CHMP recommends approval of Oczyesa® for treatment of acromegaly in the EU
Positive Opinion for Oczyesa: The European Medicines Agency's CHMP has given a positive recommendation for the market authorization of Oczyesa (octreotide subcutaneous depot) for maintaining treatment in adult acromegaly patients who have responded to somatostatin analogues.
Clinical Program Success: Oczyesa demonstrated significant improvements in IGF-1 levels, symptom control, and quality of life over 52 weeks in clinical trials, with a final decision on marketing authorization expected from the European Commission in mid-2025.
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Camurus announces favorable topline findings for CAM2056, a monthly depot formulation of semaglutide.
CAM2056 Efficacy: CAM2056 demonstrated a 9.3% weight reduction and significant A1c improvements, comparable to or exceeding the results of weekly semaglutide (Wegovy®), with a notable treatment difference of -4.1% in weight loss by Day 85.
Safety and Tolerability: The safety profile of CAM2056 was favorable, with mild to moderate gastrointestinal adverse events being the most common, and overall tolerability consistent with that of weekly semaglutide, despite higher initial doses.
Dosing Convenience: CAM2056 allows for monthly dosing with rapid initiation through biweekly doses, potentially improving patient adherence compared to weekly semaglutide.
Future Studies: Camurus plans to conduct a Phase 2b trial in 2026 to further evaluate CAM2056, focusing on longer treatment durations and higher doses.
Camurus Receives UK Approval for Oczyesa® to Treat Acromegaly
Approval Announcement: Camurus has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Oczyesa®, a once-monthly subcutaneous octreotide treatment for adult patients with acromegaly.
Clinical Efficacy: The approval is based on results from a comprehensive clinical program, including two Phase 3 studies, demonstrating effective control of acromegaly and improved patient quality of life.
Self-Administration Feature: Oczyesa® can be self-administered using a pre-filled autoinjector pen, making it convenient for patients to manage their treatment at home.
Future Developments: Camurus plans to launch Oczyesa® in the UK in the fourth quarter of 2025 and is also developing CAM2029 for other severe diseases, including gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.
Camurus' Oczyesa® receives marketing authorization for treatment of acromegaly in the EU
New Treatment Approval: The European Commission has granted marketing authorization for Oczyesa®, a once-monthly subcutaneous octreotide treatment for adults with acromegaly who have previously responded to somatostatin analogs, marking it as the first of its kind for this condition.
Clinical Benefits: Clinical trials indicate that Oczyesa® provides effective disease control, improves symptoms and quality of life, and allows for convenient self-administration using a pre-filled autoinjector pen.
Camurus' POSITANO study shows treatment effects with CAM2029 in polycystic liver disease patients
CAM2029 Study Results: The Phase 2b POSITANO study demonstrated that CAM2029 significantly reduces liver and cyst volume in patients with symptomatic polycystic liver disease (PLD) compared to placebo, while also improving symptoms.
Safety and Future Plans: CAM2029 was well tolerated with no new safety concerns, and Camurus plans to discuss a follow-up Phase 3 study with regulatory authorities in the US and Europe.
Eli Lilly Strikes $870 Million Deal to Develop Long-Acting Obesity Treatments
Collaboration Agreement: Eli Lilly & Co. has partnered with Swedish company Camurus to develop long-acting obesity treatments, valued at $870 million, utilizing Camurus’ drug delivery technology to enhance weight-loss medications like Zepbound.
Market Outlook: The collaboration aims to meet the growing demand for obesity medications by potentially offering less frequent dosing schedules, while Eli Lilly's stock holds a Strong Buy recommendation from analysts, indicating positive market sentiment.
Camurus and Lilly enter collaboration and license agreement for long-acting FluidCrystal® incretins
Collaboration Agreement: Camurus and Eli Lilly have formed a partnership to develop long-acting incretin therapies for cardiometabolic health using Camurus' FluidCrystal technology, with potential payments totaling up to $870 million for Camurus.
FluidCrystal Technology: This proprietary technology allows for the extended release of drugs through a single injection, transforming into a gel upon contact with bodily fluids, and is already validated by market approvals in multiple regions.
Camurus announces favorable topline findings for CAM2056, a monthly depot formulation of semaglutide.
CAM2056 Efficacy: CAM2056 demonstrated a 9.3% weight reduction and significant A1c improvements, comparable to or exceeding the results of weekly semaglutide (Wegovy®), with a notable treatment difference of -4.1% in weight loss by Day 85.
Safety and Tolerability: The safety profile of CAM2056 was favorable, with mild to moderate gastrointestinal adverse events being the most common, and overall tolerability consistent with that of weekly semaglutide, despite higher initial doses.
Dosing Convenience: CAM2056 allows for monthly dosing with rapid initiation through biweekly doses, potentially improving patient adherence compared to weekly semaglutide.
Future Studies: Camurus plans to conduct a Phase 2b trial in 2026 to further evaluate CAM2056, focusing on longer treatment durations and higher doses.
Camurus Receives UK Approval for Oczyesa® to Treat Acromegaly
Approval Announcement: Camurus has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Oczyesa®, a once-monthly subcutaneous octreotide treatment for adult patients with acromegaly.
Clinical Efficacy: The approval is based on results from a comprehensive clinical program, including two Phase 3 studies, demonstrating effective control of acromegaly and improved patient quality of life.
Self-Administration Feature: Oczyesa® can be self-administered using a pre-filled autoinjector pen, making it convenient for patients to manage their treatment at home.
Future Developments: Camurus plans to launch Oczyesa® in the UK in the fourth quarter of 2025 and is also developing CAM2029 for other severe diseases, including gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.
Camurus' Oczyesa® receives marketing authorization for treatment of acromegaly in the EU
New Treatment Approval: The European Commission has granted marketing authorization for Oczyesa®, a once-monthly subcutaneous octreotide treatment for adults with acromegaly who have previously responded to somatostatin analogs, marking it as the first of its kind for this condition.
Clinical Benefits: Clinical trials indicate that Oczyesa® provides effective disease control, improves symptoms and quality of life, and allows for convenient self-administration using a pre-filled autoinjector pen.
Camurus' POSITANO study shows treatment effects with CAM2029 in polycystic liver disease patients
CAM2029 Study Results: The Phase 2b POSITANO study demonstrated that CAM2029 significantly reduces liver and cyst volume in patients with symptomatic polycystic liver disease (PLD) compared to placebo, while also improving symptoms.
Safety and Future Plans: CAM2029 was well tolerated with no new safety concerns, and Camurus plans to discuss a follow-up Phase 3 study with regulatory authorities in the US and Europe.
Eli Lilly Strikes $870 Million Deal to Develop Long-Acting Obesity Treatments
Collaboration Agreement: Eli Lilly & Co. has partnered with Swedish company Camurus to develop long-acting obesity treatments, valued at $870 million, utilizing Camurus’ drug delivery technology to enhance weight-loss medications like Zepbound.
Market Outlook: The collaboration aims to meet the growing demand for obesity medications by potentially offering less frequent dosing schedules, while Eli Lilly's stock holds a Strong Buy recommendation from analysts, indicating positive market sentiment.
Camurus and Lilly enter collaboration and license agreement for long-acting FluidCrystal® incretins
Collaboration Agreement: Camurus and Eli Lilly have formed a partnership to develop long-acting incretin therapies for cardiometabolic health using Camurus' FluidCrystal technology, with potential payments totaling up to $870 million for Camurus.
FluidCrystal Technology: This proprietary technology allows for the extended release of drugs through a single injection, transforming into a gel upon contact with bodily fluids, and is already validated by market approvals in multiple regions.
