The arrival of targeted therapies has dramatically improved outcomes for patients with renal cell carcinoma (RCC). With approvals of Bayer/Onyx Pharmaceuticals' Nexavar (sorafenib), Pfizer's Sutent (sunitinib), Novartis' Afinitor (everolimus) and Wyeth's Torisel (temsirolimus), doctors now have a anumber of agents to choose from to treat patients.
However, due to the fact that in subjects with advanced RCC, who are receiving therapy, their disease will ultimately progress, physicians must choose from the drugs available to best extend survival whilst preserving quality of life. This requires consideration of the overall treatment plan from the outset, so that when selecting which agent to start treatment with, the doctor must contemplate effective options for subsequent therapy.
Current retrospective data suggest that there is no cross-resistance between tyrosine kinase inhibitors (TKIs), which means that they can be effectively used in sequence. These data also hint to a preferred treatment sequence, where patients treated with sorafenib prior to sunitinib may experience longer periods of progression-free survival compared with those receiving sunitinib then sorafenib. Furthermore, Phase III evidence indicates that the mTOR inhibitor, everolimus, retains full efficacy in patients who have already been treated with both sorafenib and sunitinib. Therefore an optimal sequence, based on currently available evidence, might be two TKIs followed by an mTOR inhibitor.
Further to this, results from a Phase III study have shown that treatment with sunitinib achieved a median overall survival (OS) greater than two years in patients with metastatic RCC. The data support the recent publication of final guidance from the UK's National Institute for Health and Clinical Excellence (NICE), which recommends the use of sunitinib for the first-line treatment of advanced RCC.
The results, published in the online edition of the Journal of Clinical Oncology, also support a recent recommendation made by a group of oncologists in the UK to use sunitinib as a first-line treatment for metastatic RCC.
The trial data showed that the median OS for patients who received sunitinib versus interferon (IFN) alpha was 26.4 versus 21.8 months, respectively (p=0.051). However, an exploratory analysis of patients who received only one line of treatment (ie, no subsequent treatments after stopping their sunitinib or IFN alpha therapies) showed that sunitinib almost doubled the median OS compared to IFN alpha (28.1 vs 14.1 months; hazard ratio=0.647; p=0.003). This is a reflection of clinical practice in the UK where generally patients are only funded for one line of treatment at most.
According to Pfizer, before NICE guidance only one-third of primary care trusts (PCTs) were funding sunitinib to some extent. Since the guidelines were published, 90 per cent of PCTs have committed to full funding of sunitinib in accordance with NICE guidance. In 2007, Pfizer cut the price of sunitinib by 5 per cent and committed to providing one cycle/course of the treatment free of charge to every eligible patient in the UK, in an effort to increase patient access. This move amounts to an average saving of between 19 and 29 per cent per patient for the cost of treatment, depending upon the type and stage of their tumour. The average annual cost for a patient taking sunitinib is £24,168.
Matthew Dennis - Editor, Cancer Drug News
Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts
Thursday, May 21, 2009
Wednesday, February 4, 2009
Pfizer to benefit from Wyeth acquisition
A definitive merger agreement has been entered into under which Pfizer will acquire Wyeth in a cash-and-stock transaction, currently valued at US$50.19 per share, or a total of approximately US$68 billion. The Boards of Directors of both companies have approved the combination, which will create one of the most diversified companies in the global healthcare industry.
Under the terms of the transaction, each outstanding share of Wyeth common stock will be converted into the right to receive US$33.00 in cash and 0.985 of a share of Pfizer common stock, subject to the terms of the merger agreement. Based on the closing price of Pfizer stock as of 23rd January, the stock component is valued at US$17.19 per share. The transaction provides immediate value to Wyeth shareholders through the cash component, as well as continued participation in the future prospects expected to result from the combination through their ownership of approximately 16 per cent of Pfizer’s shares. The transaction will be financed through a combination of cash, debt and stock. A consortium of banks has provided commitments for a total of US$22.5 billion in debt. Pfizer and Wyeth expect the transaction to close at the end of the third quarter or during the fourth quarter 2009.
