- The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants
- Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter also showcases the increasing demand for the biosimilars in today’s scenario
- Our team at PharmaShots has summarized and complied with the insights of Q1’21
AstraZeneca’s COVISHIELD Received EUA in India for COVID-19
Date – Jan 04, 2021
Product – Covishield
- India has granted the emergency use approval for AstraZeneca and the Oxford University’s COVID-19 vaccine developed by a day after an advisory panel of CDSCO issued its recommendation
- Covishield would be the first vaccine to be given the go-ahead by drug regulators in India. SII and AstraZeneca have partnered up to manufacture and distribute the vaccine in India and several other countries
- Discussion for the EUAs are underway for Bharat Biotech’s COVAXIN, Zydus Cadila’s ZyCoV-D, and Russia’s Sputnik-V. India plans to inoculate 300M of its 1.35B people in the first six to eight months of 2021
Biogen Signed a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development
Date – Jan 05, 2021
Product – N/A
- ViGeneron to receive an up front and R&D funding for the mutually agreed workplan and will receive development, regulatory and commercial milestone payments along with royalties on sales of products arising from the collaborations
- ViGeneron will optimize and validate in vitro therapeutic candidates for undisclosed target to treat inherited eye disease while Biogen has the right to add an additional reserved target within two years after the effective date
- The companies will work together on the in vivo POC and will use ViGeneron’s vgAAV technology to efficiently transduce target cells via intravitreal injections
Genentech Signed ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies
Date – Jan 07, 2021
Product – N/A
- Ribometrix to receive $25M up front, ~$1B+ as milestones along with royalties on sales of therapies emerges from the collaboration
- The companies collaborated on the discovery & preclinical development of programs. Genentech will lead further development and commercialization and will have exclusive rights to several predefined targets including an exclusive global license for the development and commercialization of molecules
- Ribometrix will leverage its discovery platform to identify & optimize small molecule compounds modulating RNA function by targeting 3D RNA structures
Date – Jan 07, 2021
Product – N/A
- The acquisition will integrate AmpTec’s PCR-based mRNA technology with Merck’s expertise in lipids manufacturing, providing combine offering across mRNA value chain
- The deal will expand Merck’s capabilities to develop & manufacture mRNA for use in vaccines, treatments, and diagnostics applicable in COVID-19 and many other diseases. Additionally, AmpTech’s diagnostic business focusing on customized long RNAs and DNAs for IVDs, complements existing Merck’s portfolio
- The addition of AmpTech’s PCR-based technology to Merck allow the companies to offer innovative technologies, products, and services, advancing life-enhancing therapies
Pfizer Reported the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD
Date – Jan 08, 2021
Product – PF-06939926
- The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across 55 sites in 15 countries.
- The first patient was dosed at a site in Barcelona, Spain on Dec 29, 2020. The 1EPs of the study is the change in NSAA @1yr, while patients will be followed in the CIFFREO study for 5yrs. after treatment with PF-06939926
- PF-06939926 is an investigational rAAV9 capsid carrying a shortened version of the human dystrophin gene (mini-dystrophin) under the control of a human muscle-specific promotor and has received the US FDA’s FT designation in Oct’2020 and ODD & RPD in May’2017
Sanofi Acquired Kymab for ~$1.45B
Date – Jan 11, 2021
Product – KY1005
- Sanofi to acquire Kymab for $1.1B up front and ~$350M following the achievement of certain milestones. The transaction is expected to be completed in H1’21
- The acquisition will add KY1005 to Sanofi’s pipeline and will expedite its presence in the field of immunology
- Sanofi will get the global rights of KY1005 which is a mAb targeting OX40-ligand, currently being evaluated in early P-I/II study as monothx. and in combination with an anti-PD-L1 for immune-mediated diseases and inflammatory disorders
Takeda and KSQ Collaborated to Develop and Commercialize Novel Immuno-Oncology Therapies
Date – Jan 15, 2021
Product – N/A
- KSQ to receive $100M+ as up front and preclinical milestones and up to $400M+/ program in option payment and development & commercialization milestones along with royalties on sales of each approved products
- The deal includes two KSQ’s previously identified & validated T-cell targets with the potential to introduce two additional targets to the collaboration
- Takeda will lead to funding for all development & commercialization activities. KSQ to get an option to participate in cost/profit sharing on one of the two products based on the T-cell targets previously identified and validated by KSQ, in the US and retain royalties on all ex-US sales for that product
Date – Jan 18, 2021
Product – Onvansertib
- The P-Ib/II study involves assessing of Onvansertib + Folfiri and bevacizumab in 44 patients with 2L treatment of KRAS-mutated mCRC. The company also provided an additional data update from its mCRC clinical program and initial findings from its EAP
- Out of the 12 P-1b patients, 42% achieved PR & 67% have shown a durable response ranging from 6.1-13.7mos. The RP2D has been established at 15mg/m2 and the P-II segment of the ongoing trial is open to full enrollment of ~26 patients across 6 sites in the US
- In the EAP, 66% of the initial 9 patients treated have shown tumor shrinkage and remain on treatment to-date with durable responses lasting an avg. of 6 mos.
