May 18

The Business Cocktail

Key Humira patent goes down via IPR—but biosims makers shouldn’t celebrate yet

One of AbbVie’s Humira patents bit the dust late Tuesday, marking a win for biosimilars makers. But they still have a long way to go before they’ll really be able to celebrate. The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) handed down a verdict in Coherus BioSciences’ favor, striking down AbbVie’s ‘135 methods patent on its top drug after an inter partes review. Barclays analysts had previously referred to the shield as “one of the cornerstones of the Humira IP estate,” which AbbVie needs to keep intact if it wants to keep copycats away from Humira’s billions in revenue. AbbVie’s ‘619 patent, which is also being challenged through the IPR process, is still several months away from a decision, and all these IPR decisions are subject to appeal. Not only this, AbbVie has already prevailed in the IPR space with a few formulations patents, including some that expire in 2022. With those factors at play, either a biosimilar needs to wait till 2022, or try to work around the upheld patents.

Teva laying off 500 at struggling sterile injectables plant in Hungary

Teva is giving up on its sterile injectables plant in Godollo, Hungary, that halted production last year after the FDA found manufacturing failings. The generics maker is laying off hundreds of workers in the next few months and will sell or close the plant by the end of next year. A Teva spokesperson confirmed reports citing its plans to shed the facility on the outskirts of Budapest. About 500 workers are at risk of losing their jobs as the company winds down production at the site with the intent of selling or closing the plant by the end of 2018. The reduction is part of the company’s global network operations strategy to align production capacity with market and patient demand globally. The announcement comes just weeks after Israeli media reported that the financially struggling and management-challenged drug maker was looking to cut up to 6,000 jobs.

GlaxoSmithKline aims for the whole consumer-health portfolio with $10.3B Novartis JV buyout

By March 2018, GlaxoSmithKline will have the option to buy out Novartis’ stake in the pair’s industry-leading consumer health JV. And it may already be getting prepared. The British drug maker is preparing for an £8 billion ($10.3 billion) offer for its partner’s 36.5% share. Industry watchers say Novartis could use this to help fund a mega takeover—and word is, the potential target is AstraZeneca. The one-two deal punch may seem far-fetched, with Novartis pledging to eschew such enormous mergers. But the GSK consumer JV move lines up with the company’s previous statements, and its new CEO, Emma Walmsley, headed up that venture until her promotion in March. The news follows just a couple of days after one key GSK investor, Neil Woodford, walked away from the stock. Glaxo has said it aims to hang onto the business, and confirmed that strategy on the company’s first-quarter earnings call.

Patheon, built on a series of acquisitions, gets acquired by Thermo Fisher in $7.2B deal

Thermo Fisher Scientific is acquiring Patheon, which has been at the center of the consolidation that has swept through contract manufacturing in recent years, in a deal valued at $7.2 billion. Waltham, Massachusetts-based Thermo Fisher announced late Monday it would pay $35 a share for Patheon, a sum that amounts to about $5.2 billion, and assume another $2 billion in debt for the Durham, North Carolina-based CDMO. Thermo Fisher said it was a logical deal for a company that provides services and equipment to the biopharma industry, and offers it entry into the high-growth contract manufacturing business—a market which it estimated to be worth about $40 billion. Patheon went public only last summer, but had revenues of about $1.9 billion in its last fiscal year, compared to the $18 billion in sales Thermo Fisher racked up in 2016. Thermo Fisher expects the deal to be “immediately and significantly accretive” adding about $0.30 a share to its earnings in the first full year on the books. It also expects to realize about $90 million in cost savings by the third year and $30 million in adjusted operating income benefits.

Johnson & Johnson’s new black-box warning on Invokana

No company in a competitive market wants to land a serious new safety warning. But that’s exactly the position Johnson & Johnson is in with Type 2 diabetes med Invokana. The FDA recently concluded that the SGLT2 drug—along with related combos Invokamet and Invokamet XR—caused an increased risk of leg and foot amputations, and it mandated that J&J update its labels accordingly. Regulators are requiring the New Jersey drug maker to add a black-box warning, the agency’s most serious, to describe the risk. The FDA’s decision follows a MedWatch safety alert from this time last year, which regulators issued after finding that patients in the Invokana arms of J&J’s two cardiovascular outcomes studies for the med were about twice as likely to experience amputations as were those in the placebo groups. J&J’s Janssen unit, for its part, said in a statement that “patient safety is our highest priority” and that it was “working with FDA to include this information in the prescribing information” for Invokana.

 

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