Mylan N.V. (MYL) Wins FDA Approval for First Generic Copaxone; Shares Soar 17%


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Mylan N.V. (NASDAQ:MYL) investors are busy throwing a party today. The reason? The FDA has approved the company’s Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. This is a generic drug version of Teva’s blockbuster multiple sclerosis drug Copaxone. Mylan will begin shipping imminently.

Mylan shares reacted to the news, rising nearly 17% in pre-market trading Wednesday.

Mylan CEO Heather Bresch 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 […] Mylan has invested tens of millions of dollars over many years to bring this important medicine to market. Providing patients, healthcare providers and caregivers with treatment options is very important when it comes to selecting the right therapy for relapsing forms of multiple sclerosis. Our commitment to the MS patient community extends beyond bringing generic versions of these products to market. Mylan also is offering comprehensive patient support services to help patients access therapy as quickly as possible and adhere to a treatment regimen that fits their needs.”

The FDA approved Mylan’s Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection and 20 mg/mL for once-daily injection as therapeutic AP-rated equivalents to Copaxone® 40 mg/mL and Copaxone® 20 mg/mL, respectively, meaning if they are substituted for their branded counterpart they can be expected to have the same clinical effect and safety profile. As part of its ANDAs, Mylan submitted rigorous side-by-side analyses, including characterization data, which demonstrated that Mylan’s Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL have the same active ingredient, dosage form, route of administration and strength as their branded counterpart. Mylan’s Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL are available by prescription only.

According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification. Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination on exclusivity at this time.

On the ratings front, MYL stock has been the subject of a number of recent research reports. In a report released today, Cantor analyst Louise Chen assigned a Hold rating on MYL, with a price target of $34, which represents a slight upside potential from current levels. Separately, BTIG’s Tim Chiang maintained a Buy rating on the stock and has a price target of $45.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Louise Chen and Tim Chiang have a yearly average loss of 8.0% and a return of 10.1% respectively. Chen has a success rate of 43% and is ranked #4567 out of 4691 analysts, while Chiang has a success rate of 49% and is ranked #977.

Overall, 5 research analysts have assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $42.50 which is 31% above where the stock closed yesterday.

Mylan N.V., is a pharmaceutical company which engages in the development, license, manufacture, market and distribution of generic, branded generic and specialty pharmaceutical products.