Date – Jan 19, 2021
Product – Byvasda
- Innovent to receive milestones for development and commercialization along with royalties on net sales of the therapy in the licensed territory. Etana is committed to launch Byvasda in Indonesia
- The collaboration will enable Byvsada to penetrate into a Southeast Asian market and allow Innovent to bolster its presence globally
- In Jan’2020, Innovent signed an out-license agreement with Coherus to commercialize the biosimilar in the US & Canada
Boston Scientific Acquired Preventice for ~$1.2B
Date – Jan 22, 2021
Product – N/A
- Boston Scientific to acquire Preventice for ~$1.2B including $925M as up front, up to an additional $300M as commercial milestones. However, Boston Scientific has built up a 22% stake in Preventice, which is expected to lower up front to $720M upfront & $230 million in milestone respectively
- The acquisition is expected to be close in mid-2021. The acquisition will add external cardiac monitoring technologies and services provider to Boston Scientific and expand its rhythm management diagnostics portfolio and capabilities
- The Preventice portfolio includes the BodyGuardian family of remote, wearable cardiac monitors for adult and pediatric patients
Date – Jan 25, 2021
Product – Lupkynis
- The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN
- The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice as fast as SoC, complete renal response @24 wks vs SoC @1year
- Lupkynis is the 1st FDA-approved oral therapy for LN and is now commercially available in the US
Date – Jan 27, 2021
Product – Rinvoq
- The approval is based on data from three pivotal clinical trials P-II SELECT-PsA 1& 2 and P-II/III SELECT-AXIS 1 involves assessing of Rinvoq in patients with PsA and AS. The studies demonstrated that it met all 1EPs & 2EPs with a safety profile consistent with that seen in RA
- The P-III studies met its 1EPs of ACR20 @12wks., showed non-inferiority to adalimumab for ACR 20 @12wks. The P-II/III study met 1EPs od ASAS 40 @15wks
- Rinvoq (15mg, PO, qd) is a selective and reversible JAK inhibitor, approved for three adult rheumatic indications in the EU: RA, PsA, AS
Date – Jan 29, 2021
Product – N/A
- CQC collaborates with Roche to design and implement noisy-intermediate-scale-quantum (NISQ) algorithms for early-stage drug discovery and development
- The collaboration will employ CQC’s quantum chemistry platform ‘EUMEN’, to augment the Roche’s AD research efforts
- The multi-year collaboration will combine the expertise of both CQC and Roche to advance the application of quantum computing to pharmaceutical relevant problems
Horizon Therapeutics Acquired Viela Bio for ~ $3.05B
Date – Feb 02, 2021
Product – N/A
- Horizon to acquire Viela Bio for $53/ share, representing an equity value of $3.05B with a 53% premium over a closing price to Viela’s on Jan 29, 2020. Additionally, AstraZeneca to divest its 26.7% ownership in Viela Bio in an exchange of ~$760 – $780M
- The transaction expected to close in Q1’21. The acquisition will bolster Horizon’s pipeline and expand its portfolio of rare diseases with the addition of Uplizna, VIB4920, VIB7734, VIB1116
- Previously, Horizon has submitted a prior approval supplement to the US FDA to support increased scale production of Tepezza for TED
Jazz Acquired GW Pharmaceuticals for $7.2B
Date – Feb 04, 2021
Product – Epidiolex
- Jazz to acquire GW Pharmaceuticals for $220/ GW ADS, out of which $200 in cash and $20 in Jazz ordinary shares, making a total deal value $7.2B with a 50% premium over a GW’s closing stock price on Feb 2, 2021. The transaction expected to close in Q2’21
- The acquisition will expand Jazz’ neuroscience portfolio and expand its footprints with the addition of Epidiolex which is the first and only FDA-approved prescription cannabidiol medicine
- Apart from Epidiolex, GW’s pipeline includes nabiximol for spasticity associated with MS and spinal cord injury as well as earlier-stage cannabinoid therapies for autism and schizophrenia
Enzene Received Marketing Authorization for Teriparatide (biosimilar) in India
