1. Scrip
  2. >>R&D

Plazomicin’s US Debut Pencilled In For 2018, Achaogen Now Searching For Ex-US Partner

 
• By John Davis

Top-line results from the pivotal Phase III EPIC study, and the smaller CARE study in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE) pathogens, should allow Achaogen to find an ex-US marketing partner and submit a US marketing application in 2017 for its potential new antibacterial, plazomicin, that could address a growing market opportunity in multidrug resistant infections.

South San Francisco biotech Achaogen Inc.has announced top-line Phase III results with its lead product, plazomicin, an engineered aminoglycoside, that it says puts it in a position potentially to offer a much needed new treatment option for serious multidrug-resistant bacterial infections.

The company believes plazomicin is unique in the way it has been engineered to make it resistant to aminoglycoside-modifying enzymes...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from R&D

Vyne Seeks Partner For Repibresib After Phase IIb Vitiligo Fail

 
• By Alaric DeArment

The Phase IIb study failed its primary and a key secondary endpoint, but showed activity on another key secondary and an exploratory endpoint.

Blenrep Questions Won’t Go Away But GSK Sees Chance To Lead In COPD

 
• By Andrew McConaghie

GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.

PTC To Challenge BioMarin In PKU With Oral Sephience

 
• By Joseph Haas

PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.

Lilly’s Jaypirca Threatens Imbruvica’s CLL Position After Phase III Results

 
• By Alaric DeArment

The BRUIN CLL-314 trial was designed to show noninferiority, but the p-value indicated a favorable result for Jaypirca in both the pre-treated and intent-to-treat populations.

More from Scrip

Quotables: Pharma Leaders On The Month’s Hot Topics

 
• By Anabel Costa-Ferreira

The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.

Cipla Revs Up Biosimilars Engine Amid Winds Of Regulatory Change

 
• By Anju Ghangurde

Cipla’s partnered filgrastim biosimilar is expected to debut in the US in Q2 FY26 and the Indian firm expects an investment return ratio for its biosimilar engine “not too far” from that of a complex generic product amid an enabling regulatory environment.

With Planned US Facility Acquisition, Celltrion Looks To Avoid US Pharma Tariffs

 
• By Jung Won Shin

Celltrion is set to acquire a US biologics manufacturing facility that will "eliminate" its US tariff risks and provide a ready-made production base for future expansion.