Articles » 2006 » July / August 2006 » Novartis


#7 Novartis



Lichtstrasse 35
CH-4056, Basel
Switzerland
Tel: (41) 61324 1111
Fax: (41) 61324 8001
www.novartis.com



Headcount 90,924
(49,308 in Pharma)
 
Year Established 1996
PharmA Revenues $20,262 +10%
Total Revenues $32,212 +14%
Net Income $6,141 +10%
R&D Budget $4,846 +19%


Drugs Approved/Launched
Drug Indication
exjade chronic iron overload
omnitrope human growth
femara hormone-sensitive breast cancer
xolair* severe allergic asthma
* In EU


Drugs Pending Approval
Drug Indication
LDT600 hepatitis B
comtan* Parkinson’s disease
exelon dementia related to Parkinson’s disease
foradil asthma
certican prevention of organ rejection
aclasta Paget’s disease
prexige osteoarthritis, acute pain
xolair allergic asthma
exforge hypertension
* In Japan


Drugs in Phase IIb and Beyond
Drug Indication
diovan/starlix type 2 diabetes, cardiovascular morbidity and mortality
lotrel accomplish high-risk hypertension
galvus type 2 diabetes
rasilez hypertension
exforge hypertension
lbm642 dyslipidemia
gleevec glioblastoma multiforme, solid tumors
ptk787 colorectal cancer, solid tumors
epo906 solid tumors
amn107 chronic myeloid leukemia
pkc412 acute myeloid leukemia
som230 acromegaly, GEP5, neuroendocrine tumors, Cushing’s disease
lbq707 solid tumors
rad001 solid tumors
exelon dementia
lic477 bipolar disorder
lamisil fungal infection of the scalp in children
qab149 asthma/COPD
nva237 COPD
ldc300 hepatitis B
rsv604 respiratory syncytial virus
visudyne AMD
sandostatin LAR diabetic retinopathy
lucentis AMD
opc759 dry eye
elidel dry eye
ptk787 AMD
aclasta osteoporosis, rheumatoid arthritis
zelnorm dyspepsia
smc021 osteoporosis
aae581 osteoporosis
IC51 Japanese Encephalitis virus


Top Selling Drugs
Drug Indication Sales (+/- %)
diovan hypertension $3,676 19%
gleevec chronic myeloid leukemia $2,170 33%
zometa bone metastasis $1,224 14%
lamisil group fungal infections $1,133 -2%
lotrel hypertension $1,075 17%
neoral immunosuppression $953 -6%
sandostatin group acromegaly $896 8%
lescol cholesterol $767 1%
voltaren rheumatoid arthritis $689 8%
trileptal epilepsy $615 19%
femara breast cancer $536 39%


Account for 68% of total pharma sales, up from 65% in 2004.

PROFILE


Novartis committed more than $13 billion to acquisitions in 2005, but it still hasn’t acquired its neighbor Roche. Instead, Novartis expanded its generic business and made a big bet on vaccines.

Novartis’s generics unit took a large step with the June and July 2005 acquisitions of Hexal AG and Eon Labs (initiated in February 2005) for a combined $8.3 billion. The new companies added $1.4 billion to the Sandoz generic unit, leading to sales growth of 54% to $4.7 billion. Novartis accounts for Sandoz separately from its branded Pharmaceuticals division. If taken together, Novartis would rank #4 on the this list.

THE LOWE DOWN

Novartis has been talking a lot in recent years about a new approach to drug discovery, which is apparently taking place at their renovated candy factory in Cambridge. From the outside, it’s hard to make out just what this is all about, although, oddly enough, in the press releases it always seems to get tied somehow to Gleevec. It’s hard to see how a company can make a strategy out of the improbable phrase “blockbuster orphan drug,” though.

