Sanofi to Manufacture Vivus' ED API

By Dan Stanton

- Last updated on GMT

Related tags Pharmacology

Snofi selected to make ED API
Snofi selected to make ED API
Vivus has selected Sanofi Chimie to manufacture the API for its ED drug due to price and capacity, the company says.

The erectile dysfunction (ED) drug Spedra, licensed from Mitsubishi Tanabe Pharma Corporation (MTPC) by Vivus, received European marketing authorization application (MAA) approval​ in June. Last week the firm announced it had selected the contract manufacturing division of Sanofi – Sanofi Chimie – on a semi-exclusive basis.

So far, Timothy Morris CEO of Vivus told Outsourcing-Pharma.com, “MTPC, the original licensor of avanafil, has made the clinical supplies and commercial supplies” ​and “will continue to do so until June of 2015” ​when amendments submitted to the EMA and FDA to include Sanofi as a qualified supplier are expected to be approved.

However, he continued, “Sanofi has better capacity than MTPC and will be able to supply product at a better price,​” and therefore production is being transferred to a facility within the EU from where Sanofi will supply the US and EU markets.

The two companies have been working together since earlier this year when they entered into a tech transfer deal for the manufacture of Spedra’s active pharmaceutical ingredient (API), avanafil. Sanofi is also expected to be named as bulk tablet manufacturer for avanafil.

Vivus holds the worldwide rights for Spedra (known as Stendra in the US) to be used as a treatment for erectile dysfunction in all markets except certain Asia-Pacific countries.

Sanofi Choses Gallus

In other news, Sanofi’s biotech subsidiary Genzyme has selected contract manufacturing organization (CMO) Gallus Biopharmaceuticals to make its acid sphingomyelinase therapy targeting the rare disease, Niemann-Pick type B.

Gallus will provide process and method development, scale-up, clinical supply and preparation for commercial manufacturing of the drug as part of a multiyear agreement, of which financial details have not been divulged.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Addressing Challenges with Clinical In-Use Testing

Addressing Challenges with Clinical In-Use Testing

Content provided by Lonza | 12-Oct-2023 | White Paper

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

PBPK modeling that saves you time and money

PBPK modeling that saves you time and money

Content provided by Lonza Small Molecules | 09-Oct-2023 | White Paper

Understanding pharmacokinetic behaviors ahead of later-stage development means making informed decisions earlier. This enhanced capability helps your drug...

Related suppliers

Follow us

Products

View more

Webinars