Ex-Unigene execs who run Enteris add API contracting service to delivery tech licensing business

By Gareth Macdonald

- Last updated on GMT

Enteris launches API manufacturing unit
Enteris launches API manufacturing unit

Related tags Pharmaceutical drug Pharmacology Food and drug administration

Enteris BioPharma has broadened its business beyond drug delivery tech licensing and launched a contract API manufacturing service.

The US firm launched the active pharmaceutical ingredient (API) contracting unit this week after installing a microbial fermenter, purification tech and a freeze dryer at its plant in New Jersey.

Company president Brian Zietsman said: "The initiation of our contract manufacturing business is an important milestone for Enteris as we seek to fully maximize the assets and expertise that we acquired when the company was launched.”

Enteris was founded in August 2013 by former executives of Unigene Laboratories and investor Victory Park Capital​ which acquired the latter firm's Peptelligence peptide delivery platform after it went bust.

Before launching the API contracting service, Enteris’s business model was similar to Unigene’s strategy of seeking royalty generating licensing deals from drugmakers keen to turn injectable peptide drugs into pills or nasal sprays.

Now however, Enteris is no longer reliant on tech licensing, or at least it will not be if the API contracting business proves successful. This is significant, because such reliance played a part in Unigene’s demise.

Calcitonin collapse

Before it went bust Unigene had been around for decades and had established licensing deals for various osteoporosis treatments with a number of drugmakers, including Upsher-Smith Laboratories​ in 2002, Tarsa Therapeutics​ in 2009 and GSK​ in 2010.

When GSK pulled out of its deal a year later for unspecified reasons​ Unigene’s share price plunged 20% despite the firm's efforts to talk up the oral parathyroid hormone formulation the pair had been developing.

But Unigene’s real problem came in 2012 when the European Medicines Agency (EMA) advised that calcitonin – the active in all of Unigene’s drugs  and an established osteoporosis therapy – only be used for short periods due to a risk of cancer​.

The US Food and Drug Administration (FDA) issued similar guidance months later​.

Unigene filed for bankruptcy in July 2013​.

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