Took this from another site and wanted to share. Good article about Leronlimab and near possibilities because of GILD misstep:
GILD’s $14 billion annual income stream could be in jeopardy, because they are literally one drug approval away from an armageddon they admit in their 10-K is coming. A small competitor, CytoDyn Inc. (OTCQB:CYDY), has been struggling for over a decade to get PRO 140 approved as a salvage therapy to drug resistant HIV patients. After two successful phase 3 studies (pivotal combination therapy and investigational monotherapy), they are in a position to file a BLA for combination therapy, but the real threat is that the data is so robust that it reduces the viral load to undetectable levels and keeps it there without the help of HAART, the current standard of care.
A monotherapy filing might come right after CytoDyn’s BLA submission and could eventually rewrite the current standard of care. PRO-140 is much more than a salvage drug, and the monotherapy has the potential to wipe out over half of GILD’s total income. This is a potent threat to GILD’s HIV dominance. There have been no real innovations in the HIV field since the disease has become more manageable using a cocktail of drugs known as the HAART treatment so how they deal with this impending threat is of real interest to GILD shareholders.
GILD would be silly not to buy or in-license CytoDyn’s PRO 140, should their phase 3 monotherapy be successful. With over $32 billion in cash and marketable securities this $100 million market cap, CYDY seems like a bargain. Other drug makers like GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), and Bristol-Myers Squibb (BMY) round out the top 11 drugs for HIV and are looking for cracks in GILD’s HIV franchise to exploit. They are likely meeting with CYDY in anticipation of the approval, and if they get wind of a monotherapy filing, this could spark a fight for control of the next generation of HIV treatment.
PRO 140 is a once a week injectable that could reshape the treatment of HIV and has a realistic shot at becoming the new standard of care that replaces over 20+ drugs currently being manufactured. Besides its potential dominant use in HIV, PRO 140 is a platform drug that could be used in Multiple Sclerosis and metastatic cancer.
Gilead and Glaxo’s Patent Infringement Could Dampen Sales Trajectory
ViiV Healthcare, which is owned by GSK, Pfizer (PFE), and Shionogi, filed suit against GILD and its HIV drug Biktarvy. Specifically, ViiV is claiming that they developed a novel scaffolding that eventually led to the development of a new compound, dolutegravir (DTG), in 2006. In March 2012, the USPTO issued patent 8,129, 385 (“the ‘385 patent”). This ‘385 patent led to the development of a new class of drugs, including Tivicay®, Triumeq® and Juluca®. Zachary Silbersher from Markman Advisors opined on the lawsuit and said:
Both Triumeq® and Juluca® are combination therapies that include DTG, and Juluca® recently received FDA approval as the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1). Thus, GSK and Gilead would appear to be facing off within the marketplace for HIV therapies using integrase inhibitors. GSK’s decision not to pursue an injunction against Biktarvy® thus appears based upon business reasons outside of its standing to request one in court.
GILD’s exposure appears to be financial in nature. Due to the timing of the suit which was filed almost simultaneously with the approval announcement means that past damages do not apply, just future damages, but GSK needs to prove infringement. The thing that makes this a harder case for GILD to defend against is that it’s not for a dosage or formulation but an actual compound. In the complaint, ViiV contends that GILD knew of the patent and the journal coverage of it and copied the structure in developing bictegravir.
In regards to exposure, a telling case is the 2015 patent fight between AstraZeneca (NASDAQ:AZN) and Apotex. Apotex launched a generic for Prilosec®. The court ruled Apotex was an infringer and assessed a 50% royalty rates. According to Zachary Shirbersher, some of the same facts in that case apply to the GSK lawsuit.
Regardless of who wins this war, history has taught investors an important lesson, that patent disputes tend to have a negative effect on sales. For example, in 2017 the widely anticipated launch of Regeneron’s (REGN) potential blockbuster drug Dupixent for the treatment of atopic dermatitis faced a major headwind when Amgen (AMGN) filed a patent infringement suit. Peak sales expectations of Dupixent pre-launch were $4 billion, but, last year, according to the 10-K, REGN reported annual sales of $256.5 million. In the latest quarter, Dupixent grossly missed estimates with $131 million in sales versus expectations of $167.6 million. The annualized run rate is $524 million, and they missed the estimates by 22%. BIKTARVY could suffer the same fate as Dupixent as this patent war continues. A settlement would be welcome news for GILD sharehold
GILD’s $14 billion annual income stream could be in jeopardy, because they are literally one drug approval away from an armageddon they admit in their 10-K is coming. A small competitor, CytoDyn Inc. (OTCQB:CYDY), has been struggling for over a decade to get PRO 140 approved as a salvage therapy to drug resistant HIV patients. After two successful phase 3 studies (pivotal combination therapy and investigational monotherapy), they are in a position to file a BLA for combination therapy, but the real threat is that the data is so robust that it reduces the viral load to undetectable levels and keeps it there without the help of HAART, the current standard of care.