Date – Feb 05, 2021
Product – Teriparatide
- The company received DCGI’s MA for Teriparatide (biosimilar) for the treatment of Osteoporosis vs anti-resorptive therapies such as bisphosphates and SERMs
- The approved product will be marketed through Alkem Laboratories as well as it explore other potential partnering opportunities
- Teriparatide will be launched in a fully compliant pen device
Date – Feb 08, 2021
Product – Elecsys GDF-15 assay
- The US FDA grants the BDD for Elecsys GDF-15 assay that is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients aged≥18yrs. with solid tumors for treatment with Pfizer’s PF-06946860
- GDF-15 assay helps to identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients and may provide a precision medicine approach to identifying patients likely to respond to a GDF-15 treatment
- Elecsys GDF-15 is a quantitative serologic, two-incubation step ECLIA using the sandwich test format for the detection of GDF-15 in human serum
Date – Feb 15, 2021
Product – Kixelle
- The EC approval follows CHMP’s positive recommendation for Kixelle to treat DM in adults, adolescents, and children aged ≥1yr. The biosimilar has been approved as a 100 units/ml solution for injection in vial & pre-filled pen presentations
- The EC’s CMA is valid in all EU Member States as well as in the EEA countries including Iceland, Liechtenstein, and Norway
- The approval will allow affordable access to a rapid-acting insulin analog for people with diabetes in the EU
Date – Feb 17, 2021
Product – Kesimpta Sensoready autoinjector pen
- The multicenter survey involves assessing Kesimpta Sensoready autoinjector pen in 80 MS patients and 50 MS nurses, with RMS who received a disease modifying treatment through a subcutaneous/intramuscular injection via an autoinjector
- The result shows MS patients and nurses prefer the Kesimpta Sensoready autoinjector pen over other autoinjectors for current treatment (84% vs 16%). The findings will be presented at the ACTRIMS Forum 2021 on Feb, 2021
- Kesimpta received positive CHMP opinion last month based on two P-III trials showed reduction of annual relapses by over 50% with more than 30% relative risk reduction of 3 mos. CDP vs teriflunomide
Merck Acquired Pandion for ~$1.85B
Date – Feb 26, 2021
Product – PT101
- Merck to acquire all outstanding shares of Pandion for $60/share in cash, representing the equity value of ~$1.85B. The transaction is expected to close in H1’21
- The acquisition will strengthen Merck’s portfolio with the addition of candidates targeting a broad range of autoimmune diseases
- Pandion is advancing a pipeline of precision immune modulators targeting critical immune control nodes along with its lead candidate (PT101) intended to treat UC and other autoimmune diseases
Samsung Bioepis Initiated P-I Study of SB17 Proposed Biosimilar to Stelara (ustekinumab)
Date – Mar 02, 2021
Product – SB17
- The P-I study assesses the PK, safety, tolerability and immunogenicity of SB17 vs Stelara (US & EU sourced) in 201 healthy males in a ratio (1:1:1) aged 18-55yrs. All IPs will be administered subcutaneously in the abdomen
- Samsung Bioepis has four biosimilar candidates – SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in P-III and SB17 (ustekinumab) in P-I clinical trial
- With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology
Fusion Acquired Ipsen’s IPN-1087 to Expand its Pipeline of Radiopharmaceuticals
Date – Mar 03, 2021
Product – IPN-1087
- Ipsen to receive 400,000 shares at closing and an additional 200,000 shares as milestones, $81.63M as development and regulatory milestones & $423.24M as commercial milestones along with royalties on net sales
- Fusion will be responsible for paying to a third-party licensor up to $84.7M in development milestones and royalties on net sales of products
- IPN-1087 is a small molecule targeting NTSR1. Fusion plans to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1
Amgen Acquired Five Prime for ~$1.9B
Date – Mar 05, 2021
Product – Bemarituzumab
