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ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 1 JDMF, 2 NDC API, 9 Listed Suppliers, $ API Reference Price

12 API Suppliers
1 JDMF
2 NDC API
9 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

99 Drugs in Development

99 Drugs in Development

FINISHED DOSAGE FORMULATIONS

159 FDF Dossiers, 9 FDA Orange Book, 8 Europe, 15 Canada, 118 Australia, 6 South Africa, 3 Listed Dossiers

159 FDF Dossiers
9 FDA Orange Book
8 Europe
15 Canada
118 Australia
6 South Africa
3 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 BASF, 1 Gangwal Chemicals, 2 Seppic

relatedExcipients
1 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 BASF
1 Gangwal Chemicals
2 Seppic

EXCIPIENTS BY APPLICATIONS

4 Solubilizers, 3 Parenteral, 2 Topical, 2 Surfactant & Foaming Agents, 1 Emulsifying Agents, 1 Thickeners and Stabilizers, 1 Taste Masking

excipientsByApplications
4 Solubilizers
3 Parenteral
2 Topical
2 Surfactant & Foaming Agents
1 Emulsifying Agents
1 Thickeners and Stabilizers
1 Taste Masking

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 315 News #PharmaBuzz

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2 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
315 News #PharmaBuzz

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5 Regulatory FDF Prices, 23 Annual Reports

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5 Regulatory FDF Prices
23 Annual Reports

MARKET PLACE

4 APIs, 10 FDF Dossiers

marketPlace
4 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

patents
8 Health Canada Patents

LGM Trastuzumab

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

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0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

FINISHED DOSAGE FORMULATIONS

159

FDF Dossiers

FDA Orange Book

Europe

Canada

118

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

14EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

API REF. PRICE (USD/KG)

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

50,097

Regulatory FDF Prices

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MARKET PLACE

API

FDF

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

315

News #PharmaBuzz

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API SUPPLIERS

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JDMF

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NDC API

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Listed Suppliers

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API Imports and Exports

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Drugs in Development

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FDF Dossiers

01

Cipla Medpro South Africa

South Africa

Excipient World

Not Confirmed

02

03

04

05

06

07

08

09

10

Sandoz B2B

Switzerland

Excipient World

Not Confirmed

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FDA Orange Book

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Canada

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Solubilizers

Parenteral

Topical

Surfactant & Foaming Agents

Emulsifying Agents

01

Nanjing Well Pharmaceutical

China

BPI Europe

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polysorbate 20

Application : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : Polysorbate 20 is used in parenteral products such as biologics. It is used as a solubilizer, surfactant, emulsifier & suspension stabilizer.

Pharmacopoeia Ref : ChP/USP/EP

Technical Specs : NA

Ingredient(s) : Polysorbate 20

02

Actylis

U.S.A

BPI Europe

Not Confirmed

Thickeners and Stabilizers

01

Nanjing Well Pharmaceutical

China

Excipient World

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polysorbate 20

Application : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : Polysorbate 20 is used in parenteral products such as biologics. It is used as a solubilizer, surfactant, emulsifier & suspension stabilizer.

Pharmacopoeia Ref : ChP/USP/EP

Technical Specs : NA

Ingredient(s) : Polysorbate 20

02

Actylis

U.S.A

Excipient World

Not Confirmed

Taste Masking

01

Gangwal Chemicals

India

BioProcess International Europe

Not Confirmed

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DATA COMPILATION #PharmaFlow

FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding.

Impressions: 10496

STOCK RECAP #PipelineProspector

Pipeline Prospector April 2024: Indices dip amid muted Q1 results; Vertex acquires Alpine Immune for US$ 4.9 bn