The new company will be an industry leader in human, animal and consumer health. With the combined biopharmaceuticals business, it will lead in primary and specialty care as well as in small and large molecules. Its geographic presence in most of the world’s developed and developing countries will be unrivalled. Wyeth already has a leadership position in growth areas, such as vaccines, nutritionals and biologics. But what will Pfizer be getting for its money?
In the oncology area, Wyeth currently markets the following products: Torisel (temsirolimus) for the treatment of advanced renal cell carcinoma, and also filed in the EU for mantle cell lymphoma; Neumega (oprelvekin) for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with non-myeloid malignancies who are at high risk of severe thrombocytopenia; Mylotarg (gemtuzumab ozogamicin) for the treatment of patients with CD33+ acute myeloid leukaemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy; and Relistor (methylnaltrexone) subcutaneous injection for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care. These will be combined with Pfizer's marketed products, which include Camptosar (irinotecan) for colorectal cancer; Sutent (sunitinib) for gastrointestinal stromal tumours and renal cell carcinoma; and Aromasin (exemestane) for breast cancer.
But what about future products? Wyeth's R&D pipeline includes the following oncology compounds: bosutinib, in Phase III for chronic myelogenous leukaemia and Phase II for breast cancer combination therapy; inotuzumab ozogamicin in Phase III for follicular non-Hodgkin's lymphoma (NHL) and Phase II for diffuse large B-cell lymphoma/NHL; and neratinib (HKI-272), which is in late-stage trials for breast cancer. Although Pfizer has many novel drugs in Phase I and II development, its current Phase III pipeline mainly consists of new indications for sunitinib. The main benefit to come from the acquisition of Wyeth will be Pfizer's increased exposure to areas of the oncology market that it does not currently serve, such as haematological cancers and supportive products.
Matthew Dennis - Editor, Cancer Drug News
Under the terms of the transaction, each outstanding share of Wyeth common stock will be converted into the right to receive US$33.00 in cash and 0.985 of a share of Pfizer common stock, subject to the terms of the merger agreement. Based on the closing price of Pfizer stock as of 23rd January, the stock component is valued at US$17.19 per share. The transaction provides immediate value to Wyeth shareholders through the cash component, as well as continued participation in the future prospects expected to result from the combination through their ownership of approximately 16 per cent of Pfizer’s shares. The transaction will be financed through a combination of cash, debt and stock. A consortium of banks has provided commitments for a total of US$22.5 billion in debt. Pfizer and Wyeth expect the transaction to close at the end of the third quarter or during the fourth quarter 2009.
The new company will be an industry leader in human, animal and consumer health. With the combined biopharmaceuticals business, it will lead in primary and specialty care as well as in small and large molecules. Its geographic presence in most of the world’s developed and developing countries will be unrivalled. Wyeth already has a leadership position in growth areas, such as vaccines, nutritionals and biologics. But what will Pfizer be getting for its money?
In the oncology area, Wyeth currently markets the following products: Torisel (temsirolimus) for the treatment of advanced renal cell carcinoma, and also filed in the EU for mantle cell lymphoma; Neumega (oprelvekin) for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with non-myeloid malignancies who are at high risk of severe thrombocytopenia; Mylotarg (gemtuzumab ozogamicin) for the treatment of patients with CD33+ acute myeloid leukaemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy; and Relistor (methylnaltrexone) subcutaneous injection for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care. These will be combined with Pfizer's marketed products, which include Camptosar (irinotecan) for colorectal cancer; Sutent (sunitinib) for gastrointestinal stromal tumours and renal cell carcinoma; and Aromasin (exemestane) for breast cancer.
But what about future products? Wyeth's R&D pipeline includes the following oncology compounds: bosutinib, in Phase III for chronic myelogenous leukaemia and Phase II for breast cancer combination therapy; inotuzumab ozogamicin in Phase III for follicular non-Hodgkin's lymphoma (NHL) and Phase II for diffuse large B-cell lymphoma/NHL; and neratinib (HKI-272), which is in late-stage trials for breast cancer. Although Pfizer has many novel drugs in Phase I and II development, its current Phase III pipeline mainly consists of new indications for sunitinib. The main benefit to come from the acquisition of Wyeth will be Pfizer's increased exposure to areas of the oncology market that it does not currently serve, such as haematological cancers and supportive products.
Matthew Dennis - Editor, Cancer Drug News
Tuesday, October 14, 2008
Market jitters affecting takeovers?
