PharmaShots' Key Highlights of Second Quarter 2023

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PharmaShots' Key Highlights of Second Quarter 2023


  • The second quarter of 2023 highlights multiple clinical trial results, approvals, and numerous deals. There are major alliances in this quarter which include Merck acquired Prometheus for ~$10.8B and Astellas entered into a definitive agreement to acquire Iveric Bio for ~$5.9B
  • The second quarter of the year also showcases multiple approvals of the therapies which include Sanofi’s Dupixent (dupilumab) received Health Canada’s approval for adults and adolescent patients aged ≥12 years with eosinophilic esophagitis
  • Our team at PharmaShots has summarized and complied with the insights of Q2'23

AstraZeneca Reports P-III Trial (DUO-O) of Lynparza (olaparib) and Imfinzi (durvalumab) for Advanced Ovarian Cancer without Tumour BRCA Mutations

Date - Apr 05, 2023                                                 

Product – Lynparza

  • The company highlighted the results from a planned interim analysis of the P-III trial evaluating Imfinzi + Pt-based CT & bevacizumab vs CT + bevacizumab in a ratio (1:1:1) in ~1200 patients at 179 study locations, followed by maintenance treatment with Imfinzi & bevacizumab with/out Lynparza
  • Lynparza, Imfinzi, CT & bevacizumab achieved an improvement in PFS. Imfinzi, CT + bevacizumab showed a numerical improvement in PFS but did not reach statistical significance at this interim analysis while OS & other 2EPs are immature and will be formally assessed at a subsequent analysis
  • The safety & tolerability were consistent with prior trials & known profiles of the individual therapies. The results will be shared with health authorities

Moderna and Merck’s mRNA-4157/V940 + Keytruda Receives PRIME Scheme Designation by the EMA for Adjuvant Treatment of High-Risk Stage III/IV Melanoma

Date - Apr 07, 2023                                                

Product – mRNA-4157/V940 + Keytruda

  • The PRIME scheme designation was granted based on the results from the P-IIb clinical trial (KEYNOTE-942) evaluating mRNA-4157/V940 + Keytruda vs Keytruda alone in patients (n=157) with stage III/IV melanoma following complete resection. The 1EPs of the study were RFS & 2EPs were distant metastasis-free survival & safety
  • The results from the study depicted statistically significant & clinically meaningful improvement in the 1EPs of RFS alone and reduced the risk of recurrence or death by 44% in mRNA-4157/V940 + Keytruda vs Keytruda
  • mRNA-4157/V940 is a single synthetic mRNA that can encode for up to 34 neoantigens. It is an mRNA-based personalised cancer vaccine that was created based on the distinct mutational signature of the patient's tumour

Merck to Acquire Prometheus for ~$10.8B

Date - Apr 17, 2023                                                

Product – PRA023

  • Merck to acquire Prometheus for $200.00/share in cash for a total equity value of ~$10.8B representing a 75% premium to the $114.01 closing price for Prometheus shares. The transaction is expected to be closed in Q3’23
  • The acquisition will allow Merck to move into immunology after promising experimental treatment for CD and UC. The transaction diversifies Merck's portfolio and will help drive its growth well into the next decade
  • Prometheus’ PRA023, a humanized mAb directed to TNF-like ligand 1A is being developed to treat UC, CD, and other autoimmune conditions while target discovery and precision medicine in inflammation and immunology are made possible by Prometheus Biosciences' extensive data set

MorphoSys and Incyte Presents Five-Year P-II Study (L-MIND) Results of Monjuvi (tafasitamab-cxix) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma AACR 2023

Date - Apr 17, 2023                                                 

Product – Monjuvi

  • The P-II study evaluating tafasitamab + lenalidomide in 81 patients who had one but no more than 3 prior lines of therapy, incl. an anti-CD20 targeting therapy who were not eligible for high-dose CT or refused subsequent autologous SCT
  • At data cut-off of Nov 2022, the therapy showed ORR (57.5%), CR (41.2%); PR (16.2%) & additional results incl. mDoR (not reached) after a median follow-up of 44.0mos., m-OS (33.5mos.) & m-PFS (11.6mos.). Among 21 patients with >60mos. of follow-up, 14 had received 1 prior line of therapy (pLoT) & 7 with ≥2 pLoT
  • Patients achieved higher ORR (67.5%) with 1 pLoT (CR = 52.5% & PR = 15%) vs 47.5% with 2 pLoT (CR = 30% & PR = 17.5%) with no new safety signals, patients experienced a lower frequency of all-grade & grade ≥3 AEs during monotx.

