Halozyme Therapeutics Inc (HALO)

[Fred Kadiddlehopper]

Do the Mdase patents precede him? I don't think so if memory serves.

[Howeeme]

There is something to be said for hiring that person. These patents precede him.

[Fred Kadiddlehopper]

Credit goes to Mark Snyder, Esq. Helen is along for the ride.

[PioneerDimension96]

Alteogen has contracts with Sanofi, MSD, Intas, Sandoz, Daichi Sankyo and AstraZeneca. With this AstraZeneca deal, Alteogen's ALT-B4 is widely considered to have no patent risk issues. Alteogen is preparing seven to eight new license outs.

[maumar]

We can only speculate and Halo's PPS rise may be related to a potential settlement with Merck and Astra Zeneca (though the fact that Alteogen added about $1.8B in market cap today certainly suggests the market doesn't think Halo's case is strong enough to get an injunction to stop the sale of SC Keytruda) but it could also be due to the string of unexpected positive news we've had recently.

Darzalex, Phesgo and Vyvgart have all been exceeding expectations to a significant degree, HexaBody-CD38, Genmab's competitor to Darzalex, failed and clinical development ended, and Vyvgart has a few near-term catalysts. Vyvgart Hytrulo won't be another Darzalex FasPro but it is shaping up to become Halo's second best-selling product. Today JPM increased ARGX's PT to $805:

"We update our model, making 3-9% 2025-29E Revenue upgrades, driven by faster CIDP uptake. We update our estimates for faster than anticipated uptake of Vyvgart in CIDP, where ARGX reported >1,000 patients on treatment at the end of Q4’24. This drives our 3-9% increase in Product sales expectations for 2025-29E.

For FY’25, our updated Revenue forecasts are 4% ahead of Bloomberg consensus and our Operating Profit is c.30% ahead: Our updated Revenue forecasts for the year are c.4% ahead of latest BBG Consensus estimates at $3.8bn vs. Cons. at $3.65bn.

Key upcoming catalysts: (i) PDUFA for Pre-Filled Syringe for Vyvgart on April 10th, 2025, which we see driving uptake given far greater convenience with self-administration; (ii) Q1’25 results on May 8th, where we forecast product sales for Vyvgart of $826m, 8% ahead of latest BBG Cons. of $765m; and (iii) presentation of Vyvgart Phase II data for Myositis, likely at EULAR, 11-14 June, which will provide more insight into efficacy in the different subgroups including IMNM (Immune-Mediated Necrotizing Myopathy), ASyS (Antisynthetase syndrome) and DM (Dermatomyositis). We currently model Myositis as a $1.6bn peak sales opportunity, which we include at a 50% risk adjustment, though we note given similar patient numbers to MG (63k Myositis in the US, vs. 60k for MG) and with less competition, Myositis could be a multi-billion $ peak sales opportunity."

[CelestialSage6]

reply plz

[PaladinConqueror59]

These people don't know anything about patents, they're just looking at MDASE. Why didn't AZ or DAIICHI sign a MDASE contract?
If the patent is flawed, they only need to provide to halo instead of offering royalties to both companies, but why?
He closed his eyes and ears.
He's ignoring Sanofi v Amgen's case.

[CelestialSage6]

How many contracts has Halozyme had in the past few years? As far as I know, none. On the other hand, Alteogen has contracts with Daiichi Sankyo and AstraZeneca.

[Howeeme]

This is a multi billion dollar issue. No one can predict how this will go. I give credit to Helen for making it tough for Merck. Halo can easily fight at the highest level.

[Fred Kadiddlehopper]

This is what I was getting at in the post I wrote here
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175890652

[maumar]

"AZ signed the Alteogen collaboration despite an escalating patent dispute around ALT-B4, a human recombinant hyaluronidase enzyme that can enable a large volume of under-the-skin administration of drugs that are otherwise typically administered as intravenous infusions.

Halozyme, developer of rival hyaluronidase enzymes, has threatened to sue Merck & Co. over its subcutaneous Keytruda, which utilizes the Alteogen technology. The U.S. drug delivery specialist argues that ALT-B4—if used in a commercial product—would infringe on its Mdase portfolio of modified hyaluronidases. Merck plans to launch the new Keytruda formulation in the U.S. this year pending FDA approval.

