Business briefs: Sanofi, Allergan, Otsuka, Genmab, NIH, Novartis, DOJ
Diabetes took the lead of yet another earnings story this week, providing a high point in Sanofi's overall depressed quarterly report, which showed sales falling just shy of 3%, to $10.5 billion compared to about $11 billion during the same period last year. Generic competition on Plavix, Avapro and Eloxatin drove down sales numbers. This was somewhat balanced out by sales in the Genzyme subsidiary, which grew over 25% compared to the same period last year to $643 million, while Lantus drove the diabetes division's almost 20% growth over the prior-year period, with $2 billion in sales.
Allergan has shelved its potential rival to Regeneron's age-related macular degeneration drug Eylea for at least two years, the company noted during its Wednesday earnings release. Reuters pointed out that the delay gives Regeneron some breathing room—RBC analyst Adnan Butt, cited by the news service, said that investor chatter indicates Allergan's Darpin could best Regeneron's treatment, which had $838 million in sales last year. Regeneron estimated in February that US Eylea sales could grow to between $1.2 billion and $1.3 billion this year.
FDA issued a warning that Otsuka's Samsca has been associated with liver damage and should not be used for more than 30 days. The regulator posted the alert Monday, and the drug maker is revising the label accordingly. The drug is for hypervolemic and euvolemic hyponatremia, a condition in which the body's water level is too high and is associated with heart or liver failure.
The difference between a clinical setting and real-world experience is of high importance to oncologists, according to a study noted by Eye for Pharma. Researchers found that 87% of polled oncologists lean on real-world experiences more than lab data when considering treatment options. This could have added significance when cross-referenced with a JD power and Associates study that showed “physicians continue to perceive the sales representative as the leading influence on their relationship with biopharmaceutical companies.” The JD Power study focused on oncologists and found these docs want reps to “anticipate their needs and offer proactive solutions.” Also of note: Genentech, Novartis and Bristol Myers-Squibb were perceived as making contributions to advancing medical care.
The Breakthrough Therapy Designation club is getting crowded—Danish drug company Genmab said Tuesday that its experimental drug for double refractory multiple myeloma drug daratumumab is now part of a group of high-touch consultancy therapies that includes Merck's advanced myeloma therapy lambrolizumab and a BMS hepatitis C combination therapy, among others. Getting the breakthrough label requires pre-clinical evidence that shows the treatment has a statistically significant advantage over current treatments based on at least one endpoint for serious or life-threatening conditions. The label means the regulator and manufacturer will work closely throughout from that point onwards to make sure trials are efficient and cover as many possible points of inquiry as possible, with the goal being an overall smoother approval process.
All cancers are personal, but an NIH oncology study has found that some cancers may be genetically related, reported the New York Times which said studies published by both Nature and the New England Journal of Medicine on Wednesday show that endometrial cancer is similar to “the worst ovarian and breast cancers” and acute myeloid leukemia. Wednesday's info share is part of a larger cancer research project that indicated earlier this year that there is a link among colon cancer, lung cancer, and a form of breast cancer. Notes NYT, the implication is that the research raises “the tantalizing possibility that the three deadly cancers might respond to the same drug.”
Novartis is offering MS patients and caregivers lunch with a side of treatment information, reported Pharmalot, which says the drug maker is making pitches in cities including Newark, NJ, as well as spots in Massachusetts and California, as another way to protect its market share in light of Biogen's MS drug Tecfidera.
The Department of Justice announced yesterday afternoon that they plan to appeal a federal judge's order which allows the FDA to make Teva's Plan-B available over-the-counter to women 15 years of age and older. Officials said the court overstepped its authority by demanding FDA make emergency contraception available instead of making a recommendation, and letting the agency make a ruling. A justice official said, under condition of anonymity, as reported by The New York Times: “We aren't focused in this appeal on the merits of the secretary's decision, what we're focused on is that the remedies that the judge ordered were beyond his authority.”