IHS Global Insight Perspective | |
Significance | Austrian biotech F-Star has signed a US$1.7-billion collaboration and licence agreement with Boehringer Ingelheim (Germany) for joint discovery of new antibody-derived therapeutic products based on its Modular Antibody Technology. Meanwhile, Boehringer Ingelheim has reported that its IPF investigational compound BIBF1120 demonstrated efficacy in a Phase II study whose data were presented at the 16th International Colloquium on Lung and Airway Fibrosis. |
Implications | The total payment to F-Star, for each programme, excluding royalties, could reach up to 180 million euro in case of full commercial success of multiple therapeutic products. |
Outlook | The deal with F-Star has the potential to add several antibody-based therapeutics to the portfolio of Boehringer, which has been very dynamic in seeking antibody opportunities in the past few years. |
Boehringer Inks Another Antibody Discovery Deal
Austrian biotech F-Star has signed a collaboration and licence agreement with Boehringer Ingelheim (Germany) to discover new antibody-derived therapeutic products based on the modular antibody technology platform developed by the Austrian firm. Up to seven targets, "which may span multiple therapeutic areas", will be nominated by Boehringer which will work in collaboration with F-Star to discover candidate therapeutics against those undisclosed targets. F-Star will receive an initial technology access fee, research-based funding and stands to receive additional licence fees, development, regulatory and commercial milestones as well as undisclosed tiered royalties on product sales. The total payment to F-Star, for each programme, excluding royalties, could reach up to 180 million euro in case of full commercial success of multiple therapeutic products. F-Star's modular antibody technology has the potential to create two molecular formats: small-sized antibody fragments with full antibody functionality (Fcab) and full length antibodies with additional functionality (mAb2). Discovering Fcabs for further global development and commercialisation by Boehringer Ingelheim either as therapeutic products or as modules for the generation of bispecific mAb2 products will be the main objective of the collaborative agreement inked between the two partners. Further details of the deal were not disclosed.
IPF Compound BIBF1120 Shows Efficacy in Phase II Study
Meanwhile, new data from a Phase II study presented at the 16th International Colloquium on Lung and Airway Fibrosis (ICLAF) suggests that Boehringer Ingelheim's investigational compound BIBF1120 might become the first approved treatment for patients with idiopathic pulmonary fibrosis (IPF). Results from the Phase II TOMORROW study show that 12 months' treatment with BIBF1120 resulted in a clinically important reduction in the rate of decline in lung function in patients with IPF. The 150-mg twice daily dose of BIBF1120 induced a 68% reduction in the rate of FVC decline (primary endpoint) compared with placebo.
Besides, the percentage of the predicted value of FVC was better preserved in the 100 mg and 150 mg twice daily BIBF1120 groups compared with placebo. Only 2.3% of patients in the 150-mg twice daily BIBF1120 group suffered from an acute exacerbation of the disease during the 12-month study period, compared with 13.8% of patients in the placebo group.
Outlook and Implications
The deal with F-Star has the potential to add several antibody-based therapeutics to the portfolio of Boehringer as the German firm will be able to select several therapeutic products from each of the seven discovery programmes. This new antibody collaboration comes only a month after Boehringer Ingelheim tied up with U.S. firm MacroGenics in a strategic alliance designed to discover, develop and commercialise antibody-based therapeutics which may target multiple therapeutic areas, including immunology, oncology, respiratory, cardiometabolic and infectious diseases (see Germany: 27 October 2010: Boehringer Ingelheim Teams Up with MacroGenics in Antibody Deal). The deal, under which MicroGenics may receive up to 2.1 billion euro development, regulatory and commercial milestone payments, will aim to discover antibodies against up to ten combinations of molecular targets.
The two consecutive deals illustrate Boehringer's aggressive collaboration strategy on the antibody front. German biotech Morphosys, U.S. firm Micromet, Swiss-based biotech company 4-Antibody and Belgian biotech Ablynx are all perfect examples of the strong interest antibodies represent for Boehringer (see Germany: 18 March 2010: Boehringer Ingelheim Signs 177-mil.-Euro Deal with 4-Antibody and Germany: 6 May 2010: Boehringer, Micromet Partner over Multiple Myeloma BiTE Antibody). Boehringer teamed up with Micromet (U.S.) and 4-Antibody (Switzerland) earlier this year, while Ablynx and Boehringer initiated a collaborative agreement in September 2007 with the objective to develop and commercialise 10 different nanobody therapeutic proteins in various therapeutic areas such as immunology, oncology, and respiratory disease. Ablynx, which is entitled to milestones payments of up to 125 million euro, has been rewarded on several occasions as Boehringer has paid five milestone payments of around 3 million euro each so far (see Germany: 4 February 2009: Ablynx Gains US$3.9-mil. Milestone Payment from Boehringer Ingelheim on Progress in Antibody Alliance).
Meanwhile, the positive results from the Phase II TOMORROW study will provide Boehringer with a solid basis to initiate Phase III development programme of its IPF investigational compound. Drug treatments that are currently available for IPF do not work very well and may have side effects. The combination of low-dose prednisone, with azothiaprine and N-acetyl cysteine is seen as the best treatment currently available but bone protection is usually prescribed in order to reduce the risk of bone thinning with prednisone, according to the national health service (NHS) which recommends a careful supervision with regular blood tests. BIBF1120 may in that context bring significant advantages over current therapeutic options as the total number of adverse events reported in the Phase II trial was similar in the BIBF1120 and placebo groups while BIBF1120 was shown to induce a significant reduction in the rate of decline in lung function. The most frequently reported adverse events in patients taking BIBF1120 were diarrhoea, nausea, vomiting, abdominal pain and reversible increases of liver transaminases. Boehringer is also investigating BIBF1120 in Phase III clinical programme for the treatment of cancer patients with advanced non-small-cell lung cancer and in patients with ovarian cancer.