Fred Kadiddlehopper
9時間前
European Commission Approves Subcutaneous RYBREVANT® (amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer
April 07 2025 - 9:29AM
https://ih.advfn.com/stock-market/NASDAQ/halozyme-therapeutics-HALO/stock-news/95796122/european-commission-approves-subcutaneous-rybrevan
PR Newswire (US)
SAN DIEGO, April 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. Additionally, it is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy.
Subcutaneous amivantamab is co-formulated Halozyme's ENHANZE® drug delivery technology.
"We are delighted to announce the European approval of the subcutaneous formulation of amivantamab, developed using our innovative ENHANZE drug delivery technology. This marks our tenth approved partner product," said Dr. Helen Torley, President and CEO of Halozyme. "The data supporting this approval showed a reduced administration time and decrease in infusion-related reactions, which could have a positive impact on the healthcare system."
The EC approval is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For detailed information on the study and its findings, please refer to Johnson & Johnson's press release issued today.1
1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in nine commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
biotechinvestor1
4日前
It might be good for you to educate yourself a bit before making such absolute forecasts.
Here are some examples of patent disputes in the pharmaceutical industry where one company acquired its opponent, showcasing how such conflicts can lead to strategic acquisitions:
1. **Pfizer and Wyeth** - **Dispute**: Pfizer and Wyeth had overlapping interests and competitive tensions in the pharmaceutical market, particularly around blockbuster drugs like Lipitor (Pfizer) and Effexor (Wyeth). While not always directly litigating over patents, their rivalry included intellectual property skirmishes related to drug formulations and market exclusivity. - **Acquisition**: In 2009, Pfizer acquired Wyeth for $68 billion. This move came as Pfizer faced the looming patent expiration of Lipitor, its top-selling cholesterol drug. By acquiring Wyeth, Pfizer gained access to Wyeth’s patent portfolio, including vaccines like Prevnar, neutralizing potential disputes and diversifying its revenue stream ahead of generic competition.
2. **Sanofi and Genzyme** - **Dispute**: Sanofi and Genzyme were entangled in patent-related competition over rare disease treatments, notably enzyme replacement therapies. Genzyme held key patents for drugs like Cerezyme (for Gaucher disease), and Sanofi, seeking to expand into the lucrative rare disease market, faced potential IP conflicts. - **Acquisition**: In 2011, Sanofi acquired Genzyme for $20.1 billion after a contentious negotiation. The acquisition resolved any brewing patent disputes by bringing Genzyme’s IP, including patents for orphan drugs, under Sanofi’s control, strengthening its position in biotechnology and specialty pharmaceuticals.
3. **Gilead Sciences and Pharmasset** - **Dispute**: Pharmasset developed sofosbuvir, a groundbreaking hepatitis C drug, and held critical patents that Gilead needed to dominate the antiviral market. Prior to the acquisition, there was potential for patent disputes as Gilead worked on similar compounds, risking infringement or licensing battles. - **Acquisition**: In 2012, Gilead acquired Pharmasset for $11 billion. This acquisition preempted any patent litigation by securing Pharmasset’s IP, including sofosbuvir (later marketed as Sovaldi), which became a multi-billion-dollar drug and solidified Gilead’s leadership in hepatitis C treatments.
4. **Merck and Schering-Plough** - **Dispute**: Merck and Schering-Plough had a history of patent tensions, particularly over cholesterol-lowering drugs. Schering-Plough’s Zetia and Merck’s Zocor were part of a competitive landscape where patent challenges and licensing disagreements loomed as generics approached. - **Acquisition**: In 2009, Merck acquired Schering-Plough for $41 billion. The merger resolved potential patent conflicts by combining their portfolios, including the lucrative Zetia/Vytorin franchise, and allowed Merck to bolster its cardiovascular offerings while avoiding prolonged legal battles.
5. **Roche and Genentech** - **Dispute**: Before its full acquisition, Roche and Genentech had a complex relationship involving patent licensing and disputes over biotech innovations, notably around monoclonal antibodies and cancer therapies like Avastin and Herceptin. Partial ownership by Roche didn’t fully eliminate IP friction. - **Acquisition**: In 2009, Roche completed its acquisition of Genentech for $46.8 billion, having previously held a majority stake. This full takeover ended any remaining patent disputes by integrating Genentech’s extensive biotech patent portfolio, enhancing Roche’s dominance in oncology and biologics.
These cases illustrate a recurring pattern in the pharmaceutical industry: patent disputes often drive companies to acquire their rivals, securing valuable intellectual property, resolving legal uncertainties, and gaining a competitive edge in high-stakes markets.
Some more non-pharma examples:
1. **Nokia and Alcatel-Lucent** - **Background**: Nokia and Alcatel-Lucent were embroiled in multiple patent disputes over telecommunications technologies, including mobile network infrastructure and related innovations. These disputes spanned several years and involved complex intellectual property litigation across various jurisdictions. - **Acquisition**: In 2015, Nokia acquired Alcatel-Lucent for approximately $16.6 billion. The acquisition gave Nokia access to Alcatel-Lucent’s extensive patent portfolio, which included around 29,000 patents, significantly strengthening Nokia’s position in the telecommunications market. The move was seen as a way to resolve ongoing disputes and consolidate resources in a competitive industry.
