As its Drug Business Sees Growth in 2019, Lonza Continues to Search for New CEO

Swiss pharma and chemical company Lonza continues to hunt for a new chief executive officer following the abrupt departure of Marc Funk, who resigned from his position eight months after taking over for Richard Ridinger, who helmed the company for seven years.

In November, the company announced that Funk had resigned from his role due to personal reasons. Prior to serving as CEO of the company, Funk was its chief operating officer. When Ridinger announced his intention to retire at the beginning of 2019, Funk was the named successor. Funk remained with the company through the start of the year to support a transition of Lonza’s leadership. Albert Baehny, chairman of the board of directors, is serving as interim CEO.

This morning, Baehny said the company looks forward to the coming challenges of 2020, including the naming of a new CEO. However, in his brief announcement, Baehny did not provide an update or timeline for when a new Group CEO would be named.

Baehny made his comments as the company delivered its full-year financial results, which showed an 11% growth in the company’s pharma business. The company said its Pharma Biotech & Nutrition business achieved double-digit sales growth above its full-year guidance for 2019. The newly expanded segment now includes the nutritional hard capsules business (acquired with Capsugel), as well as a small portfolio of nutritional ingredients and formulation services. The section delivered annual sales of CHF 4.2 billion (about $4.34 billion) all while investing in strategic growth projects.

Some of the 2019 highlights for the division included the acquisition of a sterile drug product fill and finish facility from Novartis. The site became the company’s first for its Drug Product Services (DPS). The site will be the first Lonza DPS facility to cover sterile manufacturing for clinical production and commercial launches, the company said. The new facility will help Lonza Pharma & Biotech build on existing parenteral drug product development and testing capabilities, the company said. Also, the facility will provide its customers with end-to-end service for clinical supply and launch. It will be the first sterile drug product fill and finish facility in Lonza’s network, the company said this morning.

Also, in October, Lonza and Prevail Therapeutics entered into a strategic collaboration focused on the development of the baculovirus/Sf9 expression system for Prevail’s pipeline of gene therapy programs aimed at neurodegenerative diseases. PR001 is an AAV9-based gene therapy is in development for Parkinson’s disease patients with GBA1 mutations and neuronopathic Gaucher disease patients.

But, while Lonza’s Pharma Biotech & Nutrition business grew, the company noted that its Specialty Ingredients business saw a 3.2% decline to CHF 1.7 billion ($1.76 billion).

As it looks forward to this year, Lonza said in 2020, it will “focus on executing its growth projects in another major investment year, completing the carve-out of its Specialty Ingredients segment and reviewing future plans.”

https://www.biospace.com/article/as-its-drug-business-sees-growth-in-2019-lonza-to-continue-hunt-for-new-ceo/

Newly ID’ed T-Cells Have Potential to Become Universal Cancer Therapy

It’s something of the Holy Grail, a kind of immune cell that can attack all types of cancer cells. Researchers at Cardiff University in the UK appear to have discovered just that. They published their research in the journal Nature Immunology.

The researchers essentially identified a new T-cell and its receptor that appears able to search out and kill a broad range of cancer cells, including lung, skin, blood, colon, breast, bone, prostate, ovarian, kidney and cervical cancer cells. It left noncancerous cells alone.

“There’s a chance here to treat every patient,” Andrew Sewell, professor, Division of Infection and Immunity, School of Medicine at Cardiff, told the BBC. “Previously nobody believed this could be possible. It raises the prospect of a ‘one-size-fits-all’ cancer treatment, a single type of T-cell that could be capable of destroying many different types of cancers across the population.”

The T-cell they identified interacts with a cell surface molecule, MR1. MR1 is believed to flag the abnormal metabolism inside a cancer cell.

Immuno-oncology is a rapidly expanding field, leveraging the human immune system to fight the cancer itself. The best-known examples are CAR-T therapies, notably Novartis’ Kymria (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel). These therapies essentially take immune cells from the cancer patient, engineer them to specifically attack the patient’s cancer, then are reinfused back into the patient. They become living therapies, growing in the body to attack the cancer.

They are quite effective in blood cancers but haven’t been proven to be as useful for solid tumors. These types of therapies have also been limited to certain cancers where there is a clear target to engineer the T-cells to identify.

