It took a while, but the FDA has approved two Jak inhibitors, Pfizer’s Cibinqo and Abbvie’s Rinvoq, in atopic dermatitis. Given the toxicity concerns linked with this class, it is not surprising that Jaks are only recommended for patients who have failed on or cannot take other drugs. But, in a bonus for the developers, the FDA has waved through multiple doses of both products, scotching fears that only low doses would get the nod. The next question is whether the drugs can live up to their sales expectations. At the JP Morgan conference last week Abbvie forecast Rinvoq revenues of over $7.5bn across all indications in 2025, a downgrade from its previous prediction of over $8bn. That group has much more riding on its Jak than Pfizer, which recently dialled down its commitment to the class and focused its entire JP Morgan presentation on mRNA. Although the latest green lights are probably the best that the companies could have hoped for under the circumstances, neither drug looks set to challenge Dupixent’s dominance in atopic dermatitis. Meanwhile, Lilly’s Olumiant, which has had its own worries with side effects, is still awaiting an FDA decision in the disease.
Monday, January 17, 2022
Glaxo is right to hold out for a better offer
As one of the largest consumer health businesses in the world, Glaxosmithkline’s over-the-counter unit was always likely to attract corporate rivals. Therefore the most surprising aspect of this weekend’s news – that Unilever had bid three times for the business – was that interested parties took so long to show their hands. With a value of at least £50bn ($68bn) not many could afford it, of course, and it is far from certain that Unilever will be able to offer sufficient cash to persuade the Glaxo board to veer from its long-stated strategy. The spin-off into a separately listed company, around mid-year, will proceed as planned, Glaxo insists. Many large institutional investors have expressed enthusiasm for holding the new business's shares, and several analysts have declared the offer lowball; the FT reported this weekend that offers in the region of £60bn would warrant more serious consideration. Such a sum would provide Glaxo with serious firepower to rebuild its drugs business, but a trade sale would take many more months to consummate than the spin-off, which has been years in the making and is now just around the corner. Glaxo is right to hold out for an offer it cannot refuse.
https://www.evaluate.com/vantage/articles/news/deals-snippets/glaxo-right-hold-out-better-offer
Groups slam Philip Morris, but the Vectura deal has precedent
Six respiratory health societies have slammed the recent takeover by Philip Morris of the UK drug delivery biotech Vectura, but the move, seeking to prevent tobacco companies from benefiting from such acquisitions, comes somewhat late to the game. Friday’s joint statement bans employees of tobacco-owned companies from featuring data in journals or meetings run by the European Respiratory Society, American Thoracic Society, International Union Against Tuberculosis and Lung Diseases, Asian Pacific Society of Respirology, Asociación Latino Americana De Tórax, and Global Initiative for Asthma. No products of tobacco-owned companies will be promoted at the groups’ future scientific meetings or co-sponsored conferences. This mirrors a similar stance taken by the British Thoracic Society, which last month ran an editorial entitled “Vectura and Philip Morris: the leopard has not changed its spots”. This could discourage moves such as BAT setting up a biotech business, Kbio, to use a plants to develop treatments for rare and infectious diseases. However, tobacco companies like Japan Tobacco have a long history of investing in drug development. Philip Morris itself has held a stake in Medicago, a Canadian player seeking to enter Covid vaccine business, since 2008, and last year bought Fertin Pharma and Oti-Topic too.
| A history of drug development: selected projects with tobacco company involvement | ||||
|---|---|---|---|---|
| Project | Indication | Status | Current owner | Originator |
| Vitekta (elvitegravir) | HIV | Marketed | Gilead Sciences | Japan Tobacco |
| Mekinist | Melanoma | Marketed | Novartis | Japan Tobacco |
| Enaroy (enarodustat) | Chronic kidney disease | Marketed | Torii Pharmaceutical | Japan Tobacco |
| Flutiform | Asthma | Marketed | Philip Morris | Skyepharma |
| Enerzair Breezhaler | Asthma | Marketed | Novartis/Philip Morris | Vectura |
| AirFluSal Forspiro | COPD/asthma | Marketed | Novartis/Philip Morris | Vectura |
| Ultibron Neohaler | COPD | Marketed | Novartis/Philip Morris | Vectura |
| Hualan | Influenza vaccine | Marketed | Hualan Biological Engineering | Medicago (20% owned by Philip Morris) |
| MT-2271 | Influenza vaccine | Filed | Mitsubishi Chemical | Medicago (20% owned by Philip Morris) |
| MT-2766 | Covid vaccine | Filed | Mitsubishi Chemical | Medicago (20% owned by Philip Morris) |
| Dalcetrapib | Hyperlipidaemia | Phase 3 | Dalcor Pharmaceuticals | Japan Tobacco |
| MK-5442 | Osteoporosis | Discontinued | Merck & Co | Japan Tobacco |
| MEDI-570 | Cancer | Discontinued | Astrazeneca | Japan Tobacco |
| Bradanicline | Schizophrenia | Discontinued | Catalyst Biosciences | Targacept (RJ Reynolds spin-out) |
| TC-6987 | Asthma | Discontinued | Catalyst Biosciences | Targacept (RJ Reynolds spin-out) |
| Source: Evaluate Pharma. https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/groups-slam-philip-morris-vectura-deal-has | ||||
Rabbi says security training paid off in Texas synagogue standoff
The Texas rabbi who was held hostage with three other people at his synagogue on Saturday said security courses the congregation participated in helped during the standoff.
Rabbi Charlie Cytron-Walker said in a statement that he and the three congregants are alive because of the security education they received.
He also urged other congregations, religious groups and schools to take part in similar active-shooter and security courses.
