After the blockade by fda of the pacritinib drug, the company experienced a collapse in the quotes and despite the fact that quotations did not benefit.
we see the good news from the release of the drug on.
- at the beginning of the year ctic had a meeting with ema to discuss the re-presentation of myelofibrosis question in europe. At the meeting it was decided to submit a new question mainly based on the persist 2 data and the 200mg formulation twice daily with patients under 100,000 platelets. In the studies presented at ash this dose has reserved many positive surprises. More survival, fewer side effects and a spleen response rate and significantly better symptoms than the 400mg formulation. Additionally, 25% of patients no longer needed transfusion. In the arm of the BAT there was jakafi that under the population of 100000 was ineffective. The demand in Europe was presented in June. In the summer of 2018 we will have the verdict. Meanwhile, Ctic is looking for a partner in Europe for marketing and developing the drug at other indications.
- One of the conditions of the drug release in January 2016 by FDA was the realization of a pac 203 study. The pac203 study is divided into 3 arms with 3 different doses of 100mg 200mg and 200m2 2 times a day. If persist 2 data will be confirmed in the provisional assessment, it is likely that the company will submit a request for expedited approval. The company thinks it has intermediate data in the first quarter of 2018.
In a recent conference ctic discussed the data regarding possible cti turnover. Billings are based not only on patients who have platelets below 100,000 but also on patients who are intolerant to jakafi and where the drug has lost its effectiveness. In all, there is a potential of 18,000 to 19,000 patients. With a potential market of about 1.3 billion. It can be estimated at a billed rate of 400million.
In recent months, following the entry into the capital of BVF(a major shareholder holding 19.99% of the company), the company has slowly transformed itself. Large shareholders are also present with Orbimed with 11.6% and NB CAPITAL always links to BVF with a 3,2%. The old manger and the White brothers were cleared. Numerous characters have come to the conception. The workforce has been reduced by 30% and a project is underway to rationalize operating costs.
Bvf is famed for betting on companies that are almost out of market failure. Buy troubled company shares and try to take control of the company by transforming them. Will he be right about ctic?
There are two more drugs in the ctic pipeline.
Pixantrone: Condensed Condensed in Europe 3 Line For Nhl has recently completed a Phase 3 study to get final approval in Europe and move its use to second line. Study data is expected in the first semester of 2018. In Europe, he has signed a pertneship with Servier. If positive, the data could also support approval in America.
Tosedostat: Various 2 phases in aml / mds.The drug is in phase 2 with several experiments that last for years of years. Having no partner and relying on sponsored studies, it is difficult to move the experiment forward in a short time. I wonder why the company did not find a partner and keep a drug blocked for years. Drug testing is also ongoing for metastatic pancreatic cancer with very interesting results.
Currently, the company is worth 140 million with a price per share of $ 3.20. Over the last few weeks, the volumes have increased considerably, leaving the price unchanged. A few days ago, an analyst set the price at $ 7.5. Is something going to happen on cti biopharma's actions?
It could be a nice bet, if approved pacritinib should not struggle to take a market with few competitors
Disclosure: I am/we are long CTIC.