GSK to Acquire BELLUS Health for ~$2.0B

Date - Apr 18, 2023                                                 

Product – camlipixant

  • GSK will acquire BELLUS Health for $14.75 per share in cash representing a total equity value of ~$2.0B at a premium of ~103% to BELLUS' closing stock price. The transaction is expected to close in Q3'23
  • The acquisition gives GSK access to camlipixant (highly selective P2X3 antagonist) for adult patients with RCC. The acquisition further strengthens specialty medicines and respiratory pipeline with camlipixant
  • Camlipixant is currently in P-III clinical development with anticipated regulatory approval & launch in 2026. In the P-IIb trial (SOOTHE) trial, camlipixant was shown to be effective at reducing 24hr. cough frequency with BID, 50 & 200mg oral dosing & 34% reduction in the rate vs PBO at 28 Day

Novartis to Present Five-Year (ALITHIOS) Open-Label Extension Study Results of Kesimpta (ofatumumab) for Relapsing Multiple Sclerosis at AAN 2023

Date - Apr 20, 2023                                                

Product – Kesimpta

  • The (ALITHIOS) OLE study evaluating Kesimpta which showed continuous treatment with Kesimpta for ~5yr. was associated with fewer confirmed disability worsening events vs those who switched later from teriflunomide to Kesimpta
  • ~80% remained free of 6mos. CDW, low brain volume change over 5yr. favored earlier initiation of Kesimpta, ABVC in the core P-III trials for continuous Kesimpta was -0.34%/yr. vs switch group (-0.42%/yr.) while -0.27%/yr. vs -0.28%/yr. in the extension
  • In the separate analysis, the therapy was well-tolerated with no new or increased safety risks, overall rates of AEs & SAEs were consistent with the core P-III trials, IgG levels remained stable @~5yr., treatment interruption/discontinuation due to low lgG & lgM in (0.2% & 10.3%)/ (0.2% & 3.6%) patients

Medtronic’s MiniMed 780G System Receives the US FDA’s Approval for the Treatment of Type 1 Diabetes

Date - Apr 20, 2023                                                

Product – MiniMed 780G System

  • The US FDA has approved the MiniMed 780G system with the Guardian 4 sensor. The system features SmartGuard technology that automatically adjusts insulin delivery & corrects glucose levels every 5 minutes, 24/7 with no finger pricks for basal & bolus insulin needs
  • The system also offers multiple glucose targets as compared to a single target. In a pivotal trial, use of the MiniMed 780G System was associated with a time in the range of 70-180 mg/dL of 75% & an overall time below the range of 1.8%
  • In the ADAPT study, MiniMed780G System users experienced a 27.6% increase in time in range and a 1.4% reduction in mean HbA1C over those using multiple daily injections in conjunction with an intermittently scanned CGM without increased time in hypoglycemia

Eli Lilly to Sell Baqsimi to Amphastar for ~$1B

Date - Apr 25, 2023                                                

Product – Baqsimi

  • Lilly will receive $500M in cash at closing, ~$125M upon 1yr. anniversary of closing, ~$450M in additional sales-based milestones, based on annual sales of $175M & $200M and total net sales over 5yr. of $950M. The transaction is expected to close in Q3’23
  • Lilly will be responsible for the development, manufacture & commercialization of Baqsimi. Amphastar will provide commercial investment for Baqsimi to help more insulin users be prepared with a glucagon rescue treatment for sev. hypoglycemia
  • The acquisition of Baqsimi will integrate Amphastar’s strategic vision to expand its proprietary products & enhance its diabetes portfolio. Baqsimi is the first nasally administered glucagon for sev. hypoglycemia in diabetes patients & is available in 27 international markets

