This Week in Biotech: Part 2

Editor's Note: A previous version of this article stated that Novartis will present additional data from the PANORAMA-1 at the upcoming ASH conference. The Fool regrets the error.

As I mentioned in Part 1 of this week's review of the most noteworthy biotech events, it was an incredibly busy week.

Having already reviewed the FDA actions and collaborations which led to some monstrous gains and declines this week – which you can read by clicking here – I'm now going to switch gears and highlight six companies making waves this week by reporting clinical-stage data. The good news is, with the exception of one company, it was nothing but positive news.

To the moon!
Perhaps no company delivered a more riveting clinical-stage update than Puma Biotechnology (NYSE: PBYI  ) , which on Thursday announced positive top-line results from its mid-stage I-SPY 2 trial involving neoadjuvant breast cancer treatment neratinib. According to Puma's press release, which used the Bayesian predictive model, neratinib in combination with paclitaxel and followed by a regimen of doxorubicin and cyclophosphamide demonstrated strong superiority in HER2-positive/HR-negative breast cancer. This model would suggest a 94.7% probability of superiority with this signature in phase 3 studies. Similarly, the Bayesian predictive model suggested, based on the data, a 78.1% chance that the neratinib arm would be superior to paclitaxel plus Herceptin in late-stage studies. Clearly, investors may want to wait for the actual release of the full data from this study, but shares are nonetheless up 74% for the week.

A possible multiple myeloma blockbuster in the works?
We also received exciting news from pharmaceutical giant Novartis (NYSE: NVS  ) , which announced on Friday that late-stage experimental multiple myeloma drug, LBH589 (which is given in conjunction with bortezomib and dexamethasone), met its primary endpoint in trials of slowing down cancer progression. I'd certainly wait to see additional data before getting too excited, but it's looking possible that multiple myeloma patients may have a new treatment on the horizon.

Geron has new life
Another late-week clinical study beneficiary was former stem-cell research company Geron (NASDAQ: GERN  ) , which added double-digits early in the session on Friday after the Mayo Clinic released positive data concerning its myelofibrosis drug imetelstat. According to a Bloomberg report, the Mayo Clinic studied 22 myelofibrosis patients for a period of no less than six months, noting that 41% demonstrated a response to the therapy and five patients had a partial or complete remission. This is noteworthy since very few myelofibrosis patients achieve a complete remission, so it certainly stirs the pot as to imetelstat's plain-as-day potential. Unfortunately for shareholders, Geron shares finished the day essentially flat, giving up all of its early gains.

Receptos' warm reception
Shares of newly public Receptos (NASDAQ: RCPT  ) didn't have any issues holding on to its gains, vaulting higher by 17% on the week after the independent data monitoring committee reviewed the top-line data for its Radiance trial involving RPC1063 for the treatment of relapsing multiple sclerosis and suggested Receptos continue its phase 2 trial and commence its phase 3 trial. Although Receptos is yet to release the full data from this trial and has no plans to do so before mid-2014, it did note that RPC1063's adverse event and clinical benefit profile appear similar to those FDA-approved relapsed MS treatments that are already on the market.

Shareholders breathe easier
In what was more of a confirmatory study than a clinical-stage trial, GlaxoSmithKline and Theravance reported that FDA-approved treatment Breo Ellipta worked better in treating patients with chronic obstructive pulmonary disorder, or COPD, than those patients who took Flonase, which contains one of two compounds used in Breo Ellipta. Consider this study a further indication to Glaxo and Theravance's possible dominance of the COPD arena as they ready to potentially bring Anoro Ellipta to market as well within the next two weeks (if approved).

A reason to be depressed
But they can't all be winners, can they? Spoiling it for the bunch, once again, was big pharma Eli Lilly (NYSE: LLY  ) , which racked up another failure by announcing that depression drug edivoxetine failed to beat out a placebo in one of three late-stage trials. According to Eli Lilly, it will not be pursuing any further studies of the drug. As FierceBiotech noted yesterday, Eli Lilly has now scrapped edivoxetine for depression and ramucirumab for breast cancer, and two years ago it saw solanezumab fail to meet its endpoint in Alzheimer's disease, although there may still be hope for this drug in treating very early stages of the disease. All in all, you can see why I refer to Eli Lilly as pharma's most perilous pipeline!

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  • Report this Comment On December 07, 2013, at 11:11 PM, philsie1 wrote:

    With respect to PBYI there seems to be an awful lot of excitement over very little understanding, especially when it comes to the definition of "superior" and what the implications are going forward for something that is superior.

    In the biotech world, something that is superior to another may only have a statistically better success profile by a couple percent compared to something else. So to say that neratinib has a 78% chance of being superior is like saying that frog B has an 8 in 10 chance of jumping 3% further than frog A.

    Does that mean that frog B will take the place of frog A in the jumping contest?!? Maybe, maybe not; how about if the MF dedicates some effort in analyzing that kind of possibility rather than regurgitate text that it doesn't understand in the first place.

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