2. **Google and Motorola Mobility** - **Background**: In the early 2010s, Google faced indirect patent disputes with Motorola Mobility, which was involved in litigation with competitors like Apple and Microsoft over smartphone technologies. Motorola held a valuable portfolio of patents related to mobile devices, which were critical in the escalating "smartphone patent wars." - **Acquisition**: In 2012, Google acquired Motorola Mobility for $12.5 billion. A key motivation was to gain control of Motorola’s 17,000 patents and 7,500 pending patent applications, which Google could use to defend its Android ecosystem against legal challenges from rivals. While the disputes weren’t directly between Google and Motorola, the acquisition neutralized potential conflicts and bolstered Google’s patent defenses.
4. **Microsoft and Nokia (Mobile Division)**
- **Background**: Microsoft and Nokia had a complex relationship, including patent licensing agreements and disputes related to mobile technologies. Nokia had sued various companies over patent infringements, and while Microsoft wasn’t a direct target, the broader mobile patent landscape created tensions as Microsoft developed its Windows Phone platform with Nokia as a partner. - **Acquisition**: In 2014, Microsoft acquired Nokia’s mobile phone division for $7.2 billion. This deal included a 10-year patent licensing agreement and access to Nokia’s vast patent portfolio, resolving any lingering intellectual property uncertainties and integrating Nokia’s assets into Microsoft’s mobile strategy.
5. **Broadcom and Qualcomm (Attempted Acquisition)** - **Background**: Broadcom and Qualcomm were locked in a series of patent disputes over semiconductor and wireless technologies. These disputes escalated into a hostile takeover bid when Broadcom attempted to acquire Qualcomm in 2017-2018, partly to gain control over Qualcomm’s extensive patent holdings. - **Outcome**: Although Broadcom did not succeed in acquiring Qualcomm (the deal was blocked by the U.S. government on national security grounds in 2018), this case illustrates how patent disputes can drive acquisition attempts. Had the acquisition succeeded, it would have ended their legal battles by consolidating their intellectual property under one entity.
These examples demonstrate how patent disputes can serve as a catalyst for acquisitions, allowing the acquiring company to resolve legal conflicts, secure valuable intellectual property, and strengthen its market position. In each case, the acquisition either directly or indirectly addressed the underlying patent issues by bringing the opponent’s assets under the acquiring company’s control.
maumar
6日前
"The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years,..." The article is from Seeking Alpha. This may not affect Halo, though.
"Genmab (GMAB) ADRs traded lower on Tuesday after Bernstein downgraded the Danish biotech to Underperform from Market Perform, arguing that its stock has yet to fully reflect the upcoming patent cliff for the company’s blood cancer therapy Darzalex, marketed with J&J (JNJ).
The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years, can lead to a threefold drop in GMAB’s group revenue in 2030-2040 under his base case, Bernstein analyst Justin Smith wrote.
Despite disappointing news about JNJ’s decision to opt out of HexaBody-CD38, a potential successor to Darzalex, Genmab (GMAB) shares have yet to fully discount the impact from the upcoming patent cliff, Smith added, citing his base case 2025–2029 EPS estimates for GMAB."
According to AI overview:
Darzalex (daratumumab) faces a loss of market exclusivity, with its patents expiring in 2027 in the US and 2026 in the EU, potentially leading to biosimilar competition.
Here's a more detailed breakdown:
Patent Expiration:
Darzalex's key US patents are set to expire in 2027.
The drug's patents are protected until 2026 in both the US and EU.
However, several other patents extend its exclusive protection until 2035.
Orphan Drug Exclusivity:
Darzalex has regular MP and ODE for the treatment of multiple myeloma, both of which will expire in May 2026.
Potential for Biosimilars:
The expiration of Darzalex's patents could pave the way for biosimilar versions of the drug to enter the market.
Darzalex Faspro:
Darzalex Faspro, a subcutaneous formulation of Darzalex, also has patents that are set to expire in 2035.
MysticalGladiator72
6日前
Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb received a positive CHMP opinion recommending approval for a new subcutaneous formulation of Opdivo® (nivolumab) developed with ENHANZE® technology across multiple adult solid tumor indications in the EU.
The subcutaneous formulation, which utilizes Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), would offer cancer patients a faster and more flexible treatment option. The European Commission's decision on marketing authorization is expected by June 2, 2025.
The recommendation is supported by positive Phase 3 CheckMate -67T trial results. The formulation was previously approved in the U.S. on December 27, 2024 under the brand name Opdivo Qvantig.
Halozyme's announcement of Bristol Myers Squibb receiving a positive CHMP opinion for subcutaneous Opdivo utilizing ENHANZE® technology represents a significant commercial advancement for Halozyme's drug delivery platform. This recommendation encompasses multiple solid tumor indications and builds upon the December 2024 FDA approval of Opdivo Qvantig in the U.S.
