- AMX0035
- The MAA is based on the P-II (CENTAUR) trial to evaluate AMX0035 vs PBO in 137 adults with ALS at 25 centers of NEALS
- The results showed that the patients treated with AMX0035 showed a reduction in clinical decline @ 6mos. randomized phase as measured by ALSFRS-R. In survival analysis, 44% reduction in risk of death compared to PBO, median survival through open-label long-term follow-up (25.0mos. vs 18.5mos.)
- Additionally, marketing applications are currently under review for AMX0035 to treat ALS in the US & Canada. The enrollment for the P-III (PHOENIX) clinical trial is underway in the US & EU & provides safety & efficacy data for AMX0035 to support Amylyx’ regulatory efforts
Date: Jan 03, 2022
Product- OV329
- AstraZeneca will receive $5M upfront in cash and $7.5M in shares of Ovid common stock and is eligible to receive ~$8M as potential clinical development milestones and $45M in regulatory milestones
- Total commercial milestones can sum up to $150M and tiered royalty payments ranging from the single digits up to 10% on net sales. AstraZeneca will have the right of the first negotiation to opt-in on a strategic collaboration at the time of proof of clinical efficacy
- Additionally, the company is developing OV329 which is a next-gen pregabalin for tuberous sclerosis and infantile spasms, expected to enter the clinic in 2022. Earlier, Ovid licensed soticlestat which is currently being studied in P-III trials for Dravet and Lennox Gastaut syndromes
Biohaven to Acquire Channel Biosciences for ~$3B
Date: Feb 28, 2022
Product- BHV-7000
- Biohaven acquired Knopp Biosciences' Channel Biosciences for its Kv7 channel targeting platform to advance BHV-7000 (formerly known as KB-3061)
- Knopp Biosciences to receive $100M up front including $35M in cash and $65M in Biohaven's common shares and is eligible to receive ~$3B including up to $325M in development and regulatory milestones for approvals in the US, EU and Japan & up to $250M for the Kv7 pipeline in other indications and additional country approvals, and up to $562.5M in commercial milestones along with royalties
- Channel Biosciences’s Kv7 channel targeting platform will support the advancement in ion-channel modulation to BHV-7000 (a potent activator of Kv7.2/Kv7.3). Biohaven additionally plans to bring BHV-7000 into the clinic in 2022 to treat focal epilepsy
Date: Feb 28, 2022
Product- Dupixent
- Positive detailed results from a second P-III trial of Dupixent (dupilumab-300 mg, Q1W), showed the significant improvement in signs and symptoms of EoE at 24 wks. vs. to PBO in patients aged ≥12 yrs. In 2022, regulatory filings are planned in the US and other countries
- Results showed the reduction of 64% vs. 41% in disease symptoms from baseline, DSQ improvement is 23.78 vs. 13.86 point & 59% vs. 6% of patients achieved histological disease remission
- In Sep 2020, Dupixent received BTD from the U.S. FDA for the treatment of patients aged ≥12yrs. with EoE and ODD in 2017 for the treatment of EoE
Date: Feb 23, 2022
Product- BXCL501
- The P-III (SERENITY II) trial evaluates BXCL501 (120/180mcg) vs PBO in patients with acute agitation associated with bipolar disorder
- The 1EP & 2EPs of the study showed the mean changes from baseline in PEC total score @2hrs. after treatment, greater improvement in the PEC total score @120min. after treatment. In prespecified exploratory EPs, patients experienced a treatment response @2hrs. (90.5% & 77.0%), 40% improvement from baseline on PEC score while 46% were treatment responders in the PBO
- The company is expected the US FDA approval of BXCL501 for the acute treatment of agitation associated with bipolar disorders & schizophrenia with an anticipated PDUFA date of April 5, 2022
Date: Feb 22, 2022
Product- Tremfya (guselkumab)
- The P-II (GALAXI 1) trial evaluates Tremfya vs Stelara in patients with active CD with inadequate response/intolerance to conventional therapies & biologics
- The results showed that patients treated with 200mg IV/100mg SC achieved clinical remission/corticosteroid-free clinical remission/PROs (63.9%/59%/57.4%), (73%/71.4%/69.8%) with 600mg IV & 200mg SC, 57.4%/55.7%/50.8% with 1200 mg IV/200 mg SC over 58.7%/58.7%/ 46%, respectively
