FDA News Roundup: Astellas, Sanofi Pasteur, Orexigen, and More

FDA Approves IND For Non-Hodgkins Lymphoma Drug

Biopharmaceutical company Molecular Templates got a nod of approval from the FDA on its Investigational New Drug (IND) application for MT-3724 last week. MT-3724 is a next-generation immunotoxin compound that induces direct cell death by inactivating ribosomes in CD20-expressing cells. Now that approval has been granted, the company plans to launch a phase 1 clinical trial program for the drug candidate, investigating its potential as a monotherapy in refractory non-Hodgkin’s lymphoma. The study will be held at Memorial Sloan-Kettering Cancer Center and New York University’s Langone Medical Center, joined eventually by a site in an oncology center in Texas.

Menactra Given Thumbs Up As Meningitis Booster Vaccine

Sanofi Pasteur’s Menactra gained FDA approval to be used as a booster vaccination against meningococcal disease in patients aged 15 to 55. Menactra, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, received FDA approval in 2005 as the first quadrivalent conjugate vaccine indicated to immunize against the disease caused by the 4 serotypes A, C, Y, and W-135 contained in the vaccine. The drug was investigated as a potential booster dose in an open-label trial evaluating its safety and immunogenicity in patients who had received the Menactra vaccine 4 to 6 years earlier. The CDC recommends that two doses of the meningococcal conjugate vaccine be given to adolescents age 11 to 18 — the first dose at age 11 or 12, followed by the booster at 16. The CDC emphasizes the need for a booster, as current studies are showing that the vaccine’s strength wanes five years after injection.

FDA Advisory Committee Skeptical About Hypertension Combo

In a 6 to 4 vote, the FDA’s Cardiovascular and Renal Drugs Advisory Committee chose not to recommend approval of Actavis’ New Drug Application (NDA) for the fixed-dose combination of nebivolol and valsartan in hypertension. Presented with the NDA were results from a 5,000 patient phase 3 clinical development program, in which the nebivolol/valsartan combo demonstrated efficacy in reducing diastolic and systolic blood pressure at eight weeks compared to the two drugs each being taken as a monotherapy. Both nebivolol (known as Bystolic in the U.S.) and valsartan (Diovan) are FDA approved blood pressure drugs. While regulators on the advisory committee claim that the combination drug did not present significant benefits over monotherapy, the FDA still has yet to make its final, official decision on the combination treatment.

Astellas Granted Additional Xtandi Indication

Xtandi (enzalutamide) capsules are now available to treat those with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy. The drug, an oral, once-daily androgen receptor inhibitor, was originally approved for patients with metastatic CRPC who had also received chemotherapy. The Phase 3 PREVAIL trial proved the treatment’s ability to improve survival rates by 29 percent and delay radiographic progression or death by 83 percent compared to those on placebo and GnRH therapy. Those on Xtandi also progressed more slowly to chemotherapy and a skeletal related event.

FDA Tips Scale In Favor Of Obesity Drug

Orexigen Therapeutics’ obesity drug, Contrave, was approved by the FDA following in the agency’s second review of the drug. Two years ago, the agency chose not to approve Contrave because of evidence suggesting the drug caused high pulse rates and blood pressure. However, following a more recent clinical trial, the drug demonstrated its ability to lower patients’ weight by 4.1 percent versus placebo. Forty-two percent of patients taking the drug lost at least 5 percent of their weight compared to 17 percent taking placebo. The drug is also being investigated in a 9,000 patient study in order to prove that the drug does not cause heart attacks. While final results have not yet been determined from this study, the interim results must have been positive enough for the FDA to grant final approval. Contrave is a combination treatment of two generic drugs, naltrexone and bupriopion (also known as Wellbutrin and Zyban).

Viamet Antifungal Agent Named Orphan Drug

A new anti-fungal candidate received orphan drug designation last week for the treatment of cryptococcal meningitis, an infection that affects the lining of the brain and spinal cord. The drug, VT-1129, put forth by Viamet Pharmaceuticals, has demonstrated its ability to halt the production of ergosterol, which enables fungal cells to grow and proliferate. It has also shown promise fighting the Cryptococcus species in the central nervous system in preclinical studies. The company anticipates filing an IND for VT-1129 within the first half of 2015.    

Recent Pharma Industry News, Talking Points

Citeline released a report last week that suggests clinical data transparency (aka responsible data sharing) is “in a much healthier state” than in the past. In previous studies, 23 to 57 percent of completed clinical trials did not reveal results of the study. However, in its recent analysis of 7,500 phase 2 and 3 industry sponsored trials that occurred between 2008 and 2012, Citeline found 78 percent of these trials had distributed interim or final results. This percentage increased to 81 percent when only looking at the more costly, high-profile phase 3 trials.

According to the Wall Street Journal blog, the FDA has approved 27 new novel medicines so far in 2014. This figure, which also includes biologics, is the same number of the total novel drugs approved in 2013. The blog speculates that the FDA could tie with its approval rate in 2012, during which the FDA approved 39 novel new medications. According to the agency’s 2013 report, the FDA also met 100 percent of its application reviewing goals and 74 percent of medicines were approved in the U.S. before they were approved in other countries.

Two research reports from GBI Research were released recently emphasizing the strength and value of two different therapeutic areas. According to GBI research, the global Non-Small Cell Lung Cancer (NSCLC) treatment market is set to grow at a Compound Annual Growth Rate (CAGR) of 6.6 percent, taking the markets value from $5.1 billion in 2013 to $7.9 billion by 2020. In another recent report, GBI Research found that the breast cancer pipeline is the largest and most innovative pipeline in the pharmaceutical industry today. There are currently 826 products in active development across all stages of the pharma industry. Of these, there are 245 first-in-class programs acting on 175 first-in-class molecular targets. Signal transducer proteins are currently the most widely studied first-in-class targets. Many of these first-in-class treatments are expected to make it to the market sometime in the next 10 years.