FAKING IT SO REAL
The PHAP warns against the proliferation of counterfeit drugs, which are made to look almost like the real thing
Ten percent of all the drugs circulating in the country today could be fake, warns Mr. Leo Wassmer Jr., executive vice president and chief executive officer of the Pharmaceutical and Healthcare Association of the Philippines (PHAP).
He also stresses that the problem of counterfeit drugs is not confined to the Philippines. "It is a global problem," he says. He points to the case of India as an example. He says: "India is really noted for counterfeit [drugs]. In fact, 42 percent of pharmaceutical products in India is counterfeit."
Many of the counterfeit drugs coming from India don't come from drug manufacturers themselves, but from wholesalers. Wassmer said that there are 28,000 wholesalers in India; "these wholesalers are the biggest counterfeiters."
Counterfeit routes
Wassmer says that one way through which counterfeit drugs enter the country is parallel importation, which is the practice of buying from another country cheaper versions of the exact same drugs--usually branded--already available in one country. He explains: "The proliferation of counterfeit drugs is encouraged by parallel importation. If [the government] will minimize parallel importation, that will to a certain extent help in minimizing the [problem of] counterfeit drugs."
However, parallel importation is a very small problem compared with the other way through which counterfeits enter the country--smuggling.
A number of port areas have been identified as hot spots for counterfeit drugs smuggled in from such countries as India and China, and to a lesser extent Pakistan and Bangladesh. These, says Wassmer, include Cebu, Davao, General Santos, and Zamboanga in the south; and Dagupan and Lucena in Luzon.
There is also the problem of local counterfeiters who distribute their wares locally. Wassmer says that some of these could be legitimate manufacturers of generic drugs, "but at the same time they're probably using their facilities to do counterfeiting of the big-name drugs of multinationals." However, he points out that it is very small compared with the counterfeits coming from other countries, "but if we don't control it, [it] will be big."
Safeguards
The presence of counterfeit drugs is not only a trade issue; it is a public-health concern as well. Aside from the taxes, duties, and other fees that go unpaid, the health of people--especially those who need the drugs' therapeutic benefits--is also endangered.
Wassmer believes that aside from the DTI, the Department of Health, particularly the Bureau of Food and Drugs, plays a big role in controlling the proliferation of counterfeit drugs. "It has to do with the registration of products," he says. "They should be very careful of the new products, especially, coming in. There are more and more coming in from India and China…they're not waiting for parallel importation, they are now tying up with local manufacturers. And so at some point in time, what you will see is they will be manufacturing [them] here."
BFAD, he adds, should also be very strict in monitoring the facilities of local manufacturers and the medicines being sold in drug stores and used in health facilities. "The big problem, of course, is BFAD has no money," he says. "They can't hire inspectors; so the enforcement is defective."
Wassmer believes that the DOH and the BFAD "need a lot of help from the [drug] industry." Already the PHAP--composed of 87 Filipino and multinational companies involved in the manufacture, distribution, and retail of pharmaceutical products--is actively involved in ensuring the quality and efficacy of the drugs circulating in the country, as well as in lobbying for stronger government involvement in the fight against counterfeit and low-quality drugs.
Wassmer also believes that consumers should beware of the drugs that they buy. In the past the advice was for consumers to buy only from "reputable drug stores"; unfortunately Wassmer reveals that there had been instances when certain drug-store owners themselves turned out to be "the biggest violators." At present, however, drug-store owners are also actively involved in the fight against counterfeit drugs.
"It's really a situation where the cooperation of everybody will really be required," Wassmer concludes.
Jin Paul de Guzman
Sankyo, Daiichi to merge
TOKYO
Sankyo and Daiichi Pharmaceutical have agreed to merge in October to create Japan's second-largest drugs firm. The merger would create a company with combined annual sales estimated at around US$8.7 billion, second only to Takeda Pharmaceutical Co.
Sankyo, currently ranked number two and Daiichi Pharmaceutical, number six, said they decided to merge to increase resources for research and development and to boost their domestical and global sales networks.
"The integration…will enable us to achieve a level of growth and a range of opportunities that would be out of our reach individually," Daiichi president Kiyoshi Morita said.
