This Unknown, Phase 3 Smoking Cessation Small-Cap Could Be Worth 5-30x Following FDA Approval

- Smoking and Nicotine Addiction Still a Huge Problem in the U.S. with 480K Preventable Deaths Each Year; Pfizer's Smoking Cessation Drug Chantix has become a Nearly $1 billion Product Annually

- Newly Public Achieve Life Sciences' (ACHV) Drug Cytisine may be an Equally Effective Drug, if not Better, and Phase 3 Studies Should be Complete in Coming 12-18 Months with New Drug Approval Filing After; ACHV is Valued at Paltry $20 Million in Market Capitalization as Few are Aware of the New Listing, and Based on Comparison to Chantix, ACHV Could be Worth 5-30X Based on Even Small Market Penetration if/once Approved. ACHV Could Break Out this Year as Traders Appreciate Importance of Upcoming Phase 3 Data--this is a Top Stock to Know for 2018

One of the most overlooked newly public companies of 2017 could be the biggest winner of 2018 and 2019.

Achieve Life Sciences (ACHV) is developing one of the biggest potential drugs of the next ten years, but few investors have heard of it. Cytisine is a smoking cessation product used for many years in parts of Europe and the rest of the world as an inexpensive alternative to nicotine replacement therapies and drugs like Pfizer's (PFE) Chantix and Champix. Pfizer sold an astonishing $727 MILLION of these two drugs during the first nine months of 2017, on track to become a $1 billion drug in 2018 or 2019 with continued growth.

Achieve's experimental drug cytisine works through the same mechanism of action as Chantix. It has been tested in large studies overseas, both of which proved that the drug works well at reducing nicotine cravings and ultimately improving cigarette abstinence among smokers. The hangup is a lack of well-run studies in the United States, which is why Achieve licensed rights to the drug and is about to begin their own phase 3 studies... it may just be a matter of time before Achieve is launching their own effective and possibly better drug than Chantix in the United States, with hundreds of millions in profit potential.

As investors realize the upside possibilities, ACHV could trade higher by 5X easily to reach a $100 million market value, and successful phase 3 studies could send it higher by hundreds of percent.

A Better Chantix in Cytisine?

Chantix, known chemically as varenicline and as Champix in some parts of the world, is Pfizer's wildly successful smoking cessation drug. When people smoke, nicotine travels to the brain where it attaches to nicotine receptors. Dopamine is released, which feels good, reinforcing the dopamine reward system. This makes the smoker want another cigarette and ultimately creates the nicotine addiction.

Varenicline attaches to the same nicotine receptors in the brain (specifically, the alpha4-beta2 nicotinic acetylcholine receptor) as the nicotine in cigarettes, blocking and activating the receptors so that nicotine cannot. By blocking the ability of nicotine to activate alpha4-beta2 receptors, varenicline prevents the dopaminergic stimulation that is the mechanism for the reinforcement and reward experienced when smoking.

The drug was first approved in 2006 based primarily on two identical 12-week studies showing that twice-daily administration of 1 mg of varenicline increased the rate of abstinence during weeks 9 through 12 (months 3-4) compared to GlaxoSmithKline's (GSK) Zyban and a placebo (44% vs 30% vs 17% in Study 1, and 44% vs 30% vs 18% in Study 2).Patients receiving varenicline were more likely to maintain their abstinence from 1 week after the target quit date through the end of the 12-week treatment compared with those given Zyban or placebo(29% vs 23% vs 12% in Study 1, and 29% vs 21% vs 11% in Study 2).

It's no wonder that Chantix is such a big drug - many smokers want to quit (70%, according to the FDA), and Chantix is improving their odds significantly compared to a placebo (or no treatment) and even other drugs like Zyban.

Achieve's drug cytisine is also a partial alpha4-beta2 agonist, acting on the very same central nervous system target as Chantix. Both are taken orally, but cytisine may in fact have the better drug profile.

Chantix users have been hit with some serious side effects, and the U.S. Food and Drug Administration at one point included a "Black Box Warning" on the drug's label that warned of depression, suicidal ideation, and the risk of suicide attempt. This hasn't particularly dampened demand or need for the drug as demonstrated by ongoing tremendous sales, but the label today still warns of these same serious or clinically significant neuropsychiatric adverse events.

Cytisine has been available in Eastern European countries for more than 40 years as an aid to smoking cessation under the brand name Tabex (sold by Sopharma AD). It has been studied in two successful controlled human trials, but none were designed for registering the drug with the U.S. FDA.