Assertio Holdings to Acquire Spectrum Pharmaceuticals for ~$291M

Date - Apr 26, 2023                                                

Product – N/A

  • Spectrum stockholders will receive up front of 0.1783 ASRT shares per SPPI share ($1.14/share) representing a premium of 65% plus one CVR per Spectrum share for total consideration of ~$1.34/share & an additional $0.20/share (~$43M) in cash or stock at Assertio's election for $1.34 ($291M) representing a premium of 94% to Spectrum’s latest closing price. The acquisition is expected to close in Q3’23
  • Assertio stockholders to own ~65% & Spectrum stockholders will own ~ 35% of combined company. Spectrum’s combined assets & commercial infrastructure will accelerate Rolvedon’s launch for patients' benefit & drive further growth
  • The combination of Assertio’s Omni-Channel digital sales capabilities & Rolvedon's in-person commercial team will enhance market access & growth across all products

Biogen and Ionis Receive the US FDA’s Approval of Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis

Date - Apr 26, 2023                                                

Product – Qalsody

  • The US FDA has granted accelerated approval to Qalsody (100mg/15mL) for adults with ALS who have a mutation in the SOD1 gene. The indication was approved based on a reduction in plasma NfL
  • The approval was based on 28wk. P-III study (VALOR) evaluating tofersen vs PBO in a ratio (2:1) in 108 adults aged 23-78yrs. In the primary analysis population, less decline from baseline as measured by ALSFRS-R & the results were not statistically significant
  • In the overall ITT population, 55% reduction in plasma NfL vs 12% increase in PBO. Levels of CSF SOD1 protein, an indirect measure of target engagement was reduced by 35% vs 2%. Findings from an interim analysis at 52wks. showed similar reductions in NfL in patients previously receiving PBO who initiated tofersen in OLE & those who received tofersen in 28wk. study

Starton Therapeutics to go Public via Healthwell Acquisition Corp. I SPAC Merger for ~$374M

Date - May 01, 2023                                                

Product – N/A

  • The combined company will have a pro forma enterprise value of $339M & an equity value of $374M with ~$250M held in a trust account at JPMorgan Chase Trust. The combined company will receive $50M incl. $35M held in trust & $15M in PIPE financing at $10.15/share in cash
  • Starton existing stakeholders are also eligible for 25M shares in milestones in 3 equal tranches of 8.3M payable upon the combined company share price reaching (i) $12 for 20 trading days (ii) $14 for 20 trading days, or upon completing P-Ib trials for MM (iii) $16 for 20 trading days or upon completing the bridging study. The transaction is expected to close in H2’23
  • The combined company will be renamed Starton Holdings Corp. & will be listed on NASDAQ with a focus on developing therapies for MM & chronic lymphocytic leukemia. Starton’s technology focuses to provide continuous delivery treatment for cancer patients

Astellas Entered into a Definitive Agreement to Acquire Iveric Bio for ~$5.9B

Date - May 01, 2023                                                

Product – avacincaptad pegol

  • Astellas to acquire 100% of the outstanding shares of Iveric Bio for $40.00/share in cash for a total equity value of ~$5.9B incl. 148.2M outstanding shares of Iveric Bio common stock on a fully diluted basis representing 22% premium to $32.89 closing price. The acquisition is expected to be completed in Q2’23
  • Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas & focuses on the discovery and development of novel treatments in the field of ophthalmology. The acquisition advances Astellas’ primary focus on blindness & regeneration, also enable Astellas to deliver greater VALUE to patients with ocular diseases at high risk of blindness
  • The US FDA has accepted the NDA for avacincaptad pegol (ACP) to treat GA secondary to AMD & granted priority review with an expected date on Aug 19, 2023

Elanco Animal Health’s Varenzin-CA1 Receives the US FDA’s Conditionally Approval for Nonregenerative Anemia in Cats with Chronic Kidney Disease

