PharmaShots’ Key Highlights of Second Quarter 2021
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19
The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B
Our team at PharmaShots has summarized and complied with the insights of Q2’21
BioMarin Collaborated with Allen Institute to Develop Gene Therapies for Rare Brain Diseases
Date – Apr 29, 2021
Product –N/A
- BioMarin will receive an exclusive license to each program for research, development, and commercialization of the gene therapies
- The collaboration will utilize Allen institute technologies to develop new gene therapies for rare genetic diseases of CNS by targeting gene expression to specific cells
- Allen Institute has developed modified engineering AAVs to carry genes on specific types of neurons or other cells in the brain
Voluntis Collaborated with Eisai to Develop Digital Therapeutics for Oncology Patients
Date – Apr 28, 2021
Product – N/A
- Voluntis enters into a license agreement with Eisai to design & develop DTx for patients and healthcare professionals to support cancer treatment, utilizing the Theraxium technology platform
- The DTx will be designed with the intent to be commercialized in the US, Japan and EU, which will boost Voluntis’ pipeline and global footprint
- Additionally, the partners will explore other opportunities to develop, evaluate and commercialize DTx in the field of neurology, notably AD and dementia
Date – Apr 26, 2021
Product – Nirsevimab
- The P-III MELODY study involves evaluating Nirsevimab (50mg/100mg, IM) vs PBO to determine the incidence of medically attended LRTI due to RSV confirmed by RT-PCR testing through 150days after dosing in healthy infants in a ratio (2:1) entering their first RSV season
- The study met its 1EPs i.e. reduction of LRTI due to RSV and the safety profile remains consistent with previously reported results. The regulatory submissions for all-infant indication are expected to begin in 2022
- Nirsevimab is currently being evaluated in P- II/III MEDLEY trial in preterm infants and children with CLD and CHD entering first and second RSV seasons, with expected first data in the coming mos.
Johnson & Johnson Published Results of COVID-19 Single Shot Vaccine in NEJM
Date – Apr 22, 2021
Product – COVID-19 vaccine
- The P-III ENSEMBLE trial involves assessing COVID-19 vaccine vs PBO in 43,783 enrolled participants aged ≥18yrs. with both mod. and sev. COVID-19 disease
- The trial met all 1EP & 2EPs i.e 85% efficacy in preventing disease, vaccine efficacy was consistent against symptomatic infection including in South Africa and Brazil that showed a high prevalence of SARS-CoV-2 variants
- Additionally, the trial met its co-1EPs of protecting against mod. to sev. COVID-19 that showed 67% efficacy @14days and 66 % efficacy @28days after vaccination. The vaccine demonstrated efficacy as early as 7days after vaccination, with efficacy continuing to increase 8wks. post-vaccination
ThermoFisher Acquired PPD for ~$17.4B
Date – Apr 16, 2021
Product –N/A
- ThermoFisher to acquire PPD for $47.50/share making a total purchase price of $17.4B along with ~$3.5B of net debt with a premium of ~24% to the closing price of PPD’s common stock as of Apr 13, 2021. The transaction is expected to be completed by the end of 2021
- The acquisition expands ThermoFisher’s service offering to pharma and biotech customers with the addition of highly complementary services
- The acquisition is expected to add $1.40 to Thermo Fisher’s adjusted earnings per share in the first 12 months after the deal closure
Date – Apr 16, 2021
Product – HD204 (biosimilar, bevacizumab)
- Pharmapark to get exclusive rights to commercialize HD204 and is responsible for local registration, sales, and marketing of the biosimilar in Russia in collaboration with Russian import substitution strategy
- Prestige BioPharma will be responsible for commercial supply the product out of its manufacturing facilities in Osong, Korea
- Prestige’s (HD204) is currently being evaluated in P-III SAMSON-II trial that involves assessing the safety & efficacy of HD204 to the reference, Roche’s Avastin for multiple cancer indications
Avantor Acquired Ritter and its Affiliates for ~$1.06B
Date – Apr 13, 2021
Product –N/A
- Avantor to acquire Ritter and its affiliates in an all-cash transaction with an up front equity purchase price of ~ $1.06B along with additional payments following the achievement of milestones. The transaction is expected to be completed in Q3’21
