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Scinopharm starts developing own drugs with eye on API customers

By Gareth Macdonald , 30-Jan-2013

Scinopharm teams with delivery tech firm for in-house and customer projects
Scinopharm teams with delivery tech firm for in-house and customer projects

Taiwanese API maker Scinopharm has taken a first step towards developing its own drug portfolio in partnership with delivery tech firm Foresee Pharmaceuticals.

The deal – which will see Sinopharm pay $3.6m (€m) for a minority stake in a new joint venture company – will focus on the development of a range of injectable peptide drugs that use Foresee’s controlled-release delivery tech.

Scinopharm CEO Jo Shen said the agreement signifies the firm’s “move into the new drug development field with [a] focus on applying new drug delivery technologies involving oncological APIs [active pharmaceutical ingredients].”

The first drug candidate developed under the partnership - a controlled-release version of the generic leuprolide acetate – is described as by Scinopharm as its ‘first new drug investment,’ however the firm intends to make the know-how it gains available to its API customers according to Shen. 

We are expanding our capabilities into the formulation sector providing our existing clients with one-stop service for oncological and peptide APIs and drug products, capitalizing on our expertise and leadership in their development and manufacturing.”

Scinopharm did not respond to requests for comment ahead of publication.

Expansion plan

Taiwan exported NT$1.6bn ($54.1m) worth of API in 2011 according to the Ministry of Economic Affairs’ Industry and Technology Intelligence Service (IT IS), some 65 per cent of which were produced by Sinopharm .

The CMO’s drug ingredients business is built on two foundations: its anticancer portfolio that comprises seven drug master files (DMF) registered with the US Food and Drug Administration (FDA); and its status as the sole API supplier for Clinical Data’s antidepressant, Viibryd .

But despite this dominance, the contract manufacturing organisation (CMO) has been trying to strengthen its business for the last few years first by investing in peptide production capacity in China and more recently by going public to raise funds for further growth .

The Foresee partnership is an extension of both these efforts and Scinopharm’s 2012 decision to invest in injectables capacity and set up a new high-potency actives production suite at its facility in Taiwan’s Tainan Science Park.

At the time the CMO said the move in this direction was prompted by shortages of injectable cancer meds resulting from regulatory problems at a number of key manufacturers.

The formation of the new JV comes just weeks after Ben Venue – one of the US CMOs considered responsible for the shortages – entered into a consent decree with the US FDA .

Delivery technology

Scinopharm is the second Taiwan-based firm to have been attracted by Foresee’s delivery technology. In June 2011 the Delaware, US based was approached by injectables manufacturer NangKuang Pharmaceuticals to develop a long-acting release formulation of a cancer drug.

Foresee’s technology consists of biodegradable materials dissolved in biocompatible solvents and a bioactive agent modified to optimize formulation stability and release.

The US firm claims that enhancing stability in this way allows the formulation to be pre-filled into a ready-to-use syringe with a suitable storage shelf-life. 

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