As the world financial crisis deepens, the potential takeover deals involving Genentech and Roche, as well as ImClone Systems and Bristol-Myers Squibb, continue to play out. The current market situation could have an impact on the first takeover, although the second looks more likely to proceed smoothly.
For the first time since Roche made its bid to acquire Genentech in July for US$89.00 per share, the latter's shares have dropped below the offer price, ending on 29th September at US$85.30. The uncertainty now surrounding the bid has fuelled speculation that an improved offer may not be made. When Roche proposed the deal, the cost of borrowing was not as high as it in the current climate. Now there are concerns that Roche would have trouble financing the deal, which currently stands at US$43.7 billion, given the current credit market conditions. However, many analysts believe Roche's strong balance sheet and predictable cash flow will still allow it to secure funding for the deal.
The current situation could ultimately work in Roche's favour as the company may choose to draw out the process in order to extract the lowest possible price for Genentech's remaining shares. It may be that many Genentech shareholders would also prefer to wait, given that interim results are expected in November from a key clinical trial looking at the use of Avastin (bevacizumab) in colon cancer patients who have had tumours surgically removed; final results of the 2,700-patient study are due in 2009.
As for BMS' takeover offer for ImClone, which currently stands at US$62.00 per share in cash, Carl Icahn, ImClone's Chairman of the Board, recently commented that the "hostile tender of US$62, at this time, seems absurd". ImClone reportedly has an offer from another large pharmaceutical company of US$70.00 per share, also in cash, subject to due diligence, which was scheduled to be finished on 28th September. ImClone is expecting that a solid offer from this company will be made or a formal rejection, in which case the suitor will be identified, by the end of business on 1st October. Both of these offers, BMS' valued at US$4.7 billion and the other at US$6.1 billion, do not rely on either company raising funds so should not be affected by recent financial developments.
But to add to the uncertainty, Merck KGaA has entered the fray. Although the company has said that it will not bid for ImClone on its own, it has stated that it may consider taking part in a potential approach for the company. Could it join forces with rumoured suitors, such as Eli Lilly and Pfizer, which has coincidentally said recently that it will focus its early-stage research and development programmes on high growth areas, including cancer?
Matthew Dennis - Editor, Cancer Drug News
For the first time since Roche made its bid to acquire Genentech in July for US$89.00 per share, the latter's shares have dropped below the offer price, ending on 29th September at US$85.30. The uncertainty now surrounding the bid has fuelled speculation that an improved offer may not be made. When Roche proposed the deal, the cost of borrowing was not as high as it in the current climate. Now there are concerns that Roche would have trouble financing the deal, which currently stands at US$43.7 billion, given the current credit market conditions. However, many analysts believe Roche's strong balance sheet and predictable cash flow will still allow it to secure funding for the deal.
The current situation could ultimately work in Roche's favour as the company may choose to draw out the process in order to extract the lowest possible price for Genentech's remaining shares. It may be that many Genentech shareholders would also prefer to wait, given that interim results are expected in November from a key clinical trial looking at the use of Avastin (bevacizumab) in colon cancer patients who have had tumours surgically removed; final results of the 2,700-patient study are due in 2009.
As for BMS' takeover offer for ImClone, which currently stands at US$62.00 per share in cash, Carl Icahn, ImClone's Chairman of the Board, recently commented that the "hostile tender of US$62, at this time, seems absurd". ImClone reportedly has an offer from another large pharmaceutical company of US$70.00 per share, also in cash, subject to due diligence, which was scheduled to be finished on 28th September. ImClone is expecting that a solid offer from this company will be made or a formal rejection, in which case the suitor will be identified, by the end of business on 1st October. Both of these offers, BMS' valued at US$4.7 billion and the other at US$6.1 billion, do not rely on either company raising funds so should not be affected by recent financial developments.
But to add to the uncertainty, Merck KGaA has entered the fray. Although the company has said that it will not bid for ImClone on its own, it has stated that it may consider taking part in a potential approach for the company. Could it join forces with rumoured suitors, such as Eli Lilly and Pfizer, which has coincidentally said recently that it will focus its early-stage research and development programmes on high growth areas, including cancer?
Matthew Dennis - Editor, Cancer Drug News
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