PharmaShots' Key Highlights of Third Quarter 2021

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PharmaShots' Key Highlights of Third Quarter 2021

  • The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M
  • The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, Sanofi acquired Translate Bio for ~$3.2B
  • Our team at PharmaShots has summarized and complied with the insights of Q3'21

Junshi Reports NMPA's Acceptance of sNDA for Toripalimab + CT as 1L Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Date- July 30, 2021

Product- Toripalimab

  • The sNDA is based on the P-III JUPITER-06 study evaluating toripalimab + CT vs PBO + CT in 514 patients with locally advanced or metastatic ESCC
  • The results of the study showed that toripalimab + CT significantly improved both PFS and OS for patients with advanced or metastatic ESCC, regardless of PD-L1 expression status. The data will be presented soon at ESMO 2021
  • Toripalimab is the first domestic anti-PD-1 mAb obtaining marketing approval in China and has additionally received BTD, FTD & ODD from FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma

Janssen Amends its Agreement with Protagonist to Develop and Commercialize IL-23 Antagonists

Date- July 29, 2021

Product- PN-232 and PN-235

  • Protagonist to receive ~ $900M as development & sales milestones along with $80M already received under the original agreement with royalty rates remaining unchanged. Janssen will get right to continue research on IL-23 receptor antagonists developed under collaboration for 3yrs. following the closing of the amended agreement
  • Janssen will lead all future studies beyond the currently ongoing studies with PTG-200, PN-232, and PN-235 and will be solely financially responsible for any studies. The company will deploy its capabilities & experience for further development of these assets
  • PTG-200 is currently in P-II study for CD while PN-232 and PN-235 are currently in P-I clinical development

Meiji and Dong-A ST Sign an Exclusive License Agreement with Intas to Commercialize DMB-3115, Proposed Biosimilar to Ustekinumab

Date- July 23, 2021

Product- DMB-3115

  • Meiji and Dong-A ST to receive an upfront & will be eligible to receive development & sales milestones along with profit share. The companies collaborated to commercialize DMB-3115 proposed biosimilar to ustekinumab for the treatment of inflammatory diseases such as PsO, CD & UC
  • Intas to get exclusive license rights to commercialize DMB-3115 globally, Ex-Japan, Korea & Asia. Meiji and Dong-A ST will develop and manufacture DMB-3115 and supply the product to Intas and its WW affiliates
  • DMB-3115 is being evaluated in a P-III multi-regional clinical trial to treat patients with PsO in the EU & US

Regeneron's Ronapreve Antibody Cocktail (casirivimab and imdevimab) Receives MHLW,s Approval for the Treatment of Mild to Moderate COVID-19

Date- July 20, 2021

Product- Ronapreve (casirivimab and imdevimab)

  • The approval is based on the results from a P-III trial evaluating Ronapreve (casirivimab and imdevimab) in high-risk non-hospitalized patients with COVID-19
  • The results showed a reduction in the risk of hospitalization or death by 70% in addition to the results from a P-I trial that demonstrated the safety, tolerability & PK in Japanese patients
  • This marks the first time the Ab cocktail, known as REGEN-COV in the US and Ronapreve in other countries, has received a full approval to treat COVID-19

Eli Lilly to Acquire Protomer Technologies for ~$1B

Date- July 15, 2021

Product- N/A

  • Eli Lilly to acquire Protomer Technologies for ~$1B, with the achievement of future development and commercial milestones
  • Earlier, Lilly led an equity investment in Protomer along with JDRF T1D fund that provides Lilly with 14% ownership of promotor and is currently acquiring the remaining shares of Protomer beyond the initial investment
  • The acquisition will boost Lilly's diabetes pipeline with the addition of Protomer's glucose-sensing insulin that can sense sugar levels in the blood and automatically activate as needed throughout the day

The US FDA Approves FoundationOne CDx for Alunbrig (brigatinib) in Patients with ALK+ NSCLC

Date- July 2, 2021

Product- Alunbrig (brigatinib)

  • The US FDA has approved FoundationOne CDx to be used as a CDx for Alunbrig (brigatinib) which is approved for the treatment of adult patients with ALK+ mNSCLC as detected by an FDA-approved test
  • In Sept'20, Foundation Medicine and Takeda collaborated to develop CDx for therapies in its late-stage lung portfolio
  • FoundationOne CDx is the only FDA-approved tissue-based CGP test and is now able to detect ALK+ mNSCLC and identify patients who may be appropriate for treatment with Alunbrig which is approved as a 1L or later-line therapy

BeyondSpring Signs an Exclusive Agreement with Jiangsu Hengrui to Co-Develop & Commercialize Plinabulin in Greater China

