Pharma manufacturing news in brief
pharmafile | March 27, 2012 | News story | Manufacturing and Production |Â Â Apotex, Ei Inc, Oxford Pharmascience and Bend Research, PharmaFormÂ
Apotex sues FDA, Ei expands its production facilities in North Carolina, plus new developments at PharmaForm, Oxford Pharmascience and Bend Research.
US pharma company Ei Inc is planning to expand its manufacturing and product development facilities in Kannapolis, North Carolina, spending more than $13 million on capital investments and adding 119 jobs to its current workforce of 200 over the next three years. It is also pursuing a partnership with KeraNetics, a company developing keratin-based products for woundcare, bone and nerve regeneration and cell growth, using technology developed at the nearby Wake Forest Institute for Regenerative Medicine.
US contract manufacturing organisation (CMO) PharmaForm has been selected by Corcept Therapeutics as the primary producer of its Korlym (mifepristone) product for endogenous Cushing’s syndrome, which was approved by the FDA last month. Korlym is a 300mg tablet formulation of mifepristone used to control high blood sugar levels in adult Cushing syndrome patients who have type 2 diabetes or glucose intolerance, and are not treatable with surgery. PharmaForm has been involved with the development of the product over the last several years.
Oxford Pharmascience of the UK has signed an agreement in principle with German drugmaker Hermes Pharma for the development of a new orally-disintegrating ibuprofen product using Oxford’s recently-launched OXP zero taste-masking technology. Hermes has also been granted an option to develop a second formulation based on an ibuprofen suspension delivered in a sachet. Meanwhile, Oxford has reported its 2011 financial results, and said it made a net loss of £926,000, on revenues of £292,000, and had £1.1 million in cash at the close of the year. Revenues this year should step up as shipments of another formulation technology called OXP chew are made to Brazilian licensee Ache Pharmaceuticals.
Bend Research, a specialist in formulation, engineering and process development, has launched a new initiative to expand beyond its current focus on small-molecule drugs into biotherapeutic development. The company says it will offer a wide range of services to biologic drug developers that drawn on its “extensive experience in process development, analytical sciences, and formulation science”. The initiative has grown out of a seven-year collaboration with Pfizer in which it developed new tools and models to advance the drugmaker’s biotherapeutic drug candidates and designed a “plant of the future” with 50 per cent lower capital investment and operating costs cut by two thirds.
Generic drugmaker Apotex has sued the FDA over an import alert which the company claims ‘decimated’ its business and cost it around $520 million. The agency placed three of the Canadian firm’s facilities in Ontario under an import alert after inspections uncovered GMP violations including contamination and leaking of dessicant material into primary packaging. The lawsuit claims that the FDA treated Apotex more harshly than other companies in the US and overseas with comparable problems, citing issues with a Teva plant in Israel that led to a warning letter but no import alert. The filing document is available here.
Phil Taylor
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