Company Spotlight: Flexion Therapeutics

(RTTNews) - Shares of Flexion Therapeutics Inc. (FLXN) are up 40% so far this year, well ahead of the iShares NASDAQ Biotech Index ETF (IBB), which has returned only 25% during the same period.

Flexion Therapeutics is focused on developing novel, local therapies for the treatment of patients with osteoarthritis, a type of degenerative arthritis.

In 2015, more than 14 million Americans were diagnosed with osteoarthritis of the knee (OA) and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. According to a report in the Proceedings of the National Academy of Sciences, the prevalence of knee osteoarthritis has more than doubled since 1940, from 6% to 16%.

The product candidate in focus is Zilretta, the first intra-articular, extended-release treatment for patients with OA related knee pain. Zilretta combines Triamcinolone acetonide, or TCA, a commonly administered steroid, with poly lactic-co-glycolic acid, referred to as PLGA, with the goal of providing sustained therapeutic concentrations in the joint and prolong the duration of pain relief in patients with osteoarthritis of the knee.

Zilretta is under FDA review, with a decision expected by October 6, 2017.

Opioids, immediate-release corticosteroid and hyaluronic acid IA injections are the commonly prescribed treatment options for knee pain. But they have many limitations.

Therefore, drugs that deliver quick, significant and lasting analgesic effect having a strong safety profile with low incidence of adverse effects are unmet needs in the treatment of knee osteoarthritis.

According to the Company, Zilretta has the desired characteristics of a treatment for knee osteoarthritis pain. If approved, some analysts expect Zilretta to bring in $500 million to $600 million in peak sales.

In March this year, rumors of a takeover of Flexion by Sanofi (SNY) for $1 billion were doing the rounds, and so long they have remained just rumors.

Shares of Flexion have traded in range of $15.93 to $29.41 over the last 52 weeks. The stock closed Thursday's trading at $26.68, up 3.53%.