Biotech week ahead, Jan. 27

Biotech stocks haven’t seen much of a momentum thus far in the new year amid a lack of meaningful catalysts. The bygone week saw two FDA approvals: Horizon Therapeutics PLC’s HZNP 2.83% thyroid eye disorder drug and Epizyme Inc’s EPZM 16.17% tazemetostat for epithelioid sarcoma.
The Wuhan coronavirus scare triggered strong moves in stocks of companies working on treatment/vaccines for the deadly virus.
Here are the key catalysts that could impact trading in biotech stocks in the unfolding week.

Conferences

12th Annual T-cell Lymphoma Forum: Jan. 30–Feb. 1 in San Diego, California

PDUFA Dates

Aimmune Therapeutics Inc AIMT 1.15% has a target action date of end of January for its peanut allergy treatment candidate Palforzia. An Adcom that evaluated the experimental therapy voted 7-to-2 in favor of the efficacy of Palforzia and 8-to-1 in favor of its safety.

Clinical Readouts

Miragen Therapeutics Inc MGEN 42.67% will make a poster presentation of data from the Phase 1 trial of cobomarsen, a miR inhibitor in patients with aggressive HTLV-1 Associated adult T-cell leukemia/lymphoma. The presentation is scheduled for Friday evening.

Earnings

Tuesday

• Pfizer Inc. PFE 2.17% (before the market open)

Wednesday

• Illumina, Inc. ILMN 2.27% (after the market close)
• Varian Medical Systems, Inc. VAR 0.74% (after the market close)
• Hologic, Inc. HOLX 0.19%

Thursday

• Quest Diagnostics Inc DGX 0.13% (before the market open)
• Eli Lilly And Co LLY 1.48% (before the market open)
• Biogen Inc BIIB 2.14% (before the market open)
• Amgen, Inc. AMGN 4.02% (after the market close)
• Edwards Lifesciences Corp EW 0.3% (after the market close)

IPOs

Anpac Bio-Medical Science, which focuses on early cancer screening and detection, has filed to offer 17.50 million shares in an IPO, which is expected to be priced between $14 and $16. The company is seeking to list its shares on the Nasdaq under the ticker symbol “ANPC.”
Arcutis Biotherapeutics, a biotech company developing topical therapies for common skin diseases, proposes to offer 7.8 million shares at a price range of $15-$17. The shares are to be listed on the Nasdaq under the ticker symbol “ARQT.”
Black Diamond Therapeutics, a precision oncology company, is planning an 8.9-million share IPO to be priced between $16 and $18. The company expects to list the shares on the Nasdaq under the ticker symbol “BDTX.”
https://www.benzinga.com/general/biotech/20/01/15181472/the-week-ahead-in-biotech-amgen-eli-lilly-pfizer-in-earnings-mix-ipo-flow-resumes

Coronavirus begins to hit China’s economy

Chinese President Xi Jinping has called the accelerating spread of a new coronavirus “a grave situation” as officials struggle to stop the spread of the disease that has so far infected more than 1,400 people worldwide and killed 42.

Preliminary data has also shown the scale at which the outbreak is affecting the local economy. On the first day of the Lunar New Year there was a 41.6% decline Y/Y in civil air travel, 41.5% reduction in rail travel and 25% drop in road transport.

Shanghai Disneyland has locked their doors, Starbucks (NASDAQ:SBUX) said it would shut all its outlets in Hubei province, while Marriott (NASDAQ:MAR), Hilton Worldwide (NYSE:HLT) and Hyatt Hotels (NYSE:H) are waiving cancellation fees.

Separately, Honeywell (NYSE:HON) and 3M (NYSE:MMM) are boosting production of protective face and respirator masks, while DuPont (NYSE:DD) is working to increase supply of medical body suits and other protective gear.

