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During the first nine months of the year, J&J’s drug portfolio grew in all major lines, led by solid gains in the pharmaceuticals group. Zytiga, Stelara, and Darzalex all saw impressive demand. They also helped the company deliver above-market growth in the third quarter.
However, after a couple of years of robust growth, the stock has seen some downward pressure because of new results from the Stelara phase 3 study. This trial did not flag any unknown safety risks, but it did not show that the induction and maintenance doses of the drug were effective.
But this could change in the future. The company submitted a supplemental biologics license application to the FDA in October, seeking to expand the drug’s label. In addition, a study is being conducted to evaluate the drug’s long-term effectiveness for patients with axial spondylitis.
J&J’s Janssen division recently announced the results of a three-year study of Stelara. It found that the drug is effective in patients with ulcerative colitis who have not been treated with biologics. It also found that 65% of the patients who responded to the drug were in symptomatic remission after 44 weeks of medication.
Earlier this year, Johnson & Johnson (NYSE: JNJ) was awarded FDA approval for its anti-CD38 antibody Darzalex. In addition, the company received FDA approval for a subcutaneous formulation of the drug. This new Darzalex formulation will be more convenient to administer than the intravenous version.
The new formulation is based on Halozyme’s Enhance drug delivery technology and should help drive the pipeline. It also should help J&J convert some of its existing patients to the subcutaneous form.
It’s been estimated that approximately half of all clinical trial patients experienced infusion reactions, including nausea, vomiting, and chills. The most severe forms of infusion reactions happen within four hours of the completion of the infusion. In the most common form of infusion reaction, the patient may exhibit signs such as nasal congestion, coughing, and chills.
Although there are no guarantees that Darzalex will extend the lives of cancer patients, its new subcutaneous formulation could siphon off some of its old intravenous sales. In addition, the subcutaneous version of Darzalex will likely be available soon.
Despite Imbruvica’s limited success in the U.S., the drug continues to gain traction in other parts of the world. One of the most significant growth areas is in the treatment of Waldenstrom’s macroglobulinemia, a disease that is a rare complication of hemoglobin A deficiency.
Imbruvica is an essential medical device manufactured and marketed by two companies, Johnson & Johnson and AbbVie. It is a novel compound that inhibits a protein called Bruton’s tyrosine kinase, or BTK, which plays a role in oncogenic signaling. It has been on the market for nine years.
There are numerous reasons to choose Imbruvica over competing compounds, such as Roche’s Rituxan and Bristol Myers Squibb’s Orencia. The first is that the drug has a lower risk of side effects, and the second is that it is much cheaper. This is a win-win for patients and payers alike. A new study shows that the drug has a 60 percent overall response rate through week 25.
Consumer health division
During the second quarter of 2021, Johnson & Johnson reported sales of $3.8 billion for its Consumer Health division. Including Tylenol and baby powder, J&J’s Consumer Health division generates billions in sales annually.
The Consumer Health unit will be separated from the Pharmaceuticals and Medical Devices division and become a standalone publicly-traded company. The new J&J will continue to sell prescription drugs and medical devices. It will also have a portfolio of over-the-counter medications and will be led by a new chief executive officer.
In August, former CVS Health CEO Larry Merlo joined JNJ as non-executive chair of Kenvue. This new consumer health company will include Band-Aid, Listerine, Tylenol, Neutrogena, and Baby Powder. It will be led by Thibaut Mongon, who was named chief executive officer of the new consumer health business in May.
The J&J Consumer Health Division generated $14.6 billion in revenue in 2021. The remaining J&J will continue to sell prescription drugs, medical devices, and over-the-counter medicines. Its Pharmaceuticals and Medical Devices division is expected to generate $77 billion in revenue in 2021.