“Over the years, my congregation and I have participated in multiple security courses from the Colleyville Police Department, the FBI, the Anti-Defamation League, and the Secure Community Network,” Cytron-Walker said in the statement provided to The Hill through a spokesperson. “We are alive today because of that education.”
The rabbi said the hostage-taker “became increasingly belligerent and threatening” in the last hour of the standoff, adding that without the instruction, the group would not have been prepared to act and flee when the opportunity became available.
Cytron-Walker and the congregants were released from Congregation Beth Israel in Colleyville, Texas after an hours-long standoff that started Saturday morning.
President Biden on Sunday called the incident an “act of terror.”
The FBI identified the gunman on Sunday as a British national named Malik Faisal Akram. The special agent in charge of the FBI’s Dallas Field Office, Matthew DeSarno, said Akram, 44, appeared to be the only one involved in the hostage situation.
On Sunday, however, British police arrested two teenagers in connection with the hostage-taking investigation. Greater Manchester Police wrote on Twitter that the pair of teenagers was in custody for questioning, but authorities did not said if the two had been charged.
The FBI said in a statement late Sunday that the Joint Terrorism Task Force is investigating the hostage situation. The bureau called it “a terrorism-related matter, in which the Jewish community was targeted, and is being investigated by the Joint Terrorism Task Force.”
“We never lose sight of the threat extremists pose to the Jewish community and to other religious, racial, and ethnic groups,” the FBI added.
The bureau’s comments were a departure from remarks made by DeSarno, who on Saturday night said the incident at the synagogue did not have a direct link to the Jewish community.
Cytron-Walker in the statement also said there is "no question that this was a traumatic experience.”
“We appreciate all the love, prayers and support from our local community and throughout the world. We are grateful for the outcome. We are resilient and we will recover,” he added.
Omicron threat seen 'as short term' by business leaders: Commerce Secretary
Omicron, the latest variant of COVID-19, has hit certain sectors of the economy hard, causing labor shortages and child care issues and making some Americans wary again of dining out.
But in a new interview with Yahoo Finance this week, Commerce Secretary Gina Raimondo offered hopeful news from business leaders she's spoken with recently amid all of this uncertainty.
They see [the problem] as short term," said Raimondo, who sat down in Washington, DC for an upcoming episode of Influencers with Andy Serwer. “Folks are beginning to say, ‘It feels like we are peaking, and going to start to come down the other side of the curve.’”
But, she added: “It's anyone's guess how long it will take.”
The Commerce Secretary's contacts aren't alone in this assessment: Schwab Asset Management CEO and CIO Omar Aguilar also projects diminishing omicron impacts on the business community. "We're going to have a very solid and robust earnings season," he told Yahoo Finance on Thursday, though he noted that the variant would have some impact on earnings reports.
A general view of optimism
At least in some regions of the U.S., specifically the Northeast, public health experts also appear to agree that the effects of the Omicron variant will be short term. Cases are starting to slow down in cities like New York and Chicago, where Omicron surged early on. Still, hospitalizations remain at record highs in many cities, straining medical facilities.
"We are teetering on the brink in health care" between increasing patient loads and sick staff at the hospital, Dr. Andre Campbell, a professor and ICU physician San Francisco, told Yahoo Finance Live on Friday. Still, he added, "We think that things will get better."
Around the world, there are reports that the Omicron-fueled COVID wave has shown signs it may pass. In South Africa, health officials recently announced that one of the first provinces to see Omicron “has officially exited the fourth wave in terms of the technical definition of a wave.”
Back in the U.S., Raimondo says that labor shortages are “getting better but still a real issue,” noting that recently changed guidance to quarantine for five days instead of 10 may be helping.
Raimondo has a long list of contacts in the business community since her early career as a venture capitalist and time as governor of Rhode Island, where she developed a reputation as “very high touch.”
Now, as Commerce Secretary, she often checks in with business leaders and reports that there's a general sense of optimism — as long as we don't get another variant.
Data for Omicron-specific shot likely available in March - Moderna CEO
Moderna Inc's vaccine candidate against the Omicron coronavirus variant will enter clinical development in the next few weeks and the company expects to be able to share data with regulators around March, CEO Stephane Bancel said on Monday.
Pfizer announces €520 million investment in France to fight Covid-19
Pfizer will add a production facility for its antiviral COVID-19 pill in France as part of a plan to invest 520 million euros ($594 million) in the country over the next five years, the U.S. drugmaker said on Monday.
The decision is part of Pfizer's strategy to boost global production of the pill, paxlovid, which was found to be nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness resulting from COVID-19, according to clinical trial data.
The investment will initially involve the production of active pharmaceutical ingredient (API) for paxlovid at a plant run by French pharmaceutical group Novasep, Pfizer said, noting that additional Novasep facilities will be added next year.
"Novasep will produce API for use in our manufacturing network, expected to contribute to the overall (global) effort to produce 120 million courses of treatment in 2022," it added.
The drug obtained emergency approval from the U.S. drug regulator in December, and is being assessed for possible authorisation in the European Union.
Pfizer said it expected Novasep's plant in Mourenx, in south-west France, to be incorporated into its global paxlovid supply chain in the third quarter of this year, with production being expanded to include other Novasep facilities in 2023, a spokesman said.
Novasep confirmed the production schedule adding that technical transfer, on-site development and equipment installation activities at the Mourenx plant will begin immediately, with the company planning to recruit more than 40 additional employees there.
Pfizer, which said it was too early to provide projections for the output from Novasep, said other sites around the world were also being used for the manufacturing of paxlovid, including in Ireland and Italy.
Part of the 520 million euros will also go into research in France, including partnerships with biotech firms there, according to Pfizer, which declined to give a breakdown of its investments in research and manufacturing in France.