January 24, 2000
Hello everyone, it looks like we are awful close to a decision by the FDA on Aptosyn (exisulind). For those of you who don't know, on January 11, 2000 the FDA advised Cell Pathways that it plans to evaluate the New Drug Application (NDA) for Aptosyn without requiring input from its Oncologic Drugs Advisory Committee (ODAC). This is a promising development (as you can see from the price of the stock) that suggests that the FDA has all the information needed to render a decision on approval/disapproval of Aptosyn.
A number of factors would seem to be pointing to the approval of Aptosyn (hopefully the first of many for CLPA!). It seems the FDA would be unlikely to forgo an ODAC meeting for a drug they were not going to approve. I believe the FDA would be hard pressed to deny approval of an extremely safe (and efficacious) drug without the input (and questioning) of an expert panel.
Another factor seems to be the approval of Celebrex as an "oral adjunct to usual care (endoscopic surveillance and surgery) for patients with familial adenomatous polyposis." The approval was based on "a six-month, 83-patient clinical trial, sponsored by the National Cancer Institute's Division of Cancer Prevention in collaboration with Searle." According to the company it was "the largest randomized, double-blind, placebo-controlled trial to date in FAP. The clinical study demonstrated that an oral dose of Celebrex 400 mg twice a day significantly reduced the number of adenomatous colorectal polyps by an average of 28 percent -- compared to a 5 percent reduction with placebo." Certainly the approval is great news for FAP patients but , the results from Aptosyn only look that much more impressive in comparison.
A final factor that seems to be in our favor is a statement about the Celebrex ODAC meeting by Robert J. Towarnicki. He stated that "several circumstances have led to this decision by the FDA. One is that FAP is a chronic, Orphan indication that has no approved medical treatment for the prevention of precancerous polyps." He also stated the fact that "at its December 1999 meeting, which focused on another agent for the regression of existing rectal polyps, ODAC addressed issues concerning the medical management of FAP and the Accelerated Approval process as it relates to that disease."
What does this all mean? It seems there are strong suggestions that we have imminent approval of Aptosyn in the near future. With that said, we can't forget the other possibilities (especially where the FDA is involved). It is certainly possible the FDA has decided not to approve the drug. This seems unlikely based on the study results we have seen as well as the need for therapeutic options in this disease. The other possibility is the FDA requests more studies be done. Either of these outcomes would destroy the stock (remember what happened less than a year ago!). Obviously, we believe the stock will be approved and used (not only for FAP, but also for a number of other diseases). We continue to be holders of the stock. REMEMBER, Cell Pathways is worth ALL or NOTHING, there is very little in between.
On a personal note, thanks for all of the emails, I really appreciate them. For everyone who has been an investor in Cell Pathways' short public life and especially those with the company for years, it looks like your faith and persistence have paid off. This drug will make unfathomable differences in so many lives. Hopefully, we can say we have "done well by doing good."
Cell pathways presented at a conference put on by BankBoston Robertson Stephens on November 30, 1998. The information was posted on a message board so, read it with that in mind.
Long term safety data goes out to 39 months in some patients, over 300 patients have been taking the medication for 6 months. In the companies press releases there have not been significant long-term safety concerns. The FDA set 50% polyp reduction as the minimal outcome, in early trials CLPA with Prevatac surpassed this. The National Cancer Institute is negotiating to fund two more studies. Trials are scheduled to start in two other indications, Barrett's esophagus and bronchial dysplasia. They had better hurry!!!
The assumption is that polyps will recur if the medication is withdrawn.
CLPA has a compound #461 developed as a chemotherapeutic agent. Animal studies show it to be much safer than Prevatac. In animal studies there seemed to be a synergy with taxol and cisplatin.
Cell Pathways is forming a group of smaller distributor companies in Europe. They hope to pay them distributor margins instead of a deal with "Big Pharma."
They also have published data on Prevatac inhibition of lung tumors in animal studies. It is published in Carcinogenesis, Volume 19, Issue 8: August 1998. In this study, a tumor induction protocol, consisting of NNK administration in the drinking water over several weeks to model chronic human exposure, was used to test whether the sulfone (called FGN-1) could inhibit the formation of primary lung tumors in mice. Tumor incidence decreased significantly from 96% in the control diet and 93% in the 250 FGN-1 mg/kg diet to 63 and 67% in the 500 and 750 mg FGN-1/kg diet groups, respectively. Lung tumor multiplicity decreased from 18.1 ± 3 tumors/mouse to 12.3 ± 3 (250), 5.3 ± 1 (500) and 2.1 ± 1 (750). This dose-dependent reduction in tumor formation by a non-toxic dose of FGN-1 indicates a strong chemopreventive activity against experimental induction of lung carcinogenesis.
CELL PATHWAYS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
Pro Forma
Sept. 30, Sept. 30, Dec. 31,
1998 1998 1997
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 41,909 $ 14,382 $ 8,461
Other current assets 600 417 179
Total current assets 42,509 14,799 8,640
OTHER NON CURRENT ASSETS 2,254 2,587 2,340
$ 44,763 $ 17,386 $ 10,980
LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIT)
CURRENT LIABILITIES: $ 3,883 $ 2,250 $ 3,257
LONG-TERM LIABILITIES: 146 146 9
REDEEMABLE PREFERRED STOCK: -- 1,092 1,092
STOCKHOLDERS' EQUITY
Preferred Stock -- 53,562 32,158
Common Stock 242 30 30
Additional paid-in capital 80,645 459 456
Stock subscription receivable from
issuance of Common Stock (37) (37) (37)
Deficit accumulated during the
development stage (40,116) (40,116) (25,985)
Total stockholders' equity 40,734 13,898 6,622
$ 44,763 $ 17,386 $ 10,980
CELL PATHWAYS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended Nine Months Ended
Sept. 30 Sept. 30
1998 1997 1998 1997
EXPENSES
Research and development $ 4,969 $ 2,362 $ 11,866 $5,586
General and administrative 801 243 2,768 584
Provision for the redemption of
the Redeemable Preferred Stock -- 1,017 -- 1,017
Total expenses 5,770 3,622 14,634 7,187
INTEREST INCOME 259 165 503 288
NET LOSS $(5,511) $(3,457) $(14,131) $(6,899)
Basic and diluted net loss
per common share $ (1.84) $ (1.18) $ (4.73) $ (2.47)
Shares used in computing basic and
diluted net loss per
common share 2,990,095 2,927,554 2,990,095 2,788,415