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$FCSC ($10M Cap) Files Response to CRL - possible PDUFA date of 6/22/11
publication date: Jan 5, 2011
We have unearthed an 'under the radar' low priced FDA catalyst play with Fibrocell. Lets take a look at its recent history, as well as the the companies recent actions that put them in line for a potential PDUFA date of 06/22/11.
In October the FDA convened a panel to discuss Fibrocell's product candidate laViv, a process that uses a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. They voted 11-3 that it demonstrated efficacy, but 6 - 8 that it demostrated safety. In December 2009 the FDA issued FCSC a CRL, asking for more safety data. In May the company launched a study with the oversight of the FDA. On December 17th the company submitted a complete response to the FDA and they expect to hear from the agency very soon.
Recent History:On October 9, 2009, the FDA Panel of Cellular, Tissue and Gene Therapies Advisory Committee reviewed the Company’s nasolabial fold wrinkles product candidate. The Committee voted 11 “yes” to 3 “no” that the data presented on our product demonstrated efficacy, and 6 “yes” to 8 “no” that the data demonstrated safety; both for the proposed indication of treatment of nasolabial fold wrinkles.
On December 21, 2009, Fibrocell received a Complete Response letter from the FDA related to the BLA for azficel-T, an autologous cell therapy for the treatment of moderate to severe nasolabial fold wrinkles in adults. The Complete Response letter requested that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T. The histology study (IT-H-001) will evaluate tissue treated with azficel-T as compared to tissue treated with sterile saline (placebo). The study will also provide information about the skin after treatment, including evaluation of collagen and elastin fibrils, and cellular structure of the sampled tissues. The Company submitted a proposed protocol concerning a histopathological study on biopsied samples to the FDA and to the Company’s Investigational Review Board (“IRB”). The IRB has approved the protocol and the Company received the comments from the FDA on the protocol in May 2010.
On May 13, 2010, the Company announced the initiation of a small histology study of azficel-T, an autologous cell therapy currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. The study has a target enrollment of approximately 20 participants from the completed and statistically significant pivotal Phase III studies of azficel-T (IT-R-005 and IT-R-006). The Company announced on July 8, 2010, the completion of enrollment of and first treatment visits for participants in its histology study of azficel-T. The second treatment visits for participants enrolled in the histology study of azficel-T were completed by the end of July. The third treatment visits for participants enrolled in the histology study of azficel-T were completed by the end of August.
On December 20, 2010 FCSC announced that it has submitted its complete response to the Complete Response (CR) letter issued by the U.S. Food & Drug Administration (FDA) regarding the Company’s Biologics License Application (BLA) for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles.
One of the FDA requirements was to conduct a histopathological study examining skin after injections of azficel-T. The Company’s response contained data from a 29-patient blinded study (IT-H-001). FDA participated in the design of the protocol, and consented to the unblinding of the study data. At three months, there were no unexpected results, and the study provided additional data to support the safety profile seen in the clinic.
“Azficel-T was directly compared to a placebo injection as well as untreated skin in each subject. The study results were consistent with previous clinical studies, while providing a detailed examination of azficel-T activity at the microscopic level after repeated injections,” said James Merritt, M.D., Clinical Advisor to the study and Chief Medical Officer of CBR International Corp., a Colorado based research firm who provided medical advice to Fibrocell during the study. "The study met all expectations, and importantly raised no safety concerns."
According to the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem that the response from Fibrocell Science is complete. If their response is accepted, their PDUFA date will be around 6/17/2011, as they filed a response on 12/17/10 (PR was issued next business day).
So now the question is- When should they expect to hear from the FDA. The rules are different than an NDA, because this filing is a BLA (Biologics License Application). I have contacted the company, and they informed me that the standard repose time for the FDA to respond to their filing is 14 days. This timeline crossed the holidays and the new year, so as expected, the FDA is delayed. They are expecting notification from the FDA very soon.
Obviously this creates quites the catalyst for a company that has a $10M market cap.
You can see from the above chart that FCSC traded for as high as $2.40 before its FDA panel.
Fibrocell Science’s lead therapy, azficel-T, is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. Azficel-T is currently under review by the U.S. Food & Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. Also, the Company recently submitted a clinical study report to the FDA for a Phase II/III trial of azficel-T in acne scarring.
As of November 12, 2010, the Company had cash and cash equivalents of approximately $0.2 million and liabilities of approximately $1.6 million. This obvious makes it clear that FCSC has a high risk for dilution before its expected PDUFA date of 6/17/11. Keep this mind when taking a position.
Fibrocell was formerly known as Isolagen, a company which went bankrupt in June of 2009 (link). Obviously Fibrocell has a lot riding on this BLA resubmission and its potential PDUFA date.
When I contacted the company today I was told that they expected to hear back from the FDA within 14 days of their submission, and that this was standard procedure for BLA CRL resubmission. I have been trying to find this documented as a procedure, but I have been unable to do so. However, I did find a previous example that seems to support this 14 day turnaround.
On 12/2/09 DNDN resubmitted their BLA after a CRL (link). On 12/20/09 they announced that the FDA had accepted their resubmission (link) and granted them a PDUFA date of May 1st, 2010, which was the standard 6 month review for a Class 2 submission.
Also SVNT resubmitted a BLA on 3/15/2010 (link) and they were notified of acceptance on 3/30/2010 (link).
This all lines up with what I was told by FCSC, and so we should expect to hear a response from the FDA soon.