Halozyme said it has reached out to Merck for a potential license agreement but is prepared to pursue an injunction against the sale of subcutaneous Keytruda through a lawsuit.

For its part, Merck has requested the U.S. Patent and Trademark Office to reconsider seven Mdase patents out of a total of about 100.

When asked whether AZ expects a similar patent dispute or a separate deal with Halozyme, an AZ spokesperson said the company cannot comment on third-party patents, and that it looks forward to working with Alteogen.

Besides Merck and AZ, Alteogen has recently teamed with Daiichi Sankyo to develop a subcutaneous version of the Japanese pharma’s antibody-drug conjugate Enhertu, which is partnered with AstraZeneca.

Daiichi declined to comment on the Merck case’s potential impact on its own Alteogen partnership.

“It is our goal to sign a license agreement with any company using our intellectual property to deliver drugs subcutaneously with a modified human hyaluronidase,” Halozyme CEO Helen Torley said in response to a Fierce Pharma inquiry last week about the Daiichi-Alteogen pact.

Apparently facing questions following Merck’s patent move, Alteogen in a November investor communication (Korean) stressed that the ALT-B4 patents are confirmed through in-depth analysis by both the company and each licensing partner via multiple patent law firms, according to a Google translation of the statement.

While patent protection for ALT-B4 is expected to expire in 2040, the Mdase portfolio of patents last until 2034 in the U.S. Different from Halozyme’s widely used Enhanze technology, which provides partners a specific hyaluronidase protein, Mdase represents a group of patents.

Halozyme’s IP is very broad, covering “every peptide which has 95% sequence identity to a modified hyaluronidase PH20 peptide,” Evercore ISI analyst Umer Raffat said in a recent note to clients.

Raffat expects that Merck and Halozyme will settle. The USPTO likely won’t give what Merck wants given the language used in Halozyme’s patents is not new, while Halozyme’s broad patent claims may be vulnerable in a lawsuit, he argued.

Back in 2023, the U.S. Supreme Court nixed Amgen’s PCSK9 patent bid against Sanofi because the subject patent was too broad. In a unanimous vote at the time, SCOTUS ruled that Amgen’s Repatha patents—which covered all antibodies that bind to particular amino acids on PCSK9—were invalid because they didn’t include a sufficient description to enable a skilled person to create the full scope of Amgen’s claims through a reasonable degree of experimentation.

“[S]uch written description/enablement for [Halozyme]’s broad patent would have to be established in conjunction with functional limitations limits (e.g., “increased hyaluronidase activity”)—and there’s already evidence that perhaps up to 87% of PH20 sequences potentially covered by [Halozyme]’s new IP have Less activity than unedited PH20,” Raffat noted as a potential problem for Halozyme."

https://www.fiercepharma.com/pharma/astrazeneca-signs-135b-alteogen-deal-subcutaneous-cancer-drugs-despite-merck-halozyme-patent

[biotechinvestor1]

Agreed. This is why most people think Merck will license MDASE from halo.

[Hope/Misery]

I think time is more of an issue than anything else Merck is looking at. Time is the big killer in the Pharma game. Merck has to protect a Market share they admit can be converted 40% in the first 12 to 18 months. Not to mention a Opdivo -Yervo sub q combination coming right on the heals of Optivo sub q hitting the market before they can even get out of the gate. What do you do? Especially when 40% of your bottom line is a product you can ill afford to be even cut in half in sales. Bristol beat them to market with Opdivo and then lost out to Keytruda, something that should not happen in this industry. First to market always wins. It will be interesting if Merck starts a add campaign for sub q Keytruda. They advertise like crazy Keytruda if they do not it could be a tell.

[biotechinvestor1]

Evercore ISI analyst Umer Raffat said in recent note to clients that he expects Merck and Halozyme will settle.

[biotechinvestor1]

.... 

[biotechinvestor1]

... BTW, that's not my opinion alone. 