Date- Aug 27, 2021

Product- Plinabulin

  • Wanchunbulin to receive $30M up front, $170M as regulatory and sales milestone & is eligible to receive $15M as equity investment at a pre-money valuation of $560M
  • Hengrui gets exclusive rights to commercialize & co-develop plinabulin in Greater China and will be accountable for all costs associated with the commercialization of plinabulin in the territory while Wanchunbulin will hold the manufacturing rights of plinabulin in the territory
  • Hengrui will fund 50% of the clinical development costs for additional indications of plinabulin in the territory & Wanchunbulin will be responsible for 100% of clinical and regulatory costs for the first two indications to prevent CIN & NSCLC

Novartis Kymriah (tisagenlecleucel) Fails to Meet its Primary Endpoint in P-III BELINDA Study as 2L Treatment in Aggressive B-Cell Non-Hodgkin Lymphoma

Date- Aug 24, 2021

Product- Kymriah (tisagenlecleucel)

  • The P-III BELINDA study evaluates the efficacy, safety, & tolerability of Kymriah vs SOC in patients with aggressive B-cell NHL who had the primary refractory disease or relapsed within 12mos. of 1L treatment in 73 sites across 18 countries globally
  • The study did not meet its 1EPs of EFS while the safety profile was consistent with an established safety profile of Kymriah. The therapy demonstrated strong response rates & a remarkable safety profile in r/r FL with an anticipated regulatory filing in H2'21
  • Kymriah is 1st FDA-approved CAR-T cell therapy for r/r ALL in pediatric & adult patients and r/r adult DLBCL. The company continues to accelerate the development of a next-generation platform

Merck KGaA and GSK Discontinue P-II INTR@PID BTC 055 Study of Bintrafusp Alfa as 1L Treatment of Biliary Tract Cancer

Date- Aug 24, 2021

Product- Bintrafusp Alfa

  • Merck KGaA discontinues its P-II INTR@PID BTC 055 study evaluating bintrafusp alfa with gemcitabine + cisplatin in patients with locally advanced or metastatic BTC
  • The discontinuation is based on the IDMC's recommendation following a review of data which concluded that the trial fails to meet the primary objective of OS & no new safety signals were observed
  • Bintrafusp alfa (M7824) is a bifunctional fusion protein targeting TGF-ß and PD-L1. The therapy is currently in clinical development under collaboration with GSK

The US FDA Rejects Sesen Bio's Vicineum (oportuzumab monatox-qqrs) for the Treatment of BCG-Unresponsive NMIBC

Date- Aug 16, 2021

Product-Vicineum (oportuzumab monatox-qqrs)

  • The company has received the FDA's CRL declining the approval of Vicineum's BLA to treat BCG-unresponsive NMIBC
  • The FDA has provided recommendations to conduct additional clinical/statistical data and analyses of roxadustat in addition to CMC issues related to a recent pre-approval inspection and product quality
  • The company plans to meet with the FDA as soon as possible to discuss the next steps for regulatory approval. Additionally, the therapy is currently in a P-III registration trial in the US for the treatment of BCG-unresponsive NMIBC

AbbVie Terminates its License Agreement with Molecular Partners for Abicipar Pegol

Date- Aug 10, 2021

Product- Abicipar Pegol

  • AbbVie has terminated the license agreement for abicipar pegol to treat nAMD and DME. Additionally, Molecular Partners will reacquire the development and commercial rights of abicipar globally
  • Molecular Partners will put a special committee to assess the program & figure out the next steps. Additionally, the companies will continue the ongoing discovery collaboration to evaluate additional DARPin candidates for other ophthalmic indications
  • Abicipar is a long-acting anti-VEGF DARPin molecule that is being evaluated in two P-III studies i.e., CEDAR and SEQUOIA that supported the non-inferior efficacy of Abicipar (quarterly dosing regimen) to maintain vision gains

Polpharma & Bioeq Report BLA Submission to the US FDA for FYB201 (biosimilar, ranibizumab)

Date- Aug 6, 2021

Product- FYB201 (biosimilar, ranibizumab)

  • Polpharma has reported that its JV company, Bioeq has submitted a BLA for FYB201 (biosimilar referencing Lucentis) to the FDA. FYB201 was originally licensed from Formycon AG
  • The launch of biosimilar ranibizumab may increase market competition, reduce cost and expand patient access with proven analytical & clinical similarity to Lucentis
  • Lucentis is a mAb fragment used to treat various types of macular-degenerative diseases including wet AMD, DR, macular edemas and MCNV. If approved, Coherus will commercialize FYB201 in the US

