Senores Pharmaceuticals Acquires ANDA for Enalapril Maleate Tablets from Wockhardt
• Senores Pharmaceuticals has acquired the US FDA-approved ANDA for enalapril maleate tablets in multiple dosages from Wockhardt, expanding its presence in the hypertension treatment market.
• The US market for enalapril tablets is valued at $28.60 million (MAT December 2024) according to IQVIA data, representing a significant commercial opportunity for Senores.
• With this acquisition, Senores strengthens its portfolio to 61 ANDAs and 22 CMO/CDMO commercial products approved for distribution in the United States.
Wockhardt's Novel Antibiotic 'Zaynich' Expected to Receive USFDA Approval in 2025
• Wockhardt's novel antibiotic Zaynich, a combination of Zidebactam and Cefepime targeting multi-drug resistant Gram-negative infections, is anticipated to receive USFDA approval next year.
• Clinical trials demonstrated a remarkable 100% cure rate among 30 critically ill patients with life-threatening drug-resistant infections, positioning Zaynich as a significant advancement in antimicrobial therapy.
• Wockhardt Chairman Habib Khorakiwala highlighted the company's 25-year research program that has yielded six drugs for multi-drug resistance, establishing Wockhardt as a global leader in antibiotic research.
Wockhardt's New Pneumonia Antibiotic Poised to Capture $500M Indian Market
Wockhardt has received CDSCO approval for a novel oral antibiotic targeting community-acquired bacterial pneumonia, with potential market size of ₹4,000-5,000 crore in India. The company expects to capture 65-70% market share within 4-5 years, while also pursuing international expansion and developing additional antibiotics in their pipeline.
Wockhardt's Miqnaf (Nafithromycin) Receives CDSCO Approval for CABP Treatment in Adults
• Wockhardt's Miqnaf (Nafithromycin) has been approved by CDSCO for treating community-acquired bacterial pneumonia (CABP) in adults, offering a new treatment option.
• Miqnaf is an ultra-short, once-daily, three-day oral treatment effective against CABP, including infections caused by multi-drug resistant pathogens.
• Clinical trials across multiple countries support Miqnaf's efficacy, especially against pneumococci resistant to common antibiotics like azithromycin.
• Designed to reduce hospitalizations, Miqnaf addresses the challenge of antibiotic resistance and limited coverage of atypical pathogens by current treatments.
Wockhardt's Zaynich Demonstrates Superior Efficacy in Phase III cUTI Trial
• Wockhardt's Zaynich (zidebactam/cefepime) achieved superiority over meropenem in a Phase III trial for complicated urinary tract infections (cUTI).
• The ENHANCE 1 study showed Zaynich had an 89.0% efficacy rate in combined clinical and microbiological cure, compared to 68.4% for meropenem.
• Zaynich exhibited a 96.8% clinical cure rate and a safety profile comparable to meropenem in the multi-center trial across the US, Europe, and Asia.
• Wockhardt plans to file a new drug application (NDA) with the USFDA and a marketing authorization application (MAA) with the EMA based on these results.
Wockhardt's Antibacterial Drug Zaynich Shows Promise in Treating US Cancer Patient with Resistant Infections
• Wockhardt's drug Zaynich (WCK 5222) successfully treated a US cancer patient with infections caused by highly resistant bacteria, facilitating a transplant.
• The drug effectively neutralized resistance mechanisms like IMP, NDM, and OXA-48 in Pseudomonas aeruginosa and Klebsiella pneumoniae.
• Zaynich is nearing completion of Phase III trials for global registration, with potential availability in global markets by 2026.
• Compassionate use of Zaynich has benefited 45 patients to date, addressing unmet needs for antibacterial drugs against superbugs.
Advancements in Complicated Urinary Tract Infection (cUTI) Therapeutics
• Several pharmaceutical and biotech companies are actively developing novel therapies for complicated urinary tract infections (cUTIs).
• Spero Therapeutics' Tebipenem Pivoxil Hydrobromide is in Phase III clinical trials, representing a late-stage advancement in cUTI treatment.
• Other companies like Iterum Therapeutics and Venatorx are also contributing to the cUTI therapeutics market with drugs like Sulopenem.
• Emerging therapies cover various routes of administration, molecule types, and mechanisms of action, offering diverse treatment options.
India Launches First Indigenous Antibiotic Nafithromycin to Combat Drug-Resistant Pneumonia
• India has launched Nafithromycin, its first indigenously developed macrolide antibiotic, to combat antimicrobial resistance (AMR).
• Developed by Wockhardt with BIRAC support, Nafithromycin (Miqnaf) targets Community-Acquired Bacterial Pneumonia (CABP), offering a three-day treatment regimen.
• Clinical trials showed Nafithromycin to be ten times more effective than current treatments, with superior safety and minimal side effects.