This new discovery has the potential to lead to a “universal” cancer therapy. The idea is the same. The T-cells would be extracted, genetically modified to identify the cancer cells, then injected back into the patient. However, the Cardiff group has only tested this approach in the laboratory animals and on cell cultures. More studies would need to be conducted before it could be tested in humans.

Daniel Davis, researcher at the University of Manchester, who was not involved in the study, told the BBC, “At the moment, this is very basic research and not close to actual medicines for patients. There is no question that it’s a very exciting discovery, both for advancing our basic knowledge about the immune system and for the possibility of future new medicines.”

The Cardiff group leveraged genome-wide CRISPR-Cas9 screening to identify the T-cell receptor by way of the monomorphic MHC class I-related protein, MR1 “while remaining inert to noncancerous cells.”

They tested the work in laboratory mice as well as in human melanoma cells. The research demonstrated that the melanoma patients’ T-cells could be modified to express this new TCR and kill their cancer cells in Petri dishes, but also other patients’ cancer cells. They hope to take the technique into clinical trials by the end of the year.

Sewell told the Irish Times, “We hope this new TCR may provide us with a different route to target and destroy a wide range of cancers in all individuals. Current TCR-based therapies can only be used in a minority of patients with a minority of cancers. Cancer-targeting via MR1-restricted T-cells is an exciting new frontier.”

https://www.biospace.com/article/researchers-id-immune-cell-that-can-attack-almost-all-cancer-cells/

Is Alzheimer’s Type 3 Diabetes? Novo Nordisk is Willing to Find Out

Danish company Novo Nordisk specializes in the diabetes market. The company appears to be making an entry into the Alzheimer’s market, which isn’t as unusual or unexpected as it initially sounds.

It has been postulated for some time that Alzheimer’s disease is related to blood glucose levels and has been dubbed type 3 diabetes. Type 1 is an autoimmune disease, sometimes referred to as insulin-dependent diabetes. Type 2 is typically acquired and appears more related to insulin resistance and is related to obesity.

Back in 2017, Mayo Clinic participated in a multi-institution clinical trial evaluating an insulin nasal spray on Alzheimer’s patients.

“This study has furthered our understanding of the gene that is the strongest genetic risk factor known for Alzheimer’s disease,” said Guojun Bu, a Mayo neuroscientist, at the time. “About 20% of the human population carriers this riskier form of [the gene] APOE, called E4.”

About 50% of Alzheimer’s cases are associated to APOE4 according to the study, which was published in the journal Neuron. And people with type 2 diabetes have a higher risk of Alzheimer’s disease, although the reasons for it are not completely clear. In fact, type 2 diabetes almost doubles the risk of developing Alzheimer’s disease. One possible reason is reduced blood flow to the brain because of damage to blood vessels caused by diabetes.

Now, Novo Nordisk is involved in a clinical trial using the company’s GLP-1 analogue diabetes drug Victoza to evaluate if the drug can improve brain function and cognition in Alzheimer’s patients. It is a Phase IIb clinical trial. In laboratory studies it has been shown to improve Alzheimer’s symptoms and decrease the amount of amyloid plaques in the brain, which are associated with the disease.

In an update on the trial site, it was noted that patients receiving the drug had a perceived change in their symptoms after they stopped taking it. As a result, at the end of the 12-month trial, all patients will be offered the opportunity to join a 12-month open-label extension trial.

Novo Nordisk shares recently popped, and Evaluate Pharma speculates that this was related to the company’s participation in the trial after the Danish newspaper Børsen made the link. They also cited a recent note by analysts at Bernstein titled “Is Alzheimer’s type 3 diabetes?” suggesting a role for GLP-1 drugs.

Despite the evidence, not a lot of clinical trials have been conducted testing the hypothesis. Evaluate Pharma notes, “Correlation does not equal causation, and a skeptical pharma sector has remained on the sidelines. Indeed, it is striking that the number of clinical trials testing the hypothesis can be counted on the fingers of one hand, and none has a corporate pharma company sponsor.”

These include studies by the University of Aarhus, which published data in 2016, the third Military Medical University, whose trial was completed last year but has not published the data yet, the trial mentioned earlier with the Imperial College London and Victoza, one by the Universitaria di Parma, with results expected last year, and an ongoing trial by the National Institute on Aging due in December 2022.

