Beijing aims to refill medicine chest with 'Made in China' drugs

2015-11-29 09:59:24

SHANGHAI China, already a global powerhouse in high-tech areas from solar panels to bullet trains, is turning its industrial might to the challenge of making more of its own drugs for a vast and aging population. Given the 10 years or more it typically takes to bring a new medicine to market, original "Made in China" treatments won't arrive overnight, but multinationals are already encountering more competition from local generic drugs that look set for a quantum leap in quality. The stakes are high. China is the world's second biggest drugs market behind the United States, and fast food, smoking and pollution have fueled a rise in cancers and chronic heart and lung diseases. The country also has more diabetics than any other in the world, with numbers expected to hit 151 million by 2040 from 110 million today, according to the International Diabetes Federation. That has made China a sweet spot for Denmark's Novo Nordisk; the world's biggest insulin producer has mined a rich seam in the country since opening production facilities here in 1995. By 2010, it dominated 63 percent of China's insulin market. But it has recently been losing ground to local competitors cheered on by Beijing. "China is going to be tough for us for the next couple of years," said Chief Science Officer Mads Krogsgaard Thomsen. "Right now, the country is very focused on building domestic production." Local rivals are selling both cut-price basic insulin and sophisticated modern versions, including a biosimilar copy of Sanofi's Lantus made by Chinese biotech specialist Gan & Lee Pharmaceuticals. END OF BRANDED GENERICS? Greater local competition is also evident in other areas, helping the top 10 Chinese drugmakers grow sales 12 percent on average this year, according to IMS Consulting - twice the rate of multinationals, which suffered a setback from a bribery scandal at GlaxoSmithKline two years ago. GSK itself has seen its drug sales slump. Increasing local competition is part of a structural upheaval in China's hospital-dominated prescription drug market. Selling drugs to patients at a hefty mark-up - especially off-patent Western "branded generics" - often accounts for 40-50 percent of Chinese hospitals' revenues. But the authorities are now pushing a policy of zero mark-ups, initially in smaller county hospitals. "Branded generics are something that exist today, but the need for them in 10 years time is not going to be there," said Luke Miels, AstraZeneca's global portfolio head. That means foreign firms will be more reliant on new, patented medicines, although the scale of demand for such expensive products is uncertain in a country with only basic health insurance cover. At the other end of the spectrum, multinationals aim to build up volume, often in partnership with local players, in the big markets outside China's top cities, where distribution costs are high and prices low. "It's the right thing to do, even if profit margins shrink," said the head of one big multinational. REGULATOR REFORM Pivotal to the transformation of the market is the China Food and Drug Administration, led by reformist boss Bi Jingquan since January. The watchdog has promised to speed up approval of innovative new drugs, which can take 5-7 years, while cracking down on substandard local generics. "This creates lots of opportunities for local Chinese companies that have a strong focus on innovation," said a spokesman for China's Fosun Pharma, which sees itself among the winners. It is not alone. A cluster of drug research labs in eastern Shanghai highlights the promise of China's life sciences sector. The area brings together multinational and local firms, alongside contract research businesses and small biotech operations. Among the latter is Hua Medicine, led by Chinese-born, Western-educated Chief Executive Li Chen, who used to run Roche's China R&D center. Now he is developing a novel diabetes treatment, licensed from Roche, while working on Hua's own promising leads. Another standard-bearer for Chinese biotech is Beijing-based cancer specialist BeiGene, which last month announced plans for a $100 million initial public offering on Nasdaq. At a time when China's academic researchers have grabbed headlines by editing the genes of human embryos, such start-ups highlight the commercial potential of China's biotech know-how. The history of failure in drug development suggests they won't have an easy ride, but GSK's China R&D head Min Li, a returnee from America, believes "there is a real chance for China to leap ahead in life sciences". Dennis Gillings, executive chairman of leading contract research organization Quintiles, said the number of Chinese-developed drugs in the pipeline was rising fast. "It's probably been taking everyone a little by surprise, the sheer scale of that," he said. "As we hit the next decade in the 2020s, I'd be very surprised if there wasn't at least a top 20, if not top 10, global pharma player that was headquartered in China." (Reporting by Ben Hirschler and Adam Jourdan; Editing by Will Waterman)

Eight corpses found in Mexico's Oaxaca state

2015-11-28 07:45:26

MEXICO CITY Eight men were found dead, their throats slit, in the Mexican state of Oaxaca, a local emergency services official said.The bodies were discovered in a car in a municipality on the border with the Gulf coast state of Veracruz, the official said in a message sent to Reuters on Friday evening. (Reporting by Lizbeth Diaz; Editing by Eric Meijer)

