Novel Medicines
Advancing anti-infective therapy for resistant infections
Orchid Pharma specializes in the discovery and development of innovative anti-infective therapies designed to overcome resistance mechanisms.
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OrblicefTM
(Cefepime + Enmetazobactam)
The first invented in India New Chemical Entity (NCE) to receive USFDA approval.
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Core Function
Combines a fourth-generation cephalosporin (Cefepime) with a novel beta-lactamase inhibitor (Enmetazobactam) and is used for the treatment of complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP), Hospital-acquired Pneumonia (HAP) including Ventilator-associated Pneumonia (VAP), and associated bacteremia.
Differentiation
Enmetazobactam specifically targets Class A β-lactamases, including extended-spectrum β-lactamases (ESBLs), thereby restoring cefepime activity against ESBL-producing Enterobacterales. Cefepime’s zwitterionic structure facilitates efficient penetration through the Gram-negative outer membrane, contributing to its antibacterial efficacy.
As a consequence, along with being effective against ESBL’s, Orblicef spares the usage of Carbapenams for treatment of ESBL related infections.
Publication - Kaye KS, et al. JAMA. 2022;328(13):1304-1314.
Clinical Evidence
79.1% overall success rate vs 58.9% for piperacillin-tazobactam (ALLIUM Phase 3 trial conducted in 19 countries and 112 sites)
2.6x lower microbiological recurrence (11.3% vs 29.4%)
Global Approvals
ORTAROTM
(Ceftaroline)
A 5th-generation cephalosporin engineered to address resistant Gram-positive pathogens
Core Function
An advanced 5th-generation cephalosporin that uniquely provides β-lactam monotherapy coverage for key Gram-positive pathogens, including MRSA and penicillin-resistant Streptococcus pneumoniae.
It offers an effective, well-tolerated treatment option when resistance limits conventional β-lactams or when non-β-lactam anti-MRSA therapies are undesirable.
Differentiation
Engineered for high affinity binding to PBP2a, it enables effective β-lactam monotherapy against resistant Gram-positive pathogens, including MRSA.
With a predictable cephalosporin safety profile, it offers a well-tolerated alternative to traditional anti-MRSA agents, helping avoid the toxicity concerns commonly associated with glycopeptides and lipopeptides.
Global Approvals
Clinical Evidence
84.3% clinical cure rate in CAP vs 77.7% for ceftriaxone
(FOCUS 1 & 2 trials).
91.6% clinical cure rate in cSSTI vs 92.7% for vancomycin + aztreonam (CANVAS 1 & 2 trials).
Offers a proven safety profile in patients requiring prolonged MRSA therapy.
(Sources: File TM Jr, et al. Clin Infect Dis. 2010;51(12):1395-1405; Lowy FD, et al. J Antimicrob Chemother. 2011;66 Suppl 3:iii33-44)
Cefiderocol
A "last-line" siderophore cephalosporin developed through strategic global partnerships.
Core Function
A critical treatment option for life-threatening infections caused by MDR Gram-negative bacteria.
It is active against a broad range of pathogens, including carbapenem-resistant Enterobacterales and non-fermenters, providing a solution in settings where most other available antibiotics are ineffective.
Differentiation
Utilizes a “Trojan horse” siderophore-mediated mechanism to enter bacteria via iron transport systems. It remains stable against a broad range of 𝛽-lactamases, including serine and metallo-𝛽-lactamase (MBL) carbapenemases such as NDM, VIM, and IMP, and retains activity despite porin loss or efflux mechanisms.
Global Approvals
Clinical Evidence
~73% composite clinical + microbiological success in complicated UTI vs ~55% with imipenem-cilastatin (APEKS-cUTI Phase III trial).
Non-inferior to high-dose meropenem in nosocomial pneumonia and similar (12.4% vs 11.6%) 14-day all-cause mortality (APEKS-NP Phase III).
Comparable clinical cure to Best Available Therapy in carbapenem-resistant infections; descriptive analyses noted comparable microbiological eradication (CREDIBLE-CR Phase III)
(Sources: Portsmouth JF, et al. Clin Infect Dis. 2022 (APEKS-cUTI); Wunderink RG, et al. Lancet Infect Dis. 2021 (APEKS-NP); Timsit J-F, et al. Clin Infect Dis. 2022 (CREDIBLE-CR))
Why trust Orchid
Comprehensive Regulatory Package
Complete dossiers for USFDA, EMA, UKMHRA, and DCGI approvals
Extensive clinically proven evidence-based product portfolio
Published peer-reviewed evidence-backed products
Established regulatory pathways for additional markets
Manufacturing Excellence
One of only three global facilities manufacturing sterile cephalosporin APIs to USFDA standards
Vertically integrated supply chain from intermediates to finished APIs
GLP/ISO accredited facilities (ISO 14001, ISO 45001)
Proven regulatory inspection track record (USFDA, EMA, UKMHRA)
Commercial Support
Medical affairs resources and key opinion leader engagement
Launch planning and market access expertise
Comprehensive pharmacovigilance and safety monitoring
Educational resources and HCP training programs
R&D and discovery pipeline
Our New Drug Discovery (NDD) and New Drug Delivery Systems (NDDS) divisions maintain an active pipeline of new molecules focusing on high-growth therapeutic segments.
Current R&D Initiatives
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Contact our business development team to discuss partnership opportunities for your market.
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