ETFs: FXI, KWEB, CQQQ, ASHR, YINN, TDF, MCHI, EWH, KBA, CAF, YANG, GXC, TAO, CYB, CHIX

https://seekingalpha.com/news/3534523-coronavirus-begins-to-hit-chinas-economy

Bayer gets Japanese approval for prostate cancer drug Nubeqa

Bayer and Orion’s prostate cancer drug Nubeqa (darolutamide) is gaining steam in its battle against rivals from J&J and Pfizer/Astellas as Japan becomes the latest country to approve the drug.
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorisation to Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC).
In Japan, over 89,000 men are estimated to be diagnosed with prostate cancer annually, making it the second most-common cancer diagnosis in Japanese men (after stomach cancer).
The drug was approved by the FDA in July last year. With darolutamide, Bayer is hoping to take market share from J&J’s Erleada (apalutamide) and Pfizer/Astellas’ Xtandi (enzalutamide), which have become standard therapies at several different stages of the disease.
Bayer and Orion think that their drug may have a safety advantage over competitors and is tipped to break through the billion-euro annual sales barrier.
Analysts agree that the side effect profile is favourable based on trial data so far, but efficacy is comparable and this may not be enough to win over prescribers looking for an improvement on the rivals, which have only recently been approved in this use.
The Japanese approval, like the US greenlight, is based on data from the phase 3 ARAMIS trial in men with non-metastatic castration-resistant disease, which showed a statistically significant improvement in metastasis-free survival for darolutamide plus androgen deprivation therapy (ADT).
In ARAMIS, 1,509 patients were randomised in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.
The trial showed that Nubeqa plus androgen deprivation therapy (ADT) demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT group.
J&J’s Erleada was first to market in this indication, approved in February last year after data in the SPARTAN trial showing MFS of 40.5 months, compared with 16.2 months in patients taking placebo.
Pfizer/Astellas’ rival Xtandi was approved in the same indication shortly after – in the PROSPER trial MFS was 36.6 months for those treated with Xtandi plus ADT, compared with 14.7 months in those treated with placebo and ADT.
Bayer is also developing darolutamide in metastatic hormone-sensitive prostate cancer, where the phase 3 prostate cancer trial ARASENS is testing its safety and efficacy.

Bayer gets Japanese approval for prostate cancer drug Nubeqa

Third US case of coronavirus confirmed in California

California is now home to the third US case of the deadly coronavirus, officials there revealed early Sunday, joining Chicago and the Seattle, Wash. area, where the first cases were announced last week.
The news was announced as health officials in China said that the virus’ ability to spread was stronger than earlier thought.
That’s because unlike with SARS, the coronavirus is infectious during its one-to-14-day incubation period, China’s National Health Commissioner, Ma Xiaowei, said at a Sunday press conference, Reuters reported.
News of the California case was announced by officials with the Orange County Health Care Agency.
“The OC Health Care Agency’s (HCA) Communicable Disease Control Division received confirmation from the Centers for Disease Control and Prevention (CDC) this evening that an Orange County, California case has tested positive for the novel coronavirus,” the agency said in a tweeted release.
The patient, whose identity was kept private, was described as a traveler from Wuhan, China — the outbreak’s epicenter.
The patient had reached out to the agency prior to being diagnosed, and “was provided guidance in order to reduce exposure to the public while awaiting laboratory confirmation from the CDC,” the release said.
“The individual has now been transported to a local hospital and is in isolation in good condition.” Persons the patient had close contact with are being monitored.
No additional details were released.
Worldwide, an estimated 2,000 people, almost all of them in China, have been sickened by the virus, Reuters reported.
China’s National Health Commission said Sunday that 56 people, all in China, have been killed by the disease.
Isolated cases have been reported throughout Asia, and in France and Australia.
The first case in Canada was reported Saturday night, Reuters reported.
The CDC advises that while there is as yet no vaccine, all viruses can be prevented by washing one’s hands, especially before eating, and by avoiding touching one’s eyes, nose and mouth with unwashed hands, or close contact with people who are sick.
https://nypost.com/2020/01/26/california-now-home-to-third-us-case-of-coronavirus/

Big pharma joins hunt for coronavirus vaccine as outbreak escalates

Big pharma has joined the hunt for a vaccine for the deadly coronavirus outbreak that is beginning to spread around the world from its origins in China.
As the number of confirmed cases globally increased to 800, and the death toll reached 26 people, Paul Stoffels, chief scientific officer at Johnson & Johnson, said the company’s scientists had already begun working on a potential vaccine.
In the UK, 14 people have been tested and none have been positive, although the experts predict it will reach the country.
Stoffels told the BBC Radio 4’s Today news and current affairs radio programme that J&J’s scientists have already done “basic work” on a vaccine.
Any vaccine is at least a year away said Stoffels, although this is a vast improvement on development time seen for the Ebola virus, which took several years to produce.
Stoffels told the BBC: “The sequence of the virus, the genetic material, has been available for a few weeks. Most of the laboratories in the pharmaceutical industry are able to work from that information to construct vaccines.
“As an industry we are just people and we feel about the world and use our capabilities to make a difference. The lab technicians and scientists without me asking told me today they advanced the first version of a vaccine in the laboratory.
“There is so much technology now that you can do this very fast. That will take several months before the product will be able to be tested in the clinic.”
Meanwhile, the Coalition for Epidemic Preparedness Innovations (CEPI), said it had begun three programmes to develop vaccines against the new virus strain, dubbed nCoV-2019.
The vaccine development efforts will build on existing partnerships with US biotech Inovio and The University of Brisbane in Australia.
A public-private partnership launched at Davos in 2017, CEPI is already working with Inovio on a DNA vaccine candidate against Middle East Respiratory Syndrome (MERS), and is looking at “molecular clamp” vaccines with the university that could work against several different viruses.
Moderna has agreed to manufacture an mRNA vaccine against 2019-nCoV, which will be funded by CEPI.
The Vaccine Research Center, part of the US National Institute of Allergy and Infectious Diseases (NIAID), worked with Moderna to design the vaccine.
NIAID, part of the US-government funded National Institutes of Health, will conduct pre-clinical studies and a US-based phase 1 clinical study.

