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US Pharma Drought
US pharmaceutical manufacturers invested a record amount in drug development for 2005, yet their pipelines did not show significant growth.
The US FDA approved only 20 new drugs in 2005, down from 36 in 2004, the second lowest approval amount in the past 10 years. Major pharma makers, including Pfizer, Eli Lilly, and Johnson & Johnson, did not receive approval for a single new drug invented in their own labs.
The pharma industry spent over $38 billion on drug development research in 2005, a new high. Researchers are making advances in genomics and other disease development research, creating potential new targets for treatment. read more..
Despite Losses, Ranbaxy Won’t Back Down
Ranbaxy Laboratories will not back down from its patent-busting strategy, despite a recent loss to Pfizer in the US. Ranbaxy and other Indian generic drug manufacturers are seeing diminishing profit margins and sales, especially in the US.
A December 2005 US District Court ruling blocked Ranbaxy's patent challenge to Pfizer's Lipitor, the world's top-selling drug. Effectively Pfizer has exclusive rights to sell Lipitor until its main patent expires in June 2011. The decision blocked Ranbaxy's plan to release generic Lipitor and also questioned the Indian generics industry’s patent-breaking strategy.
According to Ranbaxy Labs President Malvinder Singh, "we will contest this ruling by going on appeal… we will pull out all stops in going after [big drug companies]…we are undeterred in our effort to bring affordable generics to the world." read more...
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Nanotech Needs Safeguards?
According to a new report, US laws may not be adequately protecting the public's health and safety in the growing area of read more...
Oracle’s India Expansion
Oracle Corp, a US based business software developer, plans to add 1,400 employees to its sales, consulting and support read more...
When Pigs Glow…
Taiwan has successfully bred fluorescent green pigs that researchers hope will boost the island’s stem cell research. read more...
One Day Sale! Sanofi Out of Vaccines
In one day alone, Sanofi Pasteur has booked orders for all of its 50 million doses of flu vaccine to be produced for the read more...
Hepatitis C Advances
Vertex Pharmaceuticals is developing what many experts perceive to be the most potent of the new hepatitis medicines. A small read more...
Novartis Seeks Global Hepatitis B Drug Approval
Idenix Pharmaceuticals and Novartis have submitted a Marketing Authorization Application (MAA) to the European read more...
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Chairman's Message
Pharma Consolidation Reachs Japan
The last edition of the Avani Global Biz Catalyst offered an in-depth look at the wave of mergers and acquisitions in the US healthcare industry and their effects on the economy and participants including branded and generic manufacturers. Now, years after healthcare M&A’s became |
common among US drug makers, the same trend is being seen in Japan’s pharmaceutical industry.
In April 2005, Yamanouchi Pharmaceutical Co. and Fujisawa Pharmaceutical Co. merged into Astellas Pharma Inc. to become the second largest drug maker in Japan. However, Astellas soon lost that perch after Sankyo Co., integrated operations with Daiichi Pharmaceutical Co. in September 2005 under a joint holding company called Daiichi Sankyo Co.
These three largest Japanese drug makers each have sales of approximately one trillion yen but are still considered small in size on a global level, with Takeda ranking only 14th in the world.
Even more consolidation is expected in Japan’s pharma industry because these two top companies, long with industry leader Takeda Pharmaceutical Co., are still much smaller than the US and European pharma giants. Consolidation can be attributed to drug makers’ need to gain financial advantages in the face of increasing R&D Costs and the cost of promoting products overseas. New drug development takes more than ten years and costs of billions of yen; therefore, Japanese pharmaceutical companies can not recover their costs in the Japanese market alone and must sell their products overseas.
Japanese firms give top priority to the US market, which accounts for 50% of the global market and offers high profitability to drug makers allowed to set their own prices.
Japanese firms have also found difficulty in quickly creating sales networks in the US and Europe and many fare better if forming a venture with an established US or European marketing or distribution partner. For example, Japan’s Chugai created a global sales network after a deal with Roche Holding AG of Switzerland in 2002.
Small and midsize Japanese drug makers do not even have the resources of the larger pharma companies and must rely on domestic sales. Unfortunately, Japan’s domestic market has stagnated at about 6 trillion yen due to government medical expenditure cuts. These smaller companies with no global resources must take other steps to remain viable, including management integration, shifting operations to production to private label or generics, or aspire to new innovations. Drug makers with no pipeline and no innovations will see decreasing profits as drug prices are lowered every two years.
