Isotechnika Pharma Inc. (IPHAF/ISA.TO) - more than meets the eye

Isotechnika Pharma Inc. (IPHAF/ISA.TO)
Edmonton-based Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. There is a significant unmet medical need in the treatment of both solid organ transplantation and autoimmune disease. It is estimated that the market potential will exceed $4 billion annually in sales for calcineurin inhibitors such as voclosporin by 2010.

Trading Catalyst
PDUFA: Aug. 3, 2010

Isotechnika's partner, Lux biosciences Inc., filed an NDA with the FDA back in February (accepted for review on Mar. 30) for vocloporin (porposed name: LUVENIQ). The drug is indicated for the treatment of non-infectious uveitis involving the posterior segment of the eye, a leading cause of vision loss and long-term disability and the fourth leading cause of legal blindness in the industrialized world. Voclosporin received a priority review status which shortens the review period to within six months from the standard 10-month review. A priority review designation is given by the FDA to drugs that are considered to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. The PDUFA action date for volcloporin is scheduled for Aug. 3, 2010

If the uveitis submissions are approved in the U.S. and Europe, Isotechnika will receive milestone payments of $7.04 million and $3.52 million, respectively, from Lux, as well as royalty payments on sales of the drug. Approval will also make the regulatory path easier in other indications with voclosporin because of the large amount of already submitted safety data.

Recent Development & Price Roller Coaster
The Dermatology and Ophthalmology Drugs Advisory Committee of the FDA was scheduled to review the NDA for voclosporin on June 28, 2010, sending the share price up ~56% during the last 3 weeks in anticipation of the review. Isotechnika, however, announced today that the FDA has canceled the advisory meeting, and this immediately caused the stock to tumble, shedding everything it accumulated before the news and falling back down to $0.24. So what does this mean? It means that there's an opportunity to ride the PDUFA wave - a significant push in share price as a result of heightened interest in the FDA's ruling on a NDA in a short period of time. Seeing the potential of hitting $0.44 (pre-announcement peak), buyers can expect the current beaten down price - $0.24 (due to FDA panel cancellation) to climb back up again in advance to the FDA's final decision on volclosporin approval on Aug. 3, 2010. Being merely 6 weeks away from the key catalyst date, now would be a suitable entry time.


About Voclosporin
Voclosporin is a next generation calcineurin inhibitor, which completed a Phase 2b North American trial for the prevention of kidney rejection following transplantation. Extensions to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis have also been completed. Isotechnika's partner, Lux BioSciences, Inc., has also completed three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LUVENIQ™ by Lux) for the treatment of uveitis. In addition to the uveitis trials, Lux BioSciences, Inc. has also commenced a Phase 1 trial using their proprietary voclosporin ophthalmic solution (LX214) as a candidate for dry eye syndrome.

Amylin (AMLN) shares up 19.93% on Roche (RHHBY) NDA delay

Roche announced Friday that its Phase III clinical trials have been halted due to adverse reactions to diabetes drug candidate Taspoglutide. This will likely push back the drug's timeline to filing for a min. of 12-18 months and thus its future competitiveness given an increasing number of similar GLP-1(glucagon-like-peptide-1)-based therapies including Amylin's (AMLN) and Alkermes' (ALKS) Bydureon (PDUFA: Oct 22, 2010) and Novo Nordisk's (NVO) newly-approved Victoza. Adverse reactions experienced by patients in Roche's late trials include hypersensitivity reactions, stomach pain, heart and respiratory symptoms. Roche's shares were down 2.43% during Friday's trading.


Meanwhile, shares of AMLN and ALKS popped 19.93% and 9.43%, respectively, as investors see Roche's Taspoglutide NDA delay as a sign of security for Bydureon's marketability. The PDUFA date for Bydureon, the once-weekly version of the previously approved diabetes drug (Byetta), is scheduled for Oct 22, 2010.

Vivus Inc. (VVUS) took an unexpected dive today - great entry point?

What happened?


Shares of Vivus experienced an unexpected ~8% loss today after Lazard Ltd's analyst William Tanner downgraded shares of Vivus to "hold" from "buy," citing the risk of an unfavorable panel review taking place on July 15, 2010. The change in opinion arose out of concerns about the potential side effects, such as minor memory impairment and cardiovascular risk, previously linked to topiramate (Topamax) and phentermine, the two constituents of VVUS's weight loss drug candidate. The company has already addressed this issue by quoting results from clinical trials which showed that Qnexa, at low doses, actually improved some risk factors for heart disease, including decreasing blood pressure, bad cholesterol and triglycerides. At higher doses, Qnexa was associated with increased heart rate.

Entry point?
Basically, little has changed since the release of final phase, pivotal trial data which demonstrated a promising outlook for Qnexa and generated lots of excitement in the medical community. The drop in VVUS share price may have simply been a short term reaction to an analyst's opinion. Vivus is still a solid firm with 1 product (MUSE) on the market, 1 in Phase III, and 2 in Phase II development in addition to Qnexa. Besides the opinion of a few, many remain hopeful to see Qnexa become an FDA-approved weight loss medication on pharmacy shelf. The commercialization of Qnexa will contribute to cutting down many risk factors correlated with obesity, and hopefully alleviate the costs of treatment associated cardiovascular diseases/stroke, diabetes, and cancer.


The fall in VVUS shares may represent a discount for investors to ride the surge before the July 15 FDA panel.