- Amgen to acquire all of the outstanding shares of Five Prime for $38.00 /share in cash, representing an equity value of ~ $1.9B. The transaction is expected to close in Q2’21
- The acquisition will add Five Prime’s innovative pipeline to Amgen thus expanding its oncology portfolio and supports its international expansion strategy
- Five Prime’s bemarituzumab complements Amgen’s oncology portfolio. Bemarituzumab, is a first-in-class, P-III ready anti-FGFR2b Ab that demonstrated improvement in PFS, ORR, OS in the frontline treatment of patients with advanced gastric or GEJ cancer in its P-II study
Roche to Withdraw Tecentriq Indication in Metastatic Bladder Cancer in the US
Date – Mar 08, 2021
Product – Tecentriq (atezolizumab)
- The company reported the voluntary withdrawal of the Tecentriq (atezolizumab) indication in the US for prior-platinum treated mUC, bladder cancer
- The withdrawal was made in consultation with the US FDA to review the accelerated approvals with confirmatory trials that have not met 1EPs and have yet to gain regular approvals. The decision does not affect other approved indications for Tecentriq
- In 2016, Tecentriq has received accelerated approval based on the results from IMvigor210 study (Cohort 2) while the continued approval was contingent on the results of IMvigor211 study, which did not meet its 1EPs. Additionally, FDA designated the IMvigor130 study as the PMR which will continue until the final analysis
Date – Mar 10, 2021
Product – COVISHIELD
- The companies signed an exclusive license agreement to develop COVISHIELD + two mAb cocktail against emerging variants of SARS-CoV-2 including UK (B.1.1.7), South Africa (B.1.351), and Japan/Brazil (B.1.128) variants
- The pre-clinical development of Ab combination (IV and intranasal) including Sorrento and Mount Sinai Abs is underway
- The collaboration follows Sorrento’s efforts to eradicate COVID-19 which includes STI-2020 (COVI-AMG) and STI-2099 (COVIDROPS). The license contemplates Sorrento and Mount Sinai pursuing future collaborations in developing humanized mAb for therapeutic applications
SMA Foundation Collaborated with PTC to Discover and Develop Regenerative Medicine
Date – Mar 10, 2021
Product –N/A
- SMA Foundation and PTC will provide an initial investment of up to $60M in research to discover & develop regenerative treatments in neuromuscular diseases
- The focus of the agreement is advance scientific research in SMA and other neuromuscular disorders to develop new treatments
- The availability of several disease-modifying therapies has made regenerative interventions the next frontier in drug discovery and development
Date – Mar 22, 2021
Product – Ponvory
- The approval is based on the P-III head-to-head OPTIMUM trial involves assessing Ponvory (20 mg) vs Teriflunomide (14 mg) in adults with relapsing MS and follows >10 yrs of cumulative data demonstrating its efficacy and safety
- The results demonstrated superior efficacy in reducing annual relapses by 30.5%, no confirmed relapses (30.5% vs 61%), reducing the number of new GdE T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, confirmed disability progression
- Ponvory (ponesimod) is a selective S1P1 modulator to treat adults with relapsing MS and is the 1st and only FDA-approved oral disease modifying therapy studied against an established oral comparator
Novartis In-Licensed Fibroblast Activation Protein (FAP) to Expand its Oncology Radioligand Pipeline
Date – Mar 30, 2021
Product – N/A
- Novartis gets an exclusive WW right to develop and commercialize therapeutic applications for FAP assets including FAPI-46 and FAPI-74 under its collaboration with iTheranostics, which is an affiliate of SOFIE Biosciences
- The agreement also consists of co-exclusive rights for Novartis to develop imaging applications for FAP assets
- The company will continue to reimagine cancer care through the development of a robust radioligand therapy portfolio and actively investigate across multiple tumor types
Related Post: PharmaShots’ Key Highlights of Fourth Quarter 2020
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