Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

CASI in 2018 - What I’m hoping to hear.
1) Significant progress on Evomela status. It’s received a Priority review from the China FDA. It’s considered an unmet medical need since there isn’t any melphalan formulation available in China. When they discuss Marqibo and Zevalin which don’t have Priority review, there is a lot more hoops that they have to jump through such as running confirmatory trials that won’t start till probably 6 -18 months from now. None of that with Evomela. Here’s what CASIs CEO had to say about Evomela in a PR from Dec 2016

Ken Ren, Ph.D, CASI's Chief Executive Officer, commented, "Multiple myeloma is the second most common malignancy in blood cancers, often occurring in elderly patients. There were more than 12,000 new cases and more than 9,000 deaths from multiple myeloma in China in 2015. With the aging of China's population, the number of new cases is rapidly rising. Melphalan is extensively used worldwide in the treatment of multiple myeloma and is the main drug in pre-transplant conditioning therapy. Melphalan, however, is not currently commercially available in China. EVOMELA, an innovative and proprietary new formulation of melphalan, offers significant advantage in that it (i) does not contain propylene glycol which causes significant side effects; (ii) has longer stability; and (iii) is the only intravenous melphalan product approved for use in the high-dose conditioning indication. We look forward to working with the CFDA to advance EVOMELA towards market approval."

2) Revenue from Zevalin sales in Hong Kong? Geez, when is that going to happen? They’d PRd in July 2015 that they were going to start selling Zev there but no income yet. It’s a small market and sales won’t be meaningful but it would be nice to see.

3) Potential efficacy updates on 1) ENMD-2076 in triple negative breast cancer where there is an ongoing, not recruiting, trial of 41 pts (additionally they have a P1/2a trial in China that they are recruiting) and 2) ENMD-2076 in fibrolamellar carcinoma (FLC). I’m not expecting anything from these studies so any positives would be a nice surprise.

CASI market cap has went from under 50M to what it is now, $244M in about a years time. Being that Spectrum owns ~20% of the company that can only be a positive for Spectrum’s balance sheet. But what really intrigues me from all this is how soon will and what will Evomela’s approval do to CASIs MC, and subsequently, SPPIs Balance sheet.