Replies to post #117070 on Biotech Values

[mcbio]

Investors Overplay JAK Threat to Abbott's Humira

But do they underplay the SYK threat? LOL jk Nice article. ABT will still get theirs I'm sure. And there should still be a nice market for PFE, AZN/RIGL, and others if the JAK/SYK drugs get approved.

[DewDiligence]

ABT—A Dutch research team says Humira has a problem with neutralizing antibodies:

http://www.bloomberg.com/news/2011-04-12/abbott-s-humira-undercut-by-patients-resistance-study-finds.html

Twenty-eight percent of 272 patients developed antibodies that lowered Humira levels in the blood, researchers said today in the Journal of the American Medical Association… With today’s study, Humira joins Remicade, an arthritis medicine from Johnson & Johnson (JNJ), and Tysabri, the multiple sclerosis treatment from Biogen Idec Inc. (BIIB), as drugs found to be neutralized, at least partly, by patients’ antibodies, the researchers said. “These results could have implications for clinical practice,” said the researchers, led by Geertje Bartelds of the Jan van Breemen Research Institute in Amsterdam.

ABT’s reply (from the same Bloomberg piece):

“The formation of antibodies is well known in biologic therapies,” Derin Denham, a spokeswoman for Abbott, said in an e-mail. “The study results are consistent with what is already known about Humira” and similar medications “and is included in the Humira label.”

What does the FDA label for Humira actually say about neutralizing antibodies? It has a lot of detail:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0215lbl.pdf

Patients in Studies RA-I, RA-II, and RA-III were tested at multiple time points for antibodies to adalimumab during the 6- to l2-month period. Approximately 5% (58 of 1062) of adult rheumatoid arthrtis patients receiving HUMIRA developed low-titer antibodies to adalimumab at least once during treatment, which were neutralizing in vitro.

Patients treated with concomitant methotrexate had a lower rate of antibody development than patients on HUMIRA monotherapy (1% versus 12%). No apparent correlation of antibody development to adverse reactions was observed. With monotherapy, patients receiving ever other week dosing may develop antibodies more frequently than those receiving weekly dosing. In patients receiving the recommended dosage of 40 mg every other week as monotherapy, the ACR 20 response was lower among antibody-positive patients than among antibody-negative patients. The long-term immunogenicity of HUMIRA is unknown.

In patients with juvenile idiopathic arthrtis, adalimumab antibodies were identified in 16% of HUMIRA-treated patients. In patients receiving concomitant methotrexate, the incidence was 6% compared to 26% with HUMIRA monotherapy.

In patients with anylosing spondylitis, the rate of development of antibodies to adalimumab in HUMIRA-treated patients was comparable to patients with rheumatoid arthrtis. In patients with psoriatic arthrtis, the rate of antibody development in patients receiving HUMIRA monotherapy was comparable to patients with rheumatoid arthrtis; however, in patients receiving concomitant methotrexate the rate was 7% compared to 1% in rheumatoid arthrtis.

In patients with Crohn's disease, the rate of antibody development was 2.6%.

In patients with plaque psoriasis, the rate of antibody development with HUMIRA monotherapy was 8%. However, due to the limitation of the assay conditions, antibodies to adalimurab could be detected only when serum adalimumab levels were <2 ug/ml. Among the patients whose serum adalimumab were <2 ug/ml (approximately 40% of total patients studied), the immunogenicity rate was 20.7%. In plaque psoriasis patients who were on HUMIRA monotherapy and subsequently withdrawn from the treatment, the rate of antibodies to adalimumab after retreatment was similar to the rate observed prior to withdrawal

The bottom line, IMO, is that the Dutch study cited by Bloomberg is much ado about nothing.

[DewDiligence]

Humira hits phase-3 primary endpoint in ulcerative colitis:

http://finance.yahoo.com/news/Abbotts-HUMIRA-Adalimumab-prnews-3322579372.html?x=0&.v=1

Co-primary endpoints were the proportion of patients with clinical remission at week 8 and clinical remission at week 52. Clinical remission was defined as a Mayo Score of 2 or less with no individual sub-score greater than 1. The Mayo Score uses a 12-point scoring system to measure disease activity which is evaluated by scoring the following parameters: stool frequency, rectal bleeding, endoscopy findings and physicians global assessment. A higher Mayo Score indicates greater disease severity.

Of the 248 patients treated with HUMIRA in the study, 16.5 percent achieved clinical remission compared to 9.3 percent on placebo at week 8 (p=0.019). At week 52, 17.3 percent achieved clinical remission compared to 8.5 percent on placebo (p=0.004). These results were statistically significant compared to placebo [no kidding!].

The safety results were consistent with the known safety profile of HUMIRA.

