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Tuesday, June 28, 2022

Walgreens abandons Boots sale after market turmoil

 US pharmacy giant Walgreens has dropped plans to sell Boots, saying buyers were unable to raise enough funds due to instability in financial markets.

Walgreens said it had various offers for the pharmacy business after it put Boots up for sale in January.

But none of the offers adequately reflected the high potential value of the UK pharmacy chain, it said.

The Walgreens Boots Alliance said it would now keep Boots and the No7 beauty brand.

Potential buyers reportedly included Indian billionaire Mukesh Ambani and US buyout firm Apollo Global Management, who made an offer valuing the business at about £5bn.

The Walgreens merger deal for Boots in 2014 valued the firm at about £9bn at the time.

Walgreens said it had moved away from plans to offload Boots after an "unexpected and dramatic change" in the financial markets.

"As a result of market instability severely impacting financing availability, no third party has been able to make an offer that adequately reflects the high potential value of Boots and No7 Beauty Company," it said.

Rosalind Brewer, chief executive of Walgreens Boots Alliance, said: "We have now completed a thorough review of Boots and No7 Beauty Company, with the outcome reflecting rapidly evolving and challenging financial market conditions beyond our control."

"It is an exciting time for these businesses, which are uniquely positioned to continue to capture future opportunities presented by the growing healthcare and beauty markets.

"The board and I remain confident that Boots and No7 Beauty Company hold strong fundamental value, and longer term, we will stay open to all opportunities to maximise shareholder value for these businesses and across our company."

Retail analyst Catherine Shuttleworth said that Walgreens had wanted more for Boots than suitors had been prepared to pay for it.

"Boots needs an awful lot of work," she said.

She said raising the necessary funds to buy it would have been difficult in the current market, and that Boots has a "significant" pensions liability.

One of the main challenges for Boots, she said, is that it is possible to buy equivalent products from competitors such as supermarkets and online shops.

In addition, Boots used to get a lot of "lunchtime trade" from people working in offices in city centres, but now more people were spending time working from home.

The 173-year-old Boots business includes 2,200 UK stores.

In 2020, Walgreens cut 4,000 jobs at Boots and closed some of its shops as the Covid-19 pandemic hit sales.


https://www.bbc.com/news/business-61966202

Graybug Announces Review of Strategic Alternatives

 Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of ocular diseases, today announced that its Board of Directors will conduct a comprehensive review of strategic alternatives focused on maximizing shareholder value.

As part of this process, the Company will explore the potential for an acquisition, company sale, merger, divestiture of assets, private placement of equity securities, or other strategic transactions. As of March 31, 2022, the company’s cash, cash equivalents, and short-term investments totaled $55.3 million. Graybug has retained Piper Sandler Companies to act as its financial advisor to assist with this review process.

https://finance.yahoo.com/news/graybug-announces-review-strategic-alternatives-111500651.html

Prophase, Impact in License Agreement to Produce and Distribute Viral-Fighting Compound

 Impact Biomedical, Inc., a wholly owned subsidiary of DSS, Inc. (NYSE American: DSS), along with its scientific research partner Global Research and Discovery Group Sciences (GRDG), announced today that it signed a license agreement with ProPhase Labs (NASDAQ: PRPH) for Equivir, which has shown potential as a treatment to limit the occurrence of or reduce the risk or severity of viral outbreaks.

The agreement between GRDG and ProPhase comes just prior to the beginning of human clinical trials for Equivir, GRDG announced. GRDG has contracted with ICON plc, the world's leading clinical research organization.


Since 2019 Equivir as a treatment against viral infections has received two U.S. patents and a positive patentability report opening the door for international patent possibilities. The composition is believed to work by potentially blocking the entry of a virus into host cells, which prevents infection and replication in those host cells.

In addition to its potential use for the treatment of infection caused by various serotypes of influenza and Rhinovirus, a common viral infectious agent predominantly associated with the common cold in humans, Equivir is also believed to block the entry of Ebola virus into host cells which can prevent Ebola Virus Disease (EVD) and Ebola Hemorrhagic fever (EHF). These diseases are rare, but severe and often fatal in humans, particularly in sub-Saharan Africa. Ebola has a 90-percent death rate, according to the World Health Organization. Equivir also has possible use in the treatment of infections caused by SARS COV2.

Decibel: Positive Interim Data from Phase 1b Trial of DB-020 in Cisplatin Chemotherapy Patients

  87% of patients who experienced ototoxicity in their placebo-treated ear were protected from ototoxicity in their DB-020-treated ear –

- Data support continued development of DB-020 as a potential therapy to protect against hearing loss in patients receiving cisplatin chemotherapy for cancer –

- Management will review results during a webcast today at 8:00 a.m. EDT -

Decibel management will host a webcast regarding these interim analysis results today, Tuesday, June 28, 2022 at 8:00 a.m. EDT. The live webcast may be accessed online.

