3 Things In Biotech, April 3: Alkermes Gets Into Trouble, Puma Gets Into Your Head, Myriad Gets Into Japan
- Alkermes has a major setback in depression.
- Puma gets into the guidelines.
- Myriad proceeds to Japan with BRCA testing kit.
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Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Alkermes has a major setback in depression
Company: Alkermes (ALKS)
Therapy: ALKS 5461
Disease: Major depressive disorder
News: ALKS disclosed the receipt of a refusal to file letter from the FDA regarding their application for approval for ALKS 5461 to treat major depressive disorder. The company had hoped to market this agent for patients with depression who were not seeing an adequate response to current antidepressant therapy. The FDA felt that the evidence presented is insufficient to decide on the approval. They want to see another efficacy study, as well as a bioavailability study.
Looking forward: ALKS indicated that they do not agree with this assessment, and that they plan to appeal the refusal to file. However, I have to say that this does not bode well at all for the application in its current form. But at least we can say that the program is not dead in the water. This could, however, set the ALKS 5461 program back by a year or more, so it makes sense to try and appeal.
For now, though, I would treat buying on this drug's promise as an extremely high risk proposition.
Puma gets into the guidelines
Company: Puma Biotechnology (PBYI)
Disease: HER2-positive breast cancer
News: PBYI announced that neratinib is now being included in the NCCN's guidelines for breast cancer. More specifically, the use of this agent in patients with brain metastases secondary to their breast cancer is now given a category 2A recommendation, when used in combination with capecitabine. This means that the NCCN has reached a consensus on this use, even though the evidence may be low level (e.g., not based on randomized studies).
Looking forward: The interesting part about this news is that neratinib is not, at this time, FDA approved for treating brain metastases. But in many cases insurance companies rely on guidelines to make payment decisions. It speaks well to the underswell that's been seen with neratinib in the management of brain metastases. This could come to represent an interesting market penetration opportunity, as clinicians may be more likely to use neratinib over alternative options if there is a reasonable expectation of preventing or treating brain metastasis as a secondary effect.
This might be bigger news than it seems for the credibility of PBYI!
Myriad proceeds to Japan with BRCA testing kit
Company: Myriad Genetics (MYGN)
Therapy: BRACAnalysis companion diagnostic
Disease: HER2-negative breast cancer
News: MYGN announced that the Japanese regulators have granted manufacturing and marketing approval for their diagnostic system called BRACAnalysis, which is the companion to AstraZeneca's (AZN) olaparib. This is likely to follow shortly by approval of olaparib in patients with HER2-negative breast cancer.
Looking forward: MYGN has an interesting opportunity here if they market properly. Japan is unique in its peoples' reticence to undergo BRCA testing, due in part to cultural stigma surrounding cancer diagnosis. A positive test means your kids and grandchildren are at risk, and many patients would simply rather not know. These barriers are being breached, and that may come at just the right time for BRACAnalysis. As such, MYGN may stand to gain quite more than you'd expect from an approval in BRCA-mutated breast cancer for olaparib, and this approval here is a key first step.
Very interesting news, and it could mean very important things for MYGN in Japan.
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