- Additionally, all dose groups @ 48wk. had comparable safety data, consistent with the known safety profile for Tremfya. In dose group of 200mg IV/100mg SC, 600mg IV/200mg SC, 1200mg IV/200mg SC & Stelara, AEs were reported in 71.2%, 80.8%, 69.9% & 84.5%, respectively
Date: Feb 18, 2022
Product- Zeposia (ozanimod)
- The P-III (True North) OLE study evaluates Zeposia (0.92mg) vs PBO in 823 patients with UC with an inadequate response or intolerant to conventional therapy or a biologic agent
- The results showed that the patients achieved clinical remission, clinical response, endoscopic improvement & corticosteroid-free remission was maintained @142wks. In an interim analysis @ 46/94/142wks., 45%/ 51%/45% were in clinical remission, 80%/84%/86% achieved clinical response, 64%/34%/14% patients completed a study
- Patients achieved clinical remission & clinical response @46 & 94wk., (70% & 69%) & (95% & 98%), no new safety signals with Zeposia use in 1158 patients in the pooled population
GSK’s Benlysta (belimumab) Receives the NMPA’s Approval for the Treatment of Active Lupus Nephritis
Date: Feb 11, 2022
Product- Benlysta (belimumab)
- The approval was based on the P-III (BLISS-LN) trial to evaluate the efficacy & safety of belimumab (10mg/kg, IV) + SoC vs PBO + SoC in 448 adult patients with active LN
- The trial met its 1EPs i.e., patients treated with belimumab achieved PERR (43% vs 32%) @~2yrs. The 2EPs were also met including complete renal response @2yr. and time to renal-related event or death. The results were consistent with the known safety profile of belimumab + SoC in patients with SLE & helps to reduce the risk of worsening of kidney disease
- Benlysta is a BLyS specific inhibitor that binds to soluble BLyS & is approved in China for those aged ≥5yr. with active, autoantibody-positive SLE with high disease activity
Date: Feb 03, 2022
Product- Dolutegravir and Biktarvy
- ViiV to receive $1.25B up front which is expected in Q1’22 from Gilead along with a 3% royalty until the expiration of ViiV's US Patent No. 8,129,385 on dolutegravir in 2027 on all future US sales of Biktarvy and the bictegravir compound in other bictegravir-containing products in the future US sales
- Gilead obtains a global license to dolutegravir patent while ViiV will drop related patent litigation outside the US & settled a global patent infringement litigation b/w GSK, Shionogi & Gilead filed in Feb 2018
- Gilead’s Biktarvy is a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide & emtricitabine & infringes its patents for dolutegravir
Date: Mar 30, 2022
Product- Etrasimod
- Everest licensing partner Pfizer reported results from the 2nd P-III (ELEVATE UC 52) study evaluate etrasimod (2mg, qd) vs PBO in a ratio (2:1) in 433 patients with active UC who had prior failed or were intolerant to one conventional, biologic, or JAK inhibitor therapy
- The results showed that patients achieved an improvements in the co-primary EPs & all key 2EPs of clinical remission @12 & 52wks. The safety profile was consistent with the previous studies including the P-II (OASIS) trial
- The company will use these results along with (ELEVATE UC 12) & long-term extension from these 2 trials (ELEVATE UC OLE) for future regulatory filings with an expected initiation in 2022
Date: Mar 25, 2022
Product- Adbry (tralokinumab-ldrm)
- The P-III (ECZTEND) extension trial evaluates Adbry (300mg, q2w) vs PBO + TCS in 1400+ patients with AD who participated in the prior tralokinumab-ldrm monothx. trials
- The interim safety analysis showed that the overall safety profile was consistent with that observed in parent trials with no new safety signals & an interim efficacy analysis showed a sustained improvement in extent & severity of AD, itch severity & QoL for ~3yrs.
- From the cohort of 616 patients, 85.1% achieved 75% improvement in EASI-75, 50.5% achieved IGA 0/1 indicating clear or almost clear skin, improvements in itch & QoL as measured by 60.6% achieved a Worst Weekly Pruritus NRS score & 76.4% achieved a DLQI score
Date: Mar 25, 2022
Product- Evusheld
- AstraZeneca's Evusheld is recommended for marketing authorisation in the EU for the pre-exposure prophylaxis of COVID-19 in adults & adolescents aged ≥12yrs.