A replay of the webcast will be available online in the investor relations section of the Decibel website at www.decibeltx.com and will be archived there for 90 days.

https://finance.yahoo.com/news/decibel-therapeutics-reports-positive-data-110000908.html

UCB lowers 2022 profit expectations

 Generic competition, a complete response letter, a new acquisition and external pressures have created a perfect storm for UCB, leading the company to reduce its profit forecast for 2022.

After previously projecting a profit margin of 26% to 27% and earnings per share of €4.80 to €5.30 this year, UCB has revised those ranges to 21% to 22% and €3.70 to €4, respectively.

Like many companies, UCB is feeling the squeeze of “external headwinds” such as inflation and the war in Ukraine. Novartis’ Sandoz, Teva and Viatris can relate. The companies, and others in the trade group Medicines for Europe recently signed an open letter to the EU’s Health Council and the European Commission asking for health leaders to address spiking costs.

Merck KGaA, for its part, also recently warned of volatility in 2022.

As for UCB, its updated forecast also takes into account the generic competition for anti-epileptic drug Vimpat in the U.S., and expected competition in Europe this September.

Then, there’s the company's recent complete response letter (CRL) for plaque psoriasis prospect bimekizumab. The FDA served UCB the rejection back in May, asking the company to address certain manufacturing concerns before a potential approval. UCB expects to submit a response to the letter by the end of 2022.

Meanwhile, the drug has received marketing authorization in Europe, Japan, and recently Canada and Australia.

It’s not all bad news for UCB. The company closed an acquisition of Zogenix back in March in a deal valued at approximately €1.7 billion, gaining ownership of Fintepla, an oral treatment for Dravet syndrome and lennox-gastaut syndrome.

The new acquisition will be a slight drain on profits in 2022, but will begin to add to earnings next year, the company said.

https://www.fiercepharma.com/pharma/ucb-updates-2022-financial-guidance-citing-external-headwinds

Sanofi: Xenpozyme OKd by European Commission as first and only treatment for ASMD

 The European Commission (EC) has approved Xenpozyme® (olipudase alfa) as the first and only enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. The approval is based on positive data from the ASCEND and ASCEND-Peds clinical trials, in which Xenpozyme showed substantial and clinically relevant improvement in lung function (as measured by diffusing capacity of the lung for carbon monoxide, or DLco) and reduction of spleen and liver volumes, with a well-tolerated safety profile. Given the urgent unmet medical needs of the ASMD community, the European Medicines Agency (EMA) granted Xenpozyme PRIority MEdicines (PRIME) designation. Xenpozyme has also received special breakthrough designations from several other regulatory agencies around the world.

https://finance.yahoo.com/news/press-release-xenpozyme-olipudase-alfa-053000211.html

Biden officials press insurers on free contraception coverage

 Top Biden administration officials met with health insurance industry executives Monday to ensure that their plan members have access to contraceptive services at no cost. 

Health and Human Services Secretary Xavier Becerra and Labor Secretary Marty Walsh met with major health insurance groups and plan sponsors to remind them of the legal obligation under ObamaCare to provide contraceptive coverage for free.

The meeting comes just days after the Supreme Court overturned Roe v. Wade and left states to decide whether abortion is legal. In a concurring opinion, Justice Clarence Thomas called on the Supreme Court to reconsider its landmark 1965 case protecting access to contraceptives.

In all 50 states, the Affordable Care Act (ACA) guarantees coverage of women’s preventive services, including free birth control and contraceptive counseling, for individuals and covered dependents.

In 2020, the law provided 58 million women access to preventive services without cost sharing.

In a statement, Walsh, Becerra and and Treasury Secretary Janet Yellen said they are concerned about complaints that some plans are not following the law and denying coverage in certain instances.

“The departments expect plans and issuers to immediately take steps to ensure that they are complying, and they may take enforcement or other corrective actions as appropriate,” they said.

The ACA requires that insurers cover at least one form of contraception for each method that’s been cleared or approved by the Food and Drug Administration without cost sharing.  

“There have been troubling and persistent reports of noncompliance with these requirements,” Becerra, Yellen and Walsh wrote in a letter to payers ahead of Monday’s meeting.

“It is more important than ever to ensure access to contraceptive coverage without cost sharing, as afforded by the ACA,” they wrote.

In May, the House Oversight and Reform Committee similarly pressed major health insurers and pharmacy benefit managers on their coverage of contraceptives. Chairwoman Carolyn Maloney (D-N.Y.) sent letters to nine companies requesting information on their birth control coverage.

Advocates are concerned Republican legislatures emboldened by the decision overturning Roe could try to outlaw some emergency contraceptives such as Plan B and intrauterine devices, even though they are covered by the law’s mandate.

https://thehill.com/policy/healthcare/3538672-biden-officials-press-insurers-on-free-contraception-coverage/