Sanofi to Acquire Translate Bio for ~$3.2B

Date- Aug 3, 2021

Product- N/A

  • Sanofi to acquire all outstanding shares of Translate Bio for $38.00/share in cash making a total equity value of ~$3.2B with a premium of 30.4% to Translate Bio's one-day prior closing price of $29.15. The acquisition is expected to complete in the Q3'21
  • The acquisition will utilize mRNA technology to further accelerates Sanofi's licensed programs to develop transformative therapies & vaccines
  • In Jun'18, Sanofi entered into a license agreement with Translate Bio to develop mRNA vaccines & further expanded in 2020 for infectious diseases. Additionally, the recent acquisition of Tidal has expanded Sanofi's mRNA research capabilities in both immuno-oncology and inflammatory diseases

Merck to Acquire Acceleron for ~$11.5B

Date- Sept 30, 2021

Product- N/A

  • Merck to acquire Acceleron for $180/share in cash making a total equity value of ~$11.5B representing a premium of 2.6% to the stock's closing price. The transaction is expected to close in Q4'21
  • The acquisition will strengthen Merck's cardiovascular pipeline. Acceleron's sotatercept is currently in P-III trials & has the potential to improve short-term & long-term clinical outcomes in patients with PAH
  • In 2011, Acceleron has entered into a collaboration with BMS to develop and commercialize Reblozyl. The therapy has been approved in the US, EU, Canada, and Australia for the treatment of anemia in rare blood disorders

ViiV Healthcare Signs an Exclusive License Agreement with Shionogi to Develop S-365598 for HIV

Date- Sept 28, 2021

Product- S-365598

  • Shionogi to receive $27.2M up front, $20.4M upon the achievement of a clinical milestone along with royalties on net sales of S-365598 (HIV integrase inhibitor) & will provide the development costs up to an annual maximum
  • The collaboration will advance ViiV Healthcare's pipeline for HIV treatment. The therapy has the potential for use in ultra long-acting HIV regimens with dosing intervals of =3mos.
  • The preliminary data showed that S-365598 has a high genetic barrier and a resistance profile that are distinct from dolutegravir and cabotegravir. Additionally, both companies plan to initiate human studies of S-365598 by 2023

Bio-Thera Signs a License Agreement with Intract for Soteria and Phloral Technologies to Develop Oral Antibody Therapies

Date- Sept 28, 2021

Product- N/A

  • Intract to receive an up front, development & commercial milestone along with royalties on product sales. Bio-Thera gets global license to Intract's Soteria & Phloral oral drug delivery platform to develop a mAb product for chronic GI inflammatory diseases
  • Intract will be responsible for preclinical research of the product while Bio-Thera will get an option to expand the development of the product for multiple GI indications & will lead the manufacturing & commercialization of any approved products
  • Intract's Soteria protects proteins such as mAbs from degradation in intestinal lumen whereas Phloral utilizes pH & enzymes produced by colonic bacteria to allow payloads in the colon

Novartis to Acquire Arctos to Boost its Optogenetics Portfolio to Treat Eye Diseases

Date- Sept 21, 2021

Product- N/A

  • The acquisition expands Novartis ophthalmology portfolio with the addition of Arctos’ pre-clinical optogenetics-based AAV gene therapy program and its technology
  • The acquisition marks the Novartis commitment to identify optogenetics-based therapies for the treatment of patients with vision loss
  • Arctos has developed its technology to treat IRDs and other diseases that involve photoreceptor loss, such as AMD. Arctos optogene is delivered to specific retinal cells using gene therapy to convert targeted cells into replacement photoreceptor-like cells

Abbott's Portico with Flexnav Tavr System Receives the US FDA's Approval for the Treatment of Aortic Valve Disease

Date- Sept 21, 2021

Product- Portico

  • The US FDA has approved Abbott's Portico with FlexNav TAVR system to treat patients with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery. The system provides a safe & effective treatment option
  • Abbott's Portico is a self-expanding TAVR valve with an intra-annular leaflet that is designed to provide optimal blood flow when placed inside a patient's natural valve
  • Portico device is implanted using Abbott's FlexNav delivery system to accommodate different patient anatomies, small vessels, flexibility, tracking & precision of valve placement. Abbott offers a robust portfolio of structural heart solutions in the US including minimally invasive therapies

Merck Reports Results of Keytruda (pembrolizumab) in P-III KEYNOTE-826 Trial as 1L Treatment for Cervical Cancer

Date- Sept 20, 2021

Product- Keytruda (pembrolizumab)

