* Says cancer vaccine not strategic priority for Pfizer
* Says will conduct late-stage studies on its own
* Worldwide rights to vaccine revert to Celldex on Nov. 1
* Celldex shares tank 39 pct to lifetime low
(Adds analyst comments; updates stock movement)
By Shravya Jain
BANGALORE, Sept 3 Celldex Therapeutics Inc
(CLDX.O) said it would go it alone on the development of its
lead cancer vaccine, after partner Pfizer (PFE.N) pulled out
saying the program was no longer a strategic priority for the
Though Pfizer's pull out sent Celldex's stock crashing to a
life low, analysts said they were confident the company could
advance the vaccine into late-stage trials without a partner.
"As much as people are saying that Pfizer didn't believe in
the drug, (Pfizer) didn't really say that. It just has
different priorities," WBB Securities analyst Steve Brozak
Needham & Co analyst Mark Monane said despite a higher
financial risk, the execution risk for the drug's development
has not increased as Celldex has the experience and the
resources to take it forward.
"Celldex can bring the drug into Phase 3 in the first half
of 2011," Monane said.
In May, the company said data from a mid-stage trial of the
vaccine, called CDX-110, showed progression-free survival for
70 percent of the patients afflicted with a type of brain
tumor, and claimed the results were 40 percent better than the
current standard of care. [ID:nN20241460]
Celldex's CDX-110 is an immunotherapy vaccine -- the drug
targets a molecule that is present only in tumor cells. The
vaccine is similar to Dendreon's DNDN.O Provenge -- the only
FDA approved cancer vaccine, which treats advanced prostate
"We don't need a partner going forward. We plan on pushing
(the vaccine rindopepimut) into Phase 3 ourselves," Celldex
Chief Executive Anthony Marucci said, adding that the company
would need to raise money at "some point" to complete the
Brean Murray, Carret & Co analyst Jonathan Aschoff expects
the trial to cost less than $50 million.
Celldex, with a market value of about $146.7 million, had
cash, cash equivalents and marketable securities of $65.8
million as of June 30.
On a conference call with analysts, CEO Marucci said the
company will now need to hire more people on the clinical side.
Needham, Massachusetts-based Celldex said it would also
focus on the four other product candidates that are in ongoing
early to mid-stage studies.
It has two other cancer vaccines in early and mid stage
development, an antibody therapy for breast cancer and melanoma
in mid stage trials, and a renal disease therapy in early
In April 2008, Celldex and Pfizer Vaccines LLC had entered
into the deal for the cancer vaccine as a treatment for
patients with Glioblastoma Multiforme, a kind of brain tumor.
Pfizer had made an upfront payment of $40 million in 2008
and had also made an equity investment of $10 million in the
Celldex was also eligible to receive milestone payments of
over $390 million for the successful development and
commercialization of the drug.
Celldex Chief Financial Officer Avery Catlin said there was
no termination fee defined in the license agreement and the
companies would decide on a future course of action within the
next 60 days.
Worldwide rights to develop and market the vaccine return
to Celldex effective Nov. 1.
Celldex shares, which have fallen 27 percent over the past
three months, dropped 39 percent to a lifetime low of $2.91
before recouping some of their early losses. They were trading
down at $3.53 late afternoon.
About 5 million shares changed hands Friday, more than
14-times their 10-day average daily volume.
(Additional reporting by Esha Dey in Bangalore; Editing by
Anne Pallivathuckal, Anthony Kurian)