|
|
|
      |
 | |
|
What's New US Pharmaceutical Industry Needs To Embrace The Global Realities 
Jul 24, 2008 - 6:58:01 PM (HealthNewsDigest.com) - Will the US build a Great Wall between our pharmaceutical industry and the burgeoning markets in countries like China and India? On the heels of the heparin product issues and the announcement that the Food and Drug Administration is establishing offices for India,China and other countries, some comments are being muttered about walling off our pharmaceutical industry from the overseas market. Nothing could be more foolhardy, says Dr. Abraham Abuchowski, who just returned in early July from a six city tour of China's pharmaceutical and biopharmaceutical manufacturing and research facilities. "These countries are destined in the very near term to be global leaders in the manufacturing of pharmaceuticals and bio-pharmaceuticals," said Dr. Abuchowski, founder and president of New Jersey-based Prolong Pharmaceuticals. "Their facilities are often brand new, are well-funded by the government, and there is a commitment to building these facilities to US cGMP standards (current Good Manufacturing Standards)." Dr. Abuchowski founded Enzon, Inc (ENZN) in 1982, and was one of the inventors of the PEGylation drug delivery process in the 1970s, the gold standard for biopharmaceutical drug delivery and a process that has resulted in products with total sales in excess of $25 billion worldwide. "I founded Prolong Pharmaceuticals with precisely these international market realities in mind," said Dr. Abuchowski. The company already has a major development deal with Indian pharmaceutical giant Zydus Cadila, and expects to ink several more with both Indian and Chinese firms in the coming months. Prolong's interest in these overseas alliances lies in the opportunity the PEGylation process brings to drug development there. "PEGylation results in more efficacious drugs that circulate longer, and therefore need lower doses," explained Dr. Zachary Berk, Prolong's chief executive officer. "The combination of these two factors can result in enormous cost savings, a key driver in today's market. In addition, raw material is often plentiful and inexpensive in these countries. At the end of the day, you can take a worldwide blockbuster, multi-billion dollar drug, improve it in both cost and efficacy, and get an approval in a few short years. With approved drugs in these countries being viewed more favorably by the US FDA and regulatory agencies in other industrialized countries, the newly developed drugs can have a worldwide market in a relatively short period of time." Dr. Abuchowski said another mistake would be breaking ties which could block US drugs from the exploding consumer markets in countries like China and India. McKinsey & Co. estimates that by 2020, China's "consumer class" will have grown from today's 100 million to more than 700 million seeking the new generation of life-style and life saving pharmaceutical products. The Economist estimates that India's middle class will grow from today's 50 million to nearly 600 million by 2025. It would be foolish for us to ignore such huge market opportunities. Dr. Abuchowski applauds the plans announced by the FDA to expand overseas. "These countries need our guidance and experience on developing cGMP practices, but all the other pieces are in place there," said Dr. Abuchowski. "Like it or not, the manufacturing and development for new drugs is going to be much faster and less expensive in these countries due to the less onerous regulations and the ready cooperation of the government. In city after city in China last month, we saw sparkling new plants and facilities, and more being built all around us."The U.S. pharmaceutical business needs to understand and embrace this economic reality. "Companies in India and China are very eager to partner and work with the U.S. right now," said Dr. Abuchowski. "We bring skill sets to the table that they can use. But over time they will develop those skill sets on their own if spurned by the U.S. It would be a serious mistake to ignore this window of opportunity with the entire world market at stake." Dr. Abraham Abuchowski founded Enzon, Inc. (ENZN) in 1982, and today is the President and COO of Prolong Pharmaceuticals in Monmouth Junction, New Jersey . © Copyright by HealthNewsDigest.com |