Titan Pharmaceuticals Inc (TTNP)

[TRUISM]

TTNP: PROBUPHINE LICENSING: EU & AUSTRALIA IN THE WORKS
By John Vandermosten, CFA-08/24/2016
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During a recent call with Titan Pharmaceuticals (NASDAQ:TTNP), we spoke with CEO Sunil Bhonsle and discussed the company’s current efforts to license Probuphine outside of the US and Canada. As we have previously written, Titan and partner Braeburn Pharmaceuticals (Private) received FDA approval for the drug in late May.

Braeburn is responsible for the manufacture and marketing of the drug, and was able to rapidly fill the pipeline and train a substantial number of providers to perform the implantation procedure in the first several weeks following the nod from the FDA. Within a month, Braeburn made the first sales of Probuphine and Titan began to receive royalties.

Titan licensed to Braeburn the rights to sell Probuphine in the United States and Canada, retaining rights to sell the drug in the rest of the world. Currently, Titan is seeking a meeting with the European Medicines Agency (EMA) to determine what data and efforts are required to gain approval.

The company is employing the services of a consultant and using its internal resources to identify the most efficient route to gain the agency’s assent and to find an appropriate partner to conduct training, marketing and sales. Currently, Titan expects to meet with the EMA sometime in the fourth quarter.

In Titan’ previous meetings with the EMA, the agency was focused on reviewing new chemical entities through the centralized process, suggesting that the company would need to seek approval country by country for Probuphine. However, the EMA recently decided that they will review the buprenorphine implant, reducing the time and effort required to gain approval in the largest remaining market.

As part of the preparation process to meet with the EMA, Titan has been developing a package of data that is required for the EMA’s scientific review. The fourth quarter meeting with the EMA is expected to provide clear guidance on Probuphine’s best pathway to approval.

Australia is another attractive market as the drug substance in Probuphine has been approved by the Australian Therapeutic Goods Administration (TGA) and buprenorphine is used in the country for heroin dependence. Titan is currently in talks with the TGA and anticipates progress in this region shortly.

Concurrent with the meetings with regulatory agencies, Titan is seeking partners and is in discussions with companies with interests in the EU, Australia and Asia. Based on the current pace, the company believes they will have a partner in place by early next year.

Using agency guidance and historical precedent we anticipate it will take approximately nine months to one year after filing to receive approval from the EMA and TGA, plus an additional six months or so in Australia to determine pricing. This timeline places first license revenues in early to mid-2018. However, the exact dates for agency submissions and partner collaborations are yet to be determined; we will provide updates as they become available.




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