We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Mylan Gets Favorable Ruling Against Biogen's Tecfidera Patent
Read MoreHide Full Article
Shares of Mylan gained 2.25% after it won the district court’s decision against Biogen's (BIIB - Free Report) 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 - Free Report) 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 - Free Report) 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.
In addition to the companies you learned about above, we invite you to learn about 5 cutting-edge stocks that could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of the decade.
Image: Bigstock
Mylan Gets Favorable Ruling Against Biogen's Tecfidera Patent
Shares of Mylan gained 2.25% after it won the district court’s decision against Biogen's (BIIB - Free Report) 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 - Free Report) 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 - Free Report) 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.
5 Stocks to Soar Past the Pandemic:
In addition to the companies you learned about above, we invite you to learn about 5 cutting-edge stocks that could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of the decade.
See the 5 high-tech stocks now>>