Trend Setting: Predicting Success with Social Media

Who needs traditional prescription data to measure and predict trends when social media can do the same, if not better. Social media is now being used to predict the success of a new drug launch much faster than script data. The difference is that social media can, to a degree, explain the “why” and not just the “what.” This is the case for Tecifidera, a new multiple sclerosis (MS) drug launched this past April by Biogen Idec. According to Treato, a patient intelligence platform, Tecifidera has been the most talked about MS drug on social media. Tecfidera is the subject of 36% of discussions happening on Facebook compared to 28% for all other MS medications.

Since its launch, there have been 600 posts about Tecfidera, 30% of which indicated that the writer is a patient who was prescribed or began using the drug. Over half of patient posts indicated that patients are considering switching from Copaxone or Aubagio to Tecfidera. Although it is still too early to predict success, Gideon Mantel, Treato’s Executive Chairman and Co-founder, believes that Tecfidera will gain significant market share over competitors, assuming there are no significant side effects.
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Patient Pages: Cancer Patients Non-Adherent to Meds

Adherence to medication is still an ongoing problem, even in the case of a devastating disease diagnosis like cancer. In fact, two in three patients diagnosed with cancers such as leukemia, melanoma or non-small cell lung cancer reported that they have not adhered to their medication regimen, according to Kantar Health’s National Health and Wellness Survey (NHWS). NHWS found that the patients who were on oral therapy were either forgetting to take their medication or not taking their medicine as directed by their doctors, according to Marco DiBonaventura, PhD, Vice President, Health Outcomes, Kantar Health. Non-adherent patients tended to have worse mental health status and required hospitalization more often than adherent patients. DiBonaventura believes that pharma should focus on improving adherence rates among this patient population in order to reduce healthcare costs and resources.

Sales Sector: Price Drops for Cancer Vaccines

Merck and GlaxoSmithKline, the makers of cervical cancer vaccines, Gardisil and Cervarix, say that they would cut these drug prices to below $5 per dose for girls in the poorest countries. Merck cut their Gardisil vaccine to $4.50 and GSK’s Cervarix was cut to $4.60 per dose. Both prices were negotiated through the GAVI Alliance, an organization that delivers more vaccines to the world’s poor.

These vaccines protect against strains of the human papillomavirus (HPV) which causes 70% of cervical cancers. Gardisil and Cervarix can be given to girls as young as age nine, which makes it possible for them to be protected against cervical cancer. Without this price cut, Pap tests would be impractical and the vaccine would be too costly for women and parents to afford.

These prices will apply to a few million doses for projects happening in Kenya, Ghana, Laos, Madagascar and other poor countries. Dr. Seth Berkley, Chief Executive of GAVI Alliance hopes that 30 million girls in 40 poor countries would also be given access to these vaccines at the same price or lower, by year 2020.

Therapeutic Talk: Diabetes Management Varies Among EU’s Top Five

Cegedim Strategic Data, a leading provider of healthcare market research, released their latest research on type 2 diabetes patients treated with oral anti-diabetic drugs (OADs) or Glucagon-like peptide agonists (GP-1) in the top five European Union nations: France, Spain, Germany, Italy and the U.K.

In all five countries, results show that there are more males being treated than females with the average age of patients varying from country to country. France has the youngest average at 64.5 years old while Spain has the oldest average at 69.6 years old. Additionally, over 85% of the patients in these countries were found to be suffering from at least one prominent comorbidity associated with diabetes including hypertension (high blood pressure) and dyslipidemia.

Among these five European nations, France was shown to have the lowest percentage of diabetes patients categorized as obese at 37.4%, whereas the U.K. had the highest at 53.1% followed by Germany, which was close at 52.3%. When it came to the highest number of patients who had their diabetes in control, Germany had a high of 58.1%, and the U.K. had the lowest at 42.3%.

Overall, this analysis of 415,093 type 2 diabetes patients shows that disease management can vary greatly even among countries with seasoned healthcare systems.

DC Dispatch: Decision on SCOTUS Gene Patent Case

The Supreme Court has made a ruling in the gene patent case two months after hearing the case. The case involved Myriad Genetics, a molecular diagnostic company that was sued over its claim of patents of BRCA1 and BRCA2, biological materials whose mutations are linked to increased hereditary risk for breast and ovarian cancer. In a unanimous decision, the Supreme Court ruled that companies cannot patent human genes. The justices took the position that DNA itself is not patentable, but “complementary DNA” is.

Complementary DNA (cDNA) is artificially synthesized from the genetic template and engineered to produce gene clones. Justice Clarence Thomas, who wrote the unanimous court opinion said, “Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material.” Thomas added, “[Myriad] found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” But he said, “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.”

FDA Update

Fourth Draft Guidance on Biosimilars

The FDA’s draft guidance establishes five different types of meetings to be used at various junctures in the development cycle of a biosimilar product. The biosimilar initial advisory meetings are held to discuss general matters 90 days ahead of the FDA receiving a request from a sponsor. Type 1 meetings are held to discuss clinical hold, set protocol for evaluations, safety issues or resolve disputes; Type 2 meetings discuss a specific issue needing FDA advice; Type 3 meetings review data in-depth; and Type 4 meetings discuss the format of a biosimilar application or supplement.

Avandia Update

FDA has decided to reopen the case on GlaxoSmithKline’s Avandia and will ask an advisory committee whether or not they should lift restrictions on the drug. In 2007, eight years after the drug was FDA approved, evidence was published showing that Avandia increased the risk of heart attack by more than 40%. The FDA has asked that GSK’s clinical trial be considered for review. According to GSK’s website, the review found previously unreported cases of heart complications and fatalities, but not enough to change the conclusion that it raises cardiovascular safety risk. However, outside experts claim that the GSK trial was seriously flawed.

Recent Approvals

A major step forward was made for several cancer drugs recently. GSK’s Tafinlar (dabrafenib) and Mekinist (trametinib) received approval for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

The FDA also expanded the approved use of Amgen’s Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor. Xgeva is intended for patients whose GCTB cannot be surgically removed or when surgery is likely to result in severe morbid conditions, such as loss of limbs or joint removal.

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