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5 API Suppliers, 1 NDC API, 5 Listed Suppliers, $ API Reference Price

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38 Drugs in Development

38 Drugs in Development

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2 FDF Dossiers, 1 FDA Orange Book, 1 Listed Dossiers

2 FDF Dossiers
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1 DATA COMPILATION #PharmaFlow, 2 STOCK RECAP #PipelineProspector, 41 NEWS #PharmaBuzz

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2 STOCK RECAP #PipelineProspector
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PATENTS & EXCLUSIVITIES

3 US Patents, 1 US Exclusivities

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3 US Patents
1 US Exclusivities

Neuland Lab Ensifentrine

Synopsis

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Chemistry

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Also known as: Rpl-554, 298680-25-8, Rpl554, 1884461-72-6, Ensifentrine [inn], Ensifentrine [usan]

Molecular Formula

C₂₆H₃₁N₅O₄

Molecular Weight

477.6 g/mol

InChI Key

CSOBIBXVIYAXFM-UHFFFAOYSA-N

FDA UNII

3E3D8T1GIX

Ensifentrine is an inhaled inhibitor of the phosphodiesterase (PDE) types 3 (PDE3) and 4 (PDE4), with potential anti-inflammatory and bronchodilator activities. Upon administration, ensifentrine targets, binds to and inhibits PDE3 and PDE4, which leads to an increase of both intracellular levels of cyclic-3',5'-adenosine monophosphate (cAMP) and cAMP-mediated signaling. This may lead to bronchial smooth muscle relaxation and modulate inflammatory responses. PDE3 and PDE4, members of the PDE superfamily, hydrolyze cAMP and 3',5'-cyclic guanosine monophosphate (cGMP) to their inactive 5' monophosphates. PDE3 is the most expressed PDE isoenzyme in bronchial smooth muscle. PDE4 is expressed in immune cells including T-cells, monocytes, macrophages, neutrophils, dendritic cells and eosinophils. It plays an important role in inflammation, especially in inflammatory airway diseases.

1 2D Structure

Ensifentrine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[9,10-dimethoxy-4-oxo-2-(2,4,6-trimethylphenyl)imino-6,7-dihydropyrimido[6,1-a]isoquinolin-3-yl]ethylurea

2.1.2 InChI

InChI=1S/C26H31N5O4/c1-15-10-16(2)24(17(3)11-15)29-23-14-20-19-13-22(35-5)21(34-4)12-18(19)6-8-30(20)26(33)31(23)9-7-28-25(27)32/h10-14H,6-9H2,1-5H3,(H3,27,28,32)

2.1.3 InChI Key

CSOBIBXVIYAXFM-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=CC(=C(C(=C1)C)N=C2C=C3C4=CC(=C(C=C4CCN3C(=O)N2CCNC(=O)N)OC)OC)C

2.2 Other Identifiers

2.2.1 UNII

3E3D8T1GIX

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimidino(6,1-a)isoquinolin-4-one

2. Rpl 554

3. Rpl-554

4. Rpl554

2.3.2 Depositor-Supplied Synonyms

1. Rpl-554

2. 298680-25-8

3. Rpl554

4. 1884461-72-6

5. Ensifentrine [inn]

6. Ensifentrine [usan]

7. Ls-193855

8. 3e3d8t1gix

9. Ls-193,855

10. A]isoquinolin-3(4h)-yl}ethyl)urea

11. (e)-1-(2-(2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2h-pyrimido[6,1-a]isoquinolin-3(4h)-yl)ethyl)urea

12. 2-[9,10-dimethoxy-4-oxo-2-(2,4,6-trimethylphenyl)imino-6,7-dihydropyrimido[6,1-a]isoquinolin-3-yl]ethylurea

13. Trimethylphenyl)imino]-6,7-dihydro-2h-pyrimido[6,1-

14. N-(2-{(2e)-9,10-dimethoxy-4-oxo-2-[(2,4,6-

15. 2-(9,10-dimethoxy-4-oxo-2-(2,4,6-trimethylphenyl)imino-6,7-dihydropyrimido(6,1-a)isoquinolin-3-yl)ethylurea

16. N-(2-((2e)-9,10-dimetoxi-4-oxo-2-((2,4,6-trimetilfenil)imino)-6,7-dihidro-2h-pirimido(6,1-a)isoquinolein-3(4h)-il)etil)urea

17. Urea, N-(2-(6,7-dihydro-9,10-dimethoxy-4-oxo-2-((2,4,6-trimethylphenyl)imino)-2h-pyrimido(6,1-a)isoquinolin-3(4h)-yl)ethyl)-

