Mylan Gets Favorable Ruling Against Biogen's Tecfidera Patent

Shares of Mylan MYL gained 2.25% after it won the district court’s decision against Biogen's BIIB multiple sclerosis (MS) drug Tecfidera’s (dimethyl fumarate) patent.

The U.S. District Court for the Northern District of West Virginia invalidated Biogen's Tecfidera patent, U.S. Patent No. 8,399,514, for lack of written description. The patent claimed methods of treating MS disease using a dose of 480 mg/day of dimethyl fumarate delayed-release capsules.

This win clears the way for Mylan's launch of its dimethyl fumarate product upon the receipt of a potential FDA approval. Otherwise, generics would not have been available until 2028.

Tecfidera delayed-release capsules are used to treat adults with relapsing forms of MS. Mylan believes that it is one of the first companies to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a dimethyl fumarate product and expects to be eligible for 180 days of marketing exclusivity in the United States upon final FDA approval. The company’s ANDA is pending with the FDA.

A tentative approval would be great for Mylan, given the generic’s potential, as Biogen's total IQVIA sales in the United States for the 12 months ending Apr 30, 2020, were approximately $3.78 billion for Tecfidera.

Last week, Mylan and partner Biocon Ltd. obtained FDA approval for the New Drug Application (NDA) for diabetes treatment, Semglee (insulin glargine injection), in vial and pre-filled pen presentations. It has been approved for controlling high blood sugar in adults with type 2 diabetes, and adult and pediatric patients with type 1 diabetes.

Per the companies, Semglee has an identical amino acid sequence to Sanofi's SNY Lantus and is approved for the same indications.

These new approvals broaden Mylan’s portfolio, which comprises Glatiramer Acetate, Yupelri, biosimilars to Neulasta and Herceptin, as well as a drug-device combination product, Wixela Inhub, which is the generic of Advair Diskus.

Earlier, Mylan and partner Lupin obtained European Commission’s (EC) approval for Nepexto, a biosimilar to Enbrel, for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and pediatric plaque psoriasis.

Mylan’s stock has lost 17.6% in the year so far compared with the industry’s decline of 3.4%.

 

Meanwhile, the company’s decision to merge with Upjohn, Pfizer's PFE off-patent branded and generic established medicines business, is also encouraging. In November 2019, Mylan and Pfizer announced the name of the new entity to be Viatris. The merger will be completed in the second half of 2020.

However, the impact of the coronavirus outbreak is most likely to negatively impact the second-quarter results.

Mylan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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