Open: 11.37
High: 11.65
Low: 10.84
Close: 10.95
Volume: 11,750,800
Avg vol: 4,414,060

Disclosure: Long VVUS

Vivus Inc. (VVUS) - a short 'weight' to a fat market

VIVUS Inc. (VVUS) is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company's lead product in clinical development, Qnexa, has recently completed phase 3 clinical trials for the treatment of obesity. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes

Catalyst
FDA Advisory Panel Meeting - July 15, 2010
PDUFA Date - October 28, 2010


What is Qnexa?
Qnexa is a once-daily, combination drug (phentermine 15 mg immediate-release + topiramate 92 mg controlled-release) in Phase 3 clinical development for weight loss in obese patients and improving blood sugar control in diabetics. Phentermine is the most widely prescribed prescription weight loss drug which is available in generic forms and has a database of 1.8 million patient years of usage.

Topiramate is better known as Topamax, which has 5.8 million patient years of use and was originally developed as a seizure drug and is also used for the prevention of migraine headaches. While both components of Qnexa will be available in generic forms, topiramate is not indicated for weight loss and the dosages being evaluated in clinical trials would make dosing difficult using the two drugs individually.

Vivus holds composition of matter and method of use patents for Qnexa as a combination treatment for obesity in the unique dosage forms that were investigated in several Phase III pivotal trials last year.

Clinical Trial Results

Stage: Phase III pivotal
Trial name: EQUIP (OB-302), CONQUER (OB-303)
Trial length: 56 weeks
Total # patients: > 3,750 across 93 sites
Summary: The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.

EQUIP
-> Wt loss: 37 lbs (14.7%) and 18 lbs with full-dose Qnexa and low-dose Qnexa, respectively vs. 6 lbs in the placebo group
-> 60% of the full-dose Qnexa patients who completed the study lost at least 10% of their baseline weight
-> 43% of the full-dose Qnexa patients who completed the study lost at least 15% of their baseline weight
-> Patients treated with full-dose Qnexa had significant improvements in blood pressure, triglycerides and cholesterol

CONQUER
-> Wt loss: 30 lbs and 24 lbs with full-dose Qnexa and mid-dose Qnexa,
respectively, vs. 6 lbs in the placebo group
-> Reduction in hemoglobin A1c levels of 0.6% from 7.3% at baseline as
compared to a reduction of 0.1% from 7.4% at baseline for the
placebo patients (p<0.0001) -> 39% of the full-dose Qnexa patients who completed the study lost at
least 15% of their baseline weight

Data extracted from VVUS press release

Shares plunged 8.24% in after-hour trading following QCOR drug approval delay BUT... things may not be all negative

Investors pulled out of Questcor Pharmaceuticals (QCOR) as news around FDA's delay on QCOR's Acthar Gel approval surfaced 5 minutes after regular trading hours ended.



While this may seem like a blow to the chest for those still holding positions (which was strongly recommended against in my earlier post), it may be an opportunity to ride the waves again before the new September PDUFA. Why is this? Well, reading QCOR's press release closely, one is able to discern positive sentiment behind the approval delay, which, according to the agency, was to allow more time for them "to review information regarding labeling and potential post-approval commitments that they solicited from Questcor". Judging from this, it seems like a matter of time before Acthar Gel gets cleared by the FDA, an ultimate hope for young patients, doctors, and stakeholders.

My prediction is that the price will come down from its peak, as already happening after the news on Friday, to around $7-8, at which point it would be a great point of entry for another climb before the September 11 PDUFA. Again, like I suggested before, upon approval, the shares will likely be pushed up to $12-14. Nevertheless, since QCOR only published the FDA's response late Friday afternoon, we will have to gauge the direction as well as the magnitude of QCOR's stock movement and the state of the market as whole in order to make further decisions on the next steps. Hang on tight! We may be in for another fun ride with Questcor!

Questcor Pharma's (QCOR) shares likely to drop on after-market announcement of FDA's extension

Questcor Receives Notification of PDUFA Date Extension to September 11, 2010

UNION CITY, Calif., June 11, 2010 /PRNewswire via COMTEX News Network/ -- Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today announced that it has received notification from the U.S. Food & Drug Administration (FDA) that the PDUFA date for Questcor's supplemental new drug application (sNDA) to approve Acthar for the treatment of infantile spasms (IS) has been extended to September 11, 2010. The FDA extended the PDUFA date in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor. This follows the May 6, 2010 votes by the Advisory Committee to the Division of Peripheral and Central Nervous System Drugs of the FDA which indicated support for approval of this new Acthar indication.

"We look forward to working with the FDA over the next few months in order to finalize these critical elements," said Don M. Bailey, President and CEO of Questcor.

Investors should note that there can be no assurance that the FDA will approve this sNDA by September 11, 2010, or thereafter.

QCOR - last minute tactics

The panic and turbulence reigning the market at the moment has capped the run-up normally preceding a PDUFA action date. In Questcor Pharmaceuticals' case, you can the many spikes from the $10 mark that are rapidly being pulled back. This signifies the uneasiness of investors even with the positive outcome from the FDA's advisory meeting in early May. While the stagnate price lures many buyers to enter at the last minute, hesitant early birds, many of whom already sitting on ~50% gain (those entered ~3 mo. in advance) are reluctant to see their profit deteriorate due to the current market turmoil, and therefore attempt to unload their cargo a little sooner. As a result of the strong opposing forces, QCOR's shares have been seesawing in the week leading up to the June 11 PDUFA.


As we're merely 2 days away from hearing FDA's decision on QCOR's drug, it's going to be fascinating to see how the story unfolds in this unique market environment. I would not hold any position past tomorrow's closing bell, anticipating a robust and rapid sell-off post Friday's announcement regardless of whether or not QCOR sees an approval or a complete response letter.