Date - May 02, 2023                                                

Product – Varenzin-CA1

  • The US FDA has conditionally approved the first drug, Varenzin-CA1 (molidustat oral suspension) for the management of nonregenerative anemia in cats with CKD. The US FDA was granted the expanded conditional approval authority in the Animal Drug User Fee Act of 2018 with the program planned to sunset in 2028
  • The efficacy of molidustat oral suspension had been established based on the results of a study conducted in 2 phases in 23 cats aged 4-17yrs. from various breeds or breed mixes
  • Varenzin-CA1 is in the form of a liquid and is given by mouth to the cat qd for ~28 days & the treatment can be repeated as needed after a minimum of 7-day pause. The drug is only available by prescription from a licensed veterinarian

Eli Lilly Presents P-III Clinical Development Program Results of Lebrikizumab for Atopic Dermatitis at 5th Annual RAD Congress

Date - May 03, 2023                                                

Product – Lebrikizumab

  • The secondary analysis from the P-III trial (Advocate 1& 2) in 869 patients evaluating lebrikizumab vs PBO. The (ADhere) study evaluating lebrikizumab + TCS vs PBO + TCS in 228 patients
  • In 16wk. induction periods, the results showed an improvement or clearance of the face (62% vs 32% & 58% vs 22%) in the (Advocate 1& 2) study; 69% vs 46% in (ADhere) study, or hand dermatitis (67% vs 29% & 62% vs 19%) and 73% vs 43%, respectively. An additional secondary analysis demonstrated stable & long-lasting results of lebrikizumab (q4w or q2w)
  • 80% in (ADvocate 1 & 2) trial maintained EASI-75 response, 70% maintained EASI-75 response with no or minimal fluctuations across 10 study visits @1yr. Lilly & partner Almirall S.A. expect regulatory decisions in the US & EU in 2023

Alvotech Reports an Initiation of AVT05, a Proposed Biosimilar for Simponi and Simponi Aria to Treat Moderate to Severe Rheumatoid Arthritis

Date - May 04, 2023                                                 

Product – AVT05

  • The company initiates the P-II confirmatory patient study of AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab) evaluating the efficacy, safety, and immunogenicity of AVT05 (SC) vs EU-approved Simponi in adult patients with mod. to sev. rheumatoid arthritis
  • The primary outcome measures will be to show the comparative efficacy of AVT05 vs Simponi @16wks. based on change from baseline on a standardized DAS28-CRP which evaluates the severity of RA using clinical and laboratory data
  • Additionally, the company initiates PK study for AVT05 in Jan 2023. Golimumab is a mAb that inhibits tumor necrosis factor-alpha (TNF alpha)

Magenta Therapeutics Entered into a Definitive Merger Agreement with Dianthus Therapeutics to Advance DNTH103 for Severe Autoimmune Diseases

Date - May 04, 2023                                                

Product – DNTH103

  • The combined company will have ~$180M in cash or cash equivalents incl. ~$70M from concurrent private financing by Dianthus’ new & existing investors which is expected to provide funding into mid-2026. The transaction is expected to close in Q3’23
  • The funding will support DNTH103 through multiple clinical data catalysts incl. P-I trial in healthy volunteers & P-II trials in gMG & other indications (expected to initiate in Q1’24). The combined company focuses on advancing Dianthus’ pipeline of complement inhibitors, incl. DNTH103 which is being studied in a P-I trial (expected to be completed at the end of 2023)
  • Dianthus stockholders will own ~78.7% and pre-merger Magenta stockholders will own ~21.3% of the combined company. The combined company is expected to operate under the name Dianthus Therapeutics, Inc. & trade on the Nasdaq under the ticker “DNTH”

Sanofi’s Dupixent (dupilumab) Receives Health Canada’s Approval for Adults and Adolescent Patients Aged ≥12 Years with Eosinophilic Esophagitis

Date - May 05, 2023                                                

Product – Dupixent

  • Health Canada has approved Dupixent for patients aged ≥12yrs. The P-III trial (LIBERTY-EoE-TREET) consists of parts A & B evaluating Dupixent (300mg, qw) vs PBO in 39 & 79 patients
  • Parts A of the trial met co-1EPs & all 2EPs and showed improved structural & histologic measures while rapidly improving the ability to swallow. Additional improvements in disease severity & extent, as well as normalized gene expression associated with type 2 inflammation, were reported
  • Part B showed improvement in the signs & symptoms @24wks. & the safety results were consistent with the known safety profile of Dupixent in its approved indications. Dupixent is a fully human mAb inhibiting signaling of IL-4 & IL-13 pathways