[biotechinvestor1]

... having said this, if I were Merck, I would negotiate something with Helen now as opposed to waiting until the June US patent decision. The reason is simple. After a rejection from the US patent office, Merck's negotiating position will be significantly weakend. All those who have reviewed the Merck's petition and Halo's response opined that Halo's arguments are more compelling. Merck will likely (if they are smart) reach an agreement with Halo before June. That's what the market participants are sniffing out now. 

[biotechinvestor1]

I agree

[biotecholdguy]

One more question:
Greg Frost sold Merck a sample for testing over ten years ago (15, maybe) for their testing. Date please?
Alteogen (Company) started in South Korea, when? Date please?
(more than curious!)

[maumar]

Unfortunately, it appears that Morgan Stanley has not consulted any patent lawyers in regards to the Merck/Halozyme dispute. I agree that the risk is asymmetrically skewed to Halo's upside but I'm not sure it's insignificant in terms of Halo's standing, though it poses minimal or no risk to halo's current royalty stream. From a note dated March 9:

Updating/clarifying our thinking on latest patent newsflow

Key takeaways
Merck challenging just 7 of a broad set of HALO's MDASE patents which are seperate from HALO's ENHANZE patent family.
HALO does not currently generate any royalties from the MDASE patents.
We believe this situation poses minimal risk to HALO's current royalty stream and risk is asymmetrically skewed to HALO's upside.

A patent dispute has arisen between Halozyme and Merck related to Merck's development of a new subcutaneous injectable version of its cancer drug, Keytruda. This formulation was developed with Alteogen, not Halozyme ( here ).

We had previously written, "If Merck's challenge prevails, Halozyme might lose out on potential income and therefore raise concerns over the validity/defensibility of HALO's subQ co-formulation patents." We wish to clarify this statement. HALO has distinct and separate patent families MDASE and ENHANZE. We note that Merck is challenging just 7 of a broad set of MDASE patents, and any outcome would have no impact on the ENHANZE composition of matter or coformulation patents (even if Merck were to be successful in their challenge of the MDASE patents). Furthermore, we note: i) HALO currently does not generate any royalties from the MDASE patents; ii) All of HALO's current royalties come from the ENHANZE patents; iii) There may be only one other company (Daiichi Sankyo) developing a subcutaneous drug that might infringe on HALO's MDASE patents. As such, the risk here may be asymmetrically skewed to the upside for HALO in this particular patent situation.

The authors of this material are not acting in the capacity of attorneys, nor do they hold themselves out to be acting as such. This material is not intended as either a legal opinion or legal advice. The information provided herein does not provide all possible outcomes or the probabilities of any outcomes. The result of any legal dispute or controversy is dependent on a variety of factors, including but not limited to, the parties' historical relationship, laws pertaining to the case, relative litigation talent, trial location, jury composition, and judge composition. Investors should contact their legal advisor about any issue of law relating to the subject matter of this material.

[Fred Kadiddlehopper]

Ok, that is the date I was referring to. So it does seem that if the hearing officer or ALJ decides Merck has not stated a case to support the revocation, the matter will take a huge step in HALO's favor.

[biotechinvestor1]

No, that date in June is for the the US patent office to decide if they would even consider the petition from Merck on revoking 7 out of the 100+ MDASE patent. There is no court dates or deadlines, simply because halozyme has not filed anything against Merck yet. If US patent office denies Merck's petition and Merck decides not to license MDASE from Halo, then Halo will take action. NO LEGAL ACTAION has been initiated from halo yet.

[Fred Kadiddlehopper]

I think there might be a key date in June when the hearing officer or such decides if the case has enough merit to continue, kind of like a summary judgement. Not sure I heard this correctly but that is my impression.
Anybody?

[Howeeme]

They’re not going to hand over a billion dollars without a fight. If halo is successful at an injunction we’ll get a settlement.

[biotecholdguy]

Just ask the judge which one they'd rather have injected into THEM.

