Biogen’s BG-12 on watch for malignancy data from extension trial – source BioPharm Insight
[personally, I think this site isn't worth the web space they take up. In February, they said NDA filing would be delayed. Now this. They also wrote a bullish piece on BCRX, which makes me laugh. Also had another piece on ARQL that I didnt think highly of either. Makes me skeptical of their reporting ]
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Biogen Idec’s (NASDAQ:BIIB) BG-12 extension trial has cases of malignancies in the ongoing extension trial, a study that includes patients from both the Phase III CONFIRM and DEFINE trials, according to a person familiar with the situation. Since all patients in the extension trial are treated with active therapy, it will be difficult to assess the rate of malignancies relative to a background rate as per a placebo arm and will be difficult to draw causality, the person familiar noted.
When asked whether there have been cases of malignancies in the extension study, a Biogen spokesperson said the company has not released any data publicly on the extension study. He declined to comment on whether the company plans to release any interim data from the extension study before the estimated completion date in 2016.
Hypothetically, if the long-term data shows that patients in the extension study get different types of cancer, similar to Merck Serono’scladribine, that would be less problematic, the person familiar said. If, however, patients in the extension trial have the same type of cancer, as seen in pre-clinical data, then it would draw more attention from the neurology community, he noted.
This still does not change the fact that BG-12 is perceived to be much safer than Novartis’ Gilenya, based on the current data so far, the person familiar said.
Biogen has completed regulatory filings for approval in both the US and EU for BG-12 as a treatment for relapsing remitting multiple sclerosis (RRMS).
A second source noted via email that he cannot talk about what issues may be associated with BG-12 until Biogen “comes clean” with the research data at the upcoming American Academy of Neurology meeting. His personal opinion is that “the press releases have some information missing, as would be expected, and how the drug is publicly perceived will likely hinge on this data,” he said. “Biogen-Idec is keeping a very tight lid on information,” he said in the email.
The person familiar said the presentation at AAN is unlikely to reveal issues. Biogen is not going to release information regarding malignancies at AAN because it is in the extension trial, according to the person familiar.
The extension trial was initially a two-year trial, but is now a five-year trial, said a Biogen spokesperson The study is an additional Phase III study that evaluates the long-term safety profile of BG-12 over a five-year period, including approximately 1,700 patients. The estimated primary completion date for the extension study is June 2016, according to clinicaltrials.gov.
The Phase III DEFINE and CONFIRM studies have not shown a signal of malignancies with BG-12 that is higher than the background rate, a Biogen spokesperson said.
Data from the extension trial has been submitted as part of the FDA package, the spokesperson said. All completed and ongoing studies have been included in the FDA submission, the Biogen spokesperson said.
The company has not been notified if there will be an FDA advisory committee, the spokesperson noted. “We do keep the FDA posted on any safety events that happen in our trial, that’s normal practice as well,” the spokesperson said.
There were no malignancies in the CONFIRM study. In the DEFINE trial , there were two malignancies in the twice-daily drug group, two cases in the thrice-daily drug group and also two cases in the placebo arm, the spokesperson said. In DEFINE, there were two cases in each group, therefore there was no increased risk in the active arm and the rates were consistent with background rate, the spokesperson said. The rate of malignancies was less than 1% in the DEFINE trial, he said.
Biogen will be presenting more detailed safety and tolerability data from the CONFIRM study at AAN, a Biogen spokesperson said via email. The study will be presented on 26 April (2 pm) during Session S41: Multiple Sclerosis: Clinical Trials: Safety. The study is entitled “Safety and Tolerability of BG-12 in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Analyses From the CONFIRM Study [S41.005].
CONFIRM was a multicenter, randomized, placebo-controlled, reference comparator study that evaluated the efficacy and safety of BG-12 over two years in spell out RRMS patients. The study enrolled a total of 1,417 patients, and both dose regimens of BG-12 — 240 mg twice daily (BID) and three times daily (TID) versus placebo — showed favorable safety and tolerability profiles.
According to the AAN study abstract, overall, the incidence of adverse events (87%-94%), serious adverse events (16%-22%), including serious infections (1%-2%), and discontinuations due to AEs (10%-12%) were similar across all study groups, including placebo. The incidence of hepatic and renal events was also comparable among all study groups. The most common AEs in the BG-12 groups were flushing and gastrointestinal events. There were no malignancies in the BG-12 groups.
The company’s current language is correct, as CONFIRM and DEFINE are safe and reported no malignancies higher than the background rate, the person familiar said. There were no malignancies in the CONFIRM trial, he noted. The FDA might ask for the extension trial data, but since BG-12’s safety profile is so good from DEFINE and CONFIRM, the drug is most likely going to be approved.
Biogen has a current market cap of USD 29.96bn.
by Kimberly Ha in New York
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