  • The P-III KEYNOTE-826 trial evaluates Merck's Keytruda (200mg, IV, q3w for up to 35 cycles) + Pt-based CT vs PBO + CT with/out bevacizumab in 617 patients aged b/w 22- 82yrs. with persistent, recurrent, or metastatic cervical cancer
  • The results showed a 33% reduction in the risk of death; m-OS (24.4 vs 16.5mos.), m-PFS (10.4 & 8.2 mos.); ORR (65.9% & 50.8%); m-DoR (18.0 & 10.4mos.), TRAEs grade =3 (68.4% & 64.1%), discontinuation of the treatment due to TRAEs (31.3% & 3.3%) in patients with combination therapy. The results were consistent with/out bevacizumab use
  • Keytruda is an anti- PD-1 therapy that increases the ability of the body's immune system to help detect and fight tumor cells

Biogen to Initiate P-IIIb ASCEND Study Evaluating Higher Doses of Spinraza (nusinersen) for the Treatment of Spinal Muscular Atrophy

Date- Sept 16, 2021

Product- Spinraza (nusinersen)

  • The P-IIIb ASCEND study will evaluate the clinical outcomes & safety of the higher doses of nusinersen in 135 patients aged 5-39yrs. with SMA prior treated with Evrysdi at MRD (5mg). Patients will receive 2 loading doses of nusinersen (50mg, 2wks. apart), followed by a maintenance dose of 28mg, q4mos. in the study period & 1st patients are expected to be enrolled in 2021
  • The study will also evaluate upper limb fine motor function in patients aged =13yrs. using Konectom app & neurofilament levels as a biomarker. The therapy demonstrated a sustained efficacy & safety profile
  • Nusinersen has marketed as Spinraza with the US FDA approved dose (12mg) & is being evaluated in an ongoing DEVOTE study

AzurRx Signs a Reverse Triangular Merger Agreement to Acquire First Wave Bio for ~$229M

Date- Sept 14, 2021

Product- N/A

  • AzurRx to acquire First Wave Bio for $229M in cash & stock including development, regulatory & sales milestones. The transaction is anticipated to close imminently
  • The acquisition will boost AzurRx's GI pipeline including three new clinical IBD indications for UPS, UC & CD. In Jan'21, AzurRx in-licensed an exclusive global right to develop two niclosamide therapeutic indications for COVID-19-related GI infections & ICI-AC in cancer patients
  • AzurRx will change its corporate name to First Wave BioPharma under the new ticker symbol 'FWBI'. The acquisition allows AzurRx to retain all rights to First Wave Bio's niclosamide formulations to treat multiple GI condition

Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD

Date- Sept 10, 2021

Product- Byooviz (biosimilar, ranibizumab)

  • The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021
  • The 1EPs are changed from baseline in BCVA @8wks. and change in CST @4wks. with both EPs, followed by 52wks. The post-hoc analysis showed that the baseline age, BCVA, CST, and total lesion size were identified to be associated with the visual acuity & anatomical outcomes
  • In subgroup analysis, similar visual outcomes of 2 products in change from baseline in BCVA in multiple subgroups were observed & support an equivalent clinical efficacy. Byooviz is an effective & valuable treatment option for nAMD patients globally

Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) Receive the US FDA's Breakthrough Therapy Designation for the Treatment of Heart Failure with Preserved Ejection Fraction

Date- Sept 10, 2021

Product- Jardiance (empagliflozin)

  • The designation is based on the P-III EMPEROR-Preserved trial that evaluates the safety and efficacy of empagliflozin (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes
  • The results demonstrated a 21% reduction in risk for the composite 1EPs of CV death or hospitalization for adults with HF. The results were presented at ESC 2021 & published in NEJM
  • Empagliflozin has previously received FTD from FDA to reduce the risk of CV death and hospitalization for HF & is approved for HFrEF with/out diabetes in the EU & US. Additionally, the companies plan for global regulatory submissions for HFpEF in 2021

Sandoz Enters into a Commercialization and License Agreement with Bio-Thera to Commercialize BAT1706, a Proposed Biosimilar Avastin (bevacizumab)

Date- Sept 9, 2021

Product- BAT1706

  • Bio-Thera to receive upfront, milestones along with royalties on product sales & will be responsible for the development, manufacturing, supply of BAT1706
  • Sandoz to get rights for the commercialization of the therapy upon approval in the US, EU, Canada, and other countries. Bio-Thera's BAT1706 has completed extensive biosimilar studies, including a global P-III study
  • Bevacizumab is a humanized mAb that targets VEGF. Avastin has been approved in the US and EU to treat multiple types of cancer

