Finally some good news out of Mylan N.V. (NASDAQ: MYL), which is potentially bringing the shares back to about even for 2017. The pharmaceutical firm announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Abbreviated New Drug Applications (ANDAs) for glatiramer acetate injection, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).
Recently Mylan has been beset by tough earnings and an investigation — ultimately a settlement — over its EpiPen. The stock is down about 14% year to date, excluding Wednesday’s move, and it hit a multiyear low as recently as August that has not been seen since 2013. All this has led to a rocky year, but this FDA approval could be the turning point.
It’s worth pointing out that Mylan’s glatiramer acetate injection is a substitutable generic version of Teva’s Copaxone.
According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate injection containing a Paragraph IV certification. Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity, but the FDA has not made a formal determination on exclusivity at this time.
Copaxone is the most prescribed MS treatment for relapsing forms of MS in the United States, with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending July 31, 2017. Approximately 400,000 individuals in the country have MS, and relapsing MS accounts for 85% of initial MS diagnoses.
Heather Bresch, Mylan CEO, commented:
The FDA approvals of Mylan’s Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL as AP-rated, substitutable generics for Copaxone 20 mg/mL and 40 mg/mL, respectively, mark another significant milestone for our company, reinforce our proven capabilities in bringing complex and difficult-to-manufacture products to market, and further our commitment to providing access to high quality medicines.
Shares of Mylan closed Tuesday at $32.53, with a consensus analyst price target of $40.67 and a 52-week range of $29.39 to $45.87. Following the announcement the stock was up about 14% at $37.20 in early trading indications Wednesday.