Biogen to Sell Large-Scale Biologics Plant in Denmark to Fujifilm

Biogen (Nasdaq: BIIB) today announced that it has entered into a share purchase agreement with FUJIFILM Corporation (Fujifilm) under which Fujifilm will acquire the shares of Biogen’s subsidiary, which holds Biogen’s biologics manufacturing operations in Hillerød, Denmark, for up to $890 million in cash, subject to minimum purchase commitment guarantees and other contractual terms. The approximately 800 employees at the Hillerød subsidiary are expected to continue employment under Fujifilm ownership.

As part of the proposed transaction, Biogen also announced today that it will enter into manufacturing services agreements with Fujifilm. Following the completion of the transaction, Fujifilm will use the Hillerød site to produce commercial products for Biogen, such as TYSABRI, as well as other third-party products.

“We continually evaluate our manufacturing strategy and we believe that this agreement serves the best interest of our employees, customers, partners and shareholders,” said Michel Vounatsos, Biogen’s Chief Executive Officer. “As we continue to diversify our portfolio across multiple modalities and bring online our state-of-the-art manufacturing facility in Solothurn, Switzerland, we believe that we have enhanced our manufacturing capabilities and capacity for biologics with this transaction. Fujifilm is a well-respected leader in manufacturing biologic products and they share our pioneering culture.”

“We are proud to combine the talent and expertise of the Hillerød employees with Fujifilm’s capabilities as an industry-leading contract development and manufacturing organization,” said Paul McKenzie, Ph.D., Biogen’s Executive Vice President, Pharmaceutical Operations and Technology. “We will work with Fujifilm with the goal of ensuring a smooth transition and reliable supply for our customers and patients.”

The Hillerød site includes a 90,000L biologics production facility with assembly, labeling and packing capabilities, quality control laboratories and warehouses. The transaction is subject to closing conditions, including customary filings and clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, in the U.S., the Danish Competition Act and the Korean Monopoly Regulation and Fair Trade Act. The closing of the transaction is expected to occur in the second half of 2019.

Following the closing of the transaction, Biogen will operate manufacturing facilities in Research Triangle Park (RTP), North Carolina and Solothurn, Switzerland, which Biogen expects to be operational by the end of 2020.

Biogen expects to record a total after-tax loss in the first quarter of 2019 of approximately $130 million to $150 million, or $0.66 to $0.76 per diluted share, related to the proposed transaction. This loss includes an estimate of $120 million associated with guarantees of future minimum purchase commitments. These estimates are based on current exchange rates and business conditions.

https://www.marketscreener.com/BIOGEN-4853/news/Biogen-Enters-Into-an-Agreement-to-Sell-Its-Large-Scale-Biologics-Manufacturing-Site-in-Hiller-d-28148895/

Oxford BioMedica, Microsoft Link Up on Gene Therapy Manufacturing

Oxford BioMedica PLC said Tuesday that it has entered a research collaboration with Microsoft to use cloud and machine-learning technology to improve gene and cell therapy manufacturing.

The U.K. company said it will work with Microsoft to improve the yield of purity of its lentiviral vectors, while driving down costs.

Lentiviral vectors deliver genetic information to cells and can be used in gene therapy.

Oxford BioMedica provides its lentiviral vectors to Novartis to use in its CAR-T cancer therapy, which was recently approved in the U.K.

https://www.marketscreener.com/OXFORD-BIOMEDICA-PLC-43524070/news/Oxford-BioMedica-to-Work-With-Microsoft-on-Gene-Therapy-Manufacturing-28148992/

Sanders’ ‘Medicare for All’ pushes long-term care benefits

Sen. Bernie Sanders (I-Vt.) is raising the stakes of the “Medicare for All” debate by expanding his proposal to include long-term care, a move that is forcing other Democratic presidential candidates to take a stand on addressing one of the biggest gaps in the U.S. healthcare system.

Medicare for All is unlikely to advance in the GOP-controlled Senate, but it’s a defining issue in the early days of the Democratic primary and candidates have pointed to their support of Sanders’ legislation as proof of their progressive bona fides.

Some moderate Democrats have criticized the cost of such an expansive proposal and by adding the long-term care provision, Sanders could further expose that divide.

So far, 2020 candidates Sens. Cory Booker (D-N.J.), Kirsten Gillibrand (D-N.Y) and Kamala Harris (D-Calif.) say they’ll support Sanders’ more ambitious bill. Sen. Elizabeth Warren (D-Mass.) also backed the 2017 version of Medicare for All but has not said how long-term care might affect that.

Sanders’ move, confirmed by his office, follows action by Medicare for All allies in the House to incorporate a generous long-term care benefit in their newly introduced legislation. Medicare for All would replace the current mix of private and government financing for health care with a system paid for by the government and funded by higher taxes

As with the rest of Medicare for All, supporters aren’t saying how they would pay for long-term care, which experts estimate could cost several hundred billion dollars a year. Several independent estimates for the broader program have ranged from about $25 trillion over 10 years to $36 trillion, although supporters say it would be considerably less.

Still, the general idea of a government long-term care program has broad backing.

About two-thirds of U.S. adults favor a long-term care program similar to Medicare, according to an Associated Press-NORC Center for Public Affairs Research poll last year. That includes 76% of Democrats and 56%of Republicans.

The attention from Sanders as well as House Medicare for All leaders Reps. Pramila Jayapal (D-Wash.) and Debbie Dingell (D-Mich.) comes after advocates for disabled people lobbied them to step up coverage for long-term care in the push for a national healthcare plan.

Many Americans assume that Medicare covers long-term care, but that’s not the case. Qualifying for public coverage under Medicaid, which covers low-income people, involves spending down lifetime savings.

Long-term care has “always been the stepchild,” said Marc Cohen, a gerontology researcher and professor at the University of Massachusetts Boston. Cohen says he thinks the House plan recently introduced by Jayapal and Dingell would be “unaffordable,” but says it recognizes a need. “That is really a positive thing that someone is trying to address it,” he added.

Recent state-level efforts on long-term care have sent mixed signals. Maine voters last year rejected a referendum that would have provided home care to all seniors and disabled people regardless of income. But last month the Washington state House approved a plan creating a limited cash benefit to offset long-term care costs. The measure, sent to the state Senate, is financed with a payroll tax on employees.

Only an estimated 7 million to 8 million people have private long-term care insurance, which is costly and generally requires applicants to pass a health screening.

In Congress, the new House Medicare for All bill from Jayapal and Dingell offers the most generous benefit.

People of any age could qualify if illness, injury or age limit their ability to perform at least one “activity of daily living,” such as bathing or dressing, or one or more “instrumental activities of daily living,” such as managing money or taking prescribed medications. There would be no income or assets tests to qualify, and no copays or deductibles.

The House bill — known as H.R. 1384 — emphasizes home- and community-based care in the “least restrictive setting.” But it would also pay for nursing home care. The earlier version of the House bill included a few mentions of long-term care but did not specify benefits.

“We flip the model on its head,” Jayapal said. “Instead of saying institutional care is the default we say … you should be able to be taken care of at home, in your community.”

In his 2017 bill, Sanders left the current low-income Medicaid coverage for long-term care in place. His office says a new edition to be introduced in coming weeks will include added coverage for home- and community-based services, available to people of any age as Medicare for All benefits. Such services can include adult day care, a housekeeper, or home improvements like grab bars in the shower.

The shift by Sanders and his House counterparts came after intensive lobbying from disability rights advocates. The groups were a central part of the coalition that defeated President Donald Trump’s effort to repeal the Affordable Care Act and restrict federal financing for Medicaid.

The activists realized during that effort that even Medicare for All came up short on the needs of disabled people, said Nicole Jorwic, policy director for The Arc, which serves people with intellectual and developmental disabilities.

“If you don’t include long-term supports and services, it cannot be considered a bill that is for all people because it leaves out huge portions of the population, including people with disabilities and aging Americans,” Jorwic said.

https://www.modernhealthcare.com/politics-policy/sanders-medicare-all-expands-long-term-care-benefits

Zafgen price target lowered to $6 from $18 at Piper Jaffray

Piper Jaffray analyst Edward Tenthoff lowered his price target for Zafgen to $6 from $18 after the company announced the suspension of the planned ZGN-1258 investigational new drug application filing for Prader Willi syndrome after observing preclinical muscle toxicity in rats at four and six months. The analyst believes this IND hold is related to enhanced FDA scrutiny following a fatality caused by discontinued first-gen MetAP2 inhibitor beloranib. He calls the hold “concerning” but reiterates an Overweight rating on Zafgen shares.
https://thefly.com/landingPageNews.php?id=2877535

Care.com announces changes to approving, managing caregiver profiles

Care.com announced “certain changes to its processes for approving and managing individual caregiver profiles in its consumer marketplace.” It said in a regulatory filing, “While the Company will continue to allow newly-enrolling caregivers to prepare applications to jobs and complete their profiles, the Company is updating its practices to no longer release any applications or permit those caregivers to send messages on the platform until the completion of its preliminary screening processes. The Company also disclosed that it closes approximately 10% of caregiver accounts based on results from its preliminary screening processes.” Care.com also announced it is exploring solutions to help verify the identity of care seekers and individual caregivers in its consumer marketplace, as well as potential revisions to its closure notification policies for when it removes an individual’s account. In addition, the company announced changes to its practices related to small and medium-sized business listings on its consumer marketplace. It explains, “Like other digital platforms, the Company had used publicly available data to create directory listings for small and medium-sized businesses that provide childcare services. To enhance the quality and accuracy of the directory, the Company allowed such businesses to claim ownership over the listings the Company had created. Recently, the Company removed all listings that had not been claimed. In addition, the Company has made more prominent its notice to users that it does not verify the credentials or licensing information of businesses listed on its consumer marketplace. In the Company’s 2018 fiscal year, marketing services revenue from small and medium-sized businesses that provide childcare services represented less than 0.5% of the Company’s total revenue.” Finally, Care.com announced the creation of a new board committee whose purpose is to oversee the company’s safety and cybersecurity programs. Shares of Care.com dropped 12.5% Monday to $20.48 after a Wall Street Journal investigation found the company does not verify the credentials of recommended caregivers.
https://thefly.com/landingPageNews.php?id=2877533

2020 President’s Budget for HHS

https://www.hhs.gov/sites/default/files/fy-2020-budget-in-brief.pdf

Eisai, Imbrium Get FDA OK to File for Insomnia Treatment

Eisai Company, Ltd. (CEO: Haruo Naito, “Eisai”) and Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma, L.P. (President and CEO: Craig Landau, MD), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. A Prescription Drug User Fee Act (PDUFA) date is set for December 27, 2019.

https://www.biospace.com/article/releases/eisai-and-imbrium-therapeutics-announce-u-s-fda-filing-acceptance-of-new-drug-application-for-lemborexant-for-the-treatment-of-insomnia/