The trial of Victoza by the Imperial College London will enroll 204 patients with mild Alzheimer’s dementia and is a double-blind, placebo-controlled design that will last 12 months. Its primary endpoint is measuring rates of glucose metabolism in the brain. Secondary endpoints will look at various measures of cognition, including Adas, CDR-sum of boxes and ADSC-ADL.

The University of Aarhus study demonstrated that six months of Victoza was linked to an increase in glucose metabolism compared to placebo but was not deemed statistically significant.

https://www.biospace.com/article/novo-nordisk-quietly-enters-the-alzheimer-s-market/

Medicare to cover acupuncture for chronic low back pain

As part of CMS’ efforts to address the opioid crisis, the agency announced Jan. 21 that Medicare will cover acupuncture for people with chronic low back pain.

Under the decision, Medicare will cover up to 12 acupuncture session in 90 days. Medicare will cover an additional eight sessions for patients with chronic back pain who demonstrate improvement.

“We are dedicated to increasing access to alternatives to prescription opioids and believe that covering acupuncture for chronic low back pain is in the best interest of Medicare patients,” CMS Principal Deputy Administrator of Operations and Policy Kimberly Brandt said in a news release. “Over-reliance on opioids for people with chronic pain is one of the factors that led to the crisis, so it is vital that we offer a range of treatment options for our beneficiaries.”

For the purpose of its decision, CMS defined chronic lower back pain as lasting 12 weeks or longer, having no identifiable systemic cause and not associated with surgery or pregnancy.

Read the full decision here.

https://www.beckershospitalreview.com/finance/medicare-to-cover-acupuncture-for-chronic-low-back-pain.html

Progenics Pharma Updates on Reconstituted Board’s Strategic Review

The Board of Directors of Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, issued the following letter to shareholders:

January 21, 2020

To our shareholders:

On behalf of the Board of Directors, we are pleased to provide you with this update on our activities since you elected five new independent directors to the Company’s Board. With your clear mandate, we immediately took action to independently evaluate the business and prospects of Progenics, including the transaction with Lantheus Holdings, Inc. and to ensure that there is no interruption in the execution of the Company’s mission of developing and marketing products that improve outcomes for patients with cancer. We elected David Mims Interim Chief Executive Officer on November 15, 2019.

In recent weeks, the Progenics Board and management team have been conducting two separate reviews in parallel to evaluate the proposed Lantheus transaction as well as Progenics’ business operations and standalone prospects in the event the Lantheus transaction is not consummated.

Lantheus Transaction

Progenics and Lantheus entered into a definitive agreement on October 1, 2019, which is still in effect, under which Lantheus would acquire Progenics in an all-stock transaction. Since the Board’s reconstitution in mid-November, we have worked diligently to independently evaluate the merits and value to the Progenics shareholders of the proposed merger with Lantheus. Specifically, the Progenics Board has:

• Engaged new, independent financial and legal advisors to assist with its evaluation of the proposed merger.
• Worked with Progenics management, the Company’s existing lead financial advisor on the transaction, Jefferies LLC, and the two continuing directors to review the process that led to the Lantheus transaction, including the respective valuations of Progenics and Lantheus and the assumptions underlying those valuations, as well as other alternatives that were considered.
• Engaged in constructive discussions with Lantheus’ management and its financial advisors to review and discuss Lantheus’ business and products, and Lantheus’ view of expected strategic and financial benefits of the combination.
• While the Board continues to review the transaction, Progenics management under the Board’s oversight is engaged with Lantheus in integration planning.

Progenics’ Operations and Outlook

In parallel to the ongoing review of the Lantheus transaction, we are also conducting a thorough assessment, with the assistance of outside advisors, of Progenics’ business, products, operations, prospects and financial performance and condition. This review includes an assessment of each element of Progenics’ business, including its marketed products, each of its product candidates in development and other value creating assets with the goal of maximizing return on invested capital.

