October 2015 - November 2015
FDA Approves Two New Drug Treatments for Diabetes Mellitus
According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes. Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, nerve and kidney damage. Improvement in blood sugar control can reduce the risk of some of these long-term complications. The U.S. Food and Drug Administration has approved Tresiba and Ryzodeg 70/30 to improve blood sugar (glucose) control in adults with diabetes mellitus. Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus.
Blood Test Could Replace Biopsy for Cancer Diagnosis
A simple blood test could be on the way to replacing the biopsy as the gold standard for detecting cancer, saving lives and money, according to researchers in the UK. The new treatment was presented at the annual World Conference on Lung Cancer in Colorado by Eric Lim, consultant thoracic surgeon at Royal Brompton & Harefield National Health Service (NHS) Foundation Trust. The new study, carried out at Imperial College London, involved 223 patients with known or suspected primary or secondary lung cancer who were about to undergo surgery. In nearly 70% of cases, the blood test was accurate in predicting the presence of cancer cells.
US FDA Sends Letter to DNA4Life Over Consumer Gene Tests
The U.S. Food and Drug Administration sent a warning letter to privately held gene testing company DNA4Life over its sale of an unapproved direct-to-consumer gene test to predict drug response. In its letter, the agency said it was unable to identify any FDA clearance for the company’s test. The letter follows 23andMe’s limited relaunch last month of a series of direct-to-consumer tests after the agency ordered the tests off the market. DNA4Life told Reuters in an earlier interview that it did not believe it needed FDA approval to sell its test.
Obama Administration Sets Stage for a Debate on Drug Costs
The Obama administration set the stage for a national debate on the rising cost of prescription drugs. Saying that too many people are struggling to pay for their medications, Health and Human Services Secretary Sylvia Burwell opened a daylong forum that presented a range of perspectives, from the pharmaceutical industry to a cancer patient with $270,000 in bills for just one drug. President Barack Obama has called for giving Medicare legal authority to negotiate prices for high-cost “specialty drugs,” a small percentage of innovative medications that accounts for more than one-third of spending.
U.S Funds Optimistic About Allergan Piled in Before Pfizer Bid
Several large U.S. funds that boosted their stakes in Allergan Plc in recent months appear to be optimistic about the company’s growth prospects, even before Pfizer’s reported $150 billion takeover bid for the botox maker. Pfizer Inc is negotiating to buy Allergan, which also makes dry eye treatments, for $370 to $380 per share, a person familiar with the discussions said, compared to its current traded value of around $301. There is some dissatisfaction, however, with that price range, according to a poll by Sanford C. Bernstein research. Its poll of 87 investors showed that 54 percent wanted $390 to $400 a share, but 36 percent were satisfied with the lower reported price range.
Why New Tax Inversion Rules Won’t Stop Pfizer-Allergan Deal
Pfizer’s Allergan inversion deal may be too big for even the U.S. government to stop. The U.S. Treasury Department issued new rules to limit tax inversion deals to stop U.S. companies from cheaply picking up small companies just for tax purposes. An inversion takes place when a U.S. company buys a smaller, foreign rival and reincorporates overseas in order to avoid U.S. taxes. The new rules include provisions against “asset stuffing” and “cherry picking.” Though, neither of these rules will affect the Pfizer deal because the drug maker has agreed to pay up for rival Allergan, making the deal a so-called super inversion. Pfizer-Allergan split goes beyond 60-40 which is beyond inversion rule’s established bars. Pfizer is reportedly going to pay $150 billion for Allergan. That’s 22% higher than where the company is trading right now. And Allergan’s shares have already risen nearly 25% on the potential Pfizer deal, to around $310. Pfizer has a market cap of around $200 billion. So the combined company will be worth roughly $350 billion. The government can’t stop companies from paying up for tax inversions, even if it would be better for shareholders if it could.
Sanofi, Hanmi Seal Diabetes License Deal for up to $4.2 Billion
Sanofi has signed a license deal with Hanmi Pharmaceutical to develop experimental, long-acting diabetes treatments, the French drugmaker said on Thursday, in a move to revive its diabetes division. South Korea-based Hanmi will receive an upfront payment of 400 million euros ($434 million) and is eligible for up to 3.5 billion euros in development, registration and sales milestones, as well as double-digit royalties on net sales. In return Sanofi will get an exclusive worldwide license to develop and commercialize Hanmi’s so-called GLP-1 diabetes treatments. Hanmi will retain an exclusive option to co-commercialize the products in Korea and China.
Hanmi, Janssen Launch Up-to-$915M+ Diabetes/Obesity Alliance
Hanmi Pharmaceutical said it will partner with Johnson & Johnson’s Janssen Pharmaceuticals to develop the Korean pharma’s Phase II-ready diabetes and obesity candidate HM12525A (LAPSGLP/GCG) and other oxyntomodulin-based therapies. The collaboration could generate up to $915 million for Hanmi. Janssen agreed to obtain exclusive worldwide rights—except for Korea and China—to develop and commercialize HM12525A. In return, Janssen agreed to pay Hanmi $105 million upfront, and up to $810 million in payments tied to achieving potential clinical development, regulatory, and sales milestones. Hanmi would also be eligible for tiered double-digit royalty payments if HM12525A is successfully commercialized.