[biotechinvestor1]

Nonsense. For a company the size a Merck, market share and timing is far important than some royalties which is small potatoes for them. 
Litigation could take a long time, and in the meantime, a judge can easily put a hold on  Kaytruda subcutaneous until the case is decided. Exactly what Mark Snyder said at the investor conference i.e. Halowill seek and judge injunction to delay the launch of keytruda sc. This will delay Merck's competitive positioning against Bristol Myeres opdivo subcutaneous. Merck will gladly pay to keep its market share.

[Howeeme]

Next 6 months. And I’m no expert.

[Howeeme]

Next 6 months. And I’m no expert.

[biotecholdguy]

When do you experts think this is to be litigated & decided? Have a date?

[Howeeme]

In 20 years that I’ve held halo the only news that has leaked was evotec done by their advisors to tank the deal. There are no rumors just speculation about Merck. They are 30x the size of halo and won’t just back off. Fortunately halo can afford millions of legal fees to fight this. If you think they are just going to pay royalties without a fight you are in fantasyland.

[biotechinvestor1]

Halo is in "break out" mode!

[Fred Kadiddlehopper]

Or for today at least, the XBI is up 1.7% and so is HALO up the same.

[biotechinvestor1]

Dumb Siri dictation. Thx for correction

[Fred Kadiddlehopper]

Also could be buy the rumor, sell the news.

[biotechinvestor1]

I'm sure you have heard of "by the rumor, sell the news." Markets can anticipate in advance.

[Howeeme]

I think the stock is trading as if bets are being placed. If the deal with Merck was settled the stock would be way higher.

[biotechinvestor1]

Correction: 

[biotechinvestor1]

Halozyme has been and is trading as if it knows that Halozyme and Merck have already reached an licensing agreement.

[biotechinvestor1]

I agree that it is possible that astrzenca signed this deal with Alreogen but will never nominate a candidate or enter any trials just like Pfizer, Abbvie and Lilly did with halozyme but never move any products forward. 
The real bottom line is that any reasonable person looking at the the patent disagreement with Merck and reading their filiny has opined in favor of Halozyme. Look at the WSJ, Barons, Cowen's and Morgan Stanley (I tried to paste they opinion on this board but it does't let me). Read tge filings that I posted on this board for yourself or have any AI platform summerize them for you. You will see that halo has a far stronger position. Don't take my words for it. Read the references or look at how the market participants have voted with their money so far.

[biotechinvestor1]

... 

[biotechinvestor1]

.... one more source you should read:

[Howeeme]

Bottom line is that we have a competitor.

We need to resolve Merck patent litigation before we know how strong the patents truly are.

We need to see some action on new deals AI related or not.

There are plenty of fish in the sea for conversion to sub q so having one competitor is probably not as big a deal as it may seem now.

Competition may be way off in the distance as candidates need to go to the clinic before they have 5 years to market. Azn has to name the candidates before that even starts. Could takes years for that to even happen.

[biotechinvestor1]

XBI is in the red and halozyme just turned green deapite this Alteogen/Astrazeneca news which in my view should have been a 5-10% negative impact to halo share price. It's clear that market partcipants are seeing through the headline and have a strong coviction that MDASE patent portfolio is compelling and will prevail. 

[biotecholdguy]

Not being a moderator.

[Fred Kadiddlehopper]

One thing that is not confusing is that Helen is striking out at every at bat.

[biotechinvestor1]

Who said they are US investors?

[maumar]

Astra Zeneca is clearly not afraid of being sued by Halo and Alteogen is up 12%, close to all time highs. It's rather confusing but something other than SC keytruda may be behind Halo's recent stock action. By the way, as far as I know it is almost impossible for US based investors to buy Alteogen's shares.

[biotechinvestor1]

This is a second time in past several month when we notice an influx of Alteogen investors on this board. Last time they showed up, halozyme had a big run up. Don't be surprised if history repeats itself.

[biotechinvestor1]

Read the WSJ article and others' on this matter. Read the Merck petition and Haozyme's response. Upload their filings on ChatGPT or ask a patent attorney you know. They all favor halozyme odds at prevailing. 

[PaladinConqueror59]

He believes he is smarter than AZ's competent patent legal team lol