Zoetis’ Librela (bedinvetmab) Receives the US FDA’s Approval to Control Osteoarthritis Pain in Dogs

Date - May 08, 2023                                                

Product – Librela

  • The US FDA has approved the first anti-NGF mAb treatment, Librela (qm) for the control of pain associated with OA in dogs
  • The results from 2 field studies showed a reduction in OA over PBO and reduces pain. Acc. to studies, Librela improves people's mobility & overall QoL while Librela's effectiveness might not become apparent until after 2nd dose, dogs may also experience a reduction in pain as early as 7days after 1st dose
  • Additionally, dogs treated with bedinvetmab experienced lasting OA pain relief over the course of the study with monthly inj. in a continuation study. The therapy is expected to be available in the US in late 2023 & was approved for use in Canada, Brazil, Australia, New Zealand, Japan & other markets

Janssen Presents P-III Induction Study (QUASAR) Results of Tremfya (guselkumab) for Moderately to Severely Active Ulcerative Colitis at DDW 2023

Date - May 10, 2023                                                

Product – Tremfya

  • The new efficacy & safety data from the P-III study evaluating Tremfya vs PBO in 1064 patients who had an inadequate response or intolerance to conventional and/or advanced therapies
  • The results showed clinical remission (22.6% vs 7.9%) @12wk.; symptomatic remission (22.6% vs 12.9%) @4wk. & 49.9% vs 20.7% @12wk. Tremfya-treated patients @12wk. showed a clinical response (61.5% vs 27.9%); endoscopic improvement (26.8% vs 11.1%); histo-endoscopic mucosal (23.5% vs 7.5%) & endoscopic normalization (15.0% vs 5.0%)
  • Frequencies of TEAEs were comparable with fewer SAEs (2.9% vs 7.1%) & AEs leading to discontinuation (1.7% vs 3.9%). The safety results were consistent with a known safety profile of Tremfya in approved indications

AstraZeneca’s Ultomiris (ravulizumab) Receives EC’s Approval for the Treatment of Neuromyelitis Optica Spectrum Disorder in EU

Date - May 11, 2023                                                 

Product – Ultomiris

  • The EC has approved Ultomiris (C5 complement inhibitor) for adult patients with anti-aquaporin-4 (AQP4) Ab+ NMOSD
  • The approval was based on the results from the P-III trial (CHAMPION-NMOSD) published in the Annals of Neurology evaluating Ultomiris in 58 patients across North America, the EU, Asia-Pacific & Japan which showed that Ultomiris met the 1EPs of time to first on-trial relapse
  • Zero relapses were reported in patients with a median treatment duration of 73wks. (98.6% in relapse risk reduction) and continuing through a median duration of 90wks. & the safety & tolerability was consistent with prior studies and real-world use with no new safety signals. The regulatory submissions are under review with multiple health authorities, incl. in the US & Japan

Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics Receive NICE Recommendation of Kapruvia (difelikefalin) for CKD-Associated Pruritus

Date - May 18, 2023                                                

Product – Kapruvia

  • The NICE has recommended Kapruvia for treating patients with mod. to sev. CKD-associated pruritus in adult patients on haemodialysis in England, Wales & Northern Ireland
  • The recommendation was based on the results from the P-III trials (KALM-1 & 2) as well as supportive data from an additional 32 clinical studies evaluating Kapruvia
  • Kapruvia (difelikefalin), the first MHRA-approved treatment for the same indication while the P-III program is ongoing for pruritus in patients with notalgia paresthetica. Additionally, Cara is developing an oral formulation of difelikefalin & has initiated a P-II/III difelikefalin program to treat mod. to sev. pruritus in patients with notalgia paresthetica

enGene to go Public via Forbion European Acquisition Corp. SPAC Merger for ~$135M