As a result of this ongoing review, the Board has already initiated or supported management in the following actions to enhance the commercialization of its pipeline:

• Working with potential new treatment centers to aid them in becoming comfortable dosing AZEDRA and providing reimbursement support prior to patients being identified for treatment; and resulting in dosing patients with AZEDRA at new centers.
• Working to ensure adequate clinical supply of AZEDRA and 1095 at U.S. sites, including the Somerset, NJ, facility.
• Enhancing radiopharmaceutical manufacturing relationships to ensure the Company’s 1095 program is progressing as planned.
• Ensuring that development plans for each product maximizes return on investment.
• Capitalizing on recently announced strong positive results of the Phase 3 CONDOR Trial of PyL™ in prostate cancer and furthering plans for filing and potential for FDA approval of PyL and for PyL’s commercial readiness.
• Capitalizing on the removal of the Centre for Probe Development & Commercialization (“CPDC”) import ban and expediting the initiation of US sites for participation in the 1095 phase 2 clinical trial.
• Reviewing the Company’s financing options as a stand-alone, taking into consideration the timing and magnitude of each option.
• Initiating a search process for a permanent CEO, with the assistance of Korn Ferry, a nationally-recognized search firm, with initial interviews with candidates commencing.

As we work to enhance the long-term interests of all Progenics shareholders, we are committed to transparency for all our stakeholders. These dual strategic reviews are actively ongoing. The entire Board is engaged in the oversight of Progenics and taking necessary steps to ensure the Company is well-positioned to generate value for all shareholders.

Sincerely,

Ann MacDougall, Interim Chair
On Behalf of the Board of Directors

https://www.streetinsider.com/Corporate+News/Progenics+Pharma+%28PGNX%29+Provides+Update+on+Reconstituted+Boards+Ongoing+Strategic+Review/16355686.html

Hospitals advised to prepare for dealing with Wuhan coronavirus

U.S. hospitals should prepare “financially and operationally” to contend with a potentially deadly outbreak of the Wuhan virus that has already killed six people and sickened hundreds more in China, a major accounting firm said Tuesday.

Although the respiratory virus is in its early stages, it has already left a mounting human and economic toll, wrote Matt Wolf, who leads RSM’s healthcare valuation consulting group. On Monday, the Centers for Disease Control and Prevention announced the first domestic case of the virus, technically called 2019 Novel Coronavirus, in a Washington state patient who had recently returned from Wuhan, China. Nearly 300 people have contracted the virus in China.

Wolf compared the outbreak to the deadly Severe Acute Respiratory Syndrome (SARS) virus in 2002 and 2003, which spooked investors and prompted Chinese markets to plunge. He also cited the Ebola virus, which spread through West Africa from 2014 to 2016, killing more than 11,000 people. Ebola also killed 11 people in the U.S.

U.S. hospitals spent more than $360 million preparing for potential Ebola cases, with those designated as frontline centers shouldering more of the costs. In the case of the Wuhan virus, the potential ripple effect is far bigger, Wolf wrote.

“An epidemic in a country like China, where foreign citizens are more likely to travel to the U.S. for leisure, only magnifies the problem,” he said.

At the height of the Ebola epidemic in 2015, more than 2.6 million tourists visited the U.S. from China, compared with slightly more than 500,000 from all of Africa, Wolf said.

Beyond China and the U.S., the Wuhan virus has spread to South Korea, Japan and Thailand, Wolf wrote. The Chinese New Year starts on Jan. 25, which means many people will take time off and travel.

Nashville’s Vanderbilt University Medical Center announced Monday it had changed its electronic prompts so that any patients entering the hospital, emergency department or clinics with a fever or respiratory symptoms will be asked whether they have been to China recently or have had contact with anyone who has. Patients at risk of having the virus will be placed in isolation, said Dr. William Schaffner, professor of infectious diseases and preventive medicine at VUMC and a member of its infection control committee.

“It should offer reassurance to people in the community that we’re aware of the events that are unfolding in China and now elsewhere, including the U.S., and that we’re bringing that sense of prevention and precaution home,” he said.

Schaffner said he would be surprised if other hospitals were not implementing similar protocols.

The CDC first warned medical providers to look out for patients with respiratory symptoms and a history of travel to Wuhan, China. The agency is developing guidance for testing and managing the illness, including at home. The CDC plans to distribute a diagnostic test soon that will speed up detection time. Currently, testing must take place at the CDC.

On Friday, the CDC implemented public health screenings at airports in San Francisco, New York and Los Angeles and plans to add them in Chicago and Atlanta this week.

Originally thought to spread only from animal-to-animal, the CDC says there is growing evidence that limited person-to-person spread is happening as well, similar to how the SARS virus spread.

“It’s unclear how easily this virus is spreading between people,” the agency said.

Given there have been six deaths in China out of hundreds of infections, Schaffner said the Wuhan virus’ mortality rate is so far much lower than that of SARS or Middle East Respiratory Syndrome (MERS), both of which were sometimes as high as 50%. On the other hand, U.S. hospitals will see thousands of flu patients and many deaths from the illness, he said.