- The acquisition expands Avantor’s offering for diagnostic and drug discovery workflows
- The acquisition integrates Ritter’s liquid handling consumables platform for clinical diagnostic testing and life sciences research with Avantor’s offerings for critical lab automation workflows and global customer channel
DiaSorin Acquired Luminex for ~$1.8B
Date – Apr 13, 2021
Product –N/A
- DiaSorin to acquire Luminex for $37.00/ share in an all-cash transaction, with 23% premium based on closing stock price of Luminex on 24 Feb, 2021, making a total equity value of $1.8B
- The acquisition will boost DiaSorin’s presence in the molecular diagnostics space in the US with the addition of Luminex’s molecular diagnostics multiplexing technology and a portfolio
- Additionally, the acquisition will accelerate Luminex technology and solutions’ penetration outside the US via DiaSorin’s commercial and geographical reach
Microsoft Acquired Nuance for ~$19.7B
Date – Apr 13, 2021
Product –N/A
- Microsoft to acquire all outstanding shares of Nuance for $56.00/ share, making a total deal value of $19.7B in cash with a premium of 23% to Nuance closing price on Apr 09, including its net debt. The transaction is expected to close in 2021
- The acquisition builds on Microsoft’s efforts to deliver new cloud and AI capabilities across healthcare and other industries
- Nuance will deliver AI expertise & customer engagement solutions across IVR, virtual assistants, digital and biometric solutions to companies around the globe. The expertise will integrate with Microsoft’s cloud, including Azure, Teams, and Dynamics 365, to deliver next-generation customer engagement & security solutions
Date – Apr 9, 2021
Product – Biosimilar Pembrolizumab
- The agreement facilitates PlantForm’s collaborations in Brazil to provide affordable, effective cancer drugs to millions of Brazilians
- The 3yrs. research and development collaboration will culminate in protocols for P-I and P-III clinical trials. The companies will take biosimilar pembrolizumab to world markets, following the completion of clinical trials in Brazil
- Pembrolizumab is a biosimilar referencing Merck’s Keytruda, which is used in immunotherapy to treat a variety of cancers including melanoma, lung cancer, head and neck cancer, and stomach cancer
Hologic Acquired Mobidiag for ~ $795M
Date – Apr 9, 2021
Product –N/A
- Hologic to acquire Mobidiag for ~$795M which includes ~$714M in cash for Mobidiag’s equity and debt of $81M. The acquisition is expected to close in Q4’21
- The acquisition will accelerate Hologic’s global footprints by enabling it to expand into the large, fast-growing acute care adjacency with a near-patient testing solution that offers ease of use, multiplex capability and rapid turnaround time
- Mobidiag offers a broad range of tests and automated platforms including Amplidiag and Novodiag. Additionally, Hologic plans to invest in assay development to promote the growth of the Novodiag platform
Gilead Expanded its Collaboration with AbCellera to Develop Antibodies Against Multiple Indications
Date – Apr 5, 2021
Product –N/A
- AbCellera to receive upfront, milestone, and royalties based on the development and commercialization of Abs, emerge under the collaboration
- The expanded collaboration will utilize AbCellera’s technology stack, which includes Trianni Mouse and OrthoMab protein engineering platform
- AbCellera will generate panels of Abs against up to 8 new targets across multiple indications, selected by Gilead
ADQ Acquired Amoun Pharmaceutical from Bausch Health for ~$740M
Date – Apr 1, 2021
Product –N/A
- ADQ to acquire all the outstanding shares of Amoun Pharmaceutical from Bausch Health for ~$740M. The transaction is expected to close in H1’21
- The divestiture is part of its planned separation of Bausch & Lomb eye-care division
- The sale of Amoun marks important progress to reduce overall Bausch Health debt and plans to prepare for the spinoff of Bausch + Lomb
Novo Nordisk Resubmitted Label Expansion Application to the US FDA for Semaglutide (2.0mg)
Date – May 31, 2021
Product – Semaglutide
- The company has announced the resubmission of a label expansion application to the US FDA for the existing marketing authorization for Ozempic to introduce a new dose of 2.0mg for the Treatment of T2D
- The resubmission follows the Refusal to File letter received by the FDA on 22 March 2021. The standard review time by the FDA is 10mos.