And time and chance happen to them, too. It must have been unpleasant to be gearing up for a great big COX-2 launch just when flames started spewing out of Vioxx. But I still have a quote from the CEO, Daniel Vasella, up on my wall from a few years ago. “If you don’t spend big money and take big risks,” he told an interviewer, “you shouldn’t be in the pharmaceutical industry.”

I’ve always liked that attitude, and it’s hard to bet against a company that has it. Novartis is making big efforts in an awful lot of therapeutic areas — oncology, cardiovascular, diabetes, vaccines. They certainly have the cash to do it. Some of these, you’d think, are going to end up paying off.
—Derek Lowe
Even without Sandoz, Novartis’ Pharma division is doing just fine. The unit posted 10% revenue growth in 2005, keyed by a 19% pickup in Diovan sales and a 33% rise in cancer treatment Gleevec, which crossed the $2 billion mark in 2005. Diovan continued its strong growth in 1Q2006, up 16% to $939 million, while Gleevec rose 18% to $559 million. The company filed four more (rare) cancer indications for Gleevec in the U.S. and Europe in 1Q2006. One look at the “Drugs in Phase IIb and Beyond” section on the previous page shows that Novartis has plenty going on in its pipeline, even if iron-chelator Exjade was the only NDA approval in the past year.

The company is pushing its hypertension franchise with the applications for Exforge (a combo drug of Diovan and Pfizer’s Norvasc) and Rasilez, a renin inhibitor that treats high blood pressure in diabetics. The latter, filed with the FDA in April 2006, is projected by analysts to reach billion-dollar status before the end of the decade, which should help ameliorate Diovan’s 2012 patent expiration.

Novartis is also going after the diabetes market with Galvus, a once-daily oral treatment for type 2 diabetes. Analysts project that the drug, filed in March, could hit $2.1 billion in sales by 2012, as it competes with Merck’s Januvia.

The biggest drug approval news for Novartis came from the generic division, which received clearance in the U.S. and EU for Omnitrope, which is not a biogeneric, but a ‘follow-on version of a previously approved recombinant biotechnology drug.’ That approval may open the door to a new era of follow-on biologics, as more of the pioneer biodrugs show their age.
ACQUISITIONS

Target: Chiron Corp.
Price: $5.4 billion
Announced: May 2006

Target: NeuTec Pharma
Price: $569 million
Announced: June 2006

More Vax



In September 2005, Novartis bid to acquire beleaguered biopharma/vaccine/blood testing company Chiron for approximately $5.1 billion, a sum representing the 58% of shares that Novartis didn’t already own. The deal finally closed at $5.4 billion, giving Novartis a position in the vaccines field, a $10.8 billion market that analysts project will grow at an annual 20% clip in the next five years.

To ready the way for the Chiron integration, Novartis launched a vaccines and diagnostics business. Dr. Joerg Reinhardt, who was global head of Pharma Development, was tapped to become chief executive officer of the new division. Chiron’s biopharmaceutical products will be folded into the Pharmaceuticals division.

In May 2006, Novartis won a five-year, $220 million contract from the Department of Health and Human Services to develop a cell-culture derived flu vaccine. The funding will also help fund a new manufacturing facility for the vaccine, leading to reports that Novartis is looking for an eastern U.S. site to build a $400 million, 800-person manufacturing site.

Acquire from Strength



I’m interested in seeing how the company’s diversification works. While the generic business is producing significant revenues, the margin of operating income from that unit is about half of what the Pharmaceuticals division generates. The company also expanded its Consumer Health unit in July 2005 by acquiring Bristol-Myers Squibb’s OTC portfolio for $660 million.

None of these deals are panicked reactions to pipeline failures or product recalls. Rather, Novartis is dealing from a position of strength. The pipeline remains strong, even though the Pharmaceuticals division hasn’t had any large-scale product launches this year. It’s clear that vaccines are a major part of the company’s strategy; we’ll see if Novartis is capable of making real strides in a market not known for big profits (and well known for liability issues, antiquated manufacturing techniques, lawsuits, and price controls).