Date - May 18, 2023                                                

Product – EG-70

  • The business combination will deliver gross proceeds to enGene of ~$135M incl. Forbion Growth’s existing investment in FEAC Class A shares of $20M plus investment commitments of $115M, anchored by Forbion Growth with the participation of new institutional investors & existing enGene investors. The transaction is expected to be close in H2’23
  • Net proceeds will be used to finance enGene’s operations through multiple potential value inflection milestones towards a BLA submission in 2025 for detalimogene voraplasmid (EG-70) to treat BCG-unresponsive NMBIC with CIS
  • The transaction will support the development of earlier pipeline programs in GYN/GU malignancies & respiratory diseases. The combined company will be named “enGene Holdings Inc” & its shares are expected to be listed on Nasdaq

Ironwood to Acquire VectivBio for ~$1B

Date - May 23, 2023                                                

Product – Apraglutide

  • Ironwood will purchase all of VectivBio’s outstanding ordinary shares for $17.00/share in cash with an estimated consideration of ~$1B representing an 80% premium on the company’s avg. trading price over the previous 90 trading days. The transaction is expected to close in H2’23
  • The acquisition will strengthen Ironwood’s innovative portfolio and pipeline to advance the treatment of GI diseases along with supporting long-term profitability & cash-flow generation
  • VectivBio’s apraglutide, a next-generation, GLP-2 analog is currently in P-III for short bowel syndrome with intestinal failure (SBS-IF) which will assess clinical benefit for both SBS-IF stoma and colon-in-continuity patients & results are expected at the end of 2023

CohBar Entered into Definitive Merger Agreement with Morphogenesis to Advance Late-Stage Oncology Candidates

Date - May 24, 2023                                                

Product – IFx-Hu2.0

  • CohBar shareholders will receive a dividend of 3.30 shares of CohBar common stock & pre-merger CohBar shareholders will receive a CVR related to the disposition of any of its assets for 3yrs. The transaction is expected to close in Q3’23
  • The pre-merger CohBar equity holders will own ~15%; pre-merger Morphogenesis equity holders will own ~77% of the new company on a pro forma basis & investors would own ~9%. The combined company will operate under the name “TuHURA Biosciences, Inc” & will trade on Nasdaq, advancing a personalized cancer vaccine platform & preclinical tumor microenvironment modulator
  • The P-II/III study of IFx-Hu2.0 is expected to initiate in 2024. CohBar entered into a stock purchase agreement with an affiliate of an investor in Morphogenesis for a $15M private placement to advance the new company’s pipeline, providing a cash runway through 2024

AstraZeneca Reports the US FDA Acceptance of NDA and Granted Priority Review of Capivasertib + Faslodex (fulvestrant) for Advanced HR-Positive Breast Cancer

Date - June 12, 2023                                                

Product – Capivasertib + Faslodex

  • The US FDA has accepted the NDA & granted Priority Review for capivasertib + fulvestrant in adult patients with HR+ HER2- LA or metastatic breast cancer. The US FDA’s decision is expected in Q4’23
  • The NDA was based on the P-III trial (CAPItello-291) results presented at SABCS 2022 & published in the NEJM evaluating capivasertib + Faslodex vs PBO + Faslodex in 708 adult patients, showed a 40% reduction in risk of disease progression or death in the overall trial population; m-PFS (7.2 vs 3.6mos.), OS data were immature, early data are encouraging & the safety profile was similar to prior reported trials
  • Capivasertib was discovered by AstraZeneca in collaboration with Astex Therapeutics (and its collaboration with ICR & CRT). The company works with the US FDA to bring the therapy to patients shortly

AbbVie Reports P-III (CLL14) and (MURANO) Studies Results of Venclyxto/ Venclexta (venetoclax) for Chronic Lymphocytic Leukemia

