Frost & Sullivan Releases Drug Launch and Phase III Trial Watch List for Top Therapeutic Areas

The therapeutics market is buzzing with activity, as several promising therapies are progressing to Phase III clinical trials and many more are awaiting commercial launches. As more complex specialty products are launched, the spending on personalized medicine will grow beyond oncology into areas such as infectious diseases (virology) and cardiology.

Frost & Sullivan examined promising therapeutics for 2015 finding that oncology, cardiovascular, autoimmune/anti-inflammatories, and infectious diseases will be the top areas of investments in 2015.

“In addition, pharmaceutical companies will be keen to invest in in vitro diagnostics such as biomarkers; molecular, tissue, companion diagnostics; predisposition disease; and predictive testing,” said Frost & Sullivan Life Sciences Global Program Director Jennifer Lazar. “This is because drugs with companion diagnostics are expected to increase two- to three-fold over the next 5 years with increased focus on areas such as cardiology and inflammatory diseases.” 

Frost & Sullivan’s therapeutics’ watch list for 2015:

• Puma Biotechnology’s tyrosine kinase inhibitor, neratinib, for breast cancer adjuvant therapy: In its Phase III ExteNET trial, neratinib demonstrated significantly higher disease-free survival rates compared to placebo after adjuvant treatment with Herceptin (trastuzumab) for early-stage HER2-positive breast cancer. This therapy is awaiting FDA filing in the first hald of 2015, and potential approval and launch in the second.

• Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, nivolumab, for previously treated advanced melanoma patients: In its Phase III trial, CheckMate-066, the primary endpoint of overall survival (OS) was met. It emerged that the one-year survival rate was 73% for nivolumab against 42% for the chemotherapy, dacarbazine (DTIC) in patients with treatment-naïve BRAF wild-type advanced melanoma. The Prescription Drug User Fee Act (PDUFA) has set the likely date for FDA approval as 30 March 2015. This could translate to a launch in the second quarter of 2015.

• Novartis’ selective IL-17A inhibitor, secukinumab, for the treatment of plaque psoriasis: The Phase III trial drug, FIXTURE secukinumab, was shown to be significantly more effective in clearing skin lesions than Pfizer’s Enbrel. In October 2014, the FDA’s advisory committee recommended approval for secukinumab. Anticipate a successful product launch in the first quarter of 2015.

• Novartis’ angiotensin receptor neprilysin inhibitor (ARNi), LCZ696, for the treatment of heart failure: LCZ696 has exhibited statistically superior data to enalapril. Expect this treatment to be introduced in the second half of 2015.

• AbbVie’s ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin for the treatment of hepatitis C: This interferon-free, all oral regimen is supported by six Phase III clinical trials. This triple combination therapy will likely be commercially launched in Q1 2015.

• GlaxoSmithKline submitted a regulatory application to the European Medicines Agency (EMA) in July 2014; its launch is anticipated in 2015.

• Sanofi Pasteur's Dengue Vaccine is also expected to have a first-mover advantage, with FDA approval in 2015.

• Ebola virus vaccines consisting of cAd3-ZEBOV by GlaxoSmithKline, PSC-1001 by Newlink Genetics Corporation, and potentially an unnamed vaccine developed by Johnson & Johnson are anticipated to be entering Phase III trials in 2015.

In addition to new molecular entity (NME) product launches, there are abundant opportunities for generic and biosimilar drugs due to the patent expiry of several blockbuster drugs in 2014 and 2015. Some of those include

• Otsuka Pharmaceutical’s Abilify (anti-psychotic)
• Teva Pharmaceutical’s Copaxone (relapse-remitting multiple sclerosis)
• Novartis’ Gleevec (chronic myeloid leukemia)
• Forest Laboratories’ Namenda (Alzheimer’s disease)
• Pfizer’s Zyvox (anti-viral)
• GlaxoSmithKline’s Avodart (benign prostatic hyperplasia).

To entrench themselves in the market, technology developers could expedite the identification of biomarkers and targets for novel therapeutics. In addition, pharma/biotech and ICT companies could enhance patient awareness of product launches.