- The CHMP recommendation was based on the P-III (PROVENT) trial of Evusheld (150mg of tixagevimab & 150mg of cilgavimab, IM) which showed a 77% reduction in risk of developing symptomatic COVID-19 over PBO at the primary analysis & 83% reduction @6mos. median analysis with protection lasting @6mos. & was well-tolerated
- The new data showed that the therapy retained potent neutralizing activity against the emerging & highly transmissible BA.2 subvariant, reduced viral burden & limited inflammation in lungs across all Omicron variants
Date: Mar 21, 2022
Product- Opdualag (nivolumab and relatlimab-rmbw)
- The approval was based on the P-II/III (RELATIVITY-047) trial to evaluate relatlimab (160mg) + nivolumab (480mg) vs Opdivo (480mg, IV, q4w) alone in a ratio (1:1) in 714 patients aged ≥12yrs. with unresectable or metastatic melanoma
- The trial met its 1EPs i.e., improvement in PFS with m-PFS (10.1mos. vs 4.6mos.). The safety profile was similar to that previously reported for nivolumab with no new safety events, grade 3/4 drug-related AEs (18.9% vs 9.7%), treatment discontinuation due to AEs (14.6% vs 6.7%) & the combination resulted in increased T-cell activation
- Opdualag is the fixed-dose combination of nivolumab & relatlimab. The application has been approved under the US FDA’s RTOR pilot program
Date: Mar 09, 2022
Product- Nulibry (fosdenopterin)
- BridgeBio to receive cash payments upon the achievement of regulatory milestones & will be eligible to receive commercial milestones along with royalties on sales of Nulibry
- Sentynl to acquire global rights to Nulibry & will be responsible for the ongoing development & commercialization of Nulibry in the US along with fosdenopterin globally
- BridgeBio will be responsible to share the development responsibilities for fosdenopterin through approval of the MAA & regulatory submission with the Israeli Ministry of Health. Nulibry has been approved in the US to reduce the risk of mortality in patients with MoCD Type A & studies showed an improvement in OS over the historical control group
Date: Mar 04, 2022
Product- Lumykras (sotorasib)
- The NICE has issued a FAD recommending the use of Amgen’s Lumykras (sotorasib) on the NHS as a therapy option for the treatment of KRAS G12C mutation+ LA or metastatic NSCLC who have progressed or are intolerant to Pt-based CT & immunotherapy
- The CMA was based on the P-II (CodeBreaK 100) trial to evaluate sotorasib in 126 patients with KRAS G12C- mutated advanced NSCLC. The results showed an ORR (37.1%) & OS (12.5mos.), m-DoR (10mos.) in 46 patients with ORR
- The therapy will be available to patients in England via the Cancer Drugs Fund. Lumykras is an oral targeted therapy & has received a CMA from the MHRA for use across England, Scotland and Wales under Project Orbis
AbbVie Acquires Syndesi Therapeutics for ~$1B
Date: Mar 02, 2022
Product- SDI-118
- Syndesi shareholders to receive $130M up front & is also eligible to receive additional contingent fees of ~$870M upon the achievement of predetermined milestones
- The acquisition will expand AbbVie's neuroscience portfolio & give access to Syndesi's portfolio of novel modulators of SV2A including SDI-118 which is currently in P-Ib studies & is used to treat cognitive impairment associated with neuropsychiatric and neurodegenerative disorders including AD and major depressive disorder
- SDI-118 has been discovered by UCB & is being evaluated to target nerve terminals to enhance synaptic efficiency
Date: Mar 1, 2022
Product- Carvykti (ciltacabtagene autoleucel)
- The US FDA has approved Carvykti for the treatment of adults with r/r MM who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 mAb
- The approval was based on the P-II/III (CARTITUDE-1) study evaluating cilta-cel in 126 patients with r/r MM which showed deep and durable responses, ORR (98%) including 78% of patients achieved sCR, m-DOR (21.8mos.) at a median of 18mos. follow-up
- Carvykti is a BCMA-directed, genetically modified autologous T-cell immunotherapy & received BTD from the US FDA & NMPA, ODD from the US FDA & EMA. The therapy is available only through a restricted program under REMS
Biocon to Acquire Viatris’ Biosimilars Assets for ~$3.335B
Date: Mar 01, 2022
Product-N/A
- Viatris to receive ~$3.335B including $2B in cash & ~$335M as additional fees expected to be paid in 2024, $1B of CCPS equivalent to an equity stake of 12.9%. The transaction is expected to be close in H2’22
- The acquisition provides BBL full ownership of Viatris’ rights in biosimilars assets to recognize combined revenues & profits. BBL will gain access to a portfolio of biosimilars in insulin, oncology & immunology along with multiple other biosimilar assets
- Viatris will provide commercial & transition services to BBL for 2yrs. Biocon will also gain access to Viatris’ global biosimilars business whose revenues are estimated at $1B in 2023 along with in-licensed biosimilar assets
Related post: PharmaShots' Key Highlights of Third Quarter 2021
Tags
Biogen
Samsung Biologics
Gilead
Eleusis
Silver Spike
UCB
Zogenix
Merck
AbbVie
Dermavant
Mitsubishi Tanabe Pharma Merck
Stryker
Vocera Communications
Exscientia
Sanofi
Amylyx
Ovid Therapeutics
AstraZeneca
Biohaven
Channel Biosciences
BioXcel
Janssen
BMS
GSK
ViiV Healthcare
Pfizer
LEO Pharma
BridgeBio
Amgen
Syndesi Therapeutics
Legend Biotech
Sentynl
Biocon
Viatris
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.
