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Roche/Genentech’s Late-Stage Pipeline beyond Cancer: Ocrelizumab, against primary progressive MS & relapsing/remitting MS – $2.7 billion peak sales forecast

 

Reporter: Aviva Lev-Ari, PhD, RN

 

SOURCE

http://www.fool.com/investing/general/2016/03/19/youll-never-guess-which-pharma-likely-owns-40-of-2.aspx

 

Beyond Cancer

 

1. ocrelizumab, $2.7 billion peak sales forecast

What has the multiple sclerosis market excited about ocrelizumab is its success against primary progressive MS. Until orcrelizumab, no treatment in history has succeeded in a Phase III trial against this extremely debilitating form of MS.

Ocrelizumab is also being positioned for relapsing/remitting MS. Clinical trial data released in October showed that the treatment cut MS relapses by almost half compared with Merck’s competing drug, Rebif.

On a commercial basis, ocrelizumab’s expanded label (to include both forms of MS) should greatly increase its revenue potential. While a conservative estimate of ocrelizumab’s peak sales puts it at $2.7 billion, some see a peak sales potential for ocrelizumab in the neighborhood of $6 billion. That’s certainly a long shot, but not out of the question, since it is based on a MS market that is now worth $19 billion growing at 5% annually, with ocrelizumab eventually reaching a 30% market share.

Roche has stated plans for applying for regulatory approval for ocrelizumab in the first half of 2016. The drug’s accelerated approval status means an expedited review, with the FDA likely to take action on the application within 6 months. While ocrelizumab’s timeline depends on many variables, there is potential for sales to begin by year-end 2016.

 

Cancer Indications

 

2. Atezolizumab: $2.5 billion peak sales projected

Roche’s immuno-oncology drug atezolizumab follows ocrelizumab in blockbuster potential. Drugs such as atezolizumab (atezo) work by turning off cancer’s ability to remain undetected by the immune system, and atezo has put up some impressive data in its clinical trials. For example, in its POPLAR trial against advanced non-small-cell lung cancer, atezo doubled the likelihood of survival in patients taking the drug relative to placebo.

Being first matters, however. The market already has powerful competitors for atezo in Merck’s Keytruda and Bristol-Myers Squibb‘s (NYSE:BMY) Opdivo. On the other hand, both Keytruda and Opdivo are PD-1 treatments, and atezo works through another mechanism, PD-L1.

Genentech researchers believe PD-L1 is a more significant engine in cancer than PD-1. If they are correct, atezo will have a more long-lasting effect on stopping cancer growth, which would make the drug a potential first choice. Roche is driving some 36 studies  toward making a broad case for atezo with the FDA. Encouraging data keeps coming in. But investors should realize that how this drug will perform against competition from Keytruda and Opdivo is still very much an open question.

A more immediate commercial advantage for atezo is that Roche has a powerful in-house diagnostic division providing tools that can tag patients likely to respond to the drug. Many cancer therapies are ineffective with a large percentage of patients, and by specifically identifying those cancer patients who should benefit, Roche can personalize cancer treatment. That’s a big plus with payers, who naturally want to conserve their money for therapies more likely to be effective. As personalized medicine becomes steadily more widespread, full-year sales for Roche’s diagnostic division have grown–increasing 6% in 2015 to $10.7 billion.

Atezo’s breakthrough therapy designation gives it a solid chance of rolling out this year, but some industry watchers are deferring atezo’s projected launch date until 2017. Calculating a launch date is an inexact science, so that’s certainly possible.

3. Venetoclax: $1.4 billion projected for Roche

Roche’s third blockbuster speeding toward FDA approval is AbbVie partnered venetoclax. The drug is targeted to treat a highly virulent form of leukemia (chronic lymphocytic leukemia), specifically in those patients with a mutation that makes the cancer more aggressive and often results in shortened survival. Late-stage trials are also ongoing in non-Hodgkin’s lymphoma, acute myeloid leukemia, and multiple myeloma.

Roche has U.S. marketing rights  to the drug, and FiercePharma estimates Roche’s share of peak sales at $1.4 billion by 2020. The drug, which has already been fast-tracked for approval under the agency’s breakthrough designation last May, scored a priority review from the FDA in January. Roche expects FDA clearance in 2016.

 

SOURCE

http://www.fool.com/investing/general/2016/03/19/youll-never-guess-which-pharma-likely-owns-40-of-2.aspx

 

Other related articles published in this Open Access Online Scientific Journal include the following: 

Immune-Oncology Molecules In Development & Articles on Topic in @pharmaceuticalintelligence.com

Curators: Stephen J Williams, PhD and Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2016/01/11/articles-on-immune-oncology-molecules-in-development-pharmaceuticalintelligence-com/