Johnson & Johnson
Home  »  Community News  »  Johnson & Johnson
Sep
4
Sandeep Singh Dhillon
New Data Could Add $1.5 Billion To Sales Of Johnson & Johnson Blood Thinner – Forbes.com
Pharma News, Pharma Notables
0
,

By Matthew Herper

New data could lead doctors to use Johnson & Johnson and Bayer’s blood thinner Xarelto to prevent heart attacks in some patients, leading to a significant sales boost. In a note to investors earlier this month, Credit Suisse analyst Divan Vamil predicted that a successful result could increase sales of the drug by $1.5 billion in the U.S. alone.

Well, the results are a success, although they come with the same trade-off as any use of a blood thinner: more bleeding. In results published in the New England Journal of Medicine and presented in Barcelona at the annual meeting of the European Society of Cardiology, the combination of a low dose of Xarelto and aspirin cut the risk of heart attacks and strokes, cut the risk of heart attacks by 14%, strokes by 42%, and death by 18%. Forty-one out of every 1,000 people who took the Xarelto-and-aspirin combo would be expected to have a heart attack, stroke, or heart-related death compared to 54 among those who got aspirin alone.

The fact that Xarelto reduced the risk of overall deaths, not just heart attacks or strokes, should convince many doctors to use it. But the study looked only at a very specific group: patients who are at high risk of a heart attack or stroke, but who shouldn’t be getting a different class of clot-preventing drugs that includes the generic clopidogrel, Effient, from Eli Lilly, or Brilinta, from AstraZeneca. Patients who have recently had a heart attack, especially those who were treated by having a heart artery propped open with a metal stent, usually get these medicines for at least several months. But the 27,395-person trial specifically recruited patients who didn’t need these other drugs, and whose disease was stable.

One big opportunity for J&J and Bayer could come from a group that represented only a quarter of the patients in the study: those who’ve come to the hospital because of blood clots in their legs, known as peripheral artery disease. These are caused by artery disease, much like heart attacks and strokes.

Bleeding occurred in three patients out of every hundred in the Xarelto plus aspirin arm of the trial, a 70% increase compared to aspirin alone, although there was no difference in the number of major or fatal bleeding episodes. Peter DiBattiste, J&J’s global head of cardiovascular R&D, says that J&J plans to file with the U.S. Food And Drug Administration for approval for the new use, including the approval of a new, 2.5-milligram dose, by the end of the year.

May
19
Sandeep Singh Dhillon
The world’s largest drugmaker thinks it has 11 billion-dollar drugs in the pipeline : here’s what they treat – Business Insider
Drug Discovery, Pharma News, Pharmaceutical & Drug Delivery Journals
0
,

Johnson & Johnson just listed out the drugs it plans to file for approval over the next few years that could be “blockbusters.”

These are drugs that haven’t been approved yet, but by 2021, they could be making more than $1 billion in annual sales each.

Right now, the world’s largest drugmaker is known for its immunology drugs like Remicade, which made $4.8 billion in sales in 2016 and Stelara, as well as the bloodthinner Xarelto, which made $2.2 billion in sales in 2016.

Here’s the list of drugs J&J plans to file for approval over the next four years that could hit that blockbuster threshold, including cancer and depression treatments:

guselkumab – psoriasis (Filed for approval in 2016)
sirukumab – rheumatoid arthritis (Filed for approval in 2016)
apalutamide – pre-metastatic prostate cancer
esketamine – treatment-resistant depression
talacotuzumab – acute myeloid leukemia, a type of blood cancer
erdafitinib – solid tumors
niraparib – prostate cancer
imetelstat – myelofibrosis, a bone marrow disorder
pimodivir – influenza A
lumicitabine – respiratory syncytial virus (RSV) infection
JNJ-7922 – adjunctive treatment for major depressive disorder

Sep
20
Sandeep Singh Dhillon
J&J to Buy Abbott Vision Care Biz for $4.3B
Pharma News
0
,

Abbott announced that it will sell Abbott Medical Optics, its vision care business, to Johnson & Johnson for
$4.325 billion in cash.
“We’ve been actively and strategically shaping our portfolio, which has recently focused on developing leadership
positions in cardiovascular devices and expanding diagnostics,” said Miles D. White, chairman and chief executive
officer, Abbott. “Our vision care business will be well-positioned for continued success and advancement with Johnson & Johnson, and I’d like to thank our employees for building a successful business.”
Abbott’s vision business has products in areas including cataract surgery, laser vision correction (LASIK) and
corneal care products (contact solution, eye drops, etc).
The net impact of this transaction is not expected to impact Abbott’s overall targeted ongoing earnings per share in 2017. The transaction is expected to close in the first quarter of 2017.