18. Unii-3e3d8t1gix

19. Vmx-554

20. Rpl-554;ensifentrinum

21. Ensifentrine (usan/inn)

22. Ensifentrine [who-dd]

23. Schembl625876

24. Chembl4594287

25. Schembl20720900

26. Gtpl11865

27. Dtxsid00183983

28. Bcp31840

29. Ex-a6633

30. Who 10726

31. Sb19810

32. D11743

33. A937318

34. Q7277486

35. Ensifentrina; Ensifentrinum;rpl-554;rpl554;rpl 554

36. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimidino(6,1-a)isoquinolin-4-one

37. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimido[6,1-a]isoquinolin-4-one

38. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimido[6,1-a]isoquinolin-4-one

39. 9,10-dimethoxy-2-(2.4.6-trimethylphenylimino)-3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimido[6.1-a]isoquinolin-4-one

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₃₁N₅O₄
Molecular Weight	477.6 g/mol
XLogP3	2.7
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	6
Exact Mass	477.23760449 g/mol
Monoisotopic Mass	477.23760449 g/mol
Topological Polar Surface Area	110 Å²
Heavy Atom Count	35
Formal Charge	0
Complexity	849
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

API SUPPLIERS

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NDC API

01

HOVIONE FARMACIENCIA SA

Portugal

Boulder Peptide 2024

Not Confirmed

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Listed Suppliers

01

Neuland Laboratories

India

CPhI Worldwide, Milan

Booth #1A18

Neuland Laboratories- A dedicated 100% API provider.

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India

Virtual Booth

Digital Content

Ensifentrine

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.

02

Seqens

France

CPhI Worldwide, Milan

Booth# 2B50

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Contact Supplier

France

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Ensifentrine

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.

03

Angene International

United Kingdom

Boulder Peptide 2024

Not Confirmed

04

Chemicea

India

Boulder Peptide 2024

Not Confirmed

05

Glixx Laboratories

U.S.A

Boulder Peptide 2024

Not Confirmed

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Drugs in Development

01 Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

02 Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

03 Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

04 Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

05 Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

06 Nuance Pharma

China

Boulder Peptide 2024

Not Confirmed

07 Nuance Pharma

China

Boulder Peptide 2024

Not Confirmed

08 Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

09 Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

10 Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

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FDF Dossiers

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FDA Orange Book

01

VERONA PHARMA

United Kingdom

Boulder Peptide 2024

Not Confirmed

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Listed Dossiers

01

Verona Pharma

United Kingdom

Boulder Peptide 2024

Not Confirmed

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Digital Content

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DATA COMPILATION #PharmaFlow

