The week ahead looks to have some exciting choices for investment consideration with many pharmaceuticals trading at 52-week highs, having catalysts looming, or trading in troughs due to recent negative news. Following I present some possibilities for investors who have enough time to monitor their holdings closely for short term trades or even for opening positions for the longer term - willing to hold through the market's ups and downs. The presented stocks have catalysts that may make them worthy of additional research and investment consideration for near term entry.
Amarin Corporation (AMRN) long-time investors enjoyed a phenomenal share price run up to the July 26, 2012 FDA approval of its lead product candidate, Vascepa, to reduce triglyceride (TG) levels in adults with severe (TG greater than or equal to 500mg/dL) hypertriglyceridemia (very high triglycerides). Trading below $2 per share as recently as July of 2010, shares skimmed the $20 share price on July 3, 2011 before dipping back down to the low $6 range in late 2011 -- offering short term investors many opportunities to close their positions and buy back in at lower prices and enjoying the rise back to $15 just before the FDA's approval. Not accompanying the FDA's approval was a key designation, the coveted New Chemical Entity (NCE) designation, giving the company 5 years of marketing exclusivity for Vascepa as opposed to the standard 3 years normally given with no generic competition. Many investors think that this designation is all that stands between the company and a buyout or partnership offer.
In the meantime, Amarin appears to be taking steps toward commercialization on its own with the recent hiring of a sales force. Although the company is taking great strides at improving its value through a growing patent portfolio, investors don't seem impressed with the company still trading well under $9.00, off its 2012 and 2011 highs despite marketing approval for a large indication. The closely watched FDA Orange Book was updated on Friday, January 18th with a "no unexpired exclusivity for this product" status for the promising therapy causing a sell-off in the company's common shares with the stock closing at 8.47, down 7.53% on the day. Current and interested shareholders will likely watch trading activity closely during the week to ascertain if they wish to hold their long positions, add at any dips, or create new long positions in the company. With other clinical trials underway, a manufacturing/marketing partnership announcement a possibility, or a buyout still probable, this week and the remainder of the year could be exciting and volatile for the up-and-coming pharmaceutical.
Cellceutix Corporation (CTIX.OB) has had an exciting month since recent updates on its Phase I dose escalation trial of lead product candidate Kevetrin™ in December. The small molecule cancer drug activates the tumor suppressor protein p53. This reactivation of p53 (cancer cells have a way of inhibiting p53) induces the expressions of p21 and PUMA (p53 up-regulated modulator of apoptosis), inhibiting cancer cell growth and causing tumor cell apoptosis (programmed cell death). With Merck (MRK), Roche (RHHBY.OB), and Sanofi (SNY) each developing therapies utilizing a similar approach, positive and pertinent news from any or each of these companies would likely strongly impact the company's share price. However, the next likely major catalyst for the company will be from the pharmacokinetics study on Kevetrin™, due out any time from the company-sponsored clinical trials at Harvard University's Dana-Farber Cancer Center and Beth Israel Deaconess Medical Center, which initiated in November. Interested investors should also be monitoring the company's press releases in the coming weeks as 1H 2013 results are expected for Kevetrin™ for treating Acute Myelogenous Leukemia (AML) with the trial sponsored by "a leading European university." With Cellceutix trading with a market capitalization of $186 million, much upside is possible in the coming weeks with Kevetrin™ targeting multiple cancer types with about 10 million cancer patients possessing tumors with inactivated p53, according to the company's website. Trading with a still bullish chart with support/resistance seen at $2.00, this week could be a "make or break" week for the company's common stock chart and provide for entry at a dip or at the next leg up.
Supernus Pharmaceuticals (SUPN) investors should be closely monitoring the company's stock chart this week for signs of a possible share price change as a result of tightening of the stock's Bollinger Bands® (termed a Bollinger Band® squeeze). This chart appears to be promising as the company's common shares are trading in the low $7.00 price range despite an exciting 2012 for the company. Last year's accomplishments included a May 1st initial public offering (IPO), a tentative approval for Trokendi XR™ (extended-release topiramate) from the FDA to treat epilepsy and an FDA approval for Oxtellar XR™ (extended-release oxacarbazepine), also an anticonvulsant given to epileptic patients as well as some off-label uses. Shares traded well above the $10 share price between the June 26th Trokendi XR™ tentative approval, through the October 22nd Oxtellar XR™ approval and to an unfavorable November 29th stock offering. The $48 million stock offering was priced at $8.00, an 18.5% discount on that day's close and more than 33% discounted from the $12 share price just two days previously. Shares trended lower after the offering, settling in a tight trading range from $7.00 to $7.39 in the weeks since then.
