KYNAMRO Drug Patent Profile

Which patents cover Kynamro, and what generic alternatives are available?

Kynamro is a drug marketed by Kastle Theraps Llc and is included in one NDA. There is one patent protecting this drug.

This drug has forty-five patent family members in eleven countries.

The generic ingredient in KYNAMRO is mipomersen sodium. Additional details are available on the mipomersen sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Kynamro

Kynamro was eligible for patent challenges on January 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 29, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KYNAMRO

International Patents:	45
US Patents:	1
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for KYNAMRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYNAMRO
What excipients (inactive ingredients) are in KYNAMRO?	KYNAMRO excipients list
DailyMed Link:	KYNAMRO at DailyMed

See drug prices for KYNAMRO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KYNAMRO

Constraining patent/regulatory exclusivity:

7,511,131

NDA:

203568

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for KYNAMRO

KYNAMRO is protected by one US patents.

This potential generic entry date is based on patent 7,511,131.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013		DISCN	Yes	No	7,511,131			Y

Expired US Patents for KYNAMRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013	7,407,943
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013	5,914,396
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013	7,101,993
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013	7,015,315
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013	6,451,991
Kastle Theraps Llc	KYNAMRO	mipomersen sodium	SOLUTION;SUBCUTANEOUS	203568-001	Jan 29, 2013	6,166,197

EU/EMA Drug Approvals for KYNAMRO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Genzyme Europe BV	Kynamro	mipomersen sodium	EMEA/H/C/002429 treatment of cholesterol and hypercholesterolaemia	Refused	no	no	no		2013-05-29

International Patents for KYNAMRO

See the table below for patents covering KYNAMRO around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	294811
Japan	3535519
Japan	4293636
Germany	69332206
Japan	2010193894	ANTISENSE MODULATION OF APOLIPOPROTEIN B EXPRESSION
Austria	187771

KYNAMRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: KYNAMRO

Introduction

KYNAMRO (mipomersen) is a pharmaceutical drug developed to treat homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder characterized by extremely high levels of low-density lipoprotein (LDL) cholesterol. Here, we delve into the market dynamics and financial trajectory of KYNAMRO, highlighting its development, market performance, and the financial implications for its stakeholders.

Development and Approval

KYNAMRO was developed by Ionis Pharmaceuticals (formerly known as Isis Pharmaceuticals) and initially partnered with Genzyme, a Sanofi company. The drug received FDA approval in January 2013 for the treatment of HoFH[4].

Clinical Efficacy

KYNAMRO has demonstrated significant efficacy in reducing LDL cholesterol levels. It has shown consistent and sustained LDL reductions across five randomized placebo-controlled Phase 3 clinical trials[1].

Market Launch and Initial Performance

The launch of KYNAMRO was marked by a slow start, but it showed significant quarter-over-quarter growth in 2013. To boost sales, Genzyme expanded its sales force to support the anticipated growth[4].

Competitive Landscape

KYNAMRO entered the market at the same time as its competitor, Juxtapid (lomitapide) from Aegerion Pharmaceuticals. While Juxtapid is a daily oral medication, KYNAMRO is administered via weekly injections. Despite being priced lower than Juxtapid, KYNAMRO faced challenges due to its injectable nature and associated liver toxicity warnings[4].

Marketing and Distribution

Genzyme, with its extensive experience in marketing and distributing rare-disease drugs, played a crucial role in the initial commercialization of KYNAMRO. However, the drug's slow start prompted Genzyme to increase its marketing efforts, including expanding its sales force[4].

Acquisition by Kastle Therapeutics

In May 2016, Ionis Pharmaceuticals announced the acquisition of KYNAMRO by Kastle Therapeutics. This deal included a $15 million upfront payment, a $10 million payment three years later, and up to $70 million in sales milestones. Ionis also received a 10% common equity position in Kastle's parent company and is entitled to royalties on global sales of KYNAMRO in the mid to low teens starting in 2017[1][2].

Financial Implications for Ionis Pharmaceuticals

The acquisition by Kastle Therapeutics provided Ionis with significant financial benefits. Ionis was eligible to receive up to $95 million, including the upfront and milestone payments. Additionally, Ionis retained a 10% equity stake in Kastle's parent company and will earn royalties on KYNAMRO sales. This deal was part of Ionis's broader strategy to maximize the commercial value of its drugs while focusing on its pipeline of new therapies[1][2].

Financial Performance and Milestones

Ionis Pharmaceuticals reported strong financial results in the first quarter of 2016, partly due to the KYNAMRO deal. The company was also set to earn significant revenue from other partnered programs, including milestone payments from Bayer, AstraZeneca, and Johnson & Johnson[2].

Regulatory and Post-Marketing Commitments

The FDA required healthcare providers to be certified to prescribe KYNAMRO and pharmacies to be certified to dispense it due to liver toxicity concerns. Additionally, the FDA mandated four post-marketing safety studies to monitor potential side effects, including abnormal growths observed in some clinical trial patients[4].

Market Expansion and Patient Access

Kastle Therapeutics aimed to expand the market potential of KYNAMRO by identifying new patients in the United States and pursuing marketing approvals in other countries. This strategy was designed to bring the established rare disease therapy to more patients globally[1].

Key Takeaways

• Clinical Efficacy: KYNAMRO has consistently reduced LDL cholesterol levels in clinical trials.
• Market Dynamics: The drug faced initial slow sales but showed growth after increased marketing efforts.
• Competitive Landscape: KYNAMRO competes with Juxtapid, with differences in administration and pricing.
• Acquisition: Kastle Therapeutics acquired KYNAMRO from Ionis Pharmaceuticals, providing significant financial benefits.
• Financial Trajectory: Ionis is entitled to royalties and milestone payments, enhancing its financial position.

FAQs

What is KYNAMRO used for?

KYNAMRO is used to treat homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder characterized by extremely high levels of LDL cholesterol.

Who developed KYNAMRO?

KYNAMRO was developed by Ionis Pharmaceuticals (formerly Isis Pharmaceuticals) and initially partnered with Genzyme, a Sanofi company.

What were the initial market challenges for KYNAMRO?

The initial market challenges included slow sales, competition from Juxtapid, and concerns over liver toxicity, which required certified prescribers and pharmacies.

Who acquired KYNAMRO from Ionis Pharmaceuticals?

Kastle Therapeutics acquired KYNAMRO from Ionis Pharmaceuticals in May 2016.

What financial benefits did Ionis Pharmaceuticals receive from the acquisition?

Ionis received a $15 million upfront payment, a $10 million payment three years later, up to $70 million in sales milestones, a 10% common equity position in Kastle’s parent company, and royalties on global sales of KYNAMRO.

Sources

1. Ionis Pharmaceuticals and Kastle Therapeutics Announce Acquisition of KYNAMRO. PR Newswire.
2. IONIS PHARMACEUTICALS, INC.. Ionis Pharmaceuticals.
3. United States Securities and Exchange Commission. Esperion.
4. Sanofi expands Kynamro marketing team to spark up sales. FiercePharma.
5. Isis Reports Financial Results and Highlights for Second Quarter 2013. Ionis Pharmaceuticals.