FDA Grants Moderna/Merck Therapy Breakthrough Status

On 22 February 2023,Moderna and its partner Merck announced that Moderna's MRNA cancer vaccine MRNA-4517/V940 and Merck's Keytruda(R) cancer therapy have been granted breakthrough therapy status by the U.S. Food and Drug Administration.That means the FDA will fast-track its review of the new combination therapy.The Moderna cancer vaccine,when administered with Merck's Keytruda(R) cancer therapy following complete surgical resection,prevented recurrence of advanced melanoma skin cancer (stage III/IV) in 44% of patients in a Phase 2b clinical trial.Preliminary breakthrough designations are given when evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint. The new therapy is given for the adjuvant (prevention of cancer returning) treatment of patients with high-risk melanoma following complete surgical resection (removal).The two companies are to begin a Phase 3 clinical trial of the novel therapy.Moderna and Merck want to investigate the new therapy as an adjuvant treatment for other forms of cancer,including non-small cell lung cancer.* Earlier,the FDA granted breakthrough status to Moderna's MRNA vaccine against respiratory syncitial virus (RSV) which proved highly effective (more than 80%) at preventing RSV in a clinical trial.RSV is a serious threat primarily to children younger than five and older adults.RSV is the leading cause of hospitalization of babies.In the US,it kills an estimated 100-500 children a year and about 14,000 adults a year,but the estimate is suspected to be lowball.* Merck & Co Inc (MRK),Moderna Inc (MRNA)

Merck Expands Oncology Portfolio

On 9 December 2019,New Jersey-based pharma titan Merck announced it is acquiring biopharmaceutical prospect ArCule,Inc. for 20 dollars a share,or about 2.7 billion dollars.ArCule's lead investigational candidate,ARQ 531,is an oral medication in a phase 2 dose expansion study for the treatment of B-cell malignancies (leukemia).
ARQ 531 is a highly selective, reversible inhibitor that,in early clinical trials, demonstrated a manageable safety profile and early signs of anti-tumour activity for the treatment of patients with relapsed or refactory chronic lymphocytic leukemia (CLL) and Richter's Transformation.*
ArQule CEO Paolo Pucci said:
With this agreement,ArQule's pipeline will benefit from Merck's vast capabilities and determined engagement to benefit the patients who we have always strived to serve.*
ArQule's discovery efforts are focused on the identification and development of novel kinase inhibitors, the company noted.iAll four of its drug candidates are in targeted, biomarker-defined patient populations.*
Merck&Co Inc (MRK), ArQule Inc (ARQC)

Profile of Merck's Gardasil Vaccine

Merck and Company's Gardasil(R) vaccine is one of two vaccines that can be given to prevent human papillomavirus,or HPV,a known cause of cancer.HPV is a sexually transmitted virus that infects more than half of sexually active men and women at some point in their lives.HPV can cause cervical cancer in women.Some 12,000 American women get cervical cancer annually;about 4,000 die from it.Worldwide,it is the second leading cause of cancer death among women.HPV is also associated with vaginal and vulvar cancer in women,and anal and oropharyngeal cancer in both men and women.*Gardasil can prevent most cases of cervical cancer if given before exposure to HPV.It can also prevent vagina and vulvar cancer,and anal cancer in both males and females.This 3-dose vaccine is recommended for girls and boys ages 11-12.It is given so young because even one sexual contact can transmit HPV,and response to the vaccine is best at this age.*Gardasil is also recommended for females ages 13-26 and males ages 13-21 who missed or did not complete the vaccination series at ages 11-12.It is also recommended for men through age 26 who have sex with other men or have wealened immune systems from HIV infection,other illnesses or medications.Gardasil may be given to men through age 26 who have not completed the 3-dose series.*Gardasil has been given for about six years now and has been very safe.Some people should not get the vaccine or should wait,such as those with severe allergies to vaccine components;pregnant women;and people who are moderately to severely ill at the scheduled time of vaccination.Your medical professional will assess Gardasil's appropriateness for you.*Research at Penn State Herhsey Medical Center contributed to the development of Gardasil.*Merck and Company Inc(MRK)