• The Indian government has also initiated multiple strategies, including surveillance, awareness programs, and international collaborations, to tackle AMR comprehensively.
India Launches Nafithromycin, First Indigenous Antibiotic to Combat Antimicrobial Resistance
• Nafithromycin, India's first indigenously developed antibiotic, has been launched to combat antimicrobial resistance (AMR).
• Developed by Wockhardt with support from BIRAC, Nafithromycin is designed to treat Community-Acquired Bacterial Pneumonia (CABP).
• Clinical trials have shown Nafithromycin to be ten times more effective than azithromycin, with a safer, faster, and more tolerable three-day regimen.
• Nafithromycin awaits final CDSCO approval for manufacturing and public use, marking a significant advancement in India's fight against AMR.
India's Nafithromycin Offers New Hope Against Drug-Resistant Pneumonia
• Nafithromycin, India's first indigenous antibiotic, targets drug-resistant community-acquired bacterial pneumonia (CABP) and offers a new treatment option.
• Developed by BIRAC and Wockhardt, Nafithromycin boasts a three-day treatment regimen and is reportedly ten times more effective than azithromycin.
• Clinical trials show a 96.7% cure rate with superior safety, minimal side effects, and broad-spectrum action against typical and atypical bacteria.
• Awaiting final approval, Nafithromycin may be integrated into India's Ayushman Bharat scheme for increased accessibility and affordability.
Wockhardt Seeks DCGI Approval for Fast-Acting Insulin Analog Aspart Injection
• Wockhardt has filed for approval of its fast-acting insulin analog, Aspart injection (ASPARAPIDTM), with the Drugs Controller General of India (DCGI) in India.
• The Aspart insulin injection aims to help patients effectively manage their diabetes, offering a new treatment option in the growing Indian market.
• The Indian market for Aspart insulin is currently estimated at over Rs 260 crore, with Wockhardt anticipating significant growth in the coming years.
• Wockhardt is also developing additional insulin analogs and GLP-1 agonists to further enhance its diabetes care portfolio and provide more effective treatment solutions.
Wockhardt's Nafithromycin Poised for India Launch After Positive Phase 3 Results
• Wockhardt anticipates Indian regulatory approval for Nafithromycin 400mg, a novel pneumonia treatment, following successful Phase 3 clinical trials.
• The drug, requiring only a three-day oral therapy, demonstrated a 97% success rate in clinical trials, addressing a significant unmet need in India.
• India sees approximately 18 million pneumonia cases annually, and Nafithromycin aims to capture a domestic market potential of ₹400-500 crore within 3-5 years.
• Saudi Arabia has recognized Nafithromycin as a breakthrough medicine, with Wockhardt planning to pursue approvals in other emerging markets.
Wockhardt's Novel Antibiotic Miqnaf Receives Favorable Recommendation for CABP Treatment in India
• Wockhardt's Miqnaf (nafithromycin) received a favorable recommendation from the CDSCO's Subject Expert Committee for treating community-acquired bacterial pneumonia (CABP).
• The recommendation is based on a comprehensive review of non-clinical and Phase 1-3 clinical studies conducted over 15 years.
• Miqnaf is a once-a-day, three-day treatment, effective against multi-drug resistant pathogens causing CABP, offering a convenient monotherapy option.
• India accounts for 23% of the global community pneumonia burden, highlighting the need for effective treatments like Miqnaf to reduce hospitalization and mortality.
Wockhardt's WCK 6777 Receives FDA Fast Track for Complicated UTIs and cIAIs After Phase I Success
• Wockhardt's WCK 6777 (Ertapenem/Zidebactam) received FDA Fast Track designation for complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
• A Phase I study of WCK 6777, conducted by the NIH, demonstrated a promising safety profile in 52 healthy volunteers with no serious adverse events.
• WCK 6777 is a once-daily antibiotic designed for outpatient parenteral antimicrobial therapy (OPAT), targeting multi-drug resistant Gram-negative pathogens.
• The drug aims to address the unmet need for outpatient management of MDR infections, potentially reducing hospital admissions and facilitating early discharge.
Wockhardt's Zaynich Shows Promise Against Drug-Resistant Infections, Global Launch Targeted for 2026
• Wockhardt's antibiotic Zaynich (WCK 5222) demonstrates efficacy against multi-drug resistant pathogens, including superbugs, offering a potential breakthrough in combating antimicrobial resistance.
• Phase 3 clinical trials for Zaynich are nearing completion, with regulatory filings planned for the US, Europe, and India in the second quarter of next year, targeting potential approvals in early 2026.
• Zaynich has shown successful treatment in meningitis cases and compassionate use scenarios, with potential to treat severe infections even in ventilated patients, exhibiting a favorable safety profile.
• Wockhardt anticipates a global launch of Zaynich by mid-2026, estimating a market potential of $5 to $6 billion, addressing a critical unmet need in treating drug-resistant infections worldwide.
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