Sankyo president Takashi Shoda said: "It gives us critical mass in [research and development] and sales operations both at home and internationally, ensuring our competitiveness in the global arena."
Daiichi will exchange one share for 1.159 shares in the new holding firm while Sankyo would swap on a one-for-one basis.
The announcement follows news that third-ranked Yamanouchi Pharmaceutical and fifth-ranked Fujisawa Pharmaceutical would merge in April to form Astellas Pharma Inc., which will have estimated annual sales US$7.8 billion.
AFP
Corporate battle heads for the top
TOKYO
A corporate battle to provide hair-loss solutions in Japan heated up with the nation's top cosmetics maker Shiseido launching a new tonic to rival the market leader.
Shiseido hopes Adenogen hair tonic for men, using hair growth stimulant adenosine, will knock Taisho Pharmaceutical and its RiUP product off the top shelf.
With the launch of Adeno-gen, Shiseido hopes to double its current 10-percent market share. Adenogen is categorized as "a quasi drug" unlike top-selling RiUP, which is designated as a pharmaceutical product containing minoxidil developed by Upjohn, now Pfizer.
Taisho started selling RiUP in 1999, when it took the market leader position off Shiseido. The firm now controls about 30 percent of the Japanese market for hair-growth products, a Taisho spokesman said.
Taisho values the entire market at US$525 million in terms of shipments by manufacturers last year.
Taisho's RiUP Lady, designed for women, hit the shelves on April 1. "The market for hair-growth products for women in Japan is small; it is only approximately three billion yen. However, Taisho is aiming to expand this market by reaching out to potential customers," the company said.
AFP
No WTO pact on generic drugs
GENEVA
World Trade Organization (WTO) members were unable to make permanent a 2003 agreement on access to generic drugs for poor countries, although it was still regarded as valid on a temporary basis. The global trade body missed the March 31 deadline for amending the accord, which currently gives only a temporary waiver to intellectual-property rights.
Developing countries argued that the 2003 accord was too restrictive, which might explain why no country has yet used it to obtain medicines. The African Union described the waiver as an interim solution that "can be terminated at any time" and argued that the waiver "can pose problems and obstacles to the realization of the goal of access to affordable medicines for all."
The compromise reached in August 2003 tried to balance public-health needs and the interests of the pharmaceutical industry. Under the WTO agreement, poor countries could import cheaper generic copies of patented medicines under a so-called compulsory licensing system if they do not have the capacity to manufacture the drugs themselves.
The decision provided a temporary exemption to a WTO intellectual-property-rights agreement that had restricted use of the system for a domestic market. It was the exemption that the WTO's 148 members failed to perpetuate.
The dispute pits poor countries, which want to import cheaper generic versions of drugs, against producer countries, such as India, Brazil, and western nations, which demand protection for drug companies from possible reexports of such products.
Even without the amendment, however, the distribution of generic drugs remained possible.
Bayer gets off to favorable start
LEVERKUSEN, Germany
Bayer, the German chemicals and pharmaceuticals giant, forecasts "considerable" growth in both sales and earnings this year after business got off to a "gratifying" start in the first two months.
"We're expecting considerable growth in sales and earnings in 2005," Bayer chair Werner Wenning said.
Sales were expected to exceed US$33.4 billion this year, lower than 2004, when Bayer booked sales of US$39.8 billion. But adjusted for exchange-rate effects and divestments, the 2005 figure would actually be more than five-percent higher than the previous year's figures, the maker of aspirin said.
Underlying profits, as measured by earnings before interest, tax, and exceptional items, were expected to rise by around 20 percent from the US$2.7 billion booked in 2004.
Bayer said encouraging figures for January and February confirmed its optimism for the whole year.
IgG Boost from colostrum
At no other time is our immune system as stimulated as when we received our mother's first milk or colostrum. This yellowish fluid is rich in antibodies and minerals that confer passive immunity on the newborn. Foremost of the antibodies in colostrum is immunoglobulin G (IgG), which defends the body against diseases by sticking to allergens and invading pathogens--making it easier for phagocytes to recognize, destroy, and eliminate them. Compare this with the more aggressive defense of IgE, which promotes an allergic response, IgG's action is a kinder immune-system response.