“Familiarity, if it doesn’t breed contempt, it sometimes breeds nonchalance,” Schaffner said.

https://www.modernhealthcare.com/providers/hospitals-advised-prepare-dealing-wuhan-coronavirus

Infections Account for 13% of All Cancer Cases

An estimated 13% of all cancer cases in 2018 may be attributable to infections, concludes a new global survey.

This extrapolates to about 2.2 million cancer cases that were diagnosed worldwide, corresponding to an age-standardized incidence rate (ASIR) of 25 cases per 100,000 person-years.

The primary causes were Helicobacter pylori, human papillomavirus (HPV), hepatitis B virus (HBV), and hepatitis C virus (HCV).

Of note, a third of all global cancer cases attributable to infection occurred in China, which accounted for 42% of cancers caused by H pylori and for 69% of those caused by HBV.

“The present work estimates for the first time incidence rates of infection-attributable cancer in 2018 at an individual country level,” write the authors, led by Catherine de Martel, MD, of the Infections and Cancer Epidemiology Group at the International Agency for Research on Cancer, France.

“Our study can help to raise awareness and inform recommendations for action against cancer, which tends to be viewed as a non-communicable disease,” they add.

The findings were published online December 17 in the Lancet Global Health.

A causal association between certain infections and human malignancies is already well established, the authors comment. Previous research by de Martel and her group found that H pylori, HBV, HCV, and HPV were responsible for 1.9 million of 12.7 million cancer cases reported in 2008. Most of these were gastric, hepatic, and cervix uteri cancers.

For the current analysis, the authors used the GLOBOCAN 2018 database of cancer incidence and mortality rates. They estimated the attributable percentages and global incidence for specific cancers that have already been associated with infectious pathogens. The absolute numbers and ASIR were calculated at the country level and were stratified by sex, age group, and country.

Their results showed that H pylori was responsible for 810,000 new cancer cases in 2018 (ASIR, 8.7 cases per 100,000 person-years), primarily underlying noncardia gastric adenocarcinoma. This was followed by HPV, responsible for 690,000 new cases (ASIR, 8.0 cases per 100,000 person-years), primarily causing cervix uteri carcinoma.

HBV contributed to 360,000 new cases (ASIR, 4.1), and HCV was responsible for 160,000 new cases (ASIR, 1.7), both primarily causing hepatocellular carcinoma.

Other infectious agents, including Epstein-Barr virus, human T-cell lymphotropic virus type 1, human herpesvirus type 8 (also known as Kaposi sarcoma herpesvirus), and parasitic infections contributed to the remaining 210,000 new cases.

Variation by Sex and Income

Overall, men and women were equally affected by cancers caused by infections, but the types of pathogens and cancers varied by sex.

There was also considerable variation by geographic region. Eastern Asia had the highest rates of infection, with 37.9 cases per 100,000 person-years, followed closely by sub-Saharan Africa (33.1). Conversely, the lowest number of cases was in northern Europe (13.6) and western Asia (13.8).

China accounted for 780,000 (35%) of the new infection-attributable cases in 2018. Of those, 340,000 were linked to H pylori, and 250,000 to HBV. South Korea also had a very high incidence of cancer caused by H pylori infection (ASIR, 35.2 cases per 100,000 person-years), as did Japan (23.8). There was also a high incidence of cancer cases related to HBV in South Korea (8.6).

Cervix uteri carcinoma accounts for approximately 80% of cancers (n = 570,000 cases) that could be attributed to HPV. Women were the most affected by HPV, accounting for 90% of the 690,000 attributed cases globally. These proportions were highest in the lowest-income countries.

In contrast, the proportions of the other types of HPV-related anogenital cancers, along with head and neck cancers, were higher in high-income countries, with a greater proportion seen in men.

“It should be emphasized that the data we present here are a snapshot of the burden of cancer attributable to infections worldwide in 2018, and comparisons with previous results are not possible because of changes in data sources, notably for cancer incidence estimates, as well as other methodological modifications,” the authors write.

The study was funded by the International Agency for Research on Cancer. The authors report no relevant financial relationships.

Lancet Glob Health. Published online December 17, 2019. Full text

https://www.medscape.com/viewarticle/923982