Business Briefs Merck, GSK, Novo, Walgreen, Epocrates, Doximity
Both Merck and its rival across the pond, GSK, have announced they will cut prices for their respective cervical cancer shots in a deal that will deliver them to poor countries for under $5 a dose. The Global Alliance for Vaccinations and Immunizations will deliver the discounted vaccines to Ghana, Kenya, Laos, Madagascar, Malawi, Niger, Sierra Leone and Tanzania, the first countries to receive them. The two vaccines, Merck's Gardasil and GSK's Cervarix, can cost more than $100 per dose in developed countries. Both drugs protect against the two most deadly types of the virus: 16 and 18, which cause cervical cancer. Gardasil also boasts protection against types 6 and 11—which can cause genital warts. Merck plans to supply around 2.4 million doses of Gardasil at $4.50 per dose in the next four years, while GSK said it will price its shot 10 cents higher. The GAVI Alliance website also reported Merck may lower the price even further if total volume increases in the future.
Merck has submitted an application to FDA for approval of a new immunotherapy dissolvable tablet designed to treat ragweed pollen allergies. Merck expects FDA to compete its review in the first half of 2014. Merck's two allergy treatments, Singulair and Clarinex, went off-patent last year, and the company is hoping to replaces sales lost to generic competition. Merck reported Q1 earnings fell by 8.3% last week, as pharmaceutical sales declined.
At a Reuters Health Summit on Tuesday, Lars Sorensen, CEO of Novo Nordisk, said the company's long term growth strategy resides with Victoza or Tresiba. The Danish drug maker is looking to expand the indication of Victoza to include those who are severely obese. In a study versus Januvia, Victoza 1.8mg + metformin lowered patients weight, on average, by 7.3 lbs compared to Januvia 100mg + metformin, which saw weight loss on average of 1.8 lbs. Tresiba was denied approval in the U.S. due to cardiovascular concerns in February. Novo acknowledged at the time it would not be able to resubmit for approval in 2013. Analysts estimate FDA's ruling could delay Tresiba until 2015, with some placing the drug's entry as late as 2016. "The U.S. represents something like 50% of our growth potential," said Sorensen.
Walk-in pharmacy clinics could become a bigger deal in California if the state passes new regulations that would allow nurse practitioners to operate with greater freedom. California's legislative proposal is to cut the requirement that nurses get a doctor to approve their recommendations before taking action. NPR notes that the Golden State is one of 15 that are looking into expanding NP autonomy. The Walgreens drugstore chain is already primed for such a move – parent company Walgreen announced last month that its Take Care Clinics were expanding services to include diagnosing and treating chronic conditions like diabetes and high cholesterol. These sites are staffed by nurse practitioners and physician assistants.
Doximity's May iPad release allows doctors to sign and send faxes as well as Skype other professionals, giving a bit more insight as to just how docs are using their tablets, and a Thursday report by MobiHealth News shows just what else physicians are up to on their mobile devices: using Epocrates. MobiHealth drilled into Manhattan Research's 2013 Taking the Pulse data and reported that 50% of the 2,950 surveyed physicians used Epocrates on tablets, while 70% did so on their smartphones. Athenahealth bought the company in January.
Google's former chief health strategist Roni Zeiger has launched the online cancer community Smart Patients, reported PMLive. The site's roster of partners includes the Bonnie J Addario Lung Cancer Foundation, Cancer Commons and WorldOne Interactive among others. The site is similar to the FDA's recent Patient Network launch and other supportive communities in that it seeks to bridge the clinical and the empathetic. The site includes a clinical trial search engine along with a forum for patients to swap information and provide support.
GSK's latest stab at transparency includes putting clinical trial data online, reported EyeforPharma, which notes that the move to put anonymous info online is a make-good move of sorts in light of “being landed with a record $3 billion fine,” for misreporting Paxil clinical trial data. Part of that $3 billion was also levied because the company didn't share certain safety data for its diabetes drug Avandia and for off-label marketing of its anti-depressant Wellbutrin. The August 2012 settlement was the largest of its kind, topping the then-landmark $2.9 billion hit Pfizer took in 2005 when the DOJ said it misbranded and promoted inappropriate use for a slew of brands including Bextra, Geodon, Zyvox and Lyrica. GSK's take on the program is a bit different – the company described the initiative in a statement Tuesday as “a step towards the ultimate aim of the clinical research community developing a broader system where researchers are able to access data…by multiple organizations.” GSK said an independent third-party will oversee the password-protected site and that studies will appear after a drug has been shelved or approved.