Major new drugs for 2012
Renal cell carcinoma
Pfizer’s Inlyta (axitinib) has been approved as second line treatment for renal cell carcinoma. The drug is forecast to reach annual revenues of around $600 million by 2014, but will be entering a tough market. It will compete with Pfizer’s Sutent, Bayer’s Nexavar, GlaxoSmithKline’s Votrient, Roche’s Avastin and Novartis’ Afinitor.
But the drug is predicted to be leading the RCC field by 2019, according to analysts at Decision Resources, and is set to take a 47% share of the market based on impressive Phase III results. It was approved in late January and was launched last month.
Roche’s Avastin (bevacizumab) is now licenced for use in ovarian cancer in Europe. The new indication is forecast to make up to $1 billion in peak sales, which would offset the projected $1 billion a year loss after the FDA decided to withdraw Avastin’s breast cancer licence last year.
But the firm said it is not planning to seek this new licence in the US in the foreseeable future, after recent Phase III trials failed to show an increase in overall survival.
AstraZeneca’s Caprelsa (vandetanib) for thyroid cancer gained FDA approval in 2011 (where it is sold as Zactima), and has just been approved in Europe. It is licenced to treat patients with a rare form of the disease, and is forecast to make $500 million a year by 2014.
Roche’s metastatic melanoma drug Zelboraf (vemurafenib) gained in February a European licence to treat advanced, metastatic melanoma that over expresses the BRAF V600 mutation, which is present in around half of all advanced melanoma patients.
The drug is forecast to make $900 million in peak sales. Bristol-Myers Squibb’s rival treatment Yervoy (ipilimumab) is already on the market, however, and will provide stiff competition. Yervoy is an immunotherapy treatment, and has the potential to treat all melanoma patients.
But Zelboraf may have an edge on price, as Yervoy costs £80,000 for a full course of treatment, making it one of the most expensive cancer drugs of all time.
Roche also gained approval in January for its other skin cancer drug Erivedge (vismodegib) for advanced basal cell carcinoma, a far less deadly form of the disease (with only around 2% of all BCC cancers metastasising). BCC is the most common type of skin cancer in the world, with three out of every 10 Caucasians predicted to suffer from the disease in their lifetime.
As with melanoma, the incidence of BCC is rising, but there are currently no targeted drugs available to treat this advanced form of the disease. Analysts are predicting peak annual sales of around $533 million for the drug, given that it is the first of its kind to reach market.
Roche’s pertuzumab for HER2+ breast cancer represents a next generation form of Roche’s ageing HER2+ treatment Herceptin (trastuzumab). Filed in Europe and the US in December for metastatic breast cancer, analysts forecast peak sales of $1.8 billion or more.
Study results which showed that pertuzumab combined with Herceptin and chemotherapy significantly extended progression-free survival, compared with Herceptin and docetaxel alone.
Pfizer’s Xalkori (crizotinib) for advanced non-small cell lung cancer gained FDA approval last August, but is now looking for a European licence to help it gain the estimated $540 million in peak annual sales.
The drug works by targeting the ALK mutation in NSCLC patients, and was one of the stars of the ASCO cancer conference last year. It is likely to only help treat around 5% of all NSCLC patients, but this could increase with the use of diagnostics.
Pfizer’s bosutinib is seeking a licence for the treatment of patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase.
It will compete with Novartis’s Glivec, which also has a licence for a type of stomach cancer, and made $4.2 billion last year. Onyx took carfilzomib to the FDA with the hope of receiving priority review in multiple myeloma, only to receive word that its application would undergo a standard 10-month consideration; a decision is due from the FDA in July.
Bayer/Regeneron’s Eylea (aflibercept) is seeking a European licence for wet age-related macular oedema after being approved in the US.
Eylea is estimated to make $1.1 billion in peak annual sales, and will be competing with Novartis’s established ophthalmology drug Lucentis (ranibizumab) for wet AMD.
The bigger challenge, however, will be the competition from Roche’s Avastin, which is widely used off-label for wet AMD as it is around 250 times less expensive than Lucentis.
