[ NOVO, DRF-2725 (NN622), a PPAR alpha and gamma agonist ]
HYDERABAD, India, Sept. 7 /PRNewswire/ -- Dr. Reddy's announced today that Novo Nordisk has established
clinical proof of concept for its novel dual-acting insulin sensitiser, DRF-2725 (NN622), and that Novo Nordisk
has decided to initiate Phase 3 studies, which are expected to start later this year. Meanwhile, data from the Phase
2 studies will be presented for review to Novartis Pharma AG with which Novo Nordisk has partnered to
commercialise DRF-2725 in North America.
Tuesday October 30, 8:34 am Eastern Time
Novartis says Novo drug failed Phase II criteria
ZURICH, Oct 30 (Reuters) - Novartis AG said on Tuesday it had dropped a new
dual-acting diabetes drug from Danish firm Novo Nordisk because it failed to meet its criteria
in intermediate Phase II clinical tests.
Thomas Ebeling, head of the Swiss group's drugs division, declined to say whether the
problem related to the product's safety profile.
``We have an ambitious product profile which includes efficacy and safety and our assessment after having looked at the Phase
II data simply was that this product does not meet that target profile,'' he told reporters in a conference call before a
presentation on research and development in New York for financial analysts.
Novartis' decision to ditch plans to commercialise the drug, known as NN622, came less than a week after GlaxoSmithKline
Plc (quote from Yahoo! UK & Ireland: GSK.L) stopped development of a similar drug because of adverse side effects.
``This class of compounds is a challenging class of compounds, but it also a very attractive one,'' Ebeling said.
Novartis had only signed up the North American rights to the drug in July.
Monday October 29, 10:42 am Eastern Time
Pipelines under cloud as Novartis ditches Novo drug
(UPDATE: Adds Novartis R&D day detail, new analyst/fund manager quotes)
By Per Bech Thomsen and Ben Hirschler
COPENHAGEN/LONDON, Oct 29 (Reuters) - Switzerland's Novartis AG on Monday
ditched plans to commercialise a new diabetes drug from Danish group Novo Nordisk , casting a shadow over both
companies' pipelines.
The news, which came less than a week after GlaxoSmithKline Plc (quote
from Yahoo! UK & Ireland: GSK.L) stopped development of a similar drug
because of adverse side effects, sent Novo Nordisk shares down more
than five percent.
Shares in Novartis fell three percent as investors fretted about its line-up of
new medicines ahead of a key R&D day which the Basel-based group is
due to host in New York on Tuesday.
Novartis had only signed up the North American rights to the drug, known
as NN622, three months ago and the about-turn was seen as denting
credibility after setbacks earlier this year for its bowel drug Zelmac and
asthma treatment Xolair.
Novo Nordisk said it was sticking with NN622 and could seek a new partner in North America, adding its 2001 financial
results would not be affected by the Novartis move.
``Our development programme...continues unaffected by Novartis' decision. In terms of commercialisation of the product in
North America we will now be considering various alternatives,'' said Chief Executive Lars Rebien Sorensen.
``Results from our Phase II studies confirmed that the profile of NN622 meets the therapeutic objectives we had set.''
NN622 was licensed by Novo Nordisk from Indian drugmaker Dr. Reddy Laboratories and Novo Nordisk said it expected to
start clinical final Phase III studies later this year.
NOVARTIS ``CONCENTRATING ON PORTFOLIO''
A spokesman for Novartis declined to say what triggered the firm's decision to abandon the product. ``The only thing I can say
is that we have decided to concentrate on our remaining portfolio in diabates,'' he said.
This includes Starlix -- which is already on the market but has got off to a slow start -- and two other diabetes products in
development, including another one from Dr. Reddy.
Investors had high hopes for Novo Nordisk's product, viewed as a key potential growth driver for the world leader in diabetes
care products, with some forecasts suggesting eventual sales for the drug of $1 billion a year.
However, analysts speculated Novartis was worried NN622 would show side effect problems similar to GlaxoSmithKline's
experimental drug, GI262570, which was abandoned at a later stage of development after some patients experienced swelling.
Both the GSK and Novo Nordisk drugs are dual-acting insulin sensitisers, which lower both glucose and lipid levels in the
blood by increasing the body's sensitivity to insulin.
Novo Nordisk insisted in a conference call that NN622's side effect profile was comparable to other drugs in its class.
Nonetheless, recent Phase II data may not have been enough to convince Novartis the medicine was worth pursuing.
``It may well be Novartis have decided it is more economical to go with their own products,'' said David Beadle of UBS
Warburg.
``If the drug does not come through it would be a loss of maybe five percent on operating profit for Novo Nordisk in 2005.
For Novartis it is a marginal difference -- but it highlights pipeline issues.''
NOVARTIS R&D DAY
Investors in Novartis will be paying close attention to its R&D presentation in New York in the light of the latest setback.
Eric Bernhardt, a fund manager at Clariden Bank in Zurich, who has Novartis in his portfolio, doubts the company has any
rabbits to pull out of the hat.
``I'm not expecting any big surprises and I'm not sure there is anything dramatic they will be able to highlight,'' he said.
Most attention is likely to focus on the Novartis' COX 189 product, a second generation arthritis drug from the same chemical
stable as Merck and Co Inc's (NYSE:MRK - news) Vioxx and Pharmacia Corp's (NYSE:PHA - news) Celebrex.
The Phase III product is expected to be filed with regulators in 2002 but suggestions that this and other long-lasting arthritis
treatments might carry a small increased risk of blood clots could delay approval.
``Instead of a 2003 launch for COX 189, the market is starting to think it may be 2004 or 2005,'' said Kevin Scotcher of SG
Cowen, who nonetheless rates Novartis a ``buy''.
``Most of this is already in the market and the stock is at a discount of around a 12 percent to the sector on 2002
price/earnings,'' he said.
At 1500 GMT, Novo Nordisk shares were down 5.1 percent at 332 crowns, after a low of 326, while Novartis shed 3.1
percent to 61.05 Swiss francs. Dr. Reddy ended off 5.5 percent at 1,039.95 rupees. |
