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Amgen’s Novel Migraine Treatment Gets Key Approval

Amgen Inc. (NASDAQ: AMGN) shares saw a nice bump after the U.S. Food and Drug Administration (FDA) on Thursday approved Aimovig (erenumab), Amgen’s preventive treatment of migraine in adults. It is the first FDA-approved preventive migraine treatment in a new class of drugs, which work by blocking the activity of calcitonin gene-related peptide, which is believed to play a critical role in migraine attacks.

Aimovig’s effectiveness in preventing migraines was evaluated in three clinical trials. The first two studies compared Aimovig to placebo in participants with a history of episodic migraine. Patients receiving Aimovig on average experienced one or two fewer monthly migraine days than those on placebo. The third study evaluated patients with a history of chronic migraine. Patients in that study treated with Aimovig averaged two and a half fewer monthly migraine days in three months than those receiving placebo.

The most common side effects that patients in the clinical trials reported were constipation and injection site reactions.

Preventive medications may be an option for around 8 million Americans suffering from migraine, Amgen said. Aimovig, which is given monthly by self-injection, will have a list price of $6,900 a year, or $575 a month, the company also said. Last week, President Donald Trump blasted drugmakers and health care middlemen for making prescription medicines unaffordable for Americans. Amgen, which will market Aimovig in partnership with Novartis A.G. (NYSE: NVS), said the drug’s price “reflects the value it brings to patients and society.”

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Eli Lilly & Co. (NYSE: LLY) are among companies developing similar treatments.

Stewart J. Tepper, MD, Professor of Neurology at the Geisel School of Medicine at Dartmouth Medical School, said:

Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine. Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success.

Shares of Amgen were up almost 2% at $177.56 in Fridays premarket, with a consensus analyst price target of $194.33 and a 52-week trading range of $152.16 to $201.23.

Novartis and Teva shares were up marginally in early indications as well.

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UBS Makes Big Health Care Swap in Top Performing Q-GARP Portfolio

Nektar Therapeutics: Substantial Unlocked Value In The NKTR-358 Franchise

In my whole life, I have known no wise people (over a broad subject matter area) who didn’t read all the time – none, zero. Youd be amazed at how much Warren reads – and at how much I read. My children laugh at me. They think Im a book with a couple of legs sticking out.

– Charlie Munger

Nektar Therapeutics (NASDAQ:NKTR) is one of the most robust growers we have encountered in all our years of analytical research: this is due to many catalysts powering the firm. One, the company inked the $1.85 billion collaborative deal with Bristol-Myers Squibb (NYSE:BMY) on February 14 for the investigation of NKTR-214 in 20 different cancer indications. Nearly two months thereafter (on April 12), the company announced the dosing of the first patient in the REVEAL trial that created substantial value to this investing thesis. Nevertheless, all recent developments are minuscule compared to what will come. In this research, well elucidate the latest catalyst to give Nektar substantial upside in the long haul.

Figure 1: Nektar stock chart (Source: StockCharts)

Fundamental Analysis

Notably, we wish to provide a brief overview of Nektar for new investors. Operating out of San Francisco, CA, the company is leveraging on its expertise in polymer chemistry to develop an extremely vast and enriched pipeline (as shown in figure 2). We explicated in the prior research:

The structural adeptness of its polymer platform enabled the company to extensively customize the therapeutic behavior of many drugs. And, the targeting of well-understood pathways maximized the chances of finding molecules that have clinically meaningful benefits. At the heart of the pipeline is NKTR-214 (a CD-122 agonist), which is the first immuno-oncology (I-O) agent to both increase tumor-infiltrating lymphocytes (TILs) and to enhance PD-1 expression in human immune cells. NKTR-214 can uniquely complement checkpoint inhibitors and other anti-cancer mechanisms. Many patients have tumors that do not express PD-L1 (in which, they receive limited benefits from the treatment with checkpoint inhibitors); hence, these patients can benefit greatly from NKTR-214. That aside, we are highly interested in NKTR-262 – a novel toll-like receptor (TLR) enhancer that stimulates the bodys innate immune (defense) response to create antigen-specific T cells to fight cancer.

Figure 2: Therapeutic pipeline (Source: Dr. Tran BioSci).