- The company has submitted the label expansion application in Jan’2021, based on the P-III results that showed a significant decline in HbA1c compared to semaglutide (1.0mg) in patients with T2D
Bayer Seeks Approval of Larotrectinib for Advanced Solid Tumors in China
Date – May 25, 2021
Product – Larotrectinib
- The NDA submission is based on P-I study of adult patients, the P-II NAVIGATE trial in adult and adolescent patients and the P- I/II pediatric SCOUT trial. These trials evaluated Larotrectinib in 20+ different histologies of solid tumors with NTRK fusion
- The therapy is already approved in several countries under the brand name Vitrakvi, including the US, EU, and Japan. The regulatory filing in other countries are underway or planned
- Larotrectinib is a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion
Lilly Reported Results of Tirzepatide in SURPASS-4 Study for Patients with Type 2 Diabetes
Date – May 20, 2021
Product – Tirzepatide
- SURPASS-4 study involves assessing tirzepatide (5/10/15mg) vs insulin glargine in 2002 adults in a ratio (1:1:1:3) with T2D inadequately controlled with at least 1 and up to 3 oral antihyperglycemic medications who have increased CV risk
- The study met its 1EPs and 2EPs led to superior A1C and body weight reductions for both estimands. @52wks. A1C reduction (-2.24% / -2.43%/ -2.58% vs -1.44%); Weight reduction (-7.1/ -9.5/ -11.7kg vs +1.9 kg); patients achieving A1C <7% (81.0%/ 88.2%/ 90.7% vs 50.7%); patients achieving A1C <5.7% (23.0%/ 32.7%/ 43.1% vs 3.4%) respectively
- Lilly plan to submit registration package to regulatory authorities by the end of 2021
Date – May 20, 2021
Product – Amivantamab + Lazertinib
- The CHRYSALIS study involves assessing amivantamab as a monothx. and in combination with Lazertinib in 460 patients with advanced NSCLC with various EGFR mutations
- The updated data showed mDOR of 9.6mos. in CT-naïve patients with NSCLC & EGFR exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib. These results led to new studies evaluating the combination regimen in the P-III MARIPOSA study and P-I/Ib CHRYSALIS-2 study
- The findings will be presented at the ASCO. Additionally, Janssen will present data comparing amivantamab monotherapy and real-world therapies in the same population
BMS Extended its 2019 Collaboration with Exscientia for AI Driven Drug Discovery
Date – May 19, 2021
Product –N/A
- Exscientia to receive ~$50M as up front, ~$125M as milestones and additional clinical, regulatory, and commercial milestones of over $1.2B along with royalties on net sales of any marketed therapies resulting from the collaboration
- The expanded collaboration has the potential to add to the BMS drug pipeline whilst enhancing Exscientia’s portfolio of shared assets. The alliance will deploy AI to accelerate the discovery of small molecules in multiple therapeutic areas, including oncology & immunology
- Exscientia will take responsibility for AI-design and experimental work necessary to discover drug candidates associated with the collaboration
Date – May 13, 2021
Product – Losmapimod
- The US FDA has granted FTD to losmapimod for the treatment of FSHD while the therapy has previously received ODD for FSHD
- The company will present full data from the P-IIb ReDUX4 trial assessing losmapimod vs PBO in patients with FSHD at FSHD on June 24-25, 2021 that include 1EP results i.e., reduction from baseline of DUX4-driven gene expression and pre-specified sensitivity analysis assessing biopsies with the highest pre-treatment level of DUX4-driven gene expression
- The additional 2EPs results i.e., disease progression via skeletal muscle MRI, exploratory EPs evaluate muscle function measures and patient-reported outcomes
Date – May 10, 2021
Product – COVID-19 vaccine
- The companies initiate the BLA with the FDA for approval of the COVID-19 vaccine in patients aged ≥16yrs. The data supporting the BLA will be submitted on a rolling basis over the coming wks., with a request for Priority Review
- Additionally, the companies will submit the required manufacturing & facility data for licensure to complete the BLA. The vaccine is currently available in the US under a EUA granted from FDA on Dec 11, 2020, while 170M+ doses have been delivered in the US