This development validates Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) platform as a facilitator for subcutaneous administration of traditionally intravenous biologics. For Halozyme, each commercial implementation of ENHANZE typically generates tiered royalties on net sales plus potential milestone payments, though specific financial terms for this particular agreement weren't disclosed.
The subcutaneous formulation offers substantial clinical advantages including reduced administration time compared to IV infusions, potentially expanding Opdivo's competitive positioning against rival checkpoint inhibitors. With European Commission approval expected by June 2, 2025, this represents a near-term potential revenue catalyst for Halozyme.
Bristol Myers Squibb's Phase 3 CheckMate -67T trial provided the efficacy and safety data supporting this recommendation, suggesting the subcutaneous formulation maintained Opdivo's therapeutic profile while offering administration benefits. For Halozyme, this advancement bolsters its technology's commercial viability in high-value oncology applications while potentially reducing healthcare resource utilization – a key selling point for future ENHANZE partnerships.
https://www.stocktitan.net/news/HALO/halozyme-announces-bristol-myers-squibb-received-positive-chmp-57liwjmgzun2.html
biotechinvestor1
1週前
AI (Grock):
"Probability Assessment:- Base Case (60%): Merck opts for a licensing deal to secure the 2026 launch and avoid risk. This assumes the PGR process or litigation threat creates enough uncertainty to favor settlement, and Halozyme offers reasonable terms. The pharma industry’s tendency to settle high-stakes disputes supports this.- Alternative Case (40%): Merck fights and wins, either invalidating the patents or proving non-infringement. This hinges on strong PGR outcomes or a favorable court ruling, bolstered by Merck’s resources and Alteogen’s enzyme differentiation.
Balancing these, I’d assign a 65% probability that Merck signs a licensing agreement with Halozyme. The edge comes from Merck’s need for speed and Halozyme’s licensing track record, though Merck’s aggressive PGR strategy introduces notable uncertainty. If the PTAB denies PGR institution (mid-2025) or Halozyme pushes hard on litigation, this could shift toward a deal; if Merck gains early wins, it might drop below 50%. For now, 65% feels like a reasoned bet on pragmatism prevailing."
Minninv
2週前
Is it strange for HALO to put out an 8-k on Friday, March 21 at 4:03 pm, after the market closed for the week, regarding the March 17 retirement of Michael LaBarre?
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) On March 17, 2025, Michael J. LaBarre, Senior Vice President, Chief Technical Officer of Halozyme Therapeutics, Inc. (the “Company”) notified the Company of his decision to retire from the Company, effective March 17, 2025. The Company thanks Mr. LaBarre for his many years of service and contributions to the Company’s ENHANZE® drug delivery technology.
Minninv
2週前
Michael LaBarre Biography and Net Worth
Chief Technical Officer of Halozyme Therapeutics
Dr. LaBarre brings to Halozyme more than 25 years of experience across all aspects of biopharmaceutical research and drug development, including strong expertise in chemistry, manufacturing, and controls (CMC), regulatory strategy and product development. Dr. LaBarre joined Halozyme in 2008 and has held leadership positions in product development, alliance management, research, and regulatory affairs during that time. He is currently responsible for providing scientific and technical leadership across all Halozyme programs and is the lead expert on Halozyme’s ENHANZE® drug delivery technology.
Prior to Halozyme, Dr. LaBarre served as Vice President of Product Development at Paramount BioSciences, LLC, where he led CMC and research efforts for the product development programs within Paramount’s portfolio companies. Prior to joining Paramount, Dr. LaBarre served from 1995 to 2006 in various research and development positions at Biogen Idec (formerly IDEC before the merger with Biogen in 2004), where he supported numerous IND and BLA submissions, including those for the commercial products RITUXAN® and ZEVALIN®. Prior to IDEC, Dr. LaBarre spent two years at Vical, Inc. and he began his career at Hybritech in San Diego in 1992. Dr. LaBarre also taught chemistry laboratory for several years as an adjunct professor at Mesa Community College early in his career.
Dr. LaBarre received his B.S. in Chemistry from Southampton College of Long Island University and his Ph.D. in Chemistry from the University of Arizona.
What is Michael J. LaBarre's net worth?
The estimated net worth of Michael J. LaBarre is at least $11.11 million as of February 27th, 2025. Dr. LaBarre owns 173,756 shares of Halozyme Therapeutics stock worth more than $11,114,303 as of March 21st. This net worth approximation does not reflect any other investments that Dr. LaBarre may own. Additionally, Dr. LaBarre receives a salary of $843,890.00 as Chief Technical Officer at Halozyme Therapeutics.Learn More about Michael J. LaBarre's net worth.
How old is Michael J. LaBarre?
Dr. LaBarre is currently 60 years old. There are 2 older executives and no younger executives at Halozyme Therapeutics. The oldest executive at Halozyme Therapeutics is Dr. Helen I. Torley M.B. Ch. B., M.R.C.P., President, CEO & Director, who is 61 years old. Learn More on Michael J. LaBarre's age.
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