Apr
12
ragupathyrenganathan
Pfizer Steps Out Of Johnson & Johnson’s Shadow To Get A Tan
Pharma News
0
, ,

Johnson & Johnson’s decision to drop fulranumab leaves Pfizer’s tanezumab as the lone anti-nerve growth factor antibody in late-stage development. Bringing non-opioid painkillers to market has proven all but impossible over the years, and the canning of fulranumab ups the stakes: success for this project appears even less likely, but if it does succeed the rewards will be that much greater.

Pfizer is maximizing tanezumab’s chances by studying it in several conditions, from osteoarthritis to cancer pain. The first of its phase III trials to read out will be Tango, in chronic low back pain, nearly a year hence, and the amount of money Pfizer is throwing at development means that it needs a hit to justify the expense.

While J&J has made it clear that it is not discontinuing fulranumab in osteoarthritis pain because of any concerns about safety, instead citing “strategic portfolio prioritization”, worries that there could be read-through of some sort to tanezumab will surely linger.

The partial clinical hold on tanezumab, imposed in 2010 after cases of suspected osteonecrosis, was lifted last year, but investors are still wary of NGFs, as their limited sales forecasts show (Tanezumab’s return shows pharma has held its nerve, March 24, 2015).

Apr
7
ragupathyrenganathan
J&J’s Vaginal-Mesh Costs May Rise If $5 Million Deal Is a Guide – Bloomberg
Pharma News, Pharma Notables
0
,

Johnson & Johnson hasn’t disclosed how much it’s set aside to cover the risk from lawsuits by women who say they were injured by vaginal-mesh inserts, or what the company has already paid to settle such cases confidentially. But a $5 million settlement recently became public, giving a glimpse of how much it could cost to resolve the claims.
The accord was made part of the public record when the plaintiff’s lawyer asked a judge to approve his legal fees in the case. While it’s just one suit — J&J still faces more than 46,000 such cases, according to its regulatory filings — judges in New Jersey and West Virginia are pressing the company to resolve them.
The case that was settled “presented unique circumstances,” J&J said in an e-mailed statement. While the estimated cost of the mesh litigation isn’t broken out, “the company appropriately discloses overall litigation expenses.”
According to a court filing in Hackensack, New Jersey, the company agreed in September to pay $5 million to settle a lawsuit with Pamela Wicker, who claimed J&J’s Ethicon unit’s Prolift mesh eroded inside her, making sex painful and forcing her to endure multiple surgeries to remove the material. Before it settled, Wicker’s suit was to be the second so-called bellwether case that would help resolve the 8,700 such claims filed in New Jersey, according to court filings. In 2013, the first bellwether ended with an $11.1 million jury verdict against J&J.
‘A Bad Sign’
“This settlement is a bad sign because it shows investors it’s going to cost a lot more to deal with this liability than people expected,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.
While J&J paid less to settle with Wicker than it lost by going to trial in the earlier case, her pay-out looks big when compared to what J&J has been said to have paid out in other settlements. In January, Bloomberg reported that J&J agreed to pay $120 million to resolve 2,000 to 3,000 mesh-related suits, citing people with knowledge of the agreement.
The company has had a mixed record before juries in the mesh cases. It won several cases, but had losses in Texas, California and Pennsylvania. In February, a Philadelphia jury awarded $13.5 million to another woman who said she’d also been hurt by Prolift. And the New Jersey verdict for $11.1 million was upheld last month on appeal.
Pending Appeals
“From time to time we have agreed to resolve some cases,” New Brunswick, New Jersey-based J&J said. “We will not discuss the terms of resolutions, nor discuss our ongoing litigation strategy.”
The company is appealing the Philadelphia verdict, and still reviewing whether to contest the New Jersey decision that was upheld. J&J pared litigation expenses to $141 million in 2015, down from $1.2 billion in 2014 and $2.2 billion in 2013.
Wicker’s lawyer, Adam Slater, detailed the $5 million payment in a Nov. 3 filing seeking a judge’s approval for his $1.65 million legal fee that will come out of the accord. He declined to comment on the settlement, which hadn’t been made public until Judge Brian Marinotti approved the request.
Device Makers
Cases related to vaginal-mesh inserts, which bolster sagging organs and treat incontinence, have multiplied since they began in 2011, with more than 100,000 suits filed against more than a half-dozen device makers.
J&J faces the most claims, and began pulling some product lines off the market in 2012 after the U.S. Food and Drug Administration ordered manufacturers including J&J, Boston Scientific Corp. and C.R. Bard Inc. to study injury rates. While Boston Scientific and Bard have also settled some cases, they continue to fight claims and defend the products. Each has set aside more than $1 billion to deal with claims over the inserts.
In January, FDA officials tightened regulations after finding the inserts should be classified as higher-risk products when used to shore up organs.

May
12
ragupathyrenganathan
J&J Extends Its Hands For AIDS Children
Pharma News
0
, , , ,