On May 8, Nektar disclosed that the company has commenced the dosing of patients afflicted by systemic lupus erythematosus (SLE) in a phase 1b clinical study assessing the efficacy and safety of NKTR-358. As the first-in-class regulatory T-cell stimulator, the said drug selectively promotes the proliferation of regulatory T-cells (T-regs) needed to ameliorate the imbalance in autoimmune diseases like SLE.

We often referred to thymus (T) cells as the generals of the immune system due to their crucial roles in fighting cancers and infectious diseases. In other words, T-cells direct the activities of other immune players. Accordingly, there are various types of T-cells. As follows, killer (CD8) T-cells are responsible for the direct destruction of tumors and viruses. CD4 (helper) T-cells are involved in the intelligence gathering and memory storage (to enable the defense system to quickly launch a massive campaign when faced by the same antigen encountered previously). As for T-regs, they modulate the activities of other T-cells. And in regulating this population of specialized cells, NKTR-358 helps to restore the aforesaid imbalance seen in autoimmune diseases.

To better appreciate the ramifications of NKTR-358, lets assess the underlying science of SLE. As an autoimmune disease, SLE occurs when the body mistakenly developed antibodies against the double-stranded deoxyribonucleic acid (DNA) and the histone proteins (used to pack those genetic materials). Consequently, the patients exhibit a plethora of symptoms affecting nearly all bodily organs. Nevertheless, the constitutional symptoms (fatigue, joint pain, fever, and night sweats) are quite common. A differentiating feature is the butterfly rash found between the nasal bridge (as depicted in figure 3). Treatment-wise, the standard of care is with a low-dose steroid (prednisone) to calm the immune system, thereby deterring it from attacking the body. Notwithstanding, prolonged steroid use leads to significant adverse effects, such as bone thinning, truncal obesity, and opportunistic infections.

Figure 3: SLE rash (Source: MedicineNet)

As alluded, NKTR-358 is uniquely special because it represents a novel and unique approach toward managing SLE that is unprecedented. By targeting the interleukin-2 (IL2) complex, NKTR-358 induces T-reqs production (to suppress other immune cells). This selectivity confers great advantages in both efficacy and safety. In preclinical studies, NKTR-358 demonstrated the stellar ability to inhibit antigen-driven inflammation in a skin hypersensitivity model. The said molecule also exhibited the ability to reduce SLE progressing in a mouse paradigm.

As regards the clinical trial mentioned, the phase 1b study is a double-blinded, randomized, placebo-controlled assessment of the efficacy and safety, pharmacokinetics, and immunological effects of multiple ascending doses of NKTR-358 in 50 patients afflicted by SLE. In addition, the decrease in SLE flare will be closely monitored. Encouraged by the recent development, the SVP in charge of NKTR-358, Dr. Brian Kotzin, expressed:

NKTR-358 has the potential to address the immune system imbalance that underlies autoimmune diseases such as lupus by driving the expansion and functional activity of Tregs to restore immune homeostasis in the body. We are excited about the start of the clinical study and the potential of NKTR-358 to provide a positive benefit for patients with SLE.

Final Remarks

Harnessing the power of the highly adaptable polymer chemistry, Nektar is galvanizing an extremely enriched and vast pipeline of potential powerful blockbusters. The recent advancement of NKTR-358 is a highly promising catalyst (because it is a novel molecule with the potential to capture the gargantuan $45.5 billion market). If the clinical outcomes in the foreseeable future are as good as we anticipated, Nektar can become an acquisition target for other large biosciences such as Gilead Sciences (NASDAQ:GILD), Novartis (NYSE:NVS), Sanofi (NYSE:SNY), Merck (NYSE:MRK), and Johnson & Johnson (NYSE:JNJ). Risk-wise, it is too early in the innovation process to come to a definitive conclusion relating to the efficacy and safety of NKTR-358. And a negative data reporting for the said drug can cause the stock to tumble 30%.

