The biggest pharma M&A in years

Shire and Takeda come to terms with a $64B deal

Late Tuesday, after a fifth buyout offer from Takeda, Shire said the Japanese drugmaker had finally landed on a proposal worth recommending to shareholders. It’s a cash-and-stock bid now worth $64 billion or so, about $4 billion more than its first offer.


The deal still has to be approved by both boards and is subject to due diligence. The U.K.’s takeover board, which has strict rules for the timing and disclosure of bids, extended a deadline to give Takeda and Shire until May 8 to wrap it up.

Structured this way, the deal “seems to be much more of a merger,” Bernstein analyst Ronny Gal pointed out in a note to clients. Shire shareholders will receive 50% of the value of the combined company, and the companies will do reciprocal due diligence before any deal closes.


Novartis puts $100 million into malaria R&D

Novartis will spend more than $100 million over five years to develop new treatments for malaria. The funds will support clinical trials for two antimalarial drug candidates, KAF156 and KAE609, which are both in midstage clinical studies. Malaria deaths have dropped by 60% between 2000 and 2015. But the infection continues to kill more than 400,000 people each year. Novartis says it will make the drugs affordable in the countries that need them the most. (See more details on c&en)


Merck’s Keytruda builds its melanoma case against Opdivo with postsurgery trial win

Merck needed a big win in melanoma to help it try to catch up to archrival Bristol-Myers Squibb. And over the weekend, it got one.

At the American Association for Cancer Research annual meeting Sunday, the New Jersey drugmaker rolled out results showing that in postsurgery patients, Keytruda cut the risk of disease recurrence or death—leading to progression-free survival in those patients—by 43% compared with placebo. At the one-year mark, 75.4% of Keytruda patients hadn’t seen their disease return, while just 61% of patients on placebo could say the same. And in those with PD-L1-positive tumors, Keytruda’s benefit was even more pronounced, paring down the recurrence risk by 46%.


Roy Baynes, Merck’s head of global clinical development, in a statement called the data “compelling” and added that they “mark an important advancement for the treatment of resected stage 3 melanoma.”  (cr: FiercePharma)

Manufacturing issues stoke fears of EpiPen shortage in Britain

Manufacturing problems have created a shortage of Mylan’s EpiPens in Britain, forcing the company to ration the devices allergy patients rely on to treat anaphylactic shock.

The company announced it will ration the devices, which contain doses of adrenaline, the Daily Mail reported. A spokesperson for the company told the newspaper the shortage is the result of manufacturing delays at a subsidiary firm owned by Pfizer. Mylan has previously warned of global supply issues with the device.

The spokesperson, who was not named, told the the Daily Mail the company is currently unable to determine “when the supply constraint will be fully resolved.”

Last summer, Mylan came under intense criticism for its repeated price hikes on EpiPen, which had taken the lifesaving injector’s list price up several hundred percent over previous years. As a result of the controversy, Mylan beefed up its patient access program and rolled out a cheaper authorized generic.

India leads increasing antibiotic consumption

India’s total use of antibiotics more than doubled from 2000 to 2015, new research says, making the country the world’s biggest consumer of antibiotics and stoking fears of increasing antibiotic resistance.

When calculated as doses per 1,000 inhabitants per day, global antibiotic consumption rose 39%, with India increasing 63%, China increasing 65%, and Pakistan increasing 21%. In high-income countries, total consumption increased modestly while doses per 1,000 inhabitants per day fell 4%.

“Of particular concern was the rapid increase in the use of last-resort compounds” such as glycylcyclines, oxazolidinones, carbapenems, and polymyxins in all countries, the authors say. “Radical rethinking of policies to reduce consumption is necessary, including major investments in improved hygiene, sanitation, vaccination, and access to diagnostic tools both to prevent unnecessary antibiotic use and to decrease the burden of infectious disease.”

See more details on c&en

Novartis to expand gene therapy pipeline with acquisition of AveXis for $8.7 billion

Novartis plans to acquire the neurological gene therapy firm AveXis for $8.7 billion. The purchase will bolster the Swiss giant’s standing as a big pharma leader in the emerging gene therapy field.

AveXis’s leading drug candidate is its gene therapy to treat infants with spinal muscular atrophy type 1 (SMA1), a devastating genetic disease, sometimes called “floppy baby syndrome,” that causes weak muscles and difficulty breathing. Only 8% of afflicted infants survive to 20 months of age. Those that do rely on ventilation support and will never walk.


China pushes generics over brands with another round of new pharma policies

In a potential threat to foreign drugmakers profiting on innovative drugs, the Chinese government on Tuesday issued a new policy package—including tax breaks—to promote generics.

The package (Chinese) would allow certain qualified generics makers to be designated as high-tech enterprises, a label that comes with a 15% corporate tax rate, compared to 25% for other companies. The policy also makes clear that China considers compulsory patent licensing a bona fide option during public health emergencies or shortages of key drugs.

The government’s health department and recently rebranded drug regulator will compile and actively update a drug list that encourages companies to produce generic versions. That list will include medications for rare diseases, major infectious diseases and pediatric treatments, as well as important drugs that are running scarce.

(cr: FiercePharma)