One killed, several injured in hit-and-run crash in New York City

2015-11-27 08:52:29

One person was killed and several people were injured on a busy New York City street on Thursday when a hit-and-run driver struck a pedestrian before driving away and crashing into parked cars, police said.The driver of the car struck a woman who was crossing a busy intersection in Brooklyn around 7 p.m. local time, the New York City Police Department said. She was rushed to a nearby hospital where she was pronounced dead.After hitting the woman, the driver then accelerated down the street, crashing into parked vehicles and injuring several pedestrians, the spokesman said. Local news broadcaster WCBS-TV said at least 10 people were hurt. The extent of their injuries was not known.The driver of the vehicle fled on foot and was detained by police, the spokesman said. Charges were pending. Police were looking into whether alcohol or drugs played a role in the incident, which occurred late on the Thanksgiving Day holiday. (Reporting by Victoria Cavaliere; Edinting by Kim Coghill)

U.S. court rejects Linden Care's request for temporary restraining order

2015-11-26 05:31:33

A U.S. District Court on Wednesday denied specialty pharmacy Linden Care LLC's request for a temporary restraining order (TRO) against Express Scripts Holding Co for dropping it from its network earlier this month.Express Scripts, the largest manager of prescription drug plans in the United States, severed ties with Linden Care for dispensing drugs from Horizon Pharma Plc, which has come under fire for charging high prices.The pharmacy benefits manager also said that Linden Care did not fulfill key parts of its pharmacy network agreements.Linden Care failed to make "a clear showing that it was entitled to the relief requested" or that "extreme or very serious damage will result from a denial of preliminary relief," the District Court for the Northern District of New York said in a court filing on Wednesday. "We are disappointed in this ruling and believe we will prevail in arbitration proceedings," Marc Wiener, chief executive of Linden Care said in a statement.The Woodbury, New-York-based company provides specialty pharmacy services to the pain management industry. Express Scripts' move to drop Linden Care came as other big pharmacy benefit managers evaluated drug dispensaries, after Canadian drugmaker Valeant Pharmaceuticals International Inc came under fire for questionable practices at its partner pharmacy, Philidor Rx Services. Valeant subsequently cut ties with Philidor and said it was investigating its practices. (Reporting by Rosmi Shaji in Bengaluru; Editing by Siddharth Cavale)

Research raises questions over ADHD drug effects

2015-11-25 04:24:36

LONDON Researchers voiced concern on Wednesday about poor quality studies on the popular ADHD treatment Ritalin, saying evidence of some benefits, but also of sleep problems and appetite loss, suggests the drug should be prescribed with caution.Ritalin is sold by Swiss pharmaceutical firm Novartis NOVN.VX, known generically as methylphenidate and also sold under the brand names Concerta, Medikinet and Equasym. It has been used to treat Attention Deficit Hyperactivity Disorder (ADHD)for more than 50 years.The Cochrane Review researchers, who conducted a full assessment of studies on the benefits and harms of the Attention Deficit Hyperactivity Disorder (ADHD) drug, said evidence on its use in children was poor."Our expectations of this treatment are probably greater than they should be," said Morris Zwi, a London-based consultant child and adolescent psychiatrist, who worked on the review."Whilst our review shows some evidence of benefit, we should bear in mind that this finding was based on very low-quality evidence. What we still need are large, well-conducted trials to clarify the risks versus the benefits." Cochrane Reviews are conducted by international panels of independent researchers and considered as studies of the best available science on a topic.Jonathan Green, a professor of child and adolescent psychiatry at Britain's Manchester University who was asked to comment on the Cochrane Review, said it would be "wrong to draw the conclusion ... that methylphenidate is ineffective."In fact, clinical level evidence strongly supports the effectiveness of methylphenidate for many children with ADHD." The Cochrane Review included data from 185 randomized controlled trials involving more than 12,000 children or adolescents. The studies were conducted mainly in the United States, Canada and Europe, and each one compared Ritalin with either a placebo dummy pill or no intervention.ADHD is one of the most commonly diagnosed childhood disorders and can continue through adolescence into adulthood.Symptoms include difficulty focusing, impulsive behavior, and extreme hyperactivity. It is estimated to affect about 5 percent of children. In their review, the Cochrane researchers found that Ritalin led to modest improvements in ADHD symptoms, general behavior, and quality of life, but that side-effects included a higher risk of sleep problems and loss of appetite.The researchers added, however, that their confidence in the evidence was low since many of the trials were not conducted with sufficient rigor and results reporting was not complete."Clinicians prescribing methylphenidate must take account of the poor quality of the evidence, monitor treatment carefully, and weigh up the benefits and adverse effects," they said. ((Editing by Mark Heinrich))

Older Post
Ahead of Xi's Britain trip, China says hopes for unified EU
FDA again rejects single-dose use of AMAG's Makena
China repeats opposition to force in Syria