AstraZeneca, Sanofi Agree to Share Proprietary Compounds
AstraZeneca PLC and Sanofi SA have agreed to share thousands of their proprietary chemical compounds with each other, an unusual deal that shows the creative lengths to which pharmaceutical companies will go to pursue new drugs. The deal involves each company giving the other free access to 210,000 usually closely guarded compounds. Each company can develop any of the shared compounds without any financial obligation to the other. It is rare for companies to share their so-called compound libraries with outsiders, because these are the starting point for traditional drug development and are expensive to build up. But Mene Pangalos, head of innovative medicines development at London-based AstraZeneca, said he didn’t see “any risks” in sharing around a 10th of the company’s library with Paris-based Sanofi, even though the pair directly competes in several disease areas.
Doctors’ Proposed Ban of Drug Ads Goes After Top Magazine Ad Category
Pharmaceutical companies spent $4.5 billion on advertising prescription medications in the U.S. in 2014, up 18% from the prior year, according to data from WPP research firm Kantar Media. The American Medical Association has called for a ban of direct-to-consumer advertising of prescription drugs, a major source of ad revenue for print magazines. The AMA, a professional organization of doctors in the U.S., said it has adopted a new policy supporting the ban of such ads and for greater transparency in prescription drug prices and costs. Legislation would need to be passed by Congress to ban direct-to-consumer advertising of drugs and the issue would likely raise questions about potential First Amendment violations. Efforts to sharply restrict direct-toconsumer advertising of prescription drugs have been defeated by Congress in the past. http://www.wsj.com/articles/doctors-proposed-ban-of-drug-ads-goes-after-top-magazine-ad-category-1447885280
Coty to Buy Hypermarcas Beauty Business for About $1 Billion
Coty Inc. agreed to buy the personal-care and beauty division of Brazil’s Hypermarcas SA for about $1 billion in cash, turning again to acquisitions to expand its burgeoning cosmetics line. The Hypermarcas beauty business generated $253.5 million in revenue last year with brands such as Risqué nail polish and Paixão skin-care products. The move follows an agreement in July to acquire more than 40 Procter & Gamble Co. beauty brands, a $12.5 billion deal that’s poised to turn Coty into one of the world’s largest cosmetics companies The Hypermarcas deal gives Coty a platform to sell its existing lineup in Brazil, as well as the products it’s getting from P&G. The Hypermarcas transaction is slated to close by the end of March, while completion of the P&G deal is expected in the second half of 2016.
Dangerous Chemicals in Cosmetics Spur Action by Lawmakers
Cosmetics and skin care products are largely unregulated. Today’s products are made with chemicals like formaldehyde -- used in products from nail polish to some chemical hair straighteners - which is known to cause cancer. Other commonly used cosmetic preservatives include propylparaben and lead acetate, used in hair dye. Under the proposed law, the FDA would test whether those chemicals are being used at safe levels. If not, they can force a recall. The biggest offenders are hair products, especially straighteners, and newer nail polishes that last more than a week - all largely unregulated. That’s not the story in other countries. The European Union bans more than 1,000 chemicals from personal care products. Of those, the U.S. bans 11. Dermatologist Dr. Elizabeth Tanzi was on Capitol Hill to urge Congress to pass the tougher new legislation.
FDA Approves Cotellic as Part of Combination Treatment for Advanced Melanoma
The U.S. Food and Drug Administration has approved Cotellic, a drug produced by Swiss biotech company Roche, for use in combination with the vemurafenib medication as a treatment for advanced melanoma. The drugs are intended to target the illness after it has spread to other parts of the body or can’t be removed by surgery. The FDA said the safety and efficacy of Cotellic in combination with vemurafenib were shown in a clinical study of 495 patients with previously untreated, advanced melanoma that demonstrate the BRAF V600 mutation.
World’s Top Innovator South Korea Dominates Asian Stock Winners
South Korea, which topped the Bloomberg Innovation Index in January, is now dominating Asian stock markets with seven of the 10 best performers this year. In the Bloomberg Innovation Index for 2015, South Korea ranked No. 1 in measures of research and development, patents and post-secondary education and fourth in hi-tech companies, while scoring highly in both manufacturing and research personnel. Hanmi Science Co. and affiliate Hanmi Pharm Co. soared 919 percent and 681 percent each after clinching deals to sell lung cancer and diabetes treatments overseas. Amorepacific Corp. climbed 107 percent as its Air Cushion foundation cream won positive reviews, driving a 51 percent jump in its net profit in the nine months through September. Celltrion Inc., which developed an arthritis medicine, more than doubled. http://www.bloomberg.com/news/articles/2015-11-11/world-s-top-innovator-south-korea-dominates-asian-stock-winners
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