Pfizer and SFJ Pharmaceuticals have unveiled a deal which will see the latter conduct a late-stage trial on the drug giant’s lung cancer dacomitinib.
The compound is a pan-human epidermal growth factor receptor (pan-HER) inhibitor. The Phase III trial, which will be conducted at multiple sites in Asia and Europe, will evaluate dacomitinib in patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR.
Under the terms of the agreement, SFJ will provide the funding and clinical development supervision to generate the data necessary to support a registration dossier on dacomitinib. If approved as first-line treatment of patients with advanced NSCLC, the San Francisco-based group will be eligible to receive milestone and earn-out payments. No financial details were disclosed.
Earlier this year, the two firms partnered to run a Phase III trial in Asia of Inlyta (axitinib) for adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy. Garry Nicholson, head of Pfizer Oncology, said such partnerships enable the firm to “deliver new cancer medicines to patients as efficiently as possible around the world”. He added that NSCLC “remains a difficult disease to treat despite recent advances” and Pfizer is evaluating dacomitinib in the disease “across lines of therapy and a range of histologies and molecular subtypes”.
Settles Detrol patent row with Mylan
Meantime, Pfizer has settled litigation with Mylan relating to patents covering overactive bladder treatment Detrol LA (tolterodine) extended-release capsules.
The company says that following this settlement, the details of which are confidential, and a similar agreement reached with Impax Laboratories last month, it expects generic competition for Detrol LA to commence in the USA on January 1, 2014, “except in certain limited circumstances”, and no later than March 1 that year.
No copycat versions of the drug have been approved to date and Mylan said may launch its product as either an authorised generic or under its own Abbreviated New Drug Application. Detrol had sales of just under $60 million for the year ended June 30.