Soon enough after birth, our body is able to establish its own immune system. However, there are times when our antibody-production is weakened--from stress, exposure to pollution, poor diet, sleep deprivation, or recent illness. This creates an immunity gap, where our body is not able to marshal sufficient defense mechanisms soon enough.
These are the times when our immune system could use a boost.
Pharmanex's IgG Boost could provide this--with Colostrum MFT, a standardized concentrate of antibodies (50-percent IgG) and other immune-system components from dairy cow colostrum.
Together with Nu Skin Enterprises, Pharmanex launched IgG Boost on March 10 at The Manila Peninsula.
According to nutritional immunologist Mark Bartlett, "the gastrointestinal (GI) tract has a huge impact on our immunity." Given its huge surface area--if laid out flat, the GI tract would cover two tennis courts--70 percent of the immune system must focus on protecting it.
He pointed out that colostrum has been found to stimulate and improve is functions. IgG Boost's Colostrum MFT encapsulates, in 500 mg, this immune-system-enhancing activities. Besides immunoglobulins, IgG Boost includes lactoperoxidase, part on enzyme system that is very effective in killing bacteria, and oligosaccharides, which prevents unfriendly bacteria from sticking to the walls of the GI tract. He explained that by preventing viruses, bacteria, and their toxins from getting a foothold in the GI tract, the entire immune system would benefit.
Bartlett is senior scientist at Pharmanex, a manufacturer of nutritional supplements, which also actively participates in clinical research on human nutrition.
Its products are available locally through Nu Skin Enterprises.
Schering sees hike in profits
BERLIN
German pharmaceuticals specialist Schering expects sales to grow by around five percent this year and underlying profits to grow even faster.
"We expect currency-adjusted sales growth to be in the mid-single-digit range in 2005," Schering chair Hubertus Erlen told shareholders at the company's annual meeting. "And our aim is for operating profit to grow faster than sales."
Schering, a world leader in contraceptive and fertility drugs, said that it was standing by its target to achieve an operating margin--which measures operating profit as a proportion of sales--of 18 percent by 2006, compared with 15.5 percent in 2004.
Growth this year would be driven by sales of the group's best-selling Betaferon, a drug for multiple sclerosis, which was expected to achieve growth in the mid-single-digit range. Sales of the Yasmin contraceptive "should show strong double-digit growth," Erlen said.
Schering posted global sales of US$8.27 billion in 2004 but incurred a net loss of US$947 million. Its top grossers last year were Remicade, sales of which rose 38 percent from US$540 million in 2003 to US$746 million; Clarinex, which sold US$692 million; and Temodar, which grossed US$459 million, a 42-percent improvement from US$324 million in 2003. Over-the-counter Claritin fetched US$419 million last year.
Part of Schering's optimism this year stems from the growing sales of Vytorin, which was approved in the US in July. Vytorin, a new once-daily, cholesterol-lowering therapy marketed in partnership with Merck & Co., is a combination of Schering's Zetia (ezetimibe), a cholesterol-absorption inhibitor, and Merck's Zocor (simvastatin). It is the first single tablet to provide powerful cholesterol reduction by dual action--inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine.
The launch of Vytorin pushed Schering's sales from its cholesterol franchise to over US$1 billion last year. Zetia and Vytorin represent two of the industry's major product launches in recent years.
AFP
Court upholds Lilly's Zyprexa patent
CHICAGO
A United States District Court in Indiana has upheld Eli Lilly and Company's patent on Zyprexa, a drug for schizophrenia and bipolar disorder. The ruling was a victory for Eli Lilly, whose patent on the drug had been challenged by three generic-drug manufacturers.
"We have always been very confident that our patents are valid and enforceable and today's court ruling sends a clear message on the strength of those patents," Eli Lilly chair Sidney Taurel said.
The ruling maintains Eli Lilly's patent on Zyprexa until 2011. The generic-drug companies had "failed to prove by clear and convincing evidence that the patent is invalid," the ruling said.
AFP
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