Big pharma joins hunt for coronavirus vaccine as outbreak escalates

Scientist who simulated virus global impact: ‘Cat’s already out of the bag’

‘Probably, the cat’s already out of the bag.’

Eric Toner, M.D.

Scientist and scholar Eric Toner, quoted above in an excerpt from a Friday interview with the business-news channel CNBC, explained that China’s efforts to contain the current outbreak of a fast-moving upper-respiratory illness are “unlikely to be effective.”
The comments come as the Centers for Disease Control and Prevention confirmed a second case of coronavirus in the U.S.
Cases of the illness, which is related to SARS, or severe acute respiratory syndrome, have now turned up in a number of countries beyond China, where the illness originated in Wuhan City.
The number of infections has risen to 1,300, according to the Wall Street Journal. On top of that, the official death toll has risen to at least 42, including a doctor treating flu-stricken patients in Wuhan, from 26 yesterday. The Journal also reported that the outbreak was overwhelming China’s local-area resources and hospitals.
Beijing has shut down parts of the Great Wall, as well as more than a dozen cities, restricting movement of some 46 million people, and canceling events related to the Lunar New Year, one of the busiest periods of travel and consumerism in the country.
The Journal on Saturday, citing people described as familiar with the situation, reported that a charter flight was being arranged by the U.S. government to evacuate U.S. citizens and diplomats from Wuhan.

CNBC reported that Hong Kong leader Carrie Lam has declared a virus emergency in the city of 7.3 million, extending school cancellations until Feb. 17 and barring visits to China.
Toner, an M.D. and researcher at the Johns Hopkins Center for Health Security, took part in a simulation, undertaken in partnership with the World Economic Forum and the Bill & Melinda Gates Foundation, that posited such a disease could kill 65 million people within 18 months under the right circumstances.
Coronaviruses, with SARS among that group, are infections of the respiratory tract that can lead to illnesses like pneumonia or the common cold.
Toner told Business insider during an interview that he hasn’t completed research on the current strain of the Wuhan coronavirus, known as 2019-nCoV, but said that the death toll could run in the millions if the influenza were resistant to modern vaccines and was as easy to catch as the common flu.

To be sure, an outbreak of SARS about 17 years ago claimed nearly 800 lives and infected more than 8,000 people worldwide. However, the death toll from that 2002-03 disease was nowhere near a million.
To put things into further perspective, the most virulent pandemic, the 1918 influenza, also known as the Spanish flu, killed an estimated 20 million to 50 million people.
Toner said that his coronavirus simulation “was not [focused primarily on] the number of deaths; it was to point out that there could be societal and economic consequences from a severe pandemic, not just health consequences.” The simulation was also geared toward engendering international cooperation, making the case that governments and private companies alone can’t adequately respond to a pandemic.
One report estimates that a pandemic could cause an average annual economic loss of 0.7% of global GDP — or $570 billion.
Meanwhile, the World Health Organization on Thursday wasn’t sounding global alarm bells about the illness either, declaring the coronavirus an emergency in China but falling short of calling the outbreak an international emergency. U.S. health officials also have said that the risk domestically from the illness is low.

However, the coronavirus was exacting a toll on the U.S. stock market. The Dow Jones Industrial Average DJIA, -0.58% on Friday lost 170 points, or 0.58%, closing just beneath 28,990 after having slipped as low as 28,843 in afternoon trading. Meanwhile, the S&P 500 SPX, -0.90% fell 30 points, or 0.9%, to 3,295. The Nasdaq Composite Index COMP, -0.93% declined by 87 points, or 0.93%, to finish the week at 9,315, after touching am intraday record high in early action.
Toner said the WHO may have made a mistake by not declaring 2019-nCoV an international emergency.

https://www.marketwatch.com/story/scientist-who-simulated-the-global-impact-of-a-coronavirus-outbreak-says-the-cats-already-out-of-the-bag-and-chinas-efforts-to-contain-the-disease-unlikely-to-be-effective-2020-01-24

HHS: Calif.’s Abortion Coverage Mandate Violates Federal Law

The Department of Health and Human Services (HHS) sent California a letter saying that the state’s mandatory abortion coverage rule for insurers violates federal law and could result in federal funding for the state being withdrawn, the department announced Friday.
Roger Severino, director of HHS’s Office for Civil Rights, said Friday morning on a phone call with reporters that his office was also looking at other states for possible violation of the Weldon Amendment, which bars federal agencies from making grants to entities that discriminate against healthcare providers who don’t provide abortions. “We are aware of complaints with respect to other states and can’t comment on any potential or active investigations but we’re sending the message that if any state does what California has done would be likewise found to be in violation.”