Authors Notes: Were honored that you took the time to read our market intelligence. Founded by Dr. Hung Tran, MD, MS, CNPR, (in collaborations with Analyst Vu, and other PhDs), Integrated BioSci Investing (IBI) is delivering stellar returns. To name a few, Nektar, Spectrum, Atara, and Kite procured over 343%, 128%, 227%, and 83% profits, respectively. Our secret sauce is extreme due diligence with expert data analysis. The service features a once-weekly exclusive Alpha-Intelligence article, daily analysis/consulting, and model portfolios. Of note, there is an IBI version of this article that is a higher-level intelligence with extensive details, in which we published in advanced and exclusively for our subscribers. And we invite you to subscribe to our marketplace now to lock in the current price and save money for the future.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: I like to inform our readers of Seeking Alpha’s recent policy change, in which the company implemented the paywall (not only to my articles, but to all articles that are published over 10-day). This is in place as the company is, after all, a business. And, the revenues from ads are not adequate to support the high-quality research that the company is providing. If you are a REAL-TIME FOLLOWER, you will be notified immediately of our new research for you to continue to benefit from our due diligence. You can also gain access to all of my old articles and much more by taking the 2-week FREE trial of my marketplace, Integrated BioSci Investing.

Momenta Pharmaceuticals Contemplates Its Future

After a delay in launching Glatopa 40 mg resulted in competition, Momenta Pharmaceuticals (NASDAQ:MNTA) has decided to conduct a strategic review to determine where it should put its limited cash resources — presumably partnering or selling the remaining less-important assets — making for a rather abstract first-quarterearnings update.

Momenta Pharmaceuticals results: The raw numbers

Metric

Q1 2018

Q1 2017

Year-Over-Year Change

Revenue

$4.85 million

$26.61 million

(82%)

Income from operations

($49.0 million)

($32.6 million)

N/A

Earnings per share

($0.63)

($0.46)

N/A

Data source: Momenta Pharmaceuticals.

What happened with Momenta Pharmaceuticals this quarter?
Revenue decreased year over year due to lower sales of Glatopa 20 mg, the daily version ofTeva Pharmaceutical’s(NYSE:TEVA)multiple sclerosis drug Copaxone, after Mylan (NASDAQ:MYL) got its version of the drug approved. There was also a $9.8 million deduction from the 50% partnership with Novartis (NYSE:NVS) for inventory reserves for Glatopa 40 mg, the three-times-a-week version. Despite the competition, Novartis still has 40% of the 20 mg market, but the competition has resulted in lower prices. Momenta and Mylan, which in addition to being competitors for Copaxone generics are also partners for their biosimilar program, continue their investigation into why M834, a copycat ofBristol-Myers Squibb’s Orencia, failed a phase 1 trial in November. After discussing plans with the FDA, Momenta said it’s going to run proof-of-concept studies testing M281, which lowers immunoglobulin G (IgG) levels, in two different diseases. One trial will be in a disease for which lowering IgG levels has already been shown to help patients, such as myasthenia gravis, idiopathic thrombocytopenic purpura, or pemphigus. And for the second trial, the plan is to test M281 in a disease for which there is no currently approved treatment, potentially allowing a quicker route to approval, albeit with potentially more risk.
Diagnostic form with multiple sclerosis written on it. A book, medications, and a thermometer are scattered on top.

Image source: Getty Images.

What management had to say

Craig Wheeler, Momenta’s president and CEO,explained why the biotech plans to test M281 in a disease for which the drug’s mechanism of action has already been determined to be beneficial: “Our goal is to demonstrate the potential of our molecule in an area where the target has been validated and hopefully demonstrate that our higher potency and strong safety profile translates into best-in-class efficacy.”

Wheeler also highlighted a preclinical drug, M254, with high potential that will enter phase 1 trial in the second half of the year:

In animal models, we can reproduciblydemonstrate up to 10 times the potency of IVIG [intravenous immunoglobulin]. If we can do this in humans, it will be a game-changer for the IVIG marketplace, which today is a global supply constrained market with over $4 billion in sales in autoimmune indications. IVIG in autoimmune indications is a very difficult therapy for patients, often requiring infusions over one or more days with challenging side effects. A drug with a fraction of the volume and infusion time and with the potential to dose higher for better efficacy could create meaningful value for patients and our investors.

Looking forward

Momenta plans to complete its strategic review by the end of this quarter, so investors won’t have to wait too long to see what’s on the chopping block. Once the biotech extends its cash runway, it’ll just be a waiting game as the company’s pipeline of biosimilars and proprietary drugs make it through the clinic, and hopefully on to the market in a few years.

