News Feature | September 17, 2014

Weekly News Roundup For Pharma Manufacturers — September 17, 2014

By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch

In the news this week, generics are saving the U.S. health system trillion; “shadow” pharma contract manufacturing is on the rise; and a market survey shows that conventional tablet formulations could be losing patients’ favor. Several countries are also experiencing drug shortages, leaving many desperate for viable treatment.

2013 Generics Savings Skyrocket

According to a new report from the Generic Pharmaceutical Association (GPhA), generic drugs saved the U.S. health system $239 billion in 2014 — an increase of 14 percent from the amount saved in 2012. Thanks to generics, the health system in the past decade (2004-2013) has seen roughly $1.5 trillion in savings. Nervous system and cardiovascular treatments over the past 10 years have been the most influential, attributing $851 billion in cost savings. The GPhA expects that these savings will continue to grow as the nation enters “the era of biosimilars.” Generics currently consume 27 percent of total drug expenditures in the U.S.

HIV/AIDS Pipeline Making Progress, PhRMA Says

Pharmaceutical Research and Manufacturers of America (PhRMA) released a report last week revealing that there are currently 44 medicines and vaccines for HIV/AIDS treatment and prevention in the pipeline. More specifically, biopharmaceutical companies have been working on 25 antivirals, 16 vaccines, and three cell/gene therapies. There are currently 94 active clinical trials, with 43 seeking or not yet recruiting participants.  

India CMO Market Eyeing WHO-GMP Compliance

According to The Business Standard, more companies in India are looking to upgrade their manufacturing facilities to meet the World Health Organization-Good Manufacturing Practices (WHO-GMP) norms. There are also reports that the Centre would be willing to provide soft loans in order to incentivize the upgrading of roughly 1,000 small and medium sized pharma manufacturing facilities to ensure WHO-GMP compliance over the next year, the Indian Drug Manufacturers Association (IDMA) says. The contract pharma manufacturing industry in India is currently growing at a rate of 20 percent and accounts for roughly 50 percent of domestic production.  

Indian Pharma Entrepreneurship A “Distant Dream,” IDMA says

The Hindu Business Line recently reported that the costs of machinery, regulatory norms, and price controls are keeping new entrepreneurs from entering the country’s pharmaceutical or contract manufacturing business. The president of the IDMA says that the government is considering launching a new capital-linked subsidy scheme to enable the establishment of new small drug manufacturing units as the capital required to build these continues to increase. 

“Shadow” Contract Manufacturing On The Rise

A Life Science Leader article discusses the rising number of “shadow” contract manufacturing arrangements, in which pharma companies are turning to lower-cost countries to source generic active pharmaceutical ingredients and finished drugs. Nice Insight market research shows that strategic supply and marketing agreements are on the rise and could be lucrative and beneficial arrangements for both Indian and U.S. parties.

Conventional Tablets No Longer Favored By Patients

A recent market survey from Hermes Pharma and the Spiegel Institut Mannheim, showed that conventional tablets formulations are becoming a less favored, problematic formulation. According to the results of the survey, 55 percent of people, regardless of age or gender, have trouble swallowing tablets or capsules — difficulties which most likely could have a negative impact on compliance and on the drug’s efficacy. Patients surveyed said that, of effervescent and chewable tablets, instant drinks, orally-disintegrating granules, and lozenges, they found conventional tablets and capsules harder to swallow, less pleasant to take, and harder to remove from packaging.  The survey found that designing user-friendly dosage forms that target different cultures, ages, and preferences can help pharma companies stand out from the crowd.

Drug Shortages Hit Canada, India

The Globe and Mail reports that Canada is in the midst of a serious shortage of the bladder cancer drug, bacillus Calmette-Guérin strain tice (BGC). The shortage was caused by manufacturing issues that occurred at manufacturing plants operated by two different pharma companies. Without BCG to control symptoms, patients could be facing surgery to remove their bladders, which could result in other serious complications. To ration the supply, doctors could temporarily treat patients using one-third of a regular dose.

In addition to Canada, India is facing a shortage of medications to treat AIDS/HIV because of payment delays to manufacturers and other procurement issues. Some of these medications include tenofovir-lamivudine, nevirapine, and lopinavir-ritonavir. In order to prevent shortage, the National AIDS Control Organization (NACO) would need to supply roughly six million fixed dose combination tablets of tenofovir-300mg and lamivudine-300mg to avoid a shortage.