A monotherapy filing might come right after CytoDyn’s BLA submission and could eventually rewrite the current standard of care. PRO-140 is much more than a salvage drug, and the monotherapy has the potential to wipe out over half of GILD’s total income. This is a potent threat to GILD’s HIV dominance. There have been no real innovations in the HIV field since the disease has become more manageable using a cocktail of drugs known as the HAART treatment so how they deal with this impending threat is of real interest to GILD shareholders.
GILD would be silly not to buy or in-license CytoDyn’s PRO 140, should their phase 3 monotherapy be successful. With over $32 billion in cash and marketable securities this $100 million market cap, CYDY seems like a bargain. Other drug makers like GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), and Bristol-Myers Squibb (BMY) round out the top 11 drugs for HIV and are looking for cracks in GILD’s HIV franchise to exploit. They are likely meeting with CYDY in anticipation of the approval, and if they get wind of a monotherapy filing, this could spark a fight for control of the next generation of HIV treatment.
PRO 140 is a once a week injectable that could reshape the treatment of HIV and has a realistic shot at becoming the new standard of care that replaces over 20+ drugs currently being manufactured. Besides its potential dominant use in HIV, PRO 140 is a platform drug that could be used in Multiple Sclerosis and metastatic cancer.
Gilead and Glaxo’s Patent Infringement Could Dampen Sales Trajectory
ViiV Healthcare, which is owned by GSK, Pfizer (PFE), and Shionogi, filed suit against GILD and its HIV drug Biktarvy. Specifically, ViiV is claiming that they developed a novel scaffolding that eventually led to the development of a new compound, dolutegravir (DTG), in 2006. In March 2012, the USPTO issued patent 8,129, 385 (“the ‘385 patent”). This ‘385 patent led to the development of a new class of drugs, including Tivicay®, Triumeq® and Juluca®. Zachary Silbersher from Markman Advisors opined on the lawsuit and said:
Both Triumeq® and Juluca® are combination therapies that include DTG, and Juluca® recently received FDA approval as the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1). Thus, GSK and Gilead would appear to be facing off within the marketplace for HIV therapies using integrase inhibitors. GSK’s decision not to pursue an injunction against Biktarvy® thus appears based upon business reasons outside of its standing to request one in court.
GILD’s exposure appears to be financial in nature. Due to the timing of the suit which was filed almost simultaneously with the approval announcement means that past damages do not apply, just future damages, but GSK needs to prove infringement. The thing that makes this a harder case for GILD to defend against is that it’s not for a dosage or formulation but an actual compound. In the complaint, ViiV contends that GILD knew of the patent and the journal coverage of it and copied the structure in developing bictegravir.
In regards to exposure, a telling case is the 2015 patent fight between AstraZeneca (NASDAQ:AZN) and Apotex. Apotex launched a generic for Prilosec®. The court ruled Apotex was an infringer and assessed a 50% royalty rates. According to Zachary Shirbersher, some of the same facts in that case apply to the GSK lawsuit.
Regardless of who wins this war, history has taught investors an important lesson, that patent disputes tend to have a negative effect on sales. For example, in 2017 the widely anticipated launch of Regeneron’s (REGN) potential blockbuster drug Dupixent for the treatment of atopic dermatitis faced a major headwind when Amgen (AMGN) filed a patent infringement suit. Peak sales expectations of Dupixent pre-launch were $4 billion, but, last year, according to the 10-K, REGN reported annual sales of $256.5 million. In the latest quarter, Dupixent grossly missed estimates with $131 million in sales versus expectations of $167.6 million. The annualized run rate is $524 million, and they missed the estimates by 22%. BIKTARVY could suffer the same fate as Dupixent as this patent war continues. A settlement would be welcome news for GILD sharehold
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