AM-Pharma Enters into an Exclusive License Agreement with Kyowa Kirin to Commercialize Ilofotase Alfa in Japan

Date- Sept 8, 2021

Product- Ilofotase Alfa

  • AM-Pharma to receive $23.6M up front, $35.4M in milestones before regulatory submission, and ~$230.4M upon submission, NHI price listing & sales milestone along with royalties on sales and a drug supply fee
  • Kyowa Kirin to get the exclusive right to develop and commercialize ilofotase alfa in Japan. Ilofotase alfa is currently being evaluated in a P-III REVIVAL study in 1600 patients with SA-AKI
  • AM-Pharma is responsible for the completion of the P-III REVIVAL study & P-I PK, safety, and tolerability study in Japan. Kyowa Kirin will lead the regulatory approval process and commercialization of ilofotase alfa in Japan

Baxter to Acquire Hillrom for ~$10.5B

Date- Sept 3, 2021

Product- N/A

  • Baxter to acquire Hillrom for $156.00/ share in cash making a total equity value of ~$10.5B representing a premium of 26% to the stock's closing price of $124 and a total enterprise value of ~ $12.4B, including the assumption of debt. The acquisition is expected to be closed in early 2022
  • The acquisition will expand access to Hillrom's portfolio globally and accelerate the company's expansion into digital and connected care solutions at home or in other care settings
  • Baxter to get a broader array of medical products and services to patients and clinicians across the continuum of care. The companies expect about $250M in annual cost synergies over the next three yrs.

BMS Exercised Its Option to License Evotec’s EVT8683 for the Treatment of Neurodegenerative Disease

Date- Sept 2, 2021

Product- EVT8683

  • Evotec receives $20M as an option fee & is eligible to receive ~$250M as milestones along with royalties. BMS will be responsible for further development & commercialization of a product
  • BMS has exercised its option to license Evotec’s EVT8683 after 4.5yrs. of collaboration. Evotec’s iPSC platform allows screening of human iPSC-based disease models at high throughput in combination with unbiased transcriptome analysis
  • EVT8683 is a small molecule targeting a key cellular stress response for multiple neurodegenerative indications and is ready to enter clinical development. The candidate was originated from Evotec’s iPSC discovery platform

AstraZeneca Signs a Multiyear Agreement with Thermo Fisher to Co-Develop NGS-based CDx for Targeted Therapies

Date- Sept 2, 2021

Product- N/A

  • The collaboration will expand AstraZeneca’s portfolio of targeted therapies for cancer & other diseases. Thermo Fisher currently offers the NGS CDx solution which is approved and reimbursed by government & commercial insurers in 15+ countries, including the US, EU, Japan, South Korea & Middle East
  • The agreement also provides the technology, expertise & ability to decentralize CDx tests to AstraZeneca which will help to identify patients globally who may benefit from treatments
  • Thermo Fisher’s Ion Torrent Genexus System can be used to expand patient access to precision therapies which was launched in 2019. The system is the fully integrated NGS platform with an automated specimen workflow that delivers results in a single day

Merck and Ridgeback Initiate P-III MOVe-AHEAD Study of Molnupiravir for the Prevention of COVID-19 Infection

Date- Sept 1, 2021

Product- Molnupiravir

  • The company initiates a P-III MOVe-AHEAD trial to evaluate molnupiravir (800 mg, q12h for 5 days) vs PBO in ~1,332 participants aged 18yrs. who reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. The trial is being conducted globally
  • The 1EPs of trial i.e., proportion of participants with COVID-19 (laboratory-confirmed) @14days, percentage of participants with an AEs & who discontinued the study due to AEs
  • The safety & efficacy of molnupiravir is also being evaluated in Part 2 of an ongoing P-III MOVe-OUT trial for non-hospitalized patients with at least one risk factor due to poor disease outcomes. The results are expected in H2’21

Novartis Signs an Agreement with NHS to Commercialize Leqvio (inclisiran) for the Treatment of Cardiovascular Disease

Date- Sept 1, 2021

Product- Leqvio (inclisiran)

  • The agreement follows the NICE recommendation to deliver Leqvio via a population health management approach for high-risk cardiovascular patients across England
  • The NICE recommendation was based on Novartis’s ORION clinical research program including P- III trials ORION-9/10/11 evaluating the safety, efficacy, and tolerability of inclisiran in 3,600 patients with CVD which showed that the therapy-maintained LDL-C reduction through 6mos. dosing interval
  • Inclisiran is the 1st siRNA therapy for the reduction of LDL-C levels via RNAi & is licensed in the EU for the treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet

Related Post: PharmaShots' Key Highlights of First Quarter 2021

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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