FDA approvals slump 19% in H1 2024; NASH, COPD, PAH get new treatment options

The first half of 2024 saw a significant slowdown in approvals of new drugs and biologics by the US Food and Drug Administration (FDA) compared to the same period last year.FDA’s Center for Drug Evaluation and Research (CDER) approved 21 drugs in H1 2024, reflecting a 19 percent decrease from the 26 approvals granted in H1 2023. Of them, 81 percent (17) were first-in-class drugs (therapies that use a new and unique mechanism of action), while small molecules made up for 67 percent (14) of the total drugs approved.Similarly, the Center for Biologics Evaluation and Research (CBER) granted approvals to only eight biologics, as compared to 10 in H1 2023.Health Canada also saw a drop in drug approvals as only 10 drugs were okayed in H1 2024, as opposed to 13 approvals in H1 2023.The European Medicines Agency (EMA) saw a marginal rise in drug authorizations at 15 for H1 2024 as compared to 14 approvals in H1 2023. Interestingly, the EMA also saw a surge in pending decisions (applications under review) — from two in H1 2023 to 14 in H1 2024.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available)Merck, Madrigal, Verona bag approvals for breakthrough meds; Lilly’s donanemab okayedThe first half saw some closely watched drugs win regulatory approvals. FDA approved a breakthrough therapy from Merck — Winrevair (sotatercept) — that treats adults with hypertension caused by the constriction of arteries in the lungs, known as pulmonary arterial hypertension (PAH).Merck had acquired Winrevair through its US$ 11.5 billion acquisition of Acceleron Pharma in 2021. The therapy is set to generate nearly US$ 3 billion in global peak sales by 2028. Another breakthrough therapy approved in H1 2024 is Madrigal’s Rezdiffra (resmetirom), the first FDA-approved treatment for adults with the common fatty liver disease — nonalcoholic steatohepatitis (NASH). Rezdiffra is expected to touch sales of US$ 2.1 billion by 2028.The agency also approved the first maintenance treatment for chronic obstructive pulmonary disease (COPD) in over 20 years — Verona’s Ohtuvayre. The drug has a novel mechanism of action and is the first inhaled maintenance treatment for COPD. Approved in June by the FDA, Ohtuvayre is forecast to bring in global sales of US$ 1.5 billion by 2030.The approval of Eli Lilly’s donanemab was surprisingly delayed, and finally came through on July 2 after an FDA advisory committee voted unanimously in favor of its benefits outweighing its risks. To be sold as Kinsula, the Alzheimer's drug is estimated to bring in US$ 2.2 billion in sales by 2028.Across the pond, EMA approved Novo Nordisk’s weekly insulin injection Awiqli (insulin icodec). The replacement insulin in Awiqli acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. Meanwhile, FDA rejected this once-a-week insulin earlier this month and has requested information related to the manufacturing process.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) ImmunityBio, Geron, Day One win approvals for their oncology drugsIn what marks the first approval for ImmunityBio, FDA greenlit Anktiva (nogapendekin alfa inbakicept-pmln) as part of a combination therapy to treat a type of bladder cancer. Anktiva is a next-generation immunotherapy that creates long-term immunity by activating the so-called natural killer (NK) cells and T-cells. It will compete with Merck’s Keytruda. Anktiva’s yearly sales by 2030 are expected to be around US$ 1.7 billion.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) got the go-ahead from the FDA as the treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra’s 2028 global sales are forecast to bring in US$ 1.6 billion.FDA signed off on Geron’s Rytelo (imetelstat) for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers. This was Geron’s maiden approval and Rytelo is expected to bring in US$ 1.3 billion by 2030.Day One Biopharmaceuticals’ Ojemda (tovorafenib) was granted FDA’s accelerated approval to treat certain types of pediatric brain cancer. This is the first FDA approval of a systemic therapy for treating what is the most common form of childhood brain tumor, including fusions. Ojemda is forecast to bring in US$ 1 billion in sales by 2030.FDA granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adults in advanced stages of small cell lung cancer (SCLC) that has proven to be hard to treat or has worsened despite platinum-based chemotherapy. Imdelltra is expected to bring in annual sales of US$ 975 million by 2030.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Infectious disease drugs from Basilea, Merck, rare disease med from Ipsen bag approvalsAfter oncology, infections and infectious diseases, and rare diseases were the two therapeutic areas that saw the second and third most approvals, respectively. FDA approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for injection), an antibiotic for bacterial infections including multidrug-resistant strains.The US agency also approved Merck’s next-generation vaccine designed to protect adults from pneumococcus bacteria that causes serious illnesses and pneumonia. The jab, known as Capvaxive, helped produce an immune response against all 21 variations (serotypes) of the bacteria that it targeted. These 21 strains account for about 85 percent of invasive pneumococcal disease cases in adults aged 65 and above. FDA also approved Moderna’s mRESVIA, a messenger RNA-based (mRNA) respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by the syncytial virus. This is the first non-Covid mRNA vaccine to be approved in the US.The agency granted accelerated approval to Ipsen’s Iqirvo (elafibranor) to treat primary biliary cholangitis (PBC), a rare liver disease. This is the first new medicine approved in nearly a decade for the treatment of PBC. Orchard Therapeutics’ Lenmeldy secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder, known as metachromatic leukodystrophy (MLD). The debilitating hereditary disease affects the brain and the nervous system and causes loss of cognitive and motor functions and early death.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Our viewThe increased momentum of drug approvals witnessed after the pandemic appears to have slowed down, but what’s encouraging is the increase in first-in-class therapies, cancer drugs and promising new treatment options for a range of conditions such as PAH, NASH, and COPD.The second half has already kicked off with the approval of Lilly’s donanemab. And there are several pathbreaking drugs likely to be approved soon, such as Karuna Therapeutics’ schizophrenia drug KarXT and BridgeBio’s heart drug acoramidis. There is every possibility that new drug approvals will spring back up in H2 2024.

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STOCK RECAP #PipelineProspector

Pipeline Prospector June 2024: FDA approves Merck’s next-gen pneumococcal vaccine, Verona’s COPD therapy

