Biotech Analysis Central Pharma News: Pfizer's Unit Separation, BioCryst's Merger Collapses, Scynexis' Positive Mid …

Welcome to Biotech Analysis Central Daily News, a daily news report and analysis about what has happened lately in the biotech industry.

Pfizer Looks To Reorganize Itself Into Three Different Units

News: Recently, Pfizer (PFE) announced that it would reorganize itself into three separate units. These units will be: Innovative Medicines, Established Medicines, and Consumer Healthcare. The company is currently separated into two units which is set up as Innovative Medicines (currently housing the consumer business as well) and Essential Health (this incorporates legacy drugs like Viagra). The Consumer Healthcare consists of a lot of the over the counter products. The company stated that the effective reorganization will not take into effect until 2019.

Analysis: I believe that the biggest reason why Pfizer wanted to do this was to realize the growth trajectory of each unit as a standalone. The other reason involves the Consumer Healthcare unit itself. That’s because Pfizer has been looking to sell this unit for approximately $15 billion. Consider the notion that it also never received a satisfying offer that it could live with to sell this unit. It states that it will continue to decide the fate of this unit and ultimately make this decision sometime before the end of this year. In my opinion, I think that Pfizer could end up selling this unit if it obtains a fair offer. Of course, that if it wants to quickly unload the business unit. In that case, it may go with a lower offer.

BioCryst Drops Merger Agreement With Idera After Shareholder Revolt

News: Recently, BioCryst (BCRX) announced that it had to end the merger agreement between it and Idera Pharmaceuticals (IDRA). This year both companies had decided to merge and focus on rare diseases. The merger approval was based on the fact that the boards of both companies had approved this transaction to take place. The problem is that since the proposal was announced, shareholders of BioCryst had vehemently opposed this merger. The reason for BioCryst shareholders opposing the deal was because they felt that such a merger would undervalue the lead asset BCX7353. This lead drug is currently being tested in a phase 3 study treating patients with hereditary angiodema (HAE). HAE is a disease that causes a sudden onset of swelling and inflammation. Even though the deal fell through, BioCryst still has to pay Idera $6 million for transaction expenses.

Analysis: In my opinion, I think that BioCryst Shareholders were being to dramatic over this merger. That’s not to say that BCX7353 is not a good clinical candidate, but I think that the merger would have been better in the long run. The reason why I state that is because if BCX7353 fails, then the next most advanced candidate is in phase 2 also for HAE, but as a liquid version instead of a capsule. The way I see it is that a merger would have created a company with two phase 3 studies. The BCX7353 drugs from BioCryst and then the IMO-2125 drug from Idera in treating patients with melanoma who failed to respond to other therapies. Also, upon looking at both pipelines Idera has more candidates in phase 2 studies. I just think that both companies coming together would have been a better strategy overall. More shots on goal, would mean reduced investor risk. That would eventually lead to increased shareholder value. If the merger went through, there would have been a total of nine rare disease programs. I must state that BioCryst shareholders dropped the ball on this one for voting against the merger. Instead of looking at the whole long-term picture of the combined company, it only looked at the closest candidate BCX7353 alone. I think it was a huge mistake for BioCryst shareholders to oppose the merger.

Scynexis Antifungal Drug Passes Mid-Stage Study, Ready To Move On To Late-Stage Testing

News: Recently, Scynexis (SCYX) announced positive results from its phase 2b study treating patients with vulvovaginal candidiasis (VVC) using its candidate SCY-078. This phase 2b trial was known as the DOVE study. The study enrolled 186 patients who were given either SCY-078 or fluconazole (FLU). The primary endpoint of the study was clinical cure rate that was assessed at Day 10 Test of Cure. It was noted in the study that 14 out of 27 or 52% of the patients achieved clinical cure with the 600 mg dose of SCY-078. The standard of care FLU had a clinical cure rate of 58% or 14 out of 24 patients. However, note that this was only at Day 10. Once the patients reached the 25 day follow up visit, the results swayed in favor for SCY-078. It was noted that at the 25 day follow up visit the clinical cure rate for SCY-078 treated patients reached 70% compared to only 50% for those in the FLU arm of the study.

Analysis: This is good news for Scynexis, because it has proven SCY-078 to be superior over standard of care FLU in patients with VVC. This also confirmed the biotech’s prior positive findings in a phase 2a study in treating patients with VVC. The best part of all for obtaining positive results is because the company can now move on to initiate a phase 3 registration study. Such a study would be used to get the drug approved by the FDA. That all depends upon how well the end of phase 2 meeting goes first with the FDA in the coming months. I think the biggest reason why this news was good was because patients with VVC have limited oral treatment options. In addition, there are no approved treatments for this patient population with a recurrent form of the disease. This opens up a host of possibilities for SCY-078. The most notable long-term item being that this candidate is being explored in other fungal indications such as: Invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. I think that things can only get better for Scynexis.

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