It took only a few months after the dosing stages of NKTR-358 in in a Phase I trial for Eli Lilly to strike a deal worth $400 million with the ascending firm Nektar (NKTR) related to the drug. Eli Lilly seemed impressed with NeKtar’s drug, which was designed to treat autoimmune and other chronic inflammatory conditions.
NKTR-358 targets interleukin (IL-2) receptor complex. Nektar and Lilly believe the treatment will bring the immune system back into balance, thus play a unique role in treating autoimmune diseases.
What makes NKTR-358 so attractive to Eli Lilly is the drug’s ability to treat autoimmune disease symptoms without the side effects found in currently used immunosuppressant drugs. The drug is also designed to be self-administered by patients, which adds to its attractiveness.
Eli Lilly’s head of biotechnology and immunology research Thomas Bumol said the Nektar program was “an exciting addition” to the company’s immunology portfolio. Speaking of the deal for NKTR-358, Bumol said obtaining NKTR-358 is a reinforcement of the company’s commitment to continue growing its pipeline.
Nektar Chief Executive Officer Howard Robin said the deal with Eli Lilly will enable researchers to target a broad range of autoimmune disorders “in order to achieve its full potential as a first-in-class resolution therapeutic.
Earlier this month, Nektar presented preclinical data for NKTR-358 that demonstrated its effectiveness in achieving the promising T cell responses and suppressing inflammation in multiple preclinical models. Jonathan Zalevsky, who heads Nektar’s preclinical programs, said at the presentation that preclinical data showed the therapy “increases the suppressive capacity and prolongs activation and proliferation of regulatory T cells with limited effects on conventional T cells in order to address the imbalance found in many autoimmune diseases.”
The BEEF
– Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones.
– Nektar will be responsible for completing the Phase 1 trial.
– Both Eli Lilly and Nektar will conduct Phase 2 trials with Lilly assuming 75 percent of costs.
– Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis, according to the agreement. If approved for patients, Lilly will be responsible for global commercialization, but Nektar will have an option to co-promote in the U.S. under certain conditions.
Prohost Observations
Solid scientific fundamentals with state-of-the-art proprietary chemistry chemistry is a brief accurate description of Nektar added to them an extraordinary management business experience to satisfactorily and fairly complete the firm’s description.
Nektar’s science and technological capability attracted many high caliber biopharmaceutical companies, including Bristol-Myers Squibb (BMY); Eli Lilly (LLY) Daiichi Sankyo (DSKYF); Takeda Pharmaceuticals (TKPYY); and others. They also created many therapeutic products that have reached the market through partnerships with other drug marketers.
Last Week the firm announced exciting positive results from an oral Human Abuse Potential (HAP) study of its product NKTR-181. The drug is first-in-class opioid analgesic. Indeed, NKTR-181 is a new chemical entity (NCE) that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids.
NKTR-181 is the first analgesic opioid molecule to exhibit reduction in specific CNS-mediated side effects, like euphoria, through the strategic alteration of brain-entry kinetics…..
Read our article about this Nektar pain drug news posted under News & Comments on July 19, 2017 under News & Comments at the ProhostBiotech website.
The successful results of NKTR-181 rallied the stock.
It is interesting to note that the recent news announcing that the European Medicinal Agency (EMA) has given a thumb down to Nektar’s and Daiichi Sankyo’s drug Onzeald for breast cancer has not affected negatively Nektar’s stock price.
Nektar has reached a stage where investors recognized this firm’s scientific value and most importantly its pipeline products’ values. When it comes to a firm with solid fundamentals and great promising products to be approved soon for huge markets, investors do not follow negative calls without carefully evaluating the news and its impact on the firm.
NKTR is still trading around $23 with a market cap of $3.7 Billion.
* * * * * * *
INCYTE
Incyte’s (INCY) stock is down in midmorning today, losing over $2 and trading at $135.90. The reason for the decline is the news coming from Incyte and Eli Lilly ( LLY) that the resubmission to the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for baricitinib for moderate-to-severe rheumatoid arthritis (RA), will be delayed beyond 2017.
The companies will be further discussing the path forward with the agency, while evaluating options for resubmission. The length of time to a resubmission for the NDA will depend on which option the companies pursue and further FDA discussions, but is anticipated to be a minimum of 18 months.
The options include conducting an additional clinical study, as requested by the FDA. The firms, though, disagree with the FDA’s conclusions. They believe the existing comprehensive clinical data demonstrate there is a positive benefit/risk profile that supports baricitinib’s approval as a new treatment option for people suffering from RA in the United States.
Prohost Observations
We believe that neither Eli Lilly, nor Incyte will be badly hurt by the FDA decision even if they have to conduct the clinical trial demanded by the FDA. Eli Lilly is a giant pharmaceutical company and Incyte has great promising products in its rich pipeline with huge promises, including approved products and investigational partnered and non-partnered pipeline products of targeted and immunotherapeutic products. The firm seems also to be a target for acquisition by Gilead
Prohost Letter #412 Part 2 will be posted soon.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
Why Eli Lilly Wanted Nektar’s Drug NKTR-358 So Badly. Incyte’s Most Recent News
It took only a few months after the dosing stages of NKTR-358 in in a Phase I trial for Eli Lilly to strike a deal worth $400 million with the ascending firm Nektar (NKTR) related to the drug. Eli Lilly seemed impressed with NeKtar’s drug, which was designed to treat autoimmune and other chronic inflammatory conditions.