Newsletter Publisher:Don't Give Up On Big Pharma

Big pharmaceutical companies are often plagued by patent expirations on major products.That doesn't mean you should stop investing in them,prominent money manager and commentator Alan Lancz(pronounced Lance)points out.A frequent guest on business television,Mr.Lancz likes drugmakers Pfizer and Merck at this time.
Pfizer and Merck offer good dividend yields.As well,while stock analysts focus on their patent expirations,you don't often hear about their acquisitions or drug pipelines,such as Pfizer's acquisition of Wyeth and King Pharmaceuticals.
In the case of medical device maker Hologic,Mr.Lancz feels it's a bit toppy right now,but should be purchased at the buy limit of 17.00 or below.It closed at 17.55 on Thursday.
Hologic develops,manufactures and supplies diagnostics,medical imaging systems and surgical products for women's health needs,such as breast health products and GYN surgical products.
Alan B. Lancz is publisher of The Lancz Letter,a subscription-only newsletter that gives current recommendations and analysis on stocks,bonds,real estate,currencies and other related investment vehicles.
Pfizer(PFE),Merck(MRK),Hologic(HOLX)

From Thousands To Millions:The Jake Gittlen Cancer Research Foundation

The Jake Gittlen Cancer Research Foundation has grown fron raising 2500 dollars to a total well into the millions.Founded by Warren Gittlen as a memorial golf tournament to honor his father,who had died of cancer in 1970,the foundation funds oncology research at Penn State's Hershey Medical Center.It strives to recruit the top 10% of researchers,continuing to derive income from the golf tournament,the largest fund-raising amateur golf tournamnet in the U.S.It also receives funding from corporate sponsors-especially Giant Food Stores,which has donated over 5.4 million dollars over 28 years.Other sponsors include Giant vendors such as PepsiCo,Procter&Gamble,Clorox and Kraft Foods.
The foundation has raised more than 14 million to date.Its funds have been used to develop techniques and materials used in production of HPV vaccines such as Merck's Gardasil,a major preventitive of cervical cancer.This year,Gittlen Cancer Awareness Bracelets may be purchased for 10.00.The colorful beaded bracelets are handmade and show your support for cancer research,and all of the proceeds go to the Jake Gittlen Cancer Research Foundation.The bracelets may be purchased by emailing asgwmg@verizon.net.
Giant Food Stores operates hundreds of supermarkets in the Mid-Atlantic region.It is a brand of Dutch retailer Ahold.
Ahold(AHONY),Merck(MRK)

Health Uncle:Chickenpox Stays In You

If we've ever had chickenpox,we still have the virus in us.What is worse,the virus may come out of its dormant state and give us a potentially painful rash called shingles.Shingles affects people 60 and over.Why that is isn't fully established,though age-related immune system flaws seem to be involved.Shingles is often a blistering rash that lasts up to 30 days.Normally,the pain disappears along with the rash.Sometimes,however,it lingers for an extended period-even for years.
Merck has developed a vaccine,Zostavax,that can prevent shingles.It strengthens the immune system by exposing you to a weakened chickenpox virus.Zostavax isn't foolproof.It may not protect you at all,or only partially protect you from shingles.It is the only vaccine available for the illness,however.People with various medical conditions or in certain situations shouldn't receive the vaccine.If you are 60 or over and had chickenpox,consider consulting a doctor about being vaccinated with Zostavax.

A Thoughtful Group

As I close out the first year of this blog,I would like to thank my small group of committed readers.Knowing you are out there makes this more worthwhile.Some of you are in distant lands.Some of you are financial professionals.All are thoughtful participants in the global economy.Whatever happens in the financial markets,we are all better off for having applied our minds to this subject which affects our daily lives.The best-performing Dow stocks in 2007 as of this morning were McDonald's(MCD),Merck(MRK) and Honeywell International(HON).Such large-cap multinationals remain in favor with many analysts.