Pharma indices had begun to recede in March. Their red streak accelerated in April with the Nasdaq Biotechnology Index (NBI) falling 6 percent from 4429.97 in March to 4162.33 last month and the SPDR S&P Biotech ETF (XBI) index tripping 10 percent from 94.34 to 84.62. Similarly, the S&P Biotechnology Select Industry Index (SPSIBI) was down 11 percent from 7402.50 to 6584.40 in April.This muted performance was also reflected in the first quarter (Q1) results. Biogen, Biomarin, Roche, Gilead, Merck, Sanofi, BMS and Johnson & Johnson announced their Q1 results in April. While Roche and Biogen reported a drop in revenues, BMS posted a loss in Q1, even though its revenues increased. And Sanofi reported a 14.7 percent drop in operating income due to competition from generics and currency fluctuations. BioMarin, Gilead and Merck reported a 9 percent, 5 percent and 9 percent increase, respectively, in their Q1 revenues over Q1 2023.There were a handful of deals announced last month, the biggest being Vertex Pharmaceuticals’ acquisition of Alpine Immune Sciences for US$ 4.9 billion. The deal gives Vertex access to Alpine’s protein-based immunotherapies for autoimmune diseases.Japanese drugmaker Ono Pharmaceutical agreed to acquire Massachusetts-based Deciphera Pharmaceuticals for US$ 2.4 billion. The acquisition gives Ono access to Deciphera's oncology pipeline. Denmark’s Genmab agreed to acquire privately-owned ProfoundBio for US$ 1.8 billion. ProfoundBio has three next-generation antibody drug conjugate (ADC) candidates in its pipeline that will now go to Genmab.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel)FDA okays ImmunityBio’s Anktiva, Day One’s Ojemda for bladder, brain cancerLike March, April too saw several significant drug approvals, especially in oncology. ImmunityBio (its stock was up 50 percent in April) won its first US Food and Drug Administration (FDA) approval as the agency greenlit Anktiva as part of a combination therapy to treat a type of bladder cancer. With this approval, Anktiva will compete with Merck’s Keytruda.AstraZeneca (stock up 12 percent) and Daiichi Sankyo’s Enhertu has been granted accelerated approval in the US to treat adult patients with HER2-positive solid tumors that have spread or cannot be surgically removed. These patients have undergone prior treatment and have no satisfactory alternatives available to them. J&J and Legend’s Carvykti has become the first and only BCMA-targeted therapy approved by the FDA for patients with relapsed or refractory multiple myeloma, who have received just one prior line of treatment. The approval is an important milestone in J&J’s plans to make Carvykti a US$ 5 billion-plus asset at peak yearly sales.Day One Biopharmaceuticals’ Ojemda has been granted FDA’s accelerated approval to treat certain types of pediatric brain cancer. The pan-RAF kinase inhibitor has been okayed for patients six months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This is the first FDA approval of a systemic therapy for treating what is the most common form of childhood brain tumor.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel) Basilea’s antibiotic bags FDA nod; Vanda’s Fanapt approved for bipolar disorderThe agency also approved Vanda Pharmaceuticals’ (stock up 25 percent) Fanapt tablets for treating manic or mixed episodes associated with bipolar-1 disorder in adults. The atypical antipsychotic agent has been used for the treatment of patients with schizophrenia since its FDA approval in 2009. This second approval for bipolar-1 disorder patients (who experience manic episodes that last at least seven days) could help revive Fanapt prescriptions.FDA has also approved Basilea Pharmaceutica’s Zevtera, an antibiotic for bacterial infections including multidrug-resistant strains. The US agency has okayed it for three conditions – treatment of adults with Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections; and adult and pediatric patients with community-acquired bacterial pneumonia.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel) BMS’ schizo drug shows benefit sans weight gain; Imfinzi scores in lung cancer trialA common side effect associated with anti-psychotics is weight gain. However, interim results from a late-stage trial have shown that BMS’ schizophrenia drug KarXT continued to improve symptoms of the severe mental disease even at 52 weeks, and without weight gain.In another phase 3 trial, Imfinzi significantly improved overall survival and progression-free survival in patients with limited-stage small cell lung cancer. This makes this blockbuster drug the first and only immunotherapy to demonstrate survival benefit for this aggressive form of lung cancer. Imfinzi had posted sales of US$ 4.24 billion in 2023.Intra-Cellular Therapies said a phase 3 study of its drug Caplyta in people with major depressive disorder (MDD) met both its primary and key secondary endpoints. Given once daily as an adjunctive therapy to antidepressants, Caplyta 42 mg significantly beat the placebo at improving depression severity.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel) Zepbound shows benefit in sleep disorder; Novartis’ Fabhalta reduces proteinuriaEli Lilly’s popular weight-loss drug Zepbound cut irregular breathing episodes associated with a common sleep-related disorder – obstructive sleep apnea (OSA). Treatment with Zepbound reduced the frequency of irregular breathing episodes by as much as 63 percent in adults with OSA and obesity across two late-stage trials. Lilly plans to submit the findings to FDA to expand Zepbound’s use for OSA. Roche’s Genentech said its drug Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). A late-stage study pitted the Columvi-chemotherapy combination against a rituximab-chemotherapy combination in patients who received at least one prior line of therapy and are not candidates for autologous stem cell transplant. Patients in the Columvi group lived longer.In another late-stage trial, Novartis' drug Fabhalta reduced proteinuria (protein in the urine) in patients with IgA nephropathy by 38.3 percent. The Swiss drugmaker filed for FDA’s accelerated approval using the data, and the agency has granted it priority review.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel) Our viewAt the start of 2024, the US market saw inflation falling and there were talks of interest rate cuts by the Federal Reserve. But few months on, the outlook has darkened a bit with inflation refusing to let off steam and economic output slowing down in the US. This is getting reflected in the pharma indices and the Q1 results of several drugmakers. Though overall, we have faith in the pharma sector’s spirit of innovation and its zest for dealmaking. Despite the macroeconomic challenges, there is hope that the other three quarters of 2024 will look better.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel)

Impressions: 2147