Highlights from the pipeline

Fittingly, perhaps, with Christmas recently having come and gone and many gifts having been opened, Ben Searle, managing editor of Thomson Reuters Cortellis Competitive Intelligence, told DDNews, “There are always some surprises in the pipeline.”

The surprises come by way of the Thomson Reuters quarterly report “The Ones to Watch,” which covers the most promising drugs that are changing their clinical phase, receiving approval or have launched, based on the company’s strategic data and insight. “We follow the drugs from the early stages to the launch,” Searle says in recapping the most current issue, published in November. “We always invest hope in a new therapy and are disappointed when one doesn’t make it.”

 

In this latest review of drugs to watch, covering July to September, one of the interesting surprises for Thomson Reuters was found in Boehringer Ingelheim’s Gilotrif, which Searle calls “an interesting one, because it achieved a truly global launch, which is very difficult.” He added that Boehringer Ingelheim, the 20th largest pharmaceutical company in the world, had the global reach to launch a much-needed drug that addresses a “rapidly progressing disease with a shocking mean survival time.”

 

Gilotrif was approved in July 2013 in the United States as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC). The European Medicines Agency approved Gilotrif in September 2013 for EGFR tyrosinekinase-inhibitor-naive adult patients with locally advanced or metastatic EGFR-mutated NSCLC, suggesting that European launch will not be far behind. New drug applications have also been filed in Japan, Canada and Asia. Granted Orphan Drug designation in December 2011, Gilotrif binds irreversibly to EGFR/HER1, HER2 and HER4, targeted at patients exhibiting EGFR-mutations. NSCLC is the most widespread form of lung cancer and is often associated with EGFR mutations.

 

“Because clinical trials are often conducted on the sickest and most serious patients, this drug could be even more beneficial for less sick patients,” Searle says. “It can extend a person’s life or reduce symptoms for a while.”

 

Biocon Biopharmaceuticals’ Alzumab, a first-in-class humanized monoclonal antibody targeting the CD6 inhibitor for the treatment of chronic plaque psoriasis, is one of the first biological drugs to be developed from inception to launch in India. The drug was launched in August and at the time of launch was reported to be priced at half the cost of existing treatments available in India. Biocon is India’s largest biotechnology company, aspiring to become a $1 billion company by 2018, and, since its founding, has evolved to become a global business, according to the report.

 

Psoriasis is a problem of the aging population, according to Searle. He added that the drug is in Phase 2 clinical trials for the treatment of rheumatoid arthritis, which “affects a lot of people worldwide and could be a happy accidental side effect.”

Bayer’s Adempas, an oral sGC stimulator, almost made the list and is the first drug to be approved for the treatment of chronic thromboembolic pulmonary hypertention (CTEPH). According to forecast data from Cortellis Competitive Intelligence, sales of Adempas will reach $578 million in 2017. Pulmonary hypertension is a progressive disease associated with an increase of blood pressure in the pulmonary vasculature leading to symptoms of dizziness, angina, tachycardia, swelling of the legs, shortness of breath, fatigue, reduced exercise capacity, and, in severe cases, heart failure.

 

Searle explained, “Pulmonary hypertension makes the right side of the heart work harder than normal. In its various forms, pulmonary hypertension is a chronic, progressive, debilitating disease, often leading to death or need for lung transplantation. Adempas helps arteries relax to increase blood flow and decrease blood pressure.”

 

Adempas was registered in Canada in September 2013 for treating post-surgical CTEPH, and was subsequently approved in the United States in October 2013 for inoperative/recurrent CTEPH and Pulmonary Arterial Hypertension (PAH). A European filing for approval was submitted in February 2013 and the drug has been granted Orphan Drug designation in both the United States and Japan. In Phase 3 trials enrolling patients with PAH, and also Phase 3 trials enrolling patients with CTEPH, treatment three times daily with Adempas produced statistically significant and sustained improvements in six-minute walking distance compared with placebo.

 

The drug is also under development for idiopathic pulmonary fibrosis and systemic sclerosis.

 

“We track every novel drug anywhere in the world, and the report gives us a diverse snapshot of the pipeline,” Searle said. “There’s a great deal of diversity from life-threatening to less severe conditions being treated.”

 

“Markets are becoming more globalized,” he concluded. “We’re seeing a rebalancing of the pharma market worldwide, and it’s very interesting.”