The disparity between overseas opportunity and the Japanese domestic market is evident in the stock increases of Tanabe Seiyaku and Takeda Pharmaceutical. Tanabe Seiyaku's shares have gained 7% while Takeda's stock increased 25%.
read more...
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Pharmaceutical Packaging - $30 Billion by 2009
World pharmaceutical packaging demand is projected to increase 6.3% annually to reach over $30 billion by 2009. read more...
High Value Injectable Drugs Going Off Patent
Many injectable high value drugs going off patent in the US and Europe in the next decade. These drugs include treatments for read more...
US Insomnia on the Rise
Prescriptions for sleep drugs in the US have increased 60% in the last five years, leading to the suspicion that physicians read more... .
Biotech’s Breakthrough
The biotechnology industry had a successful year in 2005 as companies succeeded in introducing novel therapies for devastating read more... .
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India Targeted for Inhaled Insulin Market
More than half-a-dozen pharmaceutical companies are boosting production to capture India, the biggest potential market for inhaled insulin in the world.
Eli Lilly has started clinical trials on Indian diabetes patients, while Pfizer announced that it has received the FDA and EC approval for commercial production of its inhaled insulin, Exubera. Pfizer plans to carry out clinical trials in India. Pfizer may launch Exubera in India in the next two years. read more...
US Firms Key in Indian Drug Development
Goodwin Biotechnology Inc. ( Florida, US), a fully-owned subsidiary of Goa-based Wallace Pharmaceuticals is planning to offer contract manufacturing services to Indian biopharmaceutical companies. The company sees India as a “tremendous resource for us, both on the 'Buy' side as well as the 'Sell' side.”
Goodwin has a fourteen year history as a CMO. GBI's predecessor (Goodwin Institute of Cancer Research) manufactured biologics since the mid-1960s. GBI worked with small to mid-sized biotech companies, research organizations like Memorial Sloan Kettering and MD Anderson, the US Government and the National Institutes of Health (NIH), and large pharma companies including Centocor (J&J), GSK, Roche, and Menarini. read more...
Cervidil India Launch
Trigenesis Lifesciences has formed a joint venture with Controlled Therapeutics Ltd. of Scotland to market Cervidil for the first time in India beginning in March 2006. Cost for the Indian market has not yet been disclosed. The product is used to ease childbirth labor.
Trigenesis has invested around Rs. 50 lakh for the product entry to set up the refrigeration and cold storage facilities at its offices in Bangalore, Kochi, Hyderabad and Chennai. The company is conducting CME program to highlight the drug delivery device to the OB/GYN practitioners. read more...
Ranbaxy & CIH JV to Target Africa
As noted in this issue’s front page story on Ranbaxy, the company is planning more M&A’s and other market growth strategies to combat the recent downturn in its profits. To that end, Ranbaxy Laboratories Limited and Community Investment Holdings (CIH) of South Africa have formed a joint venture, Sonke Pharmaceuticals (Pty) Ltd, to market and sell Ranbaxy's anti-retroviral (ARV) products in South Africa and other African markets. Ranbaxy holds 70% equity and CIH holds 30% equity read more...
Dr. Reddy’s Eyes German Acquisition
Dr. Reddy's Laboratories has offered 450 mln eur for German generic drug maker Betapharm Arzneimittel GmbH, the fourth largest generics drug company in Germany.
The acquisition will be the biggest overseas acquisition by an Indian pharmaceuticals company.
read more...
Dr. Reddy’s COPD Venture
Dr. Reddy's Laboratories and Argenta Discovery Limited will jointly develop a novel approach to treat Chronic Obstructive Pulmonary Disease ("COPD"). They will collaborate to identify clinical candidates from a certain class of Dr. Reddy's' compounds for use as potential treatments for COPD. Both will jointly develop the selected candidates from the pre-clinical stage up to Phase IIa (proof-of-concept). On successful completion of a Phase IIa trial, the companies may either license-out the candidate for further development and commercialization to a larger pharmaceutical company or continue the further co-development and commercialization themselves. Financial terms have not been disclosed. read more...
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