- U.K. competition watchdog targets pharma for ‘substantial fines’ (fiercepharma.com)
Look out, pharma: Britain's competition watchdog is coming for you....The U.K.'s Competition and Markets Authority is planning to levy "substantial fines" this year, marking a "big step up in the scale and impact" of its enforcement activity, Alex Chisholm, head of the agency, told the Financial Times. And one of those fines will likely be directed at a pharma company...The CMA has been probing drugmakers including GlaxoSmithKline and Pfizer for alleged wrongdoing. "In high-value markets with big players, they should face big fines,"...For Pfizer, though, a resolution could still be a ways off. In August, the CMA accused the drugmaker and partner Flynn Pharma of running afoul of U.K. and European laws by jacking up costs for their epilepsy drug...The pair charged "excessive and unfair prices"...the CMA said at the time, raising costs by as much as 2,600%. Regulators plan to hand down a decision in the case in about three months..."While businesses are generally free to set prices as they see fit, those that hold a dominant position have a special responsibility to ensure that their conduct does not impair genuine competition and that their prices are not excessive and unfair,"...
- Drug Companies to Try a Unified Front Against Cancer (nytimes.com)Rival drug firms team up to test new approach to cancer treatment (statnews.com)
Several leading pharmaceutical companies are joining forces in an effort to speed the testing of new types of cancer drugs that harness the body’s immune system to battle tumors...The cooperative effort, announced Monday, will include Amgen, Celgene, GlaxoSmithKline, Pfizer, Merck...and some smaller companies. The effort, known as the National Immunotherapy Coalition, will try to rapidly test various combinations of such drugs...“The challenge of cancer is far too great for any of us to tackle alone,”...Perhaps the most exciting development in oncology now is the sudden success, after decades of failure, of efforts to unleash the immune system to control cancer...The announcement of the coalition came on the first day of the huge J.P. Morgan Healthcare Conference in San Francisco, when numerous companies make announcements. Besides the coalition announcement on Monday, one company said Sunday it was aiming for what it called the holy grail of oncology — a blood test to detect all cancers at the early, most treatable, stage...
- The top 10 pharma companies in social media (fiercepharmamarketing.com)
Chatting with the public is not in pharma's comfort zone. Drugmakers are adept at the one-way communication known as direct-to-consumer advertising, and some of them deal well with the media. Some even know how to work with patient groups. Back-and-forth with doctors? Pharma's daily bread...But put your average, everyday drug company in the middle of a public conversation, and it freezes up. Worried it will say the wrong thing, sensitive to criticism, mindful of unintended consequences, drugmakers usually prefer to stand by the punch bowl and check their iPhones for messages...You could say pharma has social anxiety...Drugmakers' usual excuse for remaining social-media wallflowers is regulation, or lack of it. The FDA's guidance on the subject is piecemeal and tardy; the agency has slapped companies for overstepping bounds they didn't know existed.
- GSK and Pfizer team up on continuous manufacturing project (in-pharmatechnologist.com)Pfizer, GEA Pharma Systems, and G-CON Manufacturing unveil a modular manufacturing prototype that runs continuously and can quickly deliver customized quantities of drugs. (automationworld.com)
Pfizer and GlaxoSmithKline have agreed to work together on the development of a new version of the former's continuous processing technology for oral solid dosage drugs...Pfizer's portable, continuous, miniature and modular (PCMM) system...is designed to break away from the conventional batch manufacturing model used in pharma and towards continuous manufacturing…In continuous manufacturing, drugs are continuously produced in highly-automated, closed units that allow changes to the production parameters on the fly…The approach only allows production to be tweaked if quality issues emerge - avoiding the need to lose an entire batch - and also ties in with the shift towards flexible manufacturing of smaller volumes for specialised applications, such as personalised medicines…Pfizer developed the first generation of its PCMM system along with GEA and G-CON, and describes it as "an autonomous and transportable pod that may be quickly shipped from location to location and readily brought online to create a fully functional module."…it takes around a year to set up, compared to two or three years for conventional production lines.
- 5 Accused of Stealing Drug Secrets From GlaxoSmithKline (nytimes.com)
Federal prosecutors in Philadelphia said on Wednesday that they had indicted five people, including two research scientists, on charges of stealing trade secrets about drugs to treat cancer and other diseases from GlaxoSmithKline...the two scientists, Yu Xue and Lucy Xi, worked at Glaxo’s research facility in Upper Merion, Pa., and emailed and downloaded confidential data about a dozen or more company products to associates who planned to sell and market the trade secrets through a company they set up in China, called Renopharma...to conceal their crime, Ms. Xue and two other associates, Tao Li and Yan Mei, agreed to put the proceeds in the name of Ms. Xue’s twin sister...who was also charged. Ms. Xi worked with Ms. Xue at Glaxo and was married to Mr. Mei...the defendants boasted that their company, based in Nanjing, had received some financial support and free laboratory space from the government and that its ultimate goal was to develop its own antibody drugs.
