By Terry Chrisomalis
Oncolytics Biotech, Inc. (USA)
On July 6, 2015 shares of Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY) went up approximately 17% after the company reported positive phase 2 results in patients with pancreatic cancer. The study known as REO 017 recruited up to 34 patients to determine if the company’s drug REOLYSIN would be able to improve upon the clinical benefit rate — CBR — and the progression-free survival — PFS — rate in patients with pancreatic cancer.
Although one thing to note was that the company wasn’t comparing the arm of the study to a placebo compound. Instead Oncolytics gave patients their drug REOLYSIN in combination with gemcitabine — a typical chemotherapy drug given to patients with pancreatic cancer as standard of care. These patients in the study were known what is called “chemotherapy naive”, meaning that these patients have previously not been treated with standard of care chemotherapy prior to being treated with drug in this trial.
Even though the trial enrolled 34 patients the results that were presented only showed 29 of the patients that were available for efficacy analysis. The trial met the primary endpoint of the CBR because the rate achieved was a CBR of 83%. More specifically:
- Partial response — 1 patient
- stable disease — 23 patients
- progressive disease 5 patients
Pancreatic cancer is rough because it is typically detected only at later stages since the patient doesn’t show any symptoms until the end of tumor progression. The fact that 23 patients saw stable disease means that the cancer hadn’t grown or spread further into the body.
This brings us to the secondary endpoint of median progression-free survival — PFS. In terms of PFS, it is a measure of how long a patient lives without progressing to a later stage with their cancer prognosis. Patients who take gemcitabine alone– historical control — always see a PFS of about 3.3 months to live, but patients who took REYOLYSIN in combination with gemcitabine saw a PFS of 4 months. This secondary endpoint is not a huge difference but allowing the patient to live even one month longer with pancreatic cancer is greatly needed.
Horizon Pharma PLC & Depomed Inc
On July 7, 2015, Horizon Pharma PLC (NASDAQ:HZNP) made a proposal to buy Depomed Inc (NASDAQ:DEPO) for $29.25 per share, which is a 42% premium over the July 6, 2015 closing share price. If this deal was to go through it would be valued at a $3 billion dollar acquisition deal. In addition this deal proposed by Horizon Pharma would be an all stock type deal — no cash given. At this time this deal needed approval by the board of directors at Depomed in order to be completed.
This wasn’t the first time that Horizon Pharma attempted to buy Depomed, because its previous attempt in May of 2015 proved to be unsuccessful. With the possible successful acquisition of Depomed, Horizon would see an increase of 2015 net sales for the year. In addition Horizon would have a combined total of 13 regulatory approved drugs in its pipeline making the company that much more valuable than ever before.
Although on July 13, 2015 Depomed enacted new rules for its “shareholder rights plan” changing the bylaws so that it is not shareholder friendly. The reason the board of directors of Depomed did this was to avoid being taken over by Horizon. For instance if Horizon attempts to buy any amount of shares over 10% of Depomed it would automatically enact a “poison-pill” that would immediately dump more shares in the market. This would make it a lot harder for Horizon to attempt to takeout Depomed common shares in the open market.
Depomed has stated that this takeover offer severely undervalues the company and that it will not want to accept the offer. Can you blame the board of directors of Depomed in doing this? After all this current offer was the same offer made back in May of 2015 that never went through. Horizon has responded back on July 13, 2015 as well stating that the board of directors of Depomed should listen to its shareholders who are happy with the takeover offer. Depomed for now continues its stance of fending off Horizon Pharma’s offer as it believes it should be valued much higher than the $29.25 per share offer made by Horizon.
Celgene Corporation & Epizyme Inc
On July 9, 2015, Epizyme had announced that it had extended a previous agreement that it made with Celgene Corporation (NASDAQ:CELG) to collaborate on several rare cancer therapies. With this new extension now the collaboration program will be extended for an additional three years. Celgene will have the option to license three pre-determined HRT inhibitors as they pass through the clinic.
Epizyme’s platform is known as “Epigenetics” and the technology is quite adaptive. That’s because the Epigenetics platform adjusts to each rare cancer by being able to modify a different approach of treatment for each. This technology platform itself doesn’t change any of the genes of the disease, instead is controls the way these genes are expressed in the body.
Epizyme with this new agreement will now have appropriate cash levels to run the company all the way up to the 2nd quarter of 2017.
The revised terms of the Epizyme and Celgene deal can be seen by the original press release shown here and below: Epizyme Announces Extension Of Celgene Research Collaboration
Under the terms of the revised agreement:
- Epizyme will receive a $10 million extension fee from Celgene in return for an option to individually license global rights for two of the targets and ex-US rights for the third target.
- Celgene may exercise its option with respect to each of the targets at the time of the IND filing for an additional pre-specified license payment.
- Epizyme will be responsible for leading and funding development for each target candidate through phase 1 clinical trials.
- Following the completion of phase 1, if Celgene chooses to continue its license for a specific target, it may do so by making an additional pre-specified payment.
- Epizyme may earn total potential milestones of up to $610 million on the three targets, including up to $75 million in development milestones and license fees, $365 million in regulatory milestones, and $170 million in sales milestones
- Epizyme also may earn a royalty of up to a low double-digit percentage on worldwide net sales for two of the product candidates, and on ex-US net sales for the third product candidate.
- Epizyme will retain global rights to the remainder of its pipeline, as Celgene’s option to license ex-US rights for any other preclinical programs will terminate.”
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