GenVec Inc.’s president and CEO said Pfizer Inc.’s decision to discontinue co-development of a cardiovascular product is a business call and has nothing to do with whether the late-stage drug works.
Pfizer, of New York, informed GenVec, of Gaithersburg, Md., that the partnership to develop BioBypass for coronary artery disease (CAD) and peripheral vascular disease (PVD) will end in six months. BioBypass is being studied in three Phase II trials.
GenVec’s stock (NASDAQ:GNVC) closed Thursday at $3.60, down 41 cents, or 10.2 percent.
The move returns all development and commercialization rights for the BioBypass angiogen to GenVec. The decision also means GenVec would not have to share any future royalties generated by BioBypass with the soon-to-be former partner.
“I want to be very clear about this point and remove any speculation that may occur regarding the data of the Phase II trials,” Paul Fischer, GenVec’s president and CEO, said during a conference call with investors Thursday. “Neither Pfizer nor GenVec has had any access to the efficacy data from these Phase II studies. Our first access to these data will not come until the third or fourth quarter of this year.
“By the end of the year we expect to have meaningful results from the ongoing Phase II studies,” Fischer said. “If the data are negative, it doesn’t matter whether Pfizer or GenVec owns BioBypass. If, however, the data are positive, it matters a great deal. By owning BioBypass, GenVec will be in a strong position to capture a much larger return on product sales and take less time to get there.”
The deal to develop BioBypass was initiated in 1997 by GenVec and Morris Plains, N.J.-based Warner-Lambert Co. Fischer said Pfizer inherited the GenVec deal, as well as many others, in its Warner-Lambert acquisition two years ago.
Since the start of the deal, Warner-Lambert/Pfizer has spent upwards of $90 million on development and other costs associated with BioBypass, Fischer said. “But based on continuous review of their product portfolio, including the products they acquired with Warner-Lambert, it was determined that BioBypass did not fit with their overall drug development strategy,” Fischer told BioWorld Today. A year ago, Pfizer ended another Warner-Lambert/GenVec collaboration, a preclinical angiogenesis program. The companies have no other collaborations. (See BioWorld Today, Jan. 26, 2001.)
The separation agreement obligates Pfizer to continue paying for trials for the next six months. Fischer said the companies are working together on a smooth transition.
The PVD Phase II trial is a placebo-controlled, double-blind, randomized study of 105 patients (35 patients per group). The endpoint is the patient’s ability to walk on a treadmill. So far, 80 patients have been enrolled.
In PVD patients, BioBypass delivers the vascular endothelial growth factor (VEGF) 121 gene to the legs so new blood vessels are formed in the diseased ischemic tissue.
Final results of a Phase I study of 33 PVD patients demonstrated that BioBypass, given by 20 intramuscular injections in and around the area in need of new blood vessels, was well tolerated.
Meanwhile, the CAD Phase II trial is a randomized, controlled study of 70 patients (35 per group). “This trial is comparing BioBypass to the best available medical care,” Fischer said. “The study is quite far along; 60 patients have enrolled. The trial is for patients with limited options. They’ve come to the end of the rope and they don’t have options.”
In this case, BioBypass delivers VEGF 121 to the heart so that new blood vessels are formed.
The third, final Phase II trials is a CAD study evaluating 12 cardiac catheter patients intended to show feasibility of the procedure.
“If the data are as positive from the Phase II trials as they were in Phase I, GenVec intends to commence Phase III in 2003,” Fischer said.
As of Dec. 31, GenVec had about $42 million in cash, which Fischer said is enough to carry the company through 2004.
When asked whether he will look for a partner to replace Pfizer, Fischer said, “We do have enough money to move this into Phase III studies in 2003, but that doesn’t preclude us from beginning to think about partnering, particularly because GenVec really is not in a position now to commercialize in Europe or in Asia. I would say this is a business decision GenVec will make when we see the data going forward. But I am comfortable in saying we will get that Phase III started if the data are good.”
Earlier this month, GenVec signed a contract with the National Institutes of Health to work with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases to develop and manufacture preventative AIDS vaccines. The agreement could mean up to $10 million over three years for GenVec. (See BioWorld Today, Jan. 11, 2002.)