- Will U.K.’s Big 3 Health-Care Stocks Bounce Back in 2016?: Chart (bloomberg.com)
Here’s what lies ahead in 2016 for each company:
- GlaxoSmithKline: CEO Andrew Witty will attend both the J.P. Morgan health-care conference in San Francisco and the World Economic Forum in Davos this month. Shares of the U.K.’s biggest drugmaker have tumbled more than 20 percent since mid-2013. With generics snapping at the heels of its best-selling lung drug Advair, Glaxo has been touting new medicines while shunning large-scale M&A deals.
- AstraZeneca: After spurning a takeover by Pfizer Inc. in 2014, CEO Pascal Soriot has built the company up with small- to mid-sized acquisitions and licensing deals, focusing on drugs for cancer, respiratory disease and diabetes. Generic versions of its blockbuster cholesterol pill Crestor will hit the market in May. Results from several key cancer drug trials are expected in the second half of this year.
- Shire: The smallest of the three companies is said to be in advanced talks with Baxalta Inc. to become the world’s biggest maker of rare-disease drugs. Shares have dropped 21 percent since Aug. 3, the day before its $30 billion offer for Baxalta was made public. On the product front, Shire awaits U.S. approval of a key drug for dry-eye disease called lifitegrast, expected late this year.
- Independent group says new Glaxo asthma drug far too expensive (reuters.com)ICER Draft Reports on Nucala® (Mepolizumab) for Asthma and Tresiba® (Insulin Degludec) for Diabetes Posted for Public Comment (icer-review.org)
An independent nonprofit organization (Institute for Clinical and Economic Review) that evaluates clinical and cost effectiveness of new medicines found the price of GlaxoSmithKline's new drug for severe asthma should be as much as 76 percent lower to justify its value, according to the group's latest draft report... analysis indicated that Glaxo's Nucala (mepolizumab) should be priced at $7,800 to about $12,000 a year, far below the drug's list price of $32,500 a year...once-monthly injectable Nucala...significantly reduces asthma attacks and symptoms and decreases the need for oral steroids. However, it found that the price was not cost-effective, and that there is uncertainty about whether the benefits will persist over the long term because of the short duration of clinical trials...ICER President Steven Pearson, in a statement, said its analyses aim "to help the health care community determine what should be used, which patients benefit most, and at what price innovative treatments represent a reasonable value."
- Will GSK’s no-speaker-fee system work? Execs say yes; critics, not so much (fiercepharmamarketing.com)
GlaxoSmithKline has taken some bold steps to polish its image, tarnished by a Chinese bribery scandal and $3 billion settlement with the U.S. government. But naysayers blame its first big moves--nixing sales-rep quotas and pegging bonuses to "softer" measures instead--for disappointing roll-outs for several new meds...Now that it's dropping the time-tested tactic of paying doctors to promote its meds, critics are piling on there, too. But the U.K.-based drugmaker is sticking to its guns, recruiting its own doctors and other experts to tout its meds...Society now sees pharma-paid doctors as "hired guns,"...The only way to avoid that rap is for drugmakers to use their own employees instead...Since GSK first announced its no-payment policy--which went into effect Jan. 1--other Big Pharmas have addressed the question. Will they do the same? Several companies are on record with an unequivocal "No," saying that their doctor-speakers are important to their promotional efforts...Time will tell whether GSK's new policy will boost its credibility without cutting into revenue. More time will tell whether a buffed-up image would translate into bigger sales.
- Reuben Guttman: The lawyer pharma loves to hate (statnews.com)
Reuben Guttman wants us all to be concerned about what’s in our medicine cabinets. A Washington lawyer who specializes in prosecuting pharmaceutical fraud, Guttman has gone after Pfizer, Abbott, GlaxoSmithKline, and several other top drug makers — and he usually wins big, recouping billions of dollars for federal and state governments...STAT talked with Guttman about bad behavior in the drug industry, and whom he trusts for his own medical care.
- The lawsuits you’ve won often center on unlawful marketing and kickback schemes. How widespread are these practices?
- How does your work as a lawyer impact the health care system?
- And the consequence for patients?
- Is there anything patients can do to protect themselves?
- Knowing what you know, do you avoid doctors and hospitals?
- What’s the next big pharma scam?
- What do you do in your spare time?
- Are you an athlete yourself?
- When you were a kid, did you fantasize about being a whistleblower attorney?
- Beijing aims to refill medicine chest with ‘Made in China’ drugs (reuters.com)
China, already a global powerhouse in high-tech areas…is turning its industrial might to the challenge of making more of its own drugs for a vast and aging population… China is the world's second biggest drugs market behind the United States…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...Pivotal to the transformation of the market is the China Food and Drug Administration…The watchdog has promised to speed up approval of innovative new drugs, which can take 5-7 years…It's probably been taking everyone a little by surprise…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.