Pregnancy rates were higher than might normally be expected with in vitro fertilization in the latest data for the Augment Fertility Treatment from OvaScience ($OVAS). But fertilization and blastocyst formation weren't particularly improved. Even the pregnancy rates don't look quite so good--when you consider all the patients who originally enrolled, noted a Leerink analyst.
The company's shares were initially up on the data that came out on March 26. However, the following day they dropped hard by 9% in early trading--to a lower point than before the data was released at the Society for Reproductive Investigation in San Francisco, CA. That leaves OvaScience trading largely flat for the year so far.
OvaScience still has a valuation of more than $1 billion. It expects to have used Augment in 1,000 treatment cycles by year-end; the company is in the process of launching ex-U.S. The company's U.S. strategy is under review, after it chose to suspend a U.S. clinical trial of Augment when it received a letter from FDA in September 2013 questioning whether the study required an IND.
In the latest data, there were 9 clinical pregnancies, defined as those identified by an ultrasound to find the first monitored heartbeat, out of 17 embryo transfers. That's a 53% success rate--much higher than the roughly 20% to 35% success rate per IVF cycle cited by The National Infertility Association.
But there are several caveats to this data, points out Leerink analyst Gina Wang.
Of the 28 patients in the study, 26 of them had the Augment treatment and only 17 of them actually completed embryo transfer cycles. So, the success rate was calculated in the most optimistic way.
Wang also noted that the average age of the pregnant women in the study was 33, which is very young for IVF and a lower age is associated with improve procedural outcomes. But she said the age of all the women in the study was not disclosed.
She also noted that the blastocyst formation rate and fertilization rate for patients who receive Augment is comparable to those prior to Augment treatment.
Augment takes the energy-producing mitochondria from a patient's own egg precursor cells and adds them to the patient's mature eggs to supplement their own mitochondria; post-treatment these are then implanted during the IVF process. OvaScience estimates a pregnancy rate of 25% to 53% based on its experience thus far with Augment, which it is monitoring via an international patient registry.
The price of Augment is $23,000 in Canada with a total cost of $32,000 for an IVF cycle with multiple embryos transferred. About $30,000 is the entire price in sites in the United Arab Emirates and Turkey, Wang noted.
Despite her skepticism regarding the latest data, Leerink's Wang maintained a $56 share price target for OvaScience, which is trading now at about $45.
- here is the release