Although Severino did not name specific states, three states require all private health plans to cover abortion with no copays, according to the Guttmacher Institute, a pro-choice organization that tracks abortion laws: Oregon, New York, and Illinois. Washington and Maine require private plans that cover prenatal care to also cover abortion. State laws covering insurance-related issues apply only to fully-insured health plans, not the “self-insured” plans offered by most large employers.
Issue Surfaced 6 Years Ago
In August 2014, California’s Department of Managed Health Care sent letters to seven health plans — Aetna, United Healthcare, Blue Shield of California, GEMCare, Anthem Blue Cross, Health Net, and Kaiser Permanente — informing them that “the Knox-Keene Health Care Service Plan Act of 1975 requires the provision of basic healthcare services and the California Constitution prohibits health plans from discriminating against women who choose to terminate a pregnancy. Thus, all health plans must treat maternity services and legal abortion neutrally” and must provide coverage for abortions. “As a result of this action, 28,000 people lost their plans that don’t cover abortion,” Severino said.
HHS received complaints about the coverage mandate from two California religious organizations, Severino said: the Missionary Guadalupanas of the Holy Spirit, a Catholic order of religious sisters; and Skyline Wesleyan Church, a non-profit Christian church. “This is a redux of the promises made under Obamacare: ‘If you like your plan, you can keep it,'” Severino said. “That’s not the case here,” since people who had previously “enjoyed abortion-free plans” had to either get another plan or drop out of insurance coverage altogether, he added. “That’s not only wrong, but it’s against the law.”
California has 30 days to come into compliance with the law, he added. “This is the second time California violated [the] Weldon amendment; now they’re repeat offenders.” Severino was referring to a 2018 Supreme Court case known as National Institute of Family and Life Advocates v. Becerra. The case involved a state requirement that crisis pregnancy centers, which offer pregnant women support services as an alternative to abortion, have to post a notice advertising that the state provides free and low-cost access to reproductive healthcare, including abortion. The Supreme Court sided with the crisis pregnancy centers, ruling that they didn’t have to post such a notice.

“Conscience laws have been left dormant and ignored by previous administrations for far too long, and violators will be held accountable,” said Severino. “If California wants to provide abortion services, they can do so. What the state is not free to do is force people to pay for other peoples’ abortions and force private employers to pay for coverage of other peoples’ abortions, and to force parents to pay for coverage for abortion for their children. That a state cannot do while receiving federal funds.”
Governor Weighs In
California Gov. Gavin Newsom (D) criticized the administration’s move. “Despite a federal opinion four years ago confirming California’s compliance with the Weldon Amendment, the Trump administration would rather rile up its base to score cheap political points and risk access to care for millions than do what’s right,” Newsom said in a statement. “California will continue to protect a woman’s right to choose, and we won’t back down from defending reproductive freedom for everybody — full stop.”
Groups on both sides of the issue also weighed in. “Today’s announcement is just the latest move in the administration’s unending effort to take away access to reproductive healthcare, including abortion, and ultimately to control women’s bodily autonomy,” Jamille Fields Allsbrook, director of women’s health and rights at the Center for American Progress, a left-leaning think tank here, said in a statement. “This rollback comes days after the Trump administration took the unprecedented step toward allowing Texas to use federal funds to discriminate against trusted family planning providers — including but not limited to Planned Parenthood — undermining patients’ access to sexual and reproductive healthcare.”
Allsbrook also criticized the Trump administration’s recently finalized rule requiring insurers on the Affordable Care Act’s health insurance exchanges who provide abortion coverage to issue separate bills for that coverage to their enrollees. “These three actions are among many this administration has taken over the course of the past 3 years to target reproductive healthcare,” she said.

Conservative Group Responds
In contrast, the Alliance Defending Freedom — a conservative legal organization — praised the move. “We commend the Trump administration and HHS’s Office for Civil Rights for investigating and taking corrective action against the state of California for its flawed policies, persistent violation of federal law, and its willful disregard for the civil rights and conscience rights of its citizens,” Alliance legal counsel Denise Harle said in a statement. “No one should force a church or any other employer to participate in funding abortion.”
The HHS action came on the same day as the annual March for Life here, organized each year by anti-abortion groups on or near the anniversary of Roe v. Wade, the 1973 Supreme Court decision legalizing abortion. President Trump appeared at the march, saying, “It is my profound honor to be the first president in history to attend the March for Life!” Previous presidents sent remarks on video to the march.
“Unborn children have never had a stronger defender in the White House,” Trump said. “Young people are the heart of the March for Life – and it is your generation that is making America a pro-family, pro-life nation!”
https://www.medpagetoday.com/obgyn/pregnancy/84528