With an FDA approval behind the company, a mid-2013 final approval ahead for Trokendi XR™ (please see a recent article more fully explaining the likely mid-year approval) and a $48 million dollar offering already out of the way, Supernus could be a solid investment moving forward. On January 14th the company announced the appointment of Mr. Victor Vaughn as senior vice president of sales. Mr. Vaughn was described as having a "proven track record" with a background uniquely fitting for the new position with experience with the Shire sales organization for 13 years with sales reaching more than $1 billion behind epilepsy drug Carbatrol® and ADHD drug Adderall XR®. The company is gearing up for its conversion from a development-phase entity to a marketing-phase entity, an exciting prospect for investors with the current market capitalization at only $180 million.
An emerging development-phase small pharmaceutical could be in the right place at the right time. Intellipharmaceutics International (IPCI) is developing a pipeline of drugs using its Hypermatrix™ technology which can be utilized to take existing immediate release drugs (often taken several times per day) and reformulating the active ingredients to have an extended-release administration schedule, reducing the number of times a drug has to be take to once or twice per 24-hour period. The company hopes to leverage the FDA's 505(2)(B) approval pathway for its clinical development, which takes advantage of using existing FDA approved drugs' safety information and shortening the clinical path to approval, saving both time and money by requiring fewer clinicals. However, as promising and solid as the path forward will likely be utilizing this approach, a recent development helps to catapult another member of the company's pipeline to the forefront for investor consideration.
A January 9th announcement by the FDA could likely have huge ramifications for pharmaceutical companies developing opioid product candidates for the use of pain management. The announcement was of draft guidance on how it may deal with regulatory decisions going forward for companies developing opioid drugs that have abuse-deterrent characteristics. In the announcement, the regulatory agency noted:
"While prescription opioids are an important component of pain management, abuse and misuse of these products have resulted in too many injuries and deaths across the United States," said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse."
Intellipharmaceutics Rexista™ is the company's tamper-resistant formulation of oxycodone hydrochloride, a powerful opioid with $2.5 billion annual sales in the U.S. An extended release formulation of oxycodone hydrochloride, Rexista™'s single dosage bioavailability was determined to be comparable to two dosages of market leader Oxycontin®, demonstrating statistical bioequivalence with the already-marketed product. With bioequivalence determined in early clinicals, Rexista™ has also demonstrated that its abuse-deterrent properties were effective in these clinicals as well. The drug has thus far shown that it can help to stave off abuse by injection when dissolved in multiple solvents and by nasal inhalation when pulverized. Rexista™ is also designed to resist quick release of the active ingredient when consumed with alcohol, a testament to its effectiveness by having oxycodone remain in the extended-release matrix (pill) under multiple conditions.
Intellipharmaceutics common shares have been trading in a fairly tight range of $2.20 to $2.50 since late November's dip to $1.99. Current levels may provide for a solid entry with support at $2.20 and more solid support at $2.00, offering reduced downside risk in the short term. Although the company has a range of products it is developing through its Hypermatrix™ platform, I believe the "sexier" and more appealing catalysts in the short term could come from clinical updates of its Rexista™ product candidate. With a current market capitalization of just $39.5 million, the upside from these levels could be substantial with little downside in the interim likely. On January 10th, the company announced that it had closed its $1.5 million convertible debenture financing. The debentures are not listed on any market and should be construed as non-dilutive. If converted to common shares, they would represent only 2.8% of total shares outstanding. Q3 2012 results released on October 2, 2012 should be reviewed by interested shareholders wanting additional financial information on the company and more information on two abbreviated new drug applications (ANDAs) filed in 2012 (with regulatory decisions likely in 2013). The company is a small capitalization company traded currently on NASDAQ. It is also a development stage company, so interested investors should consider the risks as well as the rewards depending on how events unfold in the very near future.
Disclosure: I am long SUPN. I may initiate a long position in AMRN and/or IPCI over the next 72 hours.