Leading developer of dendrimer products Starpharma Holdings Limited (ASX: SPL) shares went down by 29.643 percent on 27 December 2018 after US Food and Drug Administration (FDA) requested confirmatory clinical data for the approval VivaGel® BV which is used for the treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).
Starpharma is requesting a meeting with the FDA to discuss the data requirement, and it is very keen to secure approval as soon as possible. The company is going to discuss its next steps with its US partner, ITF Pharma, and any potential impact on its US license.
As of now, FDA has not identified any approvability issues in relation to the safety, manufacturing or quality of VivaGel® BV which is very encouraging for the company. In their advice, FDA has also acknowledged the demonstrated efficacy benefits of VivaGel® BV although they have requested confirmatory data before approval.
The CEO of Dr. Jackie Fairley said that the management of the company is very surprised and extremely disappointed with the US FDA's requirement for confirmatory data for the approval of VivaGel® BV considering the complex nature of the data provided. However, the company is greatly encouraged by the FDA’s acknowledgment of the significant unmet medical need that would be fulfilled by VivaGel®, and they have expressed a desire to work with Starpharma to secure approval to make VivaGel® BV available to women in the US as soon as possible.
Starpharma’s breakthrough product VivaGel® BV is already approved in the EU and Australia and the company is in the middle of regulatory processes for this product in other markets also which are entirely independent of FDA approval. The company has informed that the initial launches for VivaGel® BV will go forward as planned in various Mundipharma regions (including Europe) and Australia during the 1H 2019.
Aside from VivaGel® BV, the company is also going to continue to commercially exploit its broad portfolio of DEP® drugs which include DEP® docetaxel, DEP® irinotecan, DEP® cabazitaxel, and a range of other internal and partnered programs which include the novel oncology agent AZD0466, which is being developed under license by AstraZeneca.
Recently, Starpharma and ITF Pharma signed a license for the sales and marketing rights of its innovative product VivaGel® BV in the U.S. As per the terms of the License deal, besides receiving attractive tiered royalties on sales, Starpharma will also receive around AUD$142 million in regulatory approval and commercialization milestones. Initially, Starpharma will be the sole supplier of the VivaGel® BV to ITF Pharma, however, in the future, Italfarmaco may set up its own manufacturing unit after receiving the necessary approvals from US Food and Drug Administration.
In the last six months, the share price of the company decreased by 23.89 percent as on 24 December 2018. SPL’s shares traded at $0.985 with a market capitalization of circa $520.27 million as on 27 December 2018 (AEST 4:00 PM).