- The companies have also applied to expand the current EUA for the COVID-19 vaccine to include individuals aged 12-15yrs. and plans to submit sBLA in this age group once the required 6 mos. data are available
Date – May 10, 2021
Product –N/A
- Eli Lilly collaborates with DexCom, Glooko, myDiabby Healthcare and Roche to integrate the data and technology into connected insulin pen solutions and provide streamlined care for diabetes patients in markets outside the US
- The 4 companies will provide diabetes management platforms that are well-suited with Lilly’s Tempo Pen and Tempo Smart Button to help streamline diabetes management through automated data collection for insulin dose tracking
- Lilly plans to receive a CE mark for the Tempo Smart Button later in 2021 and will launch the Tempo Pen and Tempo Smart Button in various global markets following the approval
Roche’s Ab Cocktail (Casirivimab and Imdevimab) Received EUA to Treat COVID-19 in India
Date – May 6, 2021
Product – Casirivimab and Imdevimab
- The CDSCO has granted a EUA for Roche’s casirivimab and imdevimab to treat COVID-19 in India. The approval of the Ab cocktail was based on the data that has been filed for the EUA in the US and the CHMP’s opinion in the EU
- Roche will import the globally manufactured product batches to India and is collaborated with Cipla for pan-India distribution. At a global level, Roche and Regeneron are collaborating to jointly address the increasing demand
- Earlier, Roche has reported the global P-III trial of Abs vs PBO in 4,567 high-risk non-hospitalized COVID-19 patients and showed a 70% reduction in the risk of hospitalization or death and also shortened the duration of symptoms @4days
Date – May 5, 2021
Product – Amgevita (biosimilar, adalimumab)
- The company reports the availability of Amgevita, referencing Humira to treat 11 chronic inflammatory conditions in Canada
- Amgevita is available as a prefilled syringe and a prefilled pen (SureClick autoinjector) with a broad range of pack sizes to support dosing for each indication and available in a citrate-free formulation. Amgevita is reimbursed on the public drug for all indications of Humira in British Columbia, Alberta, Ontario, Quebec, New Brunswick and Newfoundland
- The approval was based on the clinical study that supports bio-similarity with the Humira and showed no clinical differences from the reference product
Date – May 4, 2021
Product – Biosimilar Aflibercept
- The company starts enrolling patients in the P-III MYLIGHT study to evaluate the safety and efficacy of biosimilar aflibercept vs Eylea in patients with nAMD for 48wks. The study is expected to enroll 460 patients across 20 countries
- The study is a part of a biosimilar development program that includes analytical, pre/ clinical data. The study focuses to confirm the efficacy & safety of biosimilar aflibercept to the Eylea
- The company has eight marketed biosimilar medicines globally and 15+ molecules in the pipeline and focuses to expand the access to affordable biologics
Samsung Bioepis Presented Results of SB11 (proposed biosimilar ranibizumab) at ARVO 2021
Date – May 3, 2021
Product – SB11 (proposed biosimilar ranibizumab)
- The company reported the results from a study based on the structural and functional analysis of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
- The analytical assessment demonstrated that structural, physicochemical characterization i.e. amino acid sequence, post-translational modifications, higher order structure, and size and charge variants of SB11 were similar to Lucentis
- The SB11 is also functionally similar to Lucentis based on a set of bioassays and binding assays covering a broad range of VEGF-related functional activities. SB11 is under review by the US FDA and EMA
AstraZeneca’s Farxiga (dapagliflozin) Received the US FDA’s Approval for Chronic Kidney Disease
Date – May 3, 2021
Product – Farxiga (dapagliflozin)
- The approval is based on P-III DAPA-CKD trial assessing Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/out T2D
- Results: 39% reduction in relative risk of worsening of renal function or risk of CV or renal death, ARR (5.3%) @2.4yrs., and reduction in the risk of death by 31%. The approval follows the US FDA’s PR designation granted in early 2021