The pharma indices were back in the black in May, and the good streak continued through June with the Nasdaq Biotechnology Index (NBI) gaining 3 percent, the SPDR S&P Biotech ETF (XBI) index up over 3.1 percent and the S&P Biotechnology Select Industry Index (SPSIBI) rising 4.25 percent.The two summer months were similar in more ways than one. In May, Eli Lilly had announced an investment of US$ 5.3 billion to boost the supply of Zepbound and Mounjaro. In June, Novo Nordisk followed suit, investing US$ 4.1 billion to develop a new manufacturing facility to boost the supply of Ozempic and Wegovy.Similarly, the US Food and Drug Administration (FDA) continued to grant vaccine approvals in June after okaying Moderna’s mRNA respiratory syncytial virus (RSV) vaccine in May. Last month, Merck’s next-generation pneumococcal vaccine won an FDA nod, and the agency expanded the use of GSK’s respiratory syncytial virus (RSV) vaccine to include adults aged 50 to 59.However, June was a lackluster month for mergers and acquisitions. The month had to be content with some tie-ups. For instance, Roche signed an up to US$ 1.8 billion deal with Boston-based startup Ascidian Therapeutics to discover and develop novel gene therapies for difficult-to-treat neurological diseases. AbbVie inked a US$ 1.7 billion agreement with China’s FutureGen to bring the latter’s next-generation treatment (FG-M701) for inflammatory bowel disease to market. Takeda signed an option agreement with China’s Ascentage Pharma for an exclusive license to a promising drug for chronic myeloid leukemia and other blood cancers. And Day One Biopharmaceuticals struck a licensing deal with MabCare for a novel antibody drug conjugate (ADC) to treat multiple cancers. The deal’s potential value is US$ 1.2 billion.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel)Merck’s pneumococcal jab wins FDA nod; Moderna’s combo vaccine scores trial winVaccines took centerstage in June. FDA approved Merck’s Capvaxive, a next-generation pneumococcal vaccine designed to protect adults from a broader range of pneumococcus bacteria strains that cause serious illnesses and pneumonia. Capvaxive targets 21 bacterial variations responsible for about 85 percent of invasive pneumococcal disease cases in older adults. Similarly, GSK secured FDA approval for its RSV vaccine for adults aged 50 to 59 years. This makes Arexvy the only RSV shot endorsed for that age group.In a late-stage trial, Moderna’s mRNA-1083, an investigational combination vaccine against influenza and Covid, elicited a higher immune response compared to separate shots in people aged 50 and over. The combo jab generated more antibodies than currently marketed flu vaccines and Moderna’s Spikevax. And the world’s first personalized mRNA cancer vaccine from Moderna has raised hopes for patients with skin cancer, as three-year data from a mid-stage trial showed some benefits on patients who took the vaccine in combination with Merck’s Keytruda.Despite these developments, Moderna’s stock dropped 19 percent in June after it said the efficacy of its RSV vaccine mRESVIA had vaned substantially to 50 percent after 18 months.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) Verona, Geron score maiden FDA approvals; BMS’ Augtyro bags tumor-agnostic nodTwo companies obtained their first FDA approvals last month. The first one was Verona Pharma (stock up 15 percent) — it received its maiden FDA approval for Ohtuvayre for treating chronic obstructive pulmonary disease (COPD). This is also the first inhaled COPD treatment with a novel mechanism of action.The second company to get its maiden FDA approval was Geron, a commercial-stage biopharmaceutical company. FDA signed off on Geron’s Rytelo for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers.In June, FDA granted accelerated approvals to at least three drugs. BMS’ Augtyro was granted FDA’s accelerated approval for treating adult and pediatric patients (over 12 years) with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, regardless of where they occur in the body.Ipsen received FDA’s accelerated approval for Iqirvo, a first-in-class, once-daily oral medication for treating primary biliary cholangitis (PBC), a progressive liver disease affecting mostly women.Sarepta Therapeutics’ (stock up 24 percent) Elevidys received accelerated approval for Duchenne muscular dystrophy (DMD) despite failing its primary endpoint in a late-stage trial.Amongst other approvals, Argenx’s Vyvgart Hytrulo was approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP). This is a novel treatment option for this rare and debilitating neuromuscular disorder. And BMS’ Krazati got its second approval for treating colorectal cancer with a specific KRAS mutation.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) GSK’s failed cancer drug posts trial win; Gilead’s HIV prophylaxis shows efficacyIn late-stage trials, GSK’s multiple myeloma therapy Blenrep cut the risk of disease progression or death by almost half compared to standard-of-care treatments. The once-failed ADC was pulled from the lucrative US market in 2022, but the results could signal a comeback for Blenrep.Intra-Cellular’s antipsychotic drug Caplyta scored another remarkable late-stage win for treating major depressive disorder (MDD). In another late-stage trial, Gilead’s (stock up 6 percent) long-acting injection proved to be more effective in preventing HIV infection in women compared to the daily pill Truvada. This is the first time that an HIV pre-exposure prophylaxis (PrEP) has shown zero infections in a phase 3 trial, the drugmaker said. Dosed just twice a year, Sunlenca could be a game-changer in HIV prevention. Analysts estimate that PrEP-related sales could be over US$ 1.7 billion.In a blow to millions affected by long Covid, Pfizer’s Paxlovid did not appear to improve the symptoms as was hoped. Pfizer’s stock fell 7 percent in June.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) Our view This was the second month when pharma indices showed an upward trend. It’s been a good first half for the US stock markets. But there are mixed reports on how markets will perform in the second half, given the uncertainties around interest rate cuts and the outcome of the presidential elections in the US slated to be held in November. Though for those tracking biopharma news, there are enough interesting developments to fret over the markets.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel)

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