Independent investigators ran two large studies of cytisine in Europe and New Zealand during 2010 to 2014. In the first, called TASC, 740 smokers were randomized to take either cytosine for 25 days, or a placebo. At the end of the study, 8.4% of cytisine patients were abstinent for one entire year, compared to 2.4% of patients taking the placebo. At 6 months, it was 10% versus 3.5% of participants. Both of these were considered statistically significant, with a p-value of less than 0.001.

In the second, called CASCAID, 1,310 smokers in New Zealand who had called the national quit hotline were randomized to receive either cytisine for 25 days or nicotine replacement therapy for 8 weeks. After one month, 40% of cytisine-takers reported continuous abstinence, compared to 31% of those getting nicotine replacement. The benefits held at 6 months, when 22% of those taking cytisine reported smoking abstinence compared to 15% of those using nicotine replacement.

These are both comparable to the results of varenicline, where the drug has about a 40-50% abstinence rate between weeks 9 and 12. A recent systematic review from the United Kingdom National Health Service that included 23 randomized trials and more than 10,000 participants found that varenicline and cytisine are both more effective than placebo for smoking cessation and estimated that cytisine may be more clinically effective and cost-effective than varenicline! Indeed, neuropsychiatric adverse events like those associated with varenicline occurred with less frequency in patients on cysitine, and only about 5% of patients taking cytisine in the previous studies reported sleep disorders or nausea, which are among the most common reported side effects of varenicline.

Achieve now plans to run two phase 3 studies of their own in the United States, with the goal of an FDA approval in 2019 or 2020, based on the yeras of compelling results and experience behind cytisine. These studies will enroll 800 and 1500 patients each and compare a 25-day course of treatment to a placebo. Both studies will measure abstinence from cigarettes at 2 months and again at 6 months, and both arms of each study will allow patients to also receive behavioral support. The studies will be complete in early 2019.This course is much shorter than most people take of varenicline, and the comparison to placebo should mean that the bar for success is very achievable.

What's It Worth? Under-the-Radar ACHV Could Be About to Break Out

With the great data backing cytisine so far and the bar for success in these studies low, ACHV should be set up for a banner 2018 and 2019 as cytisine approachs results from these two studies and a subsequent US FDA approval filing.

Smoking is still a major problem in the United States, even as smoking rates have declined in the last two decades. In a July 2017 press release, the U.S. FDA agency said, "Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year. In addition to the devastating human toll caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society, with direct health care and lost productivity costs totaling nearly $300 billion a year." The need for more, effective smoking cessation products is still huge, but few great drugs exist in the United States.

Chantix is on track to achieve $1 bln in 2017 sales, or very close to it. Cytisine could be the first follow-on drug with a similar mechanism of action and a history of success in patients across the globe. Achieve is the first company to bring this drug to the United States, and with success and approval it should someday compete with Chantix. Although it may never achieve the same $1 billion success, cytisine doesn't have to be a blockbuster drug to make ACHV a strong investment. Peeling off 20% of Pfizer's sales, or about $200 mln, could make ACHV worth $600-$1,000 mln in market value, a 3 to 5X projected peak sales number that is similar to where other drug companies have been acquired in recent history, like Gilead Sciences' (GILD) for Kite Pharmaceuticals (KITE) or Celgene (CELG) for Juno Therapeutics (JUNO).

Achieve isn't without risks, as the company needs to raise a fair amount of money in order to get their two phase 3 studies completed, and as a micro-cap company, that may not be easy. Cytisine has never been studied in studies this large, and there's some risk that the previous results won't be replicated in the United States, with more rigorous controls and more study sites in the trial. Most small-caps never make it, so understand that an investment in ACHV could be worth big upside, or nothing at all.

ACHV Could Be On Fire in 2018 As Studies Begin and Completion Approaches

The public markets haven't completely skipped over the potential in companies that address tobacco smoking or are involved in alternatives. 22nd Century Group (NYSE American: XXII) has appreciated by an amazing 400% in just one year as their low-nicotine cigarettes get increased attention from regulators and other tobacco companies. The medical and recreational marijuana sector has received equal attention as well as regulators turn their eye to this alternative, with companies like Kush Bottles Inc (OTCQB: KSHB) rallying over the last year.

Today, ACHV is completely under the radar as they begin the clinical trial process, but that won't last long, and we expect ACHV to move higher over 2018 and into 2019. With two successful phase 3 studies, potentially, in 2019, ACHV could trade into the hundreds of millions in market value, 5X return or more just to reach $100mln in market capitalization, or a 30X return if the stock were to achieve a $600 mln market cap from today's prices! With their trial completion due in about one year, now's the time to be thinking about ACHV.

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