Date - June 12, 2023                                                

Product – Venclyxto/Venclexta

  • The P-III study (CLL14) evaluating Venclyxto/Venclexta & obinutuzumab vs obinutuzumab & chlorambucil in 432 patients while the P-III trial (MURANO) evaluating Venclyxto/Venclexta & rituximab vs bendamustine & rituximab in 389 patients
  • Both studies' results showed the long-term benefits of fixed-duration venetoclax combinations. The 6yr. follow-up results from the (CLL14) study showed improved PFS & higher rates of uMRD (53.1% vs 21.7%), improved rates of TTNT (65.2% vs 37.1%), differences in PFS & TTNT benefits were maintained across all risk groups with no new safety signals
  • In the (MURANO) trial, m-PFS (54.7 vs 17.0mos.) after 7yr. of median follow-up, 7yr. OS rates (69.6% vs 51%), patients achieved uMRD (70.3%), and those patients were shown to have improved PFS & OS over patients with detectable MRD (29.7%)

Coherus BioSciences to Acquire Surface Oncology for ~$65M

Date - June 19, 2023                                                

Product – SRF388

  • Coherus will buy all outstanding Surface Oncology shares by offering its common stock at $5.2831/share resulting in a total transaction value of ~$40M along with anticipated net cash of b/w $20 & $25M
  • Surface shareholders will also receive CVRs for 70% of milestone & royalty-based value from existing partnerships with Novartis & GSK as well as CVRs for 25% of up front for any ex-US rights to SRF114 & 50% for SRF388. The transaction is expected to close in Q3’23
  • The acquisition will advance Coherus’ I-O pipeline with the addition of Surface Oncology’s clinical stage assets, SRF388, currently in P-II trials for lung & liver cancer, and SFR114 in a P-I/II study as monotx. for advanced solid tumors. Coherus plans to launch toripalimab for nasopharyngeal carcinoma, after receiving approval from the US FDA

Eli Lilly to Acquire DICE Therapeutics for ~$2.4B

Date - June 20, 2023                                                

Product – N/A

  • Eli Lilly will acquire all outstanding shares of DICE for a purchase price of $48 per share in cash representing a premium of ~40% relative to DICE’s closing price in June 2023 with a total deal value of ~$2.4B. The transaction is expected to close in Q3’23
  • DICE will use its DELSCAPE technology platform to develop novel oral therapeutic candidates, incl. oral IL-17 inhibitors which are currently in clinical development for the treatment of chronic diseases in immunology
  • Additionally, DICE is also developing oral therapeutic candidates targeting the integrin α4ß7 for the treatment of inflammatory bowel disease

Sanofi and Sobi Present P-III Study (XTEND-Kids) Results of Altuviiio for Severe Hemophilia A at ISTH 2023

Date - June 26, 2023                                                

Product – Altuviiio

  • The P-III study evaluating Altuviiio (50IU/kg, qw for 52wks.) in 75 patients aged ≤12yrs. The trial met 1EPs with no inhibitor development to factor VIII detected, median & mean ABRs were 0.00 & 0.89
  • 64% had zero bleeding episodes, 82% & 88% had zero joint bleeds & spontaneous bleeds, was well-tolerated with a similar safety profile to (XTEND-1) trial confirming safety and efficacy in adults & children with highly effective bleed protection. The 2EPs incl. ABR & maintenance of factor VIII activity above pre-specified levels
  • No serious allergic reactions, anaphylaxis, or embolic or thrombotic events were seen. Altuviiio was approved in the US for routine prophylaxis, on-demand treatment to control bleeding episodes & perioperative management in adults & children with hemophilia A

CellTrans’ Lantidra Receives the US FDA’s Approval for the Treatment of Type 1 Diabetes

Date - June 29, 2023                                                

Product – Lantidra

  • The approval was granted based on the study evaluating the safety & effectiveness of Lantidra in patients (n=30) with type 1 diabetes who are unable to approach target glycated hemoglobin due to current repeated episodes of severe hypoglycemia
  • The results from the study depicted that out of the evaluable patients, 21 did not require insulin for ≥1yr.,11 for 1-5yrs. & 10 for ≥5yrs. As per the safety data, adverse reactions depicted in patients were associated with the number of infusions & follow-up time
  • Lantidra is an allogeneic pancreatic islet cellular therapy developed from deceased donor pancreatic cells that treats type 1 diabetes through infused allogeneic islet beta cells

Related Post: PharmaShots' Key Highlights of First Quarter 2023

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