Pharmaceutical manufacturing: news in brief
from the pharmaceutical manufacturing industry.
Belgium-based UCB has released new results on Cimzia (certolizumab pegol), the first and only PEGylated anti-TNF (tumour necrosis factor) therapy. The findings, from analyses of two ongoing open-label, long-term extension studies of the Phase III PRECiSE programme, showed the drug maintained remission for up to 18 months in patients with Crohn's disease. The data also showed that some patients who were re-introduced to Cimzia after losing clinical response were re-captured with only one additional induction dose and maintained remission with no dose escalation. Preparation for a regulatory submission fro Cimzia in the treatment of rheumatoid arthritis is the US is ongoing. Novartis has had Tasigna (nilotinib) approved in the US as a new anti-cancer therapy for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML). "Tasigna represents an important advance for the small number of patients who are resistant or intolerant to prior therapy," Novartis Oncology president and chief executive David Epstein said. Taken twice daily, Tasigna works by inhibiting the proliferation of cells containing an abnormal chromosome by targeting the production of the Bcr-Abl protein, which is produced only in cells that contain the abnormal Philadelphia chromosome. Tasigna was specifically designed to target Bcr-Abl protein - thought to be the driver of the overproduction of cancer-causing white blood cells - more preferentially than Novartis' other anti-cancer drug Glivec (imatinib). Tasigna was approved in Switzerland in July and EU approval is expected by the end of this year. Javelin Pharmaceuticals has received marketing authorisation approval in the UK for Dyloject, Javelin's proprietary injectable formulation of diclofenac sodium. "Dyloject's UK approval is a milestone in establishing Javelin as a commercial provider of novel solutions for acute pain management," Javelin chief executive and chief medical officer Dr Daniel Carr said. According to a recent study, Dyloject has the potential to save the UK National Health System up to £50 per postoperative patient compared to the currently marketed formulation. Javelin plans to file a New Drug Application for FDA approval in the first half of 2009. Meanwhile, Barr Laboratories has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim's Mirapex (pramipexole dihydrochloride) tablets. Indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease, the tablet strengths available are 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg. The tentative approval reflects the FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. After Barr filed the Abbreviated New Drug Application in 2005, Boehringer Ingelheim filed suit in the US District Court in Delaware to prevent Barr from proceeding with the commercialisation of its product. A trial date had been set for November 5, but a judicial vacancy means the trial will not commence then. Seattle Genetics and MedImmune have expanded their antibody-drug conjugate collaboration with MedImmune obtaining an exclusive license to an undisclosed second antigen target under the companies existing collaboration. Seattle Genetics will receive $1.5m (€1m) as a result. The original antibody-drug conjugate collaboration began in 2005 to provide MedImmune with access to Seattle Genetics' antibody-drug conjugate technology. The technology links antibodies to drugs through proprietary linker systems. The linkers are designed to be stable in the bloodstream but to release the drug payload under specific conditions once inside target cells, thereby sparing non-target cells from the toxic effects of traditional chemotherapy. Under the collaboration MedImmune is responsible for research, product development, manufacturing and commercialisation of product candidates. Pfizer Ireland Pharmaceuticals, a subsidiary of Pfizer, has entered into an agreement to subscribe for 2,516,299 Entelos common shares at 29.1 pence per share. Under the terms of the agreement Pfizer Ireland Pharmaceuticals will invest $1.5m to acquire the shares representing 3.3 per cent of the enlarged share capital of Entelos. Following the subscription, Pfizer Ireland Pharmaceuticals will hold 6.9 per cent of the enlarged share capital of Entelos. The funds raised from the transaction will be used as additional working capital as Entelos pursues its growth strategy of building and acquiring complementary predictive technologies to generate revenue from services and technology licensing. Wyeth Consumer Healthcare has initiated a voluntary recall and replacement programme for several Robitussin and Children's Dimetapp Cold and Chest Congestion products because of a problem with a dosage cup. The programme involves the removal of seven existing products with a dosage cup that does not have a half-teaspoon mark, which is the recommended dose for children age two to under six. Replacement products with the new dosage cup are expected to be available early this month.