- The exploratory analyses of the P-III DECLARE-TIMI 58 trial evaluating the effect of Farxiga vs PBO in 14000 patients on CV outcomes support the conclusion that Farxiga is effective in patients with less advanced CKD
Novartis Reported New Data of Kesimpta (ofatumumab) in ALITHIOS Study for Multiple Sclerosis
Date – June 23, 2021
Product – Kesimpta (ofatumumab)
- The ongoing OLE of ALITHIOS study involves assessing Kesimpta in 1,703 patients with MS for ~5 yrs which showed mean IgG levels remained unchanged @ 3.5 yrs & mean IgM levels remained within the reference range with no increased risk of infections
- Additionally, the results were consistent with P- III ASCLEPIOS trials data which showed a low incidence of infections & no association was identified b/w decreased Ig levels & risk of serious infections & was a well-tolerated treatment option for patients with RMS
- Kesimpta is a targeted B-cell therapy while results are presented at EAN 2021 with other wide-ranging data to understand the impact of the immune response toward vaccinations
Organicell Reported Results of Expanded Access Trial for Zofin to Treat Mild to Moderate COVID-19
Date – June 16, 2021
Product – Zofin
- The company reported the results of an expanded access trial for Zofin in patients with COVID-19 which was conducted in Houston, TX
- The trial met EPs for safety & efficacy i.e., improved pulmonary opacities in chest X-rays which showed 83% of patients had normal lung imaging, indicated complete recovery @30 days treatment, improved biomarker levels vs respective control with p-values, mitigated mild and moderate symptoms, was well tolerated with no AEs
- The company will submit this data to FDA for a requested amendment to their approved IND to perform a PBO-controlled P-II clinical trial and also plans to submit results for scientific peer review & publication
Merck Signed ~$1.2B Supply Agreement with US Government for Molnupiravir to Treat COVID-19
Date – June 10, 2021
Product – Molnupiravir
- Merck to receive ~$1.2B to supply ~1.7M courses of molnupiravir to the US government, if its receives EUA or approval from the US FDA and expects to have 10M+ courses of therapy available by the end of 2021
- The therapy is currently being evaluated in a P-III MOVe-OUT study in non-hospitalized patients with COVID-19. Merck also plans to file for EUA or approval outside the US
- Merck is collaborated with generic manufacturers to accelerate the availability of the therapy in 104 LMICs, following the approvals or EUA by local regulatory agencies & plans to initiate a clinical program of molnupiravir for post-exposure prophylaxis in H2’21
MorphoSys Acquired Constellation Pharmaceuticals for ~$1.7B
Date – June 3, 2021
Product –N/A
- MorphoSys to acquire all of the outstanding shares of Constellation’s common stock for $34.00/ share in cash making a total equity value of $1.7B. The transaction is expected to close in Q3’21
- The acquisition will bolster Morphosys’ position in hematology-oncology & accelerates growth strategy with the addition of Constellation’s Pelabresib (CPI-0610) & CPI-0209
- Additionally, MorphoSys enters into a strategic funding partnership with Royalty Pharma, under which MorphoSys will receive $1.425B as up front, $350M as development funding bonds, $150 as milestones. Royalty Pharma will receive royalties and is expected to invest $100M in a cash capital increase of MorphoSys
Amgen and Kyowa Kirin Collaborated to Develop and Commercialize KHK4083 for Atopic Dermatitis
Date – June 1, 2021
Product – KHK4083
- Kyowa Kirin to receive ~$400M up front and an additional ~$850M as milestones along with royalties on future global sales. Both companies will share global development costs (Ex- Japan & the US)
- Amgen will responsible for the development, manufacturing, and commercialization of KHK4083 for all markets globally (Ex-Japan, where Kyowa Kirin will retain all rights) and also plans to utilize the data from its deCODE Genetics subsidiary for KHK4083 in other indications
- Kyowa Kirin will co-promote KHK4083 with Amgen in the US and have opt-in rights to co-promote KHK4083 in other markets outside the US including the EU and Asia
Related Post: PharmaShots’ Key Highlights of First Quarter 2021