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.
Company: Bristol-Myers Squibb (BMY)
Therapy: Nivolumab and ipilimumab
Disease: Advanced renal cell carcinoma, the most common form of kidney cancer
News: BMY announced that the FDA has accepted its supplemental application for the combo of nivolumab (branded Opdivo) and ipilimumab (branded Yervoy) in the first-line treatment of intermediate- or poor-risk advanced renal cell carcinoma. The FDA granted the application priority review status, with an action date of April 16, 2018.
Looking forward: This development is well and truly worth paying attention to, as BMY stands poised to become a major competitor in the renal cell carcinoma space. Checkmate-214, which has been covered in this series previously, was stopped early due to favorable efficacy compared with sunitinib, and the benefit was seen regardless of PD-L1 expression. This seems like as close to a slam dunk as you'll find, and this will pit BMY directly against the likes of Exelixis (EXEL) in the near future. So 2018 is going to be an important year for kidney cancer drug approval decisions!
Company: Shire (SHPG)
Disease: Acute lymphoblastic leukemia (ALL)
News: SHPG announced that the EC has granted approval for a lyophilized (powder) form of pegaspargase (branded Oncaspar) to be used as part of a combination regimen in patients with ALL. This builds upon the previous approval of a liquid formulation of pegaspargase, as it has similar efficacy but a much, much longer shelf life.
Looking forward: When cost is a concern, improving the quality of drugs becomes paramount. Having a shelf life that is three times longer than liquid pegaspargase likely means that uptake will be quick, as ALL is a relatively uncommon form of cancer. I could see where lyophilization could potentially lead to some dosing issues, as this must be reconstituted carefully (and anyone who has worked with lyophilized powders knows how tricky they can be sometimes!). However, I expect that this form of the drug will make its way into clinical pharmacies quickly, hopefully improving access to these important therapies.
Company: Omeros Corporation (OMER)
Therapy: Omidria (phenylephrine and ketorolac ocular solution)
Disease: Intraocular pain
News: OMER announced the supplemental approval of Omidria to include pediatric patients for the prevention and treatment of intraocular pain after eye surgery. In addition, the FDA granted a six-month extension of the marketing exclusivity for Omidria.
Looking forward: This approval should go a good ways toward improving the OMER thesis, as the company currently has been growing sales of Omidria like a weed. At last check, OMER faced operating losses of $12.7 million, so it needs to grow the Omidria franchise substantially to help offset the R&D and other expenses. There are tens of thousands of kids with cataracts, so this agent might be able to help a fairly large number of patients, although not near the size of the market in adults (unsurprisingly). Still, this is good news for OMER.
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