NKTR-358 targets interleukin (IL-2) receptor complex. Nektar and Lilly believe the treatment will bring the immune system back into balance, thus play a unique role in treating autoimmune diseases.
What makes NKTR-358 so attractive to Eli Lilly is the drug’s ability to treat autoimmune disease symptoms without the side effects found in currently used immunosuppressant drugs. The drug is also designed to be self-administered by patients, which adds to its attractiveness.
Eli Lilly’s head of biotechnology and immunology research Thomas Bumol said the Nektar program was “an exciting addition” to the company’s immunology portfolio. Speaking of the deal for NKTR-358, Bumol said obtaining NKTR-358 is a reinforcement of the company’s commitment to continue growing its pipeline.
Nektar Chief Executive Officer Howard Robin said the deal with Eli Lilly will enable researchers to target a broad range of autoimmune disorders “in order to achieve its full potential as a first-in-class resolution therapeutic.
Earlier this month, Nektar presented preclinical data for NKTR-358 that demonstrated its effectiveness in achieving the promising T cell responses and suppressing inflammation in multiple preclinical models. Jonathan Zalevsky, who heads Nektar’s preclinical programs, said at the presentation that preclinical data showed the therapy “increases the suppressive capacity and prolongs activation and proliferation of regulatory T cells with limited effects on conventional T cells in order to address the imbalance found in many autoimmune diseases.”
The BEEF
– Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones.
– Nektar will be responsible for completing the Phase 1 trial.
– Both Eli Lilly and Nektar will conduct Phase 2 trials with Lilly assuming 75 percent of costs.
– Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis, according to the agreement. If approved for patients, Lilly will be responsible for global commercialization, but Nektar will have an option to co-promote in the U.S. under certain conditions.
Prohost Observations
Solid scientific fundamentals with state-of-the-art proprietary chemistry chemistry is a brief accurate description of Nektar added to them an extraordinary management business experience to satisfactorily and fairly complete the firm’s description.
Nektar’s science and technological capability attracted many high caliber biopharmaceutical companies, including Bristol-Myers Squibb (BMY); Eli Lilly (LLY) Daiichi Sankyo (DSKYF); Takeda Pharmaceuticals (TKPYY); and others. They also created many therapeutic products that have reached the market through partnerships with other drug marketers.
Last Week the firm announced exciting positive results from an oral Human Abuse Potential (HAP) study of its product NKTR-181. The drug is first-in-class opioid analgesic. Indeed, NKTR-181 is a new chemical entity (NCE) that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids.
NKTR-181 is the first analgesic opioid molecule to exhibit reduction in specific CNS-mediated side effects, like euphoria, through the strategic alteration of brain-entry kinetics…..
Read our article about this Nektar pain drug news posted under News & Comments on July 19, 2017 under News & Comments at the ProhostBiotech website.
The successful results of NKTR-181 rallied the stock.
It is interesting to note that the recent news announcing that the European Medicinal Agency (EMA) has given a thumb down to Nektar’s and Daiichi Sankyo’s drug Onzeald for breast cancer has not affected negatively Nektar’s stock price.
Nektar has reached a stage where investors recognized this firm’s scientific value and most importantly its pipeline products’ values. When it comes to a firm with solid fundamentals and great promising products to be approved soon for huge markets, investors do not follow negative calls without carefully evaluating the news and its impact on the firm.
NKTR is still trading around $23 with a market cap of $3.7 Billion.
* * * * * * *
INCYTE
Incyte’s (INCY) stock is down in midmorning today, losing over $2 and trading at $135.90. The reason for the decline is the news coming from Incyte and Eli Lilly ( LLY) that the resubmission to the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for baricitinib for moderate-to-severe rheumatoid arthritis (RA), will be delayed beyond 2017.
The companies will be further discussing the path forward with the agency, while evaluating options for resubmission. The length of time to a resubmission for the NDA will depend on which option the companies pursue and further FDA discussions, but is anticipated to be a minimum of 18 months.
The options include conducting an additional clinical study, as requested by the FDA. The firms, though, disagree with the FDA’s conclusions. They believe the existing comprehensive clinical data demonstrate there is a positive benefit/risk profile that supports baricitinib’s approval as a new treatment option for people suffering from RA in the United States.
Prohost Observations
We believe that neither Eli Lilly, nor Incyte will be badly hurt by the FDA decision even if they have to conduct the clinical trial demanded by the FDA. Eli Lilly is a giant pharmaceutical company and Incyte has great promising products in its rich pipeline with huge promises, including approved products and investigational partnered and non-partnered pipeline products of targeted and immunotherapeutic products. The firm seems also to be a target for acquisition by Gilead
Prohost Letter #412 Part 2 will be posted soon.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
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