Your Daily Pharma Scoop: Omeros Up On Update, Synergy Sales, President’s Healthcare Plans

Analysis focus: OMER

Omeros (NASDAQ:OMER) is moving towards a rolling BLA submission for OMS721. On this good news, and despite tepid Q1 results, investors are becoming increasingly bullish the stock, as seen by its sudden 23% spike on the news of the BLA submission.

OMS721 is in trials for HSCT-TMA. This indication has roughly 2000-2500 patients per year in the US. 721 is also in trials for IgAN, which we have discussed extensively in our articles. Despite competition, which details we presented in these columns earlier, theres a strong case to be made for the drug to be a billion dollar blockbuster for Omeros. For a company with a market cap of less than $1bn at present, this is a major opportunity.

However, the stock had remained depressed for a long time based on uncertainties surrounding Omidria sales. That uncertainty has now been resolved with Omidria now receiving a two-year extension on its pricing package, and this should help the market focus on Omeros pipeline, where the real value lies.

With multiple breakthrough therapy designations, fast track designations and now a clear path towards BLA submission, this may the last time we will see this stock at these low prices.

OMS721 has accelerated approval for this indication, and the FDA has asked for further characterization of patients treated with OMS721, additional information on the historical control population and an analysis plan to assess biomarker data. With accelerated approval, none of these will delay the launch of the drug. While the company will continue with confirmatory studies prior to full approval, we really do not expect these to impact the drugs progress.

Omeros also has a long tailed pipeline after OMS721. The company has access to about $145mn in cash as of now, and Omidria sales are also adding to that amount now that the pass-through status issue has been resolved. Overall, we continue to remain bullish OMER and have conservatively valued OMER at $35 based on three indications of OMS721 and Omidria.

Stocks in News: Analysis of SGYP

Synergy Pharma down 10% premarket on soft Trulance sales in Q1

Discussion: Synergy Pharma (NASDAQ:SGYP), with its best in class Trulance drug approved in CIC and IBS-C, has not managed to take off as well as it should, and we have once again the numbers to prove it. Trulance sales stood at $8.6mn, down 8.5% sequentially, however, up 16.9% sequentially if you recognize deferred sales of $2.1mn from the previous quarter. The company has been facing a so-called shareholder activism for about a month or so now; although what that will lead to, if anything, is anybodys guess. One must also consider that Ironwood, SGYPs competitor, also had a bad quarter, missing on both revenue and EPS.

Trump drug pricing plan

Discussion: President Donald Trump provided few concrete specifics in his much-anticipated speech on drug pricing plans of the new administration, somehting that had been a major part of his campaign rhetoric. But there were some interesting aspects, like the ending of the 180-day exclusivity for new generics. This will alone help stave some of the generic competition for branded drugs because generic companies will have less incentive now to race to the finishing line. On the other hand, his plan asks the FDA to accelerate approval process for generics and biosimilars. However, the market is somewhat relieved that despite the strong rhetoric on drug pricing, nothing concrete and direct has been done in that regard.

In other news

Agenus (NYSE:AGN) is down after it entered an at-the-market sales deal covering up to 20M shares.

Novartis (NYSE:NVS) Gilenya has been approved in the pediatric population for patients with relapsing multiple sclerosis who are at least 10 years old. Previously, it was approved in the U.S. for patients at least 18 years of age.

AstraZenecas (NYSE:AZN) asthma med Fasenra (benralizumab) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) failed to demonstrate a statistically valid decrease in exacerbations, the primary endpoint. There is another ongoing phase 3 trial, and the company will assess the future of the drug after receiving results from that study.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

SeekingAlpha

Rounds Report: Omeros Rallied While Stellar FDA Due Diligence To Help Atara Biotherapeutics

You need a different checklist and different mental models for different companies. I can never make it easy by saying, Here are three things. You have to derive it yourself to ingrain it in your head for the rest of your life. – Charlie Munger

Trading Analytics

Welcome to this edition of Integrated BioSci Rounds Report for May 11, 2018. As usual, well elucidate notable trading analytics for the day, recent insider transactions, and interesting market developments. Without further ado, lets take an overall assessment of the bioscience space. As follows, the iShares of NASDAQ Biotechnology Index (NASDAQ:IBB) traded up by $2.85 (+2.75%) at $106.58. Moreover, the SPDR S&P Biotech (NASDAQ:XBI) exchanged hands $2.61 higher at $91.65 (for +2.93% gains). Its likely that investors were trading with a resurged sense of optimism to close out the week with an exclamation mark. Regardless of the daily inclination, there are substantial prospects in the bioscience sector: one that delivers hope for patients while rewarding supporters with substantial wealth in the long haul.