[DewDiligence]

Humira Is Gaining Share in Crohn’s and Psoriasis

[To be the world’s largest-selling drug (which Humira will almost certainly become in 2012), it has to be more than just a drug for RA. Crohn’s and psoriasis are two of the “ancillary” indications that have been driving the spectacular sales numbers (an $8B annualized rate in 2Q11—see #msg-65403784).]

http://www.bloomberg.com/news/2011-07-20/abbott-s-freyman-says-humira-gained-market-share-in-crohn-s-psoriasis.html

›By Alex Nussbaum - Jul 20, 2011

Revenue from Abbott Laboratories (ABT)’ top-selling drug, Humira, surged 25 percent after wresting sales from rival treatments for psoriasis and Crohn’s disease, Chief Financial Officer Thomas Freyman said.

“We’re seeing an acceleration of market growth for that product and improved market share, particularly in the Crohn’s disease and psoriasis areas,” Freyman said in a telephone interview. “We’ve also made some progress in rheumatoid arthritis.”

Humira, a treatment for autoimmune disorders that accounts for about one-fifth of Abbott’s revenue, brought in $2 billion in the second quarter. That contributed to a 9 percent gain in the company’s sales from a year earlier. Earnings jumped 50 percent to $1.94 billion, helped by a one-time tax benefit of $594 million, the Abbott Park, Illinois-based company said today in a statement.

Whether Abbott can maintain the current pace for Humira “is the $64,000 question,” said Jeff Bagley, a portfolio manager in Haverford Financial Services in Radnor, Pennsylvania, which holds 1.2 million of the company’s shares. “The uptake of this drug continues well beyond most analysts’ expectations.” [LOL—perhaps the analysts didn’t do their homework!]

The earnings gains may not have satisfied investors who had already driven up the stock this year, said Damien Conover, a Morningstar Inc. analyst in Chicago, in a telephone interview. Sales of artery-opening heart stents and diabetes supplies also declined, after taking out gains for currency-exchange rates, he said.

“Expectations may have been even higher than what they delivered,” he said in a telephone interview. “In our view, it was a very solid quarter.”

Abbott raised its forecast for full-year profit to $4.58 a share to $4.68 a share, from as much as $4.64 a share. [The old EPS range was $4.54-4.64 on a non-GAAP basis.]

Humira has been helped by expansion into countries outside the U.S., as well as approvals to treat new conditions including a form of juvenile arthritis in Japan, said Larry Peepo, Abbott’s investor-relations director, on a conference call with analysts. New indications may add $1 billion to the treatment’s peak sales, he said.

“Globally, we’re just seeing good market growth, good share performance and very good execution,” Freyman, the CFO, said on the call.

Humira, which generated $6.55 billion in sales last year, treats diseases that occur when the body’s immune system attacks the skin, joints and digestive system.

The global market for treating rheumatoid arthritis reached about $16 billion in 2010 while psoriasis and Crohn’s disease combined for $6.6 billion, said Jerry Rosenblatt, a partner at Foster Rosenblatt, a Princeton, New Jersey-based consultant that studies pharmaceutical sales.

The main threat to Humira may come from a class of experimental drugs called JAK inhibitors, led by Pfizer Inc. (PFE)’s tofacitinib [but see the counterpoint in #msg-61383188], Rosenblatt said by telephone.

Humira’s performance suggests Abbott is “going to compete right to the end and they’re going to expand right to the end,” Rosenblatt said by telephone. “That’s certainly what they’re telling the market.”

Abbott saw prescriptions decline about 5 percent for the heart medication Niaspan after a study in May questioned the treatment’s benefit for patients [#msg-63617748], Peepo said.

Niaspan Study

The National Institutes of Health said on May 25 that it had stopped the study after Niaspan failed to prevent heart attacks and may have boosted stroke risks. It’s too soon to gauge the long-term impact on the product, Peepo said.

Sales of Abbott’s nutritional supplements, led by the Similac baby formula, grew 5.4 percent. Freyman declined to comment on whether the company would be interested in bidding for the baby food unit of New York-based Pfizer. Pfizer said earlier this month that it was considering selling the division.

“In the M&A area, we’ve talked about more focus on pharmaceutical licensing opportunities and more complementary niches,” he said. “But we’re always open to anything that can add shareholder value.”

Earnings climbed to $1.23 a share from 83 cents a year earlier, Abbott said in its statement. Excluding restructuring and acquisition charges and the tax benefit, profit of $1.12 a share topped by 1 cent the average estimate of 16 analysts in a Bloomberg survey.

Revenue rose to $9.62 billion, with about half the gain due to the dollar’s slide in value against other currencies, the company said. The dollar’s decline boosted the value of sales earned outside the U.S.‹

[DewDiligence]

Re: Tofacitinib vs Humira

This might be a good time to revisit the article in #msg-61383188 and the other posts in the chain. Comments welcome.

p.s. I no longer agree with my own statement in #msg-59338771 that $1B of 2015 sales for Tofacitinib is a reasonable forecast.