1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

NPS Executes On Ultra-Orphan Gattex Launch With FDA Approval In Hand

 
• By Jessica Merrill

NPS Pharmaceuticals will price the short bowel syndrome treatment at $295,000 per year – in line with the cost of other drugs in the ultra-orphan spectrum and higher than some industry observers expected – but said the addressable patient population is lower than it previously estimated.

Now that NPS Pharmaceuticals Inc.’s first drug, the short bowel syndrome treatment Gattex (teduglutide), has been approved by FDA, the company is focused on making the product a commercial success in the ultra-orphan drug market. Gattex was approved by FDA Dec. 21, one week ahead of the PDUFA date, marking NPS’ long awaited transition from R&D boutique to commercial biopharma.

During a conference call Jan. 2 outlining the commercial launch strategy, management said it would price Gattex at $295,000 per year for treatment, significantly higher than what many analysts and investors had been expecting, but in line with other recent ultra-orphan drug launches

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 United States

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

More from North America

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.