AstraZeneca's ovarian cancer drug set to be reviewed next week
AstraZeneca decided to repeatedly rebuff Pfizer's acquisition overtures largely because it has confidence in its clinical pipeline. Next week will be the first test of the company's faith, as its platinum-sensitive relapsed ovarian cancer with germline BRCA mutation drug dubbed "olaparib" is set to be reviewed by the Food and Drug Administration on June 25.
Per usual, we should see the all-important briefing documents released two days prior to the Advisory Panel. The drug's PDUFA target action date is presently scheduled for Oct. 3.
What's key to understand is that olaparib has had a rocky developmental history, with AstraZeneca even shuttering its clinical trials at one point and taking a $285 million charge in the process. After restarting its clinical program by launching a late-stage trial last year, the company subsequently submitted a New Drug Application, or NDA, to the FDA based on the drug's midstage results. AstraZeneca has also launched a late-stage study for olaparib as a potential treatment for BRCAm breast cancer.
Given that olaparib has blockbuster potential if approved for multiple indications, it is certainly worth keeping tabs on this Advisory Committee meeting next week. Moreover, olaparib is expected to be an important driver of top line growth going forward, as the company continues to lose patent protection for former top-selling drugs like Nexium. In sum, this could be the start of AstraZeneca's recovery from the so-called patent cliff that cost the company a reported $2.2 billion last year alone.
Merrimack Pharmaceuticals will discuss late-stage study for pancreatic cancer drug
Merrimack Pharmaceuticals will give an oral presentation at the
European Society for Medical Oncology World Congress on Gastrointestinal Cancer on June 25, where it will reveal further details of its successful late-stage study for MM-398 as a second-line treatment for pancreatic cancer.
MM-398 was previously reported to increased survival by 1.9 months when used in combination with 5-fluorouracil and leucovorin, which was statistically significant compared to the control arm of 5-FU and leucovorin. But MM-398 did not confer a significant clinical benefit in terms of increased survival when used as a monotherapy.
Shares of this small-cap biotech have shot up close to 50% since announcing these top line results and investors are eagerly awaiting more news regarding a possible NDA filing with the FDA later this year.
Merrimack is slated to provide an update on the drug's safety and efficacy at this upcoming meeting. That being said, investors should keep an ear open for details regarding the company's plans for a regulatory filing and the drug's estimated market opportunity. To date, we still don't know much about how Merrimack envisions MM-398 to fit into the current landscape of pancreatic cancer treatments or its commercial potential.
And with Merrimack losing its partner Sanofi last week for the development of MM-121, the company's outlook would appear to depend even more heavily upon MM-398 going forward. Merrimack will hold a conference call at 8 a.m. E.T. on June 26 to discuss the data being presented at the conference.
George Budwell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.