Sanofi/Genzyme’s Lemtrada (alemtuzumab) is forecast to make between $750 million to $2 billion in peak sales. It is an injectable treatment that will be competing with established interferon treatments such as Merck Serono’s Rebif and Biogen’s Avonex, as well as Novartis’s new MS pill Gilenya.
Teva and Active Biotech are also looking to bring their new MS treatment Laquinimod to the market for 2012. The drug is forecast to be making $600 million in peak annual sales, but received a blow when a recent Phase III trial showed that it failed to reduce relapse rates in MS patients compared to placebo.
Teva is looking to the drug as a successor to its current injectable MS drug Copaxone (glatiramer acetate), which made the firm $3.3 billion last year.
Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) for stroke prevention in patients with atrial fibrillation is looking to gain its first US approval this year.
The drug has already gained approval for preventing blood clots after surgery in Europe. Estimates for the drug vary, from $2 billion in peak annual sales to as much as $4.6 billion.
The uncertainty is due to Eliquis’ rivals, Bayer’s Xarelto (rivaroxaban) and Boehringer Ingelheim’s Pradaxa (dabigatran), as to which will be the most efficacious. Currently, Eliquis appears to be the leader in reducing stroke in patients with AF, leading to higher sales forecasts from analysts.
Pfizer’s rheumatoid arthritis drug tofacitinib is expected to make $2.5 billion in peak annual sales, and works as a JAK inhibitor. It comes in a pill form and will compete with standard injectable drugs: Abbott’s Humira, Pfizer/Amgen’s Enbrel and J&J’s Remicade.
Its ease of administration could make the drug more attractive for doctors and patients, and was boosted by a recent head-to-head Phase III trial where it matched Humira in efficacy. But in April four patients died whilst being treated with the drug, with one patient’s death potentially related to use of the drug, leading to questions over the drug’s safety.
The EMA is set to give its judgement by the middle of the year, with the FDA following in August.
The FDA approved Vertex’s first-in-class cystic fibrosis drug Kalydeco at the end of January. Vertex’s drug is the first disease modifying therapy - albeit for just 5% of patients that carry a specific gene mutation - which means its approval is a landmark for CF sufferers.
Forest Labs and its partner, Ironwood Pharmaceuticals filed linaclotide for the treatment of irritable bowel syndrome with constipation and chronic constipation. A response from the FDA is expected in June.
Insulin degludec is Novo Nordisk’s new ultra long-acting basal insulin analogue, and looks set to change treatment significantly. Injected subcutaneously three times a week, insulin degludec works for up to 40 hours, much longer than the 18-26 hours of current marketing leading long-acting insulins: Sanofi’s Lantus (insulin glargine) and Novo’s own Levemir (insulin detemir). Filed with the FDA and EMA in September, Novo Nordisk believe it will one day overtake the current market leader, Sanofi’s Lantus, as the mainstay of insulin treatment.
Meanwhile BMS and AstraZeneca’s dapagliflozin was recently rejected by the FDA, which asked for further data before it can reconsider the application.
The FDA committee cited elevated rates of bladder and breast cancer seen in clinical studies, as well as concerns about infections and possible liver damage. Analysts had predicted peak annual sales of $1.2 billion, but the companies may struggle to convince regulators of its safety and efficacy.
Vivus’ Qnexa is the latest in a long line of treatments looking to crack the obesity market. Qnexa is a combination of appetite suppressant phentermine and seizure treatment topiramate, and was rejected by the FDA in 2010 because of safety concerns. These include elevated heart rate in some patients and potential birth defects if pregnant women use the medicine.
Qnexa has now been recommended by an FDA panel, two years after it was rejected by the US regulator. The FDA isn’t required to follow the panel’s recommendation and will come to a final decision on Qnexa by April.
The FDA has signalled that it agrees Qnexa helped patients in a clinical trial to lose more weight, and kept it off for longer than patients taking a placebo. These trial participants also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.
However, the FDA says patients taking the drug had more safety problems than patients on a placebo, including memory loss, and these problems could worsen over time. They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies. Vivus is now proposing that pregnant women are barred from taking the drug in response.