Figure 1: Notable BioSci movers. (Source: Morningstar)

Moving to specific equities, Omeros Corporation (NASDAQ:OMER) won the highlight spot of the day. The stock traded $3.76 higher at $19.89 (for 23.31% profits). Headquartered in Seattle WA, Omeros focused on the therapeutic innovation and commercialization to service inflammation, complement-mediated diseases, and central nervous system disorder (as depicted in figure 2). Already approved, Omidria is utilized to maintain the pupil size during cataract surgery and to reduce postoperative pain.


Figure 2: Therapeutic pipeline (Source: Omeros)

Today, the company reported strong earnings for Q1 2018. Notably, Omidria is providing the cash to fund further medicinal development. And, OMS-721 (the crown jewel of the pipeline) is progressing as anticipated: the miracle drug is most likely to gain an accelerated approval and ultimately to become a powerful blockbuster.

Bioscience Catalysts

On May 11, the FDA approved the use of Novartis (NYSE:NVS)s fingolimod (Gilenya) for the treatment of relapsing multiple sclerosis (MS) in children and adolescents 10 years or older. Already commercialized to treat adults with MS, Gilenya is now available for kids and teens for the first time. Commenting on the latest development, the FDA Director of Neurology (Dr. Billy Dunn) enthused,

For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis. Multiple sclerosis can have a profound impact on a childs life. This approval represents an important and needed advance in the care of pediatric patients with multiple sclerosis.

The aforementioned catalyst provides another life-saving treatment option for these patients (as MS is a deadly disease). Despite that the therapeutic benefits far outweigh the harms, there are significant adverse effects. Of note, Gilenya and other MS drugs week to suppress the immune system by attacking key immune components, thereby leading to significant adverse effects. In contrast, Atara Biotherapeutics (NASDAQ:ATRA) is innovating a stellar molecule (ATA-188) that can circumvent the said limitations. Interestingly, ATA-188 takes a completely different approach toward MS treatment. The molecule is powering a unique and novel mechanism of action not seen thus far. Rather than attacking the immune system (which causes significant adverse effects), ATA-188 suppresses the viral elements that, in and of itself, incite the immune system to flare up in the first place. With the said industrial tailwind, Atara is most likely to experience the robust value appreciation (if it can demonstrate strong clinical outcomes for ATA-188 as we prognosticated).

Final Remarks

In all, the bioscience market enjoyed a strong rally for the day. Many equities under our coverage moved significantly further north. Due to its strong earnings, Omeros Corporation procured much profits for investors. Its highly likely that the crown jewel of the pipeline (OMS-721) to deliver highly promising clinical outcomes, to gain accelerated approval, and to ultimately procure multi-blockbuster results. Last but not least, the stellar FDA due diligence to serve as industry tailwind for Atara Biotherapeutics.

Authors Notes: Were honored that you took the time to read our market intelligence. Founded by Dr. Hung Tran, MD, MS, CNPR, (in collaborations with Analyst Vu, and other PhDs), Integrated BioSci Investing (IBI) is delivering stellar returns. To name a few, Nektar, Spectrum, Atara, and Kite procured over 322%, 138%, 205%, and 83% profits, respectively. Our secret sauce is extreme due diligence with expert data analysis. The service features a once-weekly exclusive Alpha-Intelligence article, daily analysis/consulting, and model portfolios. Of note, there is an IBI version of this article that is a higher-level intelligence with extensive details, in which we published in advanced and exclusively for our subscribers. And, we invite you to subscribe to our marketplace now to lock in the current price and save money for the future.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: I like to inform our readers of Seeking Alpha’s recent policy change, in which the company implemented the paywall (not only to my articles but to all articles that are published over 10-day). This is in place, as the company is, after all, a business. And, the revenues from ads are not adequate to support the high-quality research that the company is providing. If you are a REAL TIME FOLLOWER, you will be notified immediately of our new research for you to continue to benefit from our due diligence. You can also gain access to all of my old articles and much more by taking the 2-week FREE trial of my marketplace, Integrated BioSci Investing.

Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.