Second bump in the road for Arena’s reboot

 Four years after exiting the weight-loss market and selling its obesity drug Belviq to Eisai Arena looks to have rebuilt itself around a pipeline of disparate assets. Yesterday the reboot was set back when the company’s CB2 agonist olorinab failed a phase II trial in abdominal pain due to irritable bowel syndrome. Arena had previously suggested that a 1.5-point placebo-adjusted improvement in pain score in the Captivate study would count as a success; yesterday it gave no data from Captivate, but said there was no statistically significant improvement versus placebo. Abdominal pain is a hallmark of IBS, and there had been hope for the readout given olorinab’s earlier success in a small study in pain associated with Crohn’s disease. Though Arena cited a benefit in a subgroup of Captivate patients with moderate to severe pain at baseline, it accepted that olorinab was now under review for “possible strategic options”, which usually suggests discontinuation. The bad news is that Arena’s lead project, etrasimod, failed in atopic dermatitis last year, and olorinab was supposed to have filled a gap in major catalysts until next year’s phase III etrasimod readout in ulcerative colitis.

Selected Arena pipeline assets
Project	Mechanism	2026e sales ($m)	Use	Detail
Etrasimod	S1P  receptor 1 regulator	950	Atopic dermatitis	Failed ph2 Advise trial
			Crohn's disease	Ph2 Cultivate trial reads out H2 2021
			Ulcerative colitis	Ph3 Elevate trial reads out Q1 2022
Olorinab	CB2 agonist	76	IBD-associated pain	Failed ph2 Captivate trial
Ralinepag	Prostacyclin receptor agonist	50	Pulmonary hypertension	Licensed to United Therapeutics for $800m up front
APD418	Beta 3 adrenoceptor antagonist	–	Heart failure	Said to be in ph1 (no CT.gov entry)
LP352	5-HT2C superagonist	–	Epileptic encephalopathies	Spun out into Longboard Phamacueticals
Source: Arena & EvaluatePharma sellside consensus. https://www.evaluate.com/vantage/articles/news/snippets/second-bump-road-arenas-reboot

Boston Scientific: Buys Surgical Business to Expand Kidney Stone Management

 Boston Scientific Corp. struck a deal to buy the global surgical business of privately held Lumenis Ltd. for a $1.07 billion upfront cash payment in a move to expand its kidney stone management portfolio.

The definitive agreement with an affiliate of Baring Private Equity Asia Ltd., which would retain ownership of Lumenis's global aesthetics and ophthalmology businesses, is subject to closing adjustments, Boston Scientific said Wednesday.

The Lumenis surgical business, with 2021 net sales expected to be about $200 million, includes laser systems, fibers and accessories used for urology and otolaryngology procedures, Boston Scientific said.

The medical-technology company has had a relationship with Israel-based Lumenis for more than 20 years and currently sells the Lumenis urology laser portfolio in the U.S. and Japan through a distribution arrangement. After completing the acquisition, Boston Scientific said it would sell the lasers and fibers, as well as the otolaryngology laser portfolio, to all geographies including high-growth regions such as China.

Boston Scientific said it expects to complete the transaction in the second half of the year, with the impact to its adjusted earnings per share forecast to be immaterial in 2021 but is expected to boost EPS by roughly two cents in 2022 and be increasingly accretive thereafter. Due to amortization expense and acquisition-related net charges, it said the purchase is expected to weigh on earnings this year and then be less dilutive or increasingly accretive thereafter.

https://www.marketscreener.com/quote/stock/BOSTON-SCIENTIFIC-CORPORA-11935/news/Boston-Scientific-nbsp-Buys-Surgical-Business-to-Expand-Kidney-Stone-Management-Portfolio-32592448/

Incyte, Eli Lilly: Baricitinib Meets Main Endpoint in Alopecia Areata Study

 Eli Lilly & Co. and Incyte Corp. on Wednesday said a Phase 3 study evaluating the efficacy and safety of baricitinib met the key goal in the treatment of the autoimmune disorder alopecia areata.

The companies said both the two-milligram and four-milligram once-daily doses in adults with severe alopecia areata met the primary efficacy endpoint at week 36, showing a statistically significant improvement in scalp hair regrowth compared to those on placebo.

There are currently no FDA-approved treatments for alopecia areata, which can cause unpredictable hair loss on the scalp, face and other areas of the body.

Eli Lilly and Incyte said the study marks the first Phase 3 trial with positive results in patients with the disorder, adding that they expect data from an additional Phase 3 study in the first half of the year.

Indianapolis-based Eli Lilly signed an exclusive worldwide license and collaboration agreement with Incyte, a Wilmington, Del., biopharmaceutical company, in late 2009 to develop and commercialize baricitinib and other compounds for inflammatory and autoimmune diseases.

The companies last March received breakthrough-therapy designation from the U.S. Food and Drug Administration for baricitinib for the treatment of alopecia areata.

https://www.marketscreener.com/quote/stock/INCYTE-CORPORATION-9675/news/Incyte-Eli-Lilly-nbsp-Baricitinib-Meets-Main-Endpoint-in-Alopecia-Areata-Study-32592161/

South African scientists say antibodies from variant may offer cross-protection

  Research by South African scientists suggests that antibodies triggered by exposure to the country’s dominant coronavirus variant can prevent infection by other variants, the scientists said on Wednesday.

The findings in laboratory studies offer hope that COVID-19 vaccines based on the 501Y.V2 variant first identified late last year could protect against multiple variants circulating in different parts of the world.

The more contagious variant drove a second wave of infections in South Africa that peaked in January and is believed to have spread to many other countries in Africa and other continents.

“We used plasma ... from people that were infected in this latest wave with the 501Y.V2 and we used it against the first-wave virus, ... what we found is that it could neutralise, OK not as well as it could neutralise itself but it’s not bad at all,” Alex Sigal from the Africa Health Research Institute told a news conference.

Sigal said vaccines designed with the 501Y.V2 variant in mind “might be cross-protective to other variants, ... this gives you some idea how this problem of variants can be solved”.

Penny Moore, a professor at the National Institute for Communicable Diseases, said the antibody response from the 501Y.V2 variant was only reduced threefold against the first-wave virus, whereas the response from the first-wave virus was reduced nine-fold against 501Y.V2.

“It’s not that the antibodies that are triggered by 501Y.V2 are somehow magical, there is a drop-off, ... but unlike the antibodies triggered by the original variant they seem to somehow have a little bit more breadth,” she told the same briefing.

Salim Abdool Karim, a top government adviser on COVID-19, said major vaccine manufacturers including Pfizer, AstraZeneca and Johnson & Johnson were already making vaccines based on the 501Y.V2 variant. Moderna had already adapted its shot and was putting it into human studies, he added.

He predicted that by the end of 2021 most vaccine manufacturers would have adapted their shots, “not because they are specifically worrying about the virus coming from South Africa ... but because key mutations in the 501Y.V2 are actually also present in many other variants”.

Health Minister Zweli Mkhize said the research was encouraging and that genomics surveillance had helped the government respond to the pandemic.

South Africa has recorded by far the most COVID-19 infections and deaths on the African continent, at 1.5 million cases and over 50,000 fatalities to date.

https://www.reuters.com/article/us-health-coronavirus-safrica/south-african-scientists-find-antibodies-from-variant-may-offer-cross-protection-idUSKBN2AV1NI

Telehealth company Ro to offer in-home COVID-19 vaccinations in New York state

 Telehealth company Ro said on Wednesday it was partnering with New York state’s department of health to vaccinate people who can’t leave their homes against COVID-19.

Some elderly, disabled, or otherwise homebound people may face difficulty getting a vaccine that requires them to travel to a mass vaccination site or doctor’s office.

Through the new program, which is initially starting in Yonkers, New York, these patients can make a vaccine appointment online, and a vaccinator will be sent to their home to give them a COVID-19 shot.

Ro said the service was free for the patients and that it would also arrange to cover the transportation costs for the healthcare workers. Uber is partially helping cover these costs through donated free rides, Ro said.

A company spokeswoman said in a pilot version of the program that it recently completed, 90% of patients were non-white, while nearly 60% had incomes lower than $15,000 a year. The average age was 79, she said.

Telehealth companies like Ro have boomed during the pandemic as many patients sought out virtual care for the first time.

Ro began as an online pharmacy selling erectile dysfunction drugs for men, but has since gone on to become a fully fledged telehealth company treating a variety of disorders for men and women.

In 2020, the company acquired Workpath to help it launch in-home care visits for its customers.

In late January, Reuters reported that Ro was exploring a potential deal with a blank-check acquisition company that would value it at more than $4 billion, according to sources familiar with the matter.

The sources said the talks may not lead to a deal and that the company may opt to pursue other options, like another fundraising round.

https://www.reuters.com/article/us-health-coronavirus-vaccines-ro/telehealth-company-ro-to-offer-in-home-covid-19-vaccinations-in-new-york-state-idUSKBN2AV1OU

Confirmation unsure for Biden health secretary nominee Xavier Becerra

 The U.S. Senate Finance Committee deadlocked on Wednesday over President Joe Biden’s nominee to head the Department of Health and Human Services, Xavier Becerra, raising questions about Democrats’ ability to overcome Republican opposition to the California attorney general.

The 14-14 party-line vote sent Becerra’s nomination to Senate Majority Leader Chuck Schumer and Senate Republican leader Mitch McConnell for further action. Under new rules to deal with the 50-50 Senate split between the two parties, either can file a motion to bypass a tied committee and bring matters straight to the Senate floor with a separate procedural vote.

Becerra’s fate will depend on Senate Democrats’ ability to stick together and support him, possibly with a tie-breaking vote by Vice President Kamala Harris.

The Finance Committee in the same session on Wednesday approved two other Biden nominees - Katherine Tai for U.S. Trade Representative and Wally Adeyemo for Deputy Treasury Secretary - by voice votes, indicating no significant opposition.

Two Finance Committee Republicans on Wednesday said they had opposed Becerra because of a lack of past healthcare experience and because of his challenges as California attorney general to HHS authorities to grant religious conscience waivers to Obamacare mandates to provide coverage for contraception.

“His qualifications to be HHS Secretary seem to be minimal beyond suing HHS,” said Senator Bill Cassidy, a Louisiana Republican who is also a physician.

Senator Mike Crapo of Idaho, the top Republican on the panel, said he opposed Becerra because of his challenges on behalf of California to HHS authorities on contraception. But both Crapo and Cassidy said they would work with Becerra to lower healthcare costs if he won confirmation.

On Tuesday, Biden withdrew the name of another nominee, Neera Tanden, to head the Office of Management and Budget. Her nomination ran aground over past divisive social media posts that targeted both Democrats and Republicans.

In Tanden’s case, Democrat Joe Manchin of West Virginia withdrew his support, citing Tanden’s past social media posts criticizing his daughter, the CEO of a health firm. His opposition made it impossible for Democrats to overcome unified Senate Republican opposition to Tanden.

A spokesman for Manchin could not immediately be reached for comment on Becerra’s nomination.

In choosing Becerra, a fellow Democrat and a Latino former congressman, Biden picked an administrator with a long record of supporting the Affordable Care Act, former President Barack Obama’s key domestic policy achievement. Biden has said he wants to improve the ACA, which relies on private insurers, rather than launch a new government-provided healthcare program.

On Tuesday, the Senate confirmed Commerce Secretary Gina Raimondo and White House Council of Economic Advisers Chair Cecilia Rouse, bringing the number of cabinet-level officials confirmed to 12 of 24.

https://www.reuters.com/article/us-usa-biden-nominees/confirmation-unsure-for-biden-health-secretary-nominee-xavier-becerra-idUSKBN2AV25I

Millions of U.S. households would not get COVID-19 payments under new Biden plan

 Millions of U.S. households who received coronavirus-relief payments under President Donald Trump would not get aid under a modified version of President Joe Biden’s $1.9 trillion aid package announced on Wednesday, analysts said.

Under a compromise with centrist Democrats in the Senate, those payments would only go to individuals who earned less than $80,000, or couples who earned less than $160,000.

The income cutoff had been set at $100,000 and $200,000, respectively, under a version of the bill passed by the Democratic-led House of Representatives on Saturday.

That means nearly 9 million fewer households would get direct payments this time around, said Kyle Pomerleau, a tax analyst with the conservative American Enterprise Institute.

The Institute on Taxation and Economic Policy calculated that those payments now would help 11.8 million fewer adults and 4.6 million fewer children than the more generous version that passed the House.

But 200 million adults and 80 million children would still see benefits, the left-leaning think tank estimated.

“For the bottom 60% of Americans, the folks who really need help, there would be basically no difference at all,” ITEP analyst Steve Wamhoff said.

The lower caps would reduce the cost of the massive package by between $13 billion and $20 billion, they said - roughly 1% of the total.

Some 162 million households received payments under the first round of payments included in the CARES Act of 2020, according to the Internal Revenue Service.

The Democratic-controlled Senate expects to open debate on the package as early as Wednesday, with a final vote for passage seen later in the week.

At a total cost of more than $400 billion, the direct aid is one of the largest elements in a sweeping aid package that also pays for vaccines and medical supplies to fight the COVID-19 pandemic, and earmarks hundreds of billions of dollars to help revive the world’s largest economy.

The pandemic has killed more than 515,000 Americans to date and thrown millions out of work.

The bill would provide payments of up to $1,400 per person, including children - a significant jump from the $1,200-per-person payments approved under the CARES Act and the $600-per-person payments Congress approved in December.

As in those earlier aid packages, the payments would be reduced for individuals earning more than $75,000 and couples earning more than $150,000. The compromise announced on Wednesday means the payments are phased out more dramatically.

https://www.reuters.com/article/us-health-coronavirus-usa-payments/millions-of-u-s-households-would-not-get-covid-19-payments-under-new-biden-plan-idUSKCN2AV2RX