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November will be a busy month for the FDA. There are four scheduled Prescription Drug User Fee Act (PDUFA) dates for the month. Three of these involve speculative biotech companies hoping for approval. Therefore we should see major share price shocks during November, because these stocks will either face approvals or rejections that cause traders and investors to buy and sell in hoards.

On November 12 the FDA will officially decide upon pSivida (NASDAQ:PSDV) and Alimera's (NASDAQ:ALIM) Iluvien. Iluvien is intended to treat diabetic macular edema. On December 23, 2010, the FDA sent the tandem a CRL. The FDA requested the 36-month data from Phase III safety and efficacy study for Iluvien. In the previous NDA the companies only had 24 months of data.

This can be taken as a positive or a negative. The bullish argument is the FDA was happy with the clinical trials and simply want to view the 36 month data. On the other hand, the bearish argument is more probable. The bearish argument is the FDA saw deteriorating results with the 24 month data, and wants to see if this trend continues to deteriorate over 36 months, and furthermore if this will cause severe adverse effects in the long term.

Neither stocks has seen any kind of pre-PDUFA date run, as is the norm for small cap companies. Therefore, we may see this pick up over the next two weeks. With that in mind, there is a pattern in which companies that receive a CRL do not see the same pre PDUFA date anticipation as the initial NDA.

November 13 will see one of the speculative biotech's finest companies, Intelgynx (OTCQX:IGXT), receive a decision regarding CPI-300. I say "finest" because an approval can send this stock upwards by over 100%. Nevertheless, CPI-300 is intended to treat major depressive disorder. CPI-300 was rejected in February of 2010 due to adverse food effects. However, Intelgynx management is confident the FDA will be satisfied with a simple label restriction. Will this restriction be enough to get past the FDA? This question will remain for another two weeks.

Intelgynx's share price has been holding up relatively well. Also, volume has substantially increased since mid May, as the company has gained the attention more traders. Recently the share price has found a strong floor at $0.50. We should be seeing the share price slowly climb higher, because speculative biotech traders are expecting an approval this time around. Plus, an approval would put Intelgynx on the buy block for major healthcare firms. With that said, these expectations ride on the back of CPI-300. If another CRL is sent to Intelgynx, expect a debilitating sell-off.

Regeneron (NASDAQ:REGN) will be receiving a decision on the its new wet age-related macular degeneration treatment Eylea (VEGF Trap Eye) on November 18. Eylea requires less dosing than the current treatment, Lucentis, and achieves the same results. Eylea will be dosed every eight weeks after an initial monthly dosing for the first three months. Lucentis is dosed every four weeks.

Eylea faced an FDA Advisory Committee on June 17, and the committee voted unanimously, 10-0, in favor of Eylea. One important note to make is that the Advisory Committee hinted at a future post-approval trial comparing Avastin with Eylea. However, this will not affect the FDA's decision towards Eylea, because Avastin is not approved in the U.S. for wet AMD.

You can read a short synopsis, as well as view the table comparing Eylea and Lucentis, in my June catalysts article.

Ranibizumab

(0.5mg monthly)

VEGF Trap-Eye

(0.5mg monthly)

VEGF Trap-Eye

(2mg monthly)

VEGF Trap-Eye

(2mg every 2 months)

Maintenance of vision* (% patients losing <15 letters) at week 52 versus baseline

VIEW 1

94.4%

95.9%**

95.1%**

95.1%**

VIEW 2

94.4%

96.3%**

95.6%**

95.6%**

Mean improvement in vision* (letters) at 52 weeks versus baseline (p-value versus ranibizumab 0.5mg monthly)***

VIEW 1

8.1

6.9 (NYSE:NS)

10.9 (p<0.01)

7.9 (NS)

VIEW 2

9.4

9.7 (NS)

7.6 (NS)

8.9 (NS)

*Visual acuity was measured as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart

**Statistically non-inferior based on a non-inferiority margin of 10%, using confidence interval approach (95.1% and 95% for VIEW 1 and VIEW 2, respectively)

*** Test for superiority

NS=not statistically significant

Eylea was initially delayed from the original August 20, 2011, PDUFA because Regeneron submitted an amendment to the chemistry, manufacturing, and controls section of the BLA and the FDA treated this amendment as a "major amendment."

It seems like an approval is headed Regeneron's way for two reasons: First, the company developed the drug well and received positive results. Secondly, the wet AMD market needs a second drug that doesn't cost $23,000 per year. I do not believe the FDA should approve drugs just for the sake of having competition on the market, but Eylea clearly reaches the same results as Lucentis with less dosing.

This PDUFA should cause Regeneron's stock to move quite a bit, because some analysts, such as Deutsche Bank's Robyn Kamauskas, are expecting Eylea to take at least 15% of the Lucentis market. Longer-term, investors should take a look at Regeneron, because the company filed for approval in the EU and Japan in June.

The final PDUFA for November is on the 27th. This decision is for one of speculative biotech's most watched companies: Transcept Pharmaceuticals (NASDAQ:TSPT). The FDA will be deciding upon Transcept's insomnia drug Intermezzo. Intermezzo is intended to treat patients who suffer from insomnia who wake up in the middle of the night and cannot fall back asleep. Intermezzo has given investors and traders quite a ride over the past year, and I expect this to continue. Intermezzo has already received two CRLs from the FDA, and the most recent issues were not addressed.

The FDA stated it had:

...concerns that those patients with higher zolpidem blood levels from Intermezzo could be at risk of unacceptable next-day impairment. The FDA further hypothesized that such patients may belong to distinct and identifiable demographic groups.

These problems are difficult to overcome. Another issue the FDA continues to have is the likely chance that patients will dose within four hours of driving, despite the enhanced packaging warnings. If another CRL is sent to Transcept, the only hope to get Intermezzo to market will be to lower the dosage of zolpidem. This may cause new clinical trials, but it will give Intermezzo a fighting chance to make it to market. Nevertheless, Transcept's share price is in for another sharp day. Whether the share price goes up or down, it will be at least 40% either way.

November will be seeing some big biotech trading most of the month. The majority of the companies discussed here are too small to make an impact on the broader market, but will give options traders a stressful month. As you should notice, I am bearish on several of the new treatments above.

[Ed. note: The first version of this article included Teva (NYSE:TEVA) and BioSante's (BPAX) Bio-T-Gel, but the FDA ruling date was changed from